VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_10-vv-00055
Package ID: USCOURTS-cofc-1_10-vv-00055
Petitioner: Dan Liu
Filed: 2010-01-27
Decided: 2018-07-19
Vaccine: Menactra
Vaccination date: 2008-05-30
Condition: death
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
On January 27, 2010, Shingshan Liu and Sue Wang Liu, as Personal Representatives of the Estate of Dan Liu, Deceased, filed a petition alleging that the Menactra vaccine administered to their 16-year-old son, Dan Liu, on May 30, 2008, caused an adverse reaction leading to his death on June 22, 2008. The respondent was the Secretary of Health and Human Services. Pre-vaccination medical records indicated Dan had a history of depression, sleep issues, and mild obstructive sleep apnea, for which he was being treated. An autopsy report concluded Dan died from cardiac arrhythmia of undetermined etiology. The petitioners' initial expert, Dr. Douglas Miller, a neuropathologist, reviewed the autopsy and additional tissue samples. He concluded that the cause of death was brain swelling with brainstem compression from an unknown catastrophic cause, leading to neurogenic pulmonary edema and subendocardial ischemia. He found mild lymphocytic meningitis but stated it was unlikely to have caused the severe brain swelling, opining that it was a coincidence. Dr. Miller stated he had no good answer for the cause of the cerebral edema and suggested Dan might have bumped his head. He also concluded that the Menactra vaccine, which targets bacterial meningitis, could not have caused Dan's death. Petitioners subsequently filed reports from other experts, including Dr. Yehuda Shoenfeld (immunologist), Dr. Robert Waugh (cardiologist), Dr. M. Eric Gershwin (immunologist), and Dr. Frederick Yturralde (cardiologist). These reports presented inconsistent theories, such as eosinophilic myocarditis and fulminant myocarditis, and struggled to establish a causal link to the vaccine. Dr. Shoenfeld's report was stricken. Dr. Waugh initially theorized vaccine-caused inflammation of the heart muscle, but later became ill. Dr. Yturralde described a different heart issue and deferred to the immunologist for a vaccine connection. Dr. Gershwin's reports were inconsistent regarding the type of myocarditis and its link to the vaccine. Due to the persistent lack of a viable theory of causation supported by expert opinion, the petitioners filed a motion to dismiss their own petition on July 19, 2018, stating they were unable to prove entitlement to compensation. Special Master Laura D. Millman granted this motion, dismissing the case. The decision noted that petitioners should have moved to dismiss after filing Dr. Miller's initial report, as that was when a reasonable basis to proceed ended. The case was later reviewed regarding attorneys' fees. Judge Thomas C. Wheeler reviewed the Special Master's decision on attorneys' fees, finding that the Special Master applied too burdensome a standard in evaluating the reasonable basis for the petitioners' continued pursuit of the claim. The court vacated the Special Master's fee decision and remanded the case for reconsideration of attorneys' fees and costs, stating that the Special Master overstated the strength of Dr. Miller's reports and impermissibly weighed the evidence on the merits rather than assessing feasibility.

Theory of causation field:
Petitioners alleged that the Menactra vaccine administered on May 30, 2008, caused the death of 16-year-old Dan Liu on June 22, 2008. The initial expert report by Dr. Douglas Miller concluded the cause of death was brain swelling with brainstem compression from an unknown catastrophic cause, neurogenic pulmonary edema, and subendocardial ischemia, finding the vaccine unlikely to be responsible and noting mild meningitis that was likely coincidental. Subsequent expert reports from Dr. Yehuda Shoenfeld, Dr. Robert Waugh, Dr. M. Eric Gershwin, and Dr. Frederick Yturralde proposed theories of vaccine-induced eosinophilic myocarditis or fulminant myocarditis, but these theories were inconsistent and lacked a clear causal link supported by expert opinion. The petitioners ultimately moved to dismiss their own petition due to an inability to prove entitlement. The Special Master dismissed the case, finding that a reasonable basis to proceed ended after the filing of the first expert report. The case was later remanded for reconsideration of attorneys' fees, with the reviewing judge finding the Special Master applied too stringent a standard for 'reasonable basis' and impermissibly weighed the evidence on the merits. The theory of causation was off-Table.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_10-vv-00055-0
Date issued/filed: 2018-08-13
Pages: 8
Docket text: PUBLIC DECISION (Originally filed: 07/19/2018) regarding 144 DECISION of Special Master Signed by Special Master Laura D Millman. (tlf) Service on parties made.
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Case 1:10-vv-00055-TCW Document 145 Filed 08/13/18 Page 1 of 8
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 10-55V
Filed: July 19, 2018
Not to be Published.
*************************************
SHINGSHAN LIU and SUE WANG LIU, *
as Personal Representatives of the Estate of *
DAN LIU, Deceased, *
*
Petitioners, *
* Menactra vaccine; death
v. * three weeks later; petitioners
* move for dismissal decision
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
*************************************
F. John Caldwell, Sarasota, FL, for petitioners.
Althea W. Davis, Washington, DC, for respondent.
MILLMAN, Special Master
DECISION1
Petitioners filed a petition on January 27, 2010, under the National Childhood Vaccine
Injury Act, 42 U.S.C. § 300aa-10-34 (2012), alleging that Menactra (meningococcal) vaccine
administered to their son Dan on May 30, 2008, caused an adverse reaction leading to his death
on June 22, 2008. Pet. at ¶ 11.
