Stone v. Secretary of Health & Human Services

United States Court of Appeals
for the Federal Circuit
__________________________
JENNIFER STONE and GARY STONE,
Parents and Next Friends of,
AMELIA STONE, a Minor,
Petitioners-Appellants,
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee.
__________________________
2011-5109
__________________________
Appeal from the United States Court of Federal
Claims in case no. 04-VV-1041, Senior Judge Lawrence S.
Margolis.
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SCOTT R. HAMMITT,
as the Legal Representative of his Minor Daughter,
RACHEL HAMMITT,
Petitioner-Appellant,
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee.
__________________________
2011-5117
__________________________
STONE v. HHS 2
Appeal from the United States Court of Federal
Claims in No. 07-VV-170, Judge Thomas C. Wheeler.
__________________________
ON PETITION FOR REHEARING EN BANC
__________________________
RICHARD GAGE, Richard Gage, P.C., of Cheyenne,
Wyoming, filed a consolidated petition for rehearing en
banc for petitioners-appellants in appeal no. 2011-5109.
With him on the petition was CURTIS R. WEBB, of Twin
Falls, Idaho, for petitioner-appellant in appeal no. 2011-
5117.
ALEXIS B. BABCOCK, Trial Attorney, Torts Branch,
Civil Division, United States Department of Justice, of
Washington, DC, filed a response for respondent-appellee
in appeal no. 2011-5109. With her on the response was
ALTHEA W. DAVIS, Senior Trial Counsel for respondent-
appellee in appeal no. 2011-5117; STUART F. DELERY,
Acting Assistant Attorney General, RUPA
BHATTACHARYYA, Director, MARK W. ROGERS, Deputy
Director, GABRIELLE M. FIELDING, Assistant Director, and
CATHARINE E. REEVES, Assistant Director.
__________________________
Before RADER, Chief Judge, NEWMAN, LOURIE, SCHALL ∗
BRYSON, LINN, DYK, PROST, MOORE, O’MALLEY, REYNA,
and WALLACH, Circuit Judges.
PER CURIAM.
NEWMAN, Circuit Judge, dissents from the denial of the
petition for rehearing en banc.
∗
Judge Schall participated in the decision for
panel rehearing.
3 STONE v. HHS
ORDER
A consolidated petition for rehearing en banc was filed
by the Petitioners-Appellants, and a response thereto was
invited by the court and filed by the Respondent-Appellee.
The petition for rehearing was referred to the panel that
heard the appeal, and thereafter the petition for rehear-
ing en banc and the response were referred to the circuit
judges who are authorized to request a poll of whether to
rehear the appeal en banc. A poll was requested, taken,
and failed.
Upon consideration thereof,
IT IS ORDERED THAT:
(1) The petition of Petitioners-Appellants for panel
rehearing is denied.
(2) The petition of Petitioners-Appellants for rehear-
ing en banc is denied.
(3) The mandate of the court will issue on September
4, 2012.
FOR THE COURT
August 27, 2012 /s/ Jan Horbaly
Date Jan Horbaly
Clerk
United States Court of Appeals
for the Federal Circuit
__________________________
JENNIFER STONE and GARY STONE,
Parents and Next Friends of,
AMELIA STONE, a Minor,
Petitioners-Appellants,
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee.
__________________________
2011-5109
__________________________
Appeal from the United States Court of Federal Claims
in No. 04-VV-1041, Senior Judge Lawrence S. Margolis.
- - - - - - - - - - - - - - - - - - - - - - - - - --
SCOTT R. HAMMITT,
as the Legal Representative of his Minor Daughter,
RACHEL HAMMITT,
Petitioner-Appellant,
v.
SECRETARY OF HEALTH AND HUMAN
SERVICES,
Respondent-Appellee.
__________________________
STONE v. HHS 2
2011-5117
__________________________
Appeal from the United States Court of Federal Claims
in No. 07-VV-170, Judge Thomas C. Wheeler.
__________________________
NEWMAN, Circuit Judge, dissenting from denial of the
petition for rehearing en banc.
These consolidated cases raise an important new princi-
ple, one that is fundamental to the Vaccine Act, and that
could not have arisen but for recent advances in genetic
science.
