VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_20-vv-00602
Package ID: USCOURTS-cofc-1_20-vv-00602
Petitioner: Kathy Sawvell
Filed: 2020-05-11
Decided: 2022-09-13
Vaccine: pneumococcal
Vaccination date: 2015-04-10
Condition: malignant sarcoma
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
Kathy Sawvell, a 65-year-old woman, filed a petition for compensation on May 11, 2020, alleging that the Prevnar 13 vaccination she received on April 10, 2015, caused her to develop a malignant sarcoma. Ms. Sawvell, who was represented pro se, stated that she received the vaccination in her left arm. She reported a lump in her left arm that appeared around the time of vaccination, which was later diagnosed in November 2018 as a high-grade myxofibrosarcoma. Ms. Sawvell submitted medical records and her own research, citing various medical institutions and studies, suggesting a link between aluminum adjuvants in vaccines, chronic inflammation, and cancer, specifically sarcomas. She argued that these animal studies and general medical principles regarding inflammation applied to her case. The respondent, the Secretary of Health and Human Services, argued that the claim was filed outside the statute of limitations and that Ms. Sawvell failed to provide a credible medical theory connecting the vaccine to her sarcoma, as required under the Althen standard for off-Table claims. The respondent also noted that the vaccination records indicated an injection in the right arm, not the left. Special Master Christian J. Moran reviewed the case. The public decision does not describe the specific onset of symptoms, diagnostic tests beyond biopsy and pathology reports, or treatments beyond surgical excision, reconstructive surgery, and radiation therapy. Ms. Sawvell was unable to secure an expert opinion to support her claim. The Special Master found that Ms. Sawvell did not meet her burden of proof under the Althen standard. Specifically, she failed to establish a sound medical theory connecting the Prevnar 13 vaccine to sarcoma, as her arguments relied on uncited and unverified claims, and she did not provide evidence to extrapolate findings from animal studies to humans or to explain how Prevnar 13 specifically triggers chronic inflammation leading to cancer. Furthermore, she failed to establish a logical sequence of cause and effect and did not present any argument or evidence regarding a proximate temporal relationship between the vaccination and her sarcoma. Consequently, her case was dismissed.

Theory of causation field:
Petitioner Kathy Sawvell, age 65, received a Prevnar 13 vaccination on April 10, 2015, and subsequently developed a high-grade myxofibrosarcoma. As sarcoma is not a listed "on-Table" injury for this vaccine, the claim proceeded as an "off-Table" causation-in-fact claim under the Althen standard. Petitioner, proceeding pro se, argued a theory of causation based on her research suggesting that aluminum adjuvants in vaccines can cause cancer through chronic inflammation and DNA damage, citing animal studies and general medical literature. She also claimed the lump appeared around the vaccination date. Respondent argued the claim was time-barred and that Petitioner failed to establish a credible medical theory. Special Master Christian J. Moran denied compensation, finding Petitioner failed all three prongs of the Althen test. Prong one (causal theory) failed because Petitioner's arguments were based on uncited, unverified assertions and lacked evidence to extrapolate animal study findings to humans or to link Prevnar 13 specifically to chronic inflammation and sarcoma in humans. Petitioner did not provide expert reports or medical records supporting her theory. Prong two (logical sequence of cause and effect) failed because Petitioner did not establish that the vaccine was capable of causing sarcoma. Prong three (proximate temporal relationship) failed due to a complete lack of argument or evidence presented by Petitioner regarding a medically acceptable timeframe. The case was dismissed. Attorneys involved were Kathy Sawvell (pro se) for Petitioner and Emilie Williams for Respondent. Decision date: September 13, 2022.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_20-vv-00602-0
Date issued/filed: 2022-09-13
Pages: 11
Docket text: PUBLIC DECISION (Originally filed: 8/30/2022) regarding 34 DECISION of Special Master. Signed by Special Master Christian J. Moran. (tkp) Service on parties made. (Main Document 35 replaced on 9/14/2022 to add reissued date and footnote) (sw). Petitioner served via first class mail on 09/15/2022 (cam). Modified on 9/15/2022 (cam).
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Case 1:20-vv-00602-UNJ Document 35 Filed 09/13/22 Page 1 of 11
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Originally Filed: August 30, 2022
Reissued for Public Availability: September 13, 2022
* * * * * * * * * * * * * * * * * * * * * * * * *
KATHY SAWVELL, *
* No. 20-602V
Petitioner, * Special Master Christian J.
