Godfrey v. Secretary of Health and Human Services

In the United States Court of Federal Claims
No. 10-565V
(Filed: August 19, 2015)*
*Opinion originally issued under seal on July 29, 2015
)
MEGAN L. GODFREY, )
)
Petitioner, ) Vaccine Petition; Intervening Federal
) Circuit Decision; Koehn v. Sec’y of
v. ) Health and Human Servs., 773 F.3d
) 1239 (Fed. Cir. 2014); Remand to
SECRETARY OF HEALTH AND ) Special Master
HUMAN SERVICES, )
)
Respondent. )
)
Clay Ragsdale, Birmingham, AL, for petitioner.
Jennifer Reynaud, United States Department of Justice, Civil Division,
Washington, DC, with whom were Benjamin C. Mizer, Acting Assistant Attorney
General, Rupa Bhattacharyya, Director, Torts Branch, Vincent J. Matanoski, Assistant
Director, and Catherine E. Reeves, Assistant Director.
OPINION
Pending before the court is Megan L. Godfrey’s (“Ms. Godfrey” or “petioner”)
petition for review of the June 11, 2014 decision of Chief Special Master Vowell (“chief
special master”) denying Ms. Godfrey’s claim for compensation under the National
Childhood Vaccine Injury Act of 1986, 42 U.S.C. § 300aa-1 to -34, as amended
(“Vaccine Act”). Godfrey v. Sec’y of Health and Human Services, No. 10-565, 2014
WL 3058353 (Fed. Cl. June 11, 2014) (“Decision”).
Petitioner alleges that the single dose of the Gardasil human papillomavirus
(“HPV”) vaccine she received on August 22, 2007, “substantially contributed” to her
development of juvenile ankylosing spondylitis (“JAS”).1 An entitlement hearing was
held on December 10, 2012. The chief special master, applying the test set forth in
Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005),
determined that petitioner had not met her burden of proof to show causation-in-fact.
Specifically, the chief special master found that the medical theory presented by
petitioner—which posited that the HPV vaccine could have “triggered” petitioner’s JAS
in a manner similar to other environmental triggers—was not a sufficiently plausible
theory to show that the vaccine could actually “cause” petitioner’s JAS as required under
the Althen standard. The chief special master also found that the dose of HPV vaccine
given could not have caused or triggered petitioner’s JAS symptoms. The chief special
master further determined that petitioner had failed to establish a temporal relationship
between receipt of the vaccination and her JAS diagnosis, in that it was not clear when
the petitioner contracted JAS due to the staggered onset of symptoms.
Petitioner seeks reversal of the chief special master’s decision, arguing that the
chief special master erred in rejecting petitioner’s expert’s opinion that the HPV vaccine
can trigger or cause JAS and that a single dose of the vaccine could have triggered
petitioner’s JAS. Petitioner argues that she presented a viable, legally-probable medical
1
JAS is the juvenile form of ankylosing spondylitis, and typically causes peripheral arthritis and
peripheral enthesopathies. Dec. at 11 (citing Pet.’s Ex. 52 at 2, Pet.’s Ex. 57 at 2, 4). JAS
commonly affects the pelvis, heels, knee joints, and hip joints. Id. (citing Pet.’s Ex. 56 at 575).
2
causation theory and established a proper temporal reaction, both of which petitioner
argues the chief special master improperly disregarded. In support of her petition, Ms.
Godfrey relies extensively on the recent decision of the Federal Circuit in Koehn v. Sec’y
of Health and Human Servs., 773 F.3d 1239 (Fed. Cir. 2014). Koehn also involved a
claim of injury from the HPV vaccine and discusses the testimony of the two principal
experts that appeared in this case. Petitioner argues that the Koehn decision dictates
reversal of the chief special master’s decision rejecting a finding of causation in this case
due to the Federal Circuit’s criticism of the analysis in that case. Respondent argues that
Koehn does not undermine the chief special master’s decision because the relevant
discussion is dicta and this case is factually distinct because, unlike Koehn, it involves a
disease with a strong genetic component. Therefore, the government argues that the
decision of the chief special master should be affirmed.
For the reasons set forth below, the court finds that Koehn raises issues that are
best addressed by the chief special master in the first instance. Specifically, there are
several statements in the Koehn decision which suggest that the chief special master’s
grounds for rejecting petitioner’s causation theory should be re-examined. Accordingly,
the court GRANTS IN PART petitioner’s motion and REMANDS the case for further
consideration regarding whether the Koehn decision warrants a different outcome.
