Garner v. Secretary of Health and Human Services ( 2017 )

In the United States Court of Federal Claims
No. 15-63V
(Filed Under Seal: July 31, 2017)
(Reissued: August 15, 2017) 1
**************************************** *
*
FINNETTIA GARNER, *
*
Petitioner, *
* Vaccine Act Motion for Review;
v. * Hepatitis A and B Vaccination;
* Parsonage-Turner Syndrome; Althen
SECRETARY OF HEALTH AND * Burden of Proof Requirements.
HUMAN SERVICES, *
*
Respondent. *
*
**************************************** *
Sean F. Greenwood, The Greenwood Law Firm, Houston, Texas, for Petitioner.
Daniel A. Principato, with whom were Chad A. Readler, Acting Assistant Attorney
General, C. Salvatore D’Alessio, Acting Director, Catharine E. Reeves, Deputy Director,
and Gabrielle M. Fielding, Assistant Director, Torts Branch, Civil Division, U.S.
Department of Justice, Washington, D.C., for Respondent.
OPINION AND ORDER
WHEELER, Judge.
Petitioner Finnettia Garner initiated this action in January 2015, seeking
compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §
300aa-10 et seq. (“Vaccine Act”), for injuries allegedly received from a Hepatitis A and B
vaccination in December 2011. Ms. Garner claims that the vaccination caused Parsonage-
Turner Syndrome (“PTS”), a neurological disorder of the shoulder resulting in significant
pain and weakness. The Special Master in this case denied compensation in March 2017.
11
Pursuant to Rule 18(b) of the Court’s Vaccine Rules, this opinion and order was initially filed under seal. As
required under the Rules, each party was afforded 14 days from the date of issue, until August 14, 2017, to object to
the public disclosure of any information furnished by that party. Neither party submitted any proposed redactions.
Garner v. Sec’y of Health & Human Servs., No.15-63V, 2017 WL 1713184 (Fed. Cl. Spec.
Mstr. Mar. 24, 2017) (“Decision”). Petitioner has now filed a Motion for Review with this
Court. For the reasons explained below, the Court denies Petitioner’s Motion for Review
and affirms the decision of the Special Master.
Background
I. Medical History 2
On December 13, 2011, Ms. Garner received a Twinrix vaccination, which is a
combination of the Hepatitis A and B vaccines, together with a typhoid vaccination, 3 in
preparation for a trip abroad in connection with her employment. On January 23, 2012,
Ms. Garner traveled to Angola. She states in her Affidavit (Dkt. No. 1, Exhibit 1,
“Affidavit”) accompanying the Petition that on January 27, 2012 (45 days after receipt of
the Twinrix vaccination), she experienced severe pain in her right shoulder and arm (the
vaccination had been given in her left arm). Ms. Garner reported that the pain lasted ten
days, followed by weakness for an unstated period of time. Ms. Garner did not seek
medical attention for this condition, explaining that she did not feel comfortable getting
medical attention abroad. In April 2012, approximately three months later, and after return
to the United States, Ms. Garner had a physical examination where no shoulder issues were
found; in fact Ms. Garner did not mention to the doctor any problems related to her
shoulder.
On June 15, 2012, Ms. Garner sought treatment for new, significant pain in her left
shoulder. X-rays showed a partial dislocation of the left humerus. Dr. Shah, the orthopedic
surgeon treating her on June 18, diagnosed “possible” PTS, which is a neurological
disorder causing pain and weakness in the shoulder and arm. On June 26, 2012, a physician
at TMH Neurological Institute conducted neurological tests of Ms. Garner’s left shoulder
and arm and found normal readings, although he noted that her “voluntary effort” in
contracting the muscles was poor. On July 6, 2012, Ms. Garner returned to Dr. Shah for a
follow-up appointment, and she reported to him that her pain had improved by 40 percent,
although she showed a limited range of motion in the left shoulder, and she had developed
a rash under that arm due to her inability to lift it. Dr. Shah noted that the partial dislocation
of her shoulder had improved, and he continued to diagnose possible PTS. Ms. Garner
reports in her Affidavit that at this time she was forced to work from home for about three
months until the pain subsided in September 2012.