* Moran
*
v. *
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, * entitlement, pneumococcal
* vaccine, sarcoma
Respondent. *
* * * * * * * * * * * * * * * * * * * * * * * * *
Kathy Sawvell, Prairie du Chien, Wisconsin, pro se
Emilie Williams, United States Dep’t of Justice, Washington, DC, for respondent.
UNPUBLISHED DECISION DENYING COMPENSATION1
Kathy Sawvell claims that the pneumococcal 13-valent conjugate (“Prevnar
13”) vaccine she received on April 10, 2015 caused her to develop a malignant
sarcoma. Petitioner has submitted medical records and affidavits in support of her
claim, but has been unable to secure any expert opinion on her injury. Ms. Sawvell
has not provided a reliable mechanism by which the Prevnar 13 vaccine can cause
a malignant sarcoma. Accordingly, Ms. Sawvell has not met her burden of
establishing that the Prevnar 13 vaccine caused her injury. Thus, her case is
dismissed.
1 Pursuant to Vaccine Rule 18(b), this decision was initially filed on August 30, 2022, and the parties were afforded
14 days to propose redactions. The parties did not propose any redactions. Accordingly, this decision is reissued in
its original form for posting on the court’s website.

Case 1:20-vv-00602-UNJ Document 35 Filed 09/13/22 Page 2 of 11
I. Facts
Ms. Sawvell received the Prevnar 13 vaccination at issue on April 10, 2015
from Dr. Robert Key at the Prairie Du Chien Mayo Clinic in Prairie Du Chien,
Wisconsin. ECF No. 10 at 236. At the time of vaccination, Ms. Sawvell was 65-
years old with hypertension and hypothyroidism. Id. She had a family history of
prostate, skin, uterine, lung, breast, brain, and adrenal cancers. Id. at 11-17.
Petitioner was seen by Dr. Ryan Jawitz on November 25, 2015 for an
evaluation of “suspicious growths” and skin lesions located on her chest and left
shoulder. ECF No. 1-3 at 15. She reported that the lesions were asymptomatic,
and had been present “for months.” Id. Dr. Jawitz’s exam revealed “light tan
macules in sun distribution,” regular and symmetric even-colored macules and
papules throughout petitioner’s body, bright red papules located on the body, and
“stuck-on, warty, greasy brown papules with pseudo-horn cysts located on
[petitioner’s left shoulder] and on the body throughout . . . .” Id. Dr. Jawitz
diagnosed Ms. Sawvell with dermatoheliosis, or photo-aging from excessive sun
exposure, benign nevi, acitinic keratoses, angioma, seborrheic keratoses, and
neoplasm of uncertain behavior, classified as either a cyst, lipoma, nevus, or
pilloleiomyoma. Id. at 15-16. Dr. Jawitz conducted a punch biopsy of petitioner’s
left shoulder cyst because Ms. Sawvell reported that it was “itchy and painful.” Id.
at 16.
Ms. Sawvell returned to Dr. Jawitz on December 9, 2015 to follow up on her
biopsy. ECF No. 1-3 at 20. Dr. Jawitz noted that Ms. Sawvell’s wound was healing
and that the results of her biopsy were negative, classifying her cyst as a “benign
neoplasm.” Id.
Ms. Sawvell did not file any medical records documenting treatment during
the years of 2016 and 2017; she was next seen by Dr. Stevel Halbreich on
November 19, 2018 for a “left upper extremity mass.” ECF No. 1-3 at 22. Ms.
Sawvell reported that the lump had been there for “about 2 years” and had become
red and warm to the touch. She associated the lump with her flu shot2, and
explained that it continued to get larger as it went untreated. Id. Dr. Halbreich
excised the mass and submitted it for analysis. Id. at 25. A November 21, 2018
surgical pathology report noted that the cyst was malignant, diagnosed as a “high
grade myxofibrosarcoma,” and that Ms. Sawvell’s case would be forwarded to the
2 Ms. Sawvell clarifies in her petition that she “may have unknowingly said flu instead of pneumonia vaccine or they
recorded it incorrectly. I have never had a flu shot.” Pet. Filed May 11, 2020 at 13.
