VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_14-vv-01212
Package ID: USCOURTS-cofc-1_14-vv-01212
Petitioner: Alicia Skinner-Smith
Filed: 2014-12-17
Decided: 2023-04-17
Vaccine: Tdap
Vaccination date: 2012-02-06
Condition: cellulitis
Outcome: compensated
Award amount USD: 15208

AI-assisted case summary:
Alicia Skinner-Smith filed a petition alleging that the Tdap vaccine she received on February 6, 2012, caused her to suffer an abscess, pain, and related chronic injuries. Initially, the case was dismissed by Special Master Millman for violating Section 11(a)(5)(B) of the Vaccine Act, as she determined that a prior Louisiana medical review panel proceeding constituted a pending civil action. However, this decision was reversed on review by the Court of Federal Claims, which remanded the case for further proceedings. After multiple Special Masters and extensive litigation, including expert reports and hearings, Special Master Horner issued a Ruling on Entitlement on August 15, 2022. This ruling found that the petitioner was entitled to compensation for a local cellulitis injury but not for her alleged broader chronic injury, such as Chronic Fatigue Syndrome (CFS). Subsequently, a Ruling on Damages was issued on March 22, 2023, awarding $10,125.00 for past pain and suffering and $6,000.00 for future pain and suffering related to the cellulitis, with the net present value of future pain and suffering confirmed at $5,083.00. The final decision on April 17, 2023, awarded a total lump sum of $15,208.00 to Petitioner.

Theory of causation field:
Off-Table

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_14-vv-01212-0
Date issued/filed: 2016-05-31
Pages: 4
Docket text: PUBLIC ORDER/RULING (Originally filed: 04/27/2016) regarding 45 Findings of Fact & Conclusions of Law, Scheduling Order ( Signed by Chief Special Master Nora Beth Dorsey.)(mpj) Copy to parties.
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Case 1:14-vv-01212-MBH Document 46 Filed 05/31/16 Page 1 of 4
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 14-1212V
Filed: April 27, 2016
* * * * * * * * * * * * * * * * * * * * * * * * * * * *
ALICIA SKINNER-SMITH, *
*
Petitioner * Finding of Facts; Site of Vaccination;
v. * Special Processing Unit (“SPU”)
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * * * * * * * * *
Richard Gage, Richard Gage, PC, Cheyenne, WY for petitioner.
Justine Elizabeth Walters, U.S. Department of Justice, Washington, DC, for respondent.
RULING ON FACTS1
On December 17, 2014, Alicia Skinner-Smith (“petitioner”) filed a petition for
compensation under the National Vaccine Injury Compensation Program, 42 U.S.C.
§300aa-10, §300aa-10, et seq.,2 (the “Vaccine Act” or “Program”). The petition alleges
that following the February 6, 2012 administration of her Tetanus, diphtheria, acellular
pertussis (“Tdap”) vaccination, petitioner suffered an “abscess, pain, and related
injuries.” Petition at 1, ¶4. The case was assigned to the Special Processing Unit
(“SPU”). The issue currently before the undersigned is the site of petitioner’s February
6, 2012 Tdap vaccination as the record contains conflicting evidence. After a review of
the entire record the undersigned finds petitioner received her February 6, 2012 Tdap
vaccination in the left dorsal gluteal muscle.
1 Because this unpublished ruling contains a reasoned explanation for the action in this case, the
undersigned intends to post it on the United States Court of Federal Claims' website, in accordance with
the E-Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of
Electronic Government Services). In accordance with Vaccine Rule 18(b), petitioner has 14 days to
identify and move to redact medical or other information, the disclosure of which would constitute an
unwarranted invasion of privacy. If, upon review, the undersigned agrees that the identified material fits
within this definition, the undersigned will redact such material from public access.
2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for
ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).

Case 1:14-vv-01212-MBH Document 46 Filed 05/31/16 Page 2 of 4
I. Procedural History
An initial status conference was held with the staff attorney managing this case
on January 30, 2015. During the status conference, respondent’s counsel indicated that
a discrepancy exists in the record as to the anatomical location or site of petitioner’s
February 6, 2012 Tdap vaccination. Scheduling Order, dated Feb. 2, 2015. The
undersigned notes that a contemporaneous record from Ocshner Medical Center
(“OMC”) indicates that petitioner received her vaccination in her left deltoid (Pet. Ex. 1 at
685), however in petitioner’s subsequent treatment records she indicates the
vaccination was administered in her left dorsal gluteal region (see infra at 3-4).
Thereafter, petitioner was ordered to file additional evidence regarding the site
of her vaccination. See Scheduling Orders, dated Feb. 2, 2015, March 18, 2015, and
April 23, 2015. On March 26, 2015, petitioner’s counsel filed a Memorandum Regarding
Vaccination Records (“Petitioner’s Memo” or “Pet. Memo”) and a supplemental affidavit
from petitioner. In addition to providing numerous citations in subsequent treatment
records noting her vaccination was administered in her left gluteal region, petitioner
pointed to a contemporaneous record from OMC documenting her vaccination site as
“(L)DG.” Pet. Memo, filed March 26, 2015, at 1-2. However, petitioner was unable
provide any additional evidence from OMC regarding the site of her vaccination, or the
meaning of “(L)DG,” even after attempting to obtain the information from OMC via a
subpoena. See Scheduling Order, dated July 22, 2015; Order, dated Aug. 4, 2015;
Status Report, filed Sept. 15, 2015; Status Report, filed Sept. 28, 2015; Status Report,
filed Nov. 5, 2015.
The undersigned convened a status conference on November 5, 2015 and made
the preliminary finding that petitioner’s February 6, 2012 Tdap vaccination was
administered in her left buttock based on the record as a whole and in particular the
citations referenced in Petitioner’s Memo. Scheduling Order, dated Nov. 9, 2015, at 2.
Subsequently respondent contacted the court and requested an opportunity to obtain
additional information from OMC before the undersigned issued her Fact Ruling. Id.
Thereafter, respondent served a subpoena upon OMC and obtained additional
information from the vaccine administrator. Resp. Ex. B, filed Feb. 16, 2016. OMC
consulted with the author of the note, Mary Ann Le, R.N., indicating that petitioner
received her vaccination at “(L)DG.” Ms. Le stated (L)DG is an abbreviation for “left
dorsal gluteal (muscle).”3 Resp. Ex. B at 1. Ms. Le “does not recall the treatment in
question, [and] cannot say [for certain] in what part of the patient's body the vaccine was
administered.” Id. at 2.
Respondent also filed a response to the undersigned’s preliminary findings of
fact on February 16, 2016 indicating that the issue of where petitioner received her
February 6, 2012 vaccination is now ripe for the undersigned’s ruling. Resp. Response,
filed Feb. 16, 2016, at 5. Petitioner filed no reply to respondent’s response.
3 Ms. Le indicated that “in light of other conflicting information in Ms. Skinner-Smith's chart as to the
administration route and due to the time which has elapsed since the relevant treatment, she is not
certain what she meant in this particular instance.” Resp. Ex. B at 1.
2

Case 1:14-vv-01212-MBH Document 46 Filed 05/31/16 Page 3 of 4
II. Finding of Fact
Based upon the record as a whole, and specifically the evidence described
below, the undersigned finds that the site of petitioner’s February 6, 2012 Tdap
vaccination was her left dorsal gluteal muscle.
The undersigned finds petitioner’s medical history regarding the site of her
vaccination is consistent with the following chronology and citations provided in her
medical records as set forth in Petitioner’s Memo:
February 6, 2012. Ex. 1 pg. 843. Site given (L)DG.
February 6, 2012. Ex. 1 pg. 685. Left deltoid.
February 9, 2012. Ex. 1 pg. 441. “She complains of left hip pain and lower
back pain after getting a tetanus injection in her left hip.”
February 13, 2012. Ex. 1 pg. 439. “Left buttock abscess/ cellulitis that
began 1 day after receiving tetanus shot.”
February 24, 2012. Ex. 1 pg. 661. “46 y.o. female had tetanus shot in left
buttock 2/6/12 and then developed an abscess at the site.”
February 27, 2012. Ex. 1 pg. 675. “Patient received a tetanus shot in her
left buttock area on 2/6.”
February 27, 2012. Ex. 1 pg. 680. “Pt with hx of getting a t-dap on Feb 6th
because of a burn. It was given in the left buttock region.”
June 27, 2012. Ex. 1 pg. 415. “Impression: Arthralgias. Symptoms began
after tetanus shot which was associated with cellulitis of buttocks.”
August 23, 2012. Ex. 1 pg. 22. “Patient complains of intermittent pain in
her left buttocks, leg and foot since getting a tetanus injection.”
September 21, 2012. Ex. 6 pg. 1. “She dated the beginning of symptoms
to be associated with an injection of Tetanus administered in the buttock
of the left leg.”
September 21, 2012. Ex. 6 pg. 6. “She presents with leg pain and swelling
in legs after being given a tetanus injection in buttocks instead of deltoid...”
3

Case 1:14-vv-01212-MBH Document 46 Filed 05/31/16 Page 4 of 4
February 7, 2013. Ex. 3 pg. 11. “Visit for: Last year (feb.6, 2012) - see
record from Ochsner: received T-dap to left buttocks due to er visit with
burn to rt upper ext.”
July 15, 2013. Ex. 1 pg. 168. “Last February she reports having a tetanus
shot to the left gluteal region...”
Pet. Memo at 1-2.
The undersigned further finds that “(L)DG” as referenced in petitioner’s Exhibit 1
at 843, means the “left dorsal gluteal (muscle).” Resp. Ex. B at 1.
III. Discussion
After a complete review of the entire record, and in particular the evidence cited
above, the undersigned finds that preponderant evidence supports a finding that the site
of petitioner’s February 6, 2012 Tdap vaccination was her left dorsal gluteal muscle.
The undersigned makes this finding notwithstanding the single notation that petitioner
received the vaccine in her left deltoid (Ex. 1 at 685) and Ms. Le’s inability to say
definitively in what part of the body petitioner’s vaccine was administered.
IV. Conclusion
For all these reasons, the undersigned finds that the preponderance of the
evidence demonstrates Alicia Skinner-Smith’s February 6, 2012 Tdap vaccination was
administered in her left dorsal gluteal muscle.
Respondent shall file her Rule 4(c) Report by no later than June 13, 2016.
IT IS SO ORDERED.
s/ Nora Beth Dorsey
Nora Beth Dorsey
Chief Special Master
4

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DOCUMENT 2: USCOURTS-cofc-1_14-vv-01212-2
Date issued/filed: 2018-07-20
Pages: 5
Docket text: PUBLIC DECISION (Originally filed: 06/25/2018) regarding 89 DECISION of Special Master Signed by Special Master Laura D Millman. (tlf) Service on parties made.
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Case 1:14-vv-01212-MBH Document 90 Filed 07/20/18 Page 1 of 5
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 14-1212V
Filed: June 25, 2018
To Be Published
*************************************
ALICIA SKINNER-SMITH, *
*
Petitioner, *
*
Pending civil action under Section
v. *
11 of the Vaccine Act; respondent
*
moves to dismiss.
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
*************************************
Richard Gage, Cheyenne, WY, for petitioner
Justine E. Walters, Washington, DC, for respondent.
MILLMAN, Special Master
DECISION1
On December 17, 2014, petitioner filed a petition under the National Childhood Vaccine
Injury Act, 42 U.S.C. § 300aa-10–34 (2012), alleging that tetanus, diphtheria, and acellular
pertussis (“Tdap”) vaccine administered on February 6, 2012 at Ochsner Medical Center
(“OMC”) caused her sharp pain, an abscess, and numerous other problems. Pet. at ¶¶ 1 and 4.
The case was assigned to the Special Processing Unit (“SPU”). On July 5, 2016, respondent
filed his Rule 4(c) Report opposing compensation. In his Report, respondent mentioned that the
petition indicated “a medical review panel proceeding was initiated in Louisiana” in connection
with the allegations in this case; however, no documentation in connection with these
proceedings has been provided. Doc 48, at 1-2.
1 Because this unpublished decision contains a reasoned explanation for the special master’s action in this
case, the special master intends to post this unpublished decision on the United States Court of Federal
Claims’ website, in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 note (2012)
(Federal Management and Promotion of Electronic Government Services). Vaccine Rule 18(b) states
that all decisions of the special masters will be made available to the public unless they contain trade
secrets or commercial or financial information that is privileged and confidential, or medical or similar
information whose disclosure would constitute a clearly unwarranted invasion of privacy. When such a
decision is filed, petitioner has 14 days to identify and move to redact such information prior to the
document’s disclosure. If the special master, upon review, agrees that the identified material fits within
the banned categories listed above, the special master shall redact such material from public access.

Case 1:14-vv-01212-MBH Document 90 Filed 07/20/18 Page 2 of 5
On July 13, 2016, the case was reassigned to the undersigned.
On August 3, 2016, the undersigned gave petitioner until October 3, 2016 to file an
expert report. After two motions for an extension of time, petitioner filed Dr. Janine Ferrier’s
expert report on November 14, 2016.
The undersigned gave petitioner until January 13, 2017 to file a supplemental expert
report from Dr. Ferrier after a status conference on November 14, 2016 because Dr. Ferrier did
not give a basis for her conclusion that petitioner’s receipt of the Tdap vaccine caused her
condition. On January 13, 2017, petitioner filed a motion for an extension of time to file the
report by February 27, 2017, which the undersigned granted. On February 27, 2017, petitioner
asked for an extension of time and the undersigned gave her a new deadline of April 28, 2017 to
file the report. On May 3, 2017, petitioner again asked for another extension of time until June
12, 2017 to file the report, which the undersigned granted. Petitioner did not file Dr. Ferrier’s
supplemental expert report by June 12, 2017.
On June 14, 2017, the undersigned issued the first Order to Show Cause why this case
shall not be dismissed for failure to prosecute under Vaccine Rule 21(b)(1).
On July 5, 2017, petitioner’s counsel responded to the Order to Show Cause stating Dr.
Ferrier had already opined that many of petitioner’s symptoms are related to her Tdap
vaccination and petitioner was trying to work through the OMC legal department in an attempt to
secure more cooperation from petitioner’s treating doctors.
On July 6, 2017, the undersigned ordered petitioner to file a status report advising the
Court when she expected to complete the record by August 7, 2017.
On August 7, 2017, respondent filed a motion to dismiss and his reply to petitioner’s
response to the Order to Show Cause.
On the same day, petitioner filed a status report requesting additional time to find an
expert to opine on this case. The undersigned granted petitioner’s informal motion and gave her
60 days until October 6, 2017 to complete the record. The undersigned denied respondent’s
motion to dismiss because the record in this case was incomplete.
On October 6, 2017, petitioner filed a status report which was an informal motion for an
extension of time. The undersigned gave petitioner until October 18, 2017 to file updated
medical records and a supplemental expert report.
On October 10, 2017, petitioner filed updated medical records. On October 11, 2017,
the undersigned issued an order discussing the recently filed medical records. The undersigned
suggested that petitioner’s counsel should keep in mind this case has difficulties, explained the
difficulties, and warned petitioner’s counsel that she will not award attorneys’ fees and costs
unless there was a reasonable basis to proceed.
2

Case 1:14-vv-01212-MBH Document 90 Filed 07/20/18 Page 3 of 5
On October 19, 2017, petitioner filed a status report stating she requested a conference
with her treating rheumatologist through the OMC legal department and was awaiting a
response.
Also on October 19, 2017, the undersigned held a telephonic status conference and gave
petitioner until November 20, 2017 to file outstanding records, records from the medical review
panel (“MRP”) proceeding in Louisiana, and an amended statement of completion.
On November 20, 2017, petitioner filed updated medical records and records from the
MRP proceeding in Louisiana.
On November 21, 2017, the undersigned issued the second Order to Show Cause.
Because petitioner had a pending medical malpractice claim against OMC when she filed her
petition in the Vaccine Program, the undersigned ordered petitioner to show cause by December
21, 2017 why this case shall not be dismissed under Section 11(a)(5)(B) of Vaccine Act.
On December 6, 2017, petitioner responded to the Order to Show Cause of November 21,
2017 stating petitioner never instituted a civil action for her vaccine injuries. Doc 76, at 1.
Petitioner explained that an administrative MRP procedure is a pre-screening provision required
before a civil action can be filed in Louisiana. Id. at 2. Petitioner’s administrative proceeding
was dismissed and precluded petitioner from bringing any civil action. Id.
On January 4, 2018, respondent filed the first motion for an extension of time to file his
reply to petitioner’s response, which the undersigned granted on that day. Respondent filed his
second motion for an extension of time on March 8, 2018, which the undersigned also granted
that day.
On May 7, 2018, respondent filed a reply to petitioner’s response to the Order to Show
Cause and the second motion to dismiss. In his reply, respondent stated that under Louisiana
state law, filing a request for review of a medical malpractice claim constitutes filing a
“malpractice complaint” and initiates a civil action for damages. Doc 84, at 3-4 (citing Nathan
v. Touro Infirmary, 512 So.2d 352, 353 (La. 1987)). Although the MRP does not directly
award damages, the panel is the first step in a claimant’s quest for an eventual damages award.
Id. at 6. Moreover, respondent mentioned the legislative history of the Vaccine Act that
Congress intended to force petitioners to choose a forum in Section 11. Id. at 8.
On June 1, 2018, petitioner filed a sur-response to respondent’s reply stating the MRP
proceeding in Louisiana can never amount to a “civil action for damages” but a “pre-suit”
proceeding. Doc 86, at 1-2 (citing Everett v. Goldman, 359 So.2d 1256, 1267 (La. 1978)).
Furthermore, the outcome of the panel decision is not binding since medical review panelists are
not judges. Id. at 2 (citing Medine v. Roniger, 879 So.2d 706, 715 (La. 2004)).
On June 18, 2018, respondent replied to petitioner’s sur-response stating the Louisiana
3

Case 1:14-vv-01212-MBH Document 90 Filed 07/20/18 Page 4 of 5
Supreme Court cases cited in petitioner’s sur-response reinforced the view that a MRP request is
the commencement of a civil action for damages on a medical malpractice claim under Louisiana
Law. Doc 87, at 1. Respondent reiterated that the legislative history of the Vaccine Act
precludes a petitioner from both receiving a damages award through settlement of a civil action
and filing a petition under the Act. Id. at 2.
On June 22, 2018, petitioner filed a sur-sur-response to respondent’s sur-reply reiterating
her position that she never filed a civil action. Doc 88, at 1.
DISCUSSION
42 U.S.C. § 300aa-11(a)(5)(B) provides “If a plaintiff has pending a civil action for
damages for a vaccine-related injury or death, such person may not file a petition under
subsection (b) for such injury or death.” Under Louisiana Code of Civil Procedure, “A civil
action is a demand for the enforcement of a legal right. It is commenced by the filing of a
pleading presenting the demand to a court of competent jurisdiction.” LA. CODE CIV. PROC.
ANN. art. 421 (2018). Under the Louisiana Medical Malpractice Act (“MMA”), “No action
against a health care provider covered by this part, or his insurer, may be commenced in any
court before the claimant’s proposed complaint has been presented to a medical review panel
established pursuant to this section.” LA. STAT. ANN. § 40:1231.8.B(1)(a)(i) (2017). The
Louisiana Supreme Court held in Nathan that “a medical malpractice action was in fact
commenced by the claimant’s filing with the Medical Review Panel.” Nathan v. Touro
Infirmary, 512 So.2d 352, 353 (La. 1987). The Louisiana Supreme Court explained that,
Filing a complaint with the review panel is a mandatory initial step in a malpractice
claim and a requirement before filing suit “in any court.” Therefore the filing with
the panel was equivalent to the filing of a suit and for present purposes was actually
the commencement of the suit. The legislature acknowledged this relationship
and provided that the filing of the request for a review of a claim suspended the
running of prescription, . . . , just as the filing of a suit in a competent jurisdiction
suspends the running of prescription.
Id. at 353-354. The United States Court of Federal Claims has treated “filing,” “bringing,” and
“commencing” a civil action equivalent under Section 11 of the Vaccine Act. Lamb v. Sec’y of
HHS, 24 Cl.Ct.255, 258 (1991) (“the generally accepted rule is that “filing” an action is
equivalent to “bringing” an action or to “commencing” an action under Section 11.”).2
Petitioner’s medical malpractice panel request was filed on February 5, 2013 and
dismissed on June 18, 2015. Doc 74-1, at 1, 29. Petitioner’s MRP proceeding was pending
when she filed her petition under the Vaccine Program on December 17, 2014. Because filing a
complaint with the MRP is a mandatory initial step in a malpractice claim, petitioner’s filing
2 In Lamb, the special master dismissed the petition under §11(a)(6), which prohibits participation in the
Vaccine Program when petitioner brings a civil action after November 15, 1988 for damages for a
vaccine-related injury or death before November 15, 1988.
4

Case 1:14-vv-01212-MBH Document 90 Filed 07/20/18 Page 5 of 5
with the MRP was actually the commencement of a civil action in a state court. Commencing a
civil action is deemed as equivalent to filing or bringing a civil action under Section 11 of the
Vaccine Act. The fact that the dismissal of petitioner’s MRP proceeding precluded her from
seeking a civil remedy in a state court reinforces that the MRP proceeding was a civil action.
Furthermore, there is no language in Section 11 of the Vaccine Act that requires a civil action to
be commenced in a state or federal court. The fact that the Louisiana state court Judge Henry G.
Sullivan, Jr. granted the motion to extend the MRP filed by OMC on September 22, 20143 and
dismissed the MRP proceeding on June 18, 20154 further shows that this is a civil action
according to Louisiana’s view.
A MRP proceeding can lead to damages. A MRP proceeding is the first step in a
claimant’s quest for a damages award, regardless of whether or not the MRP can directly award
damages. Moreover, the board of Louisiana Patient’s Compensation Fund (“PCF”) governs
MRP proceedings. The purpose of the PCF is to compensate victims of medical malpractice.
Although the MRP does not directly award damages, it serves a damages function for medical
malpractice claims in Louisiana.
In addition, the legislative history of the Vaccine Act makes clear that Congress intended
to force an election of fora and to prevent simultaneous dual litigation. H.R. 908, 99th Cong. §
2111 (1986); Hamilton v. Sec’y of HHS, 28 Fed.Cl. 315, 319 (1993).
Therefore, because a filing of a complaint with the MRP is a mandatory step to
commence a medical malpractice action in Louisiana that could have led to damages, petitioner’s
filing of a complaint with the Louisiana MRP constituted a civil action under Section 11 of the
Vaccine Rule.
The undersigned GRANTS respondent’s motion to dismiss and DISMISSES this case
for violation of Section 11(a)(5)(B) of the Vaccine Act.
CONCLUSION
The petition is DISMISSED. In the absence of a motion for review filed pursuant to
RCFC Appendix B, the Clerk of Court is directed to enter judgment herewith.5
IT IS SO ORDERED.
Dated: June 25, 2018 s/ Laura D. Millman
Laura D. Millman
Special Master
3 Doc 74-1, at 17.
4 Id. at 29.
5 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party, either separately or
jointly, filing a notice renouncing the right to seek review.
5

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DOCUMENT 3: USCOURTS-cofc-1_14-vv-01212-3
Date issued/filed: 2019-01-03
Pages: 29
Docket text: JUDGE VACCINE REPORTED OPINION re: 104 Judge Vaccine Reported Opinion. Signed by Senior Judge Marian Blank Horn. (jm5) Service on parties made.
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Case 1:14-vv-01212-MBH Document 105 Filed 01/03/19 Page 1 of 29
In the United States Court of Federal Claims
No. 14-1212V
Filed: December 18, 2018
Reissued for Publication: January 3, 20191
* * * * * * * * * * * * * * * *
ALICIA SKINNER-SMITH, *
* Vaccine Act; Motion for
Petitioner, * Review; 42 U.S.C. § 300aa-
v. * 11(a)(5)(B); Statutory
* construction; Louisiana
SECRETARY OF HEALTH & HUMAN * Medical Review Panel
SERVICES, * Proceedings
*
Respondent. *
*
* * * * * * * * * * * * * * * *
Richard Gage, Richard Gage, P.C., Cheyenne, WY, for Petitioner.
Robert P. Coleman, III, Trial Attorney, Torts Branch, Civil Division, United States
Department of Justice, Washington, D.C., for Respondent. With him were Gabrielle M.
Fielding, Assistant Director, Torts Branch, Civil Division, Catherine E. Reeves, Deputy
Director, Torts Branch, Civil Division, C. Salvatore D’Alessio, Acting Director, Torts
Branch, and Joseph H. Hunt, Assistant Attorney General, Civil Division.
O P I N I O N
HORN, J.
On December 17, 2014, Petitioner Alicia Skinner-Smith filed a petition for
compensation with the National Vaccine Injury Compensation Program, under the
National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1–300aa-34 (2012)
(Vaccine Act). On June 25, 2018, Special Master Laura Millman of the United States
Court of Federal Claims summarily dismissed Mrs. Skinner-Smith’s petition for lack of
subject matter jurisdiction pursuant to 42 U.S.C. § 300aa-11(a)(5)(B) (2012), which the
parties refer to as “Section 11(a)(5)(B)” of the Vaccine Act. Section 11(a)(5)(B) bars a
party from filing a petition for compensation in this court “[i]f a plaintiff has pending a civil
action for damages for a vaccine-related injury or death.” Skinner-Smith v. Sec’y of Health
& Human Servs., No. 14-1212V, 2018 WL 3991343, at *3 (Spec. Mstr. Fed. Cl. June 25,
1 This Opinion was issued under seal on December 18, 2018. The parties did not propose
redactions to the December 18, 2018 Opinion, thus, the court issues the decision without
redactions for public distribution.