This is a tragic case and the undersigned extends sympathy to petitioners for their loss.
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 1:10-vv-00055-TCW Document 145 Filed 08/13/18 Page 2 of 8
FACTS
Prevaccination records
On February 22, 2008, fourteen weeks before Dan received Menactra, he had a
neurologic consultation with Dr. James Zu, a neurologist, because of symptoms of depression,
for which Dan was seeing a psychiatrist. Med. recs. Ex. 2, at 2. Dan and his mother noticed he
had been feeling inactive, had an increase of sleep, and a loss of interest for at least one to two
years. Id. He was recently diagnosed with sleep apnea. Id. Dr. Zu concluded Dan had no
neurologic disease that would cause him depression but sent him for a brain MRI and blood tests.
Id. at 3.
On February 29, 2008, Dan had a brain MRI without contrast. Id. at 9. There was no
hemorrhage or edema. Id. There was a solitary punctate2 focus of signal abnormality in Dan’s
left frontal subcortical white matter, consistent with a focus of gliosis,3 demyelination,4 or
ischemia.5 Id.
On March 4, 2008, Dan was seen at the Respiratory Center for Children, where he was
diagnosed with circadian rhythm disorder and mild OSA (obstructive sleep apnea),6 and it was
noted that Dan was sleeping better on 3 milligrams of Melatonin (taken at 10:30 p.m.). Med.
recs. Ex. 1, at 27. Dan usually fell asleep in 10 to 15 minutes and woke at 6:00 to 7:00 a.m. Id.
He had an intermittent snore and complained of fatigue in the morning. Id. The doctor noted
that depression could affect Dan’s sleep pattern. Id. at 28. Dan also had chronic/allergic rhinitis.
Id. To deal with his rhinitis and cough, the doctor prescribed 2 sprays/nose drops of Nasonex, 10
milligrams of Singulair, and Maxair for cough. Id.
Dan’s difficulty with being able to fall asleep began in 2004. Id. at 36. During a visit to
Dr. Dagnachew Assefa of the Respiratory Center for Children on November 13, 2006, Dan’s
father noted that Dan was tired during school days and had difficulty with attention. Id. Mr. Liu
thought that Dan might be having some anxiety problems. Id.
In 2002, Dan was diagnosed with asthma and prescribed Albuterol. Id. at 73.
2 The definition of “punctate” is “resembling or marked with points or dots.” Dorland’s Illustrated Medical Dictionary
1555 (32d ed. 2012) (hereinafter, “Dorland’s”).
3 Gliosis is “an excess of astroglia in damaged areas of the central nervous system; see also astrocytosis.” Dorland’s
at 784. Astroglia or astrocytes are neuroglial cells of ectodermal origin. Dorland’s at 169.
4 Demyelination is the “destruction, removal, or loss of the myelin sheath of a nerve or nerves.” Dorland’s at 486.
5 Ischemia is a “deficiency of blood in a part, usually due to functional constriction or actual obstruction of a blood
vessel.” Dorland’s at 961.
6 Apnea is the “cessation of breathing.” Dorland’s at 116.
2

Case 1:10-vv-00055-TCW Document 145 Filed 08/13/18 Page 3 of 8
Postvaccination Records
Between his Menactra vaccination on May 30, 2008 and his death on June 22, 2008, Dan
did not see a physician.
The autopsy report concludes that Dan died from cardiac arrhythmia of undetermined
etiology. Med. recs. Ex. 4, at 5. The medical examiner notes that Dan was found unresponsive
in bed, face up, after having been heard in the bathroom at 6:00 a.m. Id. at 9. The EMT report,
states that Dan was found lying supine on his bed when his alarm clock sounded, but he did not
come out of his room. Med. recs. Ex. 6, at 2. CPR was initiated at 8:30 a.m. and discontinued at
8:31 a.m. because of obvious signs of death. Id. at 3. The field diagnosis was cardiac arrest. Id.
The police arrived that morning as well. Ex. 9, at 2.7 CPR, defibrillation, oxygen, and
chest compressions were attempted until the EMTs arrived. Id. at 4. Dan had the following
medications on his night table: Nasonex,8 Zyrtec,9 Rhinocort,10 Astelin11 (which the report
spelled “Atelin”), and Tylenol.12 Id. at 5. Officer Bradford Beirne spoke to both of Dan’s
parents. Id. They said that Dan suffered from a sleeping disorder for which he took only over-
the-counter medication. Id. Dan’s mother said that Dan did have asthma and was taking
treatment for it. Id. She stated Dan was feeling and acting normally before he went to bed on
Saturday night, June 21, 2008. Id. At about 6:20 a.m., she heard Dan get out of bed and use the
bathroom. Id. She then heard him return to his bedroom and go back to bed. Id. She said he
was supposed to wake at about 8:15 a.m. because he was going with a friend to see a show that
day. Id. When his alarm rang, but he did not get up, she went into his bedroom and observed
him lying on his bed not breathing. Id. Her husband called 911. Id.
7 Although petitioners filed the police report as Exhibit 9, it is stamped Exhibit 1 throughout. The undersigned will
continue to refer to it as Exhibit 9 since there is a set of medical records already filed as Exhibit 1.
