Argument preview: To what extent does the National Childhood Vaccine Injury Act of 1986 immunize vaccine manufacturers against design-defect claims?

By Matthew Scarola
on Oct 11, 2010 at 7:43 pm

Under Section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 (“NCVIA”),

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 scheme—involving the so-called “Vaccine Court”—to provide compensation to children with certain vaccine-related injuries.  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.

Background

When Hannah Bruesewitz was six months old, she received Wyeth’s Tri-Immunol DTP (diphtheria-tetanus-pertussis) vaccine as part of her childhood immunizations.  Shortly after receiving the vaccine, she began to suffer multiple seizures; since then, she has been developmentally impaired.   As directed by the NCVIA , Hannah’s parents filed a petition in “Vaccine Court” to seek compensation for her injuries.  A special master, however, dismissed the family’s claim on the ground that they had failed to demonstrate that the vaccine had caused Hannah’s particular injuries.    The family then filed suit in a Pennsylvania state court against Wyeth, which removed the case to federal court.  The federal district court concluded that the family’s claim was preempted by Section 22(b)(1), and the Third Circuit affirmed that decision.  The family next filed a petition for certiorari, which the Supreme Court granted on March 8, 2010.

Merits Arguments

The parties’ arguments rest primarily on conflicting interpretations of the plain text of Section 22(b)(1).  In their brief on the merits, the Bruesewitzes first rely on what they regard as the plain meaning of the term “unavoidable” in Section 22(b)(1):   in their view, it signals that manufacturers are immune from civil liability only for side effects that “could not have been prevented.” Moreover, they contend, “unavoidable” is a products-liability term of art—derived from comment k to Section 402A of the Restatement (Second) of Torts—that Congress used to refer to something that “could not have been prevented by a safer design.” And Congress’s use of the word “if” at the beginning of the clause regarding “side effects that were unavoidable” 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 “unavoidable” (requiring that such side effects be unavoidable “even though the vaccine was properly prepared and was accompanied by proper directions and warnings”) as adding two prerequisites for immunity from suit. First, they contend, elsewhere in Section 22(b) and the legislative history, Congress used the phrases “unavoidable side effects” and “side effects that were unavoidable” interchangeably.  Second, such an interpretation is most consistent with Congress’s intent to codify the meaning of “unavoidable” as a products-liability term of art.  Third, if Congress had intended to adopt Wyeth’s interpretation, it could have instead used the phrase “if … the vaccine was properly prepared and was accompanied by proper directions and warning.” Fourth, they emphasize the “longstanding presumption against preemption of state-law claims,” 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 NCVIA—which, they argue, makes clear “that Congress, the President, and vaccine manufacturers all understood…that manufacturers would remain responsible for making their vaccines as safe as possible”  That understanding, they continue, is consistent with Congress’s goals of promoting vaccine safety and guaranteeing that children injured by vaccines receive compensation.  The prospect of liability encourages manufacturers both to exercise “due care in designing vaccines” and to “keep up with scientific and technological advances.” 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 and—if they prevail—obtain compensation.

Finally, the Bruesewitzes reject any contention that allowing claims such as theirs to proceed in court would “destabilize the vaccine supply”; 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).  In its view, the statute preempts all but two kinds of state-law tort claims:  those arising from manufacturing defects and a failure to warn. If the Bruesewitzes’ interpretation were correct, Wyeth argues, Congress could have simply “end[ed] the preemption provision with the words ‘unavoidable side effects.’”   But it declined to do so, and the words that follow the word “unavoidable” are thus crucial.  Moreover, the family’s reading would “merely perpetuat[e] the status quo ante the Vaccine Act” and make “Section 22(b)(1)’s express limitation on civil liability…superfluous.” Such a result would be inconsistent with the NCVIA’s structure, which not only creates a compensation scheme but also empowers expert agencies—rather than juries, which tend to undervalue the benefits of vaccines to the general public—to evaluate designs.

Wyeth also rejects the family’s contention that Congress intended to codify the meaning of “unavoidable” employed in the product-liability context.  Wyeth counters that Section 22(b)(1) is broader than—and not a codification of—comment k, which “speaks only to a defense to strict-liability” claims and does so in the context of tort law, rather than in the administrative context.  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 “were unavoidably unsafe.”

Wyeth additionally argues that the presumption against preemption is an unnecessary tiebreaker; it is especially inappropriate here because “both parties’…interpretations…would result in some preemption of state law.” The “most authoritative piece of” legislative history—though unnecessary—“confirms that Congress intended categorically to preempt design-defect claims.”

Like the Bruesewitzes, Wyeth seeks to rely on the “purpose and policy” of the NCVIA.  Citing the “twenty new vaccines…brought to market since” 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 “plaintiffs may assert a manufacturing-defect or failure-to-warn claim.” 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, today’s market is “subject to disruption just as it was in 1986.” And without preemption, manufacturers might be overwhelmed with suits; “It 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.”  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 Wyeth’s policy concerns, the government contends that petitioners’ interpretation of Section 22(b)(1) would “expose manufacturers to greater liability for their vaccine designs than they would face under state law alone.” In 1986, no state prevented a manufacturer from invoking comment k on a case-by-case basis. “Thus, on petitioners’ 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.”  Moreover, on petitioners’ view, Congress prohibited states from affording manufacturers additional protections against design defect claims. The government argues that Section 22(b)(1) “limits certain claims against manufacturer,” while Section 22(e) “bars state restrictions on plaintiffs’ causes of action beyond the restrictions the Act imposes….” 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 “give vaccine manufacturers a stronger defense to design defect claims,” the net effect of the Act is to enlarge manufacturers’ liability—an outcome “irreconcilable with Congress’s ‘over-riding concern[]’ about ‘instability and unpredictability of the childhood vaccine market.’”