I. BACKGROUND
A. Procedural History
On August 10, 2010, Ms. Godfrey filed a petition under the Vaccine Act.
Additionally, petitioner filed her medical records, medical literature, and an expert report
3
from David Axelrod, M.D. (“Dr. Axelrod”), a clinical immunologist. On September 26,
2011, the government filed an expert report from Carlos D. Rose, M.D. (“Dr. Rose”), a
pediatric rheumatologist. On October 26, 2011, the government filed medical literature,
an expert report from Burt Zweiman, M.D. (“Dr. Zweiman”), an immunologist, and a
Vaccine Rule 4(c) report recommending against awarding compensation.
A Vaccine Rule 5 status conference was held on November 5, 2011, at which the
chief special master noted deficiencies in Dr. Axelrod’s report. Thereafter, on April 24,
2012, petitioner filed an expert report from Michael J. McCabe, Jr., Ph.D. (“Dr.
McCabe”), a toxicologist/immunologist. On June 18, 2012, the Secretary filed a
responsive expert report from Dr. Zweiman addressing Dr. McCabe’s report.
An entitlement hearing was held on December 10, 2012.2 At the hearing,
petitioner presented testimony from Dr. McCabe, while the government presented
testimony from Drs. Rose and Zweiman. On June 11, 2014, the chief special master
issued a decision denying compensation. The chief special master determined that
respondent’s experts were entitled to greater weight based on both their qualifications and
their testimony that petitioner’s causation theory was not supported by the medical and
scientific literature. On July 11, 2014, petitioner timely filed a petition for review in this
court. The petition was stayed pending the appeal in Koehn. Supplemental briefs were
2
Petitioner initially indicated that she wished to file an expert report from Anthony Turkiewicz,
M.D., her treating rheumatologist. The chief special master denied a postponement of the
hearing, but granted leave to file an affidavit. On January 18, 2013, petitioner gave notice that
no affidavit would be filed.
4
filed following the resolution of that appeal. Oral argument on the petition for review
was held on July 14, 2015.
B. Facts
Ms. Godfrey was born on August 1, 1989. Dec. at 6. Her medical records
indicate that she was generally healthy through age 18. Id. Her family medical history
included Crohn’s disease (father) and rheumatoid arthritis (paternal grandparents and
paternal aunts and uncles). Id. at 6; Pet.’s Exs. 7 at 182, 8 at 9. She participated in
athletics during high school, including as a member of the school’s cheerleading team.
Dec. at 6 & n.12.
On August 22, 2007, petitioner received HPV and meningococcal conjugate
vaccines. Id. at 6; Pet.’s Ex. 2 at 1. Four months later, on December 19, 2007, petitioner
presented to her pediatrician, Mark Woods, M.D., complaining of sharp intermittent left
hip pain that had been ongoing for three months. Dec. at 6; Pet.’s Ex. 3 at 1. She
reported no injury and an X-ray of her hip was negative. Pet.’s Ex. 3 at 1. She received
an MRI on December 28, 2007, which revealed “[b]ilateral femoral benign fibrous
dysplasia, greater on the left side than the right, and left-sided sacroiliitis, which the
radiologist thought could be inflammatory.” Dec. at 7; Pet.’s Ex. 8 at 86.
Petitioner was also treated by Steve Lovelady, M.D., an orthopedist, on December
28. Pet.’s Ex. 11 at 12-14. He found tenderness at the left sacroiliac joint and admitted
her to DCH Regional Medical Center for further evaluation to rule out osteomyelitis. Id.
He also noted that petitioner’s father suffered from inflammatory bowel disease and
anemia. Id.
5
A bone scan performed on January 8, 2008 showed “increased activity at the left
[sacroiliac] joint.” Id. at 11. It was read as indicative of hyperemia and active bone
turnover, “which could be seen in osteomyelitis or in an inflammatory sacroiliitis.” Id.
On January 14, 2008, petitioner tested positive for the HLA-B27 protein, a genetic
marker showing susceptibility to conditions such as JAS. Id. at 7. Petitioner received a
steroid injection in the left sacroiliac joint in January 2008, which relieved the left hip
pain, but she developed tenderness in her right sacroiliac joint by March 2008. Pet.’s Ex.
9 at 89-90, 122.
