Miles v. Secretary of Health and Human Services ( 2019 )

United States Court of Federal Claims
No. 12-254V
Filed under seal: December 20, 2018
Reissued: February 22, 20191
)
MARK MILES, )
Legal Representative of a Minor Child J.M., )
)
Petitioner, )
) Vaccine Case; Motion for Review;
v. ) Influenza Vaccine; Althen; Loving;
) Burden of Proof; Causation
SECRETARY OF HEALTH AND )
HUMAN SERVICES, )
)
Respondent. )
)
OPINION
John F. McHugh, Law Office of John McHugh, New York, NY, for petitioner.
Darryl R. Wishard, Vaccine/Torts Branch, Civil Division, United States Department of Justice,
Washington, DC, for respondent.
SMITH, Senior Judge:
Petitioner, Mark Miles, on behalf of and as the legal representative of a minor child, J.M.,
seeks review of a decision issued by Special Master Laura D. Millman denying his petition for
vaccine injury compensation. Petitioner brought this action pursuant to the National Childhood
Vaccine Injury Act, 42 U.S.C. §§ 300aa-10 to -34 (2012), alleging that the influenza (“flu”)
vaccine administered to his son, J.M. on October 1, 2009, caused J.M. to have a second relapse
of his preexisting nephrotic syndrome. The Special Master denied compensation, finding that
petitioner failed to provide a persuasive scientific or medical theory proving that the flu vaccine
caused J.M.’s second relapse of minimal change nephrotic syndrome. Miles v. Sec’y of Health &
Human Servs., 2019 WL 3990987 (Fed. Cl. Spec. Mstr. June 28, 2018) (Miles). Petitioner now
moves for review of this decision. For the reasons that follow, the Court DENIES his motion.
1
An unredacted version of this opinion was issued under seal on December 20, 2018. The
parties were given an opportunity to propose redactions, but no such proposals were made.
I. BACKGROUND
A brief recitation of the facts provides necessary context.2
A. Pre-Vaccination Records
J.M. was born on February 23, 2001, and he has an extensive medical history. On April
19, 2001, when J.M. was two months old, his mother took him to Willow Bend Pediatrics to be
treated for head congestion, sneezing, and loss of appetite. On April 24, 2001, J.M. received his
first DTaP, Hib, hepatitis B, and IVP vaccines. On June 12, 2001, J.M. was diagnosed with
bronchiolitis3 by Dr. Michael J. Frank at Willow Bend Pediatrics. On July 2, 2001, J.M.
received his second DTaP, Hib, hepatitis B, and IVP vaccines. On February 9, 2002, J.M. was
diagnosed with bilateral otitis media4 and bronchitis5 by Dr. Frank at Willow Bend Pediatric. On
March 26, 2002, J.M. was treated for cough and congestion by Dr. Kimberly F. Mehendale at
Willow Bend Pediatrics, at which time he was diagnosed with an upper respiratory infection
(“URI”). On April 16, 2002, J.M. received his Varivax6 and Prevnar7 vaccinations. On May 24,
2002, J.M. received his third DTaP, Hib, hepatitis B, and IVP vaccines. When J.M. was two
years old, he was again diagnosed with a URI at Willow Bend Pediatrics. On December 24,
2004, when J.M. was three years old, he was treated by Dr. Mehendale at Willow Bend
Pediatrics for a yellow runny nose, green rhinorrhea,8 and congestion. On July 12, 2005, when
J.M. was four years old, Dr. Frank treated him at Willow Bend Pediatrics for a urinary tract
infection and a spastic bladder. On August 8, 2005, J.M. received a DTaP, IPV, MMR, and
second hepatitis A vaccine. On November 20, 2006, J.M. received the FluMist9 vaccine. None
of these illnesses or vaccines triggered his minimal change nephrotic syndrome.10
2
As the basic facts here have not changed significantly, the Court’s recitation of the
background facts here draws from the Special Master’s earlier opinion in Miles.
3
Bronchiolitis is defined as “inflammation of the bronchioles, usually occurring in
children less than 2 years old and resulting from a viral infection, particularly with respiratory
syncytial virus.” Dorland’s Illustrated Medical Dictionary 252 (32nd ed. 2012) (hereinafter
“Dorland’s”).
4
Otitis media is defined as “inflammation of the middle ear.” Dorland’s at 1351.
5
Bronchitis is defined as “inflammation of a bronchus or bronchi; there are both acute and
chronic varieties. Symptoms usually include fever, coughing, and expectoration.” Dorland’s at
252.
6
Varivax is the “trademark for a preparation of varicella virus vaccine live.” Dorland’s at
2025.
7
Prevnar is the “trademark for a preparation of pneumococcal 7-valent conjugate vaccine.”
Dorland’s at 1514.
8
Rhinorrhea is defined as “the free discharge of a thin nasal mucus.” Dorland’s at 1640.
9
FluMist is the “trademark for a preparation of influenza vaccine for intranasal
administration.” Dorland’s at 720.
10
Minimal change is defined as
-2-
On September 6, 2007, J.M. went to Children’s Medical Center in Dallas, Texas, where
his medical history indicates he had a new onset of edema,11 proteinuria,12 elevated creatinine,13
and hypoalbuminemia.14 The findings on J.M.’s renal ultrasound15 were consistent with those
seen in nephrotic syndrome, including large kidneys with increased echogenicity.16 J.M. had
acute renal injury with serum creatinine concentrations of 0.8 to 1.6 mg/dl (normal being 0.3 to
0.7 mg/dl). He was started on prednisone,17 which he continued to take until February 4, 2008.
