After their daughter suffered severe health problems following a routine vaccination for diphtheria-tetanus-pertussis (“DTP”), Russell and Robalee Bruesewitz sued Wyeth, Inc., the manufacturer of the vaccine, alleging that Wyeth’s DTP vaccine was outmoded and inadequately designed. In response, Wyeth argued that Section 22(b)(1) of the National Childhood Vaccine Injury Act (“NCVIA”) exempted vaccine manufacturers from all design-defect claims, including the one asserted by the Bruesewitz family. The Third Circuit Court of Appeals agreed with Wyeth and dismissed the claim. The Supreme Court must now determine whether to sustain the categorical preclusion of all design-defect claims advanced against vaccine manufacturers, or whether to expose vaccine manufacturers to potential design-based litigation. This decision will affect the right of vaccine victims to seek compensation for their injuries and the ability of vaccine manufacturers to avoid costly litigation that may drive them out of the vaccine market.
Questions as Framed for the Court by the Parties
Whether the Third Circuit erred in holding that, contrary to its plain text and the decisions of this Court and others, section 22(b)(1) preempts all vaccine design defect claims, whether the vaccine’s side effects were unavoidable or not?
This case turns on the Supreme Court's interpretation of the word “unavoidable” as it is used in 42 U.S.C. § 300aa-22(b)(1) of the National Childhood Vaccine Injury Act (“NCVIA”). The plaintiffs, Russell and Robalee Bruesewitz (“the Bruesewitzes”) claim that, among other factors, poor design of the vaccine TRI-IMMUNOL (“DTP”) by vaccine manufacturer Wyeth, Inc. (“Wyeth”) caused an injury to their daughter, Hannah Bruesewitz (“Hannah”).
Hannah was six months old when she received her third scheduled injection of DTP on April 1, 1992. Shortly after the injection,Hannah began experiencing seizures. The seizures persisted and the Bruesewitzes counted 126 seizures over a sixteen-day period. Eventually,these seizures left Hannah lethargic, developmentally stunted, and displaying autistic-like symptoms. In 2003, doctors diagnosed Hannah with a residual seizure disorder and encephalopathy. Because of theseconditions, Hannah will likely require lifelong medical care.
Despite the success of DTP in reducing pertussis (or “whooping cough”) infections, the Bruesewitzes contend that Wyeth and other medical professionals and organizations were aware of several adverse effects associated with the vaccine. In fact, Hannah’s injection was drawn from a vaccine lot that had over sixty-five complaints of adverse reactions filed with the Food and Drug Administration (“FDA”) and the Center for Disease Control and Prevention (“CDC”).Of these, thirty-nine resulted in emergency room visits, six in hospitalizations, and two in death. In retrospect,Hannah’s physicianinsists that had she been aware of the incidents associated with this lot, she would not have administered the vaccine.
The Bruesewitzes contend that Hannah’s injuries could have been avoided had Wyeth used an alternate design called ACEL-IMUNE (“DTaP”). However, though the FDA approved DTaP in 1991, the approval extended to only the fourth and fifth injections following three scheduled injections of the DTP formula. It was not until 1996 that the FDA licensed DTaP for all five injections. Wyeth ceased distribution of DTP in 1998.
Petitioners submitted their case before the Vaccine Court, an Office of Special Masters created by Congress to adjudicate vaccine-related claims. Following a hearing, the Vaccine Court found that Hannah’s residual seizure disorder and encephalopathy were not listed on the NCVIA Vaccine Injury Table entry for DTP, and that causation was not proven. Petitioners then brought their case in state court, but Wyeth removed to federal court based on diversity of citizenship. Wyeth subsequently moved for summary judgment and was granted judgment on all counts. On appeal, the Third Circuit’s ruling affirmed that Congress intended to preempt all design-defect claims in passing Section 22(b)(1) of the NCVIA. Petitionerssubsequently appealed to the Supreme Court and the Supreme Court granted certiorari.