On April 15, 2008, petitioner was evaluated by Randy Cron, M.D., a pediatric
rheumatologist. Pet.’s Ex. 7 at 180-84. He again noted petitioner’s familial history of
Crohn’s disease and arthritis, as well as her own history of sacroiliac joint pain and the
positive test for HLA-B27. Id. He diagnosed her with HLA-B27 spondyloarthropathy.
Id. After this visit, petitioner continued her treatment, including receiving injections of
Infliximab.3 Id. at 73-77, 94-98, 132-35, 149-52, 157-61; Pet.’s Ex. 9 at 12-13.
On August 22, 2012, petitioner had an initial visit with Anthony Turkiewicz,
M.D., a rheumatologist. Pet.’s Ex. 88 at 10-14. His impression was that the petitioner
was suffering from ankylosing spondylitis/axial spondyloarthropathy, and he continued
petitioner’s prescription of Infliximab injections. Id. at 9. Ms. Godfrey states that she
3
Injections of Infliximab inhibit tumor necrosis factor- and other pro-inflammatory cytokines.
Dec. at 8 n.15 (citing Physician’s Desk Reference 1145 (58th ed. 2004)).
6
believes that “[t]his treatment has been successful in terminating [her] symptoms.” Pet.’s
Post-Hearing Br. 2.
C. The Chief Special Master’s Decision
At the entitlement hearing, Dr. McCabe, who has a Ph.D. in microbiology and
immunology but is not a medical doctor, testified that petitioner’s HPV vaccination
triggered the manifestation of her JAS.4 His theory was that the vaccination triggered the
release of pro-inflammatory cytokines and that pro-inflammatory cytokines can trigger
the onset of JAS. Dr. McCabe explained that JAS is a disease with an auto-inflammatory
etiology, which means the disease is “driven by dysregulation of the innate immune
system.” Pet.’s Ex. 52 at 3. While Dr. McCabe acknowledged that petitioner had a
genetic susceptibility for JAS and that infections, stress, and trauma are all known
environmental triggers associated with the onset of JAS, he opined that the HPV vaccine
is also a trigger because it provokes a strong antibody response that in turn causes the
production of pro-inflammatory cytokines. Dr. McCabe explained that pro-inflammatory
cytokines have been implicated in the etiology of autoimmune disorders like JAS and
testified that the HPV vaccine was likely to have acted as an environmental trigger for
petitioner. He further testified that he believed that a single dose of the HPV vaccine
would be sufficient to stimulate enough pro-inflammatory cytokines to cause the onset of
JAS. Dr. McCabe acknowledged that there was no direct evidence demonstrating that
4
Dr. McCabe has been a professor at the University of Rochester since 2000. Dec. 9. He also
reviews and testifies in cases involving environmental and occupational exposures for Robson
Forensic. Id.
7
petitioner had an inflammatory response to the vaccine, but testified that he would
“expect that her antibody titers in response to the HPV were increasing.” Tr. 39, 74-75.
The respondent addressed Dr. McCabe’s contentions with evidence from Dr.
Rose5 and Dr. Zwieman.6 Dr. Rose did not dispute that pro-inflammatory cytokines can
cause symptoms of JAS, but disputed that pro-inflammatory cytokines can cause the
onset of the disease itself. Put another way, Dr. Rose opined that there is no evidence
that pro-inflammatory cytokines play a role in the pathogenesis of JAS, which Dr. Rose
testified is caused by genetics and other stressors, and instead is more likely to be
involved in the symptomology of the disease. Dr. Zweiman testified that, given the
transient increase in cytokine levels produced by the vaccine, the evidence would not
support a finding that petitioner’s single dose would be sufficient to trigger JAS
symptoms.
Based on this evidence and taking into account the professional backgrounds of
the experts,7 the chief special master found that petitioner’s JAS was attributable to her
“genetic background, coupled with a family history and the presence of a known ‘trigger’
5
Dr. Rose is a board-certified pediatric rheumatologist and works at the Alfred I. duPont
Institute and at the Thomas Jefferson University’s Jefferson Medical College. Dec. 10.
6
Dr. Zweiman was board certified in internal medicine, allergy and clinical immunology, and
laboratory immunology and between 1963 and his death taught at the University of Pennsylvania
School of Medicine. Dec. 11.
7
The chief special master noted that she found Dr. Rose’s testimony more reliable and
persuasive. She explained that Dr. McCabe was “out of his depth in presenting a theory of the
cause of a medical condition, with little, if any, support in the medical and scientific literature”
whereas Dr. Rose, who diagnoses and treats JAS, was more “familiar with the etiologic factors
that are accepted as causal in the scientific and medical communities.” Dec. at 30.
