The National Childhood Vaccine Injury Act and Preemption: An Overview of Bruesewitz v. Wyeth
Released: 2011-10-06T00:00:00

Introduction

In October 2010, the Supreme Court heard oral arguments for Bruesewitz v. Wyeth , a case which involves the scope of the National Childhood Vaccine Injury Act. The issue before the Court was whether 42 U.S.C. Section 300aa-22(b)(1) of the act precludes all vaccine design defect claims even if the vaccine's side effects were avoidable, 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. On February 22, 2011, the Supreme Court issued its decision in Bruesewitz , affirming, by a vote of 6-2, the decision of the U.S. Court of Appeals for the Third Circuit that the federal law preempts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by the vaccine's side effects.

This report provides an overview of the structure of the Vaccine Act and the relevant facts of the Bruesewitz case. It then examines the lower court decisions before reviewing the Supreme Court decision. Finally, it discusses the decision's potential effect on preemption jurisprudence as well as on the existing Vaccine Act litigation.

Background of Bruesewitz v. Wyeth

The National Childhood Vaccine Injury Act (Vaccine Act) was enacted in 1986 and established a national vaccine program to "achieve optimal prevention of human infectious diseases through immunization and ... against adverse reaction to vaccines." Under the Vaccine Act, the National Vaccine Injury Compensation Program (Compensation Program) was established to handle claims against drug manufacturers for vaccine-related injuries and deaths. The Compensation Program 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). A petitioner is entitled to recover if the affected person (1) received a vaccine covered by the Vaccine Act; (2) suffered a "covered" injury ; and (3) it cannot be shown by a preponderance of the evidence that the injuries or death were not caused by the vaccine. A petitioner who suffers an off-Table, or non-covered, injury may still recover compensation by proving affirmatively that the vaccine caused the injury. Part B permits a petitioner to decline the result of the Vaccine Court and pursue a civil suit in state or federal district court only after a final judgment is issued by the Vaccine Court. 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. However, Section 300aa-22 places limitations on subsequent civil actions, and it is this section that is at issue in Bruesewitz v. Wyeth .

In this case, the plaintiffs/petitioners were 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. Hannah was subsequently diagnosed as having residual seizure disorder and developmental delay, for which she will likely 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. 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 FDA approved Wyeth's application for an alternative DPT vaccine, known as ACEL-IMUNE. ACEL-IMUNE does not contain the "whole-cell" component, and is reportedly less likely to cause adverse events. The FDA initially approved Wyeth's ACEL-IMUNE for use in the fourth and fifth doses of the DPT vaccine, but did not approve its use in the first three doses of the DPT vaccine until December 1996. Thus, for her third dose Hannah received the TRI-IMMUNOL vaccine because there were no non-whole-cell 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 off-Table injuries and that the petitioners had not proved causation in fact. 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 and Court of Appeals Decisions

In federal district court, the plaintiffs sued for damages to Hannah Bruesewitz, costs, punitive damages, and other legal equitable relief. They alleged four counts against Wyeth:

Count I alleged that Wyeth negligently failed to produce a safer vaccine despite knowledge of the existence and feasibility of such safer alternatives; Count II alleged that Wyeth negligently failed to warn of the actual dangers associated with the particular batch of DPT vaccine administered to Hannah; 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 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 vaccine administered to Hannah contained a manufacturing defect that made it "extra-hazardous."

The district court granted Wyeth's motion for summary judgment, concluding that Counts I and III (design defect claims) were preempted by the Vaccine Act and that the plaintiffs failed to raise any genuine issue of material fact as to Counts II and IV (failure to warn and manufacturing defect claims, respectively). The United States Court of Appeals for the Third Circuit (Third Circuit) affirmed the federal district court's decision. On appeal, the Third Circuit addressed three questions presented by the Bruesewitzes: (1) whether Section 22(b)(1) acts as a complete bar to design defect claims; (2) whether the plaintiffs met their burden under Section 22(b)(2) of the Vaccine Act to show that the defendants failed to provide an adequate warning of the alleged dangers of the vaccine; and (3) whether the plaintiffs provided sufficient evidence of a manufacturing defect to survive the defendant's motion for summary judgment.