Case 1:14-vv-01212-MBH Document 105 Filed 01/03/19 Page 2 of 29
2018) (quoting 42 U.S.C. § 300aa-11(a)(5)(B)). Special Master Millman concluded, in a
brief decision, that because Petitioner had, what Special Master Millman defined as a
pending proceeding before a medical review panel in Louisiana on the date that Petitioner
filed her petition in the above-captioned case, the petition was in “violation” of Section
11(a)(5)(8) of the Vaccine Act. See Skinner-Smith v. Sec’y of Health & Human Servs.,
2018 WL 3991343, at *4. On July 25, 2018, Petitioner filed a motion for review pursuant
to Rule 23 of the Vaccine Rules of the United States Court of Federal Claims (Vaccine
Rules) (2018) in this court to review the Special Master’s decision dismissing her petition.
BACKGROUND
Medical Review Panel Proceedings in Louisiana
In 1975, the Louisiana State legislature enacted the Louisiana Medical Malpractice
Act (MMA), LA. REV. STAT. ANN. § 40:1299.41 et seq., which was later recodified and
redesignated in 2015 as LA. REV. STAT. ANN. § 40:1231.1, et seq. (2018). See Mariakis v.
N. Oaks Health Sys., 2018-0165, p. 1 n.1 (La. App. 1 Cir. 9/21/18); --- So. 3d ---; 2018
WL 4523956, at *3 (noting that the MMA “was set forth in La. R.S. 40:1299.41, et seq.”
but that in 2015, the MMA was “redesignated” to “La. R.S. 40:1231.1., et seq.” (emphasis
in original)).2 The MMA was passed “with the intended purposes of reducing or stabilizing
medical malpractice insurance rates and ensuring the availability of affordable medical
services to the general public.” McGlothlin v. Christus St. Patrick Hosp., 2010-2775, p. 7
(La. 7/1/11), 65 So. 3d 1218, 1225. One of the principal advantages of the MMA is to limit
the liability of health care providers who qualify3 under the MMA “for all malpractice claims
because of injuries to or death of any one patient” to $100,000.00, plus interest, and “[a]ny
amount due from a judgment or settlement or from a final award in an arbitration
proceeding” in excess of $100,000.00 “shall be paid from the patient’s compensation
2 Because no substantive changes have been made to sections of the MMA relevant to
the above-captioned case, this court refers to the currently codified MMA at LA. REV. STAT.
ANN. § 40:1231.1, et seq. See In re Tillman, 2015-1114, p. 1 n.1 (La. 3/15/16); 187 So.
3d 445, 446 n.1 (noting that recodification of the MMA made “no substantive changes” to
the provisions of the MMA regarding a medical review panel proceeding, and, thus,
referred to the “law’s current designation of LSA-R.S. 40:1231.8(A)(2)(b)”); see also
Matranga v. Parish Anesthesia of Jefferson, LLC, 17-73, p. 8-9 (La. App. 5 Cir. 8/29/18);
254 So. 3d 1238, 1238 (citing to the recodified version of the MMA even though the
medical review panel proceeding was filed in 2009 and completed in 2010, years before
the MMA was recodified).
3 A health care provider qualifies for protection under the MMA by maintaining malpractice
liability insurance and filing “proof of financial responsibility” with the State of Louisiana.
See LA. REV. STAT. ANN. § 40:1231.6(A)-(B). A health care provider can choose not to
qualify under the MMA, and if so, “the patient of a health care provider who has not
qualified is no different from any other tort or contract victim, while the patient of a qualified
health care provider (one who has qualified under the act) is regulated by the act insofar
as malpractice recovery is concerned.” Everett v. Goldman, 359 So. 2d 1256, 1262 (La.
1978).
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fund.” LA. REV. STAT. ANN. § 40.1231.2(A); see also Sewell v. Doctors Hosp., 600 So. 2d
577, 578 n.1 (La. 1992). In addition, the MMA limits the total amount a claimant can
recover “for all malpractice claims for injuries to or death of a patient, exclusive of future
medical care and related benefits” to “five hundred thousand dollars plus interest and
cost.” LA. REV. STAT. ANN. § 40.1231.2(B). The Patient’s Compensation Fund (PCF) is a
fund comprised of monies stemming from “an annual surcharge” levied on “all health care
providers in Louisiana” who qualify under the MMA. Id. at § 40.1231.4(A)-(B). The annual
surcharge is collected by and deposited into the PCF by the PCF Oversight Board, which
is a nine-member Board appointed by the Governor of Louisiana and established within
the Division of Administration of Louisiana, a state executive agency within the State of
Louisiana Office of the Governor. See id. at § 40.1231.4(D)(1)(a) (“The Patient’s
Compensation Fund Oversight Board is hereby created and established in the office of
the governor, division of administration. The board shall be comprised of nine members,
appointed by the governor subject to Senate confirmation.”). The PCF Oversight Board
also carries out “[t]he functions of collecting, administering, and protecting the fund,
including all matters relating to determining surcharge rates, establishing reserves, the
evaluating and settlement of claims, and relating to the defense of the fund.” Id. at
§ 40.1231.4(A)(5)(b).
The MMA also provides that before an individual may file a medical malpractice
claim in Louisiana State Court or in any Federal District Court which has diversity
jurisdiction over a medical malpractice claim under Louisiana State law,4 an individual
must first participate in a proceeding before a panel of three medical professionals and
one attorney chairman, which in turn, issues an “expert opinion” as to whether the
evidence “supports the conclusion that the defendant or defendants acted or failed to act
within the appropriate standards of care.” Id. at § 40:1231.8(B)(1)(a)(i) (“No action against
a health care provider covered by this Part, or his insurer, may be commenced in any
court before the claimant’s proposed complaint has been presented to a medical review
panel established pursuant to this Section.”); see also Sewell v. Doctors Hosp., 600 So.
2d at 578 n.1 (noting that an advantage of the MMA is “the requirement that all claims for
malpractice must be submitted initially to a medical review panel”). As the Supreme Court
of Louisiana explained in McGlothlin v. Christus St. Patrick Hospital, 65 So. 3d at 1226,
a proceeding before a medical review panel is a “[p]retrial screening” that is
“designed to weed out frivolous claims without the delay or expense of a
court trial. It is thought that the use of such panels will encourage settlement
because both parties will be given a preliminary view of the merits of the
case. If a claim is found by the panel to be without merit it is thought that
4 See Mogabgab v. Stein, et al., 834 F. Supp. 2d 499, 499 (E.D. La. 2011) (noting that
the MMA which “provid[es] for the presentation of a claim of malpractice to a Medical
Review Panel prior to District Court proceedings is a substantive rule of law that must be
applied in a Federal diversity action”); see also Seoane v. Ortho Pharm., Inc., 472 F.
Supp. 468, 471 (E.D. La. 1979) (noting that “[t]he federal courts which have considered
this question, with one exception, have concluded that medical malpractice review panel
provisions of state laws are substantive rules of law of the forum which must be applied
by a federal court in a diversity case”).
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the claimant will be likely to abandon his claim or agree to a nominal
settlement. Moreover, a plaintiff who gains a favorable opinion from the
panel may be able to negotiate a favorable settlement with his defendants,
a procedure which also avoids much of the time and expense of a trial.”
Id. (quoting Everett v. Goldman, 359 So. 2d at 1264); Perritt v. Dona, 2002-2601, p. 8 (La.
7/2/03); 849 So. 2d 56, 61 (“The MMA requires that all claims against health care
providers be reviewed or ‘filtered’ through a medical review panel before proceeding to
any other court.”); Rhodes v. Schultis, 13-663, p. 6 (La. App. 5 Cir. 4/23/14); 140 So. 3d
331, 336 (“The Louisiana Medical Malpractice Act requires that all medical malpractice
claims against qualified health care providers are to be submitted to a medical review
panel prior to filing suit in any court. The purpose of pre-trial screening through a medical
review panel is to weed out frivolous claims without the delay or expense of a court trial.”
(internal citations omitted)); Ward v. Vivian Healthcare and Rehab. Ctr., 47,649, p. 5 (La.
App. 2 Cir. 5/15/13); 116 So. 3d 870, 874 (“One such advantage is the requirement that
a claim first be submitted to a medical review panel before the malpractice action may
commence in court. The medical review panel is a filtering process that is meant to weed
out frivolous claims or prompt defendants to settle valid claims reasonably.” (internal
citations omitted)). In addition, if the individual fails to present his or her medical
malpractice claim to a medical review panel before filing an action in a court of competent
jurisdiction, the medical malpractice lawsuit filed will be dismissed by the court as
premature. See Blevins v. Hamilton Med. Ctr., Inc., 2007-127, p. 4 (La. 6/29/07); 959 So.
2d 440, 444 (“Under the LMMA [Louisiana Medical Malpractice Act], a medical
malpractice claim against a private qualified health care provider is subject to dismissal
on a timely filed exception of prematurity if such claim has not first been reviewed by a
pre-suit medical review panel.”); see also Williamson v. Hosp. Serv. Dist. No. 1 of
Jefferson, 2004-0451, p. 4 (La. 12/1/04); 888 So. 2d 782, 785 (“An action is premature
when it is brought before the right to enforce it has accrued. Under the Medical
Malpractice Act, a medical malpractice claim against a private qualified health care
provider is subject to dismissal on a timely filed exception of prematurity if such claim has
not first been reviewed by a pre-suit medical review panel.”); Atkinson v. Lammico Ins.
Co., 2011-13, p. 3 (La. App. 3 Cir. 5/4/11); 63 So. 3d 1176, 1179 (“[I]f the plaintiff fails to
submit the claim to a medical review panel before the institution of suit, the appropriate
procedural remedy is a timely filed exception of prematurity.”).
The medical review panel proceeding is initiated when a claimant files his or her
“request for review of a malpractice claim or a malpractice complaint,” with the Division
of Administration of Louisiana, which, as previously noted, is a state executive agency
within the Office of the Governor of Louisiana. See LA. REV. STAT. ANN.
§ 40:1231.8(A)(2)(b)(i) (“The request for review of a medical malpractice claim under this
Section shall be deemed filed on the date the request is: (aa) Sent, if the request is
electronically sent by facsimile transmission or other authorized means, as provide by
R.S. 9:2615(A), to the division of administration.”). The request for review must contain
the following:
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(i) A request for the formation of a medical review panel.
(ii) The name of only one patient for whom, or on whose behalf, the request
for review is being filed; however, if the claim involves the care of a pregnant
mother and her unborn child, then naming the mother as the patient shall
be sufficient.
(iii) The names of the claimants.
(iv) The names of the defendant health care providers.
(v) The dates of the alleged malpractice.
(vi) A brief description of the alleged malpractice as to each named
defendant health care provider.
(vii) A brief description of the alleged injuries.
Id. at § 40:1231.8(A)(1)(b). The filing of a request for review suspends the “running of
prescription against all joint and solidary obligors, and all joint tortfeasors, including but
not limited to health care providers, both qualified and not qualified, to the same extent
that prescription is suspended against the party or parties that are the subject of the
request for review.” Id. at § 40:1231.8(A)(2)(a).
The Division of Administration plays a very limited role in a medical review panel
proceeding. Upon receipt of the request for review, the Division of Administration’s only
task is to forward the request to the PCF Oversight Board, which is a nine-member board
within the Division of Administration. See id. at § 40.1231.8(A)(2)(b)(ii). Once the request
is forwarded, the Division of Administration no longer plays a role in a medical review
panel proceeding, which is then overseen by two separate entities, the PCF Oversight
Board and the medical review panel. The PCF Oversight Board, which receives the
request for review of a medical panel proceeding from the Division of Administration,
oversees the clerical functions of the medical review panel proceeding, including
receiving and processing the filing fee from the claimant, notifying the defending party of
the request for review, and forwarding a copy of the request for review to the defending
party. See id. at § 40.1231.8(A)(2)(3). The Louisiana State Courts have explained that
the PCF Oversight Board’s role in a medical review panel proceeding is “clerical or
ministerial in nature to facilitate the medical review process,” and “stands in the same
position as clerks of court, who are charged by the legislature with the duty to receive and
process pleadings filed in judicial proceedings.” Franks v. La. Patient’s Compensation
Fund Oversight Bd., 2016-0765, p. 8 (La. App. 1 Cir. 5/3/17); 220 So. 3d 862, 868; see
also Berthelot v. Patients’ Compensation Fund Oversight Bd., 2007-0112, p. 10 (La. App.
1 Cir. 11/2/07); 977 So. 2d 967, 973 (“[T]he PCF’s duties under LSA-R.S. 40:1299.47 A
[sic] are not adjudicative in nature. Rather, the PCF’s mandatory duty to act when it
receives a request to invoke a medical review panel is clerical or ministerial in nature and
is designed to facilitate the medical review process.” (internal citation omitted)).
Unlike the PCF Oversight Board, the medical review panel focuses on the
substantive aspects of the proceeding. Notably, the medical review panel “is not a judge
or a jury but merely a body of experts assembled to evaluate a medical claim and to
provide an expert opinion.” Jeansonne v. Bonano, 2017-0828, p. 5 (La. App. 1 Cir.
1/23/18); 241 So. 3d 1027, 1031 (citing Derouen v. Kolb, 397 So. 2d 791, 784 (La. 1981)).
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The medical review panel is comprised of three healthcare professionals and one attorney
chairman. The four panelists are private individuals selected by the parties to participate
in the medical review panel proceeding. See LA. REV. STAT. ANN. § 40:1231.8.C. In
particular, the parties jointly select the attorney chairman, who acts “as chairman of the
panel and in an advisory capacity.” See id. Each party may then each select a medical
professional. See id. at § 40:1231.8.C.3. The two selected medical professionals then
select the third and final medical professional for the panel. See id. If a party fails to select
a medical professional, the attorney chairman shall make the selection. See id. The
medical review panel reviews the evidence submitted by the parties and has the “sole”
duty to issue an “expert opinion” as to the evidence presented. Id. at § 40:1231.8(G) (“The
panel shall have the sole duty to express its expert opinion as to whether or not the
evidence supports the conclusion that the defendant or defendants acted or failed to act
within the appropriate standards of care.”); see also McGlothlin v. Christus St. Patrick
Hosp., 65 So. 3d at 1229 (“[T]he panel’s sole duty under our medical malpractice scheme
is to express its expert opinion as to whether or not the evidence supports the conclusion
the defendant or defendants acted or failed to act within the appropriate standard of care.”
(internal quotation marks omitted)).
The medical review panel is statutorily authorized to issue one of four specific
findings in its expert opinion: (1) that the “evidence supports the conclusion that defendant
or defendants failed to comply with the appropriate standard of care as charged in the
complaint,” (2) that “[t]he evidence does not support the conclusion that the defendant or
defendants failed to meet the applicable standard of care,” (3) that “there is a material
issue of fact, not requiring expert opinion, bearing on liability for consideration” for a court
of law to the extent that a lawsuit is filed after the conclusion of the medical review panel
proceeding, and (4) if the medical review panel concludes that defendant failed to comply
with the appropriate standard of care, that “the conduct complained of was or was not a
factor of the resultant damages. If such conduct was a factor, whether the plaintiff
suffered: (a) any disability and the extent and duration of the disability, and (b) any
permanent impairment and the percentage of the impairment.” LA. REV. STAT. ANN.
§ 40:1231.8(G)(1)-(4). The medical review panel, however, does not make a finding as to
the monetary amount of damages due to a claimant nor does the medical review panel
have authority to award any damages. See id.; see also Perritt v. Dona, 849 So. 2d at 62
(“No findings are made by the panel as to damages.” (quoting Everett v. Goldman, 359
So. 2d at 1263)). Once a medical review panel proceeding has concluded, and regardless
of the conclusion reached by the medical review panel, the claimant, if he or she so
chooses, may file an action for medical malpractice in a court of competent jurisdiction.
See LA. REV. STAT. ANN. § 40:1231.8(B)(1)(a)(i); see also Beaucoudray v. Walsh, 2007-
0818, p. 18 (La. App. 4 Cir. 3/12/09); 9 So. 3d 916, 926 (“A MRP [medical review panel]
opinion adverse to a patient does not preclude the filing of a lawsuit against the qualified
healthcare providers. The provision . . . which states that the panel opinion is not
‘conclusive,’ means only that the panel opinion, whatever conclusion is reached, ‘does
not preclude subsequent filing of a lawsuit . . . .’” (internal citations omitted) (second ellipse
in original)).
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The medical review panel’s expert opinion is not binding on any future court action.
See LA. REV. STAT. ANN. § 40:1231.8(H); see also Ward v. Vivian Healthcare & Rehab.
Ctr., 116 So. 3d at 874 (“[T]he medical review panel’s findings are not binding on the
parties.” (citing Perritt v. Dona, 849 So. 2d at 62)). Specifically,
[a]ny report of the expert opinion reached by the medical review panel shall
be admissible as evidence in any action subsequently brought by the
claimant in a court of law, but such expert opinion shall not be conclusive
and either party shall have the right to call, at his cost, any member of the
medical review panel as a witness. If called, the witness shall be required
to appear and testify.
LA. REV. STAT. ANN. § 40:1231.8(H). Thus, once a claimant completes a medical review
panel proceeding and proceeds to file an action in court, the medical review panel’s expert
opinion becomes the “equivalent to expert medical evidence.” Jeansonne v. Bonano, 241
So. 3d at 1031. “However, as with any other expert testimony, the Medical Review Panel
Opinion is subject to review and a trial court may reject it as inadmissible.” Matranga v.
Parish Anesthesia of Jefferson, LLC, 14-448, p. 18 (La. App. 5 Cir. 5/14/15); 170 So. 3d
1077, 1091 (citing McGlothlin v. Christus St. Patrick Hosp., 65 So. 3d at 1227). “The
opinion, therefore, can be used by either the patient or the qualified health care provider,
and the jury, as trier of fact, is free to accept or reject any portion or all of the opinion.”
McGlothlin v. Christus St. Patrick Hosp., 65 So. 3d at 1227. In addition, “nothing in the
Medical Malpractice Act prevents Plaintiffs from presenting evidence, including expert
medical testimony, at trial that contradicts the panel’s opinion.” Rhodes v. Schultis, 140
So. 3d at 337.
During the life of a medical review panel proceeding, the parties, under very
limited, specified circumstances, may temporarily invoke the jurisdiction of a Louisiana
State Court. For example, upon the request of the parties, a court may issue an order to
extend the twelve-month time period in which the medical review panel has to issue an
opinion. See LA. REV. STAT. ANN. § 40:1231.8(B)(1)(b). Additionally, in the event a party
refuses to comply with the provisions of the MMA governing medical review panel
proceedings, the aggrieved party may “petition any district court of proper venue over the
parties for an order directing that the parties comply with the medical review panel
provisions of the medical malpractice act.” Id. at § 40:1231.8(C)(6). Also, “[u]pon request
of any party, or upon request of any two panel members, the clerk of any district court
shall issue subpoenas and subpoenas duces tecum in aid of the taking of depositions
and the production of documentary evidence for inspection and/or copying” in order to
gather evidence to be presented before a medical review panel. Id. at § 40:1231.8(D)(4).
The medical review panel, however, is the body that initially has the authority to issue an
expert opinion as to whether the defending party “acted or failed to act within the
appropriate standards of care.” Id. at § 40:1231.8(G).
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Petitioner’s Medical Review Panel Proceeding
On February 6, 2012, Petitioner Alicia Skinner-Smith received the Tetanus,
Diphtheria, Pertussis vaccination (Tdap vaccination) at the Ochsner Medical Center in
New Orleans, Louisiana, the vaccination at issue in the above-captioned case. On
February 5, 2013, Petitioner submitted a letter to the State of Louisiana’s Division of
Administration, which included a request that a medical review panel be convened to
review “the care rendered” to Petitioner during her visit to the Ochsner Medical Center
Main Campus Emergency Room on February 6, 2012, when she received her Tdap
vaccination, and also during other visits to the Ochsner Medical Center Campus on
February 24, 2012 and on February 27, 2012. Petitioner specifically alleged in her
February 5, 2013 request for review that she experienced “medical complications” from
the Tdap vaccination received on February 6, 2012 and that she was dissatisfied with
medical care rendered to her by medical personnel at the Ochsner Medical Center Main
Campus Emergency Room on February 24, 2012 and February 27, 2012.
In September of 2014, the Ochsner Clinic Foundation, the defending party in
Petitioner’s medical review panel proceeding, filed an unopposed motion in the 24th
Judicial District Court for the Parish of Jefferson, Louisiana, requesting an extension of
time “in order for the medical review panel to convene and render an opinion” on
Petitioner’s request for review pending before the medical review panel. On September
22, 2014, Louisiana State District Court Judge Henry Sullivan of the 24th Judicial District
Court for the Parish of Jefferson, Louisiana granted the Ochsner Clinic Foundation’s
motion, and “[o]rdered that the life of the Medical Review Panel examining the medical
negligence claim Alicia Skinner-Smith versus Ochsner Clinic Foundation is hereby
extended through November 18, 2015.” The medical review panel proceeding caption of
the September 22, 2014 Order read: “In re: Medical Review Panel Proceedings in the
Matter of Alicia Skinner-Smith versus Ochsner Clinic Foundation” and listed the request
for review number as 742-484.
On December 17, 2014, while Petitioner’s request for review was still pending
before the medical review panel in Louisiana, Petitioner filed her petition for compensation
with the Office of Special Masters at the United States Court of Federal Claims. Petitioner
alleges in her motion for review currently pending before this court that she sought no
further action in her medical review panel proceeding in Louisiana after filing her
December 17, 2014 petition with the United States Court of Federal Claims, Office of
Special Masters in the above-captioned case. On April 15, 2015, Louisiana State District
Court Judge Sullivan held a hearing on the Ochsner Clinic Foundation’s motion to dismiss
Petitioner’s medical review panel proceeding against the Ochsner Clinic Foundation with
prejudice and “For Failure To Comply” with a previous Order to Compel. On that same
day, April 15, 2015, Louisiana State District Court Judge Sullivan orally granted Ochsner
Clinic Foundation’s motion to dismiss and ordered that the medical review panel
reviewing Petitioner’s medical malpractice claim be dissolved, without having issued any
expert opinion. On June 2, 2015, the State of Louisiana’s Division of Administration wrote
to Petitioner, informing her that the medical review panel had been dissolved as of that
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same date, June 2, 2015. On June 18, 2015, Louisiana State District Court Judge Sullivan
memorialized his April 15, 2015 oral Order in a written Order.
The December 17, 2014 petition for compensation filed with the Office of Special
Masters in the above-captioned case alleged that the Tdap vaccination Petitioner had
received on February 6, 2012 resulted in “an abscess, pain and related injuries.”
Petitioner also alleged that she
has not, nor has anyone to Petitioner’s knowledge, filed, participated in, or
collected an award or settlement from any civil action for the above
described vaccine injury. Through previous local counsel, a medical review
panel proceeding was initiated in Louisiana. However, this is not a civil
action. No complaint was ever filed and no settlement ever reached.
Based on the record of the proceedings before Special Master Millman, the parties
spent the first year and half of Petitioner’s case investigating discrepancies in Petitioner’s
medical records, including regarding the injection site of Petitioner’s Tdap vaccine. Then,
on April 27, 2016, after extensive briefing by the parties regarding Petitioner’s injection
site, the Special Master issued a “Ruling on Facts,” concluding that “petitioner received
her February 6, 2012 Tdap vaccination in the left dorsal gluteal muscle.” With the site of
Petitioner’s vaccination officially established, on July 5, 2016, Respondent filed its report
pursuant to Rule 4(c) of the Vaccine Rules, which required Respondent to “file a report
setting forth a full and complete statement of its position as to why an award should or
should not be granted.” RCFC Vaccine Rule 4(c) (2016). Respondent opposed an award
of compensation and argued that based on the record before the court, Petitioner could
not prove that the Tdap vaccine she had received caused her injuries. Respondent also
noted in the Rule 4(c) report that the petition in the above-captioned case indicated that
Petitioner had participated in a “medical review panel proceeding” in Louisiana and
requested that Petitioner “produce all evidence, information, and documentation from the
medical review panel proceedings in Louisiana.”
For reasons not apparent in the record before the court, Petitioner delayed one
year and four months from the filing of Respondent’s July 5, 2016 Rule 4(c) report to file
the documentation regarding her medical review panel proceeding in Louisiana, which
she filed on November 20, 2017. On November 21, 2017, Special Master Millman issued
an Order to Show Cause why the petition in the above-captioned case should not be
dismissed pursuant to 42 U.S.C. § 300aa-11(a)(5)(B), which, according to the November
21, 2017 Order, “prohibits people from filing vaccine petitions while a civil action is
pending against a vaccine administrator.” Special Master Millman noted in the November
21, 2017 Order that:
When petitioner filed her petition, she had a pending medical malpractice
claim against OMC[5] [Ochsner Medical Center], which she had filed on
5 Based on the record before the court, Petitioner’s medical review panel proceeding was
not brought against the “Ochsner Medical Center” but against the “Ochsner Clinic
Foundation.”
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February 5, 2013, in the 24th Judicial District Court for the Parish of
Jefferson, State of Louisiana, Case No. 742-484, which Judge Henry G.
Sullivan, Jr. dismissed on June 18, 2015.[6] OMC was the vaccine
administrator. June 18, 2015 is six months after petitioner filed her petition
in the Vaccine Program.
(internal references omitted).
On December 6, 2017, Petitioner responded to the Special Master’s Order to Show
Cause. Petitioner argued that that she “has never instituted a civil action for her vaccine
injuries,” and indicated that the medical review panel proceeding she commenced in
Louisiana was a “pre-screening provision required before any civil action can be filed.”
Petitioner also noted that because her medical review panel proceeding was dismissed
with prejudice, under Louisiana State law, Petitioner was “legally precluded from filing a
civil action” for medical malpractice in Louisiana State Courts. On May 7, 2018
Respondent filed its response to Petitioner’s December 6, 2017 filing, arguing that under
Louisiana State law, “filing a request for review of a medical malpractice claim as
petitioner did, constitutes a ‘malpractice complaint’ and initiates a civil action for
damages.” On that same day, Respondent moved for immediate dismissal of the petition
for violating Section 11(a)(5)(B) of the Vaccine Act.
On June 25, 2018, Special Master Millman issued a five-page decision, which
dismissed the petition in the above-captioned case for violating Section 11(a)(5)(B) of the
Vaccine Act. See Skinner-Smith v. Sec’y of Health & Human Servs., 2018 WL 3991343,
at *4. Special Master Millman quoted the provision, stating: “‘[i]f a plaintiff has pending a
civil action for damages for a vaccine-related injury or death, such person may not file a
petition under subsection (b) for such injury or death.’” Id. at *3 (quoting 42 U.S.C.
§ 300aa-11(a)(5)(B)). Special Master Millman also referred to Nathan v. Touro Infirmary,
512 So. 2d 352 (La. 1987), a case decided by the Supreme Court of Louisiana, which
stated in less than clear terms:
Filing a complaint with the review panel is a mandatory initial step in a
malpractice claim and a requirement before filing suit “in any court.”
Therefore the filing with the panel was equivalent to the filing of a suit and
for present purposes was actually the commencement of the suit. The
legislature acknowledged this relationship and provided that the filing of the
request for a review of a claim suspended the running of prescription, . . . ,
just as the filing of a suit in a competent jurisdiction suspends the running
of prescription.
6 Based on the record before the court, Petitioner did not file her medical review panel
proceeding in the 24th Judicial District Court for the Parish of Jefferson, Louisiana on
February 5, 2013. Instead, as the record indicates, on February 5, 2013, Petitioner
commenced her medical review panel proceeding before the State of Louisiana Division
of Administration, a state executive agency within the Office of the Governor of Louisiana,
when she sent a letter requesting that a medical review panel proceeding be convened.
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Id. (bold in original; underscore added) (quoting Nathan v. Touro Infirmary, 512 So. 2d at
353-54). The Nathan decision states somewhat conflicting conclusions, that a Louisiana
medical review panel proceeding occurred “before filing suit ‘in any court,’” “was
equivalent to the filing of a suit,” and suspended the running of prescription “just as the
filing of a suit.” Special Master Millman, in her brief analysis, also cited general language
in Lamb v. Secretary of Health & Human Services, 24 Cl. Ct. 255, 258 (1991), a 1991
United States Claims Court case regarding a Pennsylvania State Court action. Special
Master Millman noted that:
The United States Court of Federal Claims has treated “filing,” “bringing,”
and “commencing” a civil action equivalent under Section 11 of the Vaccine
Act. Lamb v. Sec’y of HHS, 24 Cl.Ct.255 [sic], 258 (1991) (“the generally
accepted rule is that “filing” [sic] an action is equivalent to “bringing” [sic] an
action or to “commencing” [sic] an action under Section 11.”).
Skinner-Smith v. Sec’y of Health & Human Servs., 2018 WL 3991343, at *3. Special
Master Millman further indicated in her June 25, 2018 decision, without explaining or citing
the basis for her conclusion, that, “[a]lthough the MRP does not directly award damages,
it serves a damages function for medical malpractice claims in Louisiana.” Id. at *4.
Special Master Millman then concluded that, “because a filing of a complaint with the
MRP is a mandatory step to commence a medical malpractice action in Louisiana that
could have led to damages, petitioner’s filing of a complaint with the Louisiana MRP
constituted a civil action under Section 11 of the Vaccine Rule.” Id.
On July 25, 2018, Petitioner filed a motion for review of Special Master Millman’s
June 25, 2018 decision dismissing her petition in the above-captioned case. Petitioner
argues that Special Master Millman “erred as a matter of law in dismissing Petitioner’s
case after finding Petitioner violated 42 U.S.C. § 300aa-11(a)(5)(B) by filing a vaccine
petition while a civil action was pending.” On August 24, 2018, Respondent filed its
response to Petitioner’s motion for review, arguing that Special Master Millman properly
dismissed the petition and that the Special Master’s decision should be affirmed by this
court. On September 27, 2018, Petitioner filed her reply in support of her motion for
review, reiterating that the phrase “civil action” refers to “an action brought in a court of
law,” and that because her medical review panel proceeding was not before a court, it
was not a “civil action.” (citing Fed. R. Civ. P. 2 (2018); Fed. R. Civ. P. 3 (2018)). The
court heard oral argument on Petitioner’s motion for review and in response to issues
raised at the oral argument, the parties filed simultaneous supplemental briefs.
DISCUSSION
When reviewing a Special Master’s decision, the assigned Judge of the United
States Court of Federal Claims shall:
(A) uphold the findings of fact and conclusions of law of the special master
and sustain the special master’s decision,
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(B) set aside any findings of fact or conclusions of law of the special master
found to be arbitrary, capricious, an abuse of discretion, or otherwise not in
accordance with law and issue its own findings of fact and conclusions of
law, or
(C) remand the petition to the special master for further action in accordance
with the court’s direction.
42 U.S.C. § 300aa-12(e)(2). The legislative history of the Vaccine Act states: “The
conferees have provided for a limited standard for appeal from the [special] master’s
decision and do not intend that this procedure be used frequently, but rather in those
cases in which a truly arbitrary decision has been made." H.R. Rep. No. 101-386, at 517
(1989) (Conf. Rep.), reprinted in 1989 U.S.C.C.A.N. 3018, 3120.
In order to recover under the Vaccine Act, Petitioners must prove by a
preponderance of the evidence that the vaccine caused the purported injury. See W.C.
v. Sec’y of Health & Human Servs., 704 F.3d 1352, 1355-56 (Fed. Cir. 2013) (“The
Vaccine Act created the National Vaccine Injury Compensation Program, which allows
certain petitioners to be compensated upon showing, among other things, that a person
‘sustained, or had significantly aggravated’ a vaccine-related ‘illness, disability, injury, or
condition.’” (quoting 42 U.S.C. § 300aa–11(c)(1)(C))); see also Lombardi v. Sec’y of
Health & Human Servs., 656 F.3d 1343, 1350 (Fed. Cir. 2011) (“A petitioner seeking
compensation under the Vaccine Act must prove by a preponderance of the evidence
that the injury or death at issue was caused by a vaccine.”); D’Angiolini v. Sec’y of Health
& Human Servs., 122 Fed. Cl. 86, 97 (2015) (“The function of a special master is . . . to
determine based on the record evidence as a whole and the totality of the case, whether
it has been shown by a preponderance of the evidence that a vaccine caused [petitioner’s]
injury.” (alteration in original)), aff’d, 645 F. App’x 1002 (Fed. Cir. 2016); Shapiro v. Sec’y
of Health & Human Servs., 105 Fed. Cl. 353, 358 (2012), aff’d, 503 F. App’x 952 (Fed.
Cir. 2013); Jarvis v. Sec’y of Health & Human Servs., 99 Fed. Cl. 47, 54 (2011).
Regarding the standard of review, articulated in Markovich v. Secretary of Health
& Human Services, the United States Court of Appeals for the Federal Circuit wrote,
“[u]nder the Vaccine Act, the Court of Federal Claims reviews the Chief Special Master’s
decision to determine if it is ‘arbitrary, capricious, an abuse of discretion, or otherwise not
in accordance with the law.’ 42 U.S.C. § 300aa-12(e)(2)(B).” Markovich v. Sec’y of Health
& Human Servs., 477 F.3d 1353, 1355-56 (Fed. Cir.), cert. denied, 552 U.S. 816 (2007);
see also Contreras v. Sec’y of Health & Human Servs., 844 F.3d 1363, 1368 (Fed. Cir.
2017) (“We give no deference to the Claims Court’s or Special Master’s determinations
of law, but uphold the Special Master’s findings of fact unless they are arbitrary or
capricious. We review discretionary rulings . . . under the abuse of discretion standard.”
(internal quotation marks and internal citation omitted)); Deribeaux ex rel. Deribeaux v.
Sec’y of Health & Human Servs., 717 F.3d 1363, 1366 (Fed. Cir.) (noting that “we
‘perform[ ] the same task as the Court of Federal Claims and determine[ ] anew whether
the special master’s findings were arbitrary or capricious’” (brackets in original) (quoting
Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000))), reh’g
and reh’g en banc denied (Fed. Cir. 2013); W.C. v. Sec’y of Health & Human Servs., 704
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F.3d at 1355; Hibbard v. Sec’y of Health & Human Servs., 698 F.3d 1355, 1363 (Fed. Cir.
2012); Avera v. Sec’y of Health & Human Servs., 515 F.3d 1343, 1347 (Fed. Cir.) (“Under
the Vaccine Act, we review a decision of the special master under the same standard as
the Court of Federal Claims and determine if it is ‘arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with law.’” (quoting 42 U.S.C. § 300aa-
12(e)(2)(B))), reh’g and reh’g en banc denied (Fed. Cir. 2008); de Bazan v. Sec’y of Health
& Human Servs., 539 F.3d 1347, 1350 (Fed. Cir.), reh’g and reh’g en banc denied (Fed.
Cir. 2008); Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1277 (Fed. Cir.
2005); Greene v. Sec’y of Health & Human Servs., 136 Fed. Cl. 445, 451 (2018); Dodd
v. Sec’y of Health & Human Servs., 114 Fed. Cl. 43, 47 (2013). The arbitrary and
capricious standard is “well understood to be the most deferential possible.” Munn v.
Sec’y of Health & Human Servs., 970 F.2d 863, 870 (Fed. Cir. 1992).
Therefore, this court may set aside a Special Master’s decision only if the court
determines that the “findings of fact or conclusion of law of the special master . . . [are]
arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law . . . .”
42 U.S.C. § 300aa-12(e)(2)(B); see also Lombardi v. Sec’y of Health & Human Servs.,
656 F.3d at 1350 (“We uphold the special master’s findings of fact unless they are arbitrary
or capricious.”) (internal citations omitted); Moberly ex rel. Moberly v. Sec’y of Health &
Human Servs., 592 F.3d 1315, 1321 (Fed. Cir. 2010); Markovich v. Sec’y of Health &
Human Servs., 477 F.3d at 1356-57; Lampe v. Sec’y of Health & Human Servs., 219 F.3d
at 1360. The United States Court of Appeals for the Federal Circuit has indicated that:
These standards vary in application as well as degree of deference. Each
standard applies to a different aspect of the judgment. Fact findings are
reviewed by us, as by the Claims Court judge, under the arbitrary and
capricious standard; legal questions under the “not in accordance with law”
standard . . . ; and discretionary rulings under the abuse of discretion
standard. The latter will rarely come into play except where the special
master excludes evidence.
Munn v. Sec’y of Health & Human Servs., 970 F.2d at 871 n.10; see also Carson ex rel.
Carson v. Sec’y of Health & Human Servs., 727 F.3d 1365, 1369 (Fed. Cir. 2013);
Deribeaux ex rel. Deribeaux v. Sec’y of Health & Human Servs., 717 F.3d at 1366; W.C.
v. Sec’y of Health & Human Servs., 704 F.3d at 1355; Griglock v. Sec’y of Health &
Human Servs., 687 F.3d 1371, 1374 (Fed. Cir. 2012).
Regarding interpretation of the words of the Vaccine Act, this court reviews such
questions of law de novo. See R.K. on behalf of A.K. v. Sec’y of Health & Human Servs.,
125 Fed. Cl. 276, 280 (2016) (noting that a Special Master’s interpretation of the Vaccine
Act “is a question of law,” which the court reviews “de novo” (emphasis in original) (citing
Hawkins v. United States, 469 F.3d 993, 1000 (Fed. Cir. 2006) (“Statutory construction is
a matter of law that we review de novo.” (emphasis in original)))); see also Boatmon v.
Sec’y of Health & Human Servs., 138 Fed. Cl. 566, 571 (2018) (“As to questions of law,
the legal rulings made by a special master in connection with a vaccine claim are reviewed
de novo, under a ‘not in accordance with the law’ standard.”); Spahn v. Sec’y of Health &
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Human Servs., 138 Fed. Cl. 252, 257 (2018) (“The special master’s determinations of law
are reviewed de novo.” (emphasis in original) (citing Andreu ex rel. Andreu v. Sec’y of
Health & Human Servs., 569 F.3d 1367, 1373 (Fed. Cir. 2009))).
The issue before the court in the current case is whether Special Master Millman
committed legal error when she concluded that Petitioner’s medical review panel
proceeding in Louisiana was a “civil action for damages” and barred Petitioner’s claim
before the Office of Special Masters pursuant to Section 11(a)(5)(B) of the Vaccine Act.
See Skinner-Smith v. Sec’y of Health & Human Servs., 2018 WL 3991343, at *3.
Petitioner argues that her medical review panel proceeding in Louisiana was not a “civil
action for damages” within the plain meaning of Section 11(a)(5)(B) of the Vaccine Act.
According to Petitioner, a “civil action,” as defined in the Federal Rules of Civil Procedure,
commences “by filing a complaint with the court,” and, thus, a medical review panel
proceeding, in which no complaint has been or is ever filed in a court, cannot be
considered a civil action. (citing Fed. R. Civ. P. 3). Petitioner also argues that her medical
review panel proceeding “was an administrative process and Petitioner never took the
next step of filing a civil action in Louisiana.” Petitioner further argues that a medical
review panel proceeding is not an action “for damages” because a medical review panel
“has no right to award any damages.”
Respondent acknowledges that Petitioner’s February 5, 2013 letter requesting a
medical review panel proceeding, which Respondent labels as a “Complaint,”7 “was not
actually filed in a state or federal court,” but argues that Special Master Millman correctly
concluded that a medical review panel proceeding in Louisiana is a “civil action for
damages” covered by Section 11(a)(5)(B) of the Vaccine Act. Respondent reiterates
Special Master Millman’s conclusion in her June 25, 2018 decision that pursuant to the
decision by the Supreme Court of Louisiana in Nathan v. Touro Infirmary, “[f]iling a
complaint with the review panel is a mandatory initial step in a malpractice claim and a
requirement before filing suit ‘in any court.’ Therefore, the filing with the panel was
equivalent to the filing of a suit and for present purposes was actually the commencement
of the suit.” (quoting Nathan v. Touro Infirmary, 512 So. 2d at 353-54). According to
Respondent, because a medical review panel proceeding is a “mandatory initial step in a
malpractice claim” under Louisiana State law, a medical review panel proceeding should
be considered a “civil action for damages” pursuant to Section 11(a)(5)(B) of the Vaccine
Act. Respondent also argues that “an MRP proceeding can lead to damages, as it is the
initial step in a medical malpractice suit.”
Section 11(a)(5)(B) of the Vaccine Act states, “[i]f a plaintiff has pending a civil
action for damages for a vaccine-related injury or death, such person may not file a
petition under subsection (b) of this section for such injury or death.” 42 U.S.C. § 300aa-
11(a)(5)(B). A “civil action” within Section 11(a)(5)(B) of the Vaccine Act, logically,
encompasses civil actions filed in state courts. See, e.g., Aull v. Sec’y of Health & Human
7 The MMA indicates that a medical review panel proceeding is initiated when a claimant
files a “request for review of malpractice claim or a malpractice complaint,” with the States
of Louisiana’s Division of Administration. See LA. REV. STAT. ANN. § 40.1231.8(A)(1)(b),
(2)(b).
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Servs., 462 F.3d 1338, 1344 (Fed. Cir. 2006) (affirming dismissal of petition for
compensation pursuant to Section 11(a)(5)(B) of the Vaccine Act when petitioner had a
pending civil action in Kentucky State Court when the petition was filed); see also Flowers
v. Sec’y of Health & Human Servs., 49 F.3d 1558, 1559 (Fed. Cir. 1995) (affirming
dismissal of petition for compensation pursuant to Section 11(a)(5)(B) of the Vaccine Act
when petitioner had a pending civil action in Ohio State Court at the time the petition was
filed); Weddel v. Sec’y of Health & Human Servs., 23 F.3d 388, 389 (Fed. Cir. 1994)
(affirming dismissal of petition for compensation pursuant to Section 11(a)(5)(B) of the
Vaccine Act when petitioner had a pending civil action in Texas State Court at the time
the petition was filed); Huzenlaub v. Sec’y of Health & Human Servs., 34 Fed. Cl. 691,
695 (1996) (finding that petition for compensation was barred from this court pursuant to
Section 11(a)(5)(B) of the Vaccine Act when petitioner had a pending Texas State Court
action at the time the petition was filed); Allison v. Sec’y of Health & Human Servs., 23
Cl. Ct. 551, 556 (1991) (affirming Special Master’s decision to dismiss petition for
compensation when petitioner had a pending civil action before the Nevada Supreme
Court on the date she filed her petition). It appears, however, that no court has squarely
addressed whether the terms “civil action,” as used in Section 11(a)(5)(B) of the Vaccine
Act, includes proceedings, such as the medical review panel proceeding in Louisiana, in
which no complaint was ever filed in a state or federal court.
In a statutory construction analysis, the first step is “to determine whether the
language at issue has a plain and unambiguous meaning with regard to the particular
dispute in the case.” Barnhart v. Sigmon Coal Co., 534 U.S. 438, 450 (2002) (quoting
Robinson v. Shell Oil Co., 519 U.S. 337, 340 (1997)); see also Caraco Pharm. Labs., Ltd.
v. Novo Nordisk A/S, 132 S. Ct. 1670, 1680 (2012) (“We begin ‘where all such inquiries
must begin: with the language of the statute itself.’” (quoting United States v. Ron Pair
Enters., Inc., 489 U.S. 235, 241 (1989))); Jimenez v. Quarterman, 555 U.S. 113, 118
(2009) (“As with any question of statutory interpretation, our analysis begins with the plain
language of the statute.”); Click-To-Call Techs., LP v. Ingenio, Inc., YellowPages.com,
LLC, 899 F.3d 1321, 1329 (Fed. Cir. 2018) (“The first step ‘is to determine whether the
language at issue has a plain and unambiguous meaning . . . .’” (quoting Barnhart v.
Sigmon Coal Co., Inc., 534 U.S. at 450)); Starry Assocs., Inc. v. United States, 892 F.3d
1372, 1377 (Fed. Cir. 2018); Bettcher Indus., Inc. v. Bunzl USA, Inc., 661 F.3d 629, 644
(Fed. Cir.), reh’g and reh’g en banc denied (Fed. Cir. 2011); Strategic Hous. Fin. Corp. of
Travis Cnty. v. United States, 608 F.3d 1317, 1323 (Fed. Cir.) (“When interpreting any
statute, we look first to the statutory language.”), reh’g and reh’g en banc denied (Fed.
Cir. 2010), cert. denied, 562 U.S. 1221 (2011); Mgmt. and Training Corp. v. United States,
115 Fed. Cl. 26, 42 (2014) (“Principles of statutory interpretation dictate that the court
begin its analysis with the text of the regulation at issue because, if the terms of the
regulation are unambiguous, the plain language of a regulation is controlling.”). “The
plainness or ambiguity of statutory language is determined by reference to the language
itself, the specific context in which that language is used, and the broader context of the
statute as a whole.” Robinson v. Shell Oil Co., 519 U.S. at 341 (citing Estate of Cowart
v. Nicklos Drilling Co., 505 U.S. 469, 477 (1992); McCarthy v. Bronson, 500 U.S. 136,
139 (1991)); see also King v. Burwell, 135 S. Ct. 2480, 2489 (2015) (“[W]hen deciding
whether the language is plain, we must read the words ‘in their context and with a view
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to their place in the overall statutory scheme.’” (quoting FDA v. Brown & Williamson
Tobacco Corp., 529 U.S. 120, 133 (2000))). “‘Beyond the statute’s text, the traditional
tools of statutory construction include the statute’s structure, canons of statutory
construction, and legislative history.’” Bartels Trust for the Benefit of Cornell Univ. ex rel.
Bartels v. United States, 617 F.3d 1357, 1361 (Fed. Cir.) (quoting Bull v. United States,
479 F.3d 1365, 1376 (Fed. Cir. 2007)), reh’g en banc denied (Fed. Cir. 2010); see also
Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 132 S. Ct. at 1680 (“[W]e consider each
question [of statutory interpretation] in the context of the entire statute.” (citing Robinson
v. Shell Oil Co., 519 U.S. at 341)); Roberts v. Sea-Land Servs., Inc., 132 S. Ct. 1350,
1356 (2012); Bush v. United States, 655 F.3d 1323, 1329 (Fed. Cir. 2011), cert. denied,
132 S. Ct. 2681 (2012).
The initial inquiry into the statutory text ceases “if the statutory language is
unambiguous and ‘the statutory scheme is coherent and consistent.’” Barnhart v. Sigmon
Coal Co., 534 U.S. at 450 (quoting Robinson v. Shell Oil Co., 519 U.S. at 340); see also
King v. Burwell, 135 S. Ct. at 2489 (“If the statutory language is plain, we must enforce it
according to its terms.” (citing Hardt v. Reliance Standard Life Ins. Co., 560 U.S. 242, 251
(2010)); Bettcher Indus., Inc. v. Bunzl USA, Inc., 661 F.3d at 644; Arko Foods Int’l, Inc. v.
United States, 654 F.3d 1361, 1364 (Fed. Cir. 2011) (“‘[W]here Congress has clearly
stated its intent in the language of a statute, a court should not inquire further into the
meaning of the statute.’” (quoting Millenium Lumber Distrib., Ltd. v. United States, 558
F.3d 1326, 1328 (Fed. Cir.), reh’g denied (Fed. Cir. 2009)); Am. Airlines, Inc. v. United
States, 551 F.3d 1294, 1300 (Fed. Cir. 2008), reh’g granted, 319 F. App’x 914 (Fed. Cir.
2009). Thus, when the “‘statute’s language is plain, “the sole function of the courts is to
enforce it according to its terms.”’” Johnson v. United States, 529 U.S. 694, 723 (2000)
(quoting United States v. Ron Pair Enters., Inc., 489 U.S. at 241 (quoting Caminetti v.
United States, 242 U.S. 470, 485 (1917))); see also Jimenez v. Quarterman, 555 U.S. at
118; Hartford Underwriters Ins. Co. v. Union Planters Bank, N.A., 530 U.S. 1, 6 (2000));
Bartels Trust for the Benefit of Cornell Univ. ex rel. Bartels v. United States, 617 F.3d at
1361 (citing Sharp v. United States, 580 F.3d at 1237); Candle Corp. of Am. v. U.S. Int’l
Trade Comm’n, 374 F.3d 1087, 1093 (Fed. Cir.), reh’g and reh’g denied (Fed. Cir. 2004).
Indeed, in construing a statute, courts “‘must begin with the language employed by
Congress and the assumption that the ordinary meaning of that language accurately
expresses the legislative purpose.’” Schindler Elevator Corp. v. United States, 131 S. Ct.
1885, 1891 (2011) (quoting Gross v. FBL Fin. Servs., Inc., 557 U.S. 167, 175 (2009)
(internal quotation marks omitted)). Even “‘[w]hen terms used in a statute are undefined,
we give them their ordinary meaning.’” Schindler Elevator Corp. v. United States, 131 S.
Ct. at 1891 (quoting Asgrow Seed Co. v. Winterboer, 513 U.S. 179, 187 (1995)).
In interpreting the plain meaning of the statute, it is the court’s duty, if possible, to
give meaning to every clause and word of the statute. See Setser v. United States, 132
S. Ct. 1463, 1470 (2012) (“Our decision today follows the interpretive rule they invoke,
that we must ‘give effect . . . to every clause and word’ of the Act.” (omission in original)
(quoting United States v. Menasche, 348 U.S. 528, 538–39 (1955))); see also Alaska
Dep’t of Envtl. Conservation v. EPA, 540 U.S. 461, 489 n.13 (2004) (“It is, moreover, ‘“a
cardinal principle of statutory construction” that “a statute ought, upon the whole, to be so
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construed that, if it can be prevented, no clause, sentence, or word shall be superfluous,
void, or otherwise insignificant.”’” (quoting TRW Inc. v. Andrews, 534 U.S. 19, 31 (2001)
(quoting Duncan v. Walker, 533 U.S. 167, 174 (2001)))); Williams v. Taylor, 529 U.S. 362,
404 (2000) (describing as a “cardinal principle of statutory construction” the rule that every
clause and word of a statute must be given effect if possible); Sharp v. United States, 580
F.3d 1234, 1238 (Fed. Cir. 2009). Similarly, the court must avoid an interpretation of a
clause or word which renders other provisions of the statute inconsistent, meaningless,
or superfluous. See Duncan v. Walker, 533 U.S. at 174 (noting that courts should not
treat statutory terms as “surplusage”). “[W]hen two statutes are capable of co-existence,
it is the duty of the courts . . . to regard each as effective.” Radzanower v. Touche Ross
& Co., 426 U.S. 148, 155 (1976); see also Xianli Zhang v. United States, 640 F.3d 1358,
1368 (Fed. Cir.) (citing Cathedral Candle Co. v. U.S. Int’l Trade Comm’n, 400 F.3d 1352,
1365 (Fed. Cir. 2005)), reh’g and reh’g en banc denied (Fed. Cir. 2011), cert. denied, 132
S. Ct. 2375 (2012); Hanlin v. United States, 214 F.3d 1319, 1321 (Fed. Cir.), reh’g denied
(Fed. Cir. 2000).
The United States Supreme Court also has held that the specific terms of a statute
supersede general terms within that statute or within another statute that might otherwise
control. See Fourco Glass Co. v. Transmirra Prods. Corp., 353 U.S. 222, 228–29 (1957)
(“Specific terms prevail over the general in the same or another statute which otherwise
might be controlling.” (quoting D. Ginsberg & Sons v. Popkin, 285 U.S. 204, 208 (1932)));
see also Bloate v. United States, 559 U.S. 196, 207 (2010); Bulova Watch Co. v. United
States, 365 U.S. 753, 761 (1961). In addition, the Supreme Court has endorsed “the
‘normal rule of statutory construction’ that ‘identical words used in different parts of the
same act are intended to have the same meaning.’” Gustafson v. Alloyd Co., 513 U.S.
561, 570 (1995) (quoting Dep’t of Revenue of Or. v. ACF Indus., Inc., 510 U.S. 332, 342
(1994)); see also Kislev Partners, L.P. ex rel. Bahar v. United States, 84 Fed. Cl. 385,
389, recons. denied, 84 Fed. Cl. 378 (2008).
If a statute unequivocal on its face or the meaning of the statute is plain, there is
usually no need to resort to the legislative history underlying the statute. See Whitfield v.
United States, 543 U.S. 209, 215 (“Because the meaning of [the statute’s] text is plain
and unambiguous, we need not accept petitioners’ invitation to consider the legislative
history . . . .”), reh’g denied sub nom. Hall v. United States, 544 U.S. 913 (2005). But see
Chamberlain Grp., Inc. v. Skylink Techs., Inc., 381 F.3d 1178, 1196 (Fed. Cir.) (“Though
‘we do not resort to legislative history to cloud a statutory text that is clear,’ Ratzlaf v.
United States, 510 U.S. 135, 147–48 (1994), we nevertheless recognize that ‘words are
inexact tools at best, and hence it is essential that we place the words of a statute in their
proper context by resort to the legislative history.’” (quoting Tidewater Oil Co. v. United
States, 409 U.S. 151, 157 (1972))), reh’g and reh’g en banc denied (Fed. Cir. 2004), cert.
denied, 544 U.S. 923 (2005). In limited circumstances, legislative history may be helpful
in certain instances “to shed light on what legislators understood an ambiguous statutory
text to mean when they voted to enact it into law.” Bruesewitz v. Wyeth LLC, 131 S. Ct.
1068, 1081–82 (2011) (citing Exxon Mobile Corp. v. Allapatah Servs., Inc., 545 U.S. 546,
568 (2005); see also Xianli Zhang v. United States, 640 F.3d at 1373. Legislative history,
however, does not “trump[] clear text.” Bartels Trust for the Benefit of Cornell Univ. ex
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rel. Bartels v. United States, 617 F.3d at 1361 (citing Sharp v. United States, 580 F.3d at
1238; Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392, 396 (Fed. Cir. 1990)). The
Supreme Court, however, has noted that when it appears that the plain language of a
statute resolves the issue, a court is to “look to the legislative history to determine only
whether there is [a] ‘clearly expressed legislative intention’ contrary to that language,
which would require us to question the strong presumption that Congress expresses its
intent through the language it chooses.” INS v. Cardoza-Fonseca, 480 U.S. 421, 432 n.12
(1987) (citing United States v. James, 478 U.S. 597, 606 (1986), abrogated on other
grounds by Cent. Green Co. v. United States, 531 U.S. 425, 436 (2001)); Consumer
Product Safety Comm’n v. GTE Sylvania, Inc., 447 U.S. 102, 108 (1980)).
“When terms are not defined, it is a basic principal of statutory interpretation that
they are deemed to have their ordinary meaning. For that meaning, it is appropriate to
consult dictionaries.” Nielson v. Shinseki, 607 F.3d 802, 805-06 (Fed. Cir. 2010) (internal
citations omitted); see also F.D.I.C. v. Meyer, 510 U.S. 471, 476 (1994) (referring to
Black’s Law Dictionary when determining the ordinary meaning of “cognizable,” which
was not defined in the Federal Tort Claims Act); Hebah v. United States, 197 Ct. Cl. 729,
743, 456 F.2d 696, 704 (1972) (“To establish the common or plain meaning of a word or
term, this court has long accepted dictionary definitions.”); Bortone v. United States, 110
Fed. Cl. 668, 677–78 (2013) (“It is well-settled that when a statute or regulation does not
provide the definition of a term, courts construe the term in accordance with its ordinary
or natural meaning. Dictionaries can serve as the basis for determining the plain
meaning.” (internal citations omitted)); Wash. State Dep’t of Servs. for the Blind v. United
States, 58 Fed. Cl. 781, 789 (2003) (stating that “[i]n the absence of a statutory or
regulatory definition,” that the Court of Federal Claims “looks to the dictionary to establish
the plain meaning of the term”). In addition, “[i]n construing statutory language, we look
to dictionary definitions published at the time that the statute was enacted.” Res.
Conservation Grp., LLC v. United States, 597 F.3d 1238, 1243 (Fed. Cir. 2010) (footnote
omitted); see also N.Y. & Presbyterian Hosp. v. United States, 881 F.3d 877, 882 (Fed.
Cir. 2018) (“It is a fundamental canon of statutory construction that . . . words will be
interpreted as taking their ordinary, contemporary, common meaning, which may be
derived from [d]ictionaries from the era of [the statutory provision]’s enactment.” (internal
quotation marks omitted; ellipses and alterations in original)).
Respondent argues that Petitioner’s medical review panel proceeding was a “civil
action” within Section 11(a)(5)(B) of the Vaccine Act, “even if it was not actually filed in a
state or federal court.” Respondent notes that the phrase “civil action” within Section
11(a)(5)(B) of the Vaccine Act does not contain the modifier “State or Federal court” as
does Section 11(a)(2) of the Vaccine Act (codified at 42 U.S.C. § 300aa-11(a)(2)).
According to Respondent, “Congress’s choice to omit” the modifier “State of Federal
court” from Section 11(a)(5)(B) while including it in Section 11(a)(2) should not be
disregarded as “meaningless.” Respondent argues that Congress’s omission of the
modifier “State or Federal court” from Section 11(a)(5)(B) of the Vaccine Act means that
Section 11(a)(5)(B)’s “prohibition against a pending civil action is not confined to cases
filed in state and federal court.”
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Section 11(a)(2) of the Vaccine Act states that:
(2)(A) No person may bring a civil action for damages in an amount greater
than $1,000 or in an unspecified amount against a vaccine administrator or
manufacturer in a State or Federal court for damages arising from a
vaccine-related injury or death associated with the administration of a
vaccine after October 1, 1988, and no such court may award damages in
an amount greater than $1,000 in a civil action for damages for such a
vaccine-related injury or death, unless a petition has been filed, in
accordance with section 300aa-16 of this title, for compensation under the
Program for such injury or death and—
(i)(I) the United States Court of Federal Claims has issued a
judgment under section 300aa-12 of this title on such petition,
and
(II) such person elects under section 300aa-21(a) of this title
to file such an action, or
(ii) such person elects to withdraw such petition under section
300aa-21(b) of this title or such petition is considered
withdrawn under such section.
(B) If a civil action which is barred under subparagraph (A) is filed in a State
or Federal court, the court shall dismiss the action. If a petition is filed under
this section with respect to the injury or death for which such civil action was
brought, the date such dismissed action was filed shall, for purposes of the
limitations of actions prescribed by section 300aa-16 of this title, be
considered the date the petition was filed if the petition was filed within one
year of the date of the dismissal of the civil action.
42 U.S.C. § 300aa-11(a)(2) (emphasis in original). Section 11(a)(5)(B) of the Vaccine Act,
contrastingly, does not include the modifier “State of Federal court,” and instead states
that, “[i]f a plaintiff has pending a civil action for damages for a vaccine-related injury or
death, such person may not file a petition under subsection (b) of this subsection for such
injury or death.” Id. at § 300aa-11(a)(5)(B).
As support for its argument, Respondent cites to Sullivan v. McDonald, 815 F.3d
786 (Fed. Cir. 2016), in which the United States Court of Appeals for the Federal Circuit
interpreted a regulation regarding veterans’ benefits. See id. at 789-91. The facts of
Sullivan, however, are distinguishable from the above-captioned case. At issue in Sullivan
was whether a United States Department of Veterans Affairs (VA) regulation, which
required the VA to assist a veteran in obtaining VA medical records in connection with the
veteran’s disability compensation claim, imposed a duty on the VA only to obtain
“relevant” VA medical records. See id. at 791. The regulation at issue identified four
categories of different medical records that the VA would provide assistance in obtaining,
which were,
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(1) the claimant’s service medical records, if relevant to the claim; (2) other
relevant records pertaining to the claimant’s active military, naval or air
service that are held or maintained by a governmental entity; (3) VA medical
records or records of examination or treatment at non-VA facilities
authorized by VA; and (4) any other relevant records held by any Federal
department or agency.
Id. at 790–91 (emphasis in original). As quoted above, category number three, which
required the VA to obtain a veteran’s VA medical records, was the only category of
records which did not reference whether such records needed to be “relevant.” See id.
The Sullivan court explained that:
The VA knew how to indicate when it was limiting its duty to assist to
obtaining relevant records only, which it did by including the term “relevant”
as a modifier for three of the four categories of records identified in
§ 3.159(c)(3). But with respect to “VA medical records or records of
examination or treatment at non-VA facilities authorized by VA,” the modifier
“relevant” is notably absent.
Sullivan v. McDonald, 815 F.3d at 791. The Sullivan court then concluded that:
Because “we attempt to give full effect to all words contained within that
statute or regulation,” Glover [v. West], 185 F.3d [1328, 1332 (Fed. Cir.
1999)], meaning should be given to the VA’s choice to impose a relevancy
standard on the VA’s duty to assist in obtaining certain categories of
records, as well as its choice to not impose such a standard on VA medical
records. We will not read in a relevancy standard where the VA left it out.
Sullivan v. McDonald, 815 F.3d at 791.
Unlike in Sullivan, however, in which the court found that the notable absence of
the word “relevant” was indicative of Congressional intent, the absence of the phrase
“State or Federal court” from Section 11(a)(5)(B) of the Vaccine Act is neither notable nor
helpful to Respondent’s argument. In the above-captioned case, the phrase “civil action”
appears within seven subsections of Section 11(a) of the Vaccine Act, the section which
provides the various requirements for filing petitions for compensation in this court. See
42 U.S.C. § 300aa-11(a). The phrase “civil action,” however, is only qualified with the
words “State or Federal court” within Section 11(a)(2) of the Vaccine Act. See 42 U.S.C.
§ 300aa-11(a)(2). For the remaining six Sections, the Vaccine Act only refers to a “civil
action.” See 42 U.S.C. § 300aa-11(a)(3)-11(a)(8). Thus, contrary to Respondent’s
position, Section 11(a)(5)(B)’s exclusion of the modifier “State or Federal court” from the
phrase “civil action” is not notable nor indicative that, as Respondent argues, Section
11(a)(5)(B)’s “prohibition against a pending civil action is not confined to cases filed in
state and federal court.”
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Respondent also argues that, “if filing in state or federal court is inherent in the
meaning of the term civil action, as petitioner argues, the inclusion of ‘State or Federal
court’ in Section 11(a)(2) would be superfluous, rendering such a reading inconsistent
with the tenets of statutory interpretation.” The inclusion of the words “State or Federal
court” in Section 11(a)(2) of the Vaccine Act, however, does not render the plain meaning
of a “civil action,” which is commonly understood as an action filed in a court of competent
jurisdiction, superfluous. Instead, the better reading of Section 11(a)(2) of the Vaccine Act
is that the phrase “State or Federal court” clarifies that an individual cannot file a “civil
action” either in a state or federal court before filing a petition for compensation in this
court. The clarifying phrase “State or Federal court,” Section 11(a)(2) of the Vaccine Act
is directed at clarifying that a petitioner is prohibited from initiating a federal or a state
court action prior to filing a petition for compensation in this court. Thus, contrary to
Respondent’s position, a “civil action” within the meaning of Section 11(a)(5)(B) of the
Vaccine Act remains defined as an action filed in a court of competent jurisdiction.
Respondent also argues that Petitioner’s medical review panel proceeding is a
“civil action for damages” pursuant to Section 11(a)(5)(B) of the Vaccine Act because,
under Louisiana State law, legal interest on the judgment entered in a civil malpractice
lawsuit before a court of competent jurisdiction accrues from the date the request for
review is filed in a medical review panel proceeding. The date that legal interest accrues
in a medical malpractice suit before a court of competent jurisdiction in Louisiana,
however, is not dispositive. A medical malpractice claim filed in a court of competent
jurisdiction is an optional, and independent, proceeding from a pre-trial screening before
a medical review panel. As previously noted, a claimant in Louisiana may file, if he or she
so chooses, a medical malpractice lawsuit in a court of competent jurisdiction only after
the completion of a medical review panel proceeding. In addition, a Louisiana claimant is
not required to file suit following the completion of his or her medical review panel
proceeding. In fact, the MMA in Louisiana requires a claimant to participate in a pre-
screening medical review panel proceeding before filing suit, is designed such that
claimants, hopefully, will resolve claims during the medical review panel proceeding and,
thus, will not have to file suit in a court of law. As the Supreme Court of Louisiana
explained in McGlothlin v. Christus St. Patrick Hospital, a pre-trial screening before a
medical review panel is
designed to weed out frivolous claims without the delay or expense of a
court trial. It is thought that the use of such panels will encourage settlement
because both parties will be given a preliminary view of the merits of the
case. If a claim is found by the panel to be without merit it is thought that
the claimant will be likely to abandon his claim or agree to a nominal
settlement. Moreover, a plaintiff who gains a favorable opinion from the
panel may be able to negotiate a favorable settlement with his defendants,
a procedure which also avoids much of the time and expense of a trial.
McGlothlin v. Christus St. Patrick Hosp., 65 So. 3d at 1226 (quoting Everett v. Goldman,
359 So. 2d at 1264); see also Perritt v. Dona, 849 So. 2d 56, 61; Rhodes v. Schultis, 140
So. 3d at 336 (“The Louisiana Medical Malpractice Act requires that all medical
malpractice claims against qualified health care providers are to be submitted to a medical
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review panel prior to filing suit in any court. The purpose of pre-trial screening through a
medical review panel is to weed out frivolous claims without the delay or expense of a
court trial.” (internal citations omitted)); Ward v. Vivian Healthcare and Rehab. Ctr., 116
So. 3d at 874 (“[A] claim first be submitted to a medical review panel before the
malpractice action may commence in court. The medical review panel is a filtering
process that is meant to weed out frivolous claims or prompt defendants to settle valid
claims reasonably.” (internal citations omitted)). Because the filing of suit following a
medical review panel proceeding is completely optional, and is independent from a
medical review panel proceeding, the date from which legal interest would accrue on a
judgment entered in a medical malpractice suit following a medical review panel does not
support Respondent’s position that a pre-screening medical review panel proceeding in
Louisiana should be considered a “civil action for damages” pursuant to Section
11(a)(5)(B) of the Vaccine Act.
Respondent then argues that Petitioner’s medical review panel proceeding was a
“civil action for damages” pursuant to Section 11(a)(5)(B) of the Vaccine Act because
“State Court authority was exercised to first extend the duration of petitioner’s Malpractice
Claim and then to dismiss that claim.” Although the 24th Judicial District Court for the
Parish of Jefferson, Louisiana issued two procedural orders relevant to Petitioner’s
medical review panel proceeding, such actions did not transform Petitioner’s medical
review panel proceeding into a civil court action in a court of competent jurisdiction. On
September 22, 2014, the 24th Judicial District Court for the Parish of Jefferson, Louisiana
issued an Order granting an extension of time for the medical review panel to issue its
expert opinion. Then, on June 18, 2015, the 24th Judicial District Court for the Parish of
Jefferson, Louisiana issued an Order dismissing Petitioner’s medical review panel
proceeding for failure to comply with an Order to Compel. Pursuant to Louisiana State
law, the parties are allowed limited, specialized access to a local Louisiana State Court
to decide procedural and time limitation issues during a medical review panel proceeding,
such as granting time extensions or ordering the parties to comply with certain medical
review panel procedural orders. See LA. REV. STAT. ANN. § 40:1231.8(B)(1)(b), (C)(6). The
court, however, during the life of a medical panel review proceeding, has no authority to
rule on whether the defending party failed to comply with the applicable standard of care
or to award damages. The medical review panel is the only body which rules on the merits
of a claimant’s claim for medical malpractice during the life of a medical review panel
proceeding, and even then, the medical review panel has limited, expert opinion authority.
The medical review panel’s “sole duty” is to issue an expert opinion “as to whether or not
the evidence supports the conclusion that the defendant or defendants acted or failed to
act within the appropriate standards of care.” Id. at § 40:1231.8(G). Moreover, the expert
opinion itself is not binding on any future civil court proceedings. See id. at § 40:1231.8(H).
The claimant’s next step, if he or she so chooses, is to file an action in a court of
competent jurisdiction, but only if the individual has participated in the medical review
panel process can the individual claimant file a civil action in a Louisiana State Court or
in any Federal District Court which has diversity jurisdiction over a medical malpractice
claim under Louisiana State law.
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For Petitioner’s medical review panel proceeding to bar a petition for vaccine
compensation in this court pursuant to Section 11(a)(5)(B) of the Vaccine Act, Petitioner’s
previous proceeding must have been both a (1) a “civil action, (2) “for damages.” See 42
U.S.C. § 300aa-11(a)(5)(B) (noting that a petitioner is barred from filing a petition in this
court if the petitioner has “pending a civil action for damages for a vaccine-related injury
or death” (emphasis added)). Based on the plain language of this statutory provision,
Petitioner’s medical review panel proceeding does not qualify as one for either a “civil
action” or an action “for damages.” In the first place, the term “civil action” generally refers
to an action in a civil case filed in a state or federal court of competent jurisdiction.
Although the phrase “civil action” within Section 11(a)(5)(B) of the Vaccine Act is
undefined in the Vaccine Act, as previously noted, it is a “fundamental canon of statutory
construction” that words “will be interpreted as taking their ordinary, contemporary
common meaning, which may be derived from [d]ictionaries from the era of [the statutory
provision]’s enactment.” N.Y. & Presbyterian Hosp. v. United States, 881 F.3d at 882
(internal quotation marks omitted; alterations in original). Based on dictionaries in use
around the time the Vaccine Act was enacted, the plain meaning of the phrase “civil
action” is an action filed in a court of competent jurisdiction. See A Dictionary of Modern
Legal Use 20 (2d ed. 1995) (defining “action” as a “mode of proceeding in court to enforce
a private right, to redress or prevent a private wrong, or to punish a public offense”); see
also Black’s Law Dictionary 245, 28 (6th ed. 1990) (defining “Civil action” as an “[a]ction
brought to enforce, redress, or protect private rights,” and “Action” as a “lawsuit brought
in a court; a formal complaint within the jurisdiction of a court of law.”); Webster’s New
Collegiate Dictionary 12, 202 (1981) (defining “action” as “a proceeding in a court of
justice by which one demands or enforces one’s right,” and “civil” as “relating to private
rights and to remedies sought by action or suit distinct from criminal proceedings”).8
8 The legislative history of Section 11(a)(5)(B) of the Vaccine Act is consistent with the
position that the plain and unambiguous meaning of a “civil action” is an action filed in a
court of competent jurisdiction. As the Federal Circuit explained in Flowers v. Secretary
of Health & Human Services,
[a]s originally enacted, [Section 11(a)(5)] the Vaccine Act stated in pertinent
part that:
. . . .
(B) If a plaintiff who on the effective date of this subtitle had
pending a civil action for damages for a vaccine-related injury
or death does not withdraw the action under subparagraph
(A), such person may not file a petition under subsection (b)
for such injury or death.
Flowers v. Sec’y of Health & Human Servs., 49 F.3d at 1560 (emphasis in original). In
1989, Congress amended Section 11(a)(5)(B) to delete the underscored portion quoted
above. See id.; see also Omnibus Budget Reconciliation Act of 1989, Pub. L. No. 101–
239, § 6601(c)(3)(B), 103 Stat. 2106, 2285. Congress explained in a House of
Representatives Report, dated September 20, 1989, that the 1989 amendment to Section
11(a)(5)(B) provided “technical clarification of the ability of a petitioner with a civil court
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Based on the record before the court, Petitioner’s medical review panel proceeding
in Louisiana was not a civil action initiated in a court of competent jurisdiction. As required
by the MMA, before a claimant can file a medical malpractice claim in a court of competent
jurisdiction in Louisiana, a claimant is required to participate in a medical review panel
proceeding, which is a “[p]retrial screening” before a panel of medical experts, not a court
of competent jurisdiction. See McGlothlin v. Christus St. Patrick Hosp., 65 So. 3d at 1226
(noting that a medical review panel proceeding is a “[p]retrial screening” that is “designed
to weed out frivolous claims without the delay or expense of a court trial”); see also Perritt
v. Dona, 849 So. 2d at 61 (“The MMA requires that all claims against health care providers
be reviewed or ‘filtered’ through a medical review panel before proceeding to any other
court.”); Rhodes v. Schultis, 140 So. 3d at 336 (“The Louisiana Medical Malpractice Act
requires that all medical malpractice claims against qualified health care providers are to
be submitted to a medical review panel prior to filing suit in any court. The purpose of pre-
trial screening through a medical review panel is to weed out frivolous claims without the
delay or expense of a court trial.” (internal citations omitted)); Ward v. Vivian Healthcare
and Rehab. Ctr., 116 So. 3d at 874 (“[A] claim first be submitted to a medical review panel
before the malpractice action may commence in court. The medical review panel is a
filtering process that is meant to weed out frivolous claims or prompt defendants to settle
valid claims reasonably.” (internal citations omitted)).
As described above, on February 5, 2013, Petitioner commenced her required pre-
trial, medical review panel proceeding by submitting a letter to the State of Louisiana’s
Division of Administration, a Louisiana State executive agency, requesting that a medical
review panel proceeding be commenced. The State of Louisiana’s Division of
Administration forwarded her request to the PCF Oversight Board, a nine-member board
organized within the State of Louisiana’s executive branch Division of Administration. As
previously noted, the PCF Oversight Board plays a ministerial role in the medical review
panel proceeding, and oversees the various filings made by the parties to the
proceedings. See Franks v. La. Patient’s Compensation Fund Oversight Bd., 220 So. 3d
at 868; see also Berthelot v. Patients’ Compensation Fund Oversight Bd., 977 So. 2d at
973. The merits of Petitioner’s medical malpractice claim were to be reviewed by a four-
member medical review panel, which is not a judge or jury but “merely a body of experts
assembled to evaluate a medical claim and to provide an expert opinion.” Jeansonne v.
Bonano, 241 So. 3d at 1031. Further, unlike a court of competent jurisdiction, the medical
review panel’s authority is singularly limited to issuing a medical expert opinion as to
“whether or not the evidence supports the conclusion that the defendant or defendants
acted or failed to act within the appropriate standards of care.” LA. REV. STAT. ANN.
§ 40:1231.8(G). See McGlothlin v. Christus St. Patrick Hosp., 65 So. 3d at 1229 (“[T]he
action pending to enter the compensation system.” H.R. Rep. No. 247, 101st Cong., 1st
Sess. 511 (1989), reprinted in 1989 U.S.C.C.A.N. 1906, 2237 (emphasis added). Instead
of simply referring to a “civil action” in the September 20, 1989 House Report when
referring to Section 11(a)(5)(B) of the Vaccine Act, Congress, in the September 20, 1989
House Report, referred to a “civil court action,” suggesting that Congress understood that
a “civil action” within Section 11(a)(5)(B) of the Vaccine Act referred to a proceeding filed
in a court of competent jurisdiction. See id.
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panel’s sole duty under our medical malpractice scheme is to express its expert opinion
as to whether or not the evidence supports the conclusion the defendant or defendants
acted or failed to act within the appropriate standard of care.” (internal quotation marks
omitted)). In addition, the medical review panel’s expert opinion is non-binding in a future
court proceeding. See LA. REV. STAT. ANN. § 40:1231.8(H). If a claimant decides to initiate
an action in a court of competent jurisdiction following the completion of a medical review
panel, the medical review panel’s expert opinion may be introduced at trial as expert
testimony, and may be rejected or accepted by the trial court. See McGlothlin v. Christus
St. Patrick Hosp., 65 So. 3d at 1227 (“The opinion, therefore, can be used by either the
patient or the qualified health care provider, and the jury, as trier of fact, is free to accept
or reject any portion or all of the opinion.”); see also Matranga v. Parish Anesthesia of
Jefferson, LLC, 170 So. 3d at 1091 (“[A]s with any other expert testimony, the Medical
Review Panel Opinion is subject to review and a trial court may reject it as inadmissible.”
(citing McGlothlin v. Christus St. Patrick Hosp., 65 So. 3d at 1227)); Rhodes v. Schultis,
140 So. 3d at 337 (“[N]othing in the Medical Malpractice Act prevents Plaintiffs from
presenting evidence, including expert medical testimony, at trial that contradicts the
panel’s opinion.”). Notably, before the medical review panel could issue its expert opinion
in Petitioner’s medical review panel proceeding, the medical review panel was dissolved,
and the medical review panel proceeding was dismissed. Thus, no expert opinion was
ever issued in Petitioner’s medical review panel proceeding. For these reasons,
Petitioner’s pre-trial screening proceeding before a medical review panel does not qualify
as a “civil action” which would prohibit Petitioner from filing a petition for compensation in
this court pursuant to Section 11(a)(5)(B) of the Vaccine Act.
In addition, the only two decisions, albeit both unpublished and issued long ago,
by Special Masters in this court to have addressed whether a “civil action,” as used within
the Vaccine Act, include pre-trial proceedings, concluded that pre-trial proceedings were
not included within the plain meaning of a “civil action.” In Polanco v. Secretary of Health
& Human Services, No. 91-195V, 1997 WL 618256, at *4 (Fed. Cl. Spec. Mstr. Sept. 11,
1997) and in Taylor v. Secretary of Health & Human Services, No. 90–1036V, 1995 WL
729519, at *4 (Fed. Cl. Spec. Mstr. Mar. 27, 1995), the Special Masters addressed
whether either proceeding should be considered a “civil action” pursuant to Section
11(a)(6) of the Vaccine Act, which prohibits an individual from filing a petition in this court
if “a person brings a civil action after November 15, 1988 for damages for a vaccine-
related injury or death associated with the administration of a vaccine before November
15, 1998.” 40 U.S.C. § 300aa-11(a)(6). Because Section 11(a)(6) and Section 11(a)(5)(B)
of the Vaccine Act both refer to a “civil action” “for damages,” the Special Masters’
decisions in Polanco and Taylor as to what constitutes a “civil action” are instructive. Both
Special Masters found that the prior proceedings at issue in their particular cases, which,
under applicable state law, were condition precedents to filing a civil malpractice action
in court, were not to be considered a “civil action” within the meaning of Section 11(a)(6).
See Polanco v. Sec’y of Health & Human Servs., 1997 WL 618256, at *4 (finding that the
filing of a “notice of claim” in the Supreme Court of New York was not the commencement
or bringing of a civil action pursuant to Section 11(a)(6) because, according to New York
State law, the filing of a notice of claim is a “condition precedent to the commencement
of an action against a governmental entity”); see also Taylor v. Sec’y of Health & Human
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Servs., 1995 WL 729519, at *4 (finding that the filing of an action before an arbitration
board was not the commencement of a civil action pursuant to Section 11(a)(6) because,
according to Maryland State law, the arbitration board proceeding was a mere screening
process and a statutory precondition to filing a medical malpractice action). In Mrs.
Skinner-Smith’s case, Petitioner’s medical review panel proceeding, like the proceedings
at issue in Polanco and Taylor, is, pursuant to Louisiana State law, a condition precedent
to filing a medical malpractice claim in Louisiana State Court. See McGlothlin v. Christus
St. Patrick Hosp., 65 So. 3d at 1226; see also Perritt v. Dona, 849 So. 2d at 61. The court
finds that Petitioner’s medical review panel proceeding does not qualify as a “civil action,”
pursuant to Section 11(a)(5)(B) of the Vaccine Act.
Petitioner’s Louisiana medical review panel proceeding also was not an action “for
damages” within Section 11(a)(5)(B) of the Vaccine Act. As previously noted, pursuant to
Section 11(a)(5)(B) of the Vaccine Act, a petitioner is barred from filing a petition in this
court if the petitioner has “pending a civil action for damages for a vaccine-related injury
or death.” 42 U.S.C. § 300aa-11(a)(5)(B) (emphasis added). Oddly enough, although
Special Master Millman noted that a medical review panel “does not directly award
damages,” she nonetheless concluded, without citing any legal authority, that Petitioner’s
medical review panel proceeding was an action “for damages” pursuant to Section
11(a)(5)(B) of the Vaccine Act because such proceeding “can lead to damages.” Skinner-
Smith v. Sec’y of Health & Human Servs., 2018 WL 3991343, at *4. Special Master
Millman’s unsupported conclusion ignores the plain direction of the statute. The plain
meaning of the word “for,” as defined by dictionaries contemporaneous to the passage of
the Vaccine Act is to indicate “purpose.” See A Dictionary of Modern Legal Use 78
(defining “For” as a “general-purpose causal” conjunction); see also Black’s Law
Dictionary 644 (defining “For” as connoting “the end with reference to which anything is,
acts, serves, or is done. In consideration of which, in view of which, or with reference to
which, anything is done or takes place”); Webster’s New Collegiate Dictionary 444
(defining “for” as a “function word to indicate purpose”). In the phrase at issue, a “civil
action for damages,” the word “for” indicates that the purpose of the civil action should be
to obtain damages in order to bar an action in this court. Based on Louisiana State law,
a medical review panel has no authority to award damages and a damage award is not
available from a medical review panel proceeding. See LA. REV. STAT. ANN.
§ 40:1231.8(G); see also Perritt v. Dona, 849 So. 2d at 62 (“No findings are made by the
panel as to damages.” (quoting Everett v. Goldman, 359 So. 2d at 1263)). A medical
review panel proceeding is a preliminary, required step to filing a lawsuit and the panel’s
“sole” duty is to issue an expert opinion on the moving party’s medical malpractice claim.
See LA. REV. STAT. ANN. § 40:1231.8(G). If a claimant seeks an opportunity to recover
damages, the claimant has the option to file a civil lawsuit following the conclusion of a
medical panel review proceeding. See id. at § 40:1231.8(B)(1)(a)(i). Additionally, while
the medical review panel’s expert opinion may be admissible in a future civil action, it is
not “conclusive,” and has no dispositive effect on whether a claimant may succeed in a
future civil action. See id. at § 40:1231.8(H). Moreover, the expert opinion is not binding
even in a Louisiana State Court action. The court, therefore, concludes that Petitioner’s
medical review panel proceeding does not qualify as an action “for damages” which would
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prohibit Petitioner from filing a petition for compensation in this court pursuant to Section
11(a)(5)(B) of the Vaccine Act.
As indicated above, Special Master Millman concluded, without citing any relevant
legal authority and without any statutory analysis of Section 11(a)(5)(B) of the Vaccine
Act, that Petitioner’s medical review panel proceeding was a “civil action for damages”
pursuant to Section 11(a)(5)(B). See Skinner-Smith v. Sec’y of Health & Human Servs.,
2018 WL 3991343, at *3. Special Master Millman cited to the Supreme Court of Louisiana
case, Nathan v. Touro Infirmary, to support her conclusion that Petitioner’s medical review
panel proceeding was the equivalent of a “civil action” pursuant to Section 11(a)(5)(B) of
the Vaccine Act. See Skinner-Smith v. Sec’y of Health & Human Servs., 2018 WL
3991343, at *3. It is not clear why Special Master Millman considered herself bound by a
Supreme Court of Louisiana decision. This court is bound by precedent from the United
States Supreme Court, the United States Court of Appeals for the Federal Circuit, and its
predecessor, the United States Court of Claims. See Dellew Corp. v. United States, 855
F.3d 1375, 1382 (Fed. Cir. 2017) (noting that “the Court of Federal Claims must follow
relevant decisions of the Supreme Court and the Federal Circuit”); see also Coltec Indus.,
Inc. v. United States, 454 F.3d 1340, 1353 (Fed. Cir. 2006) (“There can be no question
that the Court of Federal Claims is required to follow the precedent of the Supreme Court,
our court, and our predecessor court, the Court of Claims.”).
Special Master Millman relied entirely on the non-binding Nathan decision for the
proposition that the filing of a medical review panel proceeding in the State of Louisiana
is the equivalent to commencing a civil action. See Skinner-Smith v. Sec’y of Health
& Human Servs., 2018 WL 3991343, at *3. Nathan, however, in addition to being non-
binding, is unpersuasive and distinguishable from the above-captioned case. In Nathan,
Max Nathan, Jr., the executor for Herbert Nathan, was seeking to prosecute a medical
malpractice claim in Louisiana State court. See Nathan v. Touro Infirmary, 512 So. 2d at
353. Prior to Herbert Nathan’s death in 1985, the case went through a medical review
panel proceeding in Louisiana. See id. at 352. Herbert Nathan, however, passed away
before filing a medical malpractice claim in Louisiana State Court. See id. The Nathan
court was tasked with determining whether the medical malpractice proceeding under
Louisiana State law had commenced a lawsuit, and then, assuming that it did, to
determine whether the lawsuit was a property right that Max Nathan Jr. could inherit and
prosecute. See id. The Nathan court concluded that pursuant to Louisiana State law,
Herbert Nathan had commenced a lawsuit by initiating a medical review panel
proceeding, stating that,
[f]iling a complaint with the review panel is a mandatory initial step in a
malpractice claim and a requirement before filing suit “in any court.”
Therefore, the filing with the panel was equivalent to the filing of a suit and
for present purposes was actually the commencement of the suit.
Id. at 354 (emphasis added). The Nathan court did state that a medical review panel
proceeding was the “equivalent to the filing of a suit” because “the filing of the request for
a review of a claim suspended the running of prescription.” Id. (citing LA. REV. STAT. ANN.
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§ 40:1299.47 (A)(2)(a), currently codified at LA. REV. STAT. ANN. § 40:1231.8(A)(2)(a)
(noting that the filing of a request for review of a claim by a medical review panel suspends
the “running of prescription against all joint and solidary obligors, and all joint tortfeasors,
including but not limited to health care providers, both qualified and not qualified, to the
same extent that prescription is suspended against the party or parties that are the subject
of the request for review”)). The Nathan court, however, stated that an individual must
participate in a medical review panel “before filing suit ‘in any court.’” Id. (emphasis
added). The estate issues in Nathan also are distinct from the issues raised in the case
currently before this court and the statute of limitations issue appears to have been a
critical issue in the Nathan decision. Further, since issuing Nathan, the Supreme Court
of Louisiana has explained in various opinions that a medical review panel proceeding is
a “[p]retrial” screening process that must occur before a claimant can file his or her
medical malpractice claim in court. See McGlothlin v. Christus St. Patrick Hosp., 65 So.
3d at 1226 (noting that a medical review panel proceeding is a “[p]retrial screening” that
is “designed to weed out frivolous claims without delay or expense of a court trial”); see
also Perritt v. Dona, 849 So. 2d at 61 (“The MMA requires that all claims against health
care providers be reviewed or ‘filtered’ through a medical review panel before proceeding
to any other court.”). Special Master Millman’s reliance on Nathan was misplaced.
In sum, the medical review panel proceeding commenced by Mrs. Skinner-Smith
in Louisiana on February 5, 2013 was not the initiation of a “civil action for damages”
pursuant to Section 11(a)(5)(B) of the Vaccine Act because it was not a proceeding in a
court of competent jurisdiction.9 There is nothing in the record to suggest that Petitioner
9 Both parties agree that Louisiana is not the only state which requires an individual to file
first some form of a medical review type panel proceeding before initiating a court action.
See WYO. STAT. ANN. § 9-2-1518 (2018) (“Unless submission to the panel is waived in
accordance with W.S. 9-2-1519(a), no complaint alleging malpractice shall be filed in any
court against a health care provider before a claim is made to the panel and its decision
is rendered.”); see also NEB. REV. STAT. § 44-2840 (2018) (“No action against a health
care provider may be commenced in any court of this state before the claimant’s proposed
complaint has been presented to a medical review panel.”); MONT. CODE ANN. R. § 27-6-
301 (2018) (“Claimants shall submit a case for the consideration of the panel prior to filing
a complaint in any district court.”); ME. REV. STAT. tit. 24, § 2851 (2018) (“The purpose of
mandatory prelitigation screening and mediation panels is: A. To identify claims of
professional negligence which merit compensation and to encourage early resolution of
those claims prior to commencement of a lawsuit; and B. To identify claims of professional
negligence and to encourage early withdrawal or dismissal of nonmeritorious claims.”
(emphasis in original)). Other states allow a medical review panel or mediation process
to begin after the filing of a court action. See, e.g., VA. CODE ANN. § 8.01-581.2 (2018) (“At
any time within thirty days from the filing of the responsive pleading in any action brought
for malpractice against a health care provider, the plaintiff or defendant may request a
review by a medical malpractice review panel established as provided in § 8.01-581.3.”);
see also D.C. CODE § 16-2821 (2018) (“After an action is filed in the court against a
healthcare provider alleging medical malpractice, the court shall require the parties to
enter into mediation, without discovery or, if all parties agree with only limited
discovery . . . prior to any further litigation in an effort to reach a settlement agreement.”).
28