In January 2013, Ms. Garner was involved in a motor vehicle collision and reported
left shoulder and neck pain after impact. Her medical records showed no neurological
abnormalities and reflected normal x-rays of the neck. Those treatment records make no
2
All facts relating to Petitioner’s medical history are drawn from the Special Master’s decision.
3
The typhoid vaccine is not covered under the Vaccine Act. 42 C.F.R. § 100.3(a).
2
mention of the December 2011 vaccination or the possible diagnosis of PTS. Ms. Garner
states that in March 2013 she experienced a return of the pain and weakness in the left arm
which lasted about three weeks; she noted that she did not seek medical attention because
the doctors she had seen had not offered any relief.
In December 2013, approximately a year and a half after Ms. Garner’s July 6, 2012
visit to Dr. Shah for left shoulder pain, she experienced significant shoulder pain and
weakness again, this time on the right side, and returned to see Dr. Shah. She stated in her
Affidavit that the doctor commented about the change from the left to the right shoulder,
saying that this was unusual, but that PTS could affect both arms. 4 The records show that
he diagnosed possible PTS for the right shoulder pain, and noted that her similar symptoms
in July 2012 on the left side had been completely resolved. This diagnosis appears to be
the most recent medical treatment specifically for shoulder pain. Ms. Garner stated in her
Affidavit that her most recent episode of severe shoulder pain occurred on December 18,
2014 on her right side and continued for ten days, while weakness in the right arm and
hand continue. There is no record of any medical attention for these most recent
complaints.
II. Procedural History
After Ms. Garner’s submission of her petition and relevant medical records,
Respondent filed a Rule 4(c) Report recommending denial of compensation. Dkt. No. 10.
The parties’ expert reports were filed by January 2016. Dkt. Nos. 16, 18. After a Status
Conference, the Special Master ordered Ms. Garner to file a supplemental expert report to
address issues raised in Respondent’s expert report, which she submitted in April 2016.
Dkt. No. 26. At the status conference held shortly thereafter, the Special Master indicated
to the parties that live testimony would not be required, and that Ms. Garner should file her
motion for a ruling on the record. The Motion was filed and fully briefed by October 2016.
The Special Master’s Decision denying compensation was issued in March 2017, and
Petitioner filed her Motion for Review on April 21, 2017.
III. Summary of Expert Evidence
A. Petitioner’s Expert
Petitioner’s expert opinion (Dkt. No. 16) was provided by Dr. Yehuda Shoenfeld,
head and founder of The Center for Autoimmune Diseases at Sheba Medical Center in Tel-
Aviv, Israel. He also holds the Research Chair for autoimmune diseases at Tel-Aviv
University. His work has focused on autoimmune and rheumatic diseases, and he lists
many books and papers he has published on these subjects. Dr. Shoenfeld described PTS
4
The Special Master discussed Petitioner’s claim that her PTS appeared in both arms and observed that this
could be a possibility with PTS. He thus declined to find that the “migration of symptoms from the right
to left arm” would weaken Petitioner’s case. Dec. at 24 n.18.
3
as a “rare disorder” with no definitive tests to confirm its presence. It is characterized by
an abrupt onset of shoulder pain followed by weakness and atrophy of the upper arm
muscles. Recovery is slow and may require months or years. Dr. Shoenfeld commented
that the cause of PTS is unclear but it seems to involve an interaction between genetic
predisposition, mechanical vulnerability, and an autoimmune trigger that could come from
the vaccines at issue here.