Design Defect Claims (Counts I + III)

The federal district court agreed with the conclusion and reasoning of three other court decisions that held that the Vaccine Act preempts design defect claims. In holding that the Vaccine Act categorically preempts all design defect claims, it drew four conclusions. First, it held that vaccine manufacturers would not be protected from lawsuits if case-by-case inquiries were permitted. Second, the establishment of a no-fault remedies compensation program suggests that it was Congress's intention to provide manufacturers with immunity, allowing them to improve the safety of their products through the innovation of safer alternative designs. 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, the Vaccine Act preempts state law determinations of whether a vaccine is unavoidably unsafe, because "an FDA-approved vaccine design includes the side-effects of that vaccine, and is therefore, by statutory definition, the unavoidably unsafe product subject to" immunity under the liability principles of the Restatement (Second) of Torts Section 402A comment k.

The Third Circuit upheld the district court's decision, but stated that further analysis was warranted. In particular, the court found Sections 22(a) and (b) to contain express preemption language because, like other provisions in federal law, it "conveys a clear intent to override state law civil action claims in particular, defined circumstances." The court of appeals stated that whether the plaintiffs' claims fell within the scope of preemption "hinge[d] on the word 'unavoidable.'" The 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." The defendant, on the other hand, argued that the language "preempts all claims arising from allegations of design defect." The court resolved to look at the language, structure, and legislative history of the act to ascertain the scope of preemption created by Section 22(b), concluding that it could not make such a determination from the statutory text alone.

The Court of Appeals found that the Report from the House Committee on Energy and Commerce (Commerce Report) supported the conclusion that the Vaccine Act preempts all design defect claims. In the court's analysis, most importantly, the Commerce Report "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). According to the court, any reading of the provision to permit state courts to make case-by-case determinations would exacerbate the "very problems which led to instability in the vaccine market and which caused Congress to intervene." The court acknowledged but did not find reliable a subsequent Report from the House Committee on the Budget (Budget Report) which implicates that whether vaccines are unavoidably unsafe "is [a question] left to the courts to determine in accordance with applicable law." It primarily found "the views of a subsequent Congress [to] form a hazardous basis for inferring the intent of an earlier one" 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. The Third Circuit concluded that the Commerce Report and other legislative history strongly indicate Congress's intention to preempt the specific claims asserted by the plaintiffs, as it had determined "that DPT manufacturers should be shielded from liability for injuries arising from the whole-cell pertussis vaccine."

Failure-to-Warn Claim (Count II) + Manufacturing Defect (Count IV)

The Court of Appeals affirmed the district court's decision to dismiss the Bruesewitzes' claim that the manufacturer withheld information from doctors about particularly dangerous batches of vaccines. If a 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. 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 show "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]." In the Bruesewitzes' case, the courts held that Wyeth was entitled to the presumption of proper warning, but concluded that the plaintiffs failed to provide any clear and convincing evidence sufficient for a reasonable jury to find in their favor.

The federal district court also dismissed the plaintiffs' strict liability claim that the particular dose administered to Hannah contained a manufacturing defect that made it "extra-hazardous." While the Vaccine Act did not bar such a claim, the court concluded that none of the evidence offered by the plaintiffs demonstrated that the product was defective or that "the specific lot caused any of the adverse reactions, let alone the specific reaction suffered by Hannah." The Third Circuit affirmed the decision of the district court.

The Supreme Court Decision in Bruesewitz

The only issue the Supreme Court agreed to review is whether Section 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. After hearing oral arguments on October 12, 2010, the Supreme Court issued its decision on February 22, 2011, affirming by a vote of 6-2 the Third Circuit's holding that the Vaccine Act expressly preempts all design defect claims against manufacturers.

Justice Scalia, writing for the majority, found that the text of the Vaccine Act supports an interpretation that the provision at issue preempts all design defect claims, and that this textual reading is supported by the structure of the act. Justice Sotomayor, writing a dissenting opinion, concluded the opposite. The opinions addressed several of the points raised during oral arguments, such as the potential for a superfluous interpretation of the provision, the purpose of the Vaccine Act, and the motivation for vaccine manufacturers to keep their products as up-to-date as science and technology permit.

