Immunizing Against Bad Science: The Vaccine Court and the Autism Test Cases
IMMUNIZING AGAINST BAD SCIENCE: THE VACCINE COURT AND THE AUTISM TEST CASES
LAUREN L. HAERTLEIN 0
0 Copyright © 2012 by Lauren L. Haertlein. This article is also available at
autism test case decisions raise significant “science and law” issues.6 Throughout
the autism test cases, there has been an overarching concern that a decision to
deny entitlement will result in a flood of autism claims in state courts. But
considering current scientific and medical knowledge, the concern over autism
cases moving into the civil sphere is likely overstated. Instead, attention should
be paid to how these autism claims reflect a broader concern: a loss of public
trust in vaccines.
The conclusion of the autism test cases is an opportunity to review the
success of the vaccine-injury program and its relationship to U.S. vaccination
practices. Part II of this note traces the history of vaccine-injury suits in the
United States, the creation of the Vaccine Court, and how vaccine-injury claims
are proven in the court. Part III introduces the vaccine–autism controversy and
the Vaccine Court’s decision to institute an omnibus proceeding to manage the
autism claims. Part IV provides an overview of the omnibus autism proceedings,
focusing on the Cedillo case. Part V sets forth an argument that the autism test
cases demonstrate how the current standard of proof in vaccine cases trends too
much toward awarding compensation and away from science. Vaccine Court
decisions are unlikely to restore public trust in vaccines, but the decisions can
contribute to public misperceptions. Compensating too many undeserving
petitioners undermines the integrity of vaccine safety. Accordingly, this
threatens to create a public health problem: If the standard of proof in the
Vaccine Court is too low, the court implicitly validates public fears about
vaccines and impacts public willingness to get vaccinated. To maintain public
trust in vaccines, the standard of proof in the Vaccine Court must be clearer and
more scientifically rigorous.
THE HISTORY OF VACCINE LITIGATION AND POLICY
A. Vaccine-Injury Lawsuits in the United States
Every state legally requires that children receive certain immunizations
before attending school or daycare.7 Many states provide medical, religious, and
even philosophical exemptions to vaccination requirements.8 Nevertheless, most
children in the United States today receive routine immunizations against
fourteen diseases.9 In rare cases, vaccines cause serious and even fatal
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effects.10 These side-effects can occur even if vaccines are produced and
In the mid- to late 1980s, there was a significant increase in the number of
vaccine-injury suits against vaccine manufacturers,12 possibly attributable to
heightened media coverage at the time about the risks of vaccinations. Media
coverage primarily focused on the diphtheria–tetanus–pertussis (DTP)
vaccine.13 Plaintiffs in these suits often sought millions in damages.14
Manufacturers worried that juries would award substantial damages to
sympathetic plaintiffs regardless of whether the manufacturers were at fault.15
Experiencing difficulty obtaining liability insurance, some manufacturers
withdrew from the market. Ultimately, only one commercial DTP manufacturer
remained in the U.S. market.16 In December 1984, the Centers for Disease
Control and Prevention (CDC) predicted the United States would experience
vaccine shortages as early as January 1985.17
B. The Vaccine Act
In 1986, Congress responded to the threat of a vaccine-supply crisis by
passing the National Childhood Vaccine Injury Act of 1986 (the Vaccine Act).18
The Vaccine Act created a no-fault program for resolving vaccine-injury
claims.19 Key features of this program are its relaxed procedures and unique
standard of proof.
1. The Vaccine Court The Vaccine Act created a comprehensive vaccine policy for the United States. This policy included a National Vaccine Injury Compensation Program (NVICP or the Vaccine Program), designed to be more accessible and less
adversarial than the traditional tort system.20 To adjudicate vaccine-injury
claims, the NVICP created an Office of Special Masters (OSM) in the United
States Court of Federal Claims (CFC),21 unofficially dubbed the Vaccine
Petitioners must file vaccine-injury claims with the Vaccine Court before
filing in state court.23 Special masters, without a jury, issue decisions on
entitlement.24 The Secretary of Health and Human Services (HHS) serves as the
respondent.25 Petitioners are not required to obtain legal counsel, but may
request reasonable attorneys’ fees regardless of the outcomes of their claims.26
Within thirty days after a petitioner files a claim with the Vaccine Court, the
special master assigned to the case holds a status conference with the parties to
assess the merits of the petitioner’s claim and facilitate settlement.27 If the case
goes forward, the Vaccine Court has 240 days to issue a decision or the
petitioner can exit the program and bring a claim in state court.28 After the
Vaccine Court issues a decision, a dissatisfied petitioner generally retains the
right to reject the judgment and file in state court.29 Additionally, either party
may apply to the CFC for review of a special master’s decision and appeal a
CFC decision to the U.S. Court of Appeals for the Federal Circuit.30
2. Proving a Claim in the Vaccine Court
To receive compensation, petitioners must prove they suffered one of two
kinds of injuries: “on-table” or “off-table.” On-table injuries are those listed in
the NVICP Vaccine Injury Table.31 This table includes adverse events known by
the medical community to occur after a vaccination.32 Injuries not on the table
or not occurring within the table’s timeframe constitute off-table claims. If a
petitioner proves, by a preponderance of the evidence, that he suffered an
ontable injury following an immunization, the Vaccine Court presumes the
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vaccine was the cause.33 To succeed with an off-table injury, a petitioner must
prove, by a preponderance of the evidence, that the vaccine was the
cause-infact of the injury.34 To prevent successful claims from effectively creating more
on-table injuries, decisions by special masters or the CFC are not binding on
special masters, except on remand in the same case.35 Originally, Congress
assumed that the majority of petitioners would file on-table claims. Recently,
however, the number of off-table claims has increased.36
The Vaccine Act explicitly forbids the court from finding actual causation
based solely on a petitioner’s statements unsupported by medical records or
expert medical opinion.37 Although the Vaccine Act does not require expert
testimony, experts have played an increasingly important role in successful
offtable vaccine-injury claims (not unlike non-vaccine litigation).38 This has
spurred numerous Federal Circuit decisions addressing what evidence is
necessary and sufficient to prove an off-table injury. These opinions have set a
low evidentiary bar: For example, in Knudsen v. Secretary of Department of
Health & Human Services, the Federal Circuit reversed and remanded a special
master’s decision to deny entitlement, stating that the petitioner’s theory of
causation needed only to be “‘logical’ and legally probable, not medically or
scientifically certain.”39 The court explained, “to require [the] identification and
proof of specific biological mechanisms would be inconsistent with the purpose
and the nature of the vaccine compensation program. The Vaccine Act does not
contemplate full blown tort litigation.”40 In a later case, the Federal Circuit
supported this interpretation of the standard of proof, citing Congress’s
acknowledgement that the Vaccine Program would compensate some
petitioners whose injuries were not actually vaccine-related.41 In another case,
the Federal Circuit objected to the special master’s requiring peer-reviewed
literature linking a petitioner’s vaccine and injury. The court stated that it saw
“no ‘objective confirmation’ requirement in the Vaccine Act’s preponderant
In Althen v. Secretary of Health & Human Services, the Federal Circuit
announced a new, three-prong standard of proof for off-table claims.43 Under
Althen, petitioners must present “(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.”44 If a
petitioner satisfies all three prongs, the government must prove, by a
preponderance of the evidence, an alternate cause for the petitioner’s injury.