Case 1:14-vv-01212-MBH Document 105 Filed 01/03/19 Page 29 of 29
filed a complaint that commenced an actual lawsuit in a court of competent jurisdiction.
Under Louisiana State law, Petitioner’s initiating document for her medical review panel
proceeding was a letter request sent to the State of Louisiana’s Division of Administration,
a state executive agency, requesting that a medical review panel be initiated. See LA.
REV. STAT. ANN. § 40:1231.8(A)(2)(b). In addition, before Petitioner could possibly file a
medical malpractice claim in a court of competent jurisdiction in Louisiana, the MMA
requires that Petitioner first participate in a pre-screening medical review panel
proceeding. See id. at § 40:1231.8(B)(1)(a)(i). Petitioner’s medical malpractice claim and
supporting evidence was to be presented before a panel of three medical professionals
and one attorney chairman, none of whom could act as a judge or jury, but were “merely
a body of experts assembled to evaluate a medical claim and to provide an expert
opinion.” Jeansonne v. Bonano, 241 So. 3d at 1031. Moreover, Petitioner’s medical
review panel proceeding was dismissed before the medical review panel could issue its
non-binding, expert opinion. In addition, Petitioner’s medical review panel proceeding also
was not a “civil action for damages” because damages were not an available remedy in
Petitioner’s Louisiana medical review panel proceeding. See LA. REV. STAT. ANN.
§ 40:1231.8(G); see also Perritt v. Dona, 849 So. 2d at 62 (“No findings are made by the
panel as to damages.” (quoting Everett v. Goldman, 359 So. 2d at 1263)). The court finds
that Petitioner’s initiated, pre-screening, medical review panel proceeding was not a “civil
action for damages” within Section 11(a)(5)(B) of the Vaccine Act, which would bar
Petitioner’s action before the Special Master. Petitioner’s case is remanded to the Special
Master for further proceedings on the merits of Petitioner’s claim.
CONCLUSION
Upon review of the record before the court, Special Master Millman’s June 25,
2018 decision to dismiss the petition in the above-captioned case was legal error.
Therefore, Petitioner’s motion for review is hereby GRANTED, and the above-captioned
case is remanded for further proceedings before Special Master Millman, with instructions
to reinstate Petitioner’s petition.
IT IS SO ORDERED.
s/Marian Blank Horn
MARIAN BLANK HORN
Judge
Because the timing of medical review panel or mediation proceedings vary by state, this
court’s opinion narrowly addresses the applicability of Section 11(a)(5)(B) of the Vaccine
Act to Petitioner’s medical review panel proceeding in Louisiana and Louisiana State law.
29