At issue is Section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 (“NCVIA”). The section exempts vaccine manufacturers from civil liability for “unavoidable” vaccine-related injuries or death as long as the vaccine was properly prepared and adequately labeled. The United States Court of Appeals for the Third Circuit held that Section 22(b)(1) categorically precludes all design-defect claims asserted against vaccine manufacturers. , The Supreme Court must now determine whether to uphold the Third Circuit’s ruling, or whether to adopt the interpretation proposed by Russell and Robalee Bruesewitz (“the Bruesewitzes”), who argue that Section 22(b)(1) does not protect vaccine manufacturers against all design-defect claims.
Textual and Structural Interpretation of Section 22(b)(1)
The parties disagree over the plain meaning of Section 22(b)(1). According to the Bruesewitzes, Section 22(b)(1) shields manufacturers against design-defect claims only when a vaccine’s harmful side effects could not have been prevented through a safer design. Wyeth, on the other hand, asserts that Section 22(b)(1) extends far broader protection, guarding vaccine manufacturers in absolute terms against all possible design-defect claims.
The Bruesewitzes focus on the word “unavoidable,” commonly defined as “not avoidable” or “incapable of being prevented,” to support their view that Section 22(b)(1) protects manufacturers only when a vaccine’s harmful side effects are “incapable of being prevented.” The Bruesewitzes also note that “unavoidable,” a legal term of art, entails a specialized legal meaning relating directly to the existence of a safer alternative design.
In addition, the Bruesewitzes contend that the phrasing of Section 22(b)(1) rules out the possibility that the NCVIA bestows a blanket immunity on vaccine manufacturers. The Bruesewitzes note that the NCVIA contains no language explicitly stating that all vaccines give rise to unavoidable side effects. Furthermore, the Bruesewitzes find it telling that Section 22(b)(1) is phrased in a conditional tense, suggesting that Congress did not intend to impose a sweeping categorical exemption of all design-defect claims against vaccine manufacturers. Moreover, had Congress wished to eliminate design-defect claims altogether, the Bruesewitzes assert that it could have done so directly by striking out the part of Section 22(b)(1) that refers to “side effects that were unavoidable.”
On the other hand, Wyeth argues that the Bruesewitzes’ textual interpretation results in an absurd outcome that would allow alleged vaccine victims to remain as free after the passage of the NCVIA as before to advance design-defect claims in the civil court system. In fact, Wyeth contends that the Bruesewitzes’ interpretation leads, ironically, to an expansion of manufacturer liability, exposing manufactures to design-defect claims in states whose own law forbids such claims. Furthermore, Wyeth argues that had Congress truly intended to preserve design-defect claims, it could have stopped Section 22(b)(1) after the word “unavoidable.”
Wyeth also counters the Bruesewitzes’ textual interpretation with its own close reading of the section. First, Wyeth argues that the Bruesewitzes’ interpretation relies on an erroneous treatment of “unavoidable” as a freestanding term. Second, Wyeth emphasizes the use of the definite article in Section 22(b)(1)’s reference to “the vaccine.” According to Wyeth, the reference to a specifically administered vaccine signifies that Section 22(b)(1) aims to hold manufacturers liable for the defective manufacturing or labeling of a vaccine, acts which are solely within the manufacturers’ control, but not for the negligent design of a vaccine, an act which is outside the manufacturers’ control and heavily dependent on federal regulation.
Finally, the Bruesewitzes attack Wyeth’s interpretation of Section 22(b)(1) on the ground that this interpretation subverts the Supreme Court’s long-standing presumption against preemption of state-law claims. According to the Bruesewitzes, given a choice between competing interpretations of statute, the Court should always abide by the interpretation that preserves state-law claims rather than prevents them. However, Wyeth counters that regardless of the interpretation adopted by the Court, some state-law preemption will inevitably occur.