With respect to possible effects of the Hepatitis A (“Hep A”) vaccine, Dr. Shoenfeld
cited a 2011 study of children after Hep A vaccinations which found a statistically
significant number of children with autoantibodies in their blood, signaling an autoimmune
response to the vaccine. He also pointed to a case report of a man who developed
autoimmune hepatitis after a Hep A vaccination. Turning to the Hepatitis B (“Hep B”)
vaccine, Dr. Shoenfeld referenced studies that he claimed linked Hep B to several
autoimmune diseases such as multiple sclerosis; however PTS was not included in the chart
showing possible Hep B autoimmune reactions, and Dr. Shoenfeld pointed out that because
the chart was based largely on individual case reports, “the evidence is not strong.” He
then discussed possible mechanisms such as “molecular mimicry” by which Hep B could
cause PTS by inducing the body to have an autoimmune response, although his discussion
was based on transverse myelitis (“TM”), an autoimmune disease unrelated to PTS.
Regarding the 45-day time elapsed between Petitioner’s vaccination and her first report of
shoulder problems, Dr. Shoenfeld argued that 45 days was an appropriate time for the
vaccine to have induced PTS. To support this position, he provided a chart summarizing
time lapsed after vaccination with a variety of vaccines (including Hep B) for cases of TM.
The thirteen examples where Hep B was given show time elapsed for diagnosis after
vaccination ranging from one week to 27 weeks. Each of the examples was an individual
case, and each of the cases dealt with TM and not with PTS.
B. Respondent’s Expert
Respondent’s expert opinion (Dkt. No. 18) was presented by Dr. Eric Lancaster, a
physician on staff at the Center for Autoimmune Neurology at the University of
Pennsylvania, as well as an assistant professor of neurology at the same University. He is
board certified in neurology with subspecialties in neuromuscular medicine and
neuromuscular electrodiagnostic testing, which he stated is critical for proper diagnosis of
PTS. His recent publications and research have focused on autoimmune neurological
disorders. He has treated five to ten patients with PTS, which is also known as brachial
plexitis, referring to an inflammatory injury of the network of nerves in the shoulder. After
reviewing Petitioner’s medical records, Dr. Lancaster found that the diagnosis of PTS was
not supported by the medical records, noting no showing of weakness when pain was not
present and also no indication of atrophy, sensory loss or persistent numbness. He also
observed that no detailed neurological examinations were done to investigate possible
injury to the nerves, and thus identify which nerves might be injured and what
abnormalities might have been caused. Assuming Petitioner in fact has PTS, Dr. Lancaster
4
expressed the opinion that 45 days between vaccination and reaction is too long to associate
PTS with the vaccine, citing a 1994 study of the risk of PTS after certain vaccinations (not
related to hepatitis), which found the maximum time after vaccination to be four weeks.
He also stated that there is no reliable medical evidence that hepatitis vaccines cause PTS,
and cited a 2011 Institute of Medicine study which “found no evidence to support the [Hep
B] vaccine as cause for PTS.”
C. Petitioner’s Expert Rebuttal
Dr. Schoenfeld’s rebuttal (Dkt. No. 26) filed at the request of the Special Master is
limited. He refutes Dr. Lancaster’s conclusion that there is insufficient evidence in the
medical record to support a diagnosis of PTS by stating that the treating physician’s
diagnosis and Petitioner’s Affidavit reporting her symptoms should be relied on. He then
defends his theory that molecular mimicry stemming from the Hep B vaccine could have
caused Petitioner’s PTS, citing studies that relate to the variety of antigens possibly
produced by the Hep B vaccine.
IV. Burden of Proof
Ms. Garner seeks recovery in this case for an “off-Table” injury, that is, an injury
caused by a vaccine other than those injuries listed on the Vaccine Injury Table, 42 U.S.C.
§ 300aa-14(a). In off-Table injuries, claimants must show causation in fact by a
preponderance of the evidence. 42 U.S.C. §§ 300aa-11(c)(1)(C)(ii), 300aa-13(a)(1)(A);
see also Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed. Cir.
2010). The U.S. Court of Appeals for the Federal Circuit summarized the claimant’s
evidentiary burden associated with off-Table cases in Althen v. Secretary of Health and
Human Services, 418 F.3d 1274, 1278 (Fed. Cir. 2005), holding that she must establish by
preponderant evidence:
(1) a medical theory causally connecting the vaccination and the injury;
(2) a logical sequence of cause and effect showing that the vaccination was the
reason for the injury; and
(3) a proximate temporal relationship between vaccination and injury.