================================================================================
DOCUMENT 4: USCOURTS-cofc-1_14-vv-01212-5
Date issued/filed: 2022-09-09
Pages: 52
Docket text: PUBLIC ORDER/RULING (Originally filed: 8/15/2022) regarding 160 Ruling on Entitlement. Signed by Special Master Daniel T. Horner. (amb) Service on parties made.
--------------------------------------------------------------------------------
Case 1:14-vv-01212-MBH Document 165 Filed 09/09/22 Page 1 of 52
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 14-1212V
Filed: August 15, 2022
PUBLISHED
Special Master Horner
ALICIA SKINNER-SMITH,
Petitioner,
Tetanus Diphtheria and
v.
acellular Pertussis (“Tdap”)
vaccine; cause in fact; cellulitis;
SECRETARY OF HEALTH AND
chronic fatigue syndrome (CFS)
HUMAN SERVICES,
Respondent.
Richard Gage, Richard Gage, P.C., Cheyenne, WY, for petitioner.
Terrence Kevin Mangan, Jr., U.S. Department of Justice, Washington, DC, for
respondent.
RULING ON ENTITLEMENT1
On December 17, 2014, petitioner filed a petition under the National Childhood
Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012),2 alleging that the tetanus,
diphtheria, acellular pertussis (“Tdap”) vaccine that petitioner received on February 6,
2012, caused her to suffer an abscess, pain, and related injuries that became chronic.
(ECF No. 1.) By the time of the hearing held in this case in May of 2021, petitioner had
clarified that the chronic injury she alleges is Chronic Fatigue Syndrome (“CFS”). (ECF
No. 132.) For the reasons set forth below, I conclude that petitioner is entitled to
compensation for her more limited cellulitis injury but is not entitled to compensation for
her broader CFS.
1 Because this decision contains a reasoned explanation for the special master’s action in this case, it will
be posted on the United States Court of Federal Claims’ website in accordance with the E-Government
Act of 2002. See 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the decision will be available to anyone with access to the
Internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to redact
medical or other information the disclosure of which would constitute an unwarranted invasion of privacy.
If the special master, upon review, agrees that the identified material fits within this definition, it will be
redacted from public access.
2 Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C.
§ 300aa-10-34.
1

Case 1:14-vv-01212-MBH Document 165 Filed 09/09/22 Page 2 of 52
I. Applicable Statutory Scheme
Under the National Vaccine Injury Compensation Program, compensation
awards are made to individuals who have suffered injuries after receiving vaccines. In
general, to gain an award, a petitioner must make a number of factual demonstrations,
including showing that an individual received a vaccination covered by the statute;
received it in the United States; suffered a serious, long-standing injury; and has
received no previous award or settlement on account of the injury. Finally – and the key
question in most cases under the Program – the petitioner must also establish a causal
link between the vaccination and the injury. In some cases, the petitioner may simply
demonstrate the occurrence of what has been called a “Table Injury.” That is, it may be
shown that the vaccine recipient suffered an injury of the type enumerated in the
“Vaccine Injury Table,” corresponding to the vaccination in question, within an
applicable time period following the vaccination also specified in the Table. If so, the
Table Injury is presumed to have been caused by the vaccination. § 300aa-13(a)(1)(A);
§ 300 aa-11(c)(1)(C)(i); § 300aa-14(a); § 300aa-13(a)(1)(B).
In many cases, however, the vaccine recipient may have suffered an injury not of
the type covered in the Vaccine Injury Table. In such instances, an alternative means
exists to demonstrate entitlement to a Program award. That is, the petitioner may gain
an award by showing that the recipient’s injury was “caused-in-fact” by the vaccination
in question. § 300aa-13(a)(1)(B); § 300aa-11(c)(1)(C)(ii). In such a situation, of course,
the presumptions available under the Vaccine Injury Table are inoperative. The burden
is on the petitioner to introduce evidence demonstrating that the vaccination actually
caused the injury in question. Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274,
1278 (Fed. Cir. 2005); Hines v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1525
(Fed. Cir. 1991).
The showing of “causation-in-fact” must satisfy the “preponderance of the
evidence” standard, the same standard ordinarily used in tort litigation. § 300aa-
13(a)(1)(A); see also Althen, 418 F.3d at 1279; Hines, 940 F.2d at 1525. Under that
standard, the petitioner must show that it is “more probable than not” that the
vaccination was the cause of the injury. Althen, 418 F.3d at 1279. The petitioner need
not show that the vaccination was the sole cause of the injury or condition, but must
demonstrate that the vaccination was at least a “substantial factor” in causing the
condition, and was a “but for” cause. Shyface v. Sec’y of Health & Human Servs., 165
F.3d 1344, 1352 (Fed. Cir. 1999). Thus, the petitioner must supply “proof of a logical
sequence of cause and effect showing that the vaccination was the reason for the
injury;” the logical sequence must be supported by “reputable medical or scientific
explanation, i.e., evidence in the form of scientific studies or expert medical testimony.”
Althen, 418 F.3d at 1278; Grant v. Sec’y of Health & Human Servs., 956 F.2d 1144,
1148 (Fed. Cir. 1992). A petitioner may not receive a Vaccine Program award based
solely on his or her assertions; rather, the petition must be supported by either medical
records or by the opinion of a competent physician. § 300aa-13(a)(1).
2

Case 1:14-vv-01212-MBH Document 165 Filed 09/09/22 Page 3 of 52
In what has become the predominant framing of this burden of proof, the Althen
court described the “causation-in-fact” standard, as follows:
Concisely stated, Althen’s burden is to show by preponderant evidence that
the vaccination brought about her injury by providing: (1) a medical theory
causally connecting the vaccination and the injury; (2) a logical sequence
of cause and effect showing that the vaccination was the reason for the
injury; and (3) a showing of proximate temporal relationship between
vaccination and injury. If Althen satisfies this burden, she is “entitled to
recover unless the [government] shows, also by a preponderance of the
evidence, that the injury was in fact caused by factors unrelated to the
vaccine.”
Althen, 418 F.3d at 1278 (citations omitted). The Althen court noted that a petitioner
need not necessarily supply evidence from medical literature supporting their claim, so
long as the petitioner supplies the medical opinion of an expert. Id. at 1279-80. The
court also indicated that, in finding causation, a Program fact finder may rely upon
“circumstantial evidence,” which the court found to be consistent with the “system
created by Congress, in which close calls regarding causation are resolved in favor of
injured claimants.” Id. at 1280.
In this case, none of the injuries alleged by petitioner are injuries identified by the
Vaccine Injury Table. Accordingly, petitioner must satisfy the above-described Althen
test for establishing causation in fact.
II. Procedural History
As noted above, petitioner filed her petition on December 17, 2014. (ECF No. 1.)
Since the filing of that petition, this case has had a long history under four different
special masters as two threshold issues were successively litigated before expert
presentations and an entitlement hearing were eventually reached.
Based on the allegations in the petition (abscess and related pain), this case was
initially assigned to the Special Processing Unit (“SPU”) under then Chief Special
Master Vowell. (ECF No. 5.) “The Special Processing Unit is designed to expedite the
processing of claims that have historically been resolved without extensive litigation.”
(Id. at 1.) Petitioner’s initial Statement of Completion was filed soon thereafter on
December 24, 2014. (ECF No. 7.) However, the parties engaged in litigation regarding
a threshold question of the administration site of petitioner’s vaccine, a point made
significant by petitioner’s allegation of an (abscess) injury local to the area of injection.3
3 More accurately, the medical records indicate petitioner suffered “cellulitis,” which is “an acute, diffuse,
spreading, edematous, suppurative inflammation of the deep subcutaneous tissues and sometimes
muscle, sometimes with abscess formation. It is usually caused by infection of a wound, burn, or other
cutaneous lesion by bacteria . . . .” Cellulitis, DORLAND’S MEDICAL DICTIONARY ONLINE,
https://www.dorlandsonline.com/dorland/definition?id=8514 (last accessed July 28, 2022). An “abscess”
is “a localized collection of pus within tissues, organs, or confined spaces.” Abscess, DORLAND’S MEDICAL
DICTIONARY ONLINE, https://www.dorlandsonline.com/dorland/definition?id=185 (last accessed July 28,
3

Case 1:14-vv-01212-MBH Document 165 Filed 09/09/22 Page 4 of 52
During this period, the case was reassigned to Special Master Dorsey when she
became Chief Special Master. (ECF No. 31.)
After a year and a half of litigation, Chief Special Master Dorsey issued a “Ruling
on Facts” on April 26, 2016, that addressed the parties’ dispute regarding the injection
site of petitioner’s February 6, 2012, Tdap vaccination. She concluded that petitioner
received her vaccination in her left dorsal gluteal muscle.4 (ECF No. 45; see also
Skinner-Smith v. Sec'y of Health & Human Servs., No. 14-1212V, 2016 WL 3180635
(Fed. Cl. Spec. Mstr. Apr. 27, 2016).) This is consistent with the fact finding urged by
petitioner. (ECF No. 13-2.) Respondent was ordered to file his Rule 4(c) Report, which
he did on July 5, 2016. (ECF No. 45, p. 4; ECF No. 48.) Respondent recommended
against compensation on a number of grounds. (ECF No. 48.)
Following the filing of respondent’s report, the case was reassigned out of the
SPU and to Special Master Millman. (ECF No. 50.) She initially ordered petitioner to
file an expert report. Petitioner continued to develop the record for over a year, from
August of 2016 through October of 2017, but did not file an expert report during this
period.5 However, during a status conference held October 19, 2017, Special Master
Millman specifically ordered petitioner to file materials relating to the medical review
panel referenced in the petition.6 (ECF No. 73.) Petitioner filed such materials marked
as Exhibit 14 and 15. (ECF No. 74.) The fact of petitioner’s prior medical review panel
filing then constituted the focus of the case for the next year.
Special Master Millman issued an Order to Show Cause why the case should not
be dismissed on the basis that Exhibit 14 showed petitioner to have had a medical
malpractice suit pending at the time she filed this petition. (ECF No. 75.) Following
motion practice on the issue, Special Master Millman issued a decision dismissing this
case on June 25, 2018. (ECF No. 89; see also Skinner-Smith v. Sec'y of Health &
Human Servs., No. 14-1212V, 2018 WL 3991343 (Fed. Cl. Spec. Mstr. June 25, 2018),
review granted, decision rev'd, 141 Fed. Cl. 348 (2018).) She concluded that
2022). Petitioner’s initial diagnosis was “cellulitis/left gluteal abscess.” (Ex. 1, p. 441.) However,
subsequent records suggested no evidence of an abscess underlying petitioner’s cellulitis. (Id. at 680,
705.)
4 This finding of fact is not binding on me; however, I agree with the outcome and analysis in this fact
finding and will not address the issue further. Godfrey v. Sec’y of Health & Human Servs., 2015 WL
10710961, at *9 (Fed. Cl. Spec. Mstr. Oct. 27, 2015) (noting that “[g]enerally, special masters may
change or revisit any ruling until judgment enters, even if the case has been transferred.”); see also
Hanlon v. Sec’y of Health & Human Servs., 40 Fed. Cl. 625, 630 (1998), aff’d, 191 F.3d 1344 (Fed. Cir.
1999) (special masters are not bound by their own or other special masters’ decisions).
5 Petitioner did file a letter by one of petitioner’s treating physicians, Dr. Ferrier (ECF No. 55; Ex. 8).
However, the special master required petitioner to file a further, more detailed, report explaining the basis
for the opinion stated in the letter. (ECF No. 56.) Petitioner never filed a further report from Dr. Ferrier
and ultimately argued that such a report was unnecessary. (ECF No. 63.)
6 In her petition, petitioner acknowledged the prior filing of a “medical review panel proceeding,” but
represented that no civil action had been filed. (Id. at 1-2.)
4

Case 1:14-vv-01212-MBH Document 165 Filed 09/09/22 Page 5 of 52
petitioner’s filing of a complaint with the Louisiana medical review panel constituted
initiation of a civil action under Section 11 of the Vaccine Act. (Id. at 5.)
Petitioner then pursued a successful motion for review of that dismissal decision.
On December 18, 2018, the Court of Federal Claims issued an Opinion and Order
granting petitioner’s motion for review and remanding the case for further proceedings
before the special master with instructions to reinstate the petition. (ECF No. 103; see
also Skinner-Smith v. Sec'y of Health & Human Servs., 141 Fed. Cl. 348 (2018).) Once
the case was remanded, petitioner returned to pursuing an expert to support her claim.
(ECF No. 106.)
Due to Special Master Millman’s subsequent retirement, the case was
reassigned to the undersigned’s docket on June 7, 2019. (ECF No. 110.) After several
motions for extension of time, petitioner filed her initial expert report by Dr. Charles Lapp
on August 16, 2019. (ECF No. 113; Ex. 16.) Petitioner filed a further report by Dr.
Lapp, inclusive of a physical examination, on November 15, 2019. (ECF No. 115; Ex.
21.) Respondent filed expert reports by Drs. Oddis and He on January 3, 2020. (ECF
Nos. 115-19; Exs. C-D.) Petitioner filed a responsive supplemental report by Dr. Lapp
on April 6, 2020. (ECF No. 121; Ex. 22.)
Thereafter, on May 11, 2020, a two-day entitlement hearing was scheduled to
commence May 20, 2021. (ECF No. 124.) The pre-hearing record closed on April 26,
2021 (ECF No. 126); however, petitioner filed for leave to file medical literature out of
time (ECF No. 136). Respondent filed a competing motion to strike the proposed filings.
(ECF No. 137.) On May 13, 2021, petitioner’s motion for leave to file out of time was
granted and respondent’s motion to strike denied. (ECF No. 140.) Respondent was
permitted an opportunity to address any issues that might arise during the hearing
relative to the late-filed literature with post-hearing filings. (Id.)
The hearing was held as scheduled on May 20-21, 2021 and was held via
Webex video conference due to the ongoing Covid-19 pandemic. (See Transcript of
Proceedings (“Tr.”), May 20-21, 2021, at ECF Nos. 148-49.) During the hearing,
petitioner, Dr. Lapp, Dr. Oddis, and Dr. He testified. Following the hearing, petitioner
was ordered to file two articles (by Rook and Mu respectively) referenced by Dr. Lapp
during the hearing, a graphic used during his testimony, and updated medical records.
(ECF No. 143.) Respondent was instructed to file a status report 30 days thereafter
indicating whether he would request an opportunity for further filings or otherwise
confirming the record to be complete. (Id.) On July 6, 2021, respondent confirmed the
record is complete. (ECF No. 150.)
Accordingly, this case is now ripe for resolution. In total, petitioner has filed
medical records marked as Exhibits 1-6, 11-13, 31-32, and 37-38, affidavits marked as
Exhibits 7 and 10, medical review panel Exhibits 14-15, a treating physician letter
marked as Exhibit 8, expert reports by Dr. Lapp marked as Exhibits 16, 21-22 (his
curriculum vitae as Exhibit 20), and medical literature marked as Exhibits 17-29, 23-30.
5

Case 1:14-vv-01212-MBH Document 165 Filed 09/09/22 Page 6 of 52
Respondent has filed reports, curricula vitae, and supporting medical literature by Drs.
Oddis and He marked as Exhibits C (with tabs 1-3) and D (with tabs 1-2).7
III. Factual History
a. As Reflected by the Medical Records
i. Pre-Vaccination Records
Prior to the vaccination at issue, petitioner had a history of rosacea, vitamin D
deficiency, degenerative cervical disc disease with radiculopathy, anemia, and recurrent
throat infections. (Ex. 1, p. 109, 418, 451, 574.) Additionally, petitioner had a right
rotator cuff repair on October 22, 2009, and a right shoulder arthroscopic lysis of
adhesions, arthroscopic revision, subacromial decompression, and bursectomy on
January 15, 2010. (Ex. 1, p. 430.)
On March 8, 2010, petitioner presented to Dr. Deryk Jones, the orthopedist who
performed petitioner’s rotator cuff repair surgery. (Ex. 1, p. 577.) On examination,
petitioner demonstrated a slight decrease in internal rotation on the involved side with
excellent strength and good range of motion overall. Patient appeared to be doing
“quite well overall.” (Id.)
On September 30, 2010, petitioner presented to Dr. Herbert Van Horn
complaining of “a 6-month history of recurrent throat infections, but also [] nasal
congestion symptoms and sinusitis.” (Ex. 1, p. 574.) She also complained of an “ear
ringing sensation.” (Id.) Dr. Van Horn noted in the HPI that petitioner “occasionally
takes Vicodin for her right shoulder pain as she is recovering from rotator cuff and torn
labrum surgery performed in January of this year.” (Id.) He noted that petitioner’s
family members had a history of throat and tonsillar problems. (Id.) No evidence for
recent strep cultures were found in the computer database. (Id.) Dr. Van Horn
concluded that petitioner was “not acutely ill and [did] not require antibiotics[.]” (Id. at
575.) He discussed concerns with petitioner about concomitant use of Vicodin and
Zyrtec because of sedation possibilities and encouraged petitioner to use the Vicodin
sparingly. (Id.)
On October 20, 2010, petitioner presented to Dr. Jones for a follow-up on her
right shoulder pain and pathology. (Ex. 1, p. 572.) Petitioner was “currently reporting
no significant limitations at this time.” (Id.) On examination petitioner demonstrated
mild weakness with stress of the rotator cuff musculature at the right side. (Id.)
On March 29, 2011, petitioner presented with pain and numbness in her legs that
had worsened within the past two weeks. (Ex. 1, p. 465.) Spinal MRI on April 20, 2011,
showed bulging at L3-L4 and L4-L5 and straightening of the lumbar lordosis. (Ex. 1, pp.
7 Respondent’s Exhibits A-B relate to a subpoena issued by respondent relative to litigating the site of
injection. (ECF Nos. 41, 43.)
6

Case 1:14-vv-01212-MBH Document 165 Filed 09/09/22 Page 7 of 52
477-79.) On March 31, 2011, results from petitioner’s ultrasound showed no evidence
of a lower extremity deep venous thrombosis. (Ex. 1, p. 581.)
On April 20, 2011, petitioner underwent erect weight-bearing (“stand up”) MRI of
the lumbar spine without contrast. (Ex. 1, p. 477-79.) The MRI showed (1) bulging of
the L3-L4 and L4-L5 intervertebral discs without nerve root effacement associated
therewith the patient in the passive neutral posture; (2) straightening of the lumbar
lordosis with the patient in the passive neutral posture consistent with a pattern of
muscle spasm; and (3) fibroid uterus with dominant submucosal leiomyoma measuring
approximately 2.2 cm in diameter. (Id. at 478-79.)
On May 23, 2011, petitioner established new patient care with Ochsner spine
services with complaints of lower leg pain, burning, numbness, coldness, and tingling.
She described her back pain as “mechanical in nature, worse with activity, especially
walking” and described her lower extremity pain as “burning, aching pain in her bilateral
calves and feet” which “ha[d] been going on for several years” and “relieved with
Vicodin.” (Ex. 1, p. 570.) Petitioner reported that her symptoms began years prior and
had worsened more recently. (Ex. 1, p. 461.) She further indicated that she was able to
perform her daily routine with these symptoms and was able to work despite her
condition. (Ex. 1, p. 464.) Petitioner was diagnosed with degenerative disc disease,
lumbago, and lateral lower extremity radiculopathy. (Ex. 1, pp. 570-71.)
On July 5, 2011, petitioner called her PCP Dr. Ferrier to schedule an
appointment. (Ex. 1, p. 546.) Petitioner reported “pain in her lower legs for years – she
would like to be tested for diabetes.” (Id.) She further reported problems with night
sweats and recurrent yeast infections. (Id.) On July 11, 2011, petitioner presented with
a deep nodule in her right calf, which was a lipoma that was late excised. (Ex. 1, p.
460.) Petitioner had been prescribed Vicodin over an extended period of time, first for
her shoulder pain and later for her bilateral leg pain. (E.g., Ex. 1, pp. 574-57, 465.)
On January 5, 2012, petitioner saw Dr. Deryk G. Jones regarding her right
shoulder pain and was diagnosed with right shoulder rotator cuff inflammation with
possible biceps tendinopathy and recurrent weakness of the anterior subscapularis
tendon. (Ex. 1, p. 443.)
On January 16, 2012, petitioner saw her primary care provide (“PCP”), Dr. Janine
M. Ferrier, with complaints of sore throat and bilateral ear pain that began three weeks
prior. (Ex. 1, p. 442.) Petitioner also complained of postnasal drip, hoarseness,
shortness of breath, cough, fatigue, and intermittent fever. (Id.) Physical exam findings
for mouth and throat were “[n]o tonsillar enlargement. Positive pharyngeal erythema
and pustule on the right.” (Id.) Petitioner was diagnosed with acute pharyngitis and was
prescribed clindamycin (antibiotic) and Diflucan (antifungal). (Id.)
7

