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The National Childhood Vaccine Injury Act
and Preemption: An Overview of
Bruesewitz v. Wyeth
Vivian S. Chu
Legislative Attorney
December 20, 2010
Congressional Research Service
7-5700
www.crs.gov
R41538
CRS Report for Congress
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repared for Members and Committees of Congress
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NCVIP: An Overview of Bruesewitz v. Wyeth
Summary
On October 12, 2010, the Supreme Court heard oral arguments for Bruesewitz v. Wyeth, a case
involving the scope of the National Childhood Vaccine Injury Act. The Supreme Court faces
consideration of whether 42 U.S.C. § 300aa-22(b)(1) of the act precludes all vaccine design
defect claims even if the vaccine’s side effects were avoidable, or whether the vaccine
manufacturer has to show on a case-by-case basis that the side effects could not have been
avoided by some alternatively designed vaccine. Both parties have fundamentally differing
interpretations of the statute’s plain meaning and of Congress’s intent. This report provides an
overview of the structure of the Vaccine Act and the relevant facts of the Bruesewitz case. It then
examines the district court and court of appeals decisions before discussing the arguments made
by the parties before the Supreme Court. Finally, the report looks at some of the potential
consequences that might result from the Court’s decision in favor of either the Bruesewitzes or
Wyeth. This report will be updated pending the Supreme Court’s decision.
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Contents
Introduction ................................................................................................................................ 1
Background of Bruesewitz v. Wyeth ............................................................................................. 1
United States District Court Claims and Decisions ................................................................ 3
Design Defect Claims (Counts I + III) ............................................................................. 4
Failure-to-Warn Claim (Count II) .................................................................................... 6
Manufacturing Defect Claim (Count IV) ......................................................................... 7
United States Court of Appeals Claims and Decisions ........................................................... 7
Design Defect Claims ..................................................................................................... 8
Failure-to-Warn Claim and Manufacturing Defect Claim............................................... 10
Arguments to the Supreme Court and Potential Consequences................................................... 11
Oral Argument .................................................................................................................... 11
Potential Consequences....................................................................................................... 13
Congressional Legislation ......................................................................................................... 15
Contacts
Author Contact Information ...................................................................................................... 15
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NCVIP: An Overview of Bruesewitz v. Wyeth
Introduction
On October 12, 2010, the Supreme Court heard oral arguments for Bruesewitz v. Wyeth,1 a case
involving the scope of the National Childhood Vaccine Injury Act. The issue before the Court is
whether 42 U.S.C. § 300aa-22(b)(1) of the act precludes all vaccine design defect claims even if
the vaccine’s side effects were avoidable,2 in other words whether the section preempts vaccine
design defect claims categorically, or whether the vaccine manufacturer has to show on a case-by-
case basis that the side effects could not have been avoided by some alternatively designed
vaccine.3
This report provides an overview of the structure of the Vaccine Act and the relevant facts of the
Bruesewitz case. It then examines the district court and court of appeals decisions before
reviewing the arguments made by the parties before the Supreme Court. Finally, it discusses some
of the potential consequences that might result from the Court’s decision in favor of either the
Bruesewitzes or Wyeth.
Background of Bruesewitz v. Wyeth
The National Childhood Vaccine Injury Act (Vaccine Act) was enacted in 19864 and established a
national vaccine program to “achieve optimal prevention of human infectious diseases through
immunization and to achieve optimal prevention against adverse reaction to vaccines.”5 Under the
Vaccine Act, the National Vaccine Injury Compensation Program (NVCIP) was established to
handle claims against drug manufacturers for vaccine-related injuries and deaths.6 NCVIP has
two parts. Part A creates a mandatory forum for the administration of claims by requiring
individuals who seek compensation, including the injured party’s legal representative, to file a
petition in the United States Court of Federal Claims (Vaccine Court).7 A petitioner is entitled to
recover if the affected person (1) received a vaccine covered by the Vaccine Act; (2) suffered a
“covered” injury;8 and (3) it cannot be shown by a preponderance of the evidence that the injuries
or death were not caused by the vaccine.9 A petitioner who suffers a non-covered injury may still
recover compensation by proving affirmatively that the vaccine caused the injury.10 Part B
permits a petitioner to decline the result of the Vaccine Court and pursue a civil suit in state or
1 Bruesewitz v. Wyeth, 561 F.3d 233 (3d Cir. 2009), cert. granted, 559 U.S. __ (2010); 2010 U.S. LEXIS 2266 (U.S.
March 8, 2010) (No. 09-152).
2 Brief for Petitioner at i, Bruesewitz v. Wyeth, No. 09-152 (May 24, 2010).
3 Brief for Respondent at i, Bruesewitz v. Wyeth, No. 09-152 (July 23, 2010).
4 P.L. 99-660; 100 State 3743, 3756-84 (1986), codified at 42 U.S.C. § 300aa-1 et seq.
5 42 U.S.C. § 300aa-1.
6 42 U.S.C. §§ 300aa-10 et seq.
7 Id. at § 300aa-12.
8 The Vaccine Act created the “Vaccine Injury Table,” which sets forth the “vaccines, the injuries, disabilities,
illnesses, conditions, and deaths resulting from the administration” of vaccines for which individuals may seek
compensation. Id. at § 300aa-14. For a complete list of covered vaccines and injuries, see Department of Health and
Human Services, Human Resources and Services Administration, http://www.hrsa.gov/vaccinecompensation/table.htm.
9 Id. at §§ 300aa-11, 300aa-13.
10 See Grant v. Sec’y of HHS, 956 F.2d 1144, 1148 (Fed. Cir. 1992).
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federal district court only after a final judgment is issued by the Vaccine Court.11 Any subsequent
civil action is governed by state law, including the applicable statute of limitations, which is
stayed pending the outcome of the suit filed in the Vaccine Court.12 However, § 300aa-22 places
limitations on subsequent civil actions, and it is this section that is at issue in Bruesewitz v. Wyeth.
42 U.S.C. § 300aa-22 (§ 22) provides:
(a) General Rule. Except as provided in subsections (b), (c), and (e) State law shall apply to a civil action brought for
damages for vaccine-related injury or death.