These factors are now commonly referred to as the three Althen prongs.
V. Special Master’s Decision
In denying Petitioner’s claim for compensation, the Special Master found that Ms.
Garner had failed to carry her burden of proof to establish entitlement to compensation.
He analyzed Ms. Garner’s medical theory connecting the PTS to the vaccination (Althen
prong one) concurrently with the timeframe described between vaccination and injury
(Althen prong three). Dec. at 20. In his view, Petitioner’s theory that Hep A and/or B
5
vaccines could cause PTS through a molecular mimicry mechanism has “some reliability,”
but it breaks down when applied to the events reported by Petitioner. Petitioner claimed
vaccine-induced PTS started 45 days from vaccination, but then stopped for five months
before flaring up again in June 2012 when PTS was first diagnosed by Dr. Shah. The
Special Master found no “medically plausible” explanation for the intermittent start and
stop of Petitioner’s symptoms. Id. at 21. Also, focusing on the 45-day period between
vaccination and first reported shoulder pain, the Special Master found that this was too
long a delay for PTS to be attributed to the vaccination. He discussed the chart offered by
Dr. Shoenfeld which showed time elapsed for development of vaccine-associated TM and
concluded that TM cannot be equated with PTS, which “has not been shown to involve
demyelination like TM.” He also observed that the chart proposed such a wide range of
onset times that it is almost “facially useless.” Id. at 22. He found that Respondent’s
expert, Dr. Lancaster, had persuasively established that PTS would likely occur far sooner.
He also noted a study submitted by Petitioner which showed that PTS often has a sudden
onset of severe pain, measured in just a few days after the triggering injury or vaccination.
Id. With respect to proof of Althen prong two, requiring a showing of a “logical sequence
of cause and effect” that the vaccination caused the injury, the Special Master discussed in
detail the “paucity of evidence” supporting a diagnosis of PTS in the first place. Although
he was reluctant to find “that the evidence absolutely does not support the diagnosis,” he
found that Petitioner had not shown that an autoimmune process had caused the PTS, when
other possible causes (such as the shoulder dislocation) had not been ruled out. He also
noted that none of Petitioner’s treating physicians had mentioned a link between the PTS
and vaccination. Id. at 24-25. The Special Master found that Petitioner had failed to meet
her burden of proof for Althen prongs two and three, and thus denied her claim: “The
medical record in this case reveals that Petitioner’s injury is too far removed from the time
of vaccination to plausibly suggest a link between the two, nor has Petitioner presented a
persuasive or reliable causation theory that fits the facts.” Id. at 25.
Discussion
I. Standard of Review
This Court has jurisdiction to review decisions of the Special Masters in accordance
with 42 U.S.C. § 300aa-12(e)(1)-(2). The Special Master’s findings of fact receive
deferential review under an “arbitrary and capricious” standard, while the Court reviews
legal conclusions under the “not in accordance with law” standard and discretionary rulings
for an “abuse of discretion.” Munn v. Sec’y of Health & Human Servs., 970 F.2d 863, 870
n.10 (Fed. Cir. 1992). “The arbitrary and capricious standard of review is difficult for [a
petitioner] to satisfy with respect to any issue, but particularly with respect to an issue that
turns on the weighing of evidence by the trier of fact.” Lampe v. Sec’y of Health & Human
Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000). “Weighing the persuasiveness of particular
evidence often requires a finder of fact to assess the reliability of testimony, including
6
expert testimony, and we have made clear that the special masters have that responsibility
in Vaccine Act cases.” Moberly, 592 F.3d at 1325.