8
for development of JAS,” which the chief special master identified as petitioner’s
cheerleading. Dec. 29.
Finally, the chief special master found that petitioner had also failed to satisfy the
other two Althen prongs. She noted that petitioner’s medical records merely recorded
that she had the HPV vaccine a month before she complained of her JAS symptoms
without linking the events. She further noted that she agreed with Dr. Rose that it was
not possible to determine the precise onset of petitioner’s JAS because petitioner had
initially complained of hip pain in only one hip while imaging studies showed that the
disease was present in both hips, suggesting that the disease may have existed for a
period of time without petitioner experiencing symptoms. Dec. 31.
D. The Koehn Decision
Koehn involved a claim by a 13-year-old female who developed an auto-
inflammatory disease known as systematic juvenile idiopathic arthritis (“SJIA”)
following receipt of two of three HPV vaccine doses. 773 F.3d at 1240. As in this case,
the petitioner in Koehn relied on the testimony of Dr. McCabe to support her claim that
the vaccine triggered her disease by producing cytokines. Id. at 1242. Also as in this
case, the respondent relied on the testimony of Dr. Rose to rebut Dr. McCabe’s theory.8
Id. At trial, the special master determined that the petitioner had not met her burden
under any of the Althen prongs, and specifically found against Dr. McCabe’s theory
8
Dr. Zweiman was not called as an expert in the case.
9
because it had not been peer-reviewed or published and Dr. Rose had not heard of it. Id.
at 1242-43.
In its decision, the Federal Circuit affirmed the special master, finding that
petitioner had not met Althen prong three, but stated that the special master “committed
several errors in the assessment of the first and second Althen prongs.” Id. at 1243.
Regarding prong one, the circuit criticized the special master for basing his conclusions
about the acceptance of Dr. McCabe’s theory by the scientific community on whether Dr.
Rose had heard of the theory and for finding Dr. Rose more reliable because he treats
patients. Id. at 1243-44. Regarding Dr. McCabe’s experience with patients, the circuit
stated that “[w]e see no reasonable basis for why this distinction has any meaningful
effect on the cause and effect inquiry.” Id. at 1244. Regarding Dr. McCabe’s theory
itself, the circuit stated that “[h]ad the Special Master properly evaluated the evidence,
we believe the Special Master would have likely found that Koehn met her [causation]
burden.” Id. at 1244 n.1. While the special master in that case found the Pinto article
relied on by the petitioner to be unconvincing due to Dr. Rose’s testimony that the
measurements performed in that study required a stimulus and therefore did not mirror
what might happen in the body, the circuit found that “[e]specially given the low
incidence rate of SJIA, requiring a measurement without a stimulus would have
compelled Koehn to present more than what is scientifically possible or legally
necessary.” Id. As a result, the circuit indicated that it believed that Dr. McCabe had
presented a “viable, ‘legally probable’ medical theory.” Id. (quoting Moberly v. Sec’y of
Health & Human Servs., 592 F.3d 1315, 1322 (Fed. Cir. 2010)).
10
Ultimately, the circuit agreed that Ms. Koehn had not met her burden of
establishing that the onset of symptoms had occurred within a timeframe that was
medically acceptable to infer “causation-in-fact.” Id. at 1244-45. In the opinion, the
circuit explained that Dr. McCabe had failed to explain how the timing of the SJIA onset
“aligns with the timing of a sufficient immune response in patients receiving the
vaccine,” in that Dr. McCabe agreed that the immune system produces cytokines quickly
and the petitioner’s symptoms did not appear for seven months. Id. Thus, the circuit
affirmed the special master’s decision on the ground that “Koehn did not sufficiently
establish why onset of SJIA can occur within seven months after receiving the first dose
of Gardasil, especially when cytokine release is generally a more immediate response.”
Id. at 1245.
II. STANDARD OF REVIEW
This court has jurisdiction to review the decisions of a special master in a Vaccine
Act case upon a motion from the petitioner. 42 U.S.C. § 300aa-12(e)(2). The court uses
three distinct standards of review in Vaccine Act cases: findings of fact are reviewed
under the arbitrary and capricious standard, questions of law under the not in accordance
with law standard, and discretionary rulings under the abuse of discretion standard.