2

Case 1:20-vv-00602-UNJ Document 35 Filed 09/13/22 Page 3 of 11
Soft Tissue Pathology department at Emory Hospital in Atlanta, Georgia. Id. at 28-
30. Ms. Sawvel returned to Dr. Halbreich on November 28, 2018 where she was
informed about the malignancy. It was recommended that further surgical excision
be performed to clear the margins of the lesion as well as a lymph node biopsy to
rule out any metastasis. Id. at 36-37.
Dr. Sharon Weiss of Emory Healthcare in Atlanta, Georgia returned a
pathology report on Ms. Sawvell’s cyst on December 4, 2018. ECF No. 1-3 at 39.
Dr. Weiss wrote that the slides of petitioner’s biopsy were consistent with a
“sarcoma composed of fascicles of atypical spindle cells punctuated with large
pleomorphic ones.” Id. Dr. Weiss wrote that she would consider petitioner’s lesion
an “undifferentiated pleomorphic sarcoma with focal myxoid areas, also [referred
to as a] high grade myxofibrosarcoma.” Id.
Following her sarcoma diagnosis, Ms. Sawvell began treatment and
monitoring at Moffitt Cancer Center (“Moffitt”) on December 18, 2018. ECF No.
10 at 11. On her new patient questionnaire, Ms. Sawvell stated the sarcoma first
appeared in April 2015 following a Prevnar 13 vaccination. Id. at 12. She listed a
medical history of thyroid radiation treatments, polymyalgia rheumatica, and a
family history of prostate, skin, uterine, lung, breast, brain, and adrenal cancers. Id.
at 13, 15. At Moffitt, Ms. Sawvell was seen by Drs. Ricardo Gonzales and Arvind
Sabesan who recommended an MRI and staging CT to identify any residual tumor
tissue, preoperative radiation therapy, and a final excision of any residual tissue
affected by the sarcoma. Id. at 19-20, 144-45.
Ms. Sawvell received a radiation oncology consult from Dr. Russell Palm
for pre-operative radiation therapy on December 31, 2018. ECF No. 10 at 125-30.
Later, she received a surgical consultation from Dr. Julian Pribaz who explained
that petitioner will likely need reconstructive surgery, specifically, a flap repair,
following the excision. Id. at 142-43. Ms. Sawvell received an additional opinion
regarding her sarcoma from Dr. Marilyn Bui on January 8, 2019. Dr. Bui
concurred with Dr. Weiss’ December 4, 2018 pathology report. Id. at 39.
Petitioner continued to receive regular radiation therapy leading up to her
excision on April 12, 2019. ECF No. 1-3 at 44-45, 50-55. Following the excision,
petitioner received reconstructive surgery for her surgical scar on October 22, 2019
to provide greater mobility and relieve discomfort. Id. at 57. Petitioner continues to
receive regular check ups to monitor her sarcoma for any signs of reoccurrence.
ECF No. 10 at 32-36, 45, 74, 77, 158, 164.
3

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II. Procedural History
Ms. Sawvell filed a petition for compensation and initial medical records on
May 11, 2020. Pet., filed May 11, 2020, at 1. Following the court’s pre-assignment
review process, this case was assigned to Chief Special Master Corcoran on May
15, 2020 and subsequently reassigned to my docket on May 20, 2020. ECF Nos. 4,
6.
After this case was reassigned to the undersigned’s docket, an order set an
initial status conference and described various procedural considerations that
should be kept in mind during the pendency of petitioner’s claim. Initial Order,
issued May 22, 2020. The initial status conference was held on June 9, 2020.
During that conference, the undersigned spoke with petitioner regarding her
representation, provided a list of attorneys who may be interested in taking her
case, and discussed potential obstacles in her case including the statute of
limitations and issues relating to causation. The undersigned also explained the
need for petitioner to submit additional medical records or a medical opinion to
support her theory of causation. The undersigned concluded the status conference
directing petitioner to obtain all of the necessary medical records and explaining
the process for filing as a pro se petitioner. Order, filed June 10, 2020.
Petitioner filed her medical records on August 7, 2020. ECF No. 10. I then
ordered respondent to file a status report indicating whether he believed the
medical records were complete. Order, filed Aug. 13, 2020. Respondent filed a
status report on October 5, 2020 requesting additional vaccination and chiropractic
records. Status Report, filed Oct. 5, 2020. The undersigned subsequently ordered
petitioner to file the requested records on October 6, 2020. Order, filed Oct. 6,
2020. Petitioner filed her additional medical records on October 22, 2020. Notice
of Filing, filed Oct. 22, 2020.