II. Motion for Review and Response
Petitioner argues that the Special Master committed error in finding that Petitioner
failed to meet her burden of proof to establish Althen prongs two and three. She urges that
the Special Master required an impermissible level of scientific certainty in establishing a
medically acceptable timeframe for development of her PTS. With respect to proof of
causation of the injury, Petitioner argues that more weight should be given to the treating
physician records. Petitioner also claims that the Special Master abused his discretion in
failing to hold an evidentiary hearing before making his decision on the written record,
arguing that the Special Master could not assess Petitioner’s credibility in making her
claims of injury. Petitioner claims that the absence of her testimony caused the Special
Master to “decide points against her.” Pet’rs’ Mot. for Rev. 18, Dkt. No. 35. In addition,
Petitioner filed with the Motion for Review three medical literature exhibits which were
not a part of the record below. Dkt. Nos. 34, 38. Petitioner claims that those reports should
be considered by the reviewing Court because Petitioner’s expert reports had referred to
them without actually submitting them.
Respondent counters that the Special Master applied the correct evidentiary
standards and rationally explained his conclusions. Regarding causation of the PTS,
Respondent maintains that Petitioner did not prove by preponderant evidence that the
vaccination was the “but for” cause of the injury, as required by prong two, and that a
Special Master can consider evidence of an alternate cause for an injury in assessing the
proof. Resp’t’s Mem. in Resp. to Pet’rs’ Mot for Rev. 15, Dkt. No. 40. As to Petitioner’s
challenge to the decision to rule without a hearing, Respondent points out that Petitioner
did not object to this approach in the Special Master’s proceeding and in fact filed a motion
to rule on the record, and in any event, Special Masters have wide discretion as to whether
to hold an evidentiary hearing. Finally, Respondent objects to Petitioner’s submission of
new medical literature exhibits with the Motion for Review, arguing that this Court should
decline to consider them because they were not a part of the record before the Special
Master.
Conclusion
With regard to the three medical articles filed by Petitioner which were not a part
of the record below, this Court’s Vaccine Rule 8(f)(1), found in Appendix B of the Rules
of the Court of Federal Claims, prohibits inclusion of any facts or arguments not raised
7
specifically in the record before the Special Master. For this reason the Court declines to
consider the three articles in reaching its decision.
The Court has carefully considered the parties’ arguments, the evidence of record,
and the Special Master’s decision on entitlement, and is satisfied that the Special Master
set forth a reasonable basis for his decision. To prove that the vaccination caused the injury
(Althen prong two), Petitioner must 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). The Special Master reasonably found here that there was insufficient evidence to
support Petitioner’s claim that the vaccination was the “but for” cause of her PTS. He
noted Petitioner’s failure to rule out other possible causes of her injury, which
Respondent’s evidence had suggested could have been caused by the long overseas flight
or by her dislocated shoulder. The Special Master also addressed the claimed timeframe
in this context because a medically acceptable timeframe “bolsters a link between the injury
alleged and the vaccination at issue under the ‘but-for’ prong of the causation analysis.”
Id. at 1358. In that regard he reasonably found the 45-day time between vaccination and
first claimed injury to be too long to prove causation, relying in part on Respondent’s
expert’s discussion of timeframe in the context of PTS.
Petitioner’s argument that the Special Master should have conducted an evidentiary
hearing in this case, rather than ruling on the record, is not persuasive. Vaccine Rule 8(d)
authorizes a special master to “decide a case on the basis of the written record without an
evidentiary hearing.” Moreover, Petitioner did not challenge the Special Master’s decision
to proceed without a hearing when she filed her Motion for a Ruling on the Record. Dkt.
No. 28. As to Petitioner’s claim that the Special Master “decide[d] points against her” in
the absence of live testimony, the Special Master specifically reserved judgment on the
veracity of Petitioner’s claim of PTS. Dec. at 24. He instead reasonably found that
assuming Petitioner had contracted PTS, she had failed to prove that the vaccination caused
it under the three-part Althen test.
For these reasons, the Special Master’s Decision is AFFIRMED and accordingly,
Petitioner’s Motion for Review is DENIED. Pursuant to Vaccine Rule 18(b), each party
is afforded 14 days from the date of this decision to object to the public disclosure of any
information submitted by that party. After that period, this opinion will be released to the
public.
IT IS SO ORDERED.
s/ Thomas C. Wheeler
THOMAS C. WHEELER
Judge
8