The Federal Circuit stated that “close calls regarding causation are resolved in
favor of injured claimants.”45 The CFC has characterized the petitioner’s burden
as needing only to “to ‘tip the scale’ by the slightest of evidentiary margins.”46
Before Althen, the Federal Circuit stated that a petitioner’s proof of
causation must be supported by reliable scientific or medical explanations.47 The
Federal Circuit affirmed a special master’s refusal to credit an expert opinion
without support from medical literature or studies, remarking that “[a]n expert
opinion is no better than the soundness of the reasons supporting it,”48 and
acknowledged that Congress intended special masters to have broad discretion
to assess vaccine-injury evidence.49 Even post-Althen, the Federal Circuit
remarked that “[a]lthough a Vaccine Act claimant is not required to present
proof of causation to the level of scientific certainty, the special master is
entitled to require some indicia of reliability to support the assertion of [an]
Committee further recognizes that the deeming of vaccine-relatedness adopted here may provide
compensation to some children whose illness is not, in fact, vaccine-related.”) (quoting H.R. REP. NO.
), reprinted in 1986 U.S.C.C.A.N. 6344, 6359).
42. Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1279 (Fed. Cir. 2005).
43. Id. at 1278; see also Davis, supra note 5, at 52
(“[T]he Federal Circuit relaxed the causation
standard in 2005 . . . . The special master denied Althen compensation because [the petitioner] hadn’t
proved that the vaccine caused her condition, but the appellate court reversed—and announced a new
44. Althen, 418 F.3d at 1278.
45. Id. at 1280.
46. McClendon v. Sec’y of Dep’t Health & Human Servs., 24 Cl. Ct. 329, 333 (1991).
47. See, e.g., Knudsen v. Sec’y of Dep’t of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir.
1994) (“This ‘logical sequence of cause and effect’ must be supported by a sound and reliable medical
or scientific explanation.”); Grant v. Sec’y of Dep’t of Health & Human Servs., 956 F.2d 1144, 1148
(Fed. Cir. 1992) (“A reputable medical or scientific explanation must support this logical sequence of
cause and effect.”).
48. Perreira v. Sec’y of Dep’t of Health & Human Servs., 33 F.3d 1375, 1377 n.6 (Fed. Cir. 1994)
(citing Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993)).
49. Whitecotten v. Sec’y of Health & Human Servs., 81 F.3d 1099, 1108 (Fed. Cir. 1999)
(“Congress desired the special masters to have very wide discretion with respect to the evidence they
would consider and the weight to be assigned to [it].”).
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expert witness.”50 The Federal Circuit has confirmed recently that special
masters may use Daubert factors to evaluate the reliability of scientific evidence
presented in vaccine cases.51 In Daubert v. Merrell Dow Pharmaceuticals, Inc.,
the Supreme Court announced the standard by which judges determine the
admissibility of expert witness testimony in federal courts: the scientific validity
of the underlying reasoning or methodology and its proper application to the
facts of the case.52 The Court specifically stated that judges may consider
whether the theory can or has been tested, whether it has been published or
peer-reviewed, and its reception in the scientific community.53 Nevertheless,
since Althen, the Federal Circuit has reversed and remanded a number of
Vaccine Court decisions for impermissibly raising the standard of proof.54 The
autism cases demonstrate the possible practical consequences of the current low
standard of proof on vaccination practices, underscoring the need for a more
THE VACCINE–AUTISM CONTROVERSY
A. Linking Vaccines to Autism
Since 1999, the Vaccine Court has received more than five thousand claims
alleging that a vaccine caused or contributed to a petitioner’s autism.55 To
understand the impact of these autism cases, it is important to know the history
of the vaccine–autism controversy.
Autism spectrum disorders, which vary in degrees of severity, include
complex conditions that affect individuals’ abilities to interact socially and
communicate. Symptoms typically emerge before age three.56 There is no
laboratory test for autism; diagnosis is based on certain behavioral criteria.57
Since the 1980s, autism diagnoses have been on the rise in the United States,
increasing public awareness about the disorder and fueling speculations about
The vaccine–autism theory is often attributed to British physician Andrew
Wakefield. In 1998, Wakefield published an article in The Lancet linking the
measles–mumps–rubella (MMR) vaccine to autism. The Lancet later retracted
Wakefield’s article, and in May 2010, Wakefield lost his medical license for
reasons that included unethical conduct related to his autism research.59
In the United States, the vaccine–autism controversy has centered on
thimerosal.60 Thimerosal is an ethylmercury compound that has been used as a
preservative in vaccines since the 1930s.61 In the late 1990s, the FDA indicated
that thimerosal-containing vaccines might expose children to mercury levels
exceeding federal safe-intake guidelines.62 Subsequently, the federal Public
Health Service and American Academy of Pediatrics issued joint statements
recommending thimerosal be removed from vaccines—both as a precautionary
measure and as an effort to maintain public confidence in vaccine safety.63
Today, as many as one in four Americans believe that vaccines can cause
autism.64 The media has only inflamed the public’s fears. News reports have
cited studies linking thimerosal to autism and have featured scientists who
supported the theory.65 A number of high-profile politicians and celebrities have
discussed the theory publically. In 2005, Rolling Stone magazine published an
article by Robert Kennedy, Jr.—son of the late Senator Robert Kennedy—
called “Deadly Immunity,” in which Kennedy stated, “If, as the evidence
suggests, our public-health authorities knowingly allowed the pharmaceutical
industry to poison an entire generation of American children, their actions
arguably constitute one of the biggest scandals in the annals of American
medicine.”66 In 2008, celebrity Jenny McCarthy, whose son is autistic, appeared
on Larry King’s show on CNN and argued that vaccines can cause autism.67 The
vaccine–autism theory persists in public discourse at least in part because of
media attention and affirmations from high-profile sources.
about the causes).
59. Davis, supra note 5, at 53 (“Earlier this year, The Lancet retracted Wakefield’s article, stating
that ‘several elements’ of the paper were incorrect.”); Gross, supra note 56, at 1 (“Wakefield faces
charges of serious professional misconduct before the General Medical Council (GMC) for allegedly
violating ethical research practices on several counts.”); Davis, supra note 5, at 53 (“Wakefield was
stripped of his medical license in May.”).
60. Gross, supra note 56, at 1 (describing the history of the vaccine–autism controversy in the
United Kingdom and United States).
61. Shemin, supra note 7, at 461 n.8.
62. Moreland, supra note 55, at 370.
63. Id. at 371.
64. Gross, supra note 56, at 2.
65. See, e.g., id. at 6 (discussing published accounts of scientists who support the vaccine–autism
66. Robert Kennedy Jr., Deadly Immunity, ROLLING STONE, June 20, 2005, available at
67. Larry King Live (CNN television broadcast Feb. 2
); see also Gross, supra note 56, at 5
(describing news and media coverage of the vaccine–autism controversy).
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IMMUNIZING AGAINST BAD SCIENCE
B. The Omnibus Autism Proceedings
“At its inception, it was unforeseen the [Vaccine] Program would receive
over 5,000 cases in eight years arguing a link between a vaccine and autism.”68 A
central question became how the Vaccine Program would manage the flood of
cases. In 2002, the Vaccine Court created the Omnibus Autism Proceedings
(OAP), which designated specific procedures for “aggressively, but fairly”
resolving pending and anticipated autism claims.69 Special Master George
Hastings, Jr. was selected to preside over the OAP.70 Shortly after he was
chosen, Special Masters Denise Vowell and Patricia Campbell-Smith were also
assigned to the OAP.71
Because autism is an off-table claim, petitioners must prove
causation-infact.72 The OAP employed a two-step process for resolving the autism claims.