Legislative History of the NCVIA
The Bruesewitzes assert that the NCVIA’s legislative history suggests that Section 22(b)(1) relieved vaccine manufacturers of civil liability only when their vaccines had no superior alternative design. The Bruesewitzes point out that after the NCVIA was passed, Congress refused to adopt an amendment proposed by vaccine-industry representatives that would explicitly exempt vaccine manufacturers from design-based claims. Further, the Bruesewitzes note that though Congress made several substantive modifications to the NCVIA in 1987, it did not alter the exemptions contained in Section 22(b)(1). Finally, the Bruesewitzes cite to a section of the 1987 Congressional Budget Committee Report which declares that the NCVIA does not encroach on the right of state courts to resolve questions of safe vaccine design for themselves.
In response, Wyeth argues that NCVIA was enacted not only to compensate vaccine victims for their injuries in a fair and timely manner, but also to reduce the costly burden of litigation on vaccine manufacturers. Wyeth argues that the Bruesewitzes underplay the language in the 1986 Congressional House Report that established the Vaccine Court as a complete alternative to the civil-court system. , Wyeth also argues that the Bruesewitzes are mistaken in resorting to the legislative record from 1987, which, postdating the 1986 enactment of the NCVIA, provides little more than speculation and hearsay with regard to Congress’s intent in passing the Act. Wyeth also criticizes the Bruesewitzes for basing part of their argument on isolated and casually spoken Congressional-floor comments, none of which, in Wyeth’s view, reliably capture the multilayered intent of the legislative body that enacted the NCVIA.
Policy Considerations Surrounding the NCVIA
The Bruesewitzes assert that their interpretation of Section 22(b)(1) of the NCVIA advances several important public-policy objectives. First, the Bruesewitzes argue that giving vaccine victims an opportunity to litigate design-defect claims incentivizes vaccine manufacturers to conduct careful research and to produce the safest possible vaccines. Second, the Bruesewitzes contend that because the FDA only passively supervises vaccine manufacturers, promulgating mere minimum safety requirements, the threat of civil litigation encourages manufacturers to generate vaccines that exceed the FDA’s low-slung standards. Third, the Bruesewitzes argue that the Vaccine Court established by the NCVIA does not provide vaccine victims with the same opportunity as a civil court to pursue a fair hearing of their grievances. The Bruesewitzes point out that, unlike civil court, the Vaccine Court is an expedited review process subject to strict time limits, with petitioners to Vaccine Court often denied the critical opportunity to conduct discovery. Finally, the Bruesewitzes claim that there is no empirical foundation to Wyeth’s prediction of a vaccine shortage following the exit of litigation-weary manufacturers from the vaccine market.
In response, Wyeth argues that the liability repercussions from Section 22(b)(1) already provide vaccine manufacturers with sufficient incentive to take their manufacturing, labeling, and design duties seriously. Additionally, Wyeth contends that FDA regulation of vaccine manufacturers is far more rigorous than the Bruesewitzes suggest. Further, Wyeth disputes the Bruesewitzes’ claim that vaccine manufacturers have much better access to vaccine-related information than does the FDA. Wyeth argues that through vaccine-safety surveillance programs such as the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink, federal regulators are able to accumulate just as much information on vaccine side effects as the manufacturers of these vaccines can gather. , Furthermore, according to Wyeth, the compensation scheme set up by the NCVIA provides vaccine victims with a just and generous opportunity to pursue remuneration for injuries. Finally, Wyeth asserts that there is real reason to fear that the continuing threat of design-based litigation will drive the few remaining manufacturers out of the vaccine market, potentially resulting in a vaccine shortage and an ensuing health crisis. Indeed, Wyeth argues that Section 22(b)(1) currently serves as an important barrier between vaccine manufacturers and a potentially devastating torrent of design-defect claims.
The crux of this case turns on what the Supreme Court determines to be the ultimate purpose of the National Childhood Vaccine Injury Act (“NCVIA”). Russell and Robalee Bruesewitz (“the Bruesewitzes”) contend that Congress enacted the NCVIA to promote vaccine safety and to ensure fair compensation for vaccine-related injuries. However, vaccine manufacturer Wyeth, Inc. (“Wyeth”) argues that the primary purpose of the NCVIA is to prevent vaccine manufacturers from leaving the vaccine market in fear of high litigation costs. The Bruesewitzes believe that offering vaccine manufacturers a complete defense to design-defect claims will reduce research and development budgets, hurt vaccine safety, and slow vaccine improvement. Wyeth counters that its interpretation of the NCVIA recognizes the calculus involved in weighing the public benefits of vaccines against the rare side-effects that can occur.