After petitioner filed her additional medical records, the undersigned ordered
respondent to confirm whether he believed the record was complete and propose
next steps in the case. Order, filed Oct. 23, 2020. Respondent filed a status report
indicating that he believed the record was complete and requesting a 45-day
deadline to file a Rule 4(c) report. Status Report, filed Nov. 12, 2020.
Respondent filed his Rule 4(c) report recommending that compensation be
denied on January 8, 2021. Resp’t’s Rep., filed Jan. 8, 2021. In his report,
respondent puts forth several arguments as to why petitioner should be denied
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compensation. The first is that petitioner’s claim was filed outside of the Vaccine
Act’s 36-month statute of limitations, noting that petitioner has cited a “lump” in
her left arm that appeared on the day of her vaccination as the first sign of her
sarcoma. Resp’t’s Rep. filed Jan. 8, 2021 at 6. Because this lump appeared in
April 2015, and because petitioner did not file her claim until May 11, 2020,
respondent argues that the statute of limitations should apply and bar petitioner’s
claim from moving forward. Id. Respondent also argues that petitioner’s
vaccination records documented an injection in the right arm, not the left, and
therefore, the vaccination could not have caused a left-arm sarcoma. Id. at 7.
Finally, respondent argues that in any event, petitioner has failed to carry her
burden under Althen, specifically, that she has failed to provide evidence of a
credible medical theory connecting the Prevnar 13 vaccination to sarcoma.
The undersigned next held a status conference on January 26, 2021 where he
discussed respondent’s Rule 4(c) report and explained to the parties that the next
steps in this case would involve the presentation of expert reports. Order, filed
Feb. 1, 2021.
On March 10, 2021, petitioner filed a response to respondent’s report
providing corrections to the factual record and raising objections to respondent’s
analysis of the case. Response to Resp’t’s Rep., filed Mar. 10, 2021. First,
petitioner addressed several corrections to respondent’s statement of facts. Id. at 6.
Petitioner explains that her medical records incorrectly document the location of
her vaccination, and that she did indeed receive the vaccination in her left arm. Id.
Petitioner also notes that she never received a flu shot, and that her sarcoma did not
appear until November of 2018. Id. at 7-8. Petitioner then suggests that she has
carried her burden under Althen, invoking various medical institutions which she
alleges claim that the aluminum adjuvant in Prevnar 13 is carcinogenic and can
cause sarcomas.
On March 25, 2021, I ordered petitioner to file an expert report supporting
her claim. Order, filed Mar. 25, 2021. Petitioner’s deadline was extended first on
August 17, 2021, and for a second time on October 29, 2021. Order, filed Aug. 17,
2021; Order, filed Oct. 29, 2021. Petitioner responded to the first extension order
on October 7, 2021, arguing that expert reports are only required if the medical
record is incomplete, or if the proposed medical theory is novel. Petitioner also
provided a medical argument to support her claim, restating the assertions made in
her petition and response to respondent’s Rule 4(c) report, with an additional
argument regarding Prevnar 13’s link to chronic inflammation, and chronic
5

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inflammation’s link to DNA damage leading to cancers. Response to Scheduling
Order, filed Oct. 7, 2021.
The undersigned subsequently issued an order explaining that because
sarcoma is not listed as a table-injury associated with the Prevnar 13 vaccination,
petitioner cannot use the vaccine injury table to support her claim, and will need to
do so under a causation-in-fact theory. Order, filed Oct. 29, 2021. Petitioner filed
another response to the undersigned’s order, reiterating her previous arguments
based on her own independent research, and explaining that despite diligent efforts,
she had been unable to obtain an expert willing to opine in this case. Response to
Scheduling Order, filed December 8, 2021.
The undersigned subsequently issued an order allowing for respondent to
respond to petitioner’s filing by January 14, 2022. Order, filed December 15,
2021. Respondent did not file any response, and this case was then submitted for
adjudication on January 26, 2022. Order, filed, January 26, 2022. This case is
now ripe for a ruling on entitlement.