First, the special masters would conduct an inquiry into the issue of general
causation: whether vaccines can cause autism. Second, the special masters
would apply their evidentiary findings from the general-causation inquiry to the
individual autism cases.73 OSM selected attorneys representing petitioners in
autism claims to constitute the Petitioner’s Steering Committee (PSC).74 PCS
selected general-causation-theory test cases for the OAP. Petitioners with
pending or potential autism claims could opt into the OAP. Special masters
would defer proceedings for cases in the program until after deciding the test
Ultimately, PSC presented two general-causation theories, selecting three
test cases for each theory. The first theory alleged that the MMR vaccine and
thimerosal-containing vaccines together can cause autism. The second theory
alleged that thimerosal-containing vaccines alone can cause autism.76 PSC
selected as the first theory test cases Cedillo v. Secretary of Health & Human
Services,77 Hazlehurst v. Secretary of Department of Health & Human Services,78
and Snyder v. Secretary of Department of Health & Human Services.79 The
second theory test cases were Mead v. Secretary of Health & Human Services,80
King v. Secretary of Health & Human Services,81 and Dwyer v. Secretary of
Department of Health & Human Services.82 The three special masters assigned
to the OAP would hear the general-causation evidence jointly, but would
separately decide each case assigned to them.83 In 2007, the special masters
conducted three weeks of evidentiary hearings on the first theory. Michelle
Cedillo’s case was the first to begin.84
THE AUTISM TEST CASE DECISIONS
A. Michelle Cedillo’s Case
For the first two years of Michelle Cedillo’s life, she was apparently a
healthy child.85 In December 1995, Michelle received an MMR vaccine and one
week later developed a high fever.86 In January, she had a second fever, and
Michelle’s pediatrician diagnosed her with “sinusitis v. flu.”87 At her next doctor
visit, Michelle’s pediatrician noted that Michelle was “talking less” since the
fever.88 In 1997, a different pediatrician noted Michelle’s development was
delayed, suspecting the fevers had caused neurological damage but unable to
determine if it was a “post-immunization phenomenon.”89 That same year, a
developmental psychologist diagnosed Michelle with “severe Autism” and
“profound Mental Retardation.”90
The Cedillos filed a petition in the Vaccine Court, alleging that multiple
thimerosal-containing vaccines had damaged Michelle’s immune system.91 They
claimed this damage allowed the live measles virus in the MMR vaccine to
replicate in Michelle’s body and cause inflammation in her bowels and brain.92
Michelle’s case was grouped into the OAP. At the request of the PCS and the
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IMMUNIZING AGAINST BAD SCIENCE
Cedillos’ counsel, it became a test case for the first general-causation theory.93
B. A Theory Neither Recognized by the Medical Community nor Supported
Special Master Hastings presided over Michelle’s case.94 He reviewed
twenty-three medical expert reports and 658 medical journal articles and heard
testimony from sixteen expert witnesses.95 In February of 2009, he announced
his decision to deny entitlement.
Special Master Hastings focused on the Cedillos’ failure to produce
reputable scientific evidence supporting either a general or a specific theory of
causation. He found that many of the scientific studies cited “[came] down
strongly against the petitioners’ contentions” and that “[t]he expert witnesses
presented by the respondent were far better qualified, far more experienced,
and far more persuasive than the petitioners’ experts.”96 He noted some of the
Cedillos’ evidence would not meet the Daubert standard.97 For example, Special
Master Hastings criticized a general-causation expert whose theory was neither
recognized by the medical community nor supported by “sound scientific
methods.”98 Special Master Hastings also found study results supporting the
Cedillos’ theory of specific causation unreliable.99 He concluded that
it is extremely unlikely that any of Michelle’s disorders were in any way causally
connected to her MMR vaccination, or any other vaccination. . . . After studying the
extensive evidence in this case for many months, I am convinced that the reports and
advice given to the Cedillos . . . advising the Cedillos that there is a causal connection
between Michelle’s MMR vaccination and her chronic conditions have been very
wrong. Unfortunately, the Cedillos have been misled by physicians who are guilty, in
my view, of gross medical misjudgment.100
The same day that Cedillo was announced, Special Masters Vowell and
Campbell-Smith issued decisions in Snyder and Hazlehurst, respectively, also
denying entitlement.101 All three test case petitioners applied for review by the
CFC. Although each of the test case decisions was made individually, they
involved parallel reasoning.
In their appeal, the Cedillos alleged that Special Master Hastings had
required too high a standard of proof,102 citing several Federal Circuit decisions
that reversed Vaccine Court decisions for applying a standard inconsistent with
Althen.103 Acknowledging that some of their evidence would not survive a
Daubert motion, the Cedillos identified several vaccine-injury claims that were
compensated on the basis of purportedly similar evidence.104 According to the
Cedillos, what distinguished Michelle’s case from those compensated claims was
that hers was an autism test case. The Cedillos claimed “the special master
purposely turned a blind eye on [Michelle’s] evidence . . . [and] inappropriately
assumed the respondent’s role as protector of the integrity of vaccines.”105
C. Affirming Rational and Reasonable Decisions
In 2009, the CFC individually affirmed Cedillo, Hazlehurst, and Snyder.106
Judge Wheeler issued the Cedillo opinion, agreeing that the Cedillos did not
meet their prima facie causation burden.107 Judge Wheeler stated that “[the]
Court [of Federal Claims] will not second guess a Special Master’s fact intensive
conclusions, especially when medical evidence of causation is in dispute.”108 He
noted that “[t]he evidentiary record in the [OAP test] cases easily is the largest
of all cases presented to the Court in the history of the Vaccine Act.”109 He
found that the special master had exercised valid discretion in choosing to
discredit certain studies and experts. Judge Wheeler also held that Special
Master Hastings did not improperly raise the Althen standard.110 Regarding the
Cedillos’ allegation that a lower standard had been applied in other cases, Judge
Wheeler noted that “[u]nlike medical issues raised in other Vaccine Act cases,
autism is not an area ‘bereft of complete proof.’”111 He concluded that Special
Master Hastings’s decision was “rational and reasonable in all respects” and
consistent with the law. 112
Only Cedillo and Hazlehurst were appealed to the Federal Circuit. While
the appeals were pending, the special masters issued decisions denying
entitlement in the second theory test cases.113 None of those petitioners
appealed; final judgments were entered in April of 2010.114
In their appeal to the Federal Circuit, the Cedillos described Michelle’s
experience in the Vaccine Program as “a disaster.”115 Their appeal concluded
it is essential that the Vaccine Program, rather than crippling civil litigation, resolve
[Michelle’s] case as well as those of all autistic children in OAP. Persons fairly
compensated in the Vaccine Program will not sue manufacturers. How can these
persons be kept in the Vaccine Program? The answer is simple. An evidentiary
standard that promotes congressional intent must be employed.116
On May 13, 2010, the Federal Circuit affirmed the rulings below in
Hazlehurst.117 Then in August of 2010, the Federal Circuit held that it could find
“no legal error in the standards applied by the special master” in Cedillo.
Mirroring the Hazlehurst decision,118 the Federal Circuit emphasized the
importance of the Althen standard, but found the special master’s use of the
Daubert factors had not undermined Althen.119 The Federal Circuit stated that
weighing all of the evidence necessitated assessing its reliability120 and cited
cases that emphasized special masters’ discretion to evaluate the reliability of
evidence.121 Michelle’s mother commented publically on the decision: “We are
obviously extremely disappointed. Michelle has a very strong case. The facts in
her medical records speak for themselves. Our lawyers are currently reviewing
the decision to see what legal options are available.”122
Both the Cedillos and the petitioners in Hazlehurst notified the court that
neither would seek certiorari from the Supreme Court. Subsequently, PSC
notified the court that no further test cases are contemplated.123
LESSONS FROM THE AUTISM CASES
Despite fears to the contrary, given the current state of scientific and
medical knowledge and standards of proof in the state courts, a flood of civil
litigation is unlikely to result from the OAP decisions. Evidence that vaccines
can cause autism simply is not available to meet the higher standards of proof in
the civil sphere. There is, however, a more insidious danger underlying the
autism cases: increasingly negative public opinion toward vaccines generally.