(b) Unavoidable adverse side effects; warnings
(1) No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or
death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side
effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions
and warnings. (emphasis added)
(2) For purposes of paragraph (1), a vaccine shall be presumed to be accompanied by proper directions and
warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under
the Federal Food, Drug, and Cosmetic Act [21 U.S.C. §§ 301 et seq] and section 262 of this title (including
regulations issued under such provisions) applicable to the vaccine and related to vaccine-related injury or death
for which the civil action was brought unless the plaintiff shows—
(A) that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of section 300aa-
23(d)(2) of this title, or
(B) by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its
compliance with such Act and section (and regulations issued under such provisions).
(c) Direct Warnings. No vaccine manufacturer shall be liable for civil action for damages arising from a vaccine-related
injury or death associated with the administration of a vaccine after October 1, 1988, solely due to the
manufacturer’s failure to provide direct warnings to the injured party (or the injured party’s legal representative) of
the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.
(d) Construction.—[omitted]
(e) Preemption. No State may establish or enforce a law which prohibits an individual from bringing a civil action
against a vaccine manufacturer for damages for a vaccine-related injury or death if such civil action is not barred by
this part.
In this case, plaintiffs/petitioners are the parents of Hannah Bruesewitz. They filed a claim with
the Vaccine Court in April 1995, seeking compensation on behalf of their daughter, who suffered
from several seizures shortly after receiving the third of five recommended doses of the
diphtheria-pertussis-tetanus (DPT) vaccine on April 1, 1992.13 Hannah was subsequently
diagnosed as having residual seizure disorder and developmental delay, for which she will likely
11 42 U.S.C. § 300aa-21. Upon issuance of a special master’s decision, each party has 30 days to file a motion to have
the United States Court of Federal Claims review the decision. If there is no such motion, the clerk of the United States
Court of Federal Claims shall immediately enter a judgment in accordance with the special master’s decision. The
parties may further obtain review of the judgment in the United States Court of Appeals for the Federal Circuit. Id. at
§§ 300aa-12(e)-(f). Once judgment has been entered by the United States Court of Federal Claims or by the Court of
Appeals for the Federal Circuit, a petitioner may give notice to the court that it will file a civil action in a state or
federal district court. Id. at § 300aa-21(a).
12 Id. at §§ 300aa-22(a), 21(c), 16(c). For description of typical litigation life cycle of a vaccine-related suit, see Miles
E. Coleman, An Overview of the National Childhood Vaccine Injury Act, 21 S. Carolina Lawyer 41 (May 2010).
13 Pertussis is the disease also commonly known as whooping cough.
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require medical care for the remainder of her life. The DPT vaccine that Hannah received was
marketed by Wyeth (and its predecessors) under the trade name TRI-IMMUNOL and approved in
1948.14 TRI-IMMUNOL contained whole, inactivated pertussis cells (“whole-cell”) that
effectively reduced pertussis infections and associated deaths, but it was linked to a variety of
adverse events. In December 1991, the Food and Drug Administration (FDA) approved Wyeth’s
application for an alternative DPT vaccine, known as ACEL-IMUNE. This vaccine, which
contains an “acellular pertussis component” rather than the “whole-cell,” reportedly is less likely
to cause adverse events.15 The FDA initially approved Wyeth’s ACEL-IMUNE for use in the
fourth and fifth doses of the DPT vaccine, but did not approve the general acellular pertussis
vaccine for use in the first three doses until July 1996, when it approved the license of another
pharmaceutical company. Wyeth’s ACEL-IMUNE vaccine did not receive approval for use in the
first three doses until December 1996. Thus, for her third dose Hannah received the TRI-
IMMUNOL vaccine because there were no acellular pertussis vaccines commercially available at
the time. Wyeth, the defendant/respondent, voluntarily discontinued manufacturing TRI-
IMMUNOL in 1998.
Although the plaintiffs filed their complaint with the Vaccine Court, alleging that Hannah suffered
covered injuries, the Vaccine Court held a hearing in July 2002 and concluded in December 2002
that Hannah’s injuries were not covered injuries and that the petitioners had not proved causation
in fact.16 On February 14, 2003, the plaintiffs did not accept the Vaccine Court’s judgment to
dismiss the claim with prejudice, and subsequently brought suit in the Philadelphia County Court
of Common Pleas in October 2005. Wyeth removed the action on the basis of diversity
jurisdiction to the United States District Court for the Eastern District of Pennsylvania.
United States District Court Claims and Decisions
In district court, the plaintiffs sued for damages to Hannah Bruesewitz, costs, punitive damages,
and other legal equitable relief. They alleged four counts against Wyeth:
1. Count I alleged that Wyeth negligently failed to produce a safer vaccine despite
knowledge of the existence and feasibility of such safer alternatives;
2. Count II alleged that Wyeth negligently failed to warn of the actual dangers
associated with the particular batch of DPT vaccine administered to Hannah;
3. Count III asserted strict liability for design defect, in the existence or feasibility
of safer alternative designs for the vaccine rendered the vaccine administered to
Hannah defective and unreasonably dangerous; and
4. Count IV asserted strict liability for manufacturing defect, in that, in addition to
the unreasonable danger due to the alleged design defect, the particular dose of
14 The National Health Institute first issued a product license for TRI-IMMUNOL in 1948 to American Cyanamid
Company (Cyanamid). Lederle Laboratories, an unincorporated division of Cyanamid, produced TRI-IMMUNOL. In
1994, American Home Products Corporation (AHPC) acquired Cyanamid, but later changed its name to Wyeth in
March 2002.
15 Brief for Petitioner at 17-19, Bruesewitz v. Wyeth, No. 09-152 (May 24, 2010); but see Brief for Respondent at 18-
20, Bruesewitz v. Wyeth, No. 09-152 (July 23, 2010).
16 Bruesewitz v. Sec’y of Dep’t of HHS, No. 95-0266V, 2002 WL 31965744 at *1 (Fed. Cl. December 20, 2002).
Approximately one month before the plaintiffs filed their petition with the Vaccine Court, new regulations that were
effective on March 10, 1995, deleted residual seizure disorder as a Table Injury for the DPT vaccine. Id. at *17 n.1.
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vaccine administered to Hannah contained a manufacturing defect that made it
“extra-hazardous.”17
Wyeth made a motion for summary judgment18 on grounds that (1) the Vaccine Act preempted
tort claims for the allegedly defective design of a covered vaccine, (2) § 22(c) bars the petitioners’
failure-to-warn claim, and (3) there are no genuine issues of fact for trial with respect to any
claims not found to be preempted by the Vaccine Act. In sum, the district court granted Wyeth’s
motion for summary judgment, concluding that Counts I and III were preempted by the Vaccine
Act and that plaintiffs failed to raise any genuine issue of material fact as to Counts II and IV.