Case 1:14-vv-01212-MBH Document 165 Filed 09/09/22 Page 8 of 52
ii. Vaccination and Initial Treatment
On February 6, 2012, petitioner burned her hand and went to the Ochsner
Medical Center Emergency Room for treatment. (Ex. 1, p. 684.) At the emergency
room, petitioner received a Tdap vaccine in her left dorsal gluteal muscle. See Skinner-
Smith v. Sec’y of Health & Human Servs., No. 14-1212V, 2016 WL 3180635 (Fed. Cl.
Spec. Mstr. Apr. 27, 2016). Petitioner was discharged on the same day. (Ex. 1, p.
688.)
A couple of days following her vaccination on February 9, 2012, petitioner saw
Dr. Ferrier for a follow up. (Ex. 1, p. 441.) Petitioner complained of left hip pain and
lower back pain after receiving the Tdap vaccination and that the area around the
injection was red, inflamed, and painful. (Id.) Upon examination, Dr. Ferrier noted that
petitioner’s left hand burn was dorsal between the first and second finger and that
petitioner was “positive induration of left gluteus with erythema.” (Id.) Petitioner was
assessed with cellulitis/left gluteal abscess and was referred to general surgery as well
as prescribed Bactrim. (Id.)
A handwritten note dated February 13, 2012, indicates that petitioner presented
to Dr. Michael C. Townsend for a consultation for her buttock abscess. (Ex. 1, p. 439-
40.) He diagnosed petitioner with cellulitis of the buttocks and abscess. (Id.) The
remainder of Dr. Townsend’s notes are illegible. The next day, February 14, 2012,
petitioner returned to Dr. Townsend. (Ex. 1, p. 451.) Dr. Townsend noted that
petitioner had a “localizing area of induration without frank purulence” on her left
buttocks, but that her cellulitis was resolved. (Id.) His impression also included that
petitioner had a localizing, minimally tender mass, and at that point, petitioner should
continue with antibiotics. (Id.)
On February 24, 2012, petitioner called Dr. Ferrier’s office regarding her tetanus
shot reaction. (Ex. 1, p. 542.) The note indicates that
[Petitioner] had a reaction and was put on antibiotics and pain med.
[Petitioner] was referred to Dr. Townsend to lance or remove. Dr did not do
either. [Petitioner] still in pain (pain in legs/groin area), has swelling.
[Petitioner] wanting pain med. to get her thru. [Petitioner] will be calling the
other dr. [Petitioner] would like to see Dr. Ferrier soon[.]
(Id.)
Thereafter, on February 24, 2012, petitioner returned to the emergency room
with complaints of fever. (Ex. 1, p. 692.) The records noted that petitioner’s chief
complaint was “since [tetanus] shot on 2/6 has had problems with fever, leg swelling
and [fatigue].” (Id.) Petitioner reported that her fever began suddenly about 17 days
ago, chills and sweating, night sweats, body aches, joint swelling, itching, rash, and dry
skin. (Id.) Petitioner indicated that she has received a Tdap vaccination prior without
any reaction. (Id. at 693.) On physical examination, Dr. McNulty observed “no soft
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tissue or body tenderness, no joint swelling or tenderness.” (Id. at 662.) He “[did] not
see any swelling of the thighs lower legs or feet[,] no erythema of the thighs or legs.”
(Id.) Dr. McNulty noted petitioner’s neck was “supple, no adenopathy noted.” (Id.)
Petitioner’s blood and urine cultures were collected, and the results were normal.
Petitioner was also transported for an x-ray, but discharged on the same day. (Ex. 1, pp.
693-96.)
Petitioner went back to the emergency room three days later, on February 27,
2012 with complaints of joint pain, stating that her symptoms began on February 6,
2012 after receiving Tdap immunization. (Ex. 1, p. 698.) Petitioner reported that on the
evening of her vaccination, she felt malaise and some aching fever, and by the next day
she had some swelling at the injection site and groin area. On physical exam, petitioner
had some enlarged inguinal lymph nodes and some darkening and hyperpigmentation
of her skin around her inguinal area and neck. (Id. at 705.) Additionally, it was noted
that she did not have any kind of obvious rash or redness at the injection site on her left
buttock, but there was mild tenderness and a “little knot there.” (Id.) Dr. Patricia C.
Porada’s assessment was that petitioner likely had a reaction to the Tdap vaccination,
possibly a delayed serum sickness type or hypersensitive type reaction. (Id. at 706.)
Petitioner was discharged on the same day with a primary diagnosis of fever of
unknown origin. (Id. at 703.) Dr. Porada added that a reaction can last up to 21 days
and noted that “there are other potential causes for [petitioner’s] persistent symptoms,
but these all seem to be related to the tetanus shot as these symptoms all developed
after her tetanus injection. (Id. at 706.)
On February 29, 2012, petitioner saw Dr. Ferrier for a “followup of emergency
room visit for cellulitis.” (Ex. 1, p. 436.) It was noted that petitioner completed her
antibiotics and her cellulitis was improved, but that she still had fatigue, fever, myalgias,
joint pain, swelling, headaches, back pain, and spams down the back of her legs. (Id.)
Petitioner was assessed with myalgia and fatigue and additional testing was ordered.
iii. Post Initial Treatment Records
On March 2, 2012, petitioner returned to Dr. Ferrier’s office for a follow-up visit.
(Ex. 1, p. 538.) Petitioner was referred to rheumatology “ASAP for rheumatoid arthritis,
positive CCP antibodies.” (Id.) Petitioner was informed of her results, including low
vitamin D.
On March 7, 2012, petitioner had an allergy evaluation with Dr. Jamie R. Lurie.
(Ex. 3, p. 1.) Petitioner indicated that she had a burn on her hand which led to her to
ER, where she received a tetanus shot. Petitioner reported that about 30 minutes to an
hour after the shot, petitioner had nausea, fatigue, and aching at the site of the injection,
and the next day, she had joint pain, swelling, fever, and “her nerves were firing.” (Id.)
Petitioner reported that she returned to her PCP, who referred petitioner to general
surgery for possible infection from the shot, but there was nothing to drain. Additionally,
on February 24, almost three weeks following her vaccination, petitioner went to the ER
with fatigue, fever, chills, joint pain, and rash and swelling at the vaccination site. At this
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visit with Dr. Lurie, petitioner reported that her symptoms improved, but she was still
suffering from pain in her hip where the vaccine was administered, night sweats,
fatigue, loss of appetite, middle low back pain. (Id.) Dr. Lurie stated that petitioner had
serum sickness as a reaction to Tdap vaccine with typical symptoms of fatigue, rash,
fever, joint pain, and swelling at the site. Dr. Lurie also posited that petitioner may have
had an immunologic reaction to her vaccination and referred petitioner to a
rheumatologist. (Id. at 3.)
On April 17, 2012, petitioner saw Dr. Reginald D. Sanders for musculoskeletal
pain at the referral of Dr. Lurie. (Ex. 4.) Petitioner denied any prior musculoskeletal
pains and that she developed generalized stiffness and pain in her left buttock after
receiving a tetanus shot. (Id. at 1.) Moreover, petitioner reported that she “has not
gotten back to normal since the shot,” and she has pain in the left side of her body as
well as joint pain. Petitioner was assessed with polyarthralgia. (Id.) It was noted that
petitioner did not appear to have systemic inflammatory rheumatic disease and that
petitioner declined further laboratory studies.
On April 30, 2012, petitioner presented to her PCP Dr. Ferrier complaining of a
sore throat, sinus congestion, and cough. (Ex. 1, p. 426.) She indicated that her
symptoms “started weeks ago” and “have improved.” (Id.) Petitioner was assessed
with an upper respiratory tract infection. (Id.)
On May 30, 2012, petitioner presented to Dr. Jack Jacob for an annual
gynecological examination. (Ex. 2, pp. 10-14.) Petitioner complained of “mark reaction
to pert. and Tet. shot.” (Id. at 10.) In petitioner’s past medical / surgical history, Dr.
Jacob noted “tentative [rheumatoid arthritis] after receiving PTAP [sic] (2/6/12).” (Id.)
Dr. Jacob further noted that petitioner was self-reliant in her usual daily activities. (Id. at
11.) Petitioner’s assessment was otherwise normal. (Id. at 13.)
On June 6, 2012, petitioner presented to another rheumatologist, Dr. Tamika
Webb-Detiege, complaining of arthralgias and positive CCP. (Ex. 1, p. 418.) Petitioner
recalled that hours after her tetanus vaccination she developed “severe joint pain,
fatigue, sweating, swelling of the hands, swelling and pain in the legs and hips
especially on the left, or rash that started to peel on her face and hands, fever, night
sweats and an overall feeling of malaise.” (Id.) She further noted enlarged lymph
nodes in her groin, blisters on her tongue, hoarseness in her voice, peeling around her
nails, tinnitus, and blurred vision.” (Id.) Petitioner reported to Dr. Webb-Dietiege that
her symptoms had since improved, though she continued to have achiness, involving
mainly her left leg, fatigue, and night sweats. (Id.) Her pain improved with the use of
Vicodin and ibuprofen, twice daily. (Id.) Petitioner also noted family history of
rheumatoid arthritis. (Id. at 419.) Petitioner was assessed with arthralgias where
“symptoms began after tetanus shot which was associated with cellulitis of buttocks,”
positive CCP, fatigue, night sweats, and dry mouth. (Id. at 422.)
Petitioner returned to Dr. Webb-Detiege on June 27, 2012, with a chief complaint
of arthralgias and positive CCP. (Ex. 1, p. 412.) Petitioner reported “120 minutes of
morning stiffness,” though she reported feeling better, with less joint pain and less
mental confusion. (Id.) She described pain in “muscle below knees and above feet.”
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(Id.) Petitioner reported difficult sleeping “since this started.” (Id.) Her arthritis joint
survey in the cervical spine showed no widening of the atlanto-odontoid relationship in
flexion, though the osseous elements of the cervical spine were degenerated at C5-6
with large osteophyte and slight interspace narrowing. (Id. at 415.) She showed no
arthritis in her knees, hands and wrist, or feet. (Id.) Petitioner was assessed with
arthralgias, positive CCP, fatigue, night sweats, dry mouth (“negative SSA and SSB”).
(Id.)
On August 8, 2012, petitioner was seen at the emergency department for joint
pain. (Ex. 1, p. 5.) Petitioner’s radiology results revealed no evidence of synovitis. (Id.
at 6.) Petitioner saw her PCP on August 23, 2012 for leg pain, sore throat, sinusitis,
and back pain. (Id. at 17.) Petitioner reported that her sore throat started about a week
ago and that she noticed redness of her lower legs and aching sensation after
undergoing a nuclear tag test. (Id. at 22.) Petitioner also reported intermittent pain in
her left buttock, leg, and foot since receiving a tetanus vaccination. (Id.) Petitioner was
assessed with acute pharyngitis, back pain, arthralgias, and vitamin D deficiency. (Id. at
23.)
On September 21, 2012, petitioner had an ultrasound and venous examination
with Dr. George E. Barnes. (Ex. 6.) It was noted that petitioner began having pain in
her left lower extremity on February 6, 2012, that had been increasing dramatically and
progressively. Dr. Barnes indicated that petitioner associated her symptoms with her
tetanus vaccination. (Id. at 1.) Additionally, in a handwritten note, petitioner also wrote
that she believed “DTAP compromised my health […] most of others [symptoms]
including high blood pressure level, elevated anti-CPP level, rheumatoid arthritis, weight
loss, hair loss, depleted vitamin D-level, impaired vision, sleep apnea, extreme leg pain
at site location (lower left buttock); swollen/inflamed lymph node, in groin region etc.”
(Id. at 3.) Petitioner also answered that petitioner experienced varicose veins after
trauma and had pain, swelling, spider veins, skin discoloration, and night cramps as
associated with her varicose veins. (Id. at 4.) Dr. Barnes noted that petitioner had a
history of venous varicosities, but only recently experiencing symptoms. (Id.) The
ultrasound showed evidence of venous incompetence associated with history of several
months of left lower extremity pain syndrome. (Id.) She was assessed with left leg pain
and was recommended for surgery and for a complete duplex scan study. (Id. at 7.)
On September 30, 2012, petitioner returned to Dr. Ferrier for a blood pressure
check and complained of swelling in her legs and swollen nodes in her groin. (Ex. 1, p.
46.) Additionally, petitioner reported continued left leg pain. (Id.) Petitioner then saw
Dr. Ferrier again on October 2, 2012 to address her arthralgias, myalgias, and positive
anti-CCP results. (Id. at 53.) Here, petitioner reported that her symptoms began after
receiving her tetanus shot and that serum sickness was suspected. (Id.) Under review
of systems, petitioner was positive for fatigue, red appearance of hands with cold
exposure, polyuria, dry mouth, dyspnea on exertion, and jaw pain. (Id.) Dr. Ferrier
noted that petitioner’s symptoms relating to arthralgias began after tetanus shot, “which
was associated with cellulitis of buttocks.” (Id. at 55.)
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On October 2, 2012, petitioner returned to Dr. Webb-Detiege for a follow-up
regarding her arthralgias, myalgias, and positive anti-CCP. (Ex. 1, p. 52.) She reported
“feeling better with the joint pain.” (Id.) She complained of pain in her left leg, in the
groin and down the leg, as well as a “blotchy appearance.” (Id. at 52-53.) She reported
swelling in her right and left legs, in the thighs. (Id.) Petitioner continued to report night
sweats. (Id. at 53.) She presented with a facial rash. (Id.) Petitioner now reported
family history of rheumatoid arthritis in her grandmother, mother, and maternal aunts.
(Id.) Dr. Webb-Detiege assessed petitioner with arthralgias, positive CCP, fatigue, night
sweats, dry mouth, in addition to venous insufficiency of the legs. (Id. at 55.)
Petitioner saw Dr. Ferrier on January 11, 2013 for an immune system evaluation
with complaints of sinus problem, including chills, congestion, coughing, ear pain,
headaches, neck pain, and sore throat. (Ex. 1, p. 105.) Petitioner summarized that
within two weeks of her tetanus shot in February 2012, she experienced severe
arthralgias, hair loss, rash, fever blisters, nails splitting, and elevated labs. Since then,
she has had recurrent throat and sinus infections, fatigue, insomnia, memory loss, night
sweats, jaw tightness, sinusitis, ear infection, and pharyngitis. However, petitioner has
seen a rheumatologist and extensive workup has all been normal. (Id.) Petitioner also
reported that she has had 5-6 antibiotics treatment since February. (Id.) Petitioner was
assessed with chronic sinus infection and arthralgia. (Id. at 107.)
Petitioner had a consultation with Dr. Jeffrey Coco on February 7, 2013. (Ex. 3,
p. 11.) Under reason for visit, it was listed that petitioner had Tdap vaccination and had
stiffness, pain, sweating, heart racing, and nausea the night of her shot and within 48
hours, she saw her PCP. Also, the record indicated that petitioner saw Dr. Lurie after
experiencing leg swelling, sores in mouth, hair loss, vision changes, and was placed on
antibiotics and referred for surgical intervention. Moreover, petitioner was transitioned
to narcotics to treat her joint pain. (Id.) Again, petitioner was listed as having serum
sickness and it was noted that Dr. Coco discussed the Vaccine Program with petitioner
at this visit. Petitioner was told to avoid all further vaccines. (Id. at 12.)
Petitioner frequently visited her PCP for various reasons throughout the year,
including upper respiratory infection, allergy test, conjunctivitis, sore throat, leg pain,
anemia, and venous insufficiency. (Ex. 1, pp. 127,131, 133, 152, 160, 168.) Petitioner
avoided receiving any further vaccinations, indicating that she was hesitant due to
adverse reaction from tetanus shot. (Ex. 1, p. 131.)
On July 15, 2013, petitioner was examined by Dr. Olusegun O. Osinbowale for
venous insufficiency consultation. (Ex. 1, p. 168.) Petitioner reported that since
receiving the tetanus shot, petitioner had been experiencing hot/cold sensation in both
legs, night sweats, arthralgias, swollen ankles, and leg erythema. (Id.) Dr. Osinbowale
assessed petitioner with venous insufficiency, unspecified myalgia and myositis, and
skin sensation disturbance, adding that there was discussion of the possibility of
petitioner having primary venous insufficiency rather than secondary to her other
complaints. (Id. at 171.)
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On September 3, 2013, petitioner presented to hematologist / oncologist Dr. Fu
for an initial anemia consultation. (Ex. 1, p. 202.) Petitioner’s medical history listed
anemia, degenerative disc disease, vitamin D deficiency, arthralgias, recurrent upper
respiratory infections, and urticaria (hives). (Id.) She reported “fatigue easily. I am sick
only after the tetanus shot in Feb 2012.” (Id. at 204.) Petitioner further reported skin
rash, shortness of breath, muscle pain, acute join pain, sweating, swelling lymph node,
leg swelling, muscle spasms, hair loss, dry mouth, and “[l]eft leg burning sensation after
tetanus shot in feb 2012.” (Id.) On physical examination, Dr. Fu observed no
noticeable or palpable swelling, redness, or rash around the throat or on the face and
no swollen or erythematous joints. (Id. at 207.) Dr. Fu concluded that “[t]he fact that
[petitioner] has isolated cytopenia (anemia) with normal WBC and platelet count
suggest[s] that that the possibility of bone marrow failure such as MDS, myelofibrosis,
bone marrow infiltration, etc is low, although pure red cell anaplasia can not be
excluded.” (Id. at 208.) Of note, Dr. Fu observed that petitioner had “mild elevation of
plt count,” which, in the setting of nonspecific symptoms such as myalgia, arthralgia,
skin rash, finger tingling numbness, is “likely due to chronic inflammation.” (Id.)
However, Dr. Fu wanted to rule out lymph proliferative disorder, MPD, B12 deficiency,
and monogammapathy. (Id.) Dr. Fu planned run a routine anemia work up, including a
blood smear review—and to consider a bone marrow biopsy if the blood work was
unrevealing. (Id.)
On September 11, 2013, petitioner returned to her gynecologist Dr. Jacob, for a
follow-up examination. (Ex. 2, pp. 18-21.) Petitioner’s history included “chronic
inflammation to the tetanus inj[ection], with many organ damage.” (Id. at 18.) Dr. Jacob
reported again that petitioner was self-reliant in her usual daily activities. (Id. at 19.)
She described feeling poorly, with reports of malaise and anxiety. (Id.) Petitioner
further reported muscle aches and pain localized in one or more joints, as well as
dizziness and dyspnea. (Id.)
On January 13, 2014, petitioner presented to internist Dr. Green, complaining of
a sore throat, upper respiratory infection, and nasal congestion. (Ex. 1, pp. 298-99.)
She reported to Dr. Green that she suffered from recurrent lymph node infections. (Id.
at 298.) Petitioner likewise reported that she was experiencing generalized arthralgias,
which she attributed to her tetanus injection on February 6, 2012. (Id.) On physical
examination, Dr. Green observed that petitioner’s “pharynx was infected but without
exudate” and her sinuses were tender to palpation. (Id. at 299.) She was assessed
with chronic joint paint, lymphadenitis, acute pharyngitis, and chronic rhinitis.” (Id.) Dr.
Green prescribed antibiotics.
On March 31, 2014, petitioner had an electrodiagnostic study of her left upper
and lower extremities, which revealed a delay of left median sensory distal latency that
is compatible with mild left carpal tunnel syndrome, but was otherwise normal. (Ex. 5.)
Petitioner’s clinical summary included that she received a tetanus injection with
subsequent fever, stiffness, and pain all over, which has persisted since vaccination.
(Id. at 1.)
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On May 28, 2014, petitioner presented to her PCP, Dr. Ferrier, in follow-up to her
emergency room visit for facial swelling. (Ex. 1, pp. 409-10.) Petitioner reported that
she had facial swelling primarily on the right side, with her right eye swollen shut. (Id. at
409.) She reported to Dr. Ferrier a sensation of heaviness on the right side of her face.
(Id.) Petitioner additionally reported fatigue, persistent night sweats, persistent and
intermittent swelling, initially in her extremities, now extending up to her face, associated
with a tingling sensation. (Id.) She further reported skin discoloration associated with
flareups. (Id.) Dr. Ferrier assessed petitioner with improving facial swelling and
recommended Zyrtec and Ranitidine. (Id. at 410.)
On August 4, 2014, petitioner sought treatment from her PCP, Dr. Ferrier, for
diffuse pain, complaining of burning sensation in her hands and feet. (Ex. 12, p. 3-4.)
Petitioner then returned on September 4, 2014 with complained of right leg pain at the
site of lipoma excision. (Id. at 11.) Additionally, petitioner saw Dr. Osinbowale on
September 8, 2014 for a follow up appointment regarding her venous insufficiency. (Ex.
12, p. 16.) Petitioner reported chronic intermittent neuropathic pain radiating from the
left gluteal region to the calf, burning sensations, cold sensations, and tingling and
intermittent numbness in her extremities. (Id.) Dr. Osinbowale indicated that
petitioner’s symptoms were unlikely vascular in origin. (Id. at 18.)
On November 10, 2014, petitioner presented to Dr. Nelson, complaining of eye
pain in both eyes, “stabbing pain for couple of months,” left more than right. (Ex. 12, pp.
37-38.) She commented that her peripheral vision decreased since she was last seen
(5/28/2014), on the right and left eye lateral side, though not a blind spot, but a delayed
focus. (Id. at 37.) Petitioner complained of swollen eyelids in the morning, with the right
eye feeling heavy. (Id.) Dr. Nelson assessed petitioner with bilateral eye pain and
visual disturbance. (Id. at 37-38.) Specifically, petitioner explained that she will “walk
by husband” and not know that he is in the room. (Id. at 38.) She described “problem[s]
w tetanus injection in 2012 which has led to a host of problems and she did research
which said visual problems could happen too.” (Id. (internal citation omitted).)
Petitioner’s eye exam was within normal limits, but Dr. Nelson ordered a visual field test
to rule out scotoma. (Id.)
Petitioner had an ophthalmology evaluation with Dr. Andrew W. Lawton for
problems with her peripheral vision on December 1, 2014. (Ex. 11.) Petitioner reported
that she noticed problems with her vision since she received the Tdap vaccination in
2012, specifically saying that she was “poisoned, adverse reaction.” (Id. at 5.)
Petitioner also added that she had other problems since her vaccination aside from her
vision issues, including chronic inflammation. (Id.) With regards to her vision, petitioner
reported that “she does see things to her sides. She will walk by her husband and not
see.” However, petitioner’s peripheral vision testing was normal. (Id.) Petitioner was
assessed with Keratoconjunctivitis sicca and subjective visual disturbance of both eyes.
(Id. at 5-6.)
Petitioner returned to see Dr. Ferrier on January 27, 2015, for abdominal pain,
with complaints of loss of appetite, nausea, vomiting, and diarrhea. (Ex. 12, p. 59.)
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Petitioner reported that “her symptoms are cyclical after getting a tetanus several years
ago.” (Id.) Petitioner was assessed with paresthesia with regards to her back pain,
shoulder pain, sore throat, seizures, and fatigue. (Id. at 60-61.) Overall, petitioner
visited Dr. Ferrier frequently for various concerns including sore throat, ear pain, cough,
upper respiratory infection, back pain, and swelling. (Id. at 72, 81, 86, 107.)
On February 25, 2015, petitioner visited Dr. Jones for a right shoulder evaluation.
(Ex. 11, p. 7.) According to her history of present illness, petitioner had a rotator cuff
repair in 2009, a vaccine injury in 2011, and global neurological symptoms. (Id. at 10.)
Petitioner’s shoulder pain was described as chronic, starting more than one year ago
with a history of trauma. (Id.) On physical exam, petitioner tested positive in various
tests on her right and not on her left. (Id. at 11-12.) Petitioner was ordered to continue
pain management with Dr. Ferrier. (Id. at 14.) Petitioner’s MRI found a partial tear of
the supraspinatus tendon. (Id. at 24.) On March 11, 2015, petitioner had a follow up
with Dr. Jones following her MRI studies. (Id. at 29.) Dr. Jones recorded that petitioner
was unable to get MRA due to potential allergy to dye and petitioner was unable to
obtain steroid injection due to concerns of potential reaction. (Id.) Following this visit,
petitioner decided to proceed with surgery and physical therapy. (Id. at 34-35.)
Petitioner had a neurology consultation on April 16, 2015, with Dr. Frank S. Oser.
(Ex. 11, p. 36.) Petitioner had complaints of numbness in her feet and spasms
extending from the feet and lower legs into the low back area, where onset was after
receiving her tetanus shot. (Id. at 38.) Petitioner stated that “there was some sort of an
immune reaction that took place, and associated with multiple allergic reactions, as well
as diffuse arthralgias and myalgias among other things.” (Id.) Dr. Oser indicated that
petitioner was positive for all questions asked during review of systems except for
syncope, hearing loss, and incontinence. (Id. at 39.) She was diagnosed with
numbness, pain in limb, lumbago, memory loss, and anemia. (Id. at 36.) Dr. Oser
concluded that petitioner needs daily treatment of hydrocodone to address her back and
leg pain, foot numbness, and other joint pains. (Id. at 40.) However, he indicated that
petitioner’s neurological exam was benign despite an abnormal mental status.
Petitioner was referred for formal neuropsychological testing. (Id.) Petitioner’s EMG,
conducted on May 29, 2015, showed no evidence of radiculopathy, large fiber
neuropathy, or small fiber neuropathy. (Id. at 65.)
Petitioner had an ophthalmology appointment on August 3, 2016, at Ochsner
South Shore Region. (Ex. 13.) Her visit summary listed her current problems including
anemia, arthralgia, joint pain, venous insufficiency, shoulder pain, biceps tendinitis on
right, and more. (Id. at 1.) Since petitioner’s last visit on June 23, 2016, petitioner
indicated that her visual disturbance increased and she would get random tingling
around the eyes. (Id. at 12.) Petitioner also complained of headaches, flashes of light,
frequent floaters, and more. Petitioner was diagnosed with visual disturbance and
referred to seek outside neurology care. (Id. at 13.)
On August 16, 2016, petitioner saw Dr. Tere Vives for a neuro-ophthalmology
consultation. (Ex. 13, p. 14.) Petitioner completed a questionnaire and listed under the
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chief complaint that “TDAP vaccine injury (02/06/2012) caused acute visual
disturbances without resolve.” Additionally, it was noted that petitioner’s visual
problems persisted since receiving the Tdap vaccination. (Id.) Additionally, petitioner
indicated that she experienced trauma, migraine, allergies, ear infection, attention deficit
disorder since her “TDAP vaccine injury.” (Id.) Dr. Vives diagnosed a reaction to her
tetanus shot and orbital pain. (Id. at 25.) Petitioner was prescribed gabapentin
(Neurontin) and vitamin B12 and an MRI was ordered. (Id. at 26-27.) However,
petitioner reported to Dr. Patterson on August 24, 2016, that she had an allergic
reaction to the gabapentin.8 (Ex. 12, p. 144.) The MRI studies were conducted on
August 30, 2016, and were interpreted as unremarkable. (Ex. 13, pp. 32-36.) On
September 6, 2016, Dr. Vives referred petitioner to neurologist Jesus Lovera. (Id. at 34.)
On October 18, 2016, petitioner had a neurology consultation with Dr. Jesus F.
Lovera. (Ex. 13, p. 37.) At this visit, petitioner reported that she was healthy and
started having problems in Feb 2012. Petitioner indicated that she felt sharp pain at the
injection site that radiated down the side of her leg and thereafter, her injection site
became red and she was treated for cellulitis. (Id.) Petitioner indicated that she
continued to experience ongoing symptoms, including spasms, heaviness sensation on
the legs, impaired concentration and focus, decreased appetite, dizziness, blurred
vision, and paresthesia. (Id.) Dr. Vives told Dr. Lovera that petitioner did not have optic
neuritis but that there’s a concern for an ongoing neuroimmunological problem. (Id.)
Petitioner’s brain MRI was unremarkable, but her lumbar spine radiograph showed
lumbar spondylosis and partially visualized uterine fibroids. (Id. at 38-39.) Dr. Lovera
assessed petitioner with weakness of both lower extremities and tetanus vaccine side
effects. (Id. at 40.) Dr. Lovera wrote that petitioner “had a reaction to tetanus
vaccination four years ago. She has a plethora of symptoms that have persisted since
the reaction.” (Id.)
On November 7, 2016, petitioner underwent MRI of the thoracic spine without
contrast. (Ex. 15, p. 9-10.) Petitioner’s history reported that she suffered midback and
neck pain, more prominent on the left with burning paresthesia and bilateral lower
extremity weakness. (Id. at 9.) Petitioner was assessed with mild, early changes from
thoracic spondylosis causing no canal or foraminal stenosis. (Id.) In his impression, Dr.
Harlin noted that petitioner continued to move on repeat imaging sequences, degrading
some of the images and limiting the evaluation of cord signal, especially. (Id. at 10.)
On most of the gradient axial images, there appeared to be abnormal cord signal, but
Dr. Harlin indicated that it was not correlated with T2 sequences or STIR sagittal, which
confirms that it is most likely motion artifact. (Id.) Judging by the sagittal T2 and STIR
images, Dr. Harlin noted no obvious cord signal abnormalities, but very small, focal cord
signal abnormalities which could have been obscured by the artifact. (Id.) Dr. Harlin
observed changes from cervical spondylosis were causing mild central canal stenoses
at C4-C5, C5-C6, and C6-C7. (Id.) He also observed “multilevel bilateral foraminal
stenoses.” (Id.)
8 Petitioner reported that the gabapentin was prescribed for optic neuritis; however, that diagnosis does
not appear in Dr. Vives’s record. Dr. Vives confirmed as part of her referral to neurology that petitioner
did not have optic neuritis. (Ex. 13, p. 37.)
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Petitioner had a chronic pain consult on April 21, 2017, with Dr. Gassan M.
Chaiban. (Ex. 11, p. 63.) Petitioner was reported to have a “long-standing history of
neuropathic pain dating back to a tetanus injection in 20109 which resulted in cellulitis
and an immunologic response which corresponded with the onset of the patient’s pain.”
(Id.) Dr. Chaiban noted that petitioner has been evaluated by multiple specialists but
without any clear diagnosis. (Id.) Dr. Chaiban ordered flexion extension x-rays to be
conducted and depending on the results, Dr. Chaiban wanted to enroll petitioner in
physical therapy. Additionally, Dr. Chaiban directed petitioner to follow up with
psychiatry, neurosurgical, and surgical evaluations. (Id. at 68-69.)
On June 20, 2017, petitioner sough a neurosurgical evaluation for nerve injury
with complaints of “generalized body pain and dysesthesia after tetanus injection.” (Ex.
11, p. 78.) It was recorded that petitioner began having severe left leg pain and
dysesthesia “after a supposed needle injury to the sciatic nerve.” (Id.) The impression
was that petitioner had “post-tetanus injection polyradiculoneuropathy,” and was
referred to Dr. Daniel G. Larriviere for further evaluation. (Id. at 82.) Petitioner saw Dr.
Larriviere on June 30, 2017. (Id. at 87.) Petitioner reported similarly as to prior visits,
the symptoms she experienced immediately following her Tdap vaccination as well as
the following days. In addition, petitioner reported that “[d]uring the ensuing years since
her injection, she experiences constant pain, burning, tingling, and formication
throughout her entire body, including her scalp.” (Id.) Dr. Larriviere noted that her
exam was normal and prior workup was unremarkable, and that petitioner did not have
polyneuropathy. An EMG was then ordered to confirm any evidence for neuropathy.
(Id. at 91.)
On July 12, 2017, petitioner returned to Dr. Lovera for her “ongoing autoimmune
condition.” (Ex. 15, pp. 6-11.) Petitioner reported that her condition was getting worse.
“She feels hot all the time, every time she ingests something no matter what she gets a
bad feeling of burning in her back and spreads through all of her body.” (Id. at 6.)
Likewise, “she also complains of pain over her upper and lower extremities. She
endorses fatigue, malaise. She drops things and fell twice during last couple of months.”
(Id.) Petitioner indicated that her short-term memory was impaired. (Id.) Petitioner
endorsed blurry, double vision, worse in the morning and evening. (Ex. 15, p. 6.)
Petitioner recalled a trip to the hospital due to hypertension “in the 170’s” with
numbness and paresthesia on the face and head. (Id.) She presented to the ER and
was treated for her blood pressure. (Id.) Petitioner reported that she is “normally not
hypertensive.” (Id.) Additionally, petitioner complained of hyperpigmentation on her
skin, worsening since the last visit—“[s]he has seen dermatology and they attributed
this to the tetanus shot.” (Id.) Dr. Lovera assessed petitioner with dysphagia and
“tetanus vaccine side effect.” (Ex. 15, p. 11.) Reviewing petitioner’s November 11,
2016 spinal MRI, Dr. Lovera noted that there were no cord lesions on her cervical and
thoracic spine MRIs. (Id.) Dr. Lovera planned to continue reviewing petitioner for
9 This particular record had a disclaimer, indicating that the note was generated using voice-recognition
software and therefore there may be typographical errors. (Ex. 11, p. 63.) Of note, petitioner’s tetanus
shot was in 2012.
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symptomatic management, though he was “[n]ot sure that immunosuppressant agents
would be helpful.” (Id.) He noted that he spent 50% of the time counseling petitioner
and he “agree[d] her symptoms are possibly related to her tetanus shot.” (Id.)
On August 18, 2017, petitioner presented to her PCP Dr. Ferrier for a follow-up
after presenting to the emergency department for paresthesia. (Ex. 12, p. 209.) She
presented to Dr. Ferrier complaining of tingling sensations involving the left side of her
body. (Id.) She noticed the “peak in pain” around the middle of the month. (Id.)
Petitioner further reported fatigue, diffuse myalgia, bruising, joint pain, hoarseness,
memory loss, and perspiration along her torso. (Id.) She described pain shooting down
her spine, spreading to her extremities. (Id.) Likewise, she reported feeling
lightheaded, with pain behind her eyes. (Ex. 12, p. 209.) Her symptoms were
improving, however. (Id.) Dr. Ferrier assessed petitioner with paresthesia and ordered
her to continue taking vitamin supplements and monitor her blood pressure. (Id. at 10.)
On November 1, 2017, petitioner returned to Dr. Ferrier for a follow-up visit
regarding her hypertension. (Ex. 37, p. 14.) Petitioner was not tolerating
antihypertensives. (Id.) She complained of spasms in her left leg, making walking
difficult. (Id.) She told Dr. Ferrier that her left knee was warm, with ecchymoses. (Id.)
Petitioner further complained of an aching sensation in the bottom of her foot; swelling
in her left hip, worse with weight bearing; decreased grip strength; and night sweats.
(Id.) Petitioner’s diagnoses included essential hypertension and polyneuropathy. (Id. at
15.)
On November 6, 2017, petitioner presented to Dr. Jones complaining of left knee
pain. (Ex. 38, p. 1.) Petitioner complained of joint pain, back pain, joint swelling,
muscle cramps, and muscle weakness; she denied night sweats and denied numbness
or paresthesia. (Id.) On physical examination, petitioner’s left knee, right hip, left and
right shoulder tests were normal, though petitioner demonstrated a deformity in her left
knee. (Id. at 2-4.) She had 4/5 strength in her left quadriceps and hamstring. (Id. at 4.)
Petitioner was assessed with left knee pain (unspecified chronicity), arthralgia
(unspecified joint), chronic right shoulder pain, and fibromyalgia. (Id. at 5.)
On February 6, 2018, petitioner returned to Dr. Ferrier for a follow-up for her
hypertension and chronic pain. (Ex. 37, p. 38.) She denied any chest pain or shortness
of breath, but complained of headache, blurred vision, excessive fatigue and nausea.
(Id.) Petitioner reported her ambulatory blood pressures were good, though her blood
pressures were higher in the right arm. (Id.) Dr. Ferrier ordered her to return for follow-
up in 3 months. (Id. at 39.)
On March 19, 2018, petitioner returned to Dr. Webb-Detiege with a chief
complaint of joint pain. (Ex. 38, p. 7.) Dr. Webb-Detiege noted that petitioner had
“chronic fatigue, immunologic issues and pain since tetanus shot in 2012.” (Id.)
Petitioner described night sweats, feeling like “her nerves are on fire and [] can hear her
heart race.” (Id.) She complained of 24-hour stiffness and difficulty staying on task.
(Id.) Petitioner was negative for symptoms of lupus; but positive for fatigue, fever, dry
mouth, dry eyes, cough, chest pain, headaches, adenopathy and easy
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bruising/bleeding. (Id. at 7-8.) On physical examination, petitioner had pain on
palpation for 12/18 tender points for fibromyalgia. (Id. at 8.) She also demonstrated
zero swollen and zero tender joints. (Id.) Petitioner was assessed with arthralgias
(“symptoms began after tetanus shot which was associated with cellulitis of buttocks”),
myalgias, positive CCP, fatigue, night sweats, dry mouth, venous insufficiency of the
legs, and optic neuritis.10 (Id. at 10.) Dr. Webb-Detiege ordered repeat ANA, labs, and
an arthritis survey. (Id.)
On July 17, 2018, petitioner returned to Dr. Ferrier again for a follow-up of her
hypertension. (Ex. 37, p. 87.) She denied chest pain, blurred vision, excessive fatigue,
nausea or vomiting but complained of shortness of breath and morning headaches.
(Id.) Petitioner reported that she was involved in a motor vehicle accident in April and
developed hand swelling immediately after the accident. (Id.) She also reported left
shoulder popping. (Id.) Dr. Ferrier indicated that petitioner’s blood pressure was well
controlled and ordered her to follow-up with an orthopedist and continue pain
medication for fibromyalgia. (Id. at 88.)
On August 14, 2018, petitioner presented to Dr. Ferrier complaining of right
shoulder and arm pain, pain in the right side of her neck, right wrist weakness, hand
swelling and difficulty stretching her fingers. (Ex. 37, p. 103.) She further complained of
numbness in her right upper extremity. (Id.) According to petitioner her symptoms
began 10 days prior. (Id.) Dr. Ferrier recommended salon pas for the right wrist pain.
(Id. at 104.)
On October 15, 2018, petitioner presented to Dr. Jones with bilateral shoulder
pain, right greater than left. (Ex. 38, p. 11.) She described a fall that caused a
“shocking” pain in her shoulder one month prior. (Id.) Petitioner continued to have
aching and burning in her right arm and shoulder. (Id.) She observed swelling into her
arm, causing difficulty with ADLs. (Id.) Dr. Jones noted petitioner “had a vaccine injury
in 2011 and has had global neurological symptoms.” (Id.) Dr. Jones reviewed
petitioner’s bilateral shoulder x-ray showed mild degenerative joint disease. (Id.) She
was assessed with right shoulder pain (unspecific chronicity), left shoulder pain
(unspecific chronicity), rotator cuff syndrome in the right shoulder, fibromyalgia, biceps
tendinitis in the right shoulder, and arthralgia (unspecific joint). (Id. at 15.) Dr. Jones
ordered an MRA of petitioner’s right shoulder. (Id. at 15-16.) The next day, petitioner
presented to Dr. Sisco-Wise, in the same office, who ordered an EMG to evaluate
petitioner for possible peripheral nerve compression. (Id. at 17.)
On November 19, 2018, petitioner presented to Dr. Ferrier for a follow-up on her
hypertension. (Ex. 37, p. 143.) She continued to experience joint pain but noted that
physical therapy and water therapy were helping. (Id.) She described neck pain, worse
on the right; numbness, tingling, and burning sensations in her right arm; and right-hand
pain. (Id.) Dr. Ferrier assessed petitioner with cervicalgia and prescribed hydrocodone
and ordered cervical spine MRI. (Id. at 144.)
10 Dr. Webb-Detiege noted that petitioner’s records indicated that Dr. Lovera ruled out optic neuritis, but
petitioner wished to see Dr. Webb-Detiege “because of her concern of an ongoing neuroimmunological
problem.” (Ex. 38, p. 10.)
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On January 22, 2019, petitioner presented to Dr. Chaiban for a follow-up on her
chronic pain. (Ex. 38, p. 21.) Petitioner’s EMG/NCV showed mild carpal tunnel
syndrome. (Id.) Petitioner was continuing occupational therapy, and improving, but it
was discontinued secondary for a concern of cervical radiculopathy. (Id.) Dr. Chaiban
noted petitioner’s long-standing history of neuropathic pain dating back to her tetanus
injection, having been seen by multiple specialists, including rheumatology,
hematology/oncology, neurology, cardiology and “there has not been a clear diagnosis
at this time.” (Id.) He noted that in the past petitioner “had a positive rheumatoid factor
and she has thrombocytosis, there is a question of orthostatic hypotension versus
venous insufficiency and this has been undergoing workup.” (Id.) She continued to
describe “burning tingling sensations” in her bilateral lower extremities, abdomen, and
face, with occasional facial droop. (Id.) Dr. Chaiban referred petitioner for an
allergy/immunology consult and suggested a sural nerve biopsy or cervical burst
stimulation at St. Jude. (Id. at 28.)
On March 27, 2019, petitioner presented to PA-C Erin Diebold with a
subcutaneous mass on her medial right elbow. (Ex. 38, p. 29.) Onset of her symptoms
began approximately one year prior, with gradual worsening. (Id.) She developed
progressive weakness and numbness in her fourth and fifth digits and thumb. (Id.) PA-
C Diebold noted petitioner previously had two masses removed which were diagnosed
as lipomas. (Id.)
On April 1, 2019, petitioner presented to Dr. Smith for a consultation regarding
her lipoma. (Ex. 38, p. 32.) Dr. Smith noted in the HPI that petitioner had been
diagnosed with fibromyalgia and peripheral neuropathy “as a reaction to a vaccine in
2012.”11 (Id.) Dr. Smith further noted that petitioner had not been seen by neurology or
rheumatology in over a year. (Id.) Dr. Smith assessed petitioner with right brachial
artery aneurysm but ordered repeat imaging because petitioner’s “[r]epresentative
images are not convincing.” (Id.)
On June 3, 2019, petitioner presented to Dr. Trinh with a chief complaint of right
arm lymphadenopathy. (Ex. 38, p. 34.) Upon reviewing petitioner’s labs, right arm
ultrasound, right arm vascular ultrasound, and MRI of her humerus, Dr. Trinh assessed
petitioner with chronic pain syndrome, right-hand and wrist arthritis, right epitrochlear
lymphadenopathy, positive CCP, and multiple antibiotic allergies. (Id. at 35.) Dr. Trinh
ordered follow-up laps, MRI of her right hand, wrist, and forearm, and follow-up visits
with Drs. Webb and Townsend. (Id.)
On June 5, 2019, petitioner presented to Dr. Ferrier for a follow-up of her
hypertension. (Ex. 37, p. 215.) She reported decreased sensation in her left leg and a
throbbing sensation in her right arm. (Id.) She further reported diffuse body aches,
fatigue, nausea and vomiting following her blood draw. (Id.)
11 By this time petitioner had already had a telephone interview with Dr. Lapp, though the resulting report
does not specifically confirm a diagnosis of fibromyalgia. (Ex. 16.) Petitioner was later evaluated by Dr.
Lapp in person in November of 2019. (Ex. 21.)
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On June 13, 2019, petitioner returned to Dr. Webb-Detiege for a follow-up. (Ex.
38, p 37.) She reported “24-hour stiffness during flare[s]” and described taking 4 hours
to get ready in the morning. (Id.) She described flares for the past five days to two
weeks. (Id.) Petitioner further reported losing sensation in her hands. (Id.) In addition
to her prior diagnoses, Dr. Webb-Detiege assessed petitioner with hypertension
(“worsens with flare of symptoms”). (Id. at 40.)
On June 26, 2019, petitioner presented to Dr. W. Edward Davis III for an allergy
consultation. (Ex. 38, p. 41.) Dr. Davis noted that petitioner was last seen in Allergy by
Dr. Hassett on January 11, 2013. (Id.) He noted that petitioner “attributes multiple
symptoms to her [tetanus shot] reaction, most of which have been neurologic and
muscular.” (Id.) In a detailed survey, petitioner indicated, in part, that her symptoms
occur sometimes two to three times a week, based on dietary intake, and in response to
“outdoor elements and/or contact with various chemicals or products…flare ups are
random and can appear regardless of precautions and avoiding known allergies.” (Id. at
42.) She further indicated that “food allergies only became relevant after TDAP vaccine
injury.” (Id. at 43.) Dr. Davis assessed petitioner with chronic rhinitis (“consider
allergic”), chronic cough with shortness of breath (“consider allergic component”),
history of adverse reaction to tetanus injection, and fibromyalgia. (Id. at 44.) He
ordered neuro-ophthalmology and neurology follow-ups. (Id.)
On August 7, 2019, petitioner returned to Dr. Trinh for a follow-up on her right
arm lymphadenopathy. (Ex. 38, p. 45.) She indicated that she was still awaiting MRI
and reported continued right arm pain and worse swelling since the prior visit. (Id.) Dr.
Trinh noted that an extensive infectious work-up was negative, including bartonella,
toxo, syphilis, HIV, and EBV. (Id. at 46.) She further noted “[s]uspect underlying
autoimmune process cause of right epitrochlear [lymphadenopathy].” (Id.)
On August 8, 2019, petitioner presented to Dr. Robin Davis for a neurology
consult. (Ex. 38, p. 48.) Dr. Davis discussed with petitioner that some of her weakness
may be accounted for by the carpal tunnel noted her EMG. (Id.) Petitioner was
“insistent that she has ulnar Neuropathy not median neuropathy despite the converse
being observed on her EMG.” (Id.) Dr. Davis remarked that her exam was notable only
for multiple functional signs and she complained of 10/10 pain whenever she is touched.
(Id.) Of note, Dr. Davis discussed with petitioner her (1) right carpal tunnel syndrome
(2) chronic pain syndrome and (3) excessive daytime sleepiness. (Id.) Upon review of
petitioner’s EMG, Dr. Davis confirmed her bilateral carpal tunnel syndrome “however the
patient refutes this.” (Id. at 48-49.) Petitioner also insisted that she suffered from
polyneuropathy, though her EMG in 2018 and 2018 showed only evidence of carpal
tunnel syndrome. (Id. at 49.) Dr. Davis noted that she did not receive records from
Ochsner neurology, however. (Id.) Dr. Davis was unable to identify the primary
neurologic cause for petitioner’s chronic pain but noted that she agreed with petitioner’s
PCP who recommended refraining from adding new medications. (Id. at 48.) Dr. Davis
also referred petitioner to Sleep Disorders for her excessive daytime sleepiness. (Id.)
On August 21, 2019, petitioner presented to Dr. Townsend with tender nodule on
her right medial arm. (Ex. 38, p. 52.) Dr. Townsend assessed petitioner with tender
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lymphadenopathy and recommended an excisional biopsy. (Id. at 54.) On September
11, 2019, petitioner presented for a follow-up after her reactive lymph node was
removed. (Id. at 56.)
On September 12, 2019, petitioner returned to Dr. Ferrier for another follow-up
for hypertension. (Ex. 37, p. 249.) Additionally, she reported that she was not sleeping
at night. (Id.) Petitioner complained of persistent right hand and wrist pain. (Id.) Her
MRI showed findings which could be consistent with ulnar abutment syndrome. (Id.)
On September 16, 2019, petitioner returned to Dr. Webb-Detiege. (Ex. 38, p.
57.) Petitioner noted “she is having a flare since Saturday.” (Id.) She complained of
fatigue, fever, trouble swallowing and dry mouth, dry eyes, shortness of breath, chest
pain, headaches, adenopathy, and easy bruising. (Id. at 57-58.) Dr. Webb-Detiege
assessed petitioner with undifferentiated connective tissue disease (UCTD) “manifested
by myalgias and arthralgias, reactive lymph node at right elbow, ANA, CPP, and
fatigue.” (Id. at 60.) Dr. Webb-Detiege ordered labs and messaged petitioner’s eye
doctor for clearance for Plaquenil for her UCTD. (Id.)
On October 7, 2019, petitioner presented to a new physician, Dr. Ronald French
Jr., complaining of pain and swelling in her hands. (Ex. 38, p. 63.) Dr. French Jr. noted
that petitioner had been seen by several different doctors for this issue. (Id.) He noted
that petitioner’s recent MRI showed inflammatory changes of the right wrist. (Id.) Dr.
French Jr. assessed petitioner with inflammatory arthritis of the right hand and wrist,
ulnar impaction syndrome in the right wrist, and right carpal tunnel syndrome. (Id. at
65.) Petitioner was given a corticosteroid injection in her right wrist and a wrist brace.
(Id.) Dr. French Jr. recommended possible surgery for ulnar shortening osteotomy.
