Argument preview: To what extent does the National Childhood Vaccine Injury Act of 1986 immunize vaccine manufacturers against design-defect claims?
on Oct 11, 2010 at 7:43 pm
Under Section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 (â€œNCVIAâ€),
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.
The NCVIA also created a no-fault administrative schemeâ€”involving the so-called â€œVaccine Courtâ€â€”to provide compensation to children with certain vaccine-related injuries.Â On October 12, in Bruesewitz v. Wyeth (No. 09-152), the Court will consider whether Section 22(b)(1) categorically bars state-law claims alleging that a vaccine was defectively designed.
When Hannah Bruesewitz was six months old, she received Wyethâ€™s Tri-Immunol DTP (diphtheria-tetanus-pertussis) vaccine as part of her childhood immunizations. Â Shortly after receiving the vaccine, she began to suffer multiple seizures; since then, she has been developmentally impaired.Â Â As directed by the NCVIA , Hannahâ€™s parents filed a petition in â€œVaccine Courtâ€ to seek compensation for her injuries.Â A special master, however, dismissed the familyâ€™s claim on the ground that they had failed to demonstrate that the vaccine had caused Hannahâ€™s particular injuries.Â Â Â The family then filed suit in a Pennsylvania state court against Wyeth, which removed the case to federal court.Â The federal district court concluded that the familyâ€™s claim was preempted by Section 22(b)(1), and the Third Circuit affirmed that decision.Â The family next filed a petition for certiorari, which the Supreme Court granted on March 8, 2010.
The partiesâ€™ arguments rest primarily on conflicting interpretations of the plain text of Section 22(b)(1).Â In their brief on the merits, the Bruesewitzes first rely on what they regard as the plain meaning of the term â€œunavoidableâ€ in Section 22(b)(1):Â Â in their view, it signals that manufacturers are immune from civil liability only for side effects that â€œcould not have been prevented.â€ Moreover, they contend, â€œunavoidableâ€ is a products-liability term of artâ€”derived from comment k to Section 402A of the Restatement (Second) of Tortsâ€”that Congress used to refer to something that â€œcould not have been prevented by a safer design.” And Congressâ€™s use of the word â€œifâ€ at the beginning of the clause regarding â€œside effects that were unavoidableâ€ therefore requires a case-by-case inquiry into whether a side effect was unavoidable.
The Bruesewitzes next argue that the Court should construe the statutory text following â€œunavoidableâ€ (requiring that such side effects be unavoidable â€œeven though the vaccine was properly prepared and was accompanied by proper directions and warningsâ€) as adding two prerequisites for immunity from suit. First, they contend, elsewhere in Section 22(b) and the legislative history, Congress used the phrases â€œunavoidable side effectsâ€ and â€œside effects that were unavoidableâ€ interchangeably. Â Second, such an interpretation is most consistent with Congressâ€™s intent to codify the meaning of â€œunavoidableâ€ as a products-liability term of art.Â Third, if Congress had intended to adopt Wyethâ€™s interpretation, it could have instead used the phrase â€œif â€¦ the vaccine was properly prepared and was accompanied by proper directions and warning.” Fourth, they emphasize the â€œlongstanding presumption against preemption of state-law claims,â€ particularly when Congress specifically addressed state law in other portions of the Act.
The Bruesewitzes next contend that their position is also supported by the legislative history of the NCVIAâ€”which, they argue, makes clear â€œthat Congress, the President, and vaccine manufacturers all understoodâ€¦that manufacturers would remain responsible for making their vaccines as safe as possibleâ€ Â That understanding, they continue, is consistent with Congressâ€™s goals of promoting vaccine safety and guaranteeing that children injured by vaccines receive compensation.Â The prospect of liability encourages manufacturers both to exercise â€œdue care in designing vaccinesâ€ and to â€œkeep up with scientific and technological advances.â€ Although the FDA has incomplete information on the dangers posed by vaccines, individuals who have an incentive to file a lawsuit may discover additional information andâ€”if they prevailâ€”obtain compensation.
Finally, the Bruesewitzes reject any contention that allowing claims such as theirs to proceed in court would â€œdestabilize the vaccine supplyâ€; they counter that Congress considered, but ultimately rejected, that claim over two decades ago.
