Opinion analysis: Vaccine manufacturers immunized from design-defect liability

By Matthew Scarola
on Feb 23, 2011 at 10:00 pm

Section 22(b)(1) of the National Childhood Vaccine Injury Act of 1986 (NCVIA) provides that

[n]o 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.

Yesterday, in Bruesewitz v. Wyeth (No. 09-152), the Court held that the NCVIA “preempts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects.” (For more background on the case, you can read my preview of the argument and my argument recap.)  In so doing, it likely closed the door on thousands of claims by parents alleging a link between vaccines and childhood autism.

Justice Scalia wrote the opinion of the Court, which was joined by five other Justices – the Chief Justice and Justices Kennedy, Thomas, Breyer, and Alito. (Justice Kagan was recused.) In holding that design-defect claims such as petitioners’ are preempted, the Court relied heavily on the text of the statute.  It construed the word “unavoidable” in light of the “even though” clause that followed it; thus, the Court explained, a side effect is “unavoidable” if it occurs despite proper manufacturing and warning. The vaccine’s design must be taken as a given for the word “unavoidable” to have effect; otherwise, the Court continued, a side effect could always have been avoided “by use of a differently designed vaccine not containing the harmful element.” Moreover, the fact that Congress specifically preserved liability for claims alleging defective manufacturing and inadequate warnings implies (by omission) that it did not intend to preserve state-law design-defect claims.

The Court considered, but rejected, the textualist arguments advanced by Justices Sotomayor and Ginsburg in dissent.  Among other things, the Court disputed the contention that the statutory term “unavoidable” is a term of art that was intended to incorporate comment k to Section 402A of the Restatement (Second) of Torts, which addresses “unavoidably unsafe products” and purportedly required a case-by-case inquiry. The Court reasoned that there is no reason to think that the word “unavoidable” on its own – which, it noted, is “hardly a rarely used word” – refers to “unavoidably unsafe products.”  And in any event, it continued, in 1986 – when the NCVIA was enacted – courts disagreed on the meaning of that phrase. Additionally, the Court explained, the “even though” clause on which the dissent relies “is meant to signal the unexpected: unavoidable side effects persist despite best manufacturing and labeling practices.” By contrast, by reading proper preparation and labeling as prerequisites for preemption in addition to unavoidability, the dissent would “eliminate[] any opposition between the ‘even though’ clause . . . and the word ‘unavoidable.’” Finally, although the Court conceded that its interpretation rendered superfluous a portion of the text, it countered that the dissent’s nullification of the “even though” clause precluded the application of the rule against superfluity.

The Court then turned to the structure of vaccine regulation and the NCVIA. The licenses issued for vaccines require certain warnings, directions, and manufacturing methods, but the FDA does not regulate design defects. Similarly, the NCVIA “micromanages manufacturers” in every respect except one:  “how to evaluate competing designs . . . .” Moreover, the Act captures the benefits of design-defect torts by (1) providing for federal agencies to improve vaccine design and (2) compensating victims generously. Having devised this scheme, the Court concluded, Congress’s omission of design-defect liability seems to reflects a “sensible choice to leave complex epidemiological judgments” to experts instead of jurors. Finally, the Court found support for its holding in what it described as the “Act’s structural quid pro quo”:  vaccine manufacturers fund the NCVIA’s victim-compensation scheme in exchange for protection from costly litigation.  Exposing manufacturers to liability for design-defect suits — which the Court described as “the most speculative and difficult type of products liability claims to litigate” — would do little to encourage their involvement.

The Court also disputed the dissent’s interpretation of legislative history. But given the Act’s “text and structure,” the Court felt it unnecessary to “resort to” legislative history in forming its judgment.

Justice Breyer filed a concurring opinion in which he noted that although, in his view, the Court had correctly interpreted the statutory text, he would consider other sources because “the textual question considered alone is a close one.” Placing heavy emphasis on the benefits of childhood vaccinations, and Congress’s finding that tort suits threatened those benefits, Justice Breyer thought it anomalous to allow inexpert juries to second-guess expert judgments regarding “when a vaccine is safe enough to be licensed . . . .” In particular, he accorded “significant weight” to the view of the Department of Health and Human Services that allowing design-defect lawsuits might threaten the nation’s vaccine supply. The Department’s opinion was especially significant, he argued, because other “expert public health organizations support its views” on this “medical and scientific question of great importance: how best to save the lives of children.”

Justice Sotomayor filed a dissenting opinion that was joined by Justice Ginsburg.  She argued that the Court’s holding “excises 13 words from the statutory text, misconstrues the Act’s legislative history,” disturbs Congress’s “careful balance” between compensating injured children and protecting the vaccine supply, and risks permitting manufacturers to ignore “scientific and technological advancements when designing or distributing their products.” She instead concluded that Congress intended for Section 22(b)(1) to preempt design-defect claims only when a manufacturer shows, on a case-by-case basis, “that the vaccine was properly manufactured and labeled, and that the side effects stemming from the vaccine’s design could not have been prevented by a feasible alternative design that would have eliminated the adverse side effects without compromising the vaccine’s cost and utility.”