Textual Interpretation

The Court did not perform the same preemption analysis as the Third Circuit; rather, it began by directly focusing on interpreting the text of Section 22(b)(1), which relieves vaccine manufacturers of liability, "if the injury or death resulted from the side-effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warning " (emphasis added). Noting that products liability law traditionally establishes three grounds for liability—that is, defective manufacture, inadequate directions or warnings, or defective design—the Court stated that if all three grounds for liability were intended to be preserved, "it would be strange to mention specifically only two, and leave the third to implication." The Court concluded that the provision itself "suggests that the design of the vaccine is a given, not subject to question in the tort action" (emphasis in the original). In the Court's reading, the "even though" clause "delineates the preventative measures that a vaccine manufacturer must have taken for a side-effect to be considered 'unavoidable' under the statute." Further, the clause is "meant to signal the unexpected: unavoidable side effects [which] persist despite best manufacturing and labeling practices" (emphasis in the original). Thus, according to the Court, "[p]rovided that there were proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable." It also observed that the term "unavoidable" would have little meaning if a manufacturer could be liable for failure to use a different design because "[a] side effect of a vaccine could always have been avoidable by use of a differently designed vaccine not containing the harmful element."

Although the lower courts acknowledged that Congress intended to incorporate the principle of comment k of the Restatement, which exempts from strict liability "unavoidably unsafe products," and that it supported the conclusion that design defect claims are preempted, the Court in Bruesewitz dismissed the connection. Determining the word "unavoidably," as utilized by comment k, to be very different from "unavoidable," as found in Section 22(b)(1), the Court found no reason to believe that Congress was invoking comment k when enacting Section 22(b)(1). Even though its own analysis concentrated on the text and structure of the Vaccine Act, the Court further addressed points made by the dissent, which relied heavily on the legislative history of the act. Among other things, the Court pointed out that the 1986 Commerce Report counsels injured parties who cannot prove a manufacturing or labeling defect to "pursue recompense in the compensation system, not the tort system." While the dissent asserted that the 1987 Budget Report is the proper and authoritative guide to the meaning of Section 22(b)(1), the Court immediately critiqued the dissent for using "post-enactment legislative history," stating that it is "not a legitimate tool of statutory interpretation," and that "[t]hose who voted on the relevant statutory language were not necessarily the same persons who crafted statements in the later [Budget] Report."

Lastly, the Court acknowledged the critique that its interpretation would render part of Section 22(b)(1) superfluous, specifically the words "the injury or death resulted from side effects that were unavoidable even though," because Congress could have more simply stated that liability would be barred "if ... the vaccine was properly prepared and was accompanied by proper directions and warnings." In addition to highlighting that the dissent's interpretation has superfluity problems of its own, the Court noted that the rule against giving a portion of text an interpretation which renders it superfluous only applies "if verbosity ... can be eliminated by giving ... the remainder of the text, a competing interpretation," which the Court declared could not be done in this instance.

Structural Argument

In addition to the text of the provision, the majority found that the structure of the Vaccine Act and of vaccine regulation generally supported its conclusion that Section 22(b)(1) preempts all design defect claims. In general, the majority found that

1. the lack of guidance for design defects in contrast to the extensive regulation of manufacturing and warning labels, two of the grounds for liability mentioned in the Vaccine Act, "strongly suggests that design defects were not mentioned because they are not a basis for liability"; 2. the Vaccine Act provides its own means of improving vaccine design, the establishment of the National Vaccine Program, and the possibility of license revocation if the FDA concludes the vaccine is unsafe demonstrate that Section 22(b)(1)'s "silence regarding design-defect liability was not inadvertent"; and 3. the Vaccine Act's quid pro quo structure—that is, manufacturers fund the act's compensation fund from their sales, in exchange for avoiding costly tort litigation—would have little meaning if manufacturers are still liable for claims of design defect.