On October 11, 2007, Dr. Mouin G. Seikaly, J.M.’s first pediatric nephrologist, noted J.M. had
new-onset nephrotic syndrome with proteinuria. On November 2, 2007, J.M. continued to show
signs of proteinuria, despite his regimen of 40 mg of prednisone every other day. Dr. Seikaly
was concerned that J.M. might relapse once his prednisone was reduced. Dr. Seikaly
subtle alterations in kidney function demonstrable by clinical albuminuria and the
presence of lipid droplets in cells of the proximal tubules; abnormalities of foot
processes of the glomerular epithelial cells are present but too subtle to be seen
with light microscopy. It is seen primarily in children under age 6 but sometimes
in adults with the nephrotic syndrome, and it may or may not progress to
glomerulosclerosis or glomerulonephritis.
Dorland’s at 539. Nephrotic syndrome is defined as the “general name for any of a large group
of diseases involving defective renal glomeruli, characterized by massive proteinuria and
lipiduria with varying degrees of edema, hypoalbuminemia, and hyperlipidemia.” Dorland’s at
1840.
11
Edema is defined as “the presence of abnormally large amounts of fluid in the
intercellular tissue spaces of the body, usually referring to subcutaneous tissues.” Dorland’s at
593.
12
Proteinuria is defined as “excessive serum proteins in the urine, such as in renal disease,
after strenuous exercise, and with dehydration.” Dorland’s at 1535.
13
Creatinine is defined as “the cyclic anhydride of creatine, produced as the final product of
decomposition of phosphocreatine. It is excreted in the urine; measurements of excretion rates
are used as diagnostic indicators of kidney function and muscle mass and can be used to simplify
other clinical assays.” Dorland’s at 429.
14
Hypoalbuminemia is defined as “an abnormally low albumin content of the blood.”
Dorland’s at 899.
15
Ultrasonography is defined as “the visualization of deep structures of the body by
recording the reflections of pulses of ultrasonic waves directed into the tissues.” Dorland’s at
1999.
16
Echogenicity is defined as “in ultrasound, the extent to which a structure gives rise to
reflections of ultrasound waves.” Dorland’s at 589.
17
Prednisone is “a synthetic glucocorticoid derived from cortisone, administered orally as
an anti-inflammatory and immunosuppressant in a wide variety of disorders.” Dorland’s at
1509.
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recommended starting J.M. on Tacrolimus18 and CellCept19 therapy, as he believed J.M. would
benefit from starting CellCept if he did not tolerate tapering of prednisone.
On December 19, 2007, J.M. was in remission and his steroid was slowly tapered. By
February 6, 2008, J.M. was in full remission and completely tapered off prednisone. On March
26, 2008, J.M. was still in remission and off prednisone, but he was taking Norvasc,20 5 mg twice
daily. Around that time, his Norvasc was reduced, and J.M. was started on Cozaar.21 On July
28, 2008, J.M. received his second Varivax vaccination. On November 19, 2008, J.M. received a
flu vaccine. Neither of these vaccines triggered a relapse of his nephrotic syndrome.
On June 15, 2009, Becky Nolde-Hurlbert, Dr. Seikaly’s nurse practitioner, noted that
J.M. had had proteinuria since June 10, 2009, swelling in his face and abdomen, and elevated
blood pressure. J.M. did not report any illness that could have triggered his first relapse of his
nephrotic syndrome. On June 22, 2009, J.M.’s parents reported to Willow Bend Pediatrics that
J.M. had a relapse of his nephrotic syndrome and was back on high-dose steroids. By June 29,
2009, J.M. was back in remission while taking another course of prednisone. J.M. was weaned
off prednisone by September 7, 2009.
B. Post-Vaccination Records
On October 1, 2009, J.M. received a flu vaccine. On October 9, 2009, J.M. saw Dr.
Seikaly, who noted J.M. had done well since his last visit in August 2009 until the past two
weeks when he had an increase in his urine protein and developed edema. According to the
timeline of J.M.’s medical records, the relapse must have occurred prior to his October 1, 2009
flu vaccination. J.M. reported vomiting several times on October 13, 2009. He was hungry but
unable to tolerate fluid or food. He did not have fever and had normal stools. On November 4,
2009, J.M.’s urine protein stayed mildly elevated. He was again prescribed prednisone and
weaned slowly. When J.M. was weaned to 10 mg of prednisone every 48 hours in December
2009, J.M. had his third relapse.
On February 24, 2010, RN Nolde-Hurlbert noted that “anything that affects the immune
system [] could be a contributing factor [to relapse],” but that “no cause and effect relationship
[between the flu vaccine and nephrotic syndrome relapse] has been directly documented in the
literature[;] there is only speculation.” J.M. had a fourth relapse in March of 2010 and his fifth
relapse in May of 2010.
18
Tacrolimus is defined as “a macrolide immunosuppressant of the calcineurin inhibitor
group derived from Streptomyces tsukubaensis and having actions similar to those of
cyclosporine.” Dorland’s at 1868.
19
CellCept is the “trademark for preparations of mycophenolate mofetil.” Dorland’s at
325.
