Court Opinion

ID: 4357154
Source: CourtListenerOpinion
Date Created: 2019-01-09 16:01:28.274538+00
Date Added: 2024-06-11T14:46:26.901616
License: Public Domain

United States Court of Appeals
      for the Federal Circuit
                ______________________

   LAURA OLIVER, AND, EDDIE OLIVER, JR.,
 PARENTS AND LEGAL REPRESENTATIVES OF
                   E.O., III,
            Petitioners-Appellants

                           v.

      SECRETARY OF HEALTH AND HUMAN
                  SERVICES,
              Respondent-Appellee
             ______________________

                      2017-2540
                ______________________

    Appeal from the United States Court of Federal
Claims in No. 1:10-vv-00394-EDK, Judge Elaine Kaplan.
                 ______________________

   ON PETITION FOR PANEL REHEARING AND
            REHEARING EN BANC
             ______________________

    CLIFFORD JOHN SHOEMAKER, Shoemaker and Associ-
ates, Vienna, VA, filed a combined petition for panel
rehearing and rehearing en banc for petitioners-
appellants.

    DANIEL ANTHONY PRINCIPATO, Torts Branch, Civil
Division, United States Department of Justice, Washing-
ton, DC, filed a response to the petition for respondent-
2                                                 OLIVER   v. HHS

appellee. Also represented by JOSEPH H. HUNT, C.
SALVATORE D’ALESSIO, CATHARINE E. REEVES, HEATHER L.
PEARLMAN.
               ______________________

     Before PROST, Chief Judge, NEWMAN, LOURIE, DYK,
    MOORE, O’MALLEY, REYNA, WALLACH, TARANTO, CHEN,
            HUGHES, and STOLL, Circuit Judges.
     NEWMAN, Circuit Judge, with whom REYNA, Circuit
    Judge, joins, dissents from the denial of the petition for
                       rehearing en banc.
PER CURIAM.
                           ORDER
       Appellants Laura Oliver and Eddie Oliver, Jr., par-
ents and legal representatives of E.O., III, filed a com-
bined petition for panel rehearing and rehearing en banc.
A response to the petition was invited by the court and
filed by the Secretary of Health and Human Services.
The petition for rehearing and response were first re-
ferred to the panel that heard the appeal, and thereafter
referred to the circuit judges who are in regular active
service. A poll was requested, taken, and failed.
         Upon consideration thereof,
         IT IS ORDERED THAT:
         The petition for panel rehearing is denied.
         The petition for rehearing en banc is denied.
         The mandate of the court will issue on January 16,
2019.
                                   FOR THE COURT

    January 9, 2019               /s/ Peter R. Marksteiner
         Date                     Peter R. Marksteiner
                                  Clerk of Court
  United States Court of Appeals
      for the Federal Circuit
                  ______________________

    LAURA OLIVER AND EDDIE OLIVER, JR.,
  PARENTS AND LEGAL REPRESENTATIVES OF
                    E.O., III,
             Petitioners-Appellants

                             v.

      SECRETARY OF HEALTH AND HUMAN
                 SERVICES,
              Respondent-Appellee

                  ______________________

                        2017-2540
                  ______________________

    Appeal from the United States Court of Federal
Claims in No. 1:10-vv-00394-EDK, Judge Elaine Kaplan.
                 ______________________

NEWMAN, Circuit Judge, with whom REYNA, Circuit
Judge, joins, dissenting from the denial of the petition for
rehearing en banc.
     I write in dissent, for the court’s ruling conflicts with
the terms and the premises of the Vaccine Act. Here,
baby Oliver (“E.O.”), within hours of his 6-month well-
baby DTaP vaccinations, experienced fever and seizures,
followed by more seizures and encephalopathies and
developmental injuries. The government’s position is that
the Vaccine Act is not available to E.O. because of his
genetic makeup. This ruling is legally and scientifically
2                                            OLIVER   v. HHS

incorrect. It has important implications for national
vaccine immunization programs, for scientific study now
suggests that previously unexplained vaccine injury is
related to genetic makeup. En banc attention is warrant-
ed.
The National Childhood Vaccine Injury Act of 1986
    It had long been known that a small percentage of
childhood vaccinations have led to grave injury and
permanent disability, as discussed in the legislative
record:
    Childhood vaccines are essential to maintain the
    health of our society. They have been invaluable
    weapons against the dread diseases that used to
    kill or injure hundreds of thousands of children
    every year: polio, measles, pertussis, diphtheria,
    tetanus, rubella, mumps, and smallpox. But
    while these vaccines have brought the gift of life
    and health to millions, there are a very small
    number of children every year who are injured by
    unpredictable side effects of the vaccines through
    no fault of their own or the vaccine manufactur-
    ers.
132 Cong. Rec. S17,343–02 (1986) (statement of Sen.
Kennedy). The House Report reiterated the concern for
unforeseeable injury flowing from compulsory vaccina-
tions:
    While most of the Nation’s children enjoy greater
    benefit from immunization programs, a small but
    significant number have been gravely injured.
    ....
    . . . But it is not always possible to predict who
    they will be or what reactions they will have. And
    since State law requires that all children be im-
    munized before entering school, most parents
OLIVER   v. HHS                                           3