The dissent took issue with the majority's structural arguments. Primarily, it disagreed with the majority's assertion that Congress intended to preempt design defect claims because the Vaccine Act, according to the majority, provided its own means of assuring improvements in vaccine design. Rather, the dissent stated: "neither the Act nor any other provision of federal law places a legal duty on vaccine manufacturers to improve the design of their vaccines to account for scientific and technological advances." Absent clear statutory language, the dissent did not believe that Congress intended "to eliminate the traditional incentive and deterrence functions served by state tort liability in favor of a federal regulatory scheme providing only carrots and no sticks," and that the majority's decision leaves a "regulatory vacuum in which no one ... ensures that vaccine manufacturers adequately take account of scientific and technological advancements." To this, the majority responded that the Court has never suggested that it was more likely to find preemption only if the compensation scheme or "the congressional substitute operated like the tort system."

Analysis of the Bruesewitz Decision

Prior to the decision, supporters of the respondent Wyeth, including the American Academy of Pediatrics, American Medical Association, and Infectious Diseases Society of America, argued that a decision in favor of the Bruesewitzes would leave vaccine manufacturers vulnerable to numerous lawsuits, and "could drive vaccine manufacturers from the market and halt future production and development of childhood vaccines in this country." In contrast, supporters of the Bruesewitzes, such as the National Vaccine Information Center and the Vaccine Injured Petitioners Bar Association, have argued that the approximate 5,000 claimants in Vaccine Court who claim that there is a relationship between autism and the mumps, measles, and rubella (MMR) vaccine and/or other thimerosal-containing vaccines would have no recourse if the Court decided in favor of Wyeth. They further argued that the "practical effect of the Third Circuit's opinion ... [was] to deny justice to [the Bruesewitzes and other claimants] in the Vaccine Program whose cases cannot be fully litigated given the restrictions built into the Program." Although Wyeth argued that a decision in its favor would still leave the Bruesewitzes with the ability to pursue failure-to-warn and manufacturing defect claims, supporters for the Bruesewitzes argued that "in practice, manufacturers rely on precedents that all but subsume manufacturing defect claims and failure to warn claims into design defect claims."

The Supreme Court's decision in Bruesewitz arguably has a greater practical, rather than jurisprudential, impact as it could have affected either the ability of manufacturers to continue in the vaccine industry or affected the ongoing and future proceedings of individuals seeking compensation under the Vaccine Act. Given the Court's decision in favor of Wyeth, it remains to be seen how this will influence the ongoing claims of individuals asserting a link between autism and MMR and/or thimerosal-containing vaccines, that is, the Omnibus Autism Proceedings. By August 2010, the U.S. Court of Appeals for the Federal Circuit had affirmed the decisions of the U.S. Court of Federal Claims in two test cases. Both test cases were in favor of HHS and specifically examined the issue of causation, as is required by the Vaccine Act for off-Table injuries. Similar decisions were reached with other test cases. With the Omnibus Autism Proceedings concluded, some claimants may have the option of pursuing their claims against the manufacturers in civil court. But they are precluded from asserting a design defect claim under any theory of negligence. The experience of the Bruesewitzes, whose failure-to-warn and manufacturing defect claims were dismissed for lack of evidence, may further foreshadow the difficulties that current claimants could face in bringing successful claims against the vaccine manufacturers. Separately, recent scientific publications, which have declared that there appears to be no link between immunizations and autism or other serious medical problems, may also hinder current and future claimants' ability to prove their claims.