Design Defect Claims (Counts I + III)
To determine whether the Vaccine Acts bars the plaintiffs from claiming a design defect under
state tort law, the district court examined analogous cases, two from federal district courts and
two from intermediate state appellate courts, that reached different conclusions. Using similar
reasoning, three courts held that the Vaccine Act preempts design defect claims. In Blackmon v.
American Home Products Corp,19 the federal district court found that the main purpose of the
Vaccine Act is to protect the national vaccine supply by protecting manufacturers from the
“inconsistencies of the 50-state tort system,” 20 while still providing vaccine-injured individuals
with a remedy. The Blackmon court also concluded that Congress intended to incorporate the
liability principles of the Restatement (Second) of Torts § 402A comment k21 into the Vaccine
Act, because “without a complete bar to design defect claims, § 22(b)(1) would be stripped of all
meaning.”22 While the court in Blackmon acknowledged that comment k of the Restatement
17 Bruesewitz, 508 F. Supp. 2d 430, 435 (E.D. Pa. 2007).
18 Summary judgment is a preverdict “judgment granted on a claim about which there is no genuine issue of material
fact and upon which the movant is entitled to prevail as a matter of law.” Black’s Law Dictionary 1449 (7th ed. 1999).
19 328 F. Supp. 2d 659 (S.D. Tex. 2004). In Blackmon, plaintiffs asserted strict products liability and negligence against
several vaccine companies for alleged injuries, claiming that the defendants’ products were defectively designed and
that safer alternatives existed at the time the drugs were administered. Id. at 663.
20 Blackmon, 328 F. Supp. 2d at 665.
21 Restatement (Second) of Torts § 402A cmt. k (1965) states:
Unavoidable unsafe products. There are some products which, in the present state of human
knowledge, are quite incapable of being made safe for their intended and ordinary use. These are
especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur
treatment of rabies, which not uncommonly leads to very serious and damaging consequences when
it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and
the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which
they involve. Such a product, properly prepared, and accompanied by proper directions and
warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs,
vaccines, and the like, many of which for this very reason cannot legally be sold except to
physicians, or under the prescription of a physician. It is also true in particular of many new or
experimental drugs as to which, because of lack of time and opportunity for sufficient medical
experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such
experience as there is justifies the marketing and use of the drug notwithstanding a medically
recognizable risk. The seller of such products, again with the qualification that they are properly
prepared and marketed, and proper warning is given, where the situation calls for it, is not to be
held to strict liability for unfortunate consequences attending their use, merely because he has
undertaken to supply the public with an apparently useful and desirable product, attended with a
known but apparently reasonable risk.
22 Blackmon, 328 F. Supp. 2d at 665. “In the [Blackmon] court’s view, allowing a case-by-case determination of
unavoidability would undercut not only the protections the Vaccine Act provides vaccine manufacturers, but also, the
broader ‘comprehensive regulatory scheme, administered by the FDA, to control the design and distribution of
(continued...)
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applies only to strict liability, it concluded that § 22(b)(1) would preclude a design defect claim
under all theories of liability because the section grants immunity in a “civil action for
damages.”23
A later case, Sykes v. Glaxo-SmithKline, which arose in the same federal district as Bruesewitz,
adopted the reasoning of the Blackmon court when it granted the pharmaceutical company’s
motion for summary judgment and held that the Vaccine Act preempts all design defect claims.24
The third court—a state appellate court—in New York also held that the Vaccine Act preempts all
design defect claims. In Milantrano v. Lederle Labs, the state appellate court, noting that
“[p]reemption is a question of Congressional intent,” found that the committee report for the
Vaccine Act made clear that Congress intended to preclude all design defect claims with respect
to vaccines covered by the Vaccine Act.25
On the other hand, the Bruesewitz court noted that the Georgia Court of Appeals in Ferrari v.
American Home Products rejected that the Vaccine Act preempted all design defect claims even
though it agreed with Sykes and Blackmon that “the legislative history of the Vaccine Act clearly
demonstrates congressional intent to completely preempt design defect claims.”26 The Georgia
appellate court in Ferrari found that the Supreme Court’s decision in Bates v. Dow Agrosciences27
precluded it from examining legislative history because there was no longer a rebuttable
presumption against preemption but rather “a duty to accept the reading (of the Vaccine Act) that
disfavors pre-emption.”28 The district court in Bruesewitz rejected the Ferrari court holding,
finding that the Bates ruling does not require a court to automatically accept a plausible
interpretation of a statute which disfavors preemption and that the Ferrari holding had taken the
Bates ruling out of context, giving it broader scope than appropriate.29 Notably, since the district
court’s decision in Bruesewitz, the Georgia Supreme Court has upheld the Georgia Court of
Appeals ruling, though it also disagreed with the lower court’s application of the Bates decision.30
The federal district court found that the case did not “materially deviate” from the precedents
examined, as all the plaintiffs had asserted that a vaccine was defectively designed. Using the
Sykes decision as guidance (see note 24), the district court drew four conclusions in holding that
the Vaccine Act categorically preempts all design defect claims. First, it held that vaccine
(...continued)
prescription drugs, including vaccines.’” Bruesewitz, 508 F. Supp. 2d at 441.
23 Blackmon, 328 F. Supp. 2d at 666.
24 Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 290 (E.D. Pa. 2007). In Sykes, the court based its ruling on four basic
conclusions: (1) the purpose of the Vaccine Act to protect vaccine manufacturers from the unpredictability and expense
of the tort system would be thwarted by allowing juries to decide design defect claims by evaluating whether a vaccine
was unavoidably unsafe on a case-by-case basis; (2) through the Vaccine Act, Congress delegated to the Department of
Health and Human Services, rather than the jury system, the role of assuring improvements in the quality,
effectiveness, and safety of vaccines; (3) the Vaccine Act protects manufacturers from design defect claims in
particular; and (4) comment k supports the understanding that the liability of vaccine manufacturers is limited to claims
that the vaccine deviated from its FDA-approved design. Bruesewitz, 508 F. Supp. at 441 (citing Sykes, 484 F. Supp.