The government and health professionals have looked to the Vaccine Court to
emphasize vaccine safety. If the Vaccine Program focuses too much on
compensation and not enough on science, decisions will implicitly validate
public fears about vaccines.
A. The State Court Threat
Vaccines have been described as “the next big toxic-tort battleground.”124 A
common refrain of critics is that, by denying entitlement, the Vaccine Court will
drive autism cases into the civil sphere. At the CFC 2008 Judicial Conference,
well-known plaintiff’s lawyer Kevin Conway called preventing civil suits the
Vaccine Act’s “number one” purpose.125 Mr. Conway also stated, “[M]y sense is
that the [OAP] test cases will certainly result in probably a large majority of the
cases in the vaccine program leaving . . . and going into the civil arena.”126 The
Cedillos’ last appeal to the Federal Circuit echoed Conway’s remark.127
Nevertheless, it is unlikely that the conclusion of the OAP will result in a
flood of vaccine–autism claims in the civil arena. First, the levels of review
within the Vaccine Program will likely shield against many autism cases
reaching state courts.128 Second, evidence linking vaccines and autism is not
currently available. As one scholar noted, “[b]ecause state courts must deliver
judgments based on credible evidence that satisfies traditional legal standards,
claims relying on evidence similar to that presented under the Omnibus Autism
Proceeding will have difficulty surviving judicial scrutiny.”129 Although
petitioners will have the benefit of full discovery, “it is highly unlikely that
[autism] plaintiffs will succeed without additional scientific advancements to
support their claims.”130 To date, there have been no successful vaccine–autism
claims in state courts.
B. The Resilience of the Autism Controversy in Public Discourse
The belief that vaccines cause autism raises important issues independent of
the potential for increased civil litigation. Halfway through the Cedillo hearings,
the government moved for summary judgment, but stated that it would go
forward with the proceedings to answer petitioner’s accusations for public
policy reasons.131 When the special masters released their decisions, HHS
commented, “Hopefully, the determination by the Special Masters will help
reassure parents that vaccines do not cause autism.”132
In the OAP cases, the special masters reviewed a vast amount of scientific
and medical evidence: twenty-eight medical expert testimonies, fifty expert
reports, five thousand pages of proceedings, transcripts, and briefs, and nine
hundred scientific articles.133 The decisions contain careful, analytical
assessments of the evidence and are readily accessible on the Internet through
the Vaccine Court’s website.134 They are also complex, lengthy, and detailed.
Most of the general public will not read the Vaccine Court’s decisions.
Accordingly, the public’s understanding of the decisions will be informed
largely by how the media and advocates (on both sides of the vaccine debate)
portray the decisions. Vaccine-safety proponents are at a disadvantage. It is
difficult for one hundred and seventy-four pages of scientific data and dry
expert testimony to effectively counter an emotional story about a child who,
shortly after being vaccinated, was diagnosed with a serious illness. The Cedillo
decision thus acknowledges the persuasive power of a temporal narrative.135
Further, the decisions can point only to a lack of evidence, not a definitive
answer about vaccine safety.136
“[P]arents weigh choices about vaccination using conceptions of risk,
benefit, and trust that are broader than anything that can be demonstrated
through statistics or biology.”137 The OAP decisions can only affect public
opinion about vaccines if they “encourage parents to base future healthcare
decisions on the facts embodied in the growing body of scientific evidence and
discourage . . . decisions based on fear and faith.”138 The lasting influence of the
autism controversy has been attributed to a loss of public trust in science.139
Medical anthropologist Sharon Kaufman, who has studied the vaccine–autism
controversy, claims “many parents see even the most respected vaccine experts’
perspective on the issue as just one more opinion.”140 The structure of the
Vaccine Program compounds this lack of trust. Fear of government bias
towards vaccine is a typical complaint of Vaccine Program critics; often
containing somewhat sensational overtones of government–industry
conspiracies. One scholar remarked that “NCVIA’s effect on public confidence
in vaccinations is . . . unclear . . . [but] the act’s relatively broad immunity
provisions and the barriers it creates for patients seeking jury trials have
provided rich fodder for people who distrust vaccines.”141
The autism controversy exemplifies how Vaccine Court decisions can be
characterized as propaganda for the pharmaceutical industry. In a congressional
hearing on the vaccine–autism controversy, Congressman Burton stated, “[T]he
Justice Department filed a motion asking the Special Master to keep all
information [in a case] secret . . . . That’s very disconcerting to me.”142 He also
said “The guy who headed that [Vaccine Program] advisory committee had a
stock in a company that was making the Rotoshield virus vaccine. Shouldn’t
have done it. He had a tainted point of view.”143 Congressmen Weldon
described the vaccine-injury problem as “trying to investigate a sacred cow. For
a lot of people in the medical community, there’s this tremendous fear. If you
say anything negative about vaccines, then parents will stop vaccinating their
kids and then you’ll have all these outbreaks of these diseases.”144 Certainly
many medical and public health professionals have expressed concerns about
the autism controversy reducing vaccination rates.145 Some critics have
suggested that the tone of the OAP decisions was so “adamant that . . . the
judges were aiming to broadcast a statement to the public that vaccines are
safe.”146 Indeed, the Cedillos suggested that Michelle’s case was treated
differently because the court had an interest in protecting vaccines.
Critics also suggest that the Vaccine Court is motivated by a desire to
protect the Vaccine Program itself.147 These critics argue that there is simply not
enough money in the Vaccine Trust fund to compensate all the autism claims
pending before the Vaccine Court.148 Following the OAP test case decisions, the
Department of Justice (DOJ) noted a downward trend in autism cases.149 Critics
argue that if causation had been established, more claims would have been
filed. The fact that the Vaccine Program cannot, in its present form, compensate
the autism claimants is not itself evidence of prejudice. But concern over the
financial viability of the Vaccine Program inevitably undermines the court’s
perceived objectivity and impedes its ability to influence public discourse in
favor of vaccines. This is not to suggest that the Vaccine Court does not have
the capacity to influence public opinion. The standard of proof in vaccine-injury
cases makes a critical statement to the public about vaccine safety.
C. Clarifying Althen: The Need for a More Scientific Standard of Proof
Vaccine–autism claimants and supporters have alleged that they face a
higher burden of proof than other vaccine-injury claims, frustrating
congressional intent.150 Throughout Cedillo, the petitioner questioned the
standard of proof applied in the case. Complaints about the standard of proof
are not unique to autism claims. The Vaccine Program has long been criticized
as being as adversarial as the tort system, and the DOJ has been criticized for
being overzealous in its defensive role.151 In off-table claims in particular, critics
argue that the petitioner does the “heavy lifting” and that the government tends
to assume “a more adversarial position.”152 This criticism is not entirely
unfounded. In a 2001 congressional hearing, the director of the NVICP stated,
“The program significantly reduces, but cannot eliminate, the tension and
adversity inherent with any litigation process for resolving claims.”153 Paul
Harris, representing the DOJ, attributed petitioners’ complaints not to
adversity within the system, but to “denial of scientifically unsupported
In 2010, the DOJ reported a forty percent compensation rate for
vaccineinjury claims including the autism cases, but a sixty-six percent compensation
rate for injury claims excluding autism cases.155 DOJ Deputy Director Mark
Rogers stated, “We’ve been tracking the autism cases separately because we
think they mask the background performance of the program.”156 This
statement implicitly suggests that the rate of compensation measures the success
of the Vaccine Program and demonstrates a fundamental flaw in how people
think about the system. As the Director of the NVICP remarked in 2001, “the
program was never intended to serve as a compensation source for wide range
of naturally occurring illnesses and conditions, which unfortunately affect many
of our children.”157 Instead, the program was intended to compensate for
vaccine-related injuries. Its success, therefore, should not be defined by its rate
of compensation independent of whether the claims merit compensation.