8 Nasonex is a “trademark for a preparation of mometasone furoate.” Dorland’s at 1232. Mometasone furoate is “a
synthetic corticosteroid used topically for the relief of inflammation and pruritis in corticosteroid-responsive
dermatoses and intranasally in the treatment of allergic rhinitis and other inflammatory nasal conditions.” Dorland’s
at 1174.
9 Zyrtec is a “trademark for preparations of cetirizine hydrochloride.” Dorland’s at 2097. Cetirizine hydrochloride
is “a nonsedating antihistamine (H -receptor antagonist) that is a metabolite of hydroxyzine, used in treatment of
1
allergic rhinitis and chronic idiopathic urticaria, and as a treatment adjunct in asthma. . . .” Dorland’s at 334.
10 Rhinocort is a “trademark for preparations of budesonide.” Dorland’s at 1639. Budesonide is “an
antiinflammatory glucocorticoid used by inhalation to treat asthma, intranasally to treat allergic rhinitis and other
inflammatory nasal conditions. . . .” Dorland’s at 258.
11 Astelin is a “trademark for a preparation of azelastine hydrochloride.” Dorland’s at 167. Azelastine
hydrochloride is “an antihistamine (H receptor antagonist) administered intranasally in the treatment of seasonal
1
allergic rhinitis (hay fever). . . .” Dorland’s at 187.
12 Tylenol is a “trademark for preparations of acetaminophen.” Dorland’s at 1992. Acetaminophen is “the amide of
acetic acid and p-aminophenol, having analgesic and antipyretic effects similar to aspirin’s but only weak
antiinflammatory effects.” Dorland’s at 12.
3

Case 1:10-vv-00055-TCW Document 145 Filed 08/13/18 Page 4 of 8
Officer James McCullough went to Dan’s home, photographed the body, and spoke to
Dan’s parents. Id. at 6. Dan’s father told him that Dan had been home the previous night acting
normally. Id. Dan played the piano and listened to music while he was on the computer. Id.
Dan’s father said that Dan was not complaining of any illness and had not been sick. Id. Dan’s
father said that Dan ate supper and, around 10:00 p.m., told his father that he was hungry again,
and his father cooked him some noodles. Id. Dan’s mother then said that she and her husband
went to bed, but Dan went into the bathroom around 11:00 p.m. and seemed to be there a long
time. Id. She again heard Dan in the bathroom around 6:00 or 6:30 a.m. Id. At about 8:15 a.m.,
she heard Dan’s alarm clock go off and, when she went to wake him, she found him in bed
unresponsive. Id. Officer McCullough then asked for and received permission to investigate
Dan’s computer and found that, the night before, Dan had googled “inducing diarrhea.” Id.
Officer McCullough asked Dan’s father about this, and he replied that Dan frequently had
stomach problems with constipation since childhood. Id. Dan’s father also stated that Dan had
trouble sleeping at times for which he took Melatonin, but he had run out of it on Friday. Id. In
its absence, Dan would take Tylenol P.M. (which was on the nightstand) to help him sleep. Id.
Dan’s father stated that the last time Dan was at the doctor’s was several weeks earlier to get a
shot necessary for him to attend camp. Id. He also stated that a couple of weeks ago, Dan had a
low-grade fever for a day or two and took Tylenol until it went away. Id. at 7.
Petitioners’ Medical Expert Reports
On June 5, 2012, petitioners filed the expert report of Dr. Douglas C. Miller, a
pathologist, as Exhibit 14. Dr. Miller’s CV is filed as Exhibit 15. He is board-certified in
anatomic pathology and neuropathology. Ex. 15, at 1. He did residencies in anatomic pathology
and neuropathology at Massachusetts General Hospital. Id. He won First Prize for his book
“Modern Surgical Neuropathology” in the category of Neurology Books from the British
Medical Association in 2010. Id. at 2. He is a founding member of the New York State
Association of Neuropathologists. Id. at 4. Dr. Miller is on the editorial review board of the
Journal of Child Neurology. Id. He is a reviewer for the following journals: Neurosurgery;
Journal of Neuropathology and Experimental Neurology; Brain Pathology; Journal of Neuro-
Oncology; Human Pathology; Archives of Pathology and Laboratory Medicine; Journal of
Neurology, Neurosurgery & Psychiatry; Cancer; Neurobiology of Disease; Journal of Child
Neurology; and American Journal of Clinical Pathology. Id. Dr. Miller is the author or co-
author of three books and 145 articles. Id. at 5–14.
Dr. Miller states in his expert report that he reviewed the autopsy report and slides
prepared by the Union County Medical Examiner, as well as additional fixed tissues in formalin,
from which he chose additional samples for new slides. Ex. 14, at 1. Petitioners’ counsel
requested Dr. Miller render an opinion as to the cause of Dan’s death. Id. Dr. Miller mentions
that he has been involved in another alleged vaccine-caused death case and has been a consultant
to pathologists in New York, New Jersey, and Missouri for decades. Id.
He notes that Dan’s brain weight of 1,710 grams was extremely heavy. Id. at 2. Dan’s
4

Case 1:10-vv-00055-TCW Document 145 Filed 08/13/18 Page 5 of 8
heart had pathologic indications of a lack of blood supply. Id. The lungs showed some intra-
alveolar hemorrhage and considerable edema. Id. Dan’s brain did not show any acute
hypoxic/ischemic changes. Id. at 3. The brain’s white matter did not have infiltration by
lymphocytes or macrophages and did not have gliosis. Id. There was no indication of
demyelinating disease in Dan’s brain. Id. The cortex and hippocampus did not have changes
suggestive of chronic seizure disorder. Id. Dr. Miller thought it unlikely that Dan, who did not
have a history of epilepsy, had a first seizure and died. Id.