III. Standards for Adjudication
Under the National Vaccine Injury Compensation Program, compensation
awards are made to petitioners who suffer injuries after receiving vaccines. In
order to receive compensation, a petitioner must establish several facts by a
preponderance of the evidence, including that they received a vaccination listed on
the vaccine injury table (“the table”); received it in the United States; suffered a
serious, long-standing injury; and received no previous award or settlement on
account of the injury. The final and often most disputed element in claims for
entitlement is whether the petitioner can establish a causal link between the
vaccine and the alleged injury. 42 U.S.C. § 300aa-13(a)(1)(A); 42 U.S.C. § 300
aa-11(c)(1)(C)(i); 42 U.S.C. § 300aa-14(a); 42 U.S.C. § 300aa-13(a)(1)(B). If the
vaccinee suffered an injury listed on the vaccine injury table and associated with
the vaccination they received, he or she receives a presumption of causation if he
or she can show that his or her injury occurred within the period of time specified
by the table. See 42 C.F.R. § 100.3.
When a vaccinee suffers an injury not covered by the table, petitioners may
pursue what is referred to as an “off-table” claim. 42 U.S.C. § 300aa-13(a)(1)(B);
42 U.S.C. § 300aa-11(c)(1)(C)(ii). In off-table claims, the vaccine injury table’s
presumption of causation is inoperative. Instead, the petitioner bears the burden of
introducing preponderant evidence showing that the injury was caused-in-fact by
the vaccination at issue. Althen v. Sec’y of Health & Hum. Servs., 418 F.3d 1274,
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1278 (Fe.d Cir. 2005); Hines v. Sec’y of Health & Hum. Servs., 940 F.2d 1518,
1525 (Fed. Cir. 1991). To carry their burden in these cases, petitioner must show
that the vaccine “brought about [the vaccinee’s] 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 a proximate temporal relationship between vaccination and injury.”
Althen, 418 F.3d at 1278.
The Althen court explained that petitioners are not required to provide
medical literature supporting their theory of causation so long as they supply the
medical opinion of an expert. Id. at 1279-80. The Court also indicated that program
fact finders may rely upon “circumstantial evidence” to determine causation,
reasoning that it was consistent with the “system created by Congress, in which
close calls regarding causation are resolved in favor of injured claimants.” Id. at
1280.
In both on-table and off-table claims, petitioners bear the burden of proving
their case by a preponderance of the evidence. This standard requires a “trier of
fact to believe that the existence of a fact is more probable than its nonexistence
before [he] may find in favor of the party who has the burden to persuade the judge
of the fact’s existence.” Moberly v. Sec’y of Health & Hum. Servs., 592 F.3d
1315, 1322 n.2 (Fed. Cir. 2010) (citations omitted). Proof of medical certainty is
not required. Bunting v. Sec’y of Health & Hum. Servs., 931 F.2d 867, 873 (Fed.
Cir. 1991). Although medical certainty is not required, petitioners may not carry
their burden based solely on their own assertions. Instead, the petitioner must be
supported by either medical records, or by the opinion of a competent expert. 42
U.S.C. § 300aa-13(a)(1). This means that in order to establish an off-table claim,
petitioners must provide an expert report that addresses each prong of the Althen
test, or else provide medical records that do so.
A special master may not impose an evidentiary burden that is too high,
thus, distinguishing between “preponderant evidence” and “medical certainty” is
especially important. Andreu v. Sec’y of Health & Hum. Servs., 569 F.3d 1367,
1379-80 (Fed. Cir. 2009) (reversing a special master’s decision that petitioners
were not entitled to compensation); see also Lampe v. Sec’y of Health & Hum.
Servs., 219 F.3d 1357 (Fed. Cir. 2000); Hodges v. Sec’y of Health & Hum. Servs.,
9 F.3d 958, 961 (Fed. Cir. 1993) (disagreeing with the dissenting judge’s
contention that the special master confused preponderance of the evidence with
medical certainty).
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IV. Analysis
Here, Ms. Sawvell argues that she suffered a sarcoma caused by her April
10, 2015 Prevnar 13 vaccination. Because sarcoma is not listed on the vaccine
injury table, Ms. Sawvell must establish her claim under a causation-in-fact theory.
This section will first present each parties’ arguments before proceeding to an
analysis of each Althen prong.
A. Althen Prong One: A Causal Theory Connecting the Prevnar 13
vaccine to Ms. Sawvell’s Sarcoma.