Admittedly, vaccine injuries are difficult to prove. In creating the Vaccine Act,
Congress stated, “The Committee recognizes that there is public debate over
the incidence of illnesses that coincidentally occur within a short time of
vaccination. The Committee further recognizes that the deeming of
vaccinerelatedness adopted here may provide compensation to some children whose
illness is not, in fact, vaccine-related.”158 Recognizing that some undeserving
claims will be compensated is not an endorsement of compensating frivolous
Compensating for vaccine injuries is only one of the Vaccine Program’s
multiple goals. The Vaccine Program is also intended to promote vaccine
production and protect immunization programs and practices. These goals,
although not fundamentally inconsistent, are best served by different standards
of proof. A lower standard that liberally compensates petitioners may satisfy
them and divert them from state courts. But it also may decrease public
confidence in the safety of vaccines that actually cause injury to only a very
small number of persons.
With Althen and Andreu, the Federal Circuit expressly rejected a heavily
scientific standard.159 After Althen, special masters cannot require medical
literature to support a claim or the identification of a specific biologic
mechanism.160 But Althen did not dismiss the need for theories of causation to
be supported by “reputable medical or scientific explanation[s],”161 leaving the
standard of proof unclear. Both Special Master Hastings’ and Judge Wheeler’s
remarks in their respective Cedillo decisions indicate that the Cedillos lacked
credible evidence to satisfy any standard of causation. Nevertheless, both judges
suggested that there may be different, result-changing standards of causation
for off-table claims. During the 2008 Judicial Conference, vaccine expert Dr.
Paul Offit argued it would be possible to prove that peanut butter sandwiches
cause cancer under the Althen standard.162 Because the majority of claims are
now off-table and one of the goals of the Vaccine Court is the consistent and
streamlined adjudication of cases, a well-defined standard of proof is critical to
the functionality of the program.163
The standard of proof is not merely a legal issue. The autism cases also
exemplify how the standard of proof may impact public health. Dr. Offit
warned that the Vaccine Court “has a tremendous responsibility and needs to
realize that [it does] send a message with certain decisions [it] make[s].”164 He
stated that moving away from a scientific standard “in the name of policy . . .
run[s] the risk of sending the message . . . that vaccines are causing harms that
they don’t.”165 Outbreaks of vaccine-preventable disease often start with persons
who refuse vaccination; children exempted from immunization requirements
are more likely to contract or transmit vaccine-preventable diseases.166 An
unscientific standard of proof may not only allow compensation of claims in
which vaccines did not cause injuries, but may also affect public perceptions
about vaccine safety. The worst case scenario is not, as petitioner’s attorney
Kevin Conway suggested, merely compensating an ineligible claim.167 “[A] court
ruling linking autism to vaccines could spur parents to eschew immunizations,
sparking a potentially deadly epidemic . . . [and] a resurgence of potentially
The serious consequences of low public confidence in vaccine safety are not
purely speculative. The vaccine–autism controversy has led some parents to
delay or refuse to vaccinate their children. Recently, the number of nonmedical
exemptions sought from immunization requirements has risen.169 In 2008, the
largest outbreak of measles in the United States since 2000 was reported. This
outbreak was tied to exemptions from routine immunizations.170
Further, a scientific standard is not inconsistent with congressional intent.
At the Vaccine Program’s conception, Congress stated, “No-fault vaccine
compensation proceedings raise fewer legal issues than issues of medicine.”171 In
the interest of compensating generously, the Vaccine Court should be flexible
and open to new science. Liberality is built into the structure of the Vaccine
Program. Because the Vaccine Court is not governed by federal evidentiary
rules, “petitioners may introduce a broader array of documentation . . .
including expert medical opinion, circumstantial evidence, and widely accepted,
albeit unproven, scientific theories.”172 The legislative history of the Vaccine Act
does not indicate Congress approved of an even lower standard. Indeed,
Congress rejected legislation in 2001 to lower the standard of proof173 after
public health officials expressed concerns that moving away from “a scientific
evaluation of the connection between the injury and the vaccine” might open
up compensation too broadly.174
Current direction from the Federal Circuit, however, may be inconsistent
Transcript, supra note 125, at 17, lines 23–25 (“The worst thing that could happen is
somebody gets compensated who wasn’t injured by a vaccine, and as a matter of policy, that’s
acceptable to us.”).
168. Davis, supra note 5, at 51.
169. Omer et al., supra note
166, at 1982
(stating that “[b]etween 1991 and 2004, the mean
statelevel rate of nonmedical exemptions increased from 0.98 to 1.48%,” but noting exemption rates are not
uniform across states).
170. Gross, supra note 56, at 2.
171. H.R. REP. NO. 101-386, at 515 (1989), reprinted in 1989 U.S.C.C.A.N. 3018, 3118 (also stating
that the special masters need not be lawyers but should “be well-advised on matters of health,
medicine, and public health”). Historically, all of the special masters have been lawyers. MOLLY T.
JOHNSON, CAROL E. DREW & DEAN P. MILETICH, USE OF EXPERT TESTIMONY, SPECIALIZED
DECISION MAKERS, AND CASE-MANAGEMENT INNOVATIONS IN THE NATIONAL VACCINE INJURY
COMPENSATION PROGRAM 14–15 (1999).
172. Stewart, supra note 26, at 2498.
173. H.R. 1287, 107th Cong. (1st Sess. 2001).
174. NVIP Hearing, supra note 151, at 16–17 (statement of Rep. Henry Waxman).
with congressional intent. Concluding his decision to deny entitlement, Special
Master Hastings asserted: “I have not required a level of proof greater than
‘more probable than not.’ . . . [T]his is a case in which the evidence is so
onesided that any nuances in the interpretation of the causation case law would
make no difference to the outcome of the case.”175
Special Master Hastings was referring to Althen, which instructed special
masters to resolve “close calls regarding causation . . . in favor of injured
claimants.”176 If by “close call” the Federal Circuit meant that cases in which the
petitioner’s favorable evidence is only slightly greater than that of respondent’s,
the instruction seems unnecessary. In such cases, the petitioner has met his
burden. But if the Federal Circuit meant cases in which the evidence is in
equipoise should be resolved in favor of the petitioner, this direction seems
inconsistent with the text of the Vaccine Act.177 In Cedillo, Special Master
Hastings notes, “Congress designed the Program to compensate only the
families of those individuals whose injuries or deaths can be linked causally,
either by a Table Injury presumption or by a preponderance of causation-in-fact
evidence, to a listed vaccination.”178 The Vaccine Act explicitly requires proving
causation-in-fact in off-table claims by a preponderance of the evidence.179
Finally, an explicitly non-scientific standard of proof makes adjudication of
vaccine-injury cases all the more challenging for the court and the parties.180 The
autism cases are an extreme example of how vaccine claims are increasingly a
battle of experts. Although the Cedillo decisions held that the evidence
supporting a link between vaccines and autism was not compelling, proponents
of the vaccine–autism theory adamantly disagree. In their appeal to the Federal
Circuit, the Cedillos characterized the respondent’s experts as “honest scientists
who strongly disagree with the conclusions of the petitioners’ experts.”181 The
Vaccine Court must have appropriate metrics for assessing experts’ claims.
Uncertainty does not obviate the need for the scientific method, it demonstrates
it. Science should be determined through the scientific method, not through the
courts.182 As Judge Wheeler stated, “[t]he issue before [the] Court is not to
determine the causes of autism. The Court can only hope that medical
professionals succeed in identifying the causes and developing a cure for this
The Vaccine Court sits at the intersection of law and public health.