   have no choice but to risk the chance—small as
   that may be—that their child may be injured from
   a vaccine.
H.R. Rep. No. 99-908, at 4–6 (1986), as reprinted in 1986
U.S.C.C.A.N. 6344, 6345–46.
    The legislative record states that about one half of one
percent of children each year experience vaccine-related
injury; 1 and with four million births each year in the
United States, this is about 20,000 vaccine injuries per
year. 2 The record referred to the withdrawal of vaccine
manufacturers in the United States:
   [A] major vulnerability is the unresolved public
   policy problem of liability for unavoidable injury
   in mass immunization programs. The specter of
   high and uncertain damage awards contributes to
   driving manufacturers out of vaccine produc-
   tion . . . .
Examination of the Task Force Report on the Vaccine
Pertussis: Before the Comm. on Labor & Human Res.,
98th Cong. 3 (1983) (statement of Sen. Hawkins) (“S. Hrg.
98-350”). It was reported that “there is only one pharma-
ceutical manufacturer in the entire United States for 19
types of vaccine products and no U.S. manufacturer of 11
other vaccine products.” Id. Congress also recognized the
concern for children whose “futures [had] been destroyed”

   1    To Amend the Public Health Service Act to Provide
for the Compensation of Children and Others Who Have
Sustained Vaccine-Related Injury, and for Other Purposes:
Hearing on S. 2117 Before the Comm. on Labor & Human
Res., 98th Cong. 21 (1984) (“S. Hrg. 98-1060”).
    2   Joyce A. Martin et al., Births: Final Data for 2017,
67 National Vital Statistics Reports 1, 3 (2018),
https://www.cdc.gov/nchs/data/nvsr/nvsr67/nvsr67_08-
508.pdf.
4                                            OLIVER   v. HHS

by vaccine-related injury and whose “mounting expenses
must be met.” H.R. Rep. No. 99–908, at 6 (1986), as
reprinted in 1986 U.S.C.C.A.N. 6344, 6347.
    Thus the Vaccine Act was developed as a no-fault sys-
tem to compensate “vaccine-injured persons quickly,
easily, and with certainty and generosity.” Id. at 3. The
Act is supported by payments to the Vaccine Injury Com-
pensation Trust Fund, 26 U.S.C. § 9510, funded by a tax
of “75 cents per dose of any taxable vaccine.” 26 U.S.C.
§ 4131(b)(1).
    Infant E.O.’s seizures and fever appeared the evening
of his DTaP vaccinations. The government argues and
the court holds that Vaccine Act compensation is not
available because E.O. has a genetic mutation that might
injure him at some time. This ruling negates the purpose
of the Vaccine Act, for E.O. was required to be vaccinated
and he was injured thereby. He is directly within the
letter and the purpose of the Vaccine Act.
    E.O’s vaccine injury is typical of the vaccine
    injury that necessitated the Vaccine Act
     On April 9, 2009 E.O. received his six-month well-
baby check-up. His pediatrician administered the requi-
site DTaP vaccine (diphtheria-tetanus-acellular pertus-
sis). That evening he was observed with seizures and a
fever, and was taken to the emergency room. The record
details his tragic history of seizures, encephalopathies,
and developmental disabilities.
    After E.O.’s reaction to the DTaP vaccine, his parents
obtained an analysis of his DNA. It was found that E.O.
has a mutation of the SCN1A gene—a mutation that has
been found to sometimes be associated with an epileptic
condition called “Dravet syndrome.” The government’s
position is that it is irrelevant whether the vaccine trig-
gered E.O.’s adverse reactions, for this mutation alone
could have led to injury.
OLIVER   v. HHS                                          5