(Id.) Petitioner returned to Dr. French Jr. on January 23, 2020, after undergoing ulnar
shortening osteotomy and carpal tunnel release. (See Ex. 38, pp. 71-73 (s/p two
weeks).) On March 9, 2020, petitioner returned to Dr. French Jr. for a post-op follow-up
and was “doing well, pain is minimal, definitely improving.” (Id. at 77.)
On March 23, 2020, petitioner returned to Dr. Ferrier for a follow-up visit. (Ex.
37, p. 301-02.) Petitioner complained of right forearm pain following surgery, but also
reported that sensation was returning to her fingertips in her right hand. (Id. at 301.)
Dr. Ferrier assessed petitioner with mildly elevated blood pressure but noted
improvement; and planned to continue pain control for her fibromyalgia and
polyneuropathy. (Id. at 302.)
On May 6, 2020, petitioner had a telemedicine visit with Dr. Ferrier, complaining
of stress. (Ex. 37, p. 318.) Petitioner further complained of dry skin, hair loss, mouth
sores, fatigue, insomnia, back pain, right shoulder weakness, swollen lymph nodes, ear
pain, and jaw stiffness. (Id. at 318-19.) Dr. Ferrier prescribed Ambien for petitioner’s
insomnia. (Id. at 320.)
On June 24, 2020, petitioner presented to for a follow-up with Dr. Ferrier,
complaining of bilateral leg and knee pain and additional lipoma. (Ex. 37, p. 333.) Dr.
Ferrier assessed petitioner with knee pain, unspecified chronicity, lipoma, and
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hypertension, secondary to pain, but improving. (Id. at 334.) Subsequent ultrasound
did not reveal lipoma. (Id. at 372.) Petitioner continued to report left leg pain, stinging
pain and bilateral ankle and foot swelling, hair loss, lack of sleep (secondary to pain),
headaches (due to lack of sleep), back pain, and perspiration down her back. (Id.) In
December 2020, petitioner additionally complained of being forgetful and dropping
things due to pain exacerbation. (Id. at 394.)
On March 1, 2021, petitioner returned to Dr. French Jr. with residual numbness
and tingling in her right ring and small finger. (Ex. 38, p. 81.) Petitioner indicated that
she wished to restart physical therapy on both hands. (Id.) Dr. French Jr. indicated that
he was “[n]ot sure why she is having the numbness,” so he ordered a nerve conduction
study of both arms. (Id. at 83.) A subsequent nerve conduction study of both hands
showed mild carpal tunnel syndrome bilaterally, no evidence of cubital tunnel or ulnar
nerve compression. (Id. at 84.) Dr. French Jr. administered another corticosteroid
injection and continued petitioner on anti-inflammatory medication. (Id. at 86.) Dr.
French Jr. referred petitioner to Dr. Alvah Tyson Wickboldt Jr. for her neck pain. (Ex.
38, pp. 95-99.) Dr. Wickboldt reviewed petitioner’s prior EMG and MRIs, but “given the
length of time she has been dealing with symptoms” he explained that resolution was
unlikely. (Id. at 99.) He referred petitioner for cognitive behavioral therapy. (Id.)
As of May 2021, petitioner presented to Dr. Ferrier complaining of leg pain. (Ex.
38, p. 102.) She described a heaviness sensation in her leg and shooting pain up her
right leg to her groin. (Id.) Dr. Ferrier assessed petitioner with right leg pain (awaiting
ultrasound), hypertension (elevated, likely secondary to pain), and right hip pain. (Id. at
102-03.)
b. As Reflected by Testimony/Affidavits
Petitioner averred that she received the Tdap vaccination in her left buttocks in
the emergency room on February 6, 2012. (Ex. 7.) Petitioner stated that the nurse
administering the vaccination suggested the buttock and petitioner did not protest
although she thought it was strange. (Id. at 2.) According to petitioner it was “chaotic”
at the emergency room that day and the nurse appeared to petitioner to be “rushed,
distracted, and not competent.” (Id.) Additionally, petitioner affirmed on July 2, 2017
that she has scarring with atrophy and a persistently bothersome bump at the
vaccination site. (Ex. 10.) Petitioner also indicated that the injection site was painful
upon touch with burning and itching. (Id.)
Petitioner testified that prior to vaccination she was social and active, comparing
herself to the “Energizer bunny.” (Tr. 9-10.) In contrast, she described her post-
vaccination life as follows:
I'm feeling horrible. I am not well, and I am afraid that I'm not going to get
better because I'm not getting better. And I just can't do anything normal like
I would be able to be very active and be more in control of being organized
and not fatigued. Anything I try to do makes me tired. Especially when I try
to do things, I get stressed, because I can't complete the task because I'm
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tired all the time. And I've even tried to stay in the bed longer to rest, even
to sleep, but still when I awaken, it's like I've never slept. And I've told Dr.
Ferrier, all my physicians, numerous, numerous, I'm just tired, I'm just tired.
So when I try to do a normal day's activity, which that no longer exists for
me -- I don't have any normalcy; I live day to day, because I have a lot of, I
guess you would say, symptoms that's just recurring. And the pain is
unbearable. Like right now I'm getting tired waiting, because I want to sleep,
and I'm trying to stay focused, so I can participate. And I got a little sleep
last night, but still when I awake, the hoarseness is there. I can tell when I'm
really bad because it's like I hit a wall, oomph. And even if I try to push past
it, my mind is saying I can do it, but my body's saying, we're not doing that.
Literally you're not doing that.
(Tr. 7-8.)
On cross-examination, respondent’s counsel explored details of petitioner’s
medical history and petitioner provided testimony regarding her subjective experience of
the symptoms discussed in the medical records. This related in large part to
understanding her sleep patterns and how she experienced what was reported as
insomnia and night sweats by her physicians. (Tr. 15-20.) Petitioner also indicated that
the leg pain she experienced pre-vaccination was not severe, only “normal” achiness,
and that she only ever took Vicodin for her shoulder problem. (Tr. 20-21.) Petitioner
disagreed with the medical record of May 23, 2011 (Ex. 1, p. 570) characterizing her
pain problems as “longstanding.” (Tr. 21-29.) Petitioner characterized her back and leg
pain as residual effects of her shoulder problem that were ultimately resolved by her
later 2012 surgery. (Id.) Petitioner also disagreed with a characterization in the medical
records (Ex. 1, p. 574) from September of 2010 of her having “recurrent” throat
infections, preferring to characterize them as either periodic or “off and on.” (Tr. 30-32.)
Petitioner confirmed she had an upper respiratory infection in January of 2012 (Tr. 32-
33) and reviewed the record of her January 16, 2012, encounter with Dr. Ferrier (Ex. 1,
p. 442). Petitioner acknowledged having the symptoms reported in the record, including
cough, fatigue, and intermittent fever. (Tr. 34-35.)
IV. Expert Opinions
a. Petitioner’s Experts
i. Janine M. Ferrer, M.D.
On November 2, 2016, Dr. Ferrier, petitioner’s primary care physician, wrote a
letter addressing petitioner’s claim. (Ex. 8.) Dr. Ferrier stated that petitioner received a
Tdap vaccine in her left hip in 2012 and experienced pain and redness around her
injection site. (Id.) Thereafter, petitioner experienced intermittent fatigue, fever,
myalgias, joint pains, intermittent swelling, and headaches. Additionally, Dr. Ferrier
wrote that petitioner also had other symptoms including decreased appetite, nausea,
spasms, and burning sensation in her left lower extremity. Dr. Ferrier stated that
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“[m]any of the symptoms [petitioner] has experienced may be attributable to her
vaccination, including injection site pain and redness, fever, headaches nausea, chills,
and bodyaches [sic].” (Id.) Dr. Ferrier indicated that petitioner continued to experience
symptoms intermittently.
ii. Charles Lapp, M.D.
Dr. Lapp currently is the medical director of the Hunter-Hopkins Center in North
Carolina. (Ex. 20.) He received his medical degree from Albany Medical College in
1974 and completed his residency in internal medicine and pediatrics at North Carolina
Memorial Hospital. (Id.) He has experience in diagnosis and management of CFS and
Fibromyalgia since 1985. (Ex. 16.) Dr. Lapp has published various articles covering
many topics and recently took part in an article about CFS and Myalgic
Encephalomyelitis. (Ex. 20, p. 3.)
Petitioner was evaluated by Dr. Lapp on November 12, 2019 following a phone
consultation on February 29, 2019.12 (Ex. 21.) As part of her history of present illness,
Dr. Lapp noted that petitioner experienced nausea, fatigue, and injection site pain within
30 to 60 minutes following receipt of the Tdap vaccination to her left buttock on
February 6, 2012. Additionally, the following day, petitioner experienced widespread
arthralgias, pain in the left hip and back, discomfort in the left leg, and swelling in her
hands and legs. From there, petitioner was diagnosed with cellulitis of the left buttock,
diagnosed with serum sickness following a rheumatology consult, and developed more
symptoms including malaise, insomnia, memory loss, headaches, body pain, recurrent
sore throat, cervical and inguinal lymphadenopathy. (Id. at 1.) Dr. Lapp noted that
petitioner’s symptoms persisted and that she “is almost never free of severe pain, which
12 Although the opinions of treating physicians are not binding (see § 13(b)(1)), the Federal Circuit has
recognized that “treating physicians are likely to be in the best position to determine whether ‘a logical
sequence of cause and effect show[s] that the vaccination was the reason for the injury.’” Capizzano v.
Sec'y of Health & Human Servs., 440 F.3d 1317, 1326 (Fed. Cir. 2006) (quoting Althen v. Sec'y of Health
and Human Servs., 418 F.3d 1274, 1280 (Fed. Cir. 2005)). Accordingly, such opinions are often
considered “quite probative.” Id. This logic has also been applied in the context of diagnosis. See, e.g.,
D'Angiolini v. Sec'y of Health & Human Servs., No. 99-578V, 2014 WL 1678145, at *24 (Fed. Cl. Spec.
Mstr. Mar. 27, 2014) (finding a treating physician’s opinion regarding diagnosis “worth a great deal” and
“almost definitive evidence on that point”), mot. for rev. denied, 122 Fed. Cl. 86 (2015), aff'd, 645 F. Appx.
1002 (Mem.) (Fed. Cir. 2016). However, the extra weight often assigned treating physician opinions is
premised on the notion that, in addition to being qualified to offer a medical opinion, the treating
physicians were eyewitnesses with personal knowledge of the unfolding of a petitioner’s condition. Nuttall
v. Sec’y of Health & Human Servs., 122 Fed. Cl. 821, 832-33 (2015) (explaining that the Federal Circuit
“found that a treating physician who was familiar with the patient both before and after the alleged vaccine
injury is likely to be in a better position than an expert retained after the fact” to opine with respect to
vaccine causation), aff’d 640 Fed. Appx. 996 (Mem.) (Fed. Cir. 2016). Here, Dr. Lapp’s evaluation does
not fit that context. He had one phone consultation and one in-person evaluation with petitioner, both of
which occurred years after the alleged onset of her condition. Moreover, the evaluation was for purposes
of developing Dr. Lapp’s opinion in this case and did not occur in the ordinary medical treatment context.
For these reasons, while recognizing that Dr. Lapp’s ability to conduct an in-person exam and interview
contributed to the basis for his opinion and likely added to what he was able to observe in making to his
assessment, his opinion does not qualify for any added enhancement as a treating physician in the
context of the record for this case.
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comes from all over, from muscles, bones, and joints.” (Id.) At this evaluation,
petitioner reported moderate to severe symptoms at rest, but severe symptoms with
activity. (Id. at 2.) Dr. Lapp also listed Tdap and all vaccines as part of petitioner’s
allergies. (Id. at 3.)
Under a review of systems, Dr. Lapp noted that petitioner experiences many
symptoms including flu-like feelings, recurrent sore throat, blurred vision, recurrent sinus
congestion and drainage, frequent queasiness, and more. (Ex. 21, p. 3.) Upon
examination, Dr. Lapp noted petitioner was positive for joint tenderness and limited
range of motion at the right wrist. (Id. at 4.) He also noted some elevated levels from
her laboratory. (Id.) Dr. Lapp assessed petitioner with fibromyalgia, CFS, sleep
disorder, as well as dysphagia, irritable bowel syndrome, amenia, vitamin D deficiency,
and several other conditions. (Id. at 4-5.)
Dr. Lapp reports that immune challenges, like immunizations, can cause CFS.
(Ex. 16, p. 3.) He explains that a shift in the immune response towards a TH2 profile
results in a fatiguing illness after vaccination; and moreover, overproduction of pro-
inflammatory cytokines can cause alterations in the cardiovascular and cognitive
systems. Dr. Lapp indicates that an immune imbalance toward a TH2 immune state is
observed in patients with CFS. He states that, “it is well known by researchers in this
field, that CFS is frequently triggered by infections and various immune challenges,
including vaccinations.” (Id.) Therefore, Dr. Lapp opines that petitioner has CFS and
Systemic Exertion Intolerance Disease, and that petitioner’s condition was triggered by
her receipt of the Tdap vaccination on February 6, 2012. (Id.)
In a supplemental report, Dr. Lapp provides a response to the reports from Drs.
Oddis and He. (Ex. 22.) Dr. Lapp points out that routine laboratory and diagnostics are
typically normal in CFS and fibromyalgia patients. He responds that a one-time
shoulder pain, backaches, and leg pain cannot explain the physical and cognitive
symptoms that petitioner experienced all over her body since her vaccination. Again,
Dr. Lapp emphasizes that petitioner’s rheumatologist concluded that petitioner had a
reaction to her vaccination. (Id. at 1.) He disagrees that petitioner’s condition was
caused by an infection or cellulitis. Dr. Lapp indicates that “[f]ever and swelling
occurred at the injection site within one hour of the injection, which is too rapid for
infection; and within one day the patient experienced diffuse joint pain, a clear sign of
immune reaction.” (Id.) Dr. Lapp again asserts that petitioner developed fever,
swelling, arthralgias, and other symptoms that meet the criteria for Fibromyalgia and
CFS. (Id. at 2.)
During the hearing, Dr. Lapp testified in accordance with his prior reports. (Tr. at
41-171; 176-244.) He further explained the immunology underlying his theory and
addressed specific medical record entries that he opines support his interpretation that
petitioner experienced onset of her CFS within two weeks of her Tdap vaccine. He also
discussed the relevant diagnostic criteria for CFS in detail and explained that he
believes petitioner’s treating physicians misinterpreted manifestations of petitioner’s
CFS as serum sickness.
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b. Respondent’s Experts
i. You-Wen He, M.D., Ph.D.
Dr. He currently teaches as a professor of immunology at Duke University
Medical Center and oversees four clinical trials for cancer immunology. (Ex. C.) Dr. He
also serves as a reviewer for several journals. He received his medical degree from
The Fourth Military Medical University in Xian, China in 1986 and his doctorate in
microbiology and immunology from the University of Miami School of Medicine in 1996.
(Ex. C, Tab 1.) He has ongoing research focusing on T cell receptor-activated
autophagy and immune-modulating antibody for lung cancer treatment. (Id. at 6.)
Upon review of the medical records, Dr. He concludes that petitioner had chronic
conditions that did not result in any definitive diagnosis. (Ex. C.) Dr. He opines that
CFS is poorly understood and may be related to several possible causes including
infection, immune dysfunction, endocrine-metabolic dysfunction, and neuropsychiatric
factors. (Id. at 3 (citing Stephen J. Gluckman et al., Clinical features and diagnosis of
myalgic encephalomyelitis/chronic fatigue syndrome, 11(4) UPTODATE 1 (2019) (Ex. C,
Tab 2.)).) Although Dr. Lapp cited to a case report relating vaccination and CFS, Dr. He
states that there is insufficient support for causation between vaccination and CFS. In
his opinion, it is more likely that petitioner’s chronic condition was infection-induced
since petitioner had cellulitis after her receipt of her February 6, 2012. (Id. at 3.)
During the hearing, Dr. He testified in accordance with this report. (Tr. at 282-
309.) He also provided specific criticisms of the immunology Dr. Lapp presented during
the hearing.
ii. Chester V. Oddis, M.D.
Dr. Oddis received his medical degree at Pennsylvania State University, College
of Medicine in 1980. (Ex. D, Tab 1.) He currently holds a teaching position as a
professor of medicine in the division of rheumatology and clinical immunology at the
School of Medicine at the University of Pittsburg. (Ex. D.) He is board certified in
internal medicine and rheumatology. Dr. Oddis specialized his research in myositis and
interstitial lung disease. (Id.)
Regarding petitioner’s history, Dr. Oddis notes that petitioner was never
diagnosed with either CFS or Fibromyalgia and that all her laboratory and diagnostic
studies were normal. (Ex. D, p. 3.) Additionally, Dr. Oddis points out that petitioner had
musculoskeletal problems and was treating her chronic pain following right shoulder
surgery prior to receiving the Tdap vaccination in February 2012. (Id. at 3-4.) Dr. Oddis
notes that when petitioner complained of diffuse pain, petitioner’s rheumatologist and
immunologist diagnosed petitioner with “arthralgia,” or joint pain without evidence of
inflammation. (Id. at 5.)
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Dr. Oddis opines that petitioner had chronic pain syndrome prior to vaccination
and that petitioner does not meet the criteria for the diagnosis of CFS. (Id. at 4-5.) He
indicates that petitioner has some features, but many of her symptoms were non-
specific and therefore disagrees with Dr. Lapp’s diagnosis. Dr. Oddis also notes that
the basis of Dr. Lapp’s report “sets up the potential for an extremely biased report where
a physician can suggest many of the clinical features/diagnostic criteria to a patient and
then report them.” (Id. at 5.) Aside from contesting petitioner’s diagnosis, Dr. Oddis
also opines that petitioner had “self-limited and non-specific symptoms after the Tdap
vaccination,” that never manifested into any treatable condition.
On Dr. Lapp’s theory regarding CFS and vaccination, Dr. Oddis disputes the
association and notes that “CFS is often triggered and perpetuated by an ongoing
microbial infection and that was also not the case with [petitioner].” (Id. at 6.)
During the hearing, Dr. Oddis likewise testified in accordance with his report. (Tr.
at 245-281.)
V. Discussion
a. Diagnosis
When faced with disagreement among qualified experts regarding the
identification and nature of a disputed injury, the Federal Circuit has concluded that it is
“appropriate for the special master to first determine what injury, if any, [is] supported by
the evidence presented in the record before applying the Althen test to determine
causation.” Lombardi v. Sec’y of Health & Human Servs., 656 F.3d 1343, 1351-53
(Fed. Cir. 2011). Importantly, however,“[t]he function of a special master is not to
‘diagnose’ vaccine-related injuries, but instead to determine ‘based on the record as a
whole and the totality of the case, whether it has been shown by a preponderance of the
evidence that a vaccine caused the [petitioner]’s injury.’” Andreu v. Sec’y of Health &
Human Servs., 569 F.3d 1367, 1382 (Fed. Cir. 2009) (quoting Knudsen v. Sec’y of
Health & Human Servs., 35 F.3d 543, 549 (Fed. Cir. 1994)).
Nonetheless, petitioner must “specify [her] vaccine-related injury and shoulder
the burden of proof on causation.” Broekelschen v. Sec'y of Health & Human Servs.,
618 F.3d 1339, 1346 (Fed. Cir. 2010). “Although the Vaccine Act does not require
absolute precision, it does require the petitioner to establish an injury – the Act
specifically creates a claim for compensation for ‘vaccine-related injury or death.’”
Stillwell v. Sec'y of Health & Human Servs., 118 Fed. Cl. 47, 56 (2014) (quoting
42.U.S.C. § 300aa-11(c)). And, in any event, a petitioner must prove by a
preponderance of the evidence the factual circumstances surrounding her claim. §
300aa–13(a)(1)(A).
In this case, petitioner has a complex overall medical history. Initially, petitioner
pleaded only that she suffered an abscess and unspecified “related injuries,” the
symptoms of which she alleged had become chronic. (ECF No. 1, p. 1.) Following her
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expert’s assessment, she narrowed the “related injuries” to a diagnosis of CFS in her
prehearing brief. (ECF No. 132.) However, Drs. Lapp and Oddis raise questions about
a number of specific conditions. On petitioner’s behalf, Dr. Lapp opines that petitioner
does have CFS and comorbid fibromyalgia; however, he denies that she suffered any
serum sickness as documented in the medical records. (Tr. 148.) Respondent’s
expert, Dr. Oddis, disagrees that petitioner has either CFS or fibromyalgia and further
opines that petitioner suffered a pre-existing chronic pain syndrome. (Tr. 255-56.) Dr.
Oddis does not have any opinion regarding the serum sickness diagnosis contained in
the medical records. (Id. at 280-81.) There are also references in the medical records
to possible rheumatoid arthritis. (Ex. 1, pp. 419, 422, 538; Ex. 2, p. 10.) Finally, both
experts agree that petitioner likely suffered the cellulitis documented in the medical
records. (Tr. 182, 290-91.)
i. Cellulitis
Petitioner’s medical records reflect that on February 9, 2012, she presented to
Dr. Ferrier for symptoms that included pain, redness, and inflammation at the site of her
Tdap injection.13 (Ex. 1, 441.) On examination, she had “positive induration of left
gluteus with erythema.” (Id.) The assessment was cellulitis/left gluteal abscess. (Id.)
Both Dr. Lapp and Dr. Oddis agree that a temporary cellulitis was present. (Tr. 182; Tr.
279-80.) Accordingly, there is preponderant evidence petitioner suffered cellulitis.
ii. Serum sickness
When petitioner presented for care at the emergency department on February
27, 2012, she described symptoms beyond those associated with her previously
diagnosed cellulitis and this was felt to be “most likely a reaction to the tetanus shot and
possibly a delayed serum sickness type hypersensitivity reaction . . . .” (Ex. 1, p. 706
(emphasis added).) On March 7, 2012, petitioner had a follow up with an allergist, Dr.
Lurie. (Ex. 3, pp. 1-3.) Dr. Lurie characterized petitioner as a patient with “serum
sickness non IgE immunologic reaction to DTap vaccine.” (Id. at 3.) This was based on
her symptoms being “typical” of such a reaction and it was assumed they would resolve
within weeks. (Id.) By June of that year, later records characterize serum sickness as
having been previously “suspected.” (Ex. 1, p. 412 (“serum sickness was suspected”);
Ex. 1, p. 418 (Dr. Lurie felt symptoms “may be related to serum sickness”); Ex. 1, p. 52
(repeating in October 2012 that “serum sickness was suspected”).)
On November 2, 2016, petitioner’s primary care doctor, Dr. Ferrier, wrote a letter
indicating that following her Tdap vaccination, petitioner experienced, inter alia,
“intermittent fatigue, fever, and myalgias.” (Ex. 8.) She opined that “[m]any of the
symptoms she has experienced may be attributable to her vaccination, including
injection site pain and redness, fever, headache, nausea, chills and body aches. She
continues to experience symptoms intermittently.” (Id.) However, Dr. Ferrier did not
13 The previously assigned special master also confirmed that petitioner’s Tdap vaccine was injected in a
corresponding location and I have adopted that finding as my own. (See n. 4, supra.)
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specifically invoke serum sickness in her letter. Nor was Dr. Ferrier among those
physicians who included an impression of serum sickness in petitioner’s post-
vaccination treatment records.
Taking the medical records as a whole, it does not appear that serum sickness
was ever definitively diagnosed. Dr. Lapp also opines that petitioner did not ever have
serum sickness. He bases this on two factors: the symptoms attributed to serum
sickness are better explained by his subsequent diagnosis of CFS and the symptoms
did not resolve on the appropriate time course for a serum sickness reaction. (Tr. 151,
230.) On respondent’s behalf, Dr. Oddis declined to offer an opinion as to whether
petitioner suffered a serum sickness. He indicated that it may be “reasonable,” but
noted that it is generally a difficult diagnosis to substantiate. (Tr. 280-81.) Dr. He
declined to offer any opinion as to diagnosis. (Tr. 292.)
On this record, there is not preponderant evidence that petitioner suffered a
serum sickness reaction.
iii. Chronic pain syndrome / lower extremity pain
Dr. Oddis opined that prior to vaccination (and continuing afterward), petitioner
suffered from “chronic pain syndrome.” (Ex. D, p. 4.) Dr. Lapp agreed on petitioner’s
behalf that chronic pain syndrome is a valid diagnostic entity generally, and further
indicated that “I think technically you could say she does have a chronic pain syndrome
because she has lumbago, low back pain, and she has a pain that radiates down the
leg which has not been explained despite numerous studies to try to explain it.” (Tr.
241.)
Importantly, however, Dr. Oddis is unpersuasive to the extent he would suggest
that a chronic pain syndrome in itself constitutes an explanation for the entirety of
petitioner’s presentation. Dr. Oddis opines that petitioner’s pre-vaccination
musculoskeletal complaints and her post-vaccination presentation represent “a
continuum.” (Tr. 259.) He ultimately summarized his opinion as follows: “I would just
reiterate that if somebody is on narcotics for one to two years, that implies pain, and that
pain is chronic. And that pain was well characterized in the medical record and it
predated vaccination.” (Tr. 263.) To support this view, Dr. Oddis cited the following:
Ex. 1, p. 432 (medical record regarding chronic shoulder pain); Id. at 465 (medical
record regarding leg pain); Id. at 477 (medical record regarding bulging lumbar discs);
Id. at 570 (medical record regarding lower back pain of a mechanical nature); and Id. at
546 (petitioner requesting diabetes screening for lower leg pain) (Tr. 257-58; Ex. D, p.
3-4).
Absent from Dr. Oddis’s opinion is any discussion of diagnostic standards for a
chronic pain syndrome or any broader explanation of when the label is appropriately
applied. Instead, he discusses seemingly disparate musculoskeletal symptoms with at
least suspected diagnoses and labels them as a syndrome based on petitioner’s
treatment with narcotic medication. During the hearing, Dr. Oddis was asked what
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basis he had for including petitioner’s shoulder pain in his assessment of chronic pain
syndrome when it appeared to have a clear mechanical cause treated by surgery. (Tr.
259-60.) He responded that he only included that as an example of a musculoskeletal
complaint prior to vaccination and that he is “perfectly agreeable to taking that out of the
chronic pain picture I have painted thereafter.” (Tr. 260.) Accordingly, on later
questioning, Dr. Oddis was asked:
Q: We talked a little bit earlier about the idea of the chronic pain syndrome
before vaccination and what went into that. Hypothetically, if I concluded
that I could find an explanation for every complaint the Petitioner had before
the vaccination, how would that change your opinion, if at all?
A: It wouldn’t change my opinion. I just saw it as a continuum.
(Tr. 277.) To the extent Dr. Oddis views the course of petitioner’s symptom
presentation differently than Dr. Lapp – and disagrees that the vaccination at issue
represented any inflection point – that raises a potential question under Althen prong
two, as discussed below. However, it is not credible to further suggest that petitioner’s
medical history should be entirely explained by a pain syndrome and viewed as a
continuum of that syndrome without any regard to the etiology of petitioner’s specific
musculoskeletal complaints.
During the hearing, Dr. Lapp explained that under the Fukuda criteria, which he
relies upon in part and which is discussed further below, diagnosis of CFS must exclude
conditions that could plausibly explain the relevant symptoms, particularly the fatigue.
(Tr. 52; The CDC (Fukuda 1994) Definition for Chronic Fatigue Syndrome, CFids-
Me.org, https://www.cfids-me.org/cdcdefine.html (last updated Mar. 30, 2008) (Ex. 27).)
Specifically, the Fukuda criteria explain what types of conditions exclude a diagnosis of
CFS. (Fukuda Definition, supra, at Ex. 27.) These include active medical conditions
that may explain chronic fatigue, diagnosable illnesses that may not have completely
resolved during treatment (if they explain fatigue), major depressive disorders,
substance abuse, and severe obesity. (Id.) The criteria indicate that “[a]ny unexplained
abnormality detected on examination or other testing that strongly suggests an
exclusionary condition must be resolved before attempting further classification.” (Id. at
2.) However, the criteria specify that the following does not exclude a diagnosis of CFS:
“[a]ny isolated and unexplained physical examination finding, or laboratory or imaging
test abnormality that is insufficient to strongly suggest the existence of an exclusionary
condition.” (Id.) Here, Dr. Oddis’s testimony is inadequate to establish either that the
proposed pain syndrome is a condition that can entirely explain petitioner’s relevant
symptoms, especially including fatigue, or that the findings he cites “strongly suggest”
an exclusionary condition. Rather, Dr. Oddis acknowledged during cross examination
that a patient with CFS and fibromyalgia can have other medical problems. (Tr. 275.)
Dr. Oddis’s willingness to apply a pain “syndrome” label to petitioner’s medical
history based mainly on her longer-term treatment with narcotics is also inconsistent
with his skepticism regarding other aspects of petitioner’s medical history. For example,
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Dr. Oddis was critical of Dr. Lapp’s CFS diagnosis in large part because it was not also
diagnosed by the treating specialists. (Tr. 254-55.) Yet, his chronic pain syndrome
diagnosis is similarly absent from the earlier, contemporaneous medical records.14
Additionally, to the extent his opinion hinges on longer term treatment with narcotics, he
was willing to express skepticism of petitioner’s physicians for overprescribing
antibiotics and suggested it was relevant to assessing her history longitudinally. (Tr.
275-76.) Yet, his pain syndrome assessment appears to take the advisability of
petitioner’s narcotics prescriptions at face value. Doing so is not necessarily incorrect;
however, Dr. Oddis appears to apply his skepticism selectively.
Thus, while petitioner experienced pre-vaccination lower extremity pain that was
not definitively explained, there is not preponderant evidence that this condition,
whether labeled as a chronic pain syndrome or not, excludes the diagnosis of CFS
proposed by Dr. Lapp.
iv. Rheumatoid arthritis
Petitioner tested positive for anti-CCP antibodies, a precursor to rheumatoid
arthritis, and rheumatoid arthritis was considered by her treating physicians. (See, e.g.,
Ex. 1, p. 538.) During the hearing, however, both Dr. Lapp and Dr. Oddis agreed that
petitioner did not have clinical Rheumatoid arthritis during the period at issue. Dr. Lapp
opined that rheumatoid arthritis may have developed later based on certain x-ray
findings, but that a later diagnosis of rheumatoid arthritis is not incompatible with his
opinion regarding CFS. (Tr. 232-33.) Dr. Oddis opined that petitioner’s antibody results
do not necessarily result in clinical symptoms of rheumatoid arthritis and confirmed that
he does not believe petitioner had rheumatoid arthritis clinically. (Tr. 278-79.)
Accordingly, there is not preponderant evidence that rheumatoid arthritis explains any of
petitioner’s symptoms.15
14 It appears that a “chronic pain syndrome” was referenced in petitioner’s medical records beginning in
2019. (Ex. 38, p. 34.) On June 3, 2019, petitioner presented for evaluation of a right arm
lymphadenopathy. Dr. Trinh characterized her history as including a “history of chronic pain syndrome.”
(Id.) In that same record, however, Dr. Trinh indicated that petitioner had developed CFS subsequent to
her February 2012 Tdap vaccination. (Id.) Accordingly, Dr. Trinh’s notation does not contradict Dr. Lapp’s
opinion. Additionally, in August of 2019, petitioner presented to neurologist Robin Davis, M.D., with
regard to “numerous complaints.” (Ex. 38, p. 48.) Dr. Davis was unable to identify a primary neurologic
cause and assessed a chronic pain syndrome. (Id.) Importantly, however, Dr. Davis indicated that she
did not have access to petitioner’s prior medical records and considered herself uninformed of petitioner’s
prior history. (Id.) Accordingly, it would not be accurate to interpret Dr. Davis as offering any opinion as to
petitioner’s overall course.
15 The updated medical records filed after the hearing show that petitioner was diagnosed with
undifferentiated connective tissue disease on September 16, 2019, based in part on the CCP finding. (Ex.
38, p. 60.) In making that diagnosis, Dr. Webb-Detiege appears to suggest that it could account for both
myalgia and fatigue. (Id.) This could warrant further expert opinion with respect to whether it should in
itself call the proposed CFS diagnosis into question. However, because I have in any event concluded
pursuant to Althen that petitioner’s CFS was not vaccine-caused, it is not necessary to resolve that
question.
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v. Fibromyalgia
Petitioner testified that she was diagnosed with fibromyalgia by Dr. Ferrier
subsequent to her 2012 Tdap vaccination. (Tr. 36.) However, fibromyalgia is not listed
as a diagnosis in her earlier medical records and Dr. Ferrier did not otherwise mention
fibromyalgia in her letter to the court. (Ex. 8.) The updated medical records petitioner
filed after the hearing seem to suggest Dr. Ferrier added fibromyalgia to petitioner’s
problem list in December of 2019 based on Dr. Lapp’s assessment. (Ex. 37, p. 276.)
Petitioner was assessed as having fibromyalgia by Dr. Jones on November 6, 2017.
(Ex. 38, pp 1-6.) However, the basis for that assessment is unclear as Dr. Jones noted
no tenderness on physical exam. Subsequently, in March of 2018, Dr. Webb-Detiege
conducted a tender point exam that documented tenderness at 12 of 18 points;
however, she did not specifically diagnose fibromyalgia. (Ex. 38, pp. 7-10.) Later, on
September 16, 2019, Dr. Webb-Detiege documented only 8 of 18 tender points. (Id. at
58.) Dr. Lapp opines that petitioner does have fibromyalgia based on his own
evaluation while Dr. Oddis opines that she did not based on the medical records. (Tr.
133-34, 255-56.)
Fibromyalgia is commonly comorbid to CFS, but it is not necessary to the
diagnosis. (Gluckman et al., supra, Ex. C, Tab 2, pp. 7-8.) In this case, Dr. Lapp
confirms that the fibromyalgia he opines is present is merely a comorbidity of
petitioner’s CFS. (Tr. 136.) He also confirmed during the hearing that, although he
does opine that fibromyalgia could in general be vaccine-caused, he is not aware of
literature to support that assertion and has not included fibromyalgia in his causal
opinion. (Tr. 208-09, 232.) Accordingly, petitioner’s claim does not turn on whether any
of her symptoms can be properly characterized as fibromyalgia and that specific
question need not be resolved.
vi. Chronic fatigue syndrome (CFS)
Finally, the most extensively litigated diagnosis in this case is CFS. Petitioner
was not diagnosed with CFS by any of her treating physicians prior to her evaluation by
Dr. Lapp in 2019, roughly seven years post-vaccination. Accordingly, the question of
whether she can be diagnosed with CFS turns on the persuasiveness of the experts.
CFS, also sometimes referred to as myalgic encephalomyelitis, is a condition
characterized by severe debilitating fatigue that lasts for more than six months. (L.D.
Devanur & J.R. Kerr, Chronic fatigue syndrome, J. CLIN. VIROLOGY 1, 2 (2006) (Ex. 17).)
It is diagnosed clinically and also involves muscular, infections, and neuropsychiatric
symptoms, and sleep disturbances. (Id.) The name CFS persists because it remains a
syndrome without a definitely established etiology. However, the alternative term
myalgic encephalomyelitis is meant to connote that it is a condition of widespread
inflammation and multisystemic neuropathology. (B.M. Carruthers et al., Myalgic
encephalomyelitis: international consensus criteria, 270 J. INTERN. MED. 1 (2011) (Ex.
24).)
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During the hearing, Dr. Lapp explained that there are numerous different sets of
diagnostic criteria to screen for CFS. (Tr. 156.) In this case, however, he specifically
discussed only three – the so-called Fukuda criteria issued by the CDC in 1994, a 2003
set known as the Canadian criteria that was later updated in 2011 to become the
international case definition criteria (“ICC”), and a set developed by the IOM in 2015.
(Tr. 49-58, 64-66; Carruthers et al., supra, at Ex. 24; Fukuda Definition, supra, at Ex. 27;
IOM 2015 Diagnostic Criteria, CDC.GOV, https://www.cdc.gov/me-cfs/healthcare-
providers/diagnosis/iom-2015-diagnostic-criteria.html (last updated Apr. 27, 2021) (Ex.
28).) The Canadian criteria is more symptom based. It is generally considered effective
but cumbersome and Dr. Lapp disfavors it for that reason. (Tr. 65.) It was not
discussed at length in this case.
According to Dr. Lapp, the Fukuda criteria are primarily used for research as they
have exclusion requirements that are not conducive to clinical use. (Tr. 51-52.)
Nonetheless, he did opine that application of that criteria supports petitioner’s case.
(Ex. 21, p. 4.) Dr. Lapp suggested the IOM criteria is less strict than the Fukuda criteria
and should be considered a “screening tool” for CFS. (Tr. 57.) If a person meets the
IOM criteria, they should be referred to a specialist or further screened using the
Fukuda criteria. (Id.) According to Dr. Lapp, if a person met the IOM criteria but not the
Fukuda criteria, they should be monitored as a presumptive case of CFS to see how
symptoms develop. (Tr. 156-57.) However, Dr. Lapp considers that possibility to be
“very rare.” (Id.) In this case, Dr. Lapp applied both the Fukuda criteria and the IOM
criteria and concluded that petitioner meets both. (Ex. 21, p. 4.)
For his part, Dr. Oddis stressed that sets of diagnostic criteria are primarily for
clinical trials and that “you have to be more open-ended when you look at the individual
patient in the clinical setting.” (Tr. 249.) Although Dr. Oddis never disputed that CFS
constitutes a valid diagnostic entity, during the hearing he was difficult to pin down with
regard to any further detail, seeming to betray skepticism that CFS should be applied as
a diagnosis in most cases (he prefers “fibromyalgia with chronic fatigue”). (Tr. 265-73.)
Ultimately, however, while Dr. Oddis explained that he does not use the Fukuda criteria
in his own practice, he agreed that a person meeting the Fukuda criteria could be said
to be suffering CFS. (Tr. 272-73.) In his own report, Dr. Oddis relied on the 2015 IOM
criteria to discuss whether petitioner has CFS. (Ex. D, p. 4.)
In light of the above, there is preponderant evidence that either the Fukuda
criteria or the IOM criteria could be considered sufficiently authoritative to support a
diagnosis of CFS. The 2015 IOM criteria include three mandatory “symptoms”
accompanied by at least one of two “additional manifestations.” (IOM Criteria, supra, at
Ex. 28, p. 1.) Thus, under this criteria diagnosis requires (1) a substantial impairment in
the ability to engage in pre-illness levels of activity that lasts for at least six months and
is accompanied by fatigue,16 (2) post-exertional malaise, (3) unrefreshing sleep, and (4)
16 The fatigue is further characterized as often profound, of new onset (not life-long), not the result of
ongoing or unusual excessive exertion, and not substantially alleviated by rest. (IOM Criteria, supra, at
Ex. 28, p. 1.)
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either cognitive impairment or orthostatic intolerance. (Id.) The Fukuda criteria requires
chronic fatigue meeting a specific definition (similar in description to the IOM criteria)17
accompanied by four or more of eight additionally listed symptoms18 as well as the
absence of any of a number of exclusionary conditions.19 (Fukuda Definition, supra, at
Ex. 27, pp. 1-2.)
On respondent’s behalf, Dr. Oddis testified that, although he disagrees that
petitioner has all of the features required for CFS, he agrees that petitioner had chronic
fatigue. (Tr. 255.) Further to this chronic fatigue, Dr. Lapp’s CFS diagnosis rests on the
presence of malaise, insomnia, cognitive difficulties, lymphadenopathy in the neck and
groin, and arthralgia. (Tr. 155.) This is based in part on his own assessment with
petitioner, but also cites support from the contemporaneous medical records. (See Tr.
84-86 (discussing record of February 24, 2012 (Ex. 1, p. 661, et seq.) reporting myalgia,
muscle pain, and dizziness); Tr. 86-88 (discussing record of February 27, 2012 (Ex. 1,
pp. 675, et seq) reporting swollen lymph nodes); Tr. 89-90 (discussing record of March
7, 2012 (Ex. 3, p. 1) reporting nausea, fatigue, pain at the injection site); Tr. 90-92
(discussing record of April 17, 2012 (Ex. 4, pp. 1-2) diagnosing polyarthralgia and
reporting musculoskeletal pain and insomnia).) Although Dr. Oddis is correct to note
that none of petitioner’s treating physicians diagnosed CFS, his own competing
assessment is diminished by his lack of persuasiveness in asserting the presence of a
pain syndrome to otherwise explain petitioner’s presentation. It should also be noted
that, as Dr. Lapp explained, it is not even appropriate to consider a diagnosis of CFS
until symptoms have persisted for at least six months. (Tr. 150.) Accordingly, CFS
diagnosis generally does involve hindsight. Nor is there any competing consensus from
petitioner’s treating physicians that would offer any other diagnosis to holistically explain
her history or evidence any exclusionary condition. As Dr. Lapp frames it, the question
is ultimately whether petitioner had enough symptoms to qualify for the CFS diagnosis.
(Tr. 159.)
During the hearing respondent’s counsel also challenged Dr. Lapp on several
considerations relating to specific characteristics of chronic fatigue under the diagnostic
standards. Cross examination largely consisted of discussing certain medical record
17 Specifically: “[c]linically evaluated, unexplained persistent or relapsing chronic fatigue that is of new or
definite onset (i.e, not lifelong), is not the result of ongoing exertion, is not substantially alleviated by rest,
and results in substantial reduction in previous levels of occupational, educational, social, or personal
activities.” (Fukuda Definition, supra, at Ex. 27, p. 1.)
18 The additional symptoms are: (1) substantial impairment in short-term memory or concentration, (2)
sore throat, (3) tender lymph nodes, (4) muscle pain, (5) multi-joint pain without swelling or redness, (6)
headaches of a new type, pattern, or severity, (7) unrefreshing sleep, and (8) post-exertional malaise
lasting more than 24 hours. (Fukuda Definition, supra, at Ex. 27, p. 1.)
19 Conditions that exclude a diagnosis of CFS are: “Any active medical condition that may explain the
presence of chronic fatigue, such as untreated hypothyroidism, sleep apnea and narcolepsy, and
iatrogenic conditions such as side effects of medication,” some diagnosable illnesses that may relapse or
not completely resolve, such as malignancies, or chronic cases of hepatitis B or C, or “any past or current
diagnosis of a major depressive disorder with psychotic or melancholic features,” alcohol or other
substance abuse, or severe obesity. (Fukuda Definition, supra, at Ex. 27, pp. 1-2.)
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entries that may cast doubt on Dr. Lapp’s assessment of the relevant symptoms. (Tr.
167-70 (raising that Ex. 14, p. 3 does not indicate fatigue); Tr. 176-79 (raising Ex. 2, pp.
11, 19 as records from May of 2012 and September of 2013 noting petitioner to be self-
reliant in daily activities); Tr. 185-87 (raising Ex. 1, p. 662 as February 24, 2012 physical
exam with no notation of muscle pain). Dr. Lapp provided specific answers to these
points; however, a broader point is reflected in the literature discussed below with
respect to Althen prongs two and three, which suggests that it is not unusual for CFS
symptoms to present intermittently for long periods (months to years) before becoming
constant. Accordingly, inconsistency over time within the medical records regarding
reported symptoms is not necessarily informative to the question of petitioner’s ultimate
diagnosis.
Respondent’s counsel also raised a further challenge with regard to whether
petitioner has untreated sleep apnea. Under the Fukuda criteria, sleep apnea is an
exclusionary criterion. (Fukuda Definition, supra, at Ex. 27, p. 1.) Under the IOM
criteria, unrefreshing sleep is a core criterion. (IOM Criteria, supra, at Ex. 28, p. 1.)
Respondent’s counsel questioned whether petitioner can be said to suffer unrefreshing
sleep if other conditions are preventing her from sleeping through the night. (Tr. 162-
67.) Dr. Lapp explained, however, that broken sleep patterns are typical of CFS. (Tr.
167.) Unrefreshing sleep means that the patient feels the same or worse upon waking
as they did the night before. (Tr. 164-67.) In petitioner’s own case, she does have
unrefreshing sleep and does not have confirmed sleep apnea. (Tr. 164-66.) Dr. Lapp
also explained that tiredness and sleepiness are not synonymous and that unrefreshing
sleep results in tiredness. (Tr. 193-95.)
Based on the record as a whole, Dr. Lapp is persuasive in opining that petitioner
can be diagnosed with CFS.
b. Althen Analysis
As explained above, in order to establish causation-in-fact petitioner must
preponderantly prove the three elements of the so-called Althen test. That is, petitioner
must show: (1) a medical theory causally connecting the vaccination and the injury; (2)
a logical sequence of cause and effect showing that the vaccination was the reason for
the injury; and (3) a showing of proximate temporal relationship between vaccination
and injury. Althen, 418 F.3d at 1278. Once petitioner has presented a prima facie
case, respondent may still preponderantly demonstrate petitioner’s injury was
nonetheless due to factor(s) unrelated to vaccination. Id.
i. Cellulitis
Petitioner’s allegedly vaccine-caused cellulitis was the initial basis for the petition
in this case. The Althen analysis for that injury may be addressed very briefly as the
outcome is not controversial. Althen prong one is met insofar as both Dr. Lapp and Dr.
Oddis agree that a contaminated needle puncture can cause cellulitis. (Tr. 240-41,
280.) With regard to Althen prongs two and three, the finding of fact issued in this case
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confirms the Tdap vaccine was administered in the same buttock as petitioner’s
cellulitis. (See n. 4, supra.) Additionally, petitioner’s medical records show that she
sought medical attention for her cellulitis within days of her vaccination. (Ex. 1, 441.)
The medical records clearly associate her cellulitis to the site of her Tdap injection. (Id.)
Petitioner has further represented that prior to administration, the syringe and nurse’s
gloves had been placed on a table surface she had observed to be dirty. (Ex. 14, pp. 3-
4; Tr. 39.) Dr. Lapp opined that this history of unclean administration and subsequent
infection are sufficient to support a causal opinion supporting vaccine-causation. (Tr.
240.) Respondent has offered no evidence to suggest that petitioner’s cellulitis was
caused by any factor unrelated to her vaccination. Dr. Oddis deferred to the medical
records with regard to the cellulitis diagnosis. (Tr. 280.)
Thus, even though it has not been the focus of litigation, petitioner’s cellulitis
constitutes a stand-alone vaccine injury separate from her CFS. However, given that
the cellulitis was a short-lived condition, this raises the question of whether it can satisfy
the Vaccine Act’s severity requirement without respect to the broader constellation of
chronic symptoms that petitioner characterizes as CFS. In order to state a claim for a
vaccine-related injury under the Vaccine Act, a vaccinee must have either:
(i) suffered the residual effects or complications of such illness, disability,
injury, or condition for more than 6 months after the administration of the
vaccine, or (ii) died from the administration of the vaccine, or (iii) suffered
such illness, disability, injury or condition from the vaccine which resulted
in inpatient hospitalization and surgical intervention.
§300aa-11(c)(1)(D).
As of February 14, 2012, follow-up treatment confirmed the cellulitis to be
resolved, but with a residual tender mass at the injection site. (Id. at 451.) Subsequent