Dr. Miller said the brain specimens did show focal minimal to mild lymphocytic
(“chronic”) meningitis. Id. Both sections of the cerebellum Dr. Miller took showed small areas
containing small aggregates of mature small lymphocytes in the subarachnoid space on top of the
cerebellar foliar cortical tissue contained within the leptomeninges. Id. Dr. Miller wrote that this
finding suggests Dan had viral meningitis (“aseptic meningitis”), although it might be a reaction
to something else, perhaps even an autoimmune problem. Id. Symptoms of mild fever,
headache, and lethargy are consistent with viral meningitis. Id. Dr. Miller states that he has
difficulty believing that the severe brain swelling was caused by the meningitis because the
degree and extent of meningeal inflammation was so slight. Id. Dr. Miller opines that it was
coincidence that Dan had meningitis and something else which caused acute brain swelling and
death. Id.
Dr. Miller concludes that the cause of Dan’s death was brain swelling with brainstem
compression. Id. at 4. Dan’s pulmonary hemorrhage and edema were consistent with a severe
cerebral event (“neurogenic pulmonary edema”). Id. The wavy fibers in Dan’s heart sections
were also consistent with a primary intracranial catastrophe (“encephalogenic visceral
syndrome”). Id. Dr. Miller posits the following sequence occurred to Dan, leading to his death:
cerebral edema from some unknown catastrophic cause, leading to
neurogenic pulmonary edema and histologic changes of
subendocardial ischemia, with death occurring rapidly from onset,
certainly no more than about two hours and quite possibly in only
minutes.
Id. (emphasis added).
Dr. Miller states he has “no good answer” for what caused Dan’s cerebral edema. Id. He
writes that young people are sometimes prone to “flash edema,” that is, the rapid onset and
progression of severe brain swelling from otherwise trivial blunt head trauma without any focal
brain injury. Id. He opines that Dan might have bumped his head when he went to the bathroom
at six in the morning on the day of his death. Id. Dr. Miller repeats that he finds it implausible
that the small amount of meningitis present at the time of Dan’s death was responsible for his
cerebral edema. Id.
Dr. Miller says it “makes no sense” to connect the meningitis vaccine to Dan’s death
even though he found meningitis in some of Dan’s brain sections. Id. The vaccine is directed
5

Case 1:10-vv-00055-TCW Document 145 Filed 08/13/18 Page 6 of 8
against the bacterial form of meningitis caused by Neisseria meningitides and does not include
live bacteria. Id. Meningococcal meningitis is a fulminant acute disease, which provokes an
acute inflammatory response composed of polymorphonuclear leukoctyes, unlike the course of
viral meningitides which are characterized by inflammatory infiltrates composed of mononuclear
cells, i.e., lymphocytes and some macrophage/histiocytic cells. Id. Dr. Miller states Menactra
vaccine did not infect Dan with an organism or virus causing meningitis. Id.
Dr. Miller repeats his conclusion at the end of his expert opinion: the cause of Dan’s
death was cerebral edema from some unknown catastrophic event, leading “to neurogenic
pulmonary edema and histologic changes of subendocardial ischemia, with death occurring
rapidly from onset, certainly no more than two hours and quite possibly in only minutes.” Id. at
5 (emphasis added).
Petitioners should have moved to dismiss after filing Dr. Miller’s expert report. That is
when a reasonable basis to proceed ended. However, petitioners’ counsel asked to find another
medical expert.
Over numerous years, petitioners proceeded to file four other medical doctors’ reports, all
of which proved to be defective. Dr. Yehuda Shoenfeld, an immunologist, wrote a report which
misstated Dr. Miller’s conclusion. When the undersigned called this defect to petitioners’
counsel’s attention, he moved to strike Dr. Shoenfeld’s report. The undersigned struck Dr.
Shoenfeld’s report from the record. Petitioners then retained Dr. Robert Waugh, a cardiologist,
who wrote a report stating that Dan had eosinophilic myocarditis, although no eosinophils were
detected in his heart. Dr. M. Eric Gershwin, an immunologist, then wrote a report stating that
Menactra vaccine caused Dan’s eosinophilic myocarditis. But then Dr. Waugh entered hospice
and petitioners retained another cardiologist Dr. Frederick Yturralde who wrote Dan did not have
eosinophilic myocarditis, but fulminant myocarditis. However, Dr. Yturralde could not say it
was due to the vaccination. Dr. Gershwin wrote another report repeating his prior opinion that
the vaccine caused eosinophilic myocarditis, apparently unaware that Dr. Yturralde wrote that
Dan had fulminant myocarditis not eosinophilic myocarditis. Dr. Yturralde then wrote another
expert report saying Dan died from fulminant myocarditis and stating the vaccination caused it
but did not give any basis for his opinion other than Dr. Gershwin said it did, ignoring that Dr.