In terms of jurisprudence, it has been observed that " Bruesewitz is unlikely to have a broad impact on preemption of common law tort claims given the unique nature of the congressional compensation scheme." Indeed, the Court found preemption in a "hyper-textual analysis," rather than performing a preemption analysis like the Third Circuit, beginning with the traditional presumption against preemption. Similarly, at least one commentator noted that, unlike the prior 2009-2010 Term where the Court's preemption decisions seemed to "duel over the policy arguments that underpin the preemption debate," the Bruesewitz decision and other product liability preemption cases from the 2010-2011 Term demonstrate that the Court "has resigned itself to a narrow, case-by-case approach to the preemption defense." Because of this shift, future questions on whether state tort law claims are preempted "will be resolved not on the basis of broad policy arguments but rather on a case-by-case analysis of specific statutory language, regulatory history, and federal decision-making," and will depend on "which party succeeds in defining the narrative through which a court will view its analysis." On the other hand, others have observed that the decision is consistent with the Court's evolving trend to view tort lawsuits in its preemption decisions as serving a regulatory function (i.e., deterrence or promotion of certain behaviors) rather than a compensatory function (i.e., redressing private wrongs). From this point of view, the conclusion reached in Bruesewitz fits neatly with the Court's past preemption decisions. Arguably, the Court in Cipollone v. Liggett , 505 U.S. 504 (1992) began to emphasize the regulatory nature that tort lawsuits serve over the parallel regulatory/compensatory effects of tort lawsuits. Under this continued emphasis of the regulatory paradigm, it is not surprising that Justice Scalia in Bruesewitz found the "imposition of tort liability" to impede the Vaccine Act's regulatory goals of improving vaccine designs, because such an imposition could drive manufacturers away and threaten the supply of vaccines, "much as state positive enactments might impose unreasonable burdens on manufacturers to the public good."

Lastly, the Bruesewitz decision does not address other issues with the Vaccine Act that have been the subject of some academic discussion. These include (1) the lack of a clear evidentiary standard for scrutinizing the admissibility of scientific evidence, and (2) the lack of a clear understanding of the level of proof necessary to show causation. These issues, which pertain to causation, have become more critical because "most claims are in fact for off-[T]able injuries … [whereas] in the early years of the program … ninety percent of the cases were covered [injuries]," in which case causation was presumed. These commentators observe that there has been inconsistency in Special Masters' decisions due to a lack of clarity on these particular issues. For example, under the Vaccine Act, Congress charged the U.S. Court of Federal Claims with promulgating "flexible and informal standards of admissibility of evidence," to govern the Vaccine Act litigation, which are known as the Vaccine Rules. As a result, Special Masters enjoy a great deal of discretion to admit and weigh evidence because the Federal Rules of Evidence do not apply. The Vaccine Rules specifically state that Special Masters "will not be bound by common law or statutory rules of evidence." While it has been noted that the admissibility of evidence has become very similar to the tort system in that Special Masters purport to be following the standards set forth in Daubert v. Merrell Dow Pharmaceuticals , they have "openly expressed frustration with the lack of uniform standards by which they reach entitlement decisions." The result appears to be "case-by-case jurisprudence that is void of any cohesive explanation of what it takes to prevail within the Vaccine Program." Similarly, the applicable legal standards governing causal proof in off-Table cases arguably "is a story of mixed signals from the Federal Circuit, ranging from only a minimal showing of medical opinion and circumstantial temporal evidence to mirroring the more stringent standards developed in traditional toxic tort cases." While the Bruesewitz decision provides a definitive understanding that design defect claims are precluded from being brought in state court, a lack of resolution on these causation issues may give continued rise to inconsistent case law, thereby creating unpredictability in Vaccine Act litigation for both claimants and vaccine manufacturers.

Congressional Legislation

No legislation has been introduced on this issue in the 112 th Congress, though some measures were introduced in the 111 th Congress. These and other similar bills have been introduced repeatedly in the past; however, none of them would have directly affected the outcome of the Bruesewitz case, nor overturned the Court's decision. In the 111 th Congress, these bills were (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 have amended the statute of limitations for filing a petition with the Vaccine Court. Specifically, these bills would have extended 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." The bills would have also allowed petitions to be filed notwithstanding a previous dismissal for an untimely filing. H.R. 2459 would have also addressed 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 attorneys' fees.

Congress has conducted oversight hearings on the Compensation Program, among concerns that the program was not meeting its original goals of providing expeditious and fair compensation to individuals who may have suffered harm from vaccinations. The practical effect the Bruesewitz decision may have on the autism proceedings could renew Congress's interest in evaluating the Compensation Program. If Congress finds that it wishes to give claimants, such as the 5,000 claimants mentioned above, the ability to pursue design defect claims in state courts, then it may choose to revisit the specific language at issue to clarify if the Vaccine Act precludes design defect claims. 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. 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." Furthermore, Congress could choose to amend the act to clarify the level of causation needed to be shown in order to provide more stability to the system.