In its brief, Wyeth advances a very different interpretation of Section 22(b)(1).Â In its view, the statute preempts all but two kinds of state-law tort claims:Â those arising from manufacturing defects and a failure to warn. If the Bruesewitzesâ€™ interpretation were correct, Wyeth argues, Congress could have simply â€œend[ed] the preemption provision with the words â€˜unavoidable side effects.â€™â€ Â Â But it declined to do so, and the words that follow the word â€œunavoidableâ€ are thus crucial.Â Moreover, the familyâ€™s reading would â€œmerely perpetuat[e] the status quo ante the Vaccine Actâ€ and make â€œSection 22(b)(1)â€™s express limitation on civil liabilityâ€¦superfluous.â€ Such a result would be inconsistent with the NCVIAâ€™s structure, which not only creates a compensation scheme but also empowers expert agenciesâ€”rather than juries, which tend to undervalue the benefits of vaccines to the general publicâ€”to evaluate designs.
Wyeth also rejects the familyâ€™s contention that Congress intended to codify the meaning of â€œunavoidableâ€ employed in the product-liability context.Â Wyeth counters that Section 22(b)(1) is broader thanâ€”and not a codification ofâ€”comment k, which â€œspeaks only to a defense to strict-liabilityâ€ claims and does so in the context of tort law, rather than in the administrative context.Â And in any event, prior to the enactment of the NCVIA courts were divided on the question whether comment k required a case-by-case inquiry into whether products â€œwere unavoidably unsafe.â€
Wyeth additionally argues that the presumption against preemption is an unnecessary tiebreaker; it is especially inappropriate here because â€œboth partiesâ€™â€¦interpretationsâ€¦would result in some preemption of state law.â€ The â€œmost authoritative piece ofâ€ legislative historyâ€”though unnecessaryâ€”â€œconfirms that Congress intended categorically to preempt design-defect claims.â€
Like the Bruesewitzes, Wyeth seeks to rely on the â€œpurpose and policyâ€ of the NCVIA. Â Citing the â€œtwenty new vaccinesâ€¦brought to market sinceâ€ the NCVIA was enacted, it asserts that liability is not necessary to create incentives for vaccine development. Nor are design-defect suits needed to discover information about adverse side effects, because â€œplaintiffs may assert a manufacturing-defect or failure-to-warn claim.â€ By contrast, however, preemption of state-law tort clams may be necessary to protect the vaccine supply. In 1986, Wyeth emphasizes, Congress was unwilling to risk the possibility that even one vaccine manufacturer might withdraw from the market; according to Wyeth, todayâ€™s market is â€œsubject to disruption just as it was in 1986.â€ And without preemption, manufacturers might be overwhelmed with suits; â€œIt is easy to allege that a vaccine causes a particular affliction (because nearly every child receives vaccines in the first six months of life, before most neurodevelopmental disorders first manifest) and that some alternative vaccine design supposedly could have been employed.â€Â In particular, Wyeth notes, if the Court were to hold that design-defect claims are not preempted, courts could be flooded with thousands of lawsuits (currently pending as petitions in Vaccine Court) alleging a link between vaccines and childhood autism.
In an amicus brief echoing Wyethâ€™s policy concerns, the government contends that petitionersâ€™ interpretation of Section 22(b)(1) would â€œexpose manufacturers to greater liability for their vaccine designs than they would face under state law alone.â€ In 1986, no state prevented a manufacturer from invoking comment k on a case-by-case basis. â€œThus, on petitionersâ€™ view, Congress achieved nothing in Section 22(b)(1) because it preempts liability only for conduct that state tort law would never have held tortious in the first place.â€Â Moreover, on petitionersâ€™ view, Congress prohibited states from affording manufacturers additional protections against design defect claims. The government argues that Section 22(b)(1) â€œlimits certain claims against manufacturer,â€ while Section 22(e) â€œbars state restrictions on plaintiffsâ€™ causes of action beyond the restrictions the Act imposesâ€¦.â€ So if Section 22(b)(1) gives manufacturers only the case-by-case defense to comment k that they already had before the Act, and Section 22(e) preempts existing state laws that â€œgive vaccine manufacturers a stronger defense to design defect claims,â€ the net effect of the Act is to enlarge manufacturersâ€™ liabilityâ€”an outcome â€œirreconcilable with Congressâ€™s â€˜over-riding concernâ€™ about â€˜instability and unpredictability of the childhood vaccine market.â€™â€