The first Althen prong requires the petitioner to provide a “sound and
reliable” medical theory demonstrating that the vaccine can cause the alleged
injury. Boatmon v. Sec’y of Health & Hum. Servs., 941 F.3d 1351, 1359 (Fed.
Cir. 2019) (quoting Knudsen v. Sec’y of Health & Hum. Servs., 35 F.3d 543, 548
(Fed. Cir. 1994)). Because the petitioner cannot rely on her assertions alone, she
must also offer “a reputable or scientific explanation that pertains specifically to
[her] case,” in the form of medical records or an expert opinion. Moberly, 592
F.3d at 1322; see also 42 U.S.C. § 300aa-13(a)(1).
1. Parties’ Arguments
Although petitioner did not submit any expert materials, she did submit
several narratives within her petition, medical records, and status reports where she
refers to publications from medical institutions which she argues supports her
claim. Petitioner argues that “hundreds” of pets that received alum adjuvanted
vaccines developed malignant tumors, which researchers refer to as “vaccine
induced sarcomas.” Pet., filed on May 11, 2020. She argues that these animal
studies documented tumors of a yellowish color, and because her tumor was also a
yellowish color, these animal studies are applicable to her case. Id. at 5-6.
In her second narrative, petitioner continues to reference publications by
medical institutions, but again provides no record evidence nor citations to support
her claims. Relevant to her medical theory of causation, petitioner argues that the
International Journal of Cancer reported that “concentrations of aluminum in the
range of those measured in human breasts fully transform cultural mammary
epithelial cells, thus enabling them to form tumors and masticise (sic) in well-
established mouse cancer models.” Id. at K3. Petitioner also cites the Journal of
Pediatrics which wrote that “persistent antigenic stimulation causing a chronic
immune response, could eventually evolve into a lymph node malignancy.” Id. at
K4. According to Ms. Sawvell, the Cancer Treatment Centers of America reported
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that chronic inflammation can cause or influence “1 in 5 cancers,” and the Mayo
Clinic reported that aluminum “is a sarcoma causing agent by inflaming cells for a
long period of time.” Id. Petitioner writes that “medical data shows that aluminum
adjuvants leave a ‘depot’ . . . of antigens prolonging exposure . . . and can
stimulate immune cells.” Id. She further refers to the National Cancer Institute and
Fox Chase Cancer Center both of which reported that chronic inflammation can
cause DNA cell damage and lead to cancer. Id. at K4-K5. Finally, petitioner
refers to a study she says was conducted by the USDA which found a possible link
between aluminum adjuvants and vaccine associated sarcomas in farm animals and
pets. Id. at K5-K6.
Respondent argues that petitioner has failed to carry her burden under prong
one because none of her medical records contain a causal theory, nor has she
submitted an expert report providing a credible and reliable medical theory
supporting her claim. Resp’t’s Rep., filed on Jan. 8, 2021 at 8.
2. Resolution
A petitioner may not receive compensation based solely on her assertions;
instead, the petition must be supported by medical records or the opinion of a
competent physician. 42 U.S.C. § 300aa-13(a)(1). As stated above, petitioner does
not provide any record evidence or citations to the various assertions she attempts
to put forth as medical evidence. The only submissions that resemble any sort of
citation is a list of links to the websites of the institutions she mentioned in her
narrative. However, these links only direct the Court to the institution’s home
page, and not to any resource with which the undersigned is able to verify the data
and reports mentioned in petitioner’s narratives. Ultimately, because she has
provided no supporting documentation to verify the claims made in her narratives,
I cannot credit petitioner’s claims as anything more than her own assertions.
Nothing in petitioner’s medical records suggest that any of her treating
physicians concurred with her proposed medical theory that the aluminum adjuvant
in the Prevnar 13 vaccine can cause malignant sarcomas. Petitioner has also failed
to provide any expert opinions supporting her proposed medical theory. The only
evidence petitioner has offered supporting her theory are uncited, unverified
claims. However, even if petitioner provided sufficient citations requiring the
undersigned to consider the data she refers to in her filings, her argument would
still be unpersuasive because it has virtually no impact on whether the Prevnar 13
vaccination can cause sarcomas in human beings. Petitioner’s potentially most
persuasive assertion shows a causal link between certain farm animals and pets
who received aluminum adjuvanted vaccinations. However, petitioner’s burden
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requires her to show that the biological mechanism at play in the case of farm
animals and pets applies to humans who received the Prevnar 13 vaccine as well.