exams did confirm petitioner continued to have an abnormality at the site of injection
after her cellulitis had resolved and throughout the remainder of February 2012. (Ex. 1,
p. 676 (exam noting “small pea sized area of induration” at injection site); Id. at 698
(exam noting “little knot” as of February 27, 2012); Id. at 436 (exam noting “palpable
nodule” as of February 29, 2012). These notations document only the first month of
petitioner’s injury. Thereafter, the focus of petitioner’s medical records shifted to her
other complaints; however, petitioner did specifically complain of continued left buttock
pain related to her vaccination at encounters of August 30, 2012 (Ex. 1, p. 22) and
September 21, 2012 (Ex. 6, pp. 2-3), which are both beyond six months from the date of
her vaccination. Petitioner also testified that as of the time of the hearing she still has
that nodule, explaining that “[w]hen I feel it, I can take it and squeeze it . . . .” (Tr. 14.)
In Wright v. Secretary of Health and Human Services, the Federal Circuit
explained that within the meaning of the statute a “residual effect” is “suffered” if it is a
somatic condition that is detrimental (meaning endured with distress, especially
painfully) and represents a lingering sign or symptom of the original injury. 22 F. 4th
999, 1006 (Fed. Cir. 2022). A “complication” is similarly understood, but without
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representing an “essential part of the disease.”20 Id. Here, petitioner’s medical records
corroborate that petitioner had a “knot” or “nodule” remaining after her cellulitis had
resolved and nothing in the medical records suggests that this remaining defect ever
subsequently resolved. She is also reported in the contemporaneous medical records
as having complained of left buttock pain for over six months. Petitioner also testified
that her minor disfigurement persisted to the present day and Dr. Lapp testified that it is
medically reasonable to conclude that the disfigurement petitioner described in her
testimony constitutes scar tissue from her cellulitis. (Tr. 13-14, 240-41.) Dr. Oddis
effectively agreed. (Tr. 280.) Accordingly, there is preponderant evidence that
petitioner’s cellulitis caused complications or residual effects that lasted for more than
six months.21
All of this is sufficient to preponderantly establish that petitioner’s cellulitis was
caused-in-fact by her vaccination and that petitioner’s cellulitis caused complications or
residual effects that lasted for more than six months. Petitioner is therefore entitled to
compensation for her cellulitis injury. Importantly, however, Dr. Lapp disclaimed any
causal connection between petitioner’s cellulitis and her alleged CFS. (Tr. 212; Ex. 22,
p. 1.) Accordingly, petitioner’s entitlement to compensation for her cellulitis has no
20 It has also been suggested that the Federal Circuit’s Wright decision should counsel close analysis of
the record where the injury at issue is considered “minor.” Cummings v. Sec’y of Health & Human Servs.,
No. 20-1358V, 2022 WL 962520, at *4 (Fed. Cl. Spec. Mstr. Feb. 24, 2022). Thus, for example, in
Bangerter v. Secretary of Health & Human Services, temporary weight gain in an infant that was
attributable to medication taken in treatment of a vaccine injury was not “suffered” within the meaning of
the statute for the reasons discussed in Wright. No. 15-1186V, 2022 WL 439535, at *37 (Fed. Cl. Spec.
Mstr. Jan. 18, 2022). Key to that determination was the fact that the vaccinee was an infant, his weight
normalized again as he grew, and petitioner was unpersuasive in suggesting that the temporary weight
gain had any effect on the child’s growth and development in the interim. Accordingly, while the
temporary weight gain was clearly noticed by the parents, it had not represented any detrimental effect.
Here, petitioner’s scarring or induration is by all reasonable accounts minor and inconspicuous, leaving
this a close question. However, whereas weight may be gained or lost throughout life and may be subject
to a range of interpretations as to what is healthy or appropriate, scarring is a harm in itself – that is, a
scar is indisputably damage to tissue. Moreover, in this case it appears to be permanent. Thus,
petitioner’s scar tissue might be said to be inherently detrimental regardless of whether it is painfully
endured. In any event, however, petitioner did also report experiencing continued pain in her buttock.
(Tr. 13; Ex. 1, p. 22; Ex. 6, pp. 2-3.)
21 Theoretically, petitioner’s testimony could be definitively corroborated by requiring petitioner to reveal
her disfigurement for review, likely in a photograph. In this case, however, the condition is located in a
relatively sensitive area of the body. Moreover, neither petitioner’s nor respondent’s expert suggested
any need to visually inspect petitioner’s skin before accepting her testimony based on their general
medical knowledge. In Kirby v. Secretary of Health and Human Services, the Federal Circuit held that
where medical records are silent as to whether a condition remains ongoing, a petitioner can demonstrate
the severity requirement through corroborated testimony and expert opinion confirming her symptoms are
consistent with her diagnosed injury. 997 F.3d 1378, 1381-82. On a more thoroughly contested issue
involving a less sensitive area of the body, photographic evidence may be appropriate. Here, that added
step is not warranted. Petitioner’s testimony is corroborated both by its acceptance by both parties’
experts as well as the medical records documenting the abnormality to have remained after resolution of
the initiating cellulitis. Moreover, even if the contemporaneous medical records are inadequate to fully
corroborate the fact of the scar tissue, the contemporaneous medical records do indicate that petitioner
reported pain at that location for greater than six months.
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bearing on whether she is also entitled to compensation for her alleged CFS. That
question must be answered by a separate Althen analysis relative to that injury.
ii. CFS
1. Althen Prong One22
Under Althen prong one, a petitioner must provide a “reputable medical theory,”
demonstrating that the vaccine received can cause the type of injury alleged. Pafford v.
Sec’y of Health & Human Servs., 451 F.3d 1352, 1355–56 (Fed. Cir. 2006) (citations
omitted). To satisfy this prong, petitioner's theory must be based on a “sound and
reliable medical or scientific explanation.” Knudsen, 35 F.3d at 548. Such a theory
must only be “legally probable, not medically or scientifically certain.” Id. at 549.
Generally, however, petitioners may satisfy the first Althen prong without resort to
medical literature, epidemiological studies, demonstration of a specific mechanism, or a
generally accepted medical theory. Andreu, 569 F.3d at 1378-79 (citing Capizzano v.
Sec’y of Health & Human Servs., 440 F.3d 1317, 1325-26 (Fed. Cir. 2006)). In this
case, petitioner has not met her burden under Althen prong one relative to her CFS.
There is no dispute that CFS is an immune-related condition the cause(s) of
which remain unknown. (Ex. C, p. 3; Ex. 16, p. 3.) Dr. Lapp offered some indication
that it might have an autoimmune component, but ultimately explained that the reason
CFS patients tend to have autoantibodies is unknown. (Tr. 146.) Rather, the
understanding that CFS is an immune-related condition is largely based on the
observation that it is generally preceded by a flu-like illness and has been associated
with certain viruses. (Devanur & Kerr, supra, at Ex. 17, pp. 2, 5; IOM (Institute of
Medicine), Beyond Myalgic Encephalomyelitis/Chronic fatigue syndrome, NAT. ACAD.
PRESS 1, 15 (2015) (Ex. 23).)
Dr. Lapp further hypothesizes, however, that an infection (or, according to him,
also a vaccine) can cause what becomes a chronic immune dysregulation due to an
uncontrolled production of cytokines. During the hearing, Dr. Lapp illustrated this by
reference to the below diagram presented during the hearing and later filed as Exhibit
33.
22 In her pre-hearing brief, petitioner actually presented two theories of causation. (ECF No. 132, pp. 12-
13.) The first is the one discussed below. The second theory was that petitioner’s cellulitis constituted an
infection that in turn caused her CFS. This was based on Dr. He’s statement in his expert report that
petitioner’s infection was a more likely contributor to her CFS than vaccination. (Id. at 13.) As noted in
the preceding section, however, petitioner’s own expert disclaimed any causal relationship between
petitioner’s cellulitis and her CFS. (Tr. 212; Ex. 22, p. 1.) During the hearing Dr. He also clarified, in
effect, that the fact that he indicates a local infection such as cellulitis is more likely than a vaccine to
contribute to CFS does not mean he opines that either is likely to cause CFS. (Tr. 290-92.) Dr. He
agreed with Dr. Lapp that cellulitis is unlikely to have caused CFS. (Id.)
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(Ex. 33.)
According to Dr. Lapp, when a foreign antigen (marked as a V in the upper left of
the diagram) comes in contact with a macrophage as part of the body’s immune
response, the macrophage releases cytokines, specifically the cytokine Interleukin-1
(“IL-1”). (Tr. 139.) IL-1 in turn causes lymphocytes to release further cytokines,
specifically “IL-2.” (Id.) Dr. Lapp indicates that IL-2 is then responsible for multiplying
the immune response by entering the bloodstream and activating lymphocytes to begin
a number of different processes, including producing different kinds of T-cells as well as
what are called “natural killer” (“NK”) cells. (Tr. 140.) NK cells circulate in the blood and
destroy infected cells.23 (Id.) Important to Dr. Lapp’s theory, one of the T-cells
produced as part of the immune response is “CD8/11b,” which acts as a suppressor of
the IL-1 that initiated the process depicted. (Tr. 140-41.) Without the CD8/11b
suppressor cells, the immune response will not down-regulate as it should. (Tr. 140,
223-24.) Dr. Lapp suggests that those with CFS have low NK activity as well as
dysfunction in the CD8/11b suppressor response, explaining the chronicity of CFS. (Tr.
140-41.) This leads to perpetuation of cytokine production and cytokine production
leads to the symptoms of CFS.24 (Tr. 141.) This underlying immunology speaks to the
chronicity of CFS but does not in itself reveal what potential triggers may provoke CFS.
23 Dr. He challenged this understanding of the immune response. He characterized Dr. Lapp’s diagram
as “severely outdated” and raised specific objection to the understanding that macrophages (as opposed
to dendric cells) begin the process and the specific role of NK cells. (Tr. 286-87.) To the extent Dr. He
appeared to suggest in testimony that these differences in discussing the immune system should be
viewed as fatal to petitioner’s theory, he did not specifically explain why.
24 Dr. He was also critical of Dr. Lapp’s reliance on the “CD8/11b” suppressor cell terminology, suggesting
it is no longer consistent with how these cells are currently characterized in the field of immunology. (Tr.
287.) As with the critique noted in n. 23, supra, Dr. He’s testimony was not entirely clear as to the
significance of this issue. Because Dr. He did not fully explain his criticisms of Dr. Lapp’s understanding
of the immunology, and because this case ultimately turns on other factors, I assume for purposes of this
decision that Dr. Lapp’s diagram at Exhibit 33 reasonably depicts the relevant immune response without
actually deciding that issue. Dr. He agreed that CFS symptoms are ultimately related to overproduction
of cytokines. (Ex. C, p. 3 (expressing agreement with limited aspects of Ex. 16, p. 3).)
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Important to Dr. Lapp’s theory of vaccine causation, the T-cell response can be
further divided into two profiles, “Th1” and “Th2.” (Tr. 60-61.) These two profiles
produced different cytokines. (Id.) Ordinarily, in a healthy body there is a balance
between these two profiles favoring the Th1 profile, which is the profile that helps the
body respond to viruses and yeasts. (Tr. 61.) However, CFS is thought to be a
disorder leading to an imbalance toward the Th2 profile. (Tr. 58 (citing Devanur & Kerr,
supra, at Ex. 17).) According to Dr. Lapp, the literature demonstrates the symptoms of
a fatiguing illness, such as CFS, as being related to the cytokines produced as part of
the Th2 profile. (Tr. 58, 60-61.) Dr. Lapp posits that the pertussis component of the
Tdap vaccine has been shown to result in the production of IL-4, which has in turn been
shown to initiate a shift toward a Th2 profile. (Tr. 59.) Thus, because Dr. Lapp
suggests that vaccinations “for all intents and purposes” cause low-grade infections (Tr.
138-39), he opines that the initial Th2 shift caused by the pertussis-containing
vaccination can lead to a chronic disease-causing shift to a Th2 profile due to the low
NK activity and CD8/11b dysfunction among those susceptible to CFS.25 Four articles
are key to Dr. Lapp’s theory – Mu and Sewell (1993), Rook and Zumla (1997),
Devanour and Kerr (2006), and Hardcastle, et al (2015). (Exs. 35, 34, 17, 18.)
However, these articles fall short of demonstrating what Dr. Lapp claims they support.
In 1993, Mu and Sewell, examined the effects of pertussis toxin in mice. (Hong-
Hua Mu & William Sewell, enhancement of Interleukin-4 production by pertussis toxin,
61(7) INFECT. & IMMUNITY 1 (1993) (Ex. 35).) They found that administering pertussis
toxin resulted in increased production of IL-4 and a promotion of an IgE response. (Id.)
This paper does not specifically address CFS; however, Dr. Lapp testified that this study
“states specifically that when pertussis is administered to mice cells and to human
beings, that [it] . . . directly stimulates Interleukin 4, which then drives the immune
system toward a Th2 status. And that, of course, is accompanied by other
autoantibodies and other cytokines that cause the symptoms that these patients are
having.” (Tr. 144.) The inference here is that a pertussis-containing vaccine, such as
petitioner’s Tdap vaccine, would act in the same manner.
Subsequently, in 1997, Rook and Zumla hypothesized that Gulf War Syndrome,
which is considered a fatiguing condition similar to CFS, may be due to a systemic shift
in cytokine balance toward a Th2 profile. (G.A. Rook & A. Zumla, Gulf War syndrome:
25 Dr. Lapp also cited a case report of a patient purportedly experiencing “autoimmune inflammatory
syndrome induced by adjuvants” or “ASIA” for the proposition that “[r]esearch has shown that vaccines
with adjuvants can result in chronic heightened immune response.” (Ex. 16, p. 3 (citing Ex. 19); Tr. 64,
152.) Again, however, he indicated that he could not explain why CFS patients have a tendency to have
autoantibodies. (Tr. 146.) Accordingly, he has not substantiated the relevance of literature addressing
autoimmune disease. In any event, Dr. Lapp confirmed during the hearing that while he believes the
ASIA concept supports his opinion, ASIA is not necessary to his opinion. (Tr. 238.) ASIA has been
heavily criticized in prior cases. See, e.g., D'Angiolini v. Sec'y of Health & Human Servs., No. 99-578V,
2014 WL 1678145, at *60 (Fed. Cl. Spec. Mstr. Mar. 27, 2014), mot. for review den'd, 122 Fed. Cl. 86
(2015), aff'd, 645 F. App'x. 1002 (Fed. Cir. 2016); Rowan v Sec'y of Health & Human Servs., No. 10-
272V, 2015 WL 3562409 (Fed. Cl. May 18, 2015); Harris v. Sec'y of Health & Human Servs., No. 10-
332V, 2014 WL 3159377, at *16 (Fed. Cl. Spec. Mstr. June 10, 2014).
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Is it due to a systemic shift in cytokine balance towards a Th2 profile? 349 LANCET 1
(1997) (Ex. 34).) Among other factors discussed, Rook and Zumla asserted that
soldiers had been administered multiple vaccinations capable of shifting from a Th1
immune profile to a Th2 profile. In support of this assertion, they cited the above-
discussed Mu study for the proposition that vaccines adjuvanted with pertussis are
“potently Th2.”26 (Rook & Zumla, supra, at Ex. 34, p. 2.) Dr. Lapp asserts that this
provides further evidence that a pertussis-containing vaccine can itself “cause a shift in
the immune system toward a Th2 pattern and bring on the symptoms of chronic fatigue
syndrome.” (Tr. 59.) However, even by the authors’ own characterization, this paper
presents merely a hypothesis. Moreover, the authors cited a number of factors that
working together may account for their observations. Specifically, in addition to some of
the vaccinations at issue being adjuvanted with pertussis, the authors found it significant
that the soldiers received an usually high antigen load given the multiple immunizations
administered. They also found it significant these exposures occurred in a war zone
(leading into increased cortisol and decreased dehydroepiandrosterone), and that
soldiers were also exposed to carbamate and organophosphate insecticides. (Rook &
Zumla, supra, at Ex. 34, p. 2.) The latter two factors are especially notable because
they could potentially act independent of any vaccination.
In 2006, Devanur and Kerr conducted a review of CFS literature, including Rook
and Zumla’s 1997 paper. (Devanur & Kerr, supra, at Ex. 17.) Rook and Zumula were
cited for the proposition that the pertussis adjuvant in the anthrax vaccine may cause a
systemic shift in the immune response toward Th2. (Id. at 7.) However, Devanur and
Kerr suggested that the potential relationship between Gulf War Syndrome and
vaccinations may be stronger than between vaccinations and CFS because the
immunization schedule administered to the soldiers was “intensive” and involved
multiple vaccinations. (Id.) They also again noted the stress of wartime deployment
and further observed that experimental evidence in mice suggested a causal role for the
anti-nerve gas agent pyridostimine. (Id.) In any event, respondent has also filed more
recent literature casting doubt on the hypothesis, suggesting the evidence that Gulf War
Syndrome is vaccine-caused is limited and has “inadequate support” and further
discussing other more likely causes. (Roberta F. White et al., Recent research on Gulf
War illness and other health problems in veterans of the 1991 Gulf War: Effects of
toxicant exposures during employment, 74 CORTEX 1 (2016) (Ex. C, Tab 3).)
With respect to CFS more broadly, Devanur and Kerr explained that the
pathogenesis of CFS is likely multifactorial but not completely understood. (Devanur &
Kerr, supra, at Ex. 17, p. 2.) In particular, “the precise role played by the immune
response remains to be clarified.” (Id.) The authors note, consistent with Dr. Lapp’s
opinion, that “[v]arious studies suggest that CFS exhibits a Th2 profile of CD4 helper T
lymphocyte responsiveness.” (Id. at 3.) However, the authors also explain that a
number of studies have demonstrated other potentially relevant immune findings. For
example, CFS patients have been shown to have significantly increased neutrophil
26 Rook and Zumla do not indicate what specific vaccines are adjuvanted with pertussis toxin; however,
Devanaur and Kerr (discussed below) suggest that the anthrax vaccine received by Gulf war soldiers is
adjuvanted with pertussis toxin. (Ex. 17, p. 7.)
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apoptosis and decreases in circulating IgG. (Id.) According to the authors, these
findings suggest the presence of an ongoing infection and a deficiency in anti-viral
immune activity. (Id.) Based on this literature review, the authors conclude that “[t]aken
together, these findings suggest that an underlying infection may be present in these
individuals and that the immune system is chronically activated in response.” (Id.)
Finally, the most recent of the papers stressed in this case, is a 2015 study by
Hardcastle, et al, examining immune proteins in CFS. (Sharni Lee Hardcastle et al.,
Serum immune proteins in moderate and severe chronic fatigue syndrome/myalgic
encephalomyelitis patients, 12(10) INT. J. MED. SCI. 1 (2015) (Ex. 18).) The study
compared cytokine profiles among three groups – healthy controls, moderate cases of
CFS, and severe cases of CFS. According to Dr. Lapp, this study is significant for two
reasons. First, it confirms the above-discussed decrease in NK cell and CD8 T cell
activity. Second, it shows that symptom presentation in CFS is correlated to cytokine
activity. (Tr. 62-63, 141-42.) Hardcastle, et al., indicate that prior studies have been
inconsistent in identifying alterations in cytokine patterns among CFS patients.
(Hardcastle et al., supra, at Ex. 18, p.1.) However, these prior studies involved only
moderately affected patients. The Hardcastle study purports to be the first to include
severe cases of CFS. (Id. at 5.) Importantly, however, the Hardcastle study found no
statistically significant difference in IL-4 among the groups studied, effectively
acknowledging that the study did not replicate prior studies that had suggested a Th2
profile based on increased IL-4. (Id. at 4.) The ability of the pertussis toxin generally to
enhance IL-4 in mice as observed by Mu and Sewell was the starting premise for Dr.
Lapp’s suggestion that a vaccine could trigger CFS – meaning this study directly
undercuts Dr. Lapp’s extrapolation from Mu and Sewell’s mouse model.
In sum, Dr. Lapp has presented a mouse model that suggests pertussis toxin
may increase IL-4. (Mu & Sewell, supra, at Ex. 35.) This finding contributed to a
preliminary hypothesis that a different, but potentially similar condition of Gulf War
Syndrome, might have multiple vaccinations among a number of other underlying
causal factors. (Devanur & Kerr, supra, at Ex. 17; Rook & Zumla, supra, at Ex. 34.)
However, more recent literature filed by respondent has cast doubt on that hypothesis
and Dr. Lapp himself has filed a study that failed to find any significant increase in IL-4
among actual CFS patients. (White et al., supra, at Ex. C, Tab 3; Hardcastle et al.,
supra, at Ex. 18.) On the whole, while Dr. Lapp is persuasive in suggesting CFS may
involve an aberrant chronic immune response and that CFS symptoms may be
cytokine-related, the literature suggests the underlying immune response implicated in
CFS is not well understood and with little to no evidence directly supporting vaccine
causation. This does not preponderantly support petitioner’s claim that the Tdap
vaccine can cause CFS.
Moreover, it is also difficult to square Dr. Lapp’s suggestion that vaccines are
implicated as “low grade infections” (Tr. 138-39) with his additional acknowledgment
that, whatever the immune trigger, “it would have to be a significant challenge” (Tr. 210).
When asked what he meant by a “significant” challenge, Dr. Lapp turned back to the
fact, noted above, that most CFS cases (more than seventy percent) follow infections.
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(Tr. 210.) Dr. Lapp acknowledged that a Tdap vaccine is not equivalent to an infection
and does not reproduce within the body as a live infection; however, he would not agree
that the immune system responds differently to a vaccine than an infection. (Tr. 211.)
Instead, he suggested he does not know “one way or the other.” (Id.)
In that regard, however, Dr. He indicated that vaccination and infection have
“major” differences that are both qualitative and quantitative. (Tr. 285.) He explained
that whereas an infection involves an uncontrolled response with systemwide
immunopathic replication, the response to immunization is a controlled response
happening only locally due to the fact that the vaccine antigen does not replicate like a
live infection. (Tr. 286, 301-03.) When an immunization results in a systemic response,
only the cytokines spread throughout the body. (Tr. 303.) That is, while an
immunization or local infection sees an immune response in one part of the body that
may stimulate cytokines that spread from that one location, a systemic infection
stimulates cytokines throughout the body.
Dr. Lapp acknowledged that a small, localized infection “usually” would not cause
CFS, explaining that the illnesses that precede CFS are “usually very significant
illnesses.” (Tr. 212; Ex. 22, p. 1.) And, again, as explained above, the Devanur and
Kerr article relied upon by Dr. Lapp explains that there are prior studies that include
specific immune findings beyond the Th2 shift suggestive of ongoing infection as the
driver of CFS. (Devanur & Kerr, supra, at Ex. 17, p .3.)
In one prior case, Dr. Lapp’s opinion has been accepted under Althen prong one
as supporting vaccine-causation of CFS. Bryan v. Sec’y of Health & Human Servs., No.
14-898V, 2020 WL 7089841 (Fed. Cl. Spec. Mstr Oct. 9, 2020). Importantly, however,
that case involved the flu vaccine rather than the Tdap vaccine at issue in this case.
Among other differences, in that case Dr. Lapp presented a study demonstrating that
CFS patients had statistically significantly increased IL-4 following the flu vaccine when
compared to controls. Id. at *23 (discussing Brenu, et al., The Effects of Influenza
Vaccination on Immune Function in Patients with Chronic Fatigue Syndrome/Myalgic
Encephalomyelitis, 3 INT’L J. CLIN. MED. 551-54 (2012).) That study was important to
informing the special master’s conclusion that Dr. Lapp had established that the flu
vaccine in particular can have an effect on the immune dysregulation typical of CFS.
However, there is nothing in the record of this case comparable to the Brenu study in its
ability to causally implicate the Tdap vaccine. Even with the benefit of the Brenu study,
the Bryan special master observed that the evidence supporting petitioner’s theory was
“not robust.” Id.
2. Althen Prongs Two and Three
Assuming arguendo petitioner had demonstrated that her Tdap vaccine is
capable of causing CFS, she would also have to establish that it did cause CFS in this
specific case. Pafford, 451 F.3d at 1356. This latter aspect of petitioner’s prima facie
showing is generally broken down into two further questions pursuant to Althen prongs
two and three. The second Althen prong requires proof of a logical sequence of cause
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and effect between the vaccination and injury. Althen, 418 F.3d at 1278; Andreu, 569
F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant, 956 F.2d at 1148. The third
Althen prong requires establishing a “proximate temporal relationship” between the
vaccination and the injury alleged. Althen, 418 F.3d at 1281.
The second Althen prong, requiring proof of a logical sequence of cause and
effect, is usually supported by facts derived from a petitioner's medical records. Althen,
418 F.3d at 1278; Andreu, 569 F.3d at 1375–77; Capizzano, 440 F.3d at 1326; Grant,
956 F.2d at 1148. In establishing that a vaccine “did cause” injury, the opinions and
views of the injured party's treating physicians are entitled to some weight. Andreu, 569
F.3d at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion
testimony are favored in vaccine cases, as treating physicians are likely to be in the
best position to determine whether a ‘logical sequence of cause and effect show[s] that
the vaccination was the reason for the injury’”) (quoting Althen, 418 F.3d at 1280).
However, medical records and/or statements of a treating physician's views do not per
se bind the special master to adopt the conclusions of such an individual, even if they
must be considered and carefully evaluated. See Section 13(b)(1) (providing that “[a]ny
such diagnosis, conclusion, judgment, test result, report, or summary shall not be
binding on the special master or court”); Snyder v. Sec'y of Health & Human Servs., 88
Fed. Cl. 706, 746 n.67 (2009) (“there is nothing ... that mandates that the testimony of a
treating physician is sacrosanct—that it must be accepted in its entirety and cannot be
rebutted”).
The third Althen prong requires establishing a “proximate temporal relationship”
between the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term
has been equated to the phrase “medically-acceptable temporal relationship.” Id. A
petitioner must offer “preponderant proof that the onset of symptoms occurred within a
timeframe which, given the medical understanding of the disorder's etiology, it is
medically acceptable to infer causation.” de Bazan v. Sec'y of Health & Human Servs.,
539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is a medically
acceptable timeframe must also coincide with the theory of how the relevant vaccine
can cause an injury (Althen prong one's requirement). Id. at 1352; Shapiro v. Sec'y of
Health & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den'd after remand, 105
Fed. Cl. 353 (2012), aff'd mem., 503 Fed. Appx. 952 (Fed. Cir. 2013); Koehn v. Sec'y of
Health & Human Servs., No. 11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30,
2013), mot. for review den'd (Fed. Cl. Dec. 3, 2013), aff'd, 773 F.3d 1239 (Fed. Cir.
2014).
Here, these two prongs are closely intertwined and will be addressed together.
On the surface, there is a striking temporality in this case. Petitioner received a Tdap
vaccination on February 6, 2012, reported unusual symptoms beginning that same
night, and sought follow up care rather promptly. (Ex. 1, p. 441.) Thereafter, Dr. Lapp
opines that she developed classic signs of CFS within two weeks. (Tr. 97, 114, 152.)
However, upon closer examination of Dr. Lapp’s opinion, there is no basis for finding
significance in that temporality. Even if petitioner could theoretically satisfy Althen
prong three in the sense that what Dr. Lapp proposes is generally consistent with the
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known patterns of CFS onset, the relevant literature shows these known onset patterns
to be so broad, and the basis for identifying them so vague, as to prevent Dr. Lapp from
either identifying a relevant timeframe during which causation could be inferred
pursuant to Althen prong three and/or distinguishing petitioner’s Tdap vaccine as a
more likely cause of her CFS pursuant to Althen prong two.
Petitioner was never diagnosed with CFS by any of her treating physicians prior
to consulting Dr. Lapp. Accordingly, while the treating physicians felt a vaccine reaction
was possible, they did not offer any contemporaneous opinion that petitioner suffered
vaccine-caused CFS. Instead, petitioner’s claim is based entirely on Dr. Lapp’s
hindsight. Taking petitioner’s symptoms and the close temporal relationship to
vaccination, the treating physicians were willing to opine that petitioner was suffering an
adverse vaccine reaction in the form of a likely serum sickness. (Ex. 1, p. 706; Ex. 3,
pp. 1-3.) Dr. Lapp, however, has opined that petitioner never suffered any serum
sickness reaction. Instead, he opines that the symptoms the treating physicians
identified as serum sickness were actually symptoms of the CFS itself. (Tr. 230.)
Moreover, even if petitioner did suffer a temporary serum sickness that explains her
initial symptoms, Dr. Lapp further opined that “I have never known serum sickness to
lead to chronic fatigue syndrome.” (Tr. 231.) Additionally, to the extent he opined that
petitioner suffered a vaccine-caused cellulitis, he also opined that the cellulitis would not
have caused petitioner’s CFS. (Tr. 212.) Thus, Dr. Lapp rejects either cellulitis or
serum sickness as part of the relevant causal chain, thereby dismissing any causal
connection between petitioner’s CFS and any illness documented in the medical record
that may have in turn been causally connected to the vaccination.
Instead, Dr. Lapp opines that petitioner’s initial post-vaccination presentation
constituted evidence of an inflammatory, cytokine-drive response. (Tr. 151-53.) He
opines this is evidenced by fever and flu-like symptoms as well as by elevated
sedimentation rate (“ESR”), elevated C-reactive protein (“CRP”), positive cyclic
citrullinated peptide (“CCP”), and positive antinuclear antibodies (“ANA”). 27 (Id.)
However, Dr. Lapp has explained that CFS is itself an inflammatory condition and often
is accompanied by a flu-like presentation. As discussed above, regarding Althen prong
one, Dr. Lapp is unpersuasive in seeking to extend the association between active
infection and CFS to the type of immune response that follows vaccination.
Accordingly, neither these symptoms nor these lab results necessarily point to a specific
inciting event. Additionally, in this case, petitioner’s lab work during the immediate post-
vaccination period showed normal CRP and only slightly elevated ESR. (Ex. 1, pp. 666,
668, 680.) The laboratory findings Dr. Lapp culled as significant (Tr. 132-33; Ex. 31)
were drawn later. The earliest collection date for any sample from the lab results in
petitioner’s Exhibit 31 is from March of 2018.
27 Petitioner’s EBV early antigen was also positive, which he opines evidences a viral reactivation and a
Th2 status. (Tr. 132-33, 151-53.) Dr. Lapp explained that the EBV early antigen relates to the chronic
shift toward Th2 rather than the initial cause of petitioner’s CFS and the test was not administered until
June of 2019, so the result is not helpful regarding the period of onset. (Tr. 223-24; 240.)
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This leaves the coincident timing as the main factor leading to a suspicion of
vaccine causation. Here, too, however, Dr. Lapp is unpersuasive in trying to leverage
what is broadly true of CFS as evidence that this case of CFS is vaccine-caused.
When pressed to clarify the timing of the immunology underlying his theory, Dr. Lapp
testified that he was unable to offer specifics. (Tr. 235-36.) He agreed that there would
be some latency, but suggested that it would generally be rapid, suggesting hours to
days. (Tr. 236.) Dr. Lapp primarily based his opinion on two articles that speak to the
pattern of onset for CFS, one by Evans and Jason and one by Chu, et al. (Meredyth
Evans & Leonard Jason, Onset patterns of chronic fatigue syndrome and myalgic
encephalomyelitis, 2(1) RES. CHRON. DIS. 1 (2018) (Ex. 30); Lily Chu et al., Onset
patterns and course of myalgic encephalomyelitis/chronic fatigue syndrome, 7(12)
FRONT. PEDIATR. 1 (2019) (Ex. 30). Dr. Lapp testified that
retrospectively, I feel confident that the illness started at the time of the
injection, and when you look at the records, by the time two weeks have
passed, she had all of the symptoms of chronic fatigue syndrome, so she
clearly – somewhere between immediately and two weeks, she definitely
had the chronic fatigue syndrome . . . so I think certainly her symptoms and
the onset of her illness fell within the typical onset that was described by
Chu and by Evans . . .
(Tr. 152-53 (emphasis added).) However, these papers do not reliably identify any
specific temporal relationship between CFS and a specific antecedent event.
In 2018, Evans and Jason conducted a study regarding onset patterns for CFS.
(Evans & Jason, supra, at Ex. 29.) To the extent Evans and Jason look at underlying
immune triggers, they explain that many of their participants identified specific cause(s)
of their CFS, including infectious or viral causes. (Id. at 15.) Although the authors note
that they screened more broadly for preceding events, they focused the study only on
infectious illness. (Id. at 8.) Thus, flu-like symptoms were among the onset symptoms
generally reported by respondents. (Id. at 24.) Importantly, however, the Evans and
Jason study largely focuses on duration of onset (i.e. the time from first presenting
symptom of CFS to full manifestation of the condition) rather than latency of onset from
a preceding trigger (i.e. the time from the trigger to the first symptom).
Moreover, the percentage of participants who reported a preceding infection did
not differ significantly depending on whether onset was sudden or gradual. (Evans &
Jason, supra, at Ex. 29, p.9.) Nor did all participants that described a sudden onset
identify an immediately preceding trigger. For example, participant three (of 14 from
phase two)28 described a sudden onset occurring within 24 hours and no immediately
28 The study was conducted in two phases. First, participants completed a survey (the DePaul Symptom
Questionnaire), which assesses demographic information, symptoms, and illness history. Second, a
subset of participants participated in a “semi-structured” phone interview specifically regarding onset.
(Ex. 29, p. 5.) The study had 181 participants meeting the Fukuda criteria for the first phase. (Id.) The
phase one questionnaire allowed participates to choose from seven different characterizations of onset
(meaning the period of time over which symptoms developed) ranging from 24 hours to three or more
years). Fourteen participants were recruited to take part in the second phase, two people representing
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preceding trigger. (Id. at 11 (Fig. 2).) Participants often identified more than one cause
of their CFS (Id. at 15), described varying patterns of onset including waxing and
waning presentations (Id. at 13), sometimes only recognized the progression of their
condition in hindsight (Id. at 14), and sometimes placed onset based on moments of
realization or “turning points,” rather than actual distinct onsets (Id. at 10-13). Among
those that did describe a “sudden” onset, the participants’ understanding of the term
“sudden” ranged from symptom development over a 24-hour period to symptom
development over a three or more-year period. (Id. at 10.) On the whole, the Evans
and Jason paper does not meaningfully contribute to petitioner’s claim that her CFS can
be temporally associated to her vaccination.
The second study cited by Dr. Lapp is Chu, et al.29 (Chu et al., supra, at Ex. 30.)
During the hearing Dr. Lapp confirmed that he felt the Chu study supported his theory
vis-à-vis timing. (Tr. 238-39.) Upon review, however, the Chu study actually undercuts
petitioner’s assertion of a logical sequence of cause and effect between her vaccination
and injury. Petitioner urges that her abrupt onset of CFS post-vaccination should be
considered causally meaningful. In contrast, the Chu study suggests that petitioner has
little basis for distinguishing between her vaccination and her earlier infection as the
precipitating cause of her condition.30
Chu et al. observed that “[t]he most common onset pattern was a distinct change
in health heralded by an infectious event followed by a gradual progression to becoming
consistently sick.” (Chu et al., supra, at Ex. 30, p. 8.) The authors explained that
the time from the first intimation of illness to becoming consistently sick
varied greatly: while 28% endorsed an onset period of a month or less, 38%
noted it took over 6 months. Subjects who reported an infectious precipitant
were no more likely to develop ME/CFS within 1 month or within 6 months
compared to those who noted no infectious precipitant.
(Id. at 4.) Dr. Lapp himself characterized the study as suggesting that only half of CFS
patients develop consistent CFS symptoms within six months of any initial symptom.
each of the seven onset categories. (Id.) Accordingly, phase two of the study is very small. Thus, the
authors generally seem to treat their results as anecdotal, generally characterizing the results as
representing “themes” and characterizing the study as “qualitative” and with “rich descriptions” of onset.
(Id. at 22.)
29 The Chu study is a survey of 200 CFS patients. (Chu et al., supra, at Ex. 30, pp. 2-3.)
30 The Chu paper includes a table that indicates that 10% of subjects identified a medical injection as a
factor associated with the onset of their CFS. (Chu et al., supra, at Ex. 30, p. 4.) Importantly, however,
nothing in the study provides information regarding the time between such injections and onset of CFS.
Nor does the study otherwise provide any discussion sufficient to assess the reasonableness of the
subjective claim of association. During the hearing, Dr. Lapp indicated that he spoke with Chu and
purportedly confirmed that the medical injections at issue mostly referred to vaccination. (Tr. 72.)
However, this is not confirmed by the paper itself, and in fact the paper confirms that patients having had
a flu vaccination within the preceding four weeks were specifically screened out of the study population.
(Chu et al., supra, at Ex. 30, p. 2.)
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(Tr. 70-71.) For one-third of the subjects, the preceding infectious event manifested as
respiratory symptoms. (Chu et al., supra, at Ex. 30, p. 9.)
In this case, petitioner saw Dr. Ferrier about three weeks prior to her vaccination,
on January 16, 2012, with complaints of sore throat and bilateral ear pain that began
three weeks prior. (Ex. 1, p. 442.) Petitioner also complained of postnasal drip,
hoarseness, shortness of breath, cough, fatigue, and intermittent fever. (Id.) Petitioner
was diagnosed with acute pharyngitis and was prescribed antibiotic and antifungal
treatment (clindamycin and Diflucan respectively). (Id.) According to the Chu article,
petitioner’s symptoms are consistent with the type of preceding infection that can be
causally related to CFS.31 (Chu et al., supra, at Ex. 30, p. 9; Tr. 142, 151.) This
encounter was prior to her February 6, 2012, vaccination and about five weeks prior to
what Dr. Lapp identifies as the onset of petitioner’s CFS. Moreover, Dr. Lapp himself
testified that the fatigue petitioner reported in the context of this January pharyngitis
cannot be distinguished from the fatigue she experienced post-vaccination.32 (Tr. 158-
59.) In that regard, during the Dr. Lapp testified:
THE COURT: . . . Why are we treating the vaccination as the turning point
instead of the January infection?
THE WITNESS: Because it was an acute infection that's very similar to
what she had before. It's not likely that that would carry through like that for
that period of time.
THE COURT: Well, even if –
THE WITNESS: There was no evidence that it continued. She didn't have
those symptoms at the time when she went to the ER for the burn.
THE COURT: So in the context of chronic fatigue syndrome, is it the case
that when you have an infectious precursor, you always have the infection
leading seamlessly into the chronic fatigue?
THE WITNESS: That's my experience, yes.
31 On redirect examination of Dr. Lapp petitioner’s counsel raised that there is no literature confirming that
CFS can be caused by a common cold or infection. (Tr. 242-43.) Importantly, however, the Chu article
indicates that only about a third of participants had a specific type of infection documented. (Chu et al.,
supra, at Ex. 30, p. 4, Table 2.) Nearly 40% had what was characterized as respiratory infections
(meaning sore throat, runny nose, cough, etc.). (Id.) Thus, to the extent petitioner would call into
question the ability of an unspecified upper respiratory infection to cause CFS, she would also call into
question the reliability of the Chu study itself.
32 In order for a symptom to be attributable to CFS under the Fukuda diagnostic criteria, it cannot predate
the onset of fatigue. (Tr. 179.) Thus, in petitioner’s own case, Dr. Lapp did not count sore throat as a
symptom contributing to petitioner’s CFS diagnosis under the Fukuda criteria based on his assessment of
when the continuous fatigue began. (Tr. 180-82.) Nonetheless, Dr. Lapp distinguished between
petitioner’s prior bouts of sore throat from what he characterized as more continuous pharyngitis
occurring later. (Id.)
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THE COURT: So there's never a period of latency between the infectious
precursor and the chronic fatigue?
THE WITNESS: That would be correct.
(Tr. 229-30.)
This is not persuasive in light of Dr. Lapp’s reliance on Chu et al. Chu et al.
contended that the “[i]deas about acuity and its link to infection should also be re-
examined.” (Chu et al., supra, at Ex. 30, p. 11.) The authors observed that “[s]ome
past case definitions have included onset within a few hours or days as part of their
criteria” while in “the majority of [their] subjects, the first intimation of illness to full-blown
ME/CFS often occurred over months if not years.” (Id.) The Chu authors noted that the
prior Evans study participants held widely varying conceptions of what acute onset
meant and further indicated that
We also found that there was no link between subject endorsement of an
infectious precipitant and the time span of ME/CFS development. Some
believe that an acute onset is necessarily infectious or an infectious onset
is necessarily acute. Past studies examining this relationship are mixed,
with some agreeing and others disagreeing with our result. Clinically, one
infectious yet gradual onset sequence we have observed is a
stuttering pattern whereby a subject experiences a severe infection,
returns to near-normal functioning, but then experiences recurrent
infections over months to years, recovering less each time, before
succumbing entirely to ME/CFS. Overall, we agree with Evans that onset
patterns are complicated and that simple categories do not capture this
complexity.
(Ex. 30, p. 11 (emphasis added).)
Thus, Chu et al., strongly suggest that it would be entirely in keeping with what is
known of CFS to attribute petitioner’s CFS to her prior January 2012 respiratory illness,
or even a pattern of prior illnesses, rather than her vaccination. Both the Evans and
Chu articles explain that the so called “succumbing” to CFS is not the same as onset,
which may in fact occur nascently much earlier. In that regard, the actual onset of
petitioner’s CFS is not clear. Dr. Lapp essentially confirmed this during the hearing:
THE COURT: And then the opposite side of the coin would be when you
are looking at a patient and you have a suspected trigger and then you have
the subsequent chronic fatigue syndrome, what is the outside limit for
associating the two in terms of the timing?
THE WITNESS: I don't think there is any outside limit. The papers that
-- the report on the onset of chronic fatigue syndrome, they describe
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a number of different scenarios. I have had patients, for example, that
have had mild symptoms of fatigue, occasional aches and pains, but like in
this case, they were perfectly functional, going to work and were able to
keep up house and have a normal lifestyle and that's gone on for years. And
then they had a sudden onset of something like an infection, and following
that infection, they promptly developed chronic fatigue syndrome. So I'm
not sure how you can really define that. Usually if there's a trigger like
we are talking about here, it's a fairly prompt onset of the symptoms. But
then as in this case, they seem to develop over time. So this is where I'm –
if you remember, the initial symptoms that she had, her arthralgias, hip pain,
back pain, there was some nausea and fever, and then within two weeks
she developed things like the severe fatigue and malaise. She developed
the insomnia. She developed headaches, cognitive problems. They
developed over time. That's why I'm having difficulty answering your
question. And that's why I said yesterday, I think that the injection was
clearly the trigger, but by two weeks, I felt that she was clearly looking like
chronic fatigue syndrome, which was confirmed later on.
(Tr. 236-37 (emphasis added).) On redirect examination by petitioner’s counsel, Dr.
Lapp ultimately concluded:
Q. The thing I want to ask you about specifically, the cold that she had the
month before her vaccination, do you believe that any time a person gets
a cold that any cold, so an infection, whether it's any virus, any bacteria,
anything that could trigger a sore throat, that any of those, all of those can
be a trigger to or known triggers to chronic fatigue syndrome?
A. I think they could be. It's certainly not a common presentation that we
get.
(Tr. 242-43.)
Even if there is the appearance of a temporal relationship here, Dr. Lapp has little
basis for selecting petitioner’s vaccination as the starting point of a logical sequence of
cause and effect to suggest, pursuant to Althen prong two, that her vaccination caused
her CFS. Nor has he persuasively addressed pursuant to Althen prong three what
would constitute an appropriate temporal relationship between onset of CFS and an
antecedent trigger. The Evans and Chu papers, coupled with Dr. Lapp’s own testimony,
suggest that the medical community’s understanding of the onset of CFS lacks the
degree of understanding or precision Dr. Lapp would need to pinpoint the actual onset
of her condition and/or distinguish petitioner’s vaccination as the initiating cause of her
CFS.
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VI. Conclusion
Petitioner’s complete medical history eludes easy explanation, and she does
have the undersigned’s sympathy for everything she has endured regardless of the
underlying cause. Clearly, petitioner herself has identified her Tdap vaccination as a
key turning point in her health. However, based on a review of the record, including the
expert medical opinion that has been provided, there is not preponderant evidence that
petitioner’s Tdap vaccine explains the entirety of her post-vaccination presentation. In
light of all of the above, petitioner has preponderantly shown that she suffered cellulitis
caused in fact by her February 6, 2012, Tdap vaccination. She has not preponderantly
shown either that she suffered vaccine-caused CFS or that her broader CFS
presentation is sequela of her vaccine-caused cellulitis. Accordingly, petitioner is
entitled to compensation for her cellulitis injury only. A separate damages order will
issue.
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
52