2d at 301-03).
25 801 N.Y.S.2d 506 (N.Y. App. Div. 2006).
26 Bruesewitz, 508 F. Supp. 2d at 444.
27 544 U.S. 431 (2005).
28 Ferrari v. Am. Home Prods. Corp., 650 S.E.2d 585, 589 (Ga. Ct. App. 2007).
29 Bruesewitz, 508 F. Supp. 2d at 444.
30 Ferrari v. Am. Home Prods. Corp.,668 S.E.2d 236 (Ga. 2008).
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manufacturers would not be protected from lawsuits if it allowed for case-by-case inquiries.
Second, the purpose of the Vaccine Act and its establishment of a no-fault remedies compensation
program suggests that “Congress intended to provide an umbrella under which manufacturers
would improve the safety of their products while remaining immune from design defect claims
made possible by the successful innovation of safer alternative designs.”31 Third, the
compensation scheme reflects a balance Congress struck “between the policy of widespread
distribution of childhood vaccines and the need to compensate those injured affecting that
policy.” Lastly, although the district court stated that comment k “suggests ... that the question of
whether a particular vaccine is unavoidably unsafe ... is a question of fact for a jury to
determine,” it found § 22(b) to be broader than comment k, so that the Vaccine Act preempts state
law determinations of whether a vaccine is unavoidably unsafe.32 It examined the compensation
program in light of the FDA’s role with vaccines, holding that “an FDA-approved vaccine design
includes the side-effects of that vaccine, and is therefore, by statutory definition, the unavoidably
unsafe product subject to comment k immunity.”33
Failure-to-Warn Claim (Count II)
The Bruesewitz court then addressed the plaintiffs’ claim that the manufacturer withheld
information from doctors about particularly dangerous batches of vaccines. Although § 22(c) of
the Vaccine Act “clearly bars failure-to-warn claims based on a failure to directly warn the injured
party’s legal representatives,” the plaintiffs argued that this section does not preclude their
particular claim since the court in Blackmon found that allegations of failure-to-warn “doctors
and medical intermediaries” are not subject to the prohibition of § 22(c).34 Therefore, assuming
that the plaintiffs’ failure-to-warn claim is not precluded, the Vaccine Act grants the manufacturer
the presumption of a proper warning if the manufacturer shows that it complied with the proper
FDA requirements. Once the manufacturer meets the burden, the plaintiffs then must present
evidence that the manufacturer “engaged in fraud or wrongful withholding of information” from
the Secretary of Health and Human Services (HHS) either during or after the approval process, or
“by clear and convincing evidence that the manufacturer failed to exercise due care
notwithstanding its compliance with [the laws and regulations regarding drug approval
proceedings].”35
In the Bruesewitzes’ case, the federal district court concluded that Wyeth was entitled to the
presumption of proper warning because the evidence presented demonstrated licensing and label
approval from the FDA.36 It stated, however, that the plaintiffs failed to provide any clear and
convincing evidence that the “vaccine dose in question was materially different from any other
vaccine dose for which the warning had been approved.”37 Therefore, the plaintiffs’ failure-to-
warn claim was also dismissed as they failed to produce evidence raising issues of material fact.
31 Bruesewitz, 508 F. Supp. 2d at 445.
32 Id. at 445-46.
33 Id. at 446.
34 Id. at 447 (citing Blackmon, 328 F. Supp. 2d at 666).
35 Id. at 447 (citing 42 U.S.C. §§ 300aa-22(b)(2)(A) and (B)).
36 Because the plaintiffs in Bruesewitz did not allege fraud or wrongful withholding of information from the Secretary
of HHS, they were required to show by clear and convincing evidence that the manufacturer failed to exercise due care
notwithstanding compliance with the law.
37 In support of their failure-to-warn claim, the plaintiffs identified which lot produced the dose of TRI-IMMUNOL
(continued...)
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Manufacturing Defect Claim (Count IV)
The fourth complaint the plaintiffs asserted was a strict liability claim for a manufacturing defect,
specifically that the particular dose administered to Hannah contained a manufacturing defect that
made it “extra-hazardous.”38 Wyeth conceded that the Vaccine Act did not bar such a claim;
therefore, under Pennsylvania law, a plaintiff alleging a product manufacturing defect based on a
theory of strict liability must show (1) the product was defective, (2) the defect was the proximate
cause of the plaintiffs’ injuries, and (3) the defect causing the injury existed when the product left
the seller’s hand.39 Although the plaintiffs presented some evidence, the court concluded that
none of the evidence offered demonstrated that the product was defective40 or that “the specific
lot caused any of the adverse reactions, let alone the specific reaction suffered by Hannah.”41 Due
to this lack of evidence, the court dismissed the manufacturing defect claim in favor of the
defendant.
United States Court of Appeals Claims and Decisions
The Bruesewitzes appealed the decision of the lower court to the United States Court of Appeals
for the Third Circuit. The court of appeals affirmed the judgment of the district court to grant the
motion for summary judgment in favor of Wyeth, and further analyzed the conclusions reached
by the district court. Based on the district court’s decision, the plaintiffs’ appeal presented the
court of appeals with three questions:
(1) whether § 22(b)(1) acts as a complete bar to design defect claims;
(2) have the plaintiffs in this case met their burden under § 22(b)(2) of the Vaccine Act to
show that defendants failed to provide an adequate warning of the alleged dangers of the
vaccine; and
(3) have the plaintiffs provided sufficient evidence of a manufacturing defect to survive the
defendant’s motion for summary judgment.
(...continued)
administered to Hannah as well the Vaccine Adverse Event Reporting System (VAERS) report confirming deaths and
other adverse events associated with the lot. Lots associated with deaths and adverse reactions are sometimes referred
to as “hot lots.” However, according to the evidence, a “hot lot” is not defined by the total number of adverse incidents,
but rather by the rate at which those incidents occurred. Plaintiffs have produced no evidence from which a trier of fact
could infer that the dose in question originated in a lot of vaccine associated with a disproportionate number of adverse
health effects. Bruesewitz, 508 F. Supp. 2d at 448.
38 Id. at 435 (citing Pl. Am. Comp. ¶ 37). The plaintiffs assert that the dose administered to Hannah had “an
inappropriate balance between neuro-toxins and endo-toxins in the pertussis vaccine.” Id.