Gershwin’s prior report referred only to eosinophilic myocarditis and not to fulminant
myocarditis. Following the undersigned’s order, petitioners’ counsel returned to Dr. Gershwin to
see if he would support the new view that Menactra vaccine caused Dan to have fulminant
myocarditis from which he died, but petitioners did not obtain a further report from Dr.
Gershwin, meaning even if they could have proved Dan died from fulminant myocarditis, they
could not prove the vaccine caused it.
On July 19, 2018, petitioners filed a Motion for a Decision Dismissing Their Petition.
They state that “they will be unable to prove that they are entitled to compensation in the
Vaccine Program” and that “to proceed further would be unreasonable and would waste the
resources” of the court, respondent, and the Vaccine Program. Pet’rs’ Mot. at 1.
6

Case 1:10-vv-00055-TCW Document 145 Filed 08/13/18 Page 7 of 8
The undersigned GRANTS petitioners’ Motion for a Decision Dismissing Their Petition
and DISMISSES this case.
DISCUSSION
To satisfy their burden of proving causation in fact, petitioners must prove by
preponderant evidence: “(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 v. Sec’y of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). In Althen, the Federal Circuit
quoted its opinion in Grant v. Secretary of Health and Human Services, 956 F.2d 1144, 1148
(Fed. Cir. 1992):
A persuasive medical theory is demonstrated by “proof of a logical
sequence of cause of and effect showing that the vaccination was
the reason for the injury [,]” the logical sequence being supported
by a “reputable medical or scientific explanation[,]” i.e., “evidence
in the form of scientific studies or expert medical testimony[.]”
418 F.3d at 1278.
Without more, “evidence showing an absence of other causes does not meet petitioner’s
affirmative duty to show actual or legal causation.” Grant, 956 F.2d at 1149. Mere temporal
association is not sufficient to prove causation in fact. Id. at 1148.
Petitioners must show not only that but for Menactra vaccine, their son would not have
died, but also that Menactra vaccine was a substantial factor in causing his death. Shyface v.
Sec’y of HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999).
The Vaccine Act, 42 U.S.C. § 300aa-13(a)(1), prohibits the undersigned from ruling for
petitioners based solely on their allegations unsubstantiated by medical records or medical
opinion. The medical records do not support petitioners’ allegations. The expert reports
petitioners filed do not support their allegations.
Petitioners move for a decision dismissing their petition.
The undersigned GRANTS petitioners’ motion and DISMISSES this petition.
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.13
13 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.
7

Case 1:10-vv-00055-TCW Document 145 Filed 08/13/18 Page 8 of 8
IT IS SO ORDERED.
Dated: July 19, 2018 /s/ Laura D. Millman
Laura D. Millman
Special Master
8

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DOCUMENT 2: USCOURTS-cofc-1_10-vv-00055-2
Date issued/filed: 2019-11-13
Pages: 7
Docket text: JUDGE VACCINE REPORTED OPINION re: 161 Order on Motion for Review. Signed by Judge Thomas C. Wheeler. (ejg) Service on parties made.
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Case 1:10-vv-00055-TCW Document 164 Filed 11/13/19 Page 1 of 7
In the United States Court of Federal Claims
No. 10-55V
(Filed Under Seal: October 28, 2019)
(Reissued: November 13, 2019)1
************************************ *
*
SHINGSHAN LIU and SUE WANG LIU, *
as Personal Representatives of the Estate of *
DAN LIU, Deceased, *
*
Vaccine Act Case; Review of Claim for
Petitioner, *
Attorneys’ Fees and Costs; Reasonable
*
Basis for Filing; Recovery of Fees by
v. *
Unsuccessful Petitioner; Standard of
*
Review.
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
************************************ *
Jennifer Anne Gore Maglio, Maglio Christopher & Toale, PA, Sarasota, Florida, for
Petitioners.
Daniel A. Principato, with whom were Joseph H. Hunt, Assistant Attorney General, C.
Salvatore D’Alessio, Acting Director, Torts Branch, Civil Division, Catharine E. Reeves,
Deputy Director, Torts Branch, Civil Division, and Heather L. Pearlman, Assistant
Director, Torts Branch, Civil Division, U.S. Department of Justice, Washington, D.C., for
Respondent.
OPINION AND ORDER
WHEELER, Judge.
1 Pursuant to Rule 18(b) of the Court’s Vaccine Rules, this opinion and order was initially filed
under seal. As required under the Rules, each party was afforded 14 days from the date of issue,
until November 12, 2019, to object to the public disclosure of any information furnished by that
party. Neither party submitted any proposed redactions.

Case 1:10-vv-00055-TCW Document 164 Filed 11/13/19 Page 2 of 7
This case is before the Court on Petitioners’ Motion for Review of the Special
Master’s decision partially denying Petitioners’ motion for attorneys’ fees and costs. Liu
v. Sec’y of Health & Human Servs., No. 10-55V, 2019 WL 2098165 (Fed. Cl. Spec. Mstr.
April 19, 2019) (“Fee Decision”). For the reasons explained below, the Court finds that
the Special Master applied too burdensome a standard in evaluating reasonable basis for
Petitioners’ proceeding with their claim, and thus her decision was not in accordance with
law.