Although many have expressed concerns that the decision to deny entitlement
in the autism cases will result in a flood of civil litigation, this is unlikely given
the evidence available. Although the Vaccine Program may stave off state court
suits, public health officials cannot rely on Vaccine Court decisions to restore
lost trust in science and resolve the vaccine–autism controversy. The current
standard of proof in the Vaccine Program threatens to undermine public
confidence in the safety of vaccines. To protect the integrity of U.S. vaccination
policy, the Federal Circuit should announce a clearer, more rigorously scientific
standard of proof for causation in off-table vaccine-injury claims.
6. Joëlle Anne Moreno , It's Just a Shot Away: MMR Vaccines and Autism and the End of the Daubertista Revolution , 35 WM. MITCHELL L. REV. 1511 , 1517 - 18 ( 2009 ).
7. Gordon Shemin , Mercury Rising: The Omnibus Autism Proceeding and What Families Should Know Before Rushing Out of Vaccine Court , 58 AM. U. L. REV. 459 , 468 ( 2008 ) (“Today all fifty states as well as the District of Columbia mandate childhood immunizations .”).
8. See, e.g., Toward a Twenty-First- Century , 121 HARV. L. REV. 1820 , 1825 ( 2008 ) (stating that most states allow religious exemptions and some provide philosophic exemptions to vaccination requirements).
9. Frontline: The Vaccine Wars (PBS television broadcast Apr . 27 , 2010 ).
10. See , e.g., Okianer Christian Dark, Is the National Childhood Vaccine Injury Act of 1986 the Solution for the DTP Controversy? , 19 U. TOL. L. REV . 799 , 800 , 802 ( 1994 ) (stating that for some children, “the [DTP] vaccine is extremely dangerous” and that “even when manufactured and distributed properly, can cause serious injuries, including death,” but noting that vaccine side-effects are rare).
11. Id . at 801 (discussing vaccine manufacturers' concerns that unavoidable vaccine side-effects would expose them to liability without wrongdoing).
12. See , e.g., id. at 820 , 831 - 32 ( discussing the history of suits against vaccine manufacturers).
13. Alan R. Hinman , DTP Vaccine Litigation, 140 AM. J. DISEASES CHILD . 528 , 529 ( 1986 ).
14. James O. Mason , Vaccine Supply and Liability , 101 PUB. HEALTH REP . 229 , 229 ( 1986 ).
15. See James B. Currier , Too Sick, Too Soon?: The Causation Burden Under the National Vaccine Injury Compensation Program Following De Bazan v . Secretary of Health and Human Services , 19 FED. CIR. B.J. 229 , 233 ( 2009 ) (noting that later studies confirmed most juries sympathized with vaccine-injury plaintiffs).
16. Mason , supra note 14, at 229.
17. Ctr . for Disease Control and Prevention , Diphtheria-Tetanus-Pertussis Vaccine ShortageUnited States , 34 MORBIDITY MORTALITY WKLY. REP. WKLY . 695 ( 1984 ), http://www.cdc.gov/mmwr/preview/mmwrhtml/00000452.htm.
18. Pub . L. 99 - 660 , title III , Sec . 311 ( a ), Nov. 14 , 1986 , 100 Stat. 3758 .
19. 42 U.S.C.A. § 300aa- 1 ( West 2011 ).
20. Id . § 300aa - 10 ; see also Dark, supra note 10 , at 803 (stating the Vaccine Act was intended to provide “an alternative to the tort law system”).
21. Vaccine Program Background , U.S. CT. FED. CLAIMS OFF. SPECIAL MASTERS , http://www.uscfc.uscourts.gov/sites/default/files/vaccine.background. 2010 . pdf (last visited Jan. 3 , 2010 ).
22. Mark Sherman , Parents Lose Supreme Court Appeal in Vaccine Case, U.S. NEWS & WORLD REP. (Feb. 22 , 2011 ), available at http://www.usnews.com/news/articles/2011/02/22/parents-lose -highcourt-appeal-in-vaccine-case.
23. 42 U. S.C. A. § 300aa-11(a)(2)(A).
24. Id . § 300aa - 12 (d).
25. Id . § 300aa - 12 (b)( 1 ).
26. See , e.g., Alexandra M. Stewart , When Vaccine Injury Claims Go to Court, 360 NEW ENG . J. MED . 2498 , 2498 ( 2009 ) (describing the NVICP process) .
27. VACCINE R. OF U.S. COURT OF FED . CLAIMS 5.
28. 42 U.S.C.A. § 300aa- 21 (b).
29. Id . Some claims, however, can only be brought in the Vaccine Court . Id. § 300aa - 22 .
30. Id . § 300aa - 12 (e), (f).
31. The original Vaccine Injury Table can be found at 42 U .S.C.A. §§ 300aa - 14 (a). The amended table can be found at 42 C.F.R § 100 .3 ( 2011 ).
32. E.g., Stewart, supra note 26 , at 2498.
33. 42 U. S.C. A § 300aa-13(a)(1); see also Althen v . Sec'y of Health & Human Servs., 418 F.3d 1274 , 1278 (Fed. Cir. 2005 ) (“The Act provides for the establishment of causation . . . through a statutorily-prescribed presumption of causation upon a showing that the injury falls under the Vaccine Injury Table ('Table Injury' ).”).
34. 42 U. S.C. A §§ 300aa-11(c)(1)(C)(ii)-13(a)(1)(A).
35. E.g., Hanlon v . Sec'y of Health & Human Servs., 40 Fed. Cl . 625 , 630 ( 1998 ) (“Special Masters are neither bound by their own decisions nor by cases from the Court of Federal Claims, except . . . on remand.”).
36. This is partly because HHS modified the Vaccine Injury Table in the 1990s and removed some of the more common injuries . See, e.g., Currier, supra note 15 , at 247 (“ HHS redefined the number of compensable injuries on the Injury Table. Although HHS added more vaccines to the Injury Table than it removed, the vaccines removed were involved in a large proportion of the claims before the vaccine courts .”); Katherine E. Strong, Proving Causation Under the Vaccine Injury Act: A New Approach for a New Day, 75 GEO . WASH. L. REV. 426 , 443 ( 2007 ) (stating HHS modified the table based on reports from the Institute of Medicine about whether certain vaccines caused particular injuries).
37. 42 U. S.C. A. § 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 .”).
38. See , e.g., Currier, supra note 15 , at 247 ( stating that scholars have noted the increasing importance of expert testimony and medical studies in Vaccine Court cases ).
39. 35 F.3d 543 , 548 - 49 (Fed. Cir. 1994 ).
40. Id . at 549.
41. Shyface v. Sec'y of Health & Human Servs., 165 F.3d 1344 , 1351 (Fed. Cir. 1999 ) (“The
50. Moberly v. Sec'y of Health & Human Servs., 592 F.3d 1315 , 1324 (Fed. Cir. 2010 ).
51. See , e.g., Cedillo v . Sec'y of Health & Human Servs., 617 F.3d 1328 , 1338 (Fed. Cir. 2010 ) (“We see no legal error in the standards applied by the Special Master either in judging causation or in utilizing Daubert .”); Terran v. Sec'y of Health & Human Servs., 195 F.3d 1302 , 1316 (Fed. Cir. 1999 ).
52. Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 ( 1993 ).
53. Id . at 593-95.
54. See , e.g., Andreu v . Sec'y of Health & Human Servs., 569 F.3d 1367 ( Fed. Cir . 2009 ); Capizzano v . Sec'y of Health & Human Servs., 440 F.3d 1317 ( Fed. Cir . 2006 ).
55. Regina Moreland , National Vaccine Injury Compensation Program: The Potential Impact of Cedillo for Vaccine-Related Autism Cases , 29 J. LEGAL MED . 363 , 364 ( 2008 ).