Petitioner has offered no evidence suggesting that these biological mechanisms
may occur in humans and cause similar injuries. Petitioner’s argument ultimately
asks the undersigned to assume, with no evidence, that this biological mechanism
occurring in cats, dogs, or cows, can also occur in human beings. See Depena v.
Sec’y of Health & Hum. Servs., 133 Fed. Cl. 535, 546 (2017) (ruling that special
master was not arbitrary in noting that an expert did not provide a basis for
extrapolating animal models to humans), aff’d 730 Fed. Appx. 938 (Fed. Cir.
2008).
The remainder of petitioner’s medical theory relies on the idea that chronic
inflammation may cause DNA damage that leads to cancer. Again, even if
petitioner provided reliable citations supporting her assertions, she would
nonetheless fail to carry her burden. This argument again asks the undersigned to
assume without evidence. Petitioner’s references make no mention of the Prevnar
13 vaccination, and only one mentions that aluminum can cause sarcoma, but
makes no explanation as to how or why. There is nothing in petitioner’s narratives
that explains how the Prevnar 13 vaccine triggers chronic inflammation, whether it
can trigger chronic inflammation, and under what circumstances it may trigger
chronic inflammation. Thus, even if petitioner sufficiently supported her assertions
with reliable evidence, that evidence would still fail to provide the necessary
information linking the Prevnar 13 vaccination to sarcoma via petitioner’s
proposed medical theory. Consequently, petitioner’s claim must fail on Althen
prong one.
B. Althen Prong Two: A Logical Sequence of Cause and Effect
Because petitioner has failed to establish that the Prevnar 13 vaccine can
cause a sarcoma, she necessarily must fail on Althen prong two. Where prong one
requires the petitioner to show that the vaccine she received is capable of causing
the injury she alleges, prong two requires the petitioner to show that the specific
vaccination she received did most likely cause her alleged injury. Althen, 418 F.3d
at 1278. However, because the undersigned is not persuaded that Prevnar 13 is
capable of causing sarcoma, petitioner is unable to show that her specific Prevnar
13 vaccination caused her sarcoma.
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C. Althen Prong Three: A Showing of a Proximate Temporal
Relationship Between Vaccination and Ms. Sawvell’s Sarcoma
Finally, even assuming that petitioner carried her burden under Althen
prongs one and two, petitioner did not present any argument or evidence
whatsoever on the appropriate proximate temporal relationship. This prong is
often defined as requiring the petitioner to establish a “medically-acceptable
temporal relationship,” between the vaccination and the injury, and then show that
her injury arose within that timeframe. Althen, 418 F.3d at 1281. Nothing in
petitioner’s records mentions what the medically accepted timeframe between
vaccination and sarcoma is. Thus, even if petitioner succeeded on prongs one and
two, her completely lack of discussion regarding prong three would ultimately
defeat her claim. As such, the undersigned must find that petitioner has failed to
carry her burden.
V. A Hearing is Not Required
Special masters possess discretion to decide whether an evidentiary hearing
will be held. 42 U.S.C. § 300aa-12(d)(3)(B)(v) (promulgated as Vaccine Rule 8(c)
& (d)), which was cited by the Federal Circuit in Kreizenbeck v. Sec’y of Health &
Hum. Servs., 945 F.3d 1362, 1365 (Fed. Cir. 2018).
Ms. Sawvell has had a full and fair opportunity to present her case. She was
provided ample time to collect and file her medical records, allowed to submit
narrative arguments, affidavits, and seek expert reports. Ultimately, Ms. Sawvell
was unable to secure an expert report, and unable to offer a persuasive theory by
which the Prevnar 13 vaccine can cause a sarcoma. Therefore, a hearing would not
resolve the failure to provide a sound and reliable medical theory.
VI. Conclusion
Ms. Sawvell has not met her burden of demonstrating that the Prevnar 13
vaccine was the cause-in-fact of her sarcoma. Accordingly, the Clerk’s Office is
instructed to enter judgment in accord with this decision unless a motion for review
is filed. Information about filing a motion for review, including the deadline, can
be found in the Vaccine Rules, available through the Court’s website.
IT IS SO ORDERED.
s/Christian J. Moran
Christian J. Moran
Special Master
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