Background
In 2008, Petitioners tragically experienced the sudden death of their son, Dan. On
January 27, 2010, they filed a petition under the National Vaccine Injury Compensation
Program, 42 U.S.C. §§ 300aa-10–34 (“Vaccine Act”). The petition alleged that the
Menactra (meningococcal) vaccine administered to their son on May 30, 2008, caused an
adverse reaction leading to his death at the age of 16 on June 22, 2008. During the next
eight years, Petitioners filed a series of expert reports, each advancing a different theory of
the role of the vaccine in Dan’s death. The case ultimately ended in Petitioners’ motion
to dismiss the case on July 19, 2018. Dkt. No. 143.
Petitioners’ first expert report was not filed until June 5, 2012, partly because of
difficulties in obtaining autopsy records. Dkt. No. 37. In that report, Petitioners’ expert,
Dr. Douglas Miller, a neuropathologist, concluded that the cause of death in this case was
“brain swelling with brainstem compression” due to “some unknown catastrophic cause.”
Dkt. No. 37-1 at 4 He went on to express his opinion that death occurred “rapidly from
onset, certainly no more than about two hours and quite possibly in only minutes.” Id. Dr.
Miller discounted the medical examiner’s autopsy opinion that cause of death was cardiac
arrhythmia, viewing the evidence for that diagnosis as inadequate, so that it was “informed
speculation and not to a reasonable medical probability.” Id. at 2. He also observed that
due to its formulation, the vaccine in question could not have infected Dan with an
organism or virus causing meningitis. Id. at 4. Thus, Petitioners’ expert did not support
their claims that the Menactra vaccine caused Dan’s death.
Shortly after filing Dr. Miller’s report Petitioners asked for and received an
extension of time to file another expert report. In December 2012, Petitioners filed the
expert report of Dr. Yehuda Shoenfeld. Dkt. No. 44. Dr. Shoenfeld theorized that
inflammation of the brain described in Dr. Miller’s report showed an immune reaction to
the vaccine. In the Fee Decision, the Special Master criticized this report, observing that
she thought it mischaracterized Dr. Miller’s conclusions. Fee Decision at *3.
At Respondent’s request, further evidence was gathered from Dan’s teachers and
friends regarding his behavior following his vaccination up until the time of his death. In
March 2014, the Special Master explained in a lengthy Scheduling Order why, in her view,
2

Case 1:10-vv-00055-TCW Document 164 Filed 11/13/19 Page 3 of 7
Dr. Shoenfeld’s expert report was not credible and did not satisfy Petitioners’ burden of
proof. The Special Master also explained that the evidence from friends and teachers did
not support Petitioners’ claim that Dan had been acting lethargic and sickly since the
vaccination. She observed that Petitioners’ affidavits regarding Dan’s health just prior to
his death were different from their statements to police at the time of Dan’s death, where
they told the police that Dan had not shown any signs of illness on the day before his death.
The Special Master granted Petitioners’ motion to file supplemental expert reports
addressing the issues raised in this Scheduling Order. Dkt. No. 64. Dr. Miller’s
supplemental expert report was filed on July 1, 2014. Dkt. No. 69. In that report, Dr.
Miller stated that Dan’s brain had shown very little inflammation at autopsy, and absent
that, Dr. Shoenfeld’s theory of a fatal autoimmune process in the brain caused by the
vaccine could not be supported. Petitioners did not file a supplemental expert report from
Dr. Shoenfeld.
In a July 1, 2014 Order, the Special Master summarized the Status Conference held
that day, noting that Petitioners’ counsel reported a dispute with Petitioners over whether
to go forward with the case. Dkt. No. 68. On July 8, 2014, Dr. Shoenfeld’s report was
stricken upon motion by Petitioners. Dkt. No. 71. Despite these setbacks, Petitioners
continued with the case, filing a new expert report from Dr. Waugh, a cardiologist, on
March 4, 2015. Dkt. No. 85. Dr. Waugh theorized that the vaccination caused an
inflammation of the heart muscle. In response, Respondent filed an expert report by Dr.
Sperling, a cardiologist, disputing Dr. Waugh’s theory. Dkt. No. 88. Dr. Waugh then filed
a supplemental report in response. Dkt. No. 90. The parties then indicated their inability
to settle the case after encouragement from the Special Master, and Petitioners requested
and were granted an entitlement hearing. Dkt. No. 94.
Before the entitlement hearing could be held, Respondent objected to Petitioners’
sudden addition of a new causation theory and medical literature not discussed by Dr.
Waugh. Respondent also questioned Dr. Waugh’s qualifications for the part of his opinion
relating to immunology. This resulted in postponement of the entitlement hearing as well
as filing of expert reports by immunologists, Dr. Gershwin for Petitioners and Dr. Rose for
Respondents. Dkt. Nos. 107, 111. In April 2017, Petitioners informed the Special Master
that their expert cardiologist Dr. Waugh was ill and could no longer participate in the case.
In her status conference order on this subject, the Special Master noted the difficulties with
Petitioners’ case, reminding them that “an expert’s opinion is no better than the evidence
it is based on.” Dkt. No. 117. At this time the Special Master encouraged Petitioners’
counsel to speak to his clients about dismissing the case. Fee Decision at *8.
In August 2017, Petitioners submitted an expert report from cardiologist Dr.