39 Id. at 449.
40 Wyeth disputed the plaintiffs’ allegation of an inappropriate balance between neuro-toxins and endo-toxins by
submitting the Declaration of Dr. Mary B. Ritchy, Ph.D, who stated that “The pertussis bacterium does not contain a
recognized ‘neuro-toxin’ component.” Id.
41 The court believed that the plaintiffs’ own evidence negated the possibility that one could draw an inference from a
VAERS report that the vaccine caused the reaction. Id. at 451.
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Design Defect Claims
Although the district court had concluded that the plaintiffs’ design defect claims (Counts I and
III) were preempted by the Vaccine Act, the court of appeals stated that the lower court’s analysis
warranted further examination because “the District Court did not explicitly lay out a framework
for coming to [its four] conclusions [in support of finding preemption], nor did it state whether
they were predicated on express, implied or field preemption grounds.”42 Because of this
“ambiguity” the plaintiffs, on appeal, argued that the district court’s decision was “based on some
kind of implied or field preemption,” and therefore in violation of the principle that “a district
court may not grant judgment sua sponte on grounds not requested by the moving party,” because
the defendants had only raised express preemption in their motion for summary judgment.
Disagreeing with the plaintiffs’ characterization of the district court’s decision, the court of
appeals found that it must answer four questions related to the preemption of the design defect
claims: (1) whether § 22(b) constitutes an express preemption provision; (2) whether the court
can use traditional tools of statutory interpretation, including legislative history, when construing
such a provision; (3) whether this provision preempts plaintiffs’ design defect claims; and (4)
whether the district court’s decision is consistent with this analysis.
First, the court of appeals found the language of §§ 22(a) and (b) to mirror different provisions in
federal law that the Supreme Court had characterized as express preemption provisions.43
Therefore, based on prior jurisprudence, the court concluded that the language of these sections
contains express preemption clauses as it “conveys a clear intent to override state law civil action
claims in particular, defined circumstances.”44 Second, the court found that it could not construe
the scope of preemption created by § 22(b)—“if the injury or death resulted from side effects that
were unavoidable”—from the statutory text alone. Rather, it resolved to look at the language,
structures, purpose, and legislative history of the Vaccine Act to ascertain the scope of
preemption.
Third, to determine whether the provision preempts plaintiffs’ design defect claims (i.e., the scope
of preemption), the court of appeals initially found that the structure of the provision was open to
two possible interpretations because the scope of preemption “hinge[d] on the word
42 Bruesewitz v. Wyeth, 561 F. 3d 233, 240-41 (3d Cir. 2009). Generally there are three types of preemption: express,
implied, or field preemption. Express preemption exists where a federal law contains explicit language of Congress’s
intention to preempt state law. In such cases, courts are often called upon to “identify the domain expressly pre-empted
by that language.” Medtronic, Inc v. Lohr, 518 U.S. 470 484 (1996) (internal quotation marks and citations omitted).
Implied preemption arises when state law conflicts with a federal statute when it is “impossible for a private party to
comply with both state and federal requirements,” English v. General Electric, Co., 496 U.S. 72, 78-9 (1990), or when
state law “stands as an obstacle to the accomplishment and execution of the full purpose and objectives of Congress.”
Hines v. Davidowitz, 312 U.S. 52, 67 (1941). Field preemption arises when state law occupies a “field reserved for
federal regulation.” United States v. Locke, 529 U.S. 89, 111 (2000).
43 The court found the language of § 22(b)—“[n]o vaccine manufacturer shall ...”—to be similar to the Federal
Cigarette Labeling and Advertising Act’s “No statement relating to smoking and health other than the statement
required by section 1333 of this title, shall be required on any cigarette package.” 15 U.S.C. § 1334. The court found
§ 22(a)—“[e]xcept as provided ... State law shall apply ...”—to be similar to a federal railroad safety provision which
provided “A state may adopt or continue in force any law ... until such time as the Secretary has adopted a rule ...
covering the subject matter of such State requirement. A state may adopt or continue in force an additional or more
stringent law ... when not incompatible with any Federal law ... ” 45 U.S.C. § 434 (repealed 1994). The Supreme Court
in Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001) and CSX Transportation, Inc., v. Easterwood, 507 U.S. 658
(1993), respectively, had construed each of the aforementioned provisions as express preemption provisions.
44 Bruesewitz, 561 F.3d at 243.
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‘unavoidable.’”45 According to the court of appeals’ reading, the first construction would result in
the preemption of some design defect claims, because § 22(a) “displaces state law only as defined
in subsections (b), (c), and (e)” and that in reading these provisions together “it becomes clear
that Congress intended that subsections (b) and (c) should be an outright bar to some claims.”46
The second reading considered the Georgia Supreme Court’s decision in Ferrari that the
language of § 22(b) is conditional, which “implies that some vaccine-related injuries and deaths
may be avoided,” and that if Congress had intended to preempt all design defect claims, it could
have done so by omitting the “unavoidable” clause.47 The court of appeals disagreed with the
Ferrari court’s construction, finding it contrary to the structure of the act. Moreover, the court
pointed out that when Congress enacted the Vaccine Act in 1986, several courts had already
barred strict liability design defect claims against prescription drug manufacturers under state law.
Thus, the court of appeals believed that the Ferrari court’s construction of § 22 “could create an
awkward dichotomy in the case law of [such] states—their courts would be required to engage in
case-by-case analysis of all strict liability and design defect claims brought under the Vaccine
Act, while barring strict liability design defect claims against prescription drug manufacturers.”48
Although it found congressional intent to support the first construction of the provision, the court
turned to the legislative histories relied upon by the plaintiffs and defendant to determine whether
the Vaccine Act preempts only strict liability design defect claims or those also based in
negligence. The defendant relied upon the committee report (Commerce Report) from the House
Committee on Energy and Commerce (Energy and Commerce Committee), which had
jurisdiction over the Vaccine Act.49 The court found that the Commerce Report supported the
conclusion that the Vaccine Act preempts all design defect claims, including those based in
negligence. In the court’s analysis, most importantly, the Commerce Report made clear that “the
Vaccine act reflected the principle of Restatement (Second) of Torts § 402A, comment k” and
“stated in precise and certain terms that its reference to comment k and the language of 22(b)
results in immunity for liability for all design defects, whether liability rests on theories of strict
liability or negligence” (emphasis in the original).50 According to the court, any reading of the
provision to permit state courts to make case-by-case determinations would undermine “the
objectives extolled by the Commerce Report” and exacerbate the “very problems which led to
instability in the vaccine market and which caused Congress to intervene.”51 The plaintiffs, on the
other hand, relied upon the committee report (Budget Report) from the House Committee on the
Budget that accompanied the subsequent 1987 legislation to fund the compensation program. The
Budget Report most notably stated: “The Committee stresses that there should be no
misunderstanding that the Act undertook to decide as a matter of law whether vaccines were
unavoidably unsafe or not. This question is left to the courts to determine in accordance with
45 Id. at 245. On the one hand, plaintiffs argued that it “expressly precludes only those state tort claims involving
vaccines with side effects first shown to be ‘unavoidable,’” and that “avoidability must first be determined on a case-
by-case basis.” On the other hand, the defendant argued that the language “preempts all claims arising from allegations
of design defect.” Id.