================================================================================
DOCUMENT 5: USCOURTS-cofc-1_14-vv-01212-7
Date issued/filed: 2023-04-17
Pages: 2
Docket text: PUBLIC ORDER/RULING (Originally filed: 3/29/2023) regarding 185 DECISION of Special Master Signed by Special Master Daniel T. Horner. (st) Service on parties made.
--------------------------------------------------------------------------------
Case 1:14-vv-01212-MBH Document 186 Filed 04/17/23 Page 1 of 2
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 14-1212V
Filed: March 29, 2023
UNPUBLISHED
Special Master Horner
ALICIA SKINNER-SMITH,
Petitioner,
Tetanus Diphtheria and
v.
acellular Pertussis (“Tdap”)
vaccine; cause in fact; cellulitis;
SECRETARY OF HEALTH AND
Damages
HUMAN SERVICES,
Respondent.
Richard Gage, Richard Gage, P.C., Cheyenne, WY, for petitioner.
Zoe Wade, U.S. Department of Justice, Washington, DC, for respondent.
DECISION AWARDING DAMAGES1
On December 17, 2014, petitioner filed a petition under the National Childhood
Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012),2 alleging that the tetanus,
diphtheria, acellular pertussis (“Tdap”) vaccine that petitioner received on February 6,
2012, caused her to suffer an abscess, pain, and related injuries that became chronic.
(ECF No. 1.) On August 15, 2022, I issued a Ruling on Entitlement finding petitioner
entitled to compensation, but only for a local cellulitis injury and not her alleged broader
chronic injury. (ECF No. 160; see also Skinner-Smith v. Sec’y of Health & Human
Servs., No. 14-1212V, 2022 WL 4116896 (Fed. Cl. Spec. Mstr. Aug. 15, 2022).)
I subsequently issued a Ruling on Damages that concluded petitioner should be
awarded $10,125.00 for past pain and suffering and $6,000.00 for future pain and
suffering related to her vaccine-caused cellulitis. (ECF No. 182; see also Skinner-Smith
1 Because this document contains a reasoned explanation for the special master’s action in this case, it
will be posted on the United States Court of Federal Claims’ website in accordance with the E-
Government Act of 2002. See 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of
Electronic Government Services). This means the document will be available to anyone with access
to the Internet. In accordance with Vaccine Rule 18(b), petitioner has 14 days to identify and move to
redact medical or other information the disclosure of which would constitute an unwarranted invasion of
privacy. If the special master, upon review, agrees that the identified material fits within this definition, it
will be redacted from public access.
2 Within this decision, all citations to § 300aa will be the relevant sections of the Vaccine Act at 42 U.S.C.
§ 300aa-10-34.
1

Case 1:14-vv-01212-MBH Document 186 Filed 04/17/23 Page 2 of 2
v. Sec’y of Health & Human Servs., No. 14-1212, Slip op. (Fed. Cl. Spec. Mstr. Mar. 22,
2022).) On March 28, 2023, the parties confirmed that the net present value of
petitioner’s award for future pain and suffering is $5,083.00. (ECF Nos. 183-84.)
I award Petitioner a lump sum payment of $15,208.00 in the form of a check
payable to Petitioner. This amount represents compensation for all damages that would
be available under § 15(a).
The clerk of the court is directed to enter judgment in accordance with this
decision.3
IT IS SO ORDERED.
s/Daniel T. Horner
Daniel T. Horner
Special Master
3 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice
renouncing the right to seek review.
2