    The government’s theory is not that E.O.’s genetic
mutation contributed to his injury, for that would invoke
the “preexisting condition” provision of the Vaccine Act.
See 42 U.S.C. § 300aa-33(4). Rather, the government’s
theory is that E.O.’s mutation would itself have caused
the injury he experienced; on this reasoning, the govern-
ment argued that the Vaccine Act does not apply to E.O.’s
injury. The Chief Special Master and the courts agreed.
    Despite record evidence that 20–30% of persons with
Dravet syndrome do not have the SCN1A mutation, see
Anne M. McIntosh et al., Effects of Vaccination on Onset
and Outcome of Dravet Syndrome: A Retrospective Study,
9(6) Lancet Neurol. 592–98 (2010), my colleagues refused
to consider the data that over half the persons with the
SCN1A mutation do not experience Dravet syndrome, for
these data were published after the Special Master’s
decision. See Valentina Cetica et al., Clinical and Genetic
Factors Predicting Dravet Syndrome in Infants With
SCN1A Mutations, 88(11) Neurology 1037 (2017) (report-
ing that “[w]e observed 123 different SCN1A mutations”
and that they “could not predict with high confidence
Dravet syndrome vs milder phenotypes” and “outcome is
not predetermined by genetic factors only.”).
    Nonetheless the government argues, and my col-
leagues affirm, that E.O. would have been gravely injured
due to his SNC1A mutation—that it is his “destiny”—and
that it is irrelevant that the DTaP vaccinations initiated
the seizures and their consequences. However, this is
precisely the event at which the Vaccine Act is aimed, lest
concerned parents withhold vaccinations, and concerned
manufacturers cease production of vaccines.
   Advances of science provide hope for avoid-
   ing vaccine injury—not grounds for avoiding
   compensation for vaccine injury
    The Vaccine Act and its compensation program are of
national importance, and immunizations are increasing.
6                                               OLIVER   v. HHS

A child born today may receive up to 25 vaccinations by
the age of 18 months—three doses of hepatitis B; three
doses of rotavirus; three doses of diphtheria, tetanus, and
acellular pertussis; four doses of influenza type B; four
doses of pneumococcal conjugate; three doses of inactivat-
ed poliovirus; one dose of influenza; one dose of measles,
mumps, and rubella; one dose of varicella; and two doses
of hepatitis A. 3
    The Vaccine Act places some injuries on a presump-
tive injury Table, and other injuries require evidence that
the subject “sustained, or had significantly aggravated,
any illness, disability, injury, or condition not set forth in
the Vaccine Injury Table but which was caused by a
vaccine . . . .” 42 U.S.C. § 300aa-11(c)(1)(C)(ii)(I). “Aggra-
vation” refers to a preexisting condition. See id. at
§ 300aa-33(4) (“The term ‘significant aggravation’ means
any change for the worse in a preexisting condition which
results in markedly greater disability, pain, or illness
accompanied by substantial deterioration of health.”).
    The role of genetic knowledge in the vaccine compen-
sation program requires deeper understanding than the
“destiny” pejorative that removed E.O. and others from
the program despite the direct relation between vaccina-
tion and injury. Recent years have seen powerful advanc-
es in knowledge. The Human Genome Project, starting in
1990, involved scientists around the world in identifying
and sequencing all three billion base pairs (approximately
25,000 genes) that constitute the human genome. 4 This
took 13 years and about $2.7 billion dollars. 5 Today

    3   https://www.aap.org/en-us/Documents/immuniz-
ation-_schedule2018.pdf.
    4   https://report.nih.gov/NIHfactsheets/View-
FactSheet. aspx?csid=45.
    5   https://www.genome.gov/11006943/human-
genome-project-completion-frequently-asked-questions/.
OLIVER   v. HHS                                           7

genetic analysis can be completed in a few days or hours,
and mechanization is continually adding speed and reduc-
ing cost.
    With new analytic resources, and the ever-increasing
importance of immunizations, many scientific studies
have been directed to these aspects. A review states:
“Just until recently, the idea of genetics influencing the
response to vaccine exposure began to be further ex-
plored.” John Castiblanco & Juan-Manuel Anaya, Genet-
ics and Vaccines in the Era of Personalized Medicine, 16
Current Genomics 47, 49 (2015). These authors state:
   A vaccine generally improves immunity to a par-
   ticular disease upon administration by inducing
   specific protective and efficient immune responses
   in all of the receiving population. The main
   known factors influencing the observed heteroge-
   neity for immune responses induced by vaccines
   are gender, age, co-morbidity, immune system,
   and genetic background.
Id. at Abstract. And “[t]he effect of the genetic status, in
defining the response generated directly or indirectly with
an innate or adaptative immune response, has been
demonstrated across multiple viral vaccines (e.g., small-
pox, influenza, measles, rubella, and mumps).” Id. at 47.
    The scientific literature describes new fields called
“vaccinomics” and “adversomics,” directed to understand-
ing and predicting how an individual will respond to a
vaccine, as further summarized by GA Poland et al.,
Personalized Vaccinology: A Review, 38 Vaccine 5350,
(2018). Poland et al. earlier wrote, in Heterogeneity in
Vaccine Immune Response: The Role of Immunogenetics
and the Emerging Field of Vaccinomics, 82 Clinical
Pharmacol Ther. 653 (2007):
   this new golden age of vaccinology has been
   termed “predictive vaccinology,” which will predict
8                                              OLIVER   v. HHS