46 Id.
47 Id. (citing Am. Home Prods. Corp. v. Ferrari, 668 S.E.2d 236 (Ga. 2008)).
48 Id. at 246.
49 H.Rept. 99-908 (1986).
50 Bruesewitz, 561 F. 3d at 247-8 (citing H.Rept. 99-908 at 25-26) (“If the [injured individuals] cannot demonstrate
under applicable law either that a vaccine was improperly prepared or that it was accompanied by improper directions
or inadequate warnings [they] should pursue recompense in the compensation system, not the tort system.” Id. at 26).
51 Bruesewitz, 561 F.3d. at 249.
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applicable law.”52 The court of appeals found the Budget Report problematic in that it repeatedly
used the term “the Committee” but was not clear if it referred to the Energy and Commerce
Committee from 1986, which had jurisdiction over the Vaccine Act, or the Budget Committee,
which played no role in the drafting or passage of the act.53 Furthermore, it found “the views of a
subsequent Congress [to] form a hazardous basis for inferring the intent of an earlier one”54 and
that without more, it had no grounds to conclude whether the Budget Report was an accurate
reflection of what had transpired in committee or of Congress’s motivations underlying the
enactment of the Vaccine Act in 1986.55
The court found that the Commerce Report and other legislative history indicated that Congress
intended to preempt the specific claims asserted by the plaintiffs. Both the Commerce Report and
a background report issued by the staff of the Energy and Commerce Committee contained
numerous references to the DPT vaccine, its development, the side effects, hurdles in clinical
testing, and the high number of lawsuits against the only two producers of the vaccine.56
According to the court, these two reports taken together strongly indicate that “Congress weighed
the various concerns related to the pertussis vaccine and concluded that DPT manufacturers
should be shielded from liability for injuries arising from the whole-cell pertussis vaccine.”57
Lastly, with respect to design defect claims, the court of appeals found that the district court’s
decision was consistent with an express preemption analysis and rejected the plaintiffs’ claim that
the district court’s decision was based on implied or field preemption grounds or that it violated
well-settled principles of summary judgment.58
Failure-to-Warn Claim and Manufacturing Defect Claim
In reviewing the district court’s decision on the plaintiffs’ failure-to-warn claim, the court of
appeals needed only to examine whether the plaintiffs had presented clear and convincing
evidence that Wyeth had not exercised due care. The statute shifted the burden to plaintiffs to
overcome the presumption that the manufacturer complied with warning requirements if they
could show that “(2) the manufacturer ‘failed to exercise due care.’” The plaintiffs made two
arguments against the district court’s decision on its failure-to-warn claim, one of which the court
of appeals immediately dismissed as it was based on Wyeth first showing that a safer design was
available before the presumption could apply. The second argument was whether the evidence
relied upon by the plaintiffs to show that the dose Hannah received came from a “hot lot” raised
an issue of fact. Of note, the plaintiffs relied upon the affidavit of Dr. Marks, who asserted that
batches of vaccines associated with injuries and death are sometimes called a “hot lot.” He, in
turn, based his opinion on an HHS memorandum discussing the investigation of “potential hot
lots” and that investigators needed first to identify the number of doses administered in order to
determine whether a particular vaccine lot qualifies as a “hot lot.” (See also note 37). However,
the plaintiffs supplied no further evidence, and accordingly, the court of appeals agreed with the
52 Id. (citing H.Rept. 100-391, pt. l at 691 (1987)).
53 Id. at 250.
54 Id.(quotation marks omitted) (citing United States v. Price, 361 U.S. 304, 313 (1960)).
55 Id.
56 Id. at 251 (citing Staff of H. Comm. on Energy & Commerce, 99th Cong., Childhood Immunizations, at III (1986)).
57 Id.
58 Id. at 251.
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district court that the plaintiffs did not meet their burden because the evidence they presented was
merely a scintilla and not “sufficient for a reasonably jury to find in their favor.”59
With respect to the plaintiffs’ manufacturing defect claim, the court of appeals did not review it in
much detail because the plaintiffs had “predicated their argument for manufacturing defect on the
fact that Hannah’s vaccine came from a ‘hot lot.’”60 The court of appeals, having determined that
the plaintiffs did not produce enough evidence from which a jury could conclude that Hannah
was administered a vaccine from a “hot lot,” agreed with the district court’s judgment to dismiss
the manufacturing defect claim.
Arguments to the Supreme Court and
Potential Consequences
On October 12, 2010, the Supreme Court heard the oral arguments of the petitioners, the
Bruesewitzes, and respondent, Wyeth. The only issue the Court agreed to review is whether
§ 22(b)(1) precludes all design defect claims or whether a vaccine manufacturer must show on a
case-by-case basis that the side effects at issue could not have been avoided by some differently
designed vaccine.
Oral Argument
At oral argument, both counsels for the petitioners and defendant faced difficult questions from
the Justices.61 The phrase in question was “... if the injury or death resulted from side effects that
were unavoidable even though the vaccine was properly prepared and was accompanied by
proper directions and warnings.”62 Questioning primarily revolved around the possible
interpretations of the term “unavoidable” and the potential consequences for vaccine
manufacturers and victims from such interpretations.