20
Norvasc is the “trademark for a preparation of amlodipine besylate.” Dorland’s at 1291.
21
Cozaar is the “trademark for a preparation of losartan potassium.” Dorland’s at 427.
-4-
J.M. saw his second pediatric nephrologist, Dr. Albert Quan, on May 13, 2010. Shortly
thereafter, a renal biopsy was performed, which showed no evidence of focal segmental
glomerulosclerosis22 (“FSGS”). J.M. had one Globally sclerosed glomerulus23 out of 25
glomeruli. Ultrastructural studies showed thin glomerular basement membranes.
On January 28, 2011, Dr. Quan noted that J.M. had not had a relapse since his last office
visit, and J.M. was weaned off Prograf.24 Dr. Quan prescribed Prograf on June 25, 2011. Dr.
Quan also noted that J.M.’s October 2009 flu vaccination “may have triggered the onset of his
nephrotic relapse.” J.M.’s nephrotic syndrome relapsed by the end of July 2011, but he could not
resume prednisone because his nephrotic syndrome was no longer responsive to prednisone.
On August 18, 2011, J.M. had a cardiovascular attack25 (“CVA”), and he was admitted to
Medical City Dallas hospital. He suffered three strokes, which resulted in complete paralysis on
his left side. He also had a syncopal episode26 while he was hospitalized and was treated with
anti-epileptic medications. He received inpatient and rehabilitation services until September 23,
2011. Dr. Quan noted that J.M.’s CVA was secondary to his July 2011 nephrotic relapse.
In October 2011, J.M.’s hematologist noted that he had made a remarkable post-stroke
recovery, and recommended anticoagulation therapy27 for six months. At the same time, J.M.’s
neurologist noted that he could communicate verbally with normal speech and ambulate
22
Focal segmental glomerulosclerosis is defined as
the occurrence of focal sclerosing lesions of the renal glomeruli, marked by
proteinuria, hematuria, hypertension, and the nephrotic syndrome; it may be
idiopathic or secondary to another disease, such as heroin-abuse nephropathy,
chronic interstitial nephritis, or a malignancy. Exacerbations and remissions may
occur, most often in children; progression to renal failure occurs at a variable and
unpredictable rate.
Dorland’s at 787.
23
Glomerulus is defined as “a tuft or cluster, used in anatomic nomenclature as a general
term to designate such a structure, as one composed of blood vessels or nerve fibers.” Dorland’s
at 787. Sclerosis is defined as “an induration or hardening, such as hardening of a part from
inflammation, increased formation of connective tissue, or disease of the interstitial substance.”
Dorland’s at 1680.
24
Prograf is the “trademark for preparation of tacrolimus administered orally or
intravenously.” Dorland’s at 1523.
25
Cardiovascular is defined as “pertaining to the heart and blood vessels.” Dorland’s at
295.
26
Syncope is defined as “a temporary suspension of consciousness due to generalized
cerebral ischemia; called also faint.” Dorland’s at 1818.
27
Anticoagulation therapy is defined as “the prevention of coagulation.” Dorland’s at 103.
Coagulation is defined as the “formation of a clot.” Dorland’s at 376.
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independently, but that he had residual left-sided weakness and concerns about mental
processing speed. J.M. also had improving but residual left hemiparesis.28 J.M. continued on
anti-epileptics.
As of March 2012, J.M.’s neurologist recorded that J.M. was off steroids and continued
taking anti-epileptic medicine. Dr. Quan noted that J.M. was receiving Prograf, which would
help prevent future strokes. Based on a neuropsychological evaluation performed in June 2012,
J.M. continued to have cognitive deficits secondary to his CVAs.
On October 20, 2015, J.M. saw Dr. Kazi Majeed, a pediatric neurologist. J.M. had
residual spastic hemiparesis. J.M. had a right cerebral infarct29 in August 2011. Tiny infarcts
were also seen in his left hemisphere. Testing for hypercoagulability30 showed factor V Leiden
mutation.31
C. Procedural History
Petitioner filed his Petition on behalf of J.M. with the Office of Special Masters on April
18, 2012. See generally Petition. On June 30, 2012, petitioner filed the expert report of pediatric
nephrologist, Dr. Albert H. Quan.32 On June 18, 2013, respondent filed the medical report of
28
Hemiparesis is defined as “muscular weakness or partial paralysis affecting one side of
the body.” Dorland’s at 837.
29
Cerebral infarction is defined as “an ischemic condition of the brain, producing local
tissue death and usually a persistent focal neurological deficit in the area of the distribution of
one of the cerebral arteries.” Dorland’s at 934.
30
Hypercoagulability is defined as “the state of being more readily coagulated than
normal.” Dorland’s at 888.
31
Factor V is defined as
proaccelerin: a heat- and storage-labile material, present in plasma but not in
serum, functioning in both the intrinsic and extrinsic pathways of coagulation,
catalyzing the cleavage of prothrombin to the active thrombin. Deficiency of this
factor, an autosomal recessive trait, leads to a rare hemorrhagic tendency called
parahemophilia, with varying degrees of severity.
Dorland’s at 674.
32
Dr. Quan has been board-certified in pediatric nephrology since 1993. Pl.’s Ex. 7, at 1.