Yturralde, describing a heart issue different from that relied on by Dr. Waugh, and
deferring to the immunologist for any connection to the vaccine. Dkt. No. 120. In
December 2017, the Special Master described the flaws in Petitioners’ expert’s latest
theories during a status conference. Dkt. No. 125. Respondent then substituted its expert
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cardiologist Dr. Sperling, with a new cardiologist, Dr. Yeager, who also disputed the
findings of Petitioners’ experts. Dkt. No. 131. In April 2018, the Special Master ordered
Petitioners to submit their experts’ responses to Dr. Yeager’s report. After those reports
were filed, in a July 3, 2018 Order, the Special Master “continued to state that petitioners
filed expert reports that provided inconsistent theories.” Fee Decision at *10.
Shortly after that, on July 19, 2018, Petitioners filed a motion to dismiss the case,
stating that they would be “unable to prove that they are entitled to compensation….” Dkt.
No. 143 at 1. In granting the motion to dismiss, the Special Master observed that
“Petitioners should have moved to dismiss after filing Dr. Miller’s expert report. That is
when a reasonable basis to proceed ended.” Liu v. Sec’y of Health & Human Servs., No.
10-55V, 2018 WL 3990977 at *4 (Fed. Cl. Spec. Mstr. July 19, 2018).
Law Governing Recovery of Fees
The Vaccine Act permits the award of attorneys’ fees and costs even for
unsuccessful petitioners, if the Special Master or Court determines that the petition was
brought in good faith and also that there was a “reasonable basis” for the claim. 42 U.S.C.
§ 300aa-15(e)(1). The question of having a reasonable basis for the claim is the focus of
this review, since Petitioner’s good faith in filing is not challenged. An unsuccessful
petitioner seeking fees has the burden to affirmatively demonstrate that the petition has a
reasonable basis. McKellar v. Sec’y of Health & Human Servs., 101 Fed. Cl. 297, 304
(2011) (citing Perreira v. Sec’y of Health & Human Servs., 33 F.3d 1375, 1377 (Fed. Cir.
1994)). The statute sheds no further light on the meaning of “reasonable basis” in this
context; however, in Simmons v. Sec’y of Health & Human Servs., 875 F.3d 632 (Fed. Cir.
2017), the Federal Circuit recently clarified this standard. While determination of good
faith is a subjective judgment, reasonable basis is determined on an objective basis,
inquiring as to evidentiary support for the claim described in the petition. Id. at 636. “A
claim can lose its reasonable basis as the case progresses,” R.K. v. Sec’y of Health &
Human Servs., 760 F. App’x 1010, 1012 (citing Perreira, 33 F.3d at 1376–77).
Fee Decision
After dismissal of their case, Petitioners filed for payment of attorneys’ fees and
costs totaling $281,852.59. Dkt. Nos. 147, 149. Respondent objected to paying any fees
and costs at all, maintaining that Petitioners lacked reasonable basis to file the case in the
first place. Dkt. No. 151. Petitioners replied to Respondent’s objections and increased
their requested fees and costs to add the work in filing the reply, bringing total attorneys’
fees and costs requested to $290,179.79. Dkt. No. 153.
In the Fee Decision, the Special Master found that the good faith requirement to
support payment of fees was satisfied in this case. She then reviewed the law governing
the second requirement, that Petitioners must show a reasonable basis for filing, and found
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that “reasonable basis can be lost as the case develops.” Fee Decision at *14 (citing
Perreira, 33 F.3d at 1377). The Special Master also found that, while the reasonable basis
requirement was satisfied at the time of filing, Petitioners lost reasonable basis to proceed
after the time they filed their own expert Dr. Miller’s report which failed to support vaccine
causation in June 2012. At that time “[P]etitioner’s claim was clearly undermined and no
longer objectively feasible.” Id. at *15. The Special Master observed in a footnote that
she had the “impression that [P]etitioners’ counsel never read Dr. Miller’s expert report
before he filed it….” Fee Decision at *18 n.2. She also wrote that the expert report stated
that the vaccination had nothing to do with Dan’s death. Id. She then observed that
“[P]etitioners’ counsel prolonged a case without reasonable basis for another six years.”
Id. The Special Master awarded to Petitioners attorneys’ fees until the filing of Dr. Miller’s
first report on June 5, 2012, and also added Petitioners’ claims for fees for filing the fee
motion and for replying to Respondent’s objections to fees. The Special Master denied
fees and costs for all other dates. This resulted in an award of about $75,000 in attorneys’
fees and costs, a reduction of about $215,000 from the $290,000 claimed. Petitioners have
filed a Motion to Review the decision. Dkt. No. 157.
Standard of Review
This Court has jurisdiction to review decisions of the Special Masters in accordance
with 42 U.S.C. § 300aa-12(e)(1)-(2). The Court may set aside a Special Master’s decision
only if it is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance
with law.” § 300aa-12(e)(2)(B). A Special Master’s decision on the award of attorneys’
fees to unsuccessful petitioners is discretionary, and thus is reviewed under an abuse of
discretion standard. Saxton v. Sec’y Health & Human Servs., 3 F.3d 1517, 1520 (Fed. Cir.
1993). If the Special Master “considered the relevant evidence, drew plausible inferences,
and articulated a rational basis” for the decision on the award of attorneys’ fees and costs,
the Court will not find an abuse of discretion. Graham v. Sec’y of Health & Human Servs.,
124 Fed. Cl. 574, 578 (2015) (quoting Masias v. Sec’y of Health & Human Servs., 634
F.3d 1283, 1290 (Fed. Cir. 2011)).