56. Liza Gross , A Broken Trust : Lessons from the Vaccine-Autism Wars, 7 PLOS BIOLOGY , May 2009 , at 1 , 5 ( 2009 ).
57. Shemin , supra note 7, at 478 (“ The etiology of autism remains a mystery and science has not yet been able to determine a cause .”).
58. See , e.g., Gross, supra note 56 , at 4 (discussing the rise in autism diagnoses and public theories
68. Moreland , supra note 55, at 364; see also July 2002 Autism Update , supra note 1 , at * 1 (“ Processing such a large number of cases [would] stretch thinly the resources of both the court and the bar .”).
69. E.g., Shemin, supra note 7 , at 461.
70. July 2002 Autism Update , supra note 1 , at *3.
71. The Autism Proceedings, U.S. CT. FED. CLAIMS OFF. SPECIAL MASTERS , ftp://ftp.cafc.uscourts.gov/autism/vaccine/Background_on_ the_autism_proceedings.pdf (last visited Jan. 3 , 2010 ).
72. E.g., Shemin, supra note 7 , at 476 (“ Because autism is not listed as an injury on the Vaccine Injury Table, claims alleging autism must proceed via the off-table theory .”).
73. July 2002 Autism Update , supra note 1 , at *2 (creating the OAP framework and Docket of the OAP, a public compilation of filings, court orders, decisions, and updates from the court ).
74. The Autism Proceedings, supra note 71; Health Res. and Servs . Admin., National Vaccine Injury Compensation Program: About the Omnibus Autism Proceedings , U.S. DEP'T HEALTH & HUM . SERVS., http://www.hrsa.gov/vaccinecompensation/omnibusautism. html (last updated Aug . 19 , 2010 ).
75. July 2002 Autism Update , supra note 1 , at *6.
76. Sept . 2010 Autism Update, supra note 2.
77. No. 98 - 916V , 2009 WL 331968 ( Fed . Cl. Spec. Mstr. Feb. 12 , 2009 ).
78. No. 03 - 654V , 2009 WL 332258 ( Fed . Cl. Spec. Mstr. Feb. 12 , 2009 ).
79. No. 01 - 162V , 2009 WL 332044 ( Fed . Cl. Spec. Mstr. Feb. 12 , 2009 ).
80. No. 03 - 215V , 2010 WL 892248 ( Fed . Cl. Spec. Mstr. Mar. 12 , 2010 ).
81. No. 03 - 584V , 2010 WL 892296 ( Fed . Cl. Spec. Mstr. Mar. 12 , 2010 ).
82. No. 03 - 1202V , 2010 WL 892250 ( Fed . Cl. Spec. Mstr. Mar. 12 , 2010 ).
83. Sept . 2010 Autism Update, supra note 2.
84. In re Claims for Vaccine Injuries Resulting in Autism Spectrum Disorder or a Similar Neurodevelopmental Disorder , Order Concerning Case Processing (Fed. Cl. Spec. Mstr. June 5 , 2007 ), http://www.uscfc.uscourts.gov/sites/default/files/autism/Untitled.pdf.
85. Before two years of age, Michelle reached her developmental milestones. Cedillo v. Sec'y of Health & Human Servs ., No. 98 - 916V , 2009 WL 331968, at *4 ( Fed. Cl . Feb. 12 , 2009 ).
86. Id . at *4- 5 .
87. Id . at *5.
88. Id .
89. Id . (discussing the testimony of Dr . William Masland).
90. Id . (discussing the testimony of Dr . Karlsson Roth).
91. Id . at *13. The Cedillos first filed in 1998, and then filed an amended petition in 2002.
92. Id . at *15.
93. Id . at *9.
94. Id .
95. Moreno , supra note 6, at 1514-15.
96. Cedillo , 2009 WL 331968, at *1.
97. Id . at *3, * 41 , * 91 ( discussing Daubert and its use in the Vaccine Program, and applying Daubert factors to assess the reliability of petitioner's experts' unpublished work).
98. Janice G . Inman, The Autism Cases, and What's Next: Part One of a Two-Part Article, 26 No. 8 MED . MALPRACTICE L. & STRATEGY 1 ( 2009 ) (describing the Cedillo decisions ).
99. Id .
100. Cedillo , 2009 WL 331968, at * 134 - 35 .
101. Sept . 2010 Autism Update, supra note 2.
102. Brief for Petitioners-Appellants at 15 -16, Cedillo v. Sec'y of Health & Human Services , (Fed. Cir. 2010 ) (No. 2010 - 5004 ), 2010 WL 464240 (stating the special master “chose to impose upon Michelle an unattainable standard of proof”).
103. Id . at 19; see also Janice G. Inman, The Autism Cases: In Vaccination Case, Losing Side Casts Doubt on Special Master's Impartiality, Part Two of a Two-Part Article, 26 No. 9 MED . MALPRACTICE L. & STRATEGY 1 ( 2009 ) (describing the Cedillo decisions ).
104. Brief for Petitioners-Appellants, supra note 102 , at 20- 21 . Further, the Cedillos asserted Daubert applied solely to judicial review of scientific methods, not to expert conclusions . Id. at 65.
105. Petitioner 's Memo in Support of Motion for Review of Special Master's Decision of Feb . 12 , 2009 at 4, Cedillo v. Sec'y of Dep't of Health & Human Servs ., No.98-916V (Fed. Cl. Spec. Mstr. Mar . 16 , 2009 ).
106. Sept . 2010 Autism Update, supra note 2.
107. Cedillo v. Sec'y of Health & Human Servs , 89 Fed. Cl. 158 , 183 ( 2009 ).
108. Id . at 178 (citing Hodges v . Sec'y of Health & Human Servs., 9 F.3d 958 , 961 (Fed. Cir. 1993 ); Moberly v . Sec'y Health & Human Servs., 85 Fed. Cl . 571 , 597 ( 2009 )).
109. Id . at 167.
110. Id . at 182-83.
111. Id . at 184.
112. Id .
113. Hearings for the second theory were held a year later , in 2008 . Sept. 2010 Autism Update ,
124. Davis , supra note 5 , at 49.
125. Concurrent Vaccine Program/Vaccine Compensation Under the Act: A Mix of Science and Policy?, at 16, lines 3-8 (Transcript of 2008 Judicial Conference of the U.S. Court of Fed . Claims) [ hereinafter 2008 Transcript] . When enacting the Vaccine Act, Congress stated that the “relative certainty and generosity of the [Vaccine Program]'s awards [would] divert a significant number of potential plaintiffs from litigation .” H.R. REP . No. 99 - 908 , at 13 ( 1986 ), reprinted in 1986 U.S. C.C. A .N. 6344 , 6354 .
126. Dep 't of Health & Human Servs ., Transcript of Advisory Comm'n on Childhood Vaccines Meeting 46 (June 10, 2010 ) [hereinafter Advisory Comm'n June Meeting] (statement of Kevin Conway, petitioner's attorney) .
127. See supra , Part III. C (discussing the Cedillos' appeal to the Federal Circuit) .
128. Stewart , supra note 26, at 2499-500.
129. Id . at 2500.
130. Id . Some plaintiffs' attorneys criticize the limited discovery in Vaccine Court cases as an impediment to their success.
131. Moreland , supra note 55, at 373 (describing the Cedillo hearing ).
132. Press Release, Statement from the Department of Health and Human Services Regarding the Decisions of the U.S. Court of Federal Claims in the Omnibus Autism Proceedings (Dep't of Health & Human Servs .) (Feb. 12 , 2009 ), available at http://www.hhs.gov/news/press/2009pres/02/20090212a.html.
133. Ross D. Silverman , Litigation, Regulation, and Education-Protecting the Public's HealthThrough Childhood Immunization, 360 NEW ENG . J. MED 2500 , 2500 ( 2009 ).