He is licensed to practice in Texas. He was an Associate Professor of Pediatrics at the University
of Texas Southwestern Medical Center from 1993–2006. At the time of the expert report
submission, he was the Medical Director of Pediatric Nephrology and Pediatric Renal
Transplantation at Medical City Children’s Hospital and the Medical Director of Pediatric
Dialysis at Home Kidney Care. He became J.M.’s treating nephrologist in May 2010. He
reviewed J.M.’s medical records and medical literature regarding nephrotic syndrome and
vaccinations.
-6-
pediatric nephrologist, Dr. Barnard S. Kaplan.33 Respondent filed the expert report of
immunologist, Dr. Arnold I. Levinson, on October 28, 2013.34 On June 3, 2014, petitioner filed
the expert report of immunologist, Dr. Joseph A. Bellanti.35 Dr. Kaplan submitted supplemental
expert reports on July 17, 2014 and September 21, 2015. On August 12, 2014, Dr. Levinson
submitted a supplemental expert report. Dr. Bellanti submitted a supplemental expert report on
October 10, 2014. Dr. Quan’s expert report was filed on January 2, 2015. An entitlement
hearing was held on October 17 and 18, 2017, and Special Master Millman denied petitioner’s
claim on June 28, 2018, finding that petitioner failed to provide a persuasive scientific or medical
theory proving that the flu vaccine caused J.M.’s second relapse of minimal change nephrotic
syndrome. Decision of the Special Master (hereinafter “Dec.”) at 62. Petitioner filed his Motion
for Review on July 30, 2018. See generally Motion for Review (hereinafter “MFR”).
Respondent filed its Response to petitioner’s Motion for Review on August 28, 2018. See
generally Response to Motion for Review (hereinafter “Resp. to MFR”). Petitioner’s Motion is
fully briefed and ripe for review.
33
Dr. Kaplan was the chief of Pediatric Nephrology at the Children’s Hospital of
Philadelphia (“CHOP”) until he resigned in 2010. Resp’t’s Ex. A. He continues to work in the
Division of Nephrology three days a week, seeing old and new patients. He is also Professor of
Pediatrics and Medicine at the University of Pennsylvania, Perelman School of Medicine. He is
board-certified in pediatrics and pediatric nephrology. He has been practicing pediatric
nephrology for 35 years. He has studied and published papers and chapters on nephrotic
syndrome and co-edited a textbook in which nephrotic syndrome and immunization of children
with renal disease is discussed extensively. He has taught these subjects to medical students,
interns, residents, and renal fellows at CHOP.
34
Dr. Levinson is board-certified in internal medicine and allergy and clinical immunology.
Resp’t’s Ex. D, at 1. He is Emeritus Professor of Medicine and Neurology at the University of
Pennsylvania, Perelman School of Medicine. Resp’t’s Ex. E, at 2. He used to be Chief of the
Allergy and Immunology Section, Director of the Fellowship Training Program in Allergy and
Immunology, and Director of the Center or Clinical Immunology. He currently serves as
Associate Dean for Research. He was author or co-author of 11 articles and 42 editorials,
chapters, and invited journal reviews.
35
Dr. Bellanti is Director of the International Center for Interdisciplinary Studies of
Immunology at Georgetown University School of Medicine and Professor of Pediatrics and
Microbiology-Immunology at the same institution. Pl.’s Ex. 23, at 1. He lists 269 articles dating
from 1961–2013, 200 abstracts dating from 1962–2008, and 59 books or chapters in books
dating from 1971–2012. Of his 269 articles, Dr. Bellanti was co-author on just four articles
having to do with the kidney; only one of those four concerned minimal change nephrotic
syndrome, and it was published in 1981. Of his 200 abstracts, only one concerned the kidney.
None of his books or chapters concerned the kidneys.
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II. STANDARD OF REVIEW
Under the Vaccine Act, this Court may review a special master’s decision upon the
timely request of either party. See 42 U.S.C. § 300aa-12(e)(1)–(2). In that instance, the Court
may:
“(A) uphold the findings of fact and conclusions of law. . . , (B) set aside any
findings of fact or conclusion of law. . . found to be arbitrary, capricious, an abuse
of discretion, or otherwise not in accordance with law. . . , or, (C) remand the
petition to the Special Master for further action in accordance with the court’s
direction.”
Id. at § 300aa-12(e)(2)(A)–(C). Findings of fact and discretionary rulings are reviewed under an
“arbitrary and capricious” standard, while legal conclusions are reviewed de novo. Munn v.
Sec’y of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992).
This Court cannot “substitute its judgment for that of the special master merely because it
might have reached a different conclusion.” Snyder ex rel. Snyder v. Sec’y of Dep’t of Health &
Human Servs., 88 Fed. Cl. 706, 718 (2009). “Reversal is appropriate only when the special
master’s decision is arbitrary, capricious, an abuse of discretion, or not in accordance with the
law.” Id. Under this standard, a special master’s decision “must articulate a rational connection
between the facts found and the choice made.” Cucuras v. Sec’y of Dep’t of Health & Human
Servs., 26 Cl. Ct. 537, 541–42 (1992), aff’d, 993 F.2d 1525 (Fed. Cir. 1993) (citing Burlington
Truck Lines, Inc. v. United States, 371 U.S. 156, 168 (1962)). This standard is “highly
deferential.” Hines v. Sec’y of Dep’t of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir.
1991). “If the special master has considered the relevant evidence of record, drawn plausible
inferences and articulated a rational basis for the decision, reversible error will be extremely
difficult to demonstrate.” Id.
III. DISCUSSION
Althen v. Secretary of Health & Human Services provides the evidentiary burden for
petitioners attempting to succeed in a vaccine petition based on causation. See generally Althen
v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005). In order to prove
causation-in-fact, a petitioner must
show by preponderant evidence that the vaccination brought about [petitioner’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.
Id. at 1278. In order to succeed, petitioners must provide a “reputable medical or scientific
explanation” for their claim. Id. Loving v. Secretary of Health and Human Services provides the
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“correct framework for evaluating off-table significant aggravation claims.” W.C. v. Sec’y of
Health and Human Servs., 704 F.3d 1352, 1357 (Fed. Cir. 2013) (citing Loving v. Sec’y of
Health and Human Servs., 86 Fed. Cl. 135, 144 (Fed. Cl. 2009)). The Loving test is comprised
of the following six parts:
(1) the person’s condition prior to administration of the vaccine, (2) the person’s
current condition (or the condition following the vaccination if that is also
pertinent), (3) whether the person’s current condition constitutes a “significant
aggravation” of the person’s condition prior to the vaccination, (4) a medical
theory causally connecting such a significantly worsened condition to the
vaccination, (5) a logical sequence of cause and effect showing that the
vaccination was the reason for the significant aggravation, and (6) a showing of a
proximate temporal relationship between the vaccination and the significant
aggravation.
Loving, 86 Fed. Cl. at 144.
Within this framework, petitioner makes five numbered objections to the June 28, 2018
decision. See MFR at 3–5. First, petitioner asserts that the Special Master rejected the
well-supported and generally-recognized theory that nephrotic syndrome is caused by an adverse
immune reaction, significantly raising petitioner’s burden of proof in violation of limitations set
by Althen. Id. at 3. Second, petitioner argues that the Special Master further rejected the
petitioner’s plausible theory of causation by adopting an idiopathic or unknown cause for the
injury in violation of 42 U.S.C. § 300aa-13(a)(2)(A). Id. at 3–4. Third, petitioner argues that the
Special Master rejected the well-accepted theory of causation based upon the credibility of the
treating physician which was arbitrary and capricious, as well as in violation of the instructions
in Andreu ex rel. Andreu v. Sec’y of Health and Human Servs. Id. at 4 (citing Andreu, 569 F.3d
1367, 1375 (Fed Cir. 2009)). Fourth, petitioner contends that the Special Master arbitrarily and
capriciously misconstrued petitioner’s claim to be that the vaccine injury took place on the first
through the second of October 2009, when petitioner actually claimed that the injury was the
exacerbation of the syndrome from steroid-sensitive to steroid-dependent following the vaccine,
an aggravation that was not discovered until December of 2009, well within the three-day to
eight-week period consistent with an immune reaction. Id. at 4. Finally, petitioner alleges that
the Special Master arbitrarily and capriciously ignored the testimony of all the experts in finding
that the vaccine did not cause J.M.’s strokes. Id. at 5.
A. Burden of Proof
In his Motion for Review, petitioner alleges that “by rejecting a well[-]accepted theory of
causation based upon inconclusive new research, the Special Master impermissibly increased the
petitioner’s burden of proof.” MFR at 34. In making this assertion, petitioner posits that he has
satisfied the three-prong test set forth in Althen, and is, therefore, “entitled to recover unless the
respondent shows, also by a preponderance of the evidence, that the injury was in fact caused by
factors unrelated to the vaccine.” Id. at 35 (quoting Knudsen v. Sec’y of Health and Human
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Servs., 35 F.3d 543, 547 (Fed. Cir. 1994)). Petitioner goes on to argue that “those factors cannot
include any idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor,
injury, illness, or condition.” Id. (citing 42 U.S.C. § 300aa-13(a)(2)(a)).
In her decision, Special Master Millman accurately articulates petitioner’s burden of
proof in vaccine compensation cases. A petitioner must provide a persuasive medical theory.
“A persuasive medical theory is demonstrated by ‘proof of a logical sequence of cause and effect
showing that the vaccination was the reason for the injury.’” Dec. at 57 (citing Althen, 418 F.3d
at 1278 (quoting Grant v. Sec’y of Health and Human Servs., 956 F.2d 1144, 1148 (Fed. Cir.
1992))). The Special Master then goes on to point out that “[w]ithout more, ‘evidence showing
an absence of other causes does not meet petitioner’s affirmative duty to show actual or legal
causation.’” Id. (citing Grant, 956 F.2d at 1149). Finally, a “[m]ere temporal association is not
sufficient to prove causation in fact.” Id. (citing Grant, 956 F.2d at 1148).
Petitioner clearly misapplies the law in his Motion for Review. Petitioner argues that
“[t]he respondent has not proven by a preponderance of any evidence that there is an alternate
cause of nephrotic syndrome or how an alternate cause, if discovered, can lead to the aggravation
of the nephrotic state.” MFR at 37. Petitioner alone bears the burden of proving his theory of
causation. “[T]he statutory standard of preponderance of the evidence requires a petitioner to
demonstrate that the vaccine more likely than not caused the condition alleged.” LaLonde v.
Sec’y of Health and Human Servs., 746 F.3d 1334, 1339 (Fed. Cir. 2014). If the petitioner is
unsuccessful in meeting this burden, that burden does not then shift to the respondent to prove an
alternative persuasive medical theory for the petitioner’s injury. Bradley v. Sec’y of Health and
Human Servs., 991 F.2d 1507, 1575 (Fed. Cir. 1993); see also Doe 11 v. Sec’y of Health and
Human Servs., 601 F.3d 1349, 1358 (Fed. Cir. 2010); Deribeaux v. Sec’y of Health and Human
Servs., 105 Fed. Cl. 583, 587 (2012), aff’d, 717 F.3d 1363 (Fed. Cir. 2013). Respondent need
only “offer evidence to demonstrate the inadequacy of the petitioner’s evidence on a requisite
element of the petitioner’s case in chief.” De Bazan v. Sec’y of Health and Human Servs., 593
F.3d 1347, 1353 (Fed. Cir. 2008).
Petitioner undercuts his argument by pointing out that his theory of causation is not well
documented among medical literature and remains unproven. MFR at 36. Undeterred, petitioner
then attempts to shift the burden of proof to respondent by stating that “[t]he respondent has not
proven by a preponderance of any evidence that there is an alternate cause of nephrotic
syndrome or how an alternate cause, if discovered, can lead to the aggravation of the nephrotic
state.” Id. at 37. Here, it is again important to note that “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. As the burden rests solely on the petitioner to prove his medical theory, and as the
Special Master reasonably determined that petitioner did not meet that burden, the Court finds
that petitioner’s burden was not unreasonably elevated.
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B. Theory of Causation
Petitioner’s second numbered objection alleges that the Special Master rejected the
petitioner’s plausible theory of causation by adopting an idiopathic or unknown cause for the
injury in violation of 42 U.S.C. § 300aa-13(a)(2)(A). MFR at 3–4. In making this assertion,
petitioner once again misapplies the law. Althen requires that petitioners must provide a
“reputable medical or scientific explanation” for their claim.” Althen, 418 F.3d at 1278. “The
determination of whether a proffered theory of causation is ‘reputable’ may ‘involve an
assessment of the relevant scientific data.’” Hazlehurst ex rel. Hazlehurst v. Sec’y of Health &
Human Servs., 88 Fed. Cl. 473, 479 (2009) (quoting Andreu, 569 F.3d at 1379). The Special
Master clearly engaged in such an analysis.
In her decision, Special Master Millman narrows down petitioner’s case to the following
two main issues:
(1) is minimal change nephrotic syndrome an immune-mediated illness as the
medical profession once believed or is it a podoctyopathy as the medical
profession currently believes; and (2) do prior flu vaccinations create an
anamnestic response so that a flu vaccination can cause a relapse of minimal
change nephrotic syndrome within one day without any systemic symptoms such
as fever, malaise, lethargy, arthralgia, etc.
Dec. at 58. After careful review of the record, Special Master Millman determined that “minimal
change nephrotic syndrome is not immune-mediated, contrary to [petitioner’s expert,] Dr.
Bellanti’s[,] entire presentation.” Id. She goes on to point out that:
Once the medical theory that flu vaccine caused an innate immune reaction
followed by an adaptive immune response becomes irrelevant to the current
understanding of minimal change nephrotic syndrome, the linchpin of petitioner’s
allegations disappears and we are left with no persuasive medical theory linking
the 2009 flu vaccination to J.M.’s second relapse of minimal change nephrotic
syndrome, subsequent relapses, and three cerebral arterial strokes.
Id. at 58–59. Having deemed the petitioner’s medical theory unpersuasive, the Special Master
need go no further. The Special Master determined that “Greenbaum’s article supports Dr.
Kaplan’s thesis that viewing minimal change nephrotic syndrome as immune-mediated is no
longer the current medical view.” Id. at 61. It seems clear to the Court that Special Master
Millman determined that the flu vaccine was not the cause of J.M.’s nephrotic syndrome relapse
because the petitioner’s theory of causation was unpersuasive and insufficient.
In his second numbered objection, petitioner clearly misconstrues the law. Section
300aa-13(a)(1)(B) of United States Code Title 42 requires that the petitioner has demonstrated
by a preponderance of the evidence that it has met the requirements of 42 U.S.C. §
300aa-11(c)(1). Only once the petitioner has met that burden, does the Special Master need to
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analyze whether “there is not a preponderance of the evidence that the illness, disability, injury,
condition, or death described in the petition is due to factors unrelated to the administration of
the vaccine described in the petition.” Id. Section 300aa-13(a)(2)(a) of United States Code Title
42 requires that those “factors unrelated to the administration of the vaccine” not include any
“idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor, injury,
illness, or condition.” Id. However, those rules, when read together, clearly place the burden on
the petitioner to establish his case, before the respondent is required to refute it. Once the
Special Master determines that petitioner fails to meet the standard set forth in 42 U.S.C. §
300aa-11(c)(1), the analysis need go no further. Respondent is not required to disprove a theory
of causation that the Special Master has already determined to be insufficient. Therefore, the
Special Master did not err in finding that petitioner failed to demonstrate his theory of causation
by a preponderance of the evidence.
C. Expert Credibility
In his third numbered objection, petitioner argues that the Special Master was arbitrary
and capricious in finding that Dr. Quan was less credible than respondent’s expert, thereby
rejecting a well-founded theory of causation in favor of new research. MFR at 39. In making
this argument, petitioner contends that “[r]ejection of a generally accepted theory of causation
based upon credibility raises the petitioners burden of proof and is an error of law,” which,
petitioner believes violates the standard set forth in Andreu. MFR at 42.
In her decision, Special Master Millman acknowledged the following:
The Federal Circuit in Capizzano v. Secretary of Health and Human Services, 440
F.3d 1317, 1326 (Fed. Cir. 2006), emphasized that the special masters are to
evaluate seriously the opinions of petitioner’s treating doctors since “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.”
Dec. at 59 (citing Capizzano, 440 F.3d at 1326; Broekelschen v. Sec’y of Health and Human
Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010); Andreu, 569 F.3d at 1375). She then goes on to
state that “[t]he undersigned considers seriously the opinion of Dr. Quan, J.M.’s second pediatric
nephrologist.” Id.
In its response, respondent correctly points out that “‘there is nothing in Andreu that
mandates that the testimony of a treating physician is sacrosanct—that it must be accepted in its
entirety and cannot be rebutted.’” Respondent’s Response to Petitioner’s Motion for Review
(hereinafter “Resp.”) at 16 (citing Snyder, 88 Fed. Cl. at 745 n.67; 42 U.S.C. § 300aa-13(b)(1)
(statements of treating physicians are not binding on special masters)). Respondent goes on to
argue that “[a] treating physician’s opinion on vaccine causation is only as strong as its
underlying basis.” Id. (citing Perreira v. Sec’y of Health and Human Servs., 33 F.3d 1375, 1377
n.6 (Fed. Cir. 1994); See also Dobrydnev v. Sec’y of Health and Human Servs., 566 Fed. Appx.
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976, 982–983 (Fed. Cir. 2014) (holding that the Special Master was correct in noting that “when
an expert assumes facts that are not supported by preponderance of the evidence, a finder of fact
may properly reject the expert’s opinion”).
Special Master Millman repeatedly cited to both the expert reports and testimony of Dr.
Quan, but ultimately determined that petitioner’s theory of relapse was inadequate. The Special
Master found that “[Dr. Quan] succinctly described the problem with understanding minimal
change nephrotic syndrome in his expert report.” Dec. at 59. She further found that “Dr. Quan
also made some other important admissions,” including that “it was impossible to say if a flu
shot would make a relapse already in progress worse,” and that “one does not really know if
there is a natural course of minimal change nephrotic syndrome.” Id. at 61 (citing Transcript of
Proceedings (hereinafter “Tr.”) at 66, 225). Ultimately, Special Master Millman found that these
admissions, as well as respondent’s evidence disputing the petitioner’s theory of causation,
tipped the scale firmly in respondent’s direction.
Petitioner may not like the outcome of Special Master Millman’s analysis, but “it is
important to recognize that Special Masters may use their discretion in weighing expert
testimony.” Cunningham v. Sec’y of Health and Human Servs., 2017 WL 1174448 at 5(Fed. Cl.
Jan. 25, 2017). “‘[R]eversible error will be extremely difficult to demonstrate’ where the special
master ‘has considered the relevant evidence of record, drawn plausible inferences and
articulated a rational basis for the decision.’” Porter, 663 F.3d at 1253–54 (quoting Hines, 940
F.2d at 1528); see also Lombardi v. Sec’y of Health & Human Servs., 656 F.3d at 1343, 1353
(Fed. Cir. 2010). The Court does not believe the Special Master’s decision runs afoul of this
deferential standard, and, as such, her findings as to Dr. Quan’s expert opinions are neither
arbitrary nor capricious.
D. Althen and Loving Standards
In his fourth numbered objection, petitioner argues that the Special Master was arbitrary
and capricious in finding that the onset of J.M.’s nephrotic syndrome relapse occurred too soon
after administration of the flu vaccine. MFR at 4. In order to prevail under both Althen and
Loving¸ petitioner must show by a preponderance of the evidence a proximate temporal
relationship between vaccination and injury or significant aggravation. Althen, 418 F.3d at 1278;
see also Loving, 86 Fed. Cl. at 144. The Court does not believe that the Special Master erred in
determining that petitioner has not met the requisite burden.
Medical literature seems to support the Special Master’s findings that vaccination could
not trigger a relapse that began less that twenty-four hours after administration of the vaccine.
The Special Master cites to a number of case studies with a causal connection between vaccine
administration and nephrotic syndrome, but those case studies document relapses occurring, five
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days,36 eight days,37 three weeks,38 and four weeks39 after vaccination. Moreover, Special
Master Millman points to the relationship between nephrotic syndrome and proteinuria and
edema. For example, the Special Master highlights the Fluss article, which posits that “nephrotic
syndrome is a common renal disorder in children characterized by severe proteinuria,
hypoalbuminemia, and edema.” Dec. at 23 (citing Pl.’s Ex. 2740). She also notes the testimony
of Dr. Bellanti, who stated that “[n]ephrotic syndrome refers to a group of kidney disorders
involving loss of protein through the kidneys, called proteinuria, leading to low protein levels in
the blood, predominantly called hypoalbuminemia, causing water to be drawn into soft tissues,
called edema.” Id. at 42 (citing Tr. at 154). J.M. had a five-pound weight gain between
September 30, 2009 and October 1, 2009, and he had three plus proteins in his urine on October
2, 2009.
In determining whether a special master’s finding of fact is arbitrary and capricious, this
Court must look to plausibility, not to whether it is supported by a preponderance of the
evidence. As long as the finding of fact is “based on evidence in the record that [is] not wholly
implausible, [this Court is] compelled to uphold the finding as not being arbitrary or capricious.”
Porter v. Sec’y of Health & Human Servs., 663F.3d 1242, 1249 (Fed. Cir. 2012) (quoting Cedillo
v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010)). Ultimately, Special
Master Millman determined the following:
J.M.’s second relapse of minimal change nephrotic syndrome either began before
he received his flu vaccination on October 1, 2009, simultaneously with the
vaccination, or within 16 hours of the vaccination when petitioner measured the
protein in J.M.’s urine on October 2, 2009 and it was plus 3, meaning proteinuria.
Any of those three onsets is problematic for petitioner prevailing in this case.
36
B.D. Humphreys, et al., Minimal-change nephrotic syndrome in a hematopoietic stem-
cell transplant recipient, 2 NATURE CLIN PRACTICE NEPHROL 9:535-39 (2006).
37
I. Islek, et al., Nephrotic syndrome following hepatitis B vaccination, 14 PEDIATR
NEPHROL 89–90 (2004); describing a four-year-old boy whose eyelids swelled eight days after
his third hepatitis B vaccination.
38
C-D Kao, et al., Guillain-Barré syndrome coexisting with pericarditis or nephrotic
syndrome after influenza vaccination, 106 CLIN NEUROL NEUROSURG 136–38 (2004);
describing the three-week onset of nephrotic syndrome after flu vaccination as creating suspicion
of a causal relationship.
39
C. Clajus, et al., Minimal change nephrotic syndrome in an 82 year old patient following
a tetanus-diphtheria-poliomyelitis-vaccination, 10 BMC NEPHROL 21–25 (2009); describing
an 82-year-old woman with edema occurring four weeks after the TD/Polio vaccine, typical for
nephrotic syndrome.
40
J. Fluss, et al., Cerebral sinovenous thrombosis and idiopathic nephrotic syndrome in
childhood: report of four new cases and review of the literature, 165 EUR J PEDIATR 709–16
(2006).
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Dec. at 60. It seems wholly plausible to this Court that the weight gain, which signaled edema,
and the proteinuria began prior to and unrelated to the vaccination. As such, the Court must
uphold Special Master Millman’s findings as neither arbitrary nor capricious.
E. Expert Testimony
In his final numbered objection, petitioner argues that the Special Master arbitrarily and
capriciously ignored the testimony of all the experts in finding that the vaccine did not cause
J.M.’s strokes. MFR at 5. In making this assertion, petitioner points to “Dr. Quan’s conclusion
that J.M.’s strokes were caused by thrombosis resulting from his prolonged poorly controlled
nephrotic state.” Id. at 47. That conclusion alone is not enough to link J.M.’s second relapse of
minimal change nephrotic syndrome to the flu vaccine.
Petitioner’s argument is a bit of a misnomer. He asks the Court to determine that the
Special Master erred in not finding that J.M.’s strokes were a direct result of his October 2009
flu vaccine, despite the fact that none of the experts ever attempted to find such a direct causal
link. In his testimony, Dr. Quan testified that he believed that “flu vaccine led to J.M.’s new
onset of his latest relapse that finally led to his stroke.” Tr. at 64. Yet, petitioner’s argument
omits the important intermediate step between the vaccine and the strokes—nephrotic syndrome.
Special Master Millman noted Dr. Quan’s testimony that “[a] poorly controlled nephrotic
syndrome has a higher risk of stroke or any other type of clotting complication.” Dec. at 37
(citing Tr. at 64). She also highlights the testimony of Dr. Kaplan, who could not “ascribe J.M.’s
strokes to the flu vaccine or to his nephrotic syndrome.” Dec. at 52 (citing Tr. at 370).
Ultimately, Special Master Millman found that “the issue of J.M.’s strokes is an enigma that
neither Dr. Quan nor Dr. Kaplan could explain in terms of sequelae.” Id. at 59.
Even if the Special Master had accepted Dr. Quan’s testimony and found that J.M.’s
nephrotic syndrome caused his strokes, petitioner’s theory still fails. The important causal link
remains absent. Special Master Millman determined that “petitioner has failed to provide a
persuasive scientific or medical theory proving that flu vaccine caused J.M.’s second relapse of
minimal change nephrotic syndrome.” Dec. at 62. Having arrived at that conclusion, it logically
follows that the strokes resulting from the nephrotic syndrome relapse cannot be causally linked
to that same vaccination. As such, Special Master Millman did not err in her determination that
flu vaccine did not cause J.M.’s strokes.
III. CONCLUSION
The Court finds that petitioner has not met his burden of proof in alleging that his
October 2009 influenza vaccine resulted in J.M.’s nephrotic syndrome relapse or significantly
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worsened his nephrotic syndrome. For the foregoing reasons, the Court DENIES petitioner’s
Motion for Review.41
IT IS SO ORDERED.
s/ Loren A. Smith
Loren A. Smith,
Senior Judge
41
This opinion shall be unsealed, as issued, after January 3, 2019 unless the parties,
pursuant to Vaccine Rule 18(b), identify protected and/or privileged materials subject to
redaction prior to that date. Said materials shall be identified with specificity, both in terms of
the language to be redacted and the reasons therefor.
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