Arguments
Motion for Review
In their Motion for Review, Petitioners challenge the denial of the majority of their
submitted fees and costs, arguing that the Special Master applied an impermissibly elevated
standard for determining reasonable basis. They point out that because the Special Master
determined that reasonable basis was lost after submission of the first expert report, there
was no analysis of the reasonable basis for the remaining activity in the case, which formed
a significant portion of the fees and costs. Dkt. No. 157 at 15. Petitioners argue that
vaccine case law addressing reasonable basis reveals that courts look to “medical support,
in the form of expert reports, medical literature, and medical records showing a causal
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connection” to evaluate the requisite evidentiary support. Id. at 14. Here, they argue,
Petitioners offered eight expert reports by three qualified experts, each of the opinion that
the vaccine caused Dan’s death. Id. They also filed 57 medical articles supporting the
expert opinions, as well as medical records, including the autopsy report. This
“demonstrated that Petitioners’ claim was, at a minimum, feasible.” Id. They further
maintain that the Special Master inaccurately summarized the opinion of their first expert,
Dr. Miller. The Special Master stated in the Fee Decision that Dr. Miller had declared the
vaccination to be “unrelated” to Dan’s death, and Petitioners assert that Dr. Miller made
no such finding. Further, the Special Master failed to mention Dr. Miller’s statement in his
supplemental report that there could have been a cardiac arrhythmia. Id. at 16. In sum,
Petitioners maintain that the Special Master “impermissibly engaged in weighing the
evidence rather than deciding feasibility.” Id. at 18 (citing Santacroce v. Sec’y of Health
& Human Servs., No. 15-555V, 2018 WL 405121 (Fed. Cl. Jan. 5, 2018)).
Respondent’s Arguments
Respondent opposes the Motion for Review by arguing that “petitioners did not
offer any evidence of a factual or medical basis for their claim of vaccine-causation at any
point.” Dkt. No. 160 at 13. Respondent points out that, although Petitioners claim that
they submitted ample evidence to support reasonable basis, quantity is not enough.
Respondent maintains that because Petitioners’ experts failed to agree on one theory, a
reasonable basis for proceeding was never established.
Discussion
The question for decision before this Court is whether the Special Master abused
her discretion by applying too stringent a standard in analyzing Petitioners’ reasonable
basis for continuing the case. In the Fee Decision, the Special Master relied on her
conclusions from Petitioners’ first expert report, the Miller report, to dismiss the
evidentiary value of all of the following expert reports and supporting literature submitted
by Petitioners. However, a reading of the Miller report and supplemental report leads the
Court to conclude that it does not contain the definitive opinions described by the Special
Master.
The certainty of Dr. Miller’s conclusions was diminished because he frequently
pointed out the limitations of the autopsy records, samples, and photographs in finding a
conclusive cause of death, finally commenting that “this was not a well-done autopsy.”
Dkt. No. 37-1 at 4. The Special Master found that “Dr. Miller also ruled out cardiac
arrhythmia as the cause of Dan’s death.” Fee Decision at *15. But in fact, while Dr. Miller
noted that the cardiac arrythmia theorized by the Medical Examiner was “informed
speculation,” Id. at 2, this statement is not conclusive and could be subject to challenge.
Moreover, in Dr. Miller’s supplemental report, he opines that “there could have been a
cardiac arrythmia based on the finding of a thick interventricular septum . . . .” Dkt. No.
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69-1 at 2. This might open the door to a heart-related theory such as those discussed by
Petitioners’ later experts. In his supplemental report Dr. Miller also addressed Dr.
Shoenfeld’s hypothesis of an autoimmune reaction affecting the brain, observing that “I
cannot say one way or the other whether that hypothesis is accurate.” Id. at 2. While Dr.
Miller pointed out that there was no evidence that the vaccine caused meningitis, he did
not state that “the cause of Dan’s death was not related to his meningococcal vaccination,”
as stated by the Special Master in her Fee Opinion at *15.
This Court has noted, that, “[w]hile the Court certainly supports the development of
meaningful standards to determine . . . reasonable basis . . . , that goal must be balanced
against the public policy of encouraging access by vaccine petitioners to competent
counsel.” Allicock v. Sec’y Health & Human Servs., 128 Fed. Cl. 724, 727 (2016) (citing
Chuisano v. United States, 116 Fed. Cl. 276, 285 (2014)). In this case, the Court finds that
the Special Master overstated the strength of the Miller expert and supplemental reports
while weighing the feasibility of Petitioners’ continued efforts to demonstrate vaccine
causation. The Special Master impermissibly engaged in weighing the evidence presented
on the merits, rather than deciding if Petitioners’ claims were feasible. In this case, the
Special Master’s finding that all reasonable basis was lost after the filing of Dr. Miller’s
first report is not supported by the record and thus not in accordance with law. It may be,
however, that further review of the record will yield a clearer understanding of the point
where Petitioners’ pursuit of this case may have lost its reasonable basis.
For these reasons, the Petitioner’s Motion for Review is GRANTED. The Special
Master’s Fee Decision is VACATED, and this case is REMANDED to the Office of
Special Masters for consideration of Petitioners’ motion for attorneys’ fees and costs
consistent with this opinion.
IT IS SO ORDERED.
s/Thomas C. Wheeler
THOMAS C. WHEELER
Judge
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