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”). See Bruesewitz v. Wyeth Inc., 561 F.3d 233, 245 (3d Cir. 2009). 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”). See id. at 237.
Hannah was six months old when she received her third scheduled injection of DTP on April 1, 1992. See Bruesewitz, 561 F.3d at 236. Shortly after the injection, Hannah began experiencing seizures. See id. The seizures persisted and the Bruesewitzes counted 126 seizures over a sixteen-day period. See Brief for Petitioners, Russell Bruesewitz and Robalee Bruesewitz at 19–20. Eventually, these seizures left Hannah lethargic, developmentally stunted, and displaying autistic-like symptoms. See id. at 20. In 2003, doctors diagnosed Hannah with a residual seizure disorder and encephalopathy. See id. Because of these conditions, Hannah will likely require lifelong medical care. See Bruesewitz, 561 F.3d at 236.
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. See Bruesewitz, 561 F.3d at 236. 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”). See id. Of these, thirty-nine resulted in emergency room visits, six in hospitalizations, and two in death. See id. In retrospect, Hannah’s physician insists that had she been aware of the incidents associated with this lot, she would not have administered the vaccine. See id.
The Bruesewitzes contend that Hannah’s injuries could have been avoided had Wyeth used an alternate design called ACEL-IMUNE (“DTaP”). See Bruesewitz, 561 F.3d at 236. 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. See id. It was not until 1996 that the FDA licensed DTaP for all five injections. See id. at 237. Wyeth ceased distribution of DTP in 1998. See id.
Petitioners submitted their case before the Vaccine Court, an Office of Special Masters created by Congress to adjudicate vaccine-related claims. See Bruesewitz, 561 F.3d. at 237. 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. See id. Petitioners then brought their case in state court, but Wyeth removed to federal court based on diversity of citizenship. See id. Wyeth subsequently moved for summary judgment and was granted judgment on all counts. See id. 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. See id. at 255–56. Petitioners subsequently 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”). See 42 U.S.C. §§ 300aa-1 et seq. 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. 42 U.S.C. § 300aa-22(b)(1). 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. See Bruesewitz v. Wyeth, Inc., 561 F.3d 233, 235 (3d Cir. 2009). 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. See Brief for Petitioners, Russell Bruesewitz and Robalee Bruesewitz at 25.
Textual and Structural Interpretation of Section 22(b)(1)
The parties disagree over the plain meaning of Section 22(b)(1). See Brief for Petitioners at 29; Brief for Respondent, Wyeth, Inc. at 24. 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. See Brief for Petitioners at 29. 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. See Brief for Respondent at 24.
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.” See Brief for Petitioners at 29. 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. See id. at 30–31.
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. See Brief for Petitioners at 32–35. The Bruesewitzes note that the NCVIA contains no language explicitly stating that all vaccines give rise to unavoidable side effects. See id. at 32. 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. See id. at 35. 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.” See id. at 39.
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. See Brief for Respondent at 4. 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. See id. at 44. 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.” See id. at 32.
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. See id. at 30–32. Second, Wyeth emphasizes the use of the definite article in Section 22(b)(1)’s reference to “the vaccine.” See id. at 31. 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. See id.
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. See Brief for Petitioners at 40–41. 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. See id. at 40. However, Wyeth counters that regardless of the interpretation adopted by the Court, some state-law preemption will inevitably occur. See Brief for Respondent at 44–45.
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. See Brief for Petitioners at 44. 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. See id. at 45. 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). See id. at 51. 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. See id. at 50.
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. See Brief for Respondent at 47. 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. See id. at 2, 46–47. 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. See id. at 49–50. 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. See id. at 51.
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. See id. at 27. 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. See id. at 7–9, 54. 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. See id. at 56–57. 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. See id. 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. See id. at 58.
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. See Brief for Respondent at 37. Additionally, Wyeth contends that FDA regulation of vaccine manufacturers is far more rigorous than the Bruesewitzes suggest. See id. at 11–13. Further, Wyeth disputes the Bruesewitzes’ claim that vaccine manufacturers have much better access to vaccine-related information than does the FDA. See id. at 54. 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. See id. at 13–14, 54. 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. See id. at 16–18. 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. See id. at 47. 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. See id. at 55--57.
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. See Brief for Petitioners, Russell Bruesewitz and Robalee Bruesewitz at 51. 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. See Brief for Respondent, Wyeth, Inc. at 2. 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. See Brief for Petitioners at 27. 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. See Brief for Respondent at 25.
The American Academy of Pediatrics (“AAP”) describes the threat vaccine manufacturers faced when Congress enacted the NCVIA. See Brief of Amici Curiae American Academy of Pediatrics, et al. in Support of Respondent at 15. AAP points out that litigation had substantially impacted manufacturers’ malpractice coverage. See id. 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. See id. at 17–18. In fact, by 1986, only two companies still produced DTP. See id.
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. See Brief of Amicus Curiae Marguerite Willner in Support of Petitioner at 6. 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. See id. 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. See Brief of Amici Curiae Glaxosmithkline LLC, et al. (“Vaccine Manufacturers”) in Support of Respondent at 24–25.
Additionally, the National Vaccine Information Center (“NVIC”) believes that the Vaccine Court created by the NCVIA is no longer adequately compensating the injured. See Brief of Amici Curiae National Vaccine Information Center, et al., in Support of Petitioner at 14. 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. See id. at 15. Furthermore, over time, the balance of cases has shifted to off-Table cases where applicants need to prove causation. See id. 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. See id. However, the United States submits that modifications to the Table merely reflect the scientific evidence available. See Brief of Amicus Curiae United States in Support of Respondent at 29–30.
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. See Brief of Amicus Curiae National Vaccine Petitioners Bar Association, et al. (“VIPB”) in Support of Petitioner at 11. Marguerite Willner concurs that the lack of discovery impedes an applicant’s ability to prove causation. See Brief of Marguerite Willner at 25. However, the Vaccine Manufacturers warn that significant vaccine-related litigation may follow from the Supreme Court’s decision. See Brief of Vaccine Manufacturers at 23. 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. See Brief of VIPB at 26–27. 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.” See Brief of Vaccine Manufacturers at 23. 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.