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Argument recap: Court considers vaccine design-defect liability

At Tuesday’s oral argument in Bruesewitz v. Wyeth (No. 09-152), the Court – with Justice Kagan recused – focused predominantly on the consequences of its decision for vaccine manufacturers and victims.

On behalf of the Bruesewitz family, David Frederick argued that the National Childhood Vaccine Injury Act of 1986 only provides manufacturers with a case-by-case defense to design-defect claims. A manufacturer could be held liable, he argued, for side effects that were not “unavoidable” – which he defined as effects that could be prevented by using a different vaccine design, given current scientific knowledge. However, Justices Scalia and Alito pressed Frederick on whether that interpretation rendered surplusage portions of the statute.

Justice Ginsburg asked Frederick about the alternative interpretation (for which the Chief Justice voiced support) of “unavoidable” advanced by the United States, which would preclude liability when the side effects were, in her words, “unavoidable in the vaccine that had gained FDA approval.” And Justice Scalia suggested that assessing “unavoidable” in terms of other vaccines could prompt comparisons with less effective vaccines. Frederick “concede[d]” that alternative designs must be at least as effective as the vaccine in question for liability to attach.

Justice Breyer next asked whether a holding in favor of the Bruesewitzes might undermine Congress’s intent by “driving certain vaccines from the market.” Frederick first emphasized that a clear statement by Congress is required before state law can be preempted.  But in any event, he continued, the “vast majority” of people accept the vaccine court’s judgment, and that even unsuccessful claimants may choose not to sue because of the difficulty of proving a state-law claim. Chief Justice Roberts countered, however, that the threat of liability includes concern for the size of even infrequent judgments, telling Frederick that “[i]t doesn’t take too many $60 million verdicts to make you come out on the other side of your calculus.”

The conversation turned to manufacturers who know that their vaccine designs are defective. Justice Kennedy suggested that because regulators can decertify vaccines, liability only affects conduct when manufacturers have information that a regulator lacks. Frederick countered that the FDA was not legally obligated to “engage in a comparative safety analysis.” And he argued that Wyeth’s interpretation would immunize manufacturers from liability until the FDA required them to withdraw a vaccine. Chief Justice Roberts suggested that the alternative was having a jury assess alternative designs, sometimes before the efficacy of those designs was clear. Defending against such lawsuits, Justice Kennedy added, “is a tremendous expense.”

Kathleen Sullivan, representing Wyeth, began by reminding the Court that the NCVIA was enacted “against the backdrop of a wave of tort litigation.” When Justice Sotomayor asked why Congress did not make the vaccine court an exclusive remedy, Sullivan responded that Congress was concerned about design-defect claims, which it expressly preempted. Justices Kennedy and Ginsburg both later asked why Congress did not express that concern using clearer, more direct language.

Justices Kennedy and Sotomayor inquired about when and why a manufacturer would remove a defectively designed drug that still had FDA approval. Sullivan in part responded that if a manufacturer “withholds knowledge of adverse side effects from the FDA,” it forfeits a statutory presumption that its warnings were adequate, thereby risking liability. Justices Kennedy and Sotomayor both pointed out that a warning need not disