Rus v. Secretary of Health and Human Services , 2016 U.S. Claims LEXIS 1957 ( 2016 )

In the United States Court of Federal Claims
No 12-631V
Filed Under Seal: December 8, 2016
Reissued for Publication: January 2, 2017*
)
GRZEGORZ RUS and AGNIESZKA )
RUS, as Parents and Natural Guardians of )
A.R., a minor, )
) National Childhood Vaccine Injury Act
Petitioners, ) (“Vaccine Act”), 42 U.S.C. § 300aa–1 to
) –34 (2012).
v. )
)
SECRETARY OF HEALTH AND )
HUMAN SERVICES, )
)
Respondent. )
)
Kate Gerayne Westad, Larkin Hoffman Daly & Lindgren Ltd., Minneapolis, MN, for
petitioners.
Amy Kokot, Trial Attorney, Heather L. Pearlman, Assistant Director, Catharine E.
Reeves, Acting Deputy Director, C. Salvatore D’Alessio, Acting Director, and Benjamin C.
Mizer, Principal Deputy Assistant Attorney General, Torts Branch, Civil Division, United States
Department of Justice, Washington, DC, for respondent.
MEMORANDUM OPINION AND ORDER
GRIGGSBY, Judge
I. INTRODUCTION
Petitioners, Grzegorz and Agnieszka Rus, parents of A.R., a minor child, seek review of
the June 23, 2016, decision of the special master denying their claim for compensation under the
National Childhood Vaccine Injury Act (“Vaccine Act”), 42 U.S.C. § 300aa–1 to –34 (2012).
*
This Memorandum Opinion and Order was originally filed under seal on December 8, 2016 (docket
entry no. 90). The parties were given an opportunity to advise the Court of their views with respect to
what information, if any, should be redacted. The parties filed a joint status report on December 30,
2016, notifying the Court that they do not believe any information should be redacted (docket entry no.
92). And so, the Court is reissuing its Memorandum Opinion and Order dated December 8, 2016 without
redactions.
Petitioners allege that their minor child suffers from nephrotic syndrome, resulting from a
hepatitis A vaccination that she received on October 30, 2009. For the reasons set forth below,
the Court DENIES petitioners’ motion for review and SUSTAINS the decision of the special
master.
II. FACTUAL AND PROCEDURAL BACKGROUND1
A. Factual Background
1. A.R.’s Medical History
The medical history of petitioners’ daughter, A.R., is discussed in detail in the special
master’s June 23, 2016, decision (“Special Master’s Decision”) and can be briefly summarized
here. Rus v. Sec’y of Health & Human Servs., No. 12-631V, 2016 WL 4013709 (Fed. Cl. Spec.
Mstr. June 23, 2016). A.R. was born on August 31, 2006. Dec. at *2; Pet. Ex. 1 at 1. A.R. has
no family history of kidney or renal disease, or nephrotic syndrome. Dec. at *1; TR at 12.
Today, A.R. has nephrotic syndrome, defined by symptoms such as protein in the urine, low
blood protein levels, edema (swelling) and high cholesterol. TR at 46; Resp. Brief at n.2.
On October 30, 2009, A.R. visited her pediatrician for her 3-year well-child visit, where
she was noted to be a healthy child that was developing normally. Dec. at *1; TR at 30-32.
During this visit, A.R. received her first hepatitis A vaccination. Dec. at *1; TR at 32; Pet. Ex. 2
at 1.
On October 31, 2009, A.R. was taken to the hospital due to fever and a febrile seizure.
Dec. at *2; TR at 33-34, 40; Pet. Ex. 3 at 46. A.R.’s hospital records show that A.R. had a body
temperature of 104.1 F at the time, and that A.R. did not present with edema. Pet. Ex. 3 at 46;
TR at 39. The attending physician’s notes in A.R.’s hospital record for this visit state that “I
1
The facts recounted in this Memorandum Opinion and Order are taken from the special master’s April
25, 2016, decision in Rus v. Sec’y of Health & Human Servs., No. 12-631V, 2016 WL 4013709 (Fed. Cl.
Spec. Mstr. June 23, 2016) (“Dec.”); the transcript of the entitlement hearing before the special master
held on September 17, 2015 (“Tr.”); petitioners’ exhibits filed before the Office of Special Master (“Pet.
Ex.”); petitioners’ motion for review (“Pet. Mot.”); and respondent’s response to petitioners’ motion for
review (“Resp. Brief”). Except where otherwise noted, the facts recited herein are undisputed.
2
suspect that the child had a febrile seizure tonight, which was brought on by the fever, which is
likely secondary to her being vaccinated 2 days ago.” Pet. Ex. 3 at 46; see also Dec. at *2.
Laboratory results from tests done on November 1, 2009, show that A.R.’s albumin–a
blood protein that when low, indicates malnutrition, liver problems, or that the patient is spilling
protein into the urine–was normal. Dec. at *2; TR at 37-38; Pet. Ex. 12 at 3. In addition, these
tests show that A.R.’s total blood protein was slightly decreased, and her urine protein was
elevated. Dec. at *2; TR at 36; Pet. Ex. 12 at 3.
After being discharged from the hospital, A.R. visited her pediatrician on November 1,
2009. Dec. at *2. During this visit, A.R.’s pediatrician noted that A.R. had a wet cough and an
upper respiratory infection. Id. On November 4, 2009, A.R. visited her pediatrician again. Id.;
TR at 42. During this subsequent visit, A.R.’s pediatrician observed that A.R. had facial
swelling. Dec. at *2. During this visit, A.R.’s pediatrician performed laboratory tests which
showed decreased albumin, decreased total blood protein, marked proteinuria2, high triglycerides
and high cholesterol. Id.; Pet. Ex. 3 at 79. It is undisputed in this matter that A.R. suffered from
diagnosable nephrotic syndrome at the time of her November 4, 2009, visit to the pediatrician.
Dec. at *8; Pet. Mot. at 10-11; TR at 47-50.
A.R. subsequently visited her pediatrician on November 5, 2009, and November 9, 2009.
Dec. at *2. During these visits, the pediatrician observed that A.R.’s facial swelling had
decreased and that she seemed to be recovering. Id. On November 11, 2009, A.R. visited a
nephrologist, Dr. Jeff Stein. TR at 171.
In January 2010, A.R.’s nephrotic syndrome went into remission. Pet. Ex. 4 at 8.
However, A.R. has experienced at least two relapses of these symptoms since that time. Dec. at
*2.
2
Proteinuria is the “[p]resence of urinary protein in amounts exceeding 0.3 g in a 24-hour urine collection
or in concentrations more than 1 g per liter in a random urine collection on two or more occasions at least
6 hours apart.” Stedman’s Medical Dictionary 730680 (updated Nov. 2014).
3
2. Nephrotic Syndrome
Nephrotic syndrome is a kidney disorder that causes, among other things, the body to
excrete too much protein into the urine. TR at 46. Nephrotic syndrome commonly involves
symptoms such as protein in the urine, low blood protein levels, edema and high cholesterol. TR
at 46; Resp. Ex. A at 2, 6.
When a person suffers from nephrotic syndrome, a breakdown in the kidney’s ability to
keep proteins in the blood and out of the urine occurs. TR at 76-78. In this regard, the
glomerular basement membrane (“GBM”) in the kidneys is responsible for keeping blood out of
the urine. Id. at 72, 76. The GBM is comprised of several different types of cells, including
podocytes and foot processes. Id. at 76–77.
3. The Entitlement Hearing
On September 25, 2012, petitioners filed a petition for vaccine compensation on behalf of
A.R. under the Vaccine Act. Dec. at *1; see generally Pet. Petition. The special master
convened an entitlement hearing on petitioners’ claim for compensation under the Vaccine Act
on September 17, 2015. Dec. at *1; see generally TR.
During the entitlement hearing, Agnieszka Rus and petitioners’ medical expert, Dr. Jan T.
Kielstein, testified on behalf of the petitioners. See generally TR. The government’s medical
expert, Dr. Bernard S. Kaplan, testified on behalf of the respondent. Id.
Ms. Rus testified that A.R. was a healthy, lively child prior to October 30, 2009. Id. at 9.
Ms. Rus further testified that A.R. did not have a family history of nephrotic syndrome. Id. at
12.
Dr. Kielstein is currently an Associate Professor of Medicine at the Department of
Internal Medicine in the Division of Nephrology and Hypertension at the Medical School in
Hannover, Germany. Pet. Ex. 13 at 1. During the entitlement hearing, Dr. Kielstein opined that
the hepatitis A vaccination caused A.R.’s nephrotic syndrome. TR at 86-87. Dr. Kielstein also
put forward two medical theories to support this opinion: (1) a specific T-cell response (the “T-
cell medical theory”) and (2) an inflammatory cykotine response to the vaccination that alters a
unspecific pathway involving angiopoietin-like 4 (“ANGPTL4 medical theory”). Id. at 72-86.
 With respect to the T-cell medical theory, Dr. Kielstein testified that all vaccinations are
intended to cause an adaptive immune response, and this response occurs primarily in the T-cells
in the case of the hepatitis A vaccine. TR at 115; Dec. at *10. And so, he theorized that
nephrotic syndrome could be caused by a T-cell response to the vaccination, whereby T-cell
dysfunction results in the production of a circulating glomerular permeability factor. Pet. Ex. 12
at 5. Dr. Kielstein also theorized that the circulating glomerular permeability factor could
“directly induce[ ] foot process fusion resulting in severe alteration of the glomerular filter
system and resulting in marked proteinuria.” Id.; see also TR at 86.
With respect to the timing associated with the T-cell medical theory, Dr. Kielstein also
testified that “we need more than a day or two for a T-cell response, and so the lowest time span
we are talking about here is about four days.” TR at 75. He acknowledged, however, that A.R.’s
nephrotic syndrome symptoms began 36-40 hours after vaccine. Id. at 49, 73-75, 107, 116.
With respect to the ANGPTL4 medical theory, Dr. Kielstein testified that ANGPTL4 is
analogous to barbed wire that covers a fence–in this case, the GBM–to help keep proteins out of
the urine. Id. at 77. Dr. Kielstein theorized that any vaccination could cause an inflammatory
response in the body that alters the production of ANGPTL4. Id. at 80-84. Specifically, Dr.
Kielstein testified that such inflammatory response may cause overproduction of a form of
ANGPTL4 lacking sialic acid residues would cause binding of ANGPTL4 to the glomerular
basement membrane, thereby inducing the development of nephrotic-range proteinuria. TR at
81-92; see also Dec. at *9; Pet. Mot. at 13-14.
In addition, to support his theory that vaccinations set off an inflammatory response that
may cause nephrotic syndrome, Dr. Kielstein offered anecdotal case reports and medical studies
finding that the meningococcal and hepatitis B vaccinations may cause relapses in cases of
established nephrotic syndrome. Pet. Ex. 15, 25. He also put forward case reports showing that
certain vaccinations, other than the hepatitis A vaccine, may cause other diseases or syndromes,
one case report demonstrating that nephrotic syndrome occurred after a hepatitis B vaccination, a
case report demonstrating that the hepatitis A vaccine allegedly caused autoimmune hepatitis and
A.R.’s medical history from October 30, 2009, onward. Pet. Ex. 12, 16-20, 22-24, 26-27. Dr.
Kielstein acknowledged, however, that he was not aware of any cases demonstrating that the
hepatitis A vaccination caused nephrotic syndrome. TR at 118.
5
Dr. Kielstein also relied upon two 2014 medical studies−Lionel C. Clement et al.,
Circulating Angiopoietin–Like 4 Links Proteinuria With Hypertriglyceridemia in Nephrotic
Syndrome, 20 Nature Medicine 37 (2014) and Sumant S. Chugh, et al., Angiopoietin–Like 4
Based Therapeutics for Proteinuria and Kidney Disease, 5 Frontiers in Pharmacology 23/1
(2014)−to support the ANGPTL4 medical theory. Dec. at *10; Pet. Ex. 34, 35. The Clement
study demonstrates that the manipulation of a certain type of ANGPTL4 is an important mediator
of nephrotic syndrome and a critical link between proteinuria and hypertriglyceridemia. Pet. Ex.
34. The Chugh study demonstrates that the manipulation of a certain type of ANGPTL4 may
improve proteinuria. Pet. Ex. 35.
The government’s medical expert, Dr. Bernard Kaplan, testified that he did not find any
evidence in the record that the hepatitis A vaccination that A.R. received on October 30, 2009,
contributed to her nephrotic syndrome.4 TR at 131. In this regard, Dr. Kaplan testified that there
is no medical literature showing that the hepatitis A vaccine precipitates nephrotic syndrome. Id.
at 132. He also offered an opinion about the medical literature relied upon by the petitioners to
support their T-Cell and ANGPTL4 medical theories. Dr. Kaplan also testified that there is no
medical literature showing that vaccines affect ANGPTL4 production. Id. at 143-44. Dr. Kaplan
further testified that there are “gaping holes” in the T-cell medical theory. Id. at 146-47; Resp.
Ex. C at 2.
Dr. Kaplan also opined that, if nephrotic syndrome was caused by an inflammatory
response to any vaccination as the petitioners suggests, diagnoses of nephrotic syndrome should
have risen over the past 50 years, as vaccinations have increased during this time period. TR at
149-50. He noted, however, that diagnoses of nephrotic syndrome have remained “absolutely
constant.” Id. at 132. And so, Dr. Kaplan concluded that the case reports and medical literature
cited by Dr. Kielstein do not demonstrate that the hepatitis A vaccination is linked to the new-
onset nephrotic syndrome. Id. at 160-61.
3
Dr. Kaplan is a pediatric nephrologist in the Division of Nephrology in the Children’s Hospital of
Philadelphia. Resp. Ex. B at 2.
6
4. The Special Master’s Decision
On June 23, 2016, the special master issued a decision denying petitioners’ claim for
compensation under the Vaccine Act. See generally Dec. In the decision, the special master
determined that petitioners had failed to prove by preponderant evidence that the hepatitis A
vaccination caused A.R.’s nephrotic syndrome under Althen Prong I. Id. at *1; see Althen v.
Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
As an initial matter, the special master addressed the legal standard petitioners are
required to meet to receive compensation under the Vaccine Program. Dec. at *3. Specifically
relevant here, the special master determined that petitioners were required to prove each Althen
prong by preponderant evidence, including Althen Prong I which requires petitioners to provide
“a medical theory causally connecting the vaccination and the injury.” Id. (citing Althen, 418
F.3d at 1278). The special master also determined that, in presenting a theory causally
connecting the vaccination and the injury, “a claimant need not produce medical literature or
epidemiological evidence to establish causation under the Vaccine Act. . . .” Id. at *4. But, the
special master determined that petitioners’ causation theory must be supported by a “‘sound and
reliable’ medical or scientific explanation.” Id. at *7 (quoting Knudsen ex rel. Knudsen v. Sec’y
of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994)).
Applying the aforementioned standard, the special master determined that the petitioners
had met their burden of proof with respect to Althen Prongs II and III, but that the petitioners
failed to meet their burden with respect to Althen Prong I. Id. at *9, 12. In reaching this
conclusion, the special master found that:
In determining whether petitioner is entitled to compensation, a special master must
consider the entire record and is not bound by any particular piece of evidence.
§ 13(b)(1) (stating a special master is not bound by any “diagnosis, conclusion,
judgment, test result, report, or summary” contained in the record). Thus a special
master must weigh and evaluate opposing expert opinions, medical and scientific
evidence, and the evidentiary record in deciding whether petitioners have met their
burden of proof.
Id. at *4.
To determine whether petitioners had met their burden with respect to Althen Prong I, the
special master reviewed petitioners’ two medical causation theories, the T-cell medical theory
7
and the ANGPTL4 medical theory. The special master characterized petitioners’ T-cell medical
theory as proposing that nephrotic syndrome:
[C]ould be caused by a “specific” T-cell response to vaccination where systemic T-
cell dysfunction results in the production of a circulating glomerular permeability
factor, which directly induces podocyte foot process fusion. . . . The foot process
fusion would severely alter the glomerular filter system, resulting in proteinuria.
Id. at *5. To that end, the special master also found that the timing of the T-cell medical theory
put forward by Dr. Kielstein did not comport with the progression of A.R.’s symptoms. Id. at
*8.
In this regard, the special master noted that Dr. Kielstein testified that a T-cell response to
a vaccination would take about four days. Id. (citing TR at 75). But, the special master also
noted that Dr. Kielstein testified that the likely onset of A.R.’s nephrotic syndrome occurred
within 36 to 40 hours of the vaccination. Id. at *12 (citing TR at 73-75).
The special master also considered the petitioners’ ANGPTL4 medical theory, and he
noted that Dr. Kielstein offered anecdotal case reports, medical studies finding that the
meningococcal and hepatitis B vaccinations may cause relapses in cases of established nephrotic
syndrome, case reports showing that certain vaccinations other than hepatitis A may cause other
diseases or syndromes, one case report demonstrating that the hepatitis A vaccine allegedly
caused autoimmune hepatitis, and A.R.’s own medical progression from October 30, 2009
onward, to support this theory. Dec. at *6, 11. The special master also noted that, during the
entitlement hearing, Dr. Kielstein admitted he was not aware of any cases demonstrating that the
hepatitis A vaccination caused nephrotic syndrome. Id. at *6; TR at 118.
With respect to the Clement medical study that the petitioners put forward to support
their ANGPTL4 medical theory, the special master determined that “the Clement study appeared
to demonstrate that enhancement of ANGPTL4 reduced existing proteinuria, but did not address
how the ANGPTL4 may have been altered in the podocytes in the first place, leading to the onset
of the disease.” Dec. at *12 (citing Pet. Ex. 34).
The special master also determined that “[w]hile innate or inflammatory disruption of the
angiopoietin-like 4 pathway may, at some point, prove to be a viable theory, at the present time it
appears to be a bridge too far, too vague and too uncertain in terms of the triggering mechanism
8
and sequence of the events in this case.” Id. And so, the special master concluded that Dr.
Kielstein:
[A]cknowledged that there remains great mystery in the understanding of the
causation of this disease. Without an understanding of the causation of the disease,
it is not possible to come to a conclusion about vaccine causation or causation by a
specific vaccine such as a hepatitis A.
Id.
And so, on June 23, 2016, the special master issued a decision denying petitioners’
request for compensation. See generally Dec. Petitioners, alleging error, seek review of the
Special Master’s Decision.
B. Procedural Background
On June 22, 2016, petitioners filed a motion for review of the Special Master’s Decision.
See generally Pet. Mot. The government filed a response to petitioners’ motion for review on
August 22, 2016. See generally Resp. Brief. Petitioners’ motion for review having been fully
briefed, the Court resolves the pending motion.
III. STANDARDS FOR DECISION
A. Standard Of Review
The United States Court of Federal Claims has jurisdiction to review the record of the
proceedings before a special master and, upon such review, may:
(A) uphold the findings of fact and conclusions of law of the special master and
sustain the special master’s decision,
(B) set aside any findings of fact or conclusions of law of the special master found
to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance
with law and issue its own findings of fact and conclusions of law, or
(C) remand the petition to the special master for further action in accordance with
the court’s direction.
42 U.S.C. § 300aa–12(e)(2).
The special master’s determinations of law are reviewed de novo. Andreu ex rel. Andreu
v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1373 (Fed. Cir. 2009). The special master’s
findings of fact are reviewed for clear error. Id.; see also Broekelschen v. Sec’y of Health &
9
Human Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010) (“We uphold the special master’s findings
of fact unless they are arbitrary or capricious.”) (citation omitted). In addition, a special master’s
findings regarding the probative value of the evidence and the credibility of witnesses will not be
disturbed so long as they are “supported by substantial evidence.” Doe v. Sec’y of Health &
Human Servs., 601 F.3d 1349, 1355 (Fed. Cir. 2010) (citation omitted); see also Burns v. Sec’y
of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (holding that the decision of
whether to accord greater weight to contemporaneous medical records or later given testimony is
“uniquely within the purview of the special master”). This “level of deference is especially apt
in a case in which the medical evidence of causation is in dispute.” Hodges v. Sec’y of Health &
Human Servs., 9 F.3d 958, 961 (Fed. Cir. 1993). And so, the Court will “not substitute its own
judgment for that of the special master if the special master has considered all relevant factors,
and has made no clear error of judgment.” Lonergan v. Sec’y of Health & Human Servs., 27
Fed. Cl. 579, 580 (1993).
B. Vaccine Injury Claims
Pursuant to the Vaccine Act, the Court shall award compensation if a petitioner proves,
by a preponderance of the evidence, all of the elements set forth in 42 U.S.C. § 300aa–11(c)(1),
unless there is a preponderance of evidence that the illness is due to factors unrelated to the
administration of the vaccine. 42 U.S.C. § 300aa–13(a)(1). A petitioner can recover either by
proving an injury listed on the Vaccine Injury Table (“Table”), or by proving causation-in-fact.
See 42 U.S.C. §§ 300aa–11(c)(1)(C); Althen, 418 F.3d at 1278. And so, to receive compensation
under the National Vaccine Injury Compensation Program, a petitioner must prove either that:
(1) the petitioner suffered a “Table Injury” that corresponds to one of the vaccinations in
question within a statutorily prescribed period of time or, in the alternative, (2) the petitioner’s
illnesses were actually caused by a vaccine. See 42 U.S.C. §§ 300aa–13(a)(1)(A), 300aa–
11(c)(1)(C)(i-ii), 300aa–14(a); see also Moberly v. Sec’y of Health & Human Servs., 592 F.3d
1315, 1321 (Fed. Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320
(Fed. Cir. 2006).
In addition, in Table and non-Table cases, a petitioner bears a “preponderance of the
evidence” burden of proof. 42 U.S.C. §§ 300aa–13(a)(1)(A); Althen, 418 F.3d at 1278 (citing
Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999)). And so,
10
a petitioner must offer evidence that leads the “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, 592 F.3d at 1322 n.2 (brackets
existing) (internal quotation omitted); see also Snowbank Enter. v. United States, 6 Cl. Ct. 476,
486 (1984) (holding that mere conjecture or speculation is insufficient under a preponderance
standard).
To establish a prima facie case when proceeding on a causation-in-fact theory, as
petitioners seek to do in this matter, a petitioner must “prove, by a preponderance of the
evidence, that the vaccine was not only a but-for cause of the injury but also a substantial factor
in bringing about the injury.” Shyface, 165 F.3d at 1352. “[T]o show that the vaccine was a
substantial factor in bringing about the injury, the petitioner must show ‘a medical theory
causally connecting the vaccination and the injury.’” Id. at 1352-53 (quoting Grant v. Sec’y of
Health & Human Servs., 956 F.2d 1144, 1148 (Fed. Cir. 1992) (per curiam)). In other words,
“[t]here must be a ‘logical sequence of cause and effect showing that the vaccination was the
reason for the injury,’” id. at 1353 (quoting Grant, 956 F.2d at 1148), and “[t]his ‘logical
sequence of cause and effect’ must be supported by a sound and reliable medical or scientific
explanation.” Knudsen, 35 F.3d at 548 (quoting Jay v. Sec’y of Health & Human Servs., 998
F.2d 979, 984 (Fed. Cir. 1993)); see also 42 U.S.C. § 300aa–13(a)(1) (“The special master or
court may not make such a finding based on the claims of a petitioner alone, unsubstantiated by
medical records or by medical opinion.”). However, medical or scientific certainty is not
required. Knudsen, 35 F.3d at 548-49.
In Althen, the Federal Circuit addressed the three elements that a petitioner must provide
to prove causation-in-fact:
(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. All three prongs “must cumulatively show that the vaccination was a
‘but-for’ cause of the harm, rather than just an insubstantial contributor in, or one among several
possible causes of, the harm.” Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355
(Fed. Cir. 2006). In addition, if a petitioner establishes a prima facie case, the burden shifts to
11
the respondent to show, by a preponderance of the evidence, that the injury was caused by a
factor unrelated to the vaccine. See 42 U.S.C. § 300aa–13(a)(1)(B); Shalala, 514 U.S. at 270-71.
But, regardless of whether the burden of proof ever shifts to the respondent, the special master
may consider the evidence presented by the respondent in determining whether the petitioner has
established a prima facie case. See Stone v. Sec’y of Health & Human Servs., 676 F.3d 1373,
1379 (Fed. Cir. 2012) (“[E]vidence of other possible sources of injury can be relevant not only to
the ‘factors unrelated’ defense, but also to whether a prima facie showing has been made that the
vaccine was a substantial factor in causing the injury in question.”); de Bazan v. Sec’y of Health
& Human Servs., 539 F.3d 1347, 1353 (Fed. Cir. 2008) (“The government, like any defendant, is
permitted to offer evidence to demonstrate the inadequacy of the petitioner’s evidence on a
requisite element of the petitioner’s case[-]in-chief.”).
IV. LEGAL ANALYSIS
Petitioners enumerate three objections to the special master’s decision. See generally Pet.
Mot. First, petitioners argue that the special master erred as a matter of law by holding
petitioners to a higher burden of proof than required under the Vaccine Act to prove the causal
relationship between the vaccination and the injury under Althen Prong I. Pet. Mot. at 2, 17.
Second, petitioners argue that the special master “failed to consider the medical and scientific
evidence contained in the record as a whole” in evaluating their claim under the first prong of
Althen. Id. at 2. Finally, petitioners also argue that the special master erred in finding that
petitioners’ expert, Dr. Kielstein, testified that there was “great mystery in the understanding of
the causation of” nephrotic syndrome. Id. at 3 (quoting Dec. at *12).
The government counters that the special master’s decision to deny compensation in this
case is reasonable, in accordance with law and supported by the record evidence. See generally
Resp. Brief. For the reasons discussed below, the Court agrees. And so, the Court SUSTAINS
the decision of the special master.
A. The Special Master Applied The Correct Burden Of Proof
As an initial matter, the record demonstrates that the special master correctly applied the
law in determining the burden of proof that petitioners must meet to satisfy the medical theory
prong of Althen. In their motion for review, petitioners argue that the special master imposed too
high of a burden of proof on petitioners to prove “a medical theory causally connecting the
12
vaccination and the injury.” Pet. Mot. at 2; 15 (citing Althen, 418 F.3d at 1278). The Court
reviews the special master’s determination of law de novo. Andreu, 569 F.3d at 1373.
The record evidence shows that the special master correctly applied the burden of proof
for petitioners’ vaccine injury claim. In his decision, the special master determined that
petitioners were required to prove each prong under the Federal Circuit’s decision in Althen v.
Secretary of Health and Human Services by a preponderance of the evidence. Dec. at *7 (citing
Althen, 418 F.3d at 1278). The special master also determined that, in putting forth their theory
causally connecting the vaccination and the injury the petitioners “need not produce medical
literature or epidemiological evidence to establish causation under the Vaccine Act.” Id. at *4.
In addition, the special master concluded that petitioners’ medical theories in this case must be
supported by a “‘sound and reliable’ medical or scientific explanation” under Althen Prong I. Id.
at *7 (quoting Knudsen, 35 F.3d at 548).
The special master’s decision correctly states the legal standard under the Federal
Circuit’s decision in Althen. Althen, 418 F.3d at 1278. And so, the special master did not err as
a matter of law in determining the burden of proof for the petitioners’ claim in this action.
The record evidence also shows that the special master correctly applied this burden of
proof to the medical theories put forward by the petitioners to support their vaccine injury claim.
In this regard, the special master determined that petitioners’ T-cell medical theory−that
nephrotic syndrome could be caused by a T-cell response to the vaccination−did not fit within
the timeline that the petitioners’ medical expert identified for the onset of A.R.’s symptoms.
Dec. at *12. Specifically, Dr. Kielstein testified during the entitlement hearing that it would take
approximately four days for a T-cell reaction to occur after a vaccination. Id. (citing TR at 73-
75). But, as the special master noted in his decision, Dr. Kielstein acknowledged in his
testimony that A.R.’s nephrotic syndrome symptoms first occurred just 36-40 hours after A.R.
received the hepatitis A vaccination. Id.
Given this, the special master appropriately determined that petitioners had not shown, by
a preponderance of the evidence, that their T-cell medical theory could causally connect the
hepatitis A vaccination that A.R. received on October 30, 2009 to the onset of A.R.’s nephrotic
syndrome. Id. at *8, 12. And so, the special master did not err as a matter of law in reaching this
conclusion.
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The special master also properly applied the legal standard under Althen in considering
the petitioners’ ANGPTL4 medical theory. In this regard, the record evidence shows that the
special master determined that the medical literature upon which the petitioners relied to support
this medical theory did not link any vaccines to dysfunction in the ANGPTL4. Id. at *11. The
special master also noted that the government’s expert, Dr. Kaplan, testified that “in spite of
“hundreds of millions of vaccines” administered worldwide over the last 50 years,” the
prevalence of nephrotic syndrome has remained “absolutely constant.” Dec. at *11 (quoting TR
at 132). And so, the special master concluded that the absence of a correlation between the
increase in the number of vaccinations and the prevalence of nephrotic syndrome cast doubt
upon the petitioners’ ANGPTL4 medical theory. Dec. at *11.
Given the lack of evidence to support either of petitioners’ medical theories, the special
master found that “[t]he bigger problem is that there seems to be a genuine lack of understanding
about the cause of this disease entity among nephrologists even though nephrotic syndrome has
been studied for many years.” Id. And so, the special master reasonably concluded there was
insufficient evidence for the petitioners to meet their burden of proof under Althen Prong I. Id. at
*12.
B. The Special Master Appropriately Considered
The Medical And Scientific Evidence In The Record
Petitioners’ argument that the special master erred by failing to consider the medical and
scientific evidence contained in the record is similarly unsupported by the evidence. Pet. Mot. at
2. As discussed above, the special master’s findings of fact are reviewed for clear error. Andreu,
569 F.3d at 1373; see also Broekelschen, 618 F.3d at 1345. In addition, the special master’s
findings regarding the probative value of the evidence and the credibility of witnesses will not be
disturbed so long as they are “supported by substantial evidence.” Doe, 601 F.3d at 1355
(citations omitted); see also Burns, 3 F.3d at 417.
The record evidence shows that special master properly considered the medical literature
relied upon by the petitioners in reaching his decision. Dec. at *11. In particular, the special
master specifically considered the Chugh medical study put forward by the petitioners, and the
special master noted in his decision that, “Chugh reported that “the central role played by
[angiopoietin-like 4] in nephrotic syndrome . . . suggests that manipulating [angiopoietin-like 4]
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related pathways in the context of therapeutics has a high chance of success.” Id. at *10 (citing
Pet. Ex. 35).
The special master also considered the Clement medical study, which the petitioners also
advanced to support their claim. In this regard, the special master acknowledged that the
Clement medical study “demonstrated that angiopoietin-like 4 is an important biological
mediator of nephrotic syndrome and is a critical link between proteinuria and
hypertriglyceridemia.” Id. at *10 (citing Pet. Ex. 34). The special master ultimately determined,
however, that neither the Clement nor the Chugh medical study linked the hepatitis A
vaccination−or any vaccine−to dysfunction in the ANGPTL4. Dec. at *11-12. And so, the
special master reasonably concluded that the medical literature relied upon by the petitioners did
not support their ANGPTL4 medical theory.
The record evidence also shows that the special master appropriately considered Dr.
Kielstein’s expert reports and testimony in support of the petitioners’ claim. See generally Dec.;
Pet. Mot. at 7-8; TR at 24-118; Pet. Ex. 14-20, 22-27, 32-35. For example, the special master
notes in his decision that Dr. Kielstein attempted to relate the medical theories discussed in the
Chugh and Clements medical studies to A.R.’s case in his testimony. Dec. at *11 (citing TR at
83).
With respect to the ANGPTL4 medical theory, the special master also notes in his
decision that Dr. Kielstein testified that the high fever that A.R. experienced during her October
31, 2009, visit to the emergency room suggested a cytokine response that could have been
secondary to the hepatitis A vaccine. Dec. at *11. The special master further notes, however,
that Dr. Kielstein testified that he did not know whether a cytokine response could have caused
A.R.’s symptoms, “because we are making the data, looking at that, and this is a very fascinating
field.” Id.; TR at 84. And so, the evidentiary record shows that the special master reasonably
concluded that Dr. Kielstein was unable to link the hepatitis A vaccination to A.R.’s nephrotic
syndrome. Dec. at *11.
In addition, the record evidence demonstrates that the special master considered the case
reports that the petitioners put forward to support their medical theories. Specifically, the special
master noted in his decision that Dr. Kielstein provided case reports demonstrating that vaccines
other than the hepatitis A vaccine may cause nephrotic syndrome. Dec. at *6; see also Pet. Ex.
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15-20, 22. The special master also noted in his decision that two of the case reports provided by
petitioners show that diseases other than nephrotic syndrome have occurred following
vaccinations other than the hepatitis A vaccination. Dec. at *6; see Pet. Ex. 23-24. But, as the
special master correctly concluded in his decision, none of these case reports show that the
hepatitis A vaccination causes nephrotic syndrome. Dec. at *6, 11; see also Pet. Ex. 15-20, 22-
24, 27.
Lastly, the record before the Court makes clear that the special master afforded
appropriate weight to all of the evidence discussed above. The special master notes in his
decision that Dr. Kielstein testified that “he was not aware of any case reports showing the
development of nephrotic syndrome following a Hep A vaccine, and he was not aware of any
medical literature where the authors assert a causal connection between Hep A and nephrotic
syndrome.” Id. at *6 (citing TR at 118). In addition, the special master noted that Dr. Kielstein
also testified that “the existing literature was a ‘low-quality database,’ as the studies are not
‘prospective, randomized studies.’” Id. (quoting TR at 65). Given Dr. Kielstein’s testimony, it
was certainly reasonable for the special master to afford limited weight to the medical literature
and case studies advanced by the petitioners. And so, the Court will not disturb the special
master’s findings regarding the probative value of this evidence. Doe, 601 F.3d at 1355.
In sum, given the evidence in the record, it is not surprising that the petitioners do not
point to any specific medical or scientific evidence that the special master failed to consider in
deciding their vaccine injury claim. See generally Pet. Mot. Nor do petitioners demonstrate that
the special master failed to properly weigh this evidence in reaching his decision on that claim.
And so, the evidentiary record here demonstrates that the special master did not err in
considering the medical and scientific evidence to support petitioners’ claim.
C. The Special Master Correctly Characterized Dr. Kielstein’s Testimony
As Conveying That The Cause Of Nephrotic Syndrome Remains Unknown
Lastly, petitioners’ final challenge–that the special master erred in characterizing Dr.
Kielstein’s testimony as conveying that there was “great mystery in the understanding of the
causation of [nephrotic syndrome]”–is equally without evidentiary support. Dec. at *12; Pet.
Mot. at 12-13.
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In this regard, the record evidence shows that Dr. Kielstein made several statements in his
expert reports and during his expert testimony that support the special master’s factual finding
that there is uncertainty about the causes of nephrotic syndrome. See TR; Pet. Ex. 12, 30, 31.
Specifically, the record before the Court shows that Dr. Kielstein states in his expert report dated
August 15, 2014, that “the exact underlying cause of [nephrotic syndrome] is not fully
understood.” Pet. Ex. 12. In his supplemental expert report, dated March 6, 2014, Dr. Kielstein
also states that “[u]nraveling the pathophysiology of minimal change nephritic [sic] syndrome is
an ongoing endeavor.” Pet. Ex. 30.
Dr. Kielstein expressed a similar view during the entitlement hearing. For example, the
following exchange occurred during Dr. Kielstein’s testimony about the petitioners’ ANGPTL4
medical theory:
THE COURT: And are you suggesting that the injury [the inflammatory response
to the vaccination] causes some loss of the angiopoietin-like 4?” . . .
DR. KIELSTEIN: “The question is can we, from the data we have, identify the
single mechanism that is – that is inducing that [the nephrotic syndrome]? I’m not
able to do that. What I am doing is to offer possible explanations. . . .”
TR at 80-81.
Dr. Kielstein’s own testimony and expert reports make clear that Dr. Kielstein
represented to the Court that the cause of nephrotic syndrome remains undetermined. Given this,
the special master did not err in characterizing Dr. Kielstein’s testimony as conveying that there
remains “great mystery in the understanding of the causation of this disease.” Dec. at *12. And
so, the Court will not set aside the findings of the special master.
V. CONCLUSION
In sum, the record evidence in this case demonstrates that petitioners have not
demonstrated that the special master erred in considering their vaccine injury claim. To the
contrary, the record evidence in this matter demonstrates that the special master’s decision was
reasonable, supported by the evidence and in accordance with law.
And so, for the foregoing reasons, the Court DENIES petitioners’ motion for review and
SUSTAINS the decision of the special master.
The Clerk is directed to enter judgment accordingly.
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Each party to bear their own costs.
Some of the information contained in this Memorandum Opinion and Order may be
considered privileged, confidential, or sensitive personally-identifiable information that should
be protected from disclosure. Accordingly, this Memorandum Opinion and Order shall be
FILED UNDER SEAL. The parties shall review the Memorandum Opinion and Order to
determine whether, in their view, any information should be redacted prior to publication. The
parties shall also FILE, by December 30, 2016, a joint status report identifying the information,
if any, that they contend should be redacted, together with an explanation of the basis for each
proposed redaction.
IT IS SO ORDERED.
s/ Lydia Kay Griggsby
LYDIA KAY GRIGGSBY
Judge
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