    the likelihood of a vaccine response or an adverse
    response to a vaccine, the number of doses needed
    and even whether a vaccine is likely to be of bene-
    fit (i.e., is the individual at risk for the outcome
    for which the vaccine is being administered?).
Id. at Abstract. See also Jennifer A. Whitaker et al.,
Adversomics: A New Paradigm for Vaccine Safety and
Design, 14 Expert Review Vaccines 935 (2015):
    [T]he field of vaccine adversomics is in its infancy.
    At this time, these technologies are not being used
    clinically. The first step in advancing this science
    is to use adversomics research techniques to un-
    derstand the mechanisms behind adverse events
    that have a causal relationship with immuniza-
    tion . . . . The precise mechanisms of adverse reac-
    tions associated with vaccines are not well
    understood.          Understanding the molecu-
    lar/genetics/proteomics level (i.e., adversomics) in-
    volvement, specifically how genetics (genomics
    and transcriptomics) impact the development of
    vaccine adverse reactions, may aid in the design of
    newer and safer vaccine candidates.
Id. at 939.
   Rebecca E. Chandler, Harm Caused by Vaccines
Might Vary Between Individuals, 358 British Medical
Journal (Online) (2017), refers to:
    A growing number of publications in the literature
    describe links between [adverse events following
    immunization] and individual variation. . . . [in-
    cluding] the discovery of genetic variants associ-
    ated with an increased risk of febrile convulsions
    after the measles, mumps, and rubella and small-
    pox vaccines.
   There’s much more. The government’s theory that the
mere existence of E.O’s SCN1A mutation doomed him to a
OLIVER   v. HHS                                           9

lifetime of seizures and disability—although no sign
appeared until the night of his DTaP vaccination, has
been overtaken by science. The court’s ruling is a misap-
plication of knowledge and a distortion of the Vaccine Act.
   En banc action is required, to correct our
   precedent in view of advances in knowledge
    I am optimistic that advances in science may reduce
the 20,000 new vaccine injuries per year, by providing
predictability and preventive capability. Meanwhile, the
court has erred in removing vaccine-injured children from
access to the Vaccine Act if they are found to have a
genetic mutation. Several decisions of this court have
accepted this flawed premise.
    In Snyder v. Sec’y of Health & Human Servs., 553 F.
App’x 994, 1004 (Fed. Cir. 2014), this court held that “the
evidence supports a finding that the SCN1A gene muta-
tion was, more likely than not, the sole cause” of the
seizure disorders that occurred upon vaccination. This
over-simplification has been discredited, see Cetica, supra.
Until legislative attention brings the statute into conform-
ity with advancing science it befalls the court to do our
best to get it right.
    In Deribeaux ex rel. Deribeaux v. Sec’y of Health &
Human Servs., 717 F.3d 1363, 1368 (Fed. Cir. 2013),
although the infant experienced a prolonged seizure the
day after the DTaP vaccination, and continued to experi-
ence seizures and convulsions, this court affirmed the
Special Master’s finding that “the SCN1A gene mutation
was the sole substantial cause of Deribeaux’s seizure
disorder and developmental delays.” However, the wealth
of scientific knowledge between then and now teaches
that a “sole” cause is rare indeed.
   In Stone v. Sec’y of Health & Human Servs., 676 F.3d
1373 (Fed. Cir. 2012), rehearing denied, 690 F.3d 1380,
1382 (Fed. Cir. 2012), this court held that a mutation was
10                                            OLIVER   v. HHS

solely responsible for the child’s seizures that were initi-
ated by the vaccination.
    In all of these cases, there was a direct cause-and-
effect relation between vaccination and the seizure re-
sponse, yet the court held that the vaccination did not
bring the injury within the Vaccine Act. This is a case of
“a little knowledge” producing an over-simplification of
extraordinarily complex relationships, while contravening
the purposes of the Vaccine Act: to share the burden of
vaccine injury, while preserving the development and
manufacture of vaccines.
                           ***
    The government argued that E.O. would have been
gravely injured independent of his six-month vaccina-
tions. This is not only contrary to the statute; it is also
contrary to the scientific evidence, for it is conceded that
E.O.’s DTaP vaccinations triggered an immediate reaction
of seizures and fever, followed by more seizures, encepha-
lopathies, and ensuing disability.
    The only difference between this case and a compen-
sable case was that E.O.’s parents had his DNA analyzed.
Modern science is starting to explain what had previously
been inexplicable. In retrospect, had E.O.’s mutation
been known before his routine six-month vaccination, the
vaccination might not have occurred. But DNA analysis
before vaccination is not compulsory—vaccination is
compulsory.
    We should rehear en banc, to apply the Vaccine Act in
accordance with its purpose. From the denial of reconsid-
eration, I respectfully dissent.