The American Academy of Pediatrics (“AAP”) describes the threat vaccine manufacturers faced when Congress enacted the NCVIA. AAP points out that litigation had substantially impacted manufacturers’ malpractice coverage. Consequently, vaccine prices ballooned to cover these costs, sometimes by as much as 900 percent, and Congress was justifiably worried about shortages as some manufacturers chose to exit the market instead.In fact, by 1986, only two companies still produced DTP.
However, Marguerite Willner, a former representative for the Advisory Commission on Childhood Vaccines, contends that the government is not equipped to adequately protect children from vaccine-design injuries and that tort litigation provides a necessary incentive for manufacturers to focus on safety. Specifically, Willner asserts that prior to Food and Drug Administration (“FDA”) approval, the testing population for vaccines was too small to adequately assess the risk of injury. However, vaccine manufacturers Glaxosmithkline LLC, Merck Sharp & Dohme Corp., and Sanofi Pasteur, Inc. (“Vaccine Manufacturers”) argue that because the FDA controls the licensing of vaccines, and because the Center for Disease Control (“CDC”) is the largest vaccine purchaser and distributor, the government is in the best position to control, monitor, and respond to risk.
Additionally, the National Vaccine Information Center (“NVIC”) believes that the Vaccine Court created by the NCVIA is no longer adequately compensating the injured. The NVIC points out that nine new vaccines have been recommended since 1986, but that the NCVIA Vaccine Injury Table has not undergone a corresponding expansion. Furthermore, over time, the balance of cases has shifted to off-Table cases where applicants need to prove causation. In fact, the NVIC reports removal of some injuries from the Injury Table, including Hannah’s condition, which means that she could have been compensated had she filed her application only one month earlier. However, the United States submits that modifications to the Table merely reflect the scientific evidence available.
The Vaccine Injured Petitioners Bar Association (“VIPB”) contend that, although the Vaccine Court system was intended to speed up the compensation process, the Court’s efficiency measures, such as the lack of discovery, prevent some cases from being fully and fairly litigated. Marguerite Willner concurs that the lack of discovery impedes an applicant’s ability to prove causation. However, the Vaccine Manufacturers warn that significant vaccine-related litigation may follow from the Supreme Court’s decision In rebuttal, the VIPB points to its collective experience as representatives for vaccine-injured parties and to the dearth of examples where applicants decide to opt out of the Vaccine Court system and pursue their case in civil court. The Vaccine Manufacturers believe that allowing state courts to reconsider the design of FDA-approved vaccines will interrupt the current system such that various courts throughout the country could decide that vaccine manufacturers were responsible for offering possible alternatives that “the FDA did not – and would not – license.” Hence, the Supreme Court’s decision will not only impact how victims of vaccine related injuries can seek compensation, but also could seriously impact all parts of the vaccine industry.
The United States Supreme Court’s decision in this case will affect whether vaccine victims can seek recovery for design-defects by vaccine manufacturers. Russell and Robalee Bruesewitz argue that the National Childhood Vaccine Injury Act (“NCVIA”) does not protect vaccine manufacturers against all design-defect claims. Wyeth, however, argues that the motivating force behind Section 22(b)(1) of the NCVIA was Congress’ desire to shield vaccine manufacturers against costly design-based litigation that threatened to drive those manufacturers out of the vaccine market. A decision for the Bruesewitzes will enable alleged vaccine victims to seek compensation for their injuries in state court, providing victims with an alternative to the NCVIA’s Vaccine Court, but also risk the possibility of a “patchwork” approach across states to questions of vaccine design and vaccine safety. Alternatively, a decision for Wyeth will protect vaccine manufacturers against the debilitating threat of civil litigation but would also remove a powerful incentive motivating vaccine manufacturers to strive for the safest possible vaccine designs.