Amelia Stone and Rachel Hammitt were healthy in-
fants, and developing normally until they received their
second vaccinations for Diptheria-Tetanus-acellular Pertus-
sis ("DTaP"), after which both experienced seizures. The
government conceded that the seizures were a result of the
vaccination. These events were followed by additional
seizures and developmental delays, eventually diagnosed as
Severe Myoclonic Epilepsy of Infancy ("SMEI"), also known
as Dravet's Syndrome, a severe seizure disorder that ap-
pears during the first year of life and is characterized by
febrile and other types of seizures, including myoclonic
seizures, cognitive impairment, developmental delays in
language and motor skills, and hyperactivity. See Snyder v.
Sec'y of HHS, 102 Fed. Cl. 305, 310 n. 16 (Fed. Cl. 2011).
The Secretary conceded that the seizures triggered by
the vaccinations marked the onset of the course of illness for
both previously healthy infants. Secretary’s brief in Stone v.
HHS, filed Oct. 27, 2012, at 17. The Special Master stated
that ordinarily, there would be no issue as to entitlement to
compensation under the Vaccine Act. See Stone v. HHS,
3 STONE v. HHS
2010 WL 1848220, at *7 (Special Master Report that “the
undersigned finds that petitioners would have likely demon-
strated entitlement to compensation if respondent had not
demonstrated that Amelia’s SMEI was caused by the ge-
netic mutation located in her SCN1a gene”) (quoted in
Secretary’s brief 10). Nevertheless, the Special Master and
the Court of Federal Claims denied Vaccine Act relief on the
ground that causation had not been shown. They held that
a DNA mutation in the SCN1A gene of each infant, which
the government’s experts testified appeared to be associated
with the seizure disorder of both claimants, could have
eventually produced the disorder.
These claimants plainly met the conditions for Vaccine
Act compensation, as summarized in Althen v. Sec'y of HHS,
418 Fed. 3d 1274 (Fed. Cir. 2005):
Concisely stated, [petitioner's] burden is to 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 relation-
ship between vaccination and injury. If [a peti-
tioner] satisfies this burden, she is entitled to
recover unless the [government] shows, also by a
preponderance of evidence, that the injury was in
fact caused by factors unrelated to the vaccine.
Id. at 1278 (internal citation omitted). The Vaccine Act was
enacted because it was known that some small percentage of
vaccine recipients will inevitably have highly adverse reac-
tions, no matter how pure the vaccine. Legislative testi-
mony emphasized that "approximately one dose of DPT
STONE v. HHS 4
vaccine in 310,000 will cause a severe adverse reaction,” and
that "[o]ther vaccines also cause problems in some recipi-
ents." 131 Cong. Rec. 6456 (1985).
The statistical record shows that: "Millions of children
are immunized yearly and of these, a small percentage have
adverse reactions, of which the most serious are retardation
and death." 132 Cong. Rec. 30121 (1986). Senator Kennedy
observed that “[i]n some cases, vaccination has meant death
or disease because of reactions that we do not fully under-
stand and which are probably unavoidable,” and that “there
are contraindications to the administration of even the
safest vaccines.” National Childhood Vaccine Injury Act of
1985: Hearing on S. 827 Before the S. Comm. on Labor and
Human Resources, 99th Cong. 4 (1985). Assistant Secretary
for Health Edward N. Brandt testified that “properly manu-
factured and administered vaccines can, on occasion, cause
unavoidable damage,” and that:
Although the occurrence of adverse events following
immunization can be minimized, it cannot be elimi-
nated entirely. Thus, there will always be a small
number of individuals who are harmed by the vac-
cines that protect our society.
Vaccine Injury Compensation: Hearings on H. R. 5810
Before the Subcomm. on Health and the Environment of the
H. Comm. on Energy and Commerce, 98th Cong. 61-62
(1984). Advances in genetic science are helping to explain
these observations.
Meanwhile, the situation is precisely that for which the
statute was enacted. These seriously disabled petitioners
are squarely within the purpose of the Vaccine Act, and
fully entitled to the compensation provided by statute.
From the denial of compensation, I respectfully dissent.