Masias v. Sec’y of Health & Human Servs., 634 F.3d 1283, 1287-88 (Fed. Cir. 2011);
Munn v. Sec’y of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992); see
42 U.S.C § 300aa-12(e)(2)(B). In this connection, the court does not “reweigh the factual
evidence,” “assess whether the special master correctly evaluated the evidence,” or
“examine the probative value of the evidence or the credibility of the witnesses.” Lampe
11
v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000) (internal
quotation marks omitted) (quoting Munn, 970 F.2d at 871). If the special master “has
considered the relevant evidence of record, drawn plausible inferences and articulated a
rational basis for the decision,” then “reversible error is extremely difficult to
demonstrate.” Id. at 1360 (internal quotation marks omitted) (quoting Hines ex rel.
Sevier v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)).
III. DISCUSSION
A. Vaccine Act Standards
Under the Vaccine Program, there are two types of claims: claims based on
injuries listed in the Vaccine Injury Table (“Table”) and claims based on injuries not
listed in the Table, known as off-Table claims. If the petitioner presents a Table claim,
the petitioner is granted a presumption of causation if he or she shows that he or she
received a vaccine listed in the Table, that he or she suffered an injury listed in the Table,
and that the injury occurred within the prescribed time period. See Andreu v. Sec’y of
Health & Human Servs., 569 F.3d 1367, 1374 (Fed. Cir. 2009) (describing Table cases).
In an off-Table case, like the present case, a petitioner who received a vaccine listed in
the Table but suffered an injury not listed on the table does not receive a presumption of
causation, and instead must prove causation by a preponderance of the evidence. See
Moberly, 592 F.3d at 1321 (describing off-Table cases).
In order to prove causation in an off-Table case, the petitioner must show that the
injury “was caused by a vaccine” listed in the Table. 42 U.S.C. § 300aa-
12
11(c)(1)(C)(ii)(I). The Federal Circuit explained the evidentiary burden placed on
petitioners to show causation-in-fact in Althen, stating that a petitioner must
show by preponderant evidence that the vaccination brought about her
injury by providing: (1) a medical theory causally connecting the
vaccination and the injury; (2) a logical sequence of cause and effect
showing that the vaccination was the reason for the injury; and (3) a
showing of a proximate temporal relationship between vaccination and
injury.
418 F.3d at 1278. This showing of causation requires “a reputable medical or scientific
explanation that pertains specifically to the petitioner’s case, although the explanation
need only be ‘legally probable, not medically or scientifically certain.’” Broekelschen v.
Sec’y of Health & Human Servs., 618 F.3d 1339, 1345 (Fed. Cir. 2010) (quoting
Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548-49 (Fed. Cir. 1994)).9
Once the petitioner satisfies this burden under Althen, he or she is “entitled to
recover unless [the respondent] shows, also by a preponderance of evidence, that the
injury was in fact caused by factors unrelated to the vaccine.” Walther v. Sec’y of Health
& Human Servs., 485 F.3d 1146, 1151-52 (Fed. Cir. 2007) (quoting Whitecotton v. Sec’y
of Health & Human Servs., 17 F.3d 376 (Fed. Cir. 1994), rev’d on other grounds sub
nom. Shalala v. Whitecotton, 514 U.S. 268 (1995)) (citing Knudsen, 35 F.3d at 547).
The evidence presented to establish an unrelated cause of injury may also be considered
9
This determination is notably different from a medical diagnosis: “the function of a special
master is not to ‘diagnose’ vaccine-related injuries, but instead to determine ‘based on the record
evidence as a whole and the totality of the case, whether it has been shown by a preponderance
of the evidence that a vaccine caused the [petitioner’s] injury.’” Andreu, 569 F.3d at 1382
(quoting Knudsen, 35 F.3d at 549).
13
in determining whether the petitioner has met the burden of establishing a prima facie
case in the first instance. Stone v. Sec’y of Health & Human Servs., 676 F.3d 1373,
1379-80 (Fed. Cir. 2012).
B. The Chief Special Master’s Conclusions Regarding Causation-In-Fact
Should Be Re-Evaluated in Light of Koehn
The primary dispute between the parties in this case concerns the first Althen
prong. Specifically, petitioner argues that she met her burden of demonstrating a legally
probable and biologically-plausible mechanism causally connecting her receipt of a
single dose of the HPV vaccine with the onset of her JAS. The government, as noted
above, argues that petitioner failed to establish such a connection by a preponderance of
the evidence as required by Althen.