Counsel for the petitioners advanced their argument that while Congress provided several
defenses for manufacturers, each is to apply on a case-by-case basis and “[t]here are no absolute
provisions that preclude a State law claim.”63 Because petitioners’ counsel argued that a
manufacturer could be held liable for side effects that were not “unavoidable,” which he defined
as effects that could be prevented by using a different vaccine design, given current scientific
knowledge, Justices Scalia and Alito queried whether his interpretation of “unavoidable” would
then render the latter half of the phrase “even though....” as surplus. Counsel countered that it was
not surplus because it was consistent with the intent behind comment k of the Restatements in
that if “there is no way in science we can design a safer product, there will be a defense to a claim
of strict liability unless or provided that the product is properly manufactured and warned
59 Id. at 253-54.
60 Id. at 255.
61 Justice Elena Kagan recused herself from this hearing. Robert Barnes, “Justices Split on Childhood-Vaccine Case,”
Wash. Post, October 13, 2010 at A2.
62 42 U.S.C. § 300aa-22(b).
63 Transcript of Oral Argument at 4, Bruesewitz v. Wyeth, No. 09-152 (argued October 12, 2010).
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against.”64 In addition, counsel argued that the respondent’s interpretation would render some
language surplus because “[t]hey took the concept of unavoidability completely out of the
statute.”65 After being pressed by Justice Scalia that his interpretation would be problematic if it
meant assessing “unavoidable” in terms of other vaccines which could prompt comparisons with
less effective vaccines, petitioners’ counsel conceded that alternative designs must be at least as
effective as the vaccine in question for liability to attach.66 Justice Breyer asked whether a holding
in the petitioners’ favor would undermine Congress’s intent by “driving certain vaccines from the
market” because of the threat of liability.67 Counsel emphasized that the “vast majority” of people
accept the Vaccine Court’s judgment and that many do not pursue a state law claim because “it’s
difficult to win these kinds of cases in State courts.”68 However, Chief Justice Roberts pointed out
that the threat of liability also includes the size of the judgments since “[i]t doesn’t take too many
$60 million verdicts to make you come out on the other side of your calculus.”69 Toward the end
of his argument, petitioners’ counsel emphasized, possibly in an effort to assure the Justices, that
it would be a rare instance when there is a state lawsuit because the compensation fund takes care
of a vast majority of the claims and that “for many vaccines there is no safer alternative,” and
thus no design defect claim.70
Counsel for the respondent reminded the Court that the Vaccine Act was passed “against the
backdrop of a wave of tort litigation that threatened to drive manufacturers out,” to which Justice
Sotomayor pressed counsel to explain why Congress did not just make the Vaccine Court the
exclusive remedy.71 Similarly, Justices Kennedy and Ginsburg asked why Congress did not
express its concern about preempting design defect claims using clearer, more direct language.72
Justices Sotomayor and Kennedy asked what would motivate a manufacturer to act quickly to
voluntarily remove a defectively designed drug that still had FDA approval. Counsel responded
that in addition to § 27 requiring the Secretary of HHS to promote safer vaccines and reduce the
number of side effects, there are “grave consequences if a manufacturer withholds knowledge of
adverse effects from the FDA,” because it will lose its presumption under § 22(b)(2) that its
warnings were correct.73 However, Justices Sotomayor and Kennedy both countered that the
warning need not say that there is a better product or safer alternative.74 Respondent’s counsel
indicated that allowing design defect claims to be litigated on a case-by-case basis would be
costly because it would require “shadowboxing an infinite number of theories about how there
could have been a safer vaccine.” Justice Ginsburg contested, seemingly in light of petitioners’
argument, that the Vaccine Court allows all but a small number of claims to reach state court.75
64 Id. at 8 (emphasis added).
65 Id. at 9.
66 Id. at 11-12.
67 Id. at 16.
68 Id. at 18.
69 Id. at 20.
70 Id. at 22-25.
71 Id. at 25-26.
72 Id. at 28.
73 Id. at 31-32.
74 Id. at 33.
75 Id. at 41-43.
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However, respondent’s counsel emphasized that the 5,000 claimants who allege a link between
autism and vaccine may ultimately pursue state-law remedies.76
The Court also heard arguments from the Assistant to the Solicitor General on behalf of the
United States, who submitted a brief in support of the respondent. He turned the Court’s attention
to the role of the Centers for Disease Control and Prevention (CDC) because the no-fault remedy
and preemption provisions of the Vaccine Act apply only to categories of vaccines recommended
by the CDC for “routine administration to children.”77 The government informed the Court that,
in making its recommendations, the CDC looks at whether it “is the most efficacious drug with
the least adverse effects,” and publishes its findings in its official journal.78 When pressed by
Chief Justice Roberts as to whether the CDC’s report makes direct comparisons between types of
vaccines, the government seemed to answer that the CDC does not make direct comparisons but
rather, by staying engaged in the direction of the research, makes its determinations in a
“comparative way” when it recommends one vaccine over another. More importantly, however,
the government emphasized that “it would be extraordinary ... to imagine that Congress set up a
system in which juries would effectively be second-guessing decisions.”79 Finally, when asked by
Justice Ginsburg if, in the petitioners’ case, there is any actionable claim for “not disclosing that
there were a number of adverse ... reactions to [the] particular lot,” the government, consistent
with the respondent’s argument, said that the petitioners could bring either a labeling claim or a
manufacturing defect claim, which the lower courts had dismissed on the facts.80
Potential Consequences
Based on the Justices’ questioning during oral argument, it is unclear how the Court will decide
this case. According to reports, the Court seemed to “struggle to divine the balance Congress had
meant to strike” by enacting the law to compensate people injured by vaccines while barring
some, but not all, lawsuits against vaccine manufacturers.81 Notably, only eight Justices are
participating and a 4-4 decision would automatically affirm the court of appeal’s decision in favor
of the respondent, Wyeth.
As has been emphasized by the respondent, other supporters such as American Academy of
Pediatrics, American Medical Association, and Infectious Diseases Society of America, as well as
other scientists, have argued that a decision in favor of the petitioners will leave vaccine
manufacturers vulnerable to numerous lawsuits, “could drive vaccine manufacturers from the
market and halt future production and development of childhood vaccines in this country.”82
Furthermore, as the respondent highlighted, there are about 5,000 claimants in Vaccine Court who
claim that there is a relationship between the mumps, measles, and rubella vaccine and autism.83
76 Id. at 42.
77 Id. at 44-45.
78 Id. at 49.
79 Id. at 52.
80 Id. at 54.
81 Adam Liptak, “Vaccine Case Before Justices Turn on the Language of the Law,” N.Y. Times, October 12, 2010.
82 Jennifer Couzin-Frankel, “Closely Watched Vaccine Injury Claim Reaches Supreme Court,” ScienceInsider October
12, 2010, http://news.sciencemag.org/scienceinsider/2010/10/closely-watched-vaccine-injury.html.