134. Moreno , supra note 6, at 1531 (describing the potential impact of the Vaccine Court decisions on public opinion because they contain “careful synthesis of available scientific evidence that is easily accessible to the public”).
135. Cedillo v. Sec'y of Health & Human Servs ., No. 98 - 916V , 2009 WL 331968, at * 135 ( Fed. Cl . Spec. Mstr. Feb. 12 , 2009 ) (“Nor do I doubt that Michelle's parents and relatives are sincere in their belief that the MMR vaccine played a role in causing Michelle's devastating disorders. Certainly, the mere fact that Michelle's autistic symptoms first became evident to her family during the months after her MMR vaccination might make them wonder about a possible causal connection .”).
136. E.g., Gross, supra note 56 , at 6.
137. Silverman , supra note 133, at 2501 (describing the “extremely negative response to the decision by the governor of Texas to circumvent the legislature and issue an executive order mandating the vaccination of adolescent girls against the human papillomavirus”).
138. Moreno , supra note 6, at 1517.
139. Gross , supra note 56, at 1.
140. Id . at 6.
141. Wendy E. Parmet , Pandemic Vaccines-The Legal Landscape, 362 NEW ENG. J. MED . 1949 , 1950 ( 2010 ).
142. Vaccines and the Autism Epidemic: Reviewing the Federal Government's Track Record and Charting a Course for the Future: Hearing Before the H . Comm. on Gov't Reform, 107th Cong . 7 ( 2002 ) [hereinafter Autism Hearings] (statement of Rep . Dan Burton).
143. Id . at 27 (statement of Rep . Dan Burton, referring to Dr. Paul Offit).
144. Id . at 6 (statement of Rep . Dave Weldon).
145. See Thomas L. Hafemeister , Other Developments, 27 DEV. MENTAL HEALTH L. 73 , 73 ( 2008 ) (stating that “many doctors and public health officials . . . are concerned that assertions of a vaccineautism link may lead parents to forgo vaccinating their children”).
146. Davis , supra note 5 , at 53.
147. Id . at 51 (“ Parents and their lawyers . . . [have] been vocal critics of the vaccine court, arguing that the judges decided to 'protect' the vaccine program by reassuring parents that vaccinations are safe, rather than fulfilling their responsibility to help injured children .”).
148. See Shemin, supra note 7 , at 493 n. 185 (“ Simple calculation demonstrates that there is currently not enough money in the Vaccine Trust Fund to compensate the approximately 4900 claims should the special masters find in their favor .”); Moreland, supra note 55, at 369 ( stating that the NVICP “could be bankrupt if petitioners in autism cases are given compensation through the Program” ).
149. Advisory Comm'n June Meeting , supra note 126, at 10 (statement of Geoffrey Evens, Dir., Div. of Vaccine Injury Comp. Program).
150. Davis , supra note 5 , at 51. Alexandra Dunn , Assistant Dean of Environmental Law Programs at Pace Law School , commented, “ The disappointing factor here is that a court that was created to be the best venue for these injuries is not fulfilling its purpose . . . . Over time, when it comes to [autism claims], the court seems to be raising the bar for causation .” Id.
151. The National Vaccine Injury Program: Is It Working As Congress Intended?: Hearing Before the H . Comm. on Gov't Reform, 107th Cong . 3 ( 2001 ) [hereinafter NVIP Hearing] (statement of Rep. Dan Burton) (“The Government hires teams of medical witnesses to try to disprove families' cases . . . . We 're supposed to be helping these people. But if you talk to some of these families, they feel like they've been put through the wringer by their own Government .”).
152. Shemin , supra note 7, at 476.
153. NVIP Hearing, supra note 151, at 59 (statement of Thomas E. Balbier, Jr., Dir., Nat'l Vaccine Injury Comp . Program).
154. Id . at 85 (written statement of Paul C. Harris, Sr., Deputy Assistant Att'y Gen., Civil Div ., U.S. Dep't of Justice).
155. Advisory Comm'n June Meeting , supra note 126, at 24-25 (statement of Mark Rogers, Deputy Dir., U.S. Dep't of Justice).
156. Id . at 24.
157. NVIP Hearing, supra note 151, at 60 (statement of Thomas E. Balbier, Jr., Dir., Nat'l Vaccine Injury Comp . Program).
158. H.R. REP . No. 99 - 908 , at 18 ( 1986 ), reprinted in 1986 U.S. C.C. A .N. 6344 , 6359 . The Cedillos quoted this passage in their appeal to the Federal Circuit .
159. Althen rejected a prior case requiring proof of confirmation of medical plausibility from the medical community and literature because such a standard would prevent “the use of circumstantial evidence . . . and negate the system created by Congress” with the Vaccine Act . Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 , 1280 (Fed. Cir. 2005 ). Subsequently, in Andreu, the Federal Circuit noted, “a paucity of medical literature supporting a particular theory of causation cannot serve as a bar to recover.” Andreu v . Sec'y of Health & Human Servs., 569 F.3d 1367 , 1379 (Fed. Cir. 2009 ).
160. Minutes of Advisory Commission on Childhood Vaccines Meeting , Agenda Item: Omnibus Autism Proceedings Update and Implications of Causation Standard in the Program-Chief Special Master Gary Golkewicz, at 8 (Mar. 6 , 2008 ) [hereinafter Advisory Comm'n OAP Update] .
161. 418 F.3d at 1278.
162. 2008 Transcript, supra note 125, at 26, lines 5-10, 16 - 18 .
163. See H.R. REP . No. 99 - 908 , at 3 ( 1986 ), reprinted in 1986 U.S. C.C. A .N. 6344 , 6344 (describing the aims of the program as adjudicating claims “quickly, easily and with certainty and generosity”); see also Davis, supra note 56, at 43 (citing one lawyer's description of the court as “streamlined and intended to provide consistency”); Currier, supra note 15, at 240 (“In light of the objectives of the Vaccine Act, the proper allocation of the burden of proving causation is essential to ensure that the Compensation Program remains an accessible forum for recovery .”).
164. 2008 Transcript, supra note 125, at 25, lines 19- 25 .
165. Id . at 24, lines 1- 22 .
166. Saad B. Omer et al., Vaccine Refusal , Mandatory Immunization, and the Risks of VaccinePreventable Diseases, 360 New Eng . J. Med 1981 , 1982 - 84 ( 2009 ) (describing study results finding children who were exempted from required vaccines were thirty-five times as likely to contract measles as non-exempted children and stating that a 2008 measles outbreak originated in individuals who
175. Cedillo v. Sec'y of Health & Human Servs ., No. 98 - 916V , 2009 WL 331968, at * 134 ( Fed. Cl . Feb. 12 , 2009 ).
176. Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 , 1280 (Fed. Cir. 2005 ).
177. Advisory Comm'n OAP Update, supra note 160 ( Chief Special Master Gary Golkewicz stating, “I'm one of those that does not understand how you have close calls go to one side or the other because the standard of proof in the statute is preponderance of evidence which by definition is 50.1 percent .”).
178. Cedillo , 2009 WL 331968, at *135.
179. 42 U. S.C. A. § 300aa-13 (requiring a preponderance of the evidence) .
180. Advisory Comm'n OAP Update, supra note 160 (stating that uncertainty regarding what proof is required “means the parties looking at the same evidence are reaching different conclusions”).
181. Brief for Petitioners-Appellants, supra note 102 , at 35.
182. E.g., Autism Hearings, supra note 142, at 5 (statement of Rep . Henry Waxman) (“But I think still these issues of science ought to be decided by the scientific method .”); 2008 Transcript, supra note 125, at 9, lines 8- 11 (Dr. Paul Offit stating, “ I think that scientific questions are answered in scientific