According to petitioner, the expert testimony that she presented established a
legally probable theory that the HPV vaccine can be an environmental trigger that can
cause the onset of JAS in genetically-predisposed individuals, in the same manner as
other known environmental triggers such as bacterial infections or traumatic stress
injuries. Petitioner notes that the parties’ experts agreed on the genetic components of
JAS, the identified environmental triggers, the existence of other unidentified
environmental triggers, the mechanisms by which environmental triggers initiate the
disease process, and the similarity of the immune response elicited by the HPV vaccine to
the immune response to known environmental triggers. In addition, petitioner argues that
Dr. McCabe’s opinion was supported by scientific studies showing that the HPV vaccine
triggers a response that is associated with the onset of diseases like JAS. In such
14
circumstances, petitioner argues that the chief special master’s failure to find a causal
connection between receipt of the HPV vaccine and the onset of JAS was arbitrary and
capricious. Regarding the second Althen prong, petitioner further argues that Dr.
McCabe was able to demonstrate through existing studies that a single dose of the HPV
vaccine would be sufficient to trigger a response capable of causing JAS symptoms.
Petitioner argues that she presented sufficient evidence to support the third Althen prong
in that her symptoms began within one month of her receiving the HPV vaccine and thus
her vaccination and the onset of symptoms were temporally-related. Finally, petitioner
argues that the discussion in Koehn regarding Dr. McCabe’s testimony in that case
demonstrates that the chief special master’s rejection of his testimony in favor of Dr.
Rose’s testimony was erroneous. According to petitioner, the Federal Circuit’s
approving statements and analysis in Koehn mean that Dr. McCabe’s theory should be
accepted in this case.
In response, the government argues that the chief special master’s decision is
rationally supported by the evidence presented and that nothing in the Koehn decision
warrants a reversal of the decision. According to the government, petitioner presented a
theory that the HPV vaccine might be a trigger for JAS symptoms but failed to present
evidence to support a finding that the HPV vaccine actually “causes” JAS as required by
the Althen test. The government relied on the testimony of its expert to draw a
distinction, which the chief special master accepted, between the vaccine triggering the
onset of symptoms in a patient with existing-but-dormant JAS and the vaccine actually
causing JAS itself. The government further argues that its experts demonstrated that
15
there is no reliable evidence in the medical literature for petitioner’s theory that a single
dose of the HPV vaccine could trigger the onset of JAS or its symptoms. The
government contends that the chief special master properly agreed with its expert that the
study that Dr. McCabe relied upon was based on in-vitro responses and thus did not
establish what an in-vivo response would be. Thus, the government argued that the chief
special master was correct in finding that the government’s experts effectively rebutted
petitioner’s causation theory. In addition, as noted above, the government argues that the
chief special master’s rejection of petitioner’s temporal evidence is supported by the
evidence presented.
Based on the circuit’s intervening decision in Koehn, the court finds that this
matter should be remanded to the chief special master to evaluate in the first instance
whether, as the circuit suggested in Koehn, Dr. McCabe has identified a legally probable
theory of causation with regard to the HPV vaccine to satisfy the first prong of Althen in
cases involving auto-inflammatory diseases. See Graves v. Sec’y of Health and Human
Servs., 101 Fed. Cl. 310, 314 & n.2 (2011) (remanding for damages determination where
an intervening Federal Circuit decision “potentially expands the scope of recovery”
(citing Zatuchni v. Sec’y of Health & Human Servs., 516 F.3d 1312 (Fed. Cir. 2008))).
While the court recognizes that the circuit’s criticisms of the special master’s decision in
Koehn with regard to causation are dicta, the court notes that there are sufficient
similarities regarding the auto-inflammatory illnesses at issue in both cases to warrant a
review. In this connection, the court also recognizes that there are also differences
between the diseases at issue in both cases and in the dosages and the timing of
16
petitioner’s reactions. The significance of these similarities and differences are matters
that are best left for the chief special master to determine in the first instance, rather than
this court.10
IV. CONCLUSION
Accordingly, for the reasons set forth above, petitioner’s motion for review is
GRANTED-IN-PART and the case is REMANDED for further proceedings in
accordance with this opinion. The chief special master shall perform the re-evaluation
within 90 days, in accordance with Vaccine Rule 28(b).
IT IS SO ORDERED.
s/Nancy B. Firestone
NANCY B. FIRESTONE
Judge
10
The court also notes that the chief special master made a finding of a more likely alternative
environmental trigger as the cause of petitioner’s JAS. This conclusion was not discussed at
length and may warrant further explanation in her new review.
17