83 National Vaccine Injury Compensation Program- About the Omnibus Autism Proceeding, http://www.hrsa.gov/
vaccinecompensation/omnibusproceeding.htm.
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These claims could be the next batch of claims to enter, and possibly overwhelm, the state courts
if the Court finds in favor of the petitioner.
Those on the opposing side, such as the National Vaccine Information Center (NVIC), argue that
those same 5,000 claimants would have no recourse if the Court decides in favor of the
respondent. NVIC argues that because the “overwhelming majority of cases in vaccine court
today are ‘off-table,’” (i.e., not injuries recognized by the Vaccine Injury Table; see note 8) the
parties in those situations are “unable to take advantage of presumptive causation” and ultimately
would have to participate in costly, time-consuming causation hearings, which are highly
adversarial and generally end without compensation.84 Likewise, the Vaccine Injured Petitioners
Bar Association (VIPBA), in conjunction with other groups, submitted a brief in support of the
petitioners and argued that the “practical effect of the Third Circuit’s opinion ... is to deny justice
to petitioners in the Vaccine Program whose cases cannot be fully litigated given the restrictions
built into the Program.”85 Knowing that the tool of discovery in litigation creates incentives for
greater vaccine safety, VIPBA emphasized that this “inspired Congress to keep the tort option
available as a safety incentive.”86 Even if vaccine manufacturers were to argue that a decision of
the Court affirming the Third Circuit opinion would only preclude design defect claims based on
theories of both strict liability and negligence, leaving petitioners with the ability to pursue
failure-to-warn and manufacturing defect claims, VIPBA noted that “in practice, manufacturers
rely on precedents that all but subsume manufacturing defect claims and failure to warn claims
into design defect claims.”87 Such parties, therefore, argue that a decision in favor of the
manufacturer would have detrimental effects on one’s ability to obtain a remedy, or even bring a
suit, for “off-table” injury-related vaccine claims.
Though not mentioned during oral arguments, the Court could choose to read the design defect
provision narrowly so that it would only preclude strict liability claims like comment k in § 402A
of the Restatement. This, however, would depend on how the Court treats the legislative history
relied upon by the parties. While the respondents relied upon the Commerce Report from 1986,
the petitioners referred to the Budget Report from 1987 to explain the structure and intent of
Congress, even though the Budget Report did not accompany the original language of the Vaccine
Act. Which document the Supreme Court finds indicative of the legislative history may or may
not have ramifications on how it recognizes the persuasiveness of such documents in future cases.
Lastly, it will be interesting to see if the Supreme Court considers the Georgia Supreme Court’s
Ferrari decision, which held that § 22(b) requires a case-by-case determination, in deciding this
case even though both the U.S. district court and U.S. court of appeals dismissed the Georgia
court’s reasoning in Ferrari.
84 Brief of Amici Curiae National Vaccine Information Center, Its Cofounders and 24 Other Organizations In Support
of Petitioners at 14, Bruesewitz v. Wyeth, No. 09-152 (May 24, 2010).
85 Brief of Vaccine Injured Petitioners Bar Association, The George Washington University Law School Vaccine Injury
Clinic, and Zenoria Phillips Deloatch of Moshella F. Roberts, as Amici Curiae in Support of Petitioners at 24-25,
Bruesewitz v. Wyeth, No. 09-152 (May 24, 2010). They noted that in order for the Vaccine Act to provide “swift and
simple justice,” Congress put in “[r]estrictions on discovery, evidence, and motion practices ... to speed up the
process,” but that given these limits, the “Vaccine Program cannot provide satisfactory relief for every family of a
vaccine-injured child.” Id. at 25.
86 Id. at 21.
87 Id. at 24-25 n.8.
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Congressional Legislation
Although the Supreme Court in Bruesewitz faces a decision of whether the language of the
Vaccine Act preempts design defect claims, the measures introduced during the 111th Congress
that would amend the act would not appear to directly affect the case pending before the Court.
These bills are (1) H.R. 2459, the National Vaccine Injury Compensation Program Improvement
Act of 2009, by Representative Dan Burton, and (2) H.R. 4096, the National Vaccine Injury
Compensation Program Modernization Act of 2009, by Representative Tom Perriello. Both bills
would amend the statute of limitations for filing a petition with the Vaccine Court. Specifically,
these bills would extend the period for filing a petition with the Vaccine Court to within two years
after the date of the bill’s enactment if an injury or death occurs as a result “of a vaccine set forth
in the Vaccine Injury Table that is administered after September 30, 1988, and before the date of
the [bill’s] enactment.”88 The bills would also allow petitions to be filed notwithstanding a
previous dismissal for an untimely filing. H.R. 2459 would also address the basis for calculating
projected lost earnings, the increase of award in the case of a vaccine-related death, allowing
compensation for family counseling expenses as well as interim attorney fees. In the past,
Congress has introduced legislation to overturn a decision by the Supreme Court. One prominent
decision was Riegel v. Medtronic, where the Court held that the Medical Device Amendments of
1976 (MDA) expressly preempted state tort law claims.89 In the aftermath, legislation was
introduced, though not enacted, that would have amended the MDA to provide “[n]othing in this
section shall be construed to modify or otherwise affect any action for damages or the liability of
any person under the law of the State.”90 Thus, depending upon the Supreme Court’s decision in
Bruesewitz, Congress may choose to revisit the specific language at issue to clarify if the Vaccine
Act precludes design defect claims.
Author Contact Information
Vivian S. Chu
Legislative Attorney
vchu@crs.loc.gov, 7-4576
88 111th Congress, H.R. 2459, Section 7; H.R. 4096, Section 2 (2009).
89 128 S. Ct. 999 (2008). For more information on this case, see CRS Report R40534, Riegel v. Medtronic, Inc.:
Federal Preemption of State Tort Law Regarding Medical Devices with FDA Premarket Approval, by Vanessa K.
Burrows.
90 111th Congress, H.R. 1346, Medical Devices Safety Act; S. 540, Medical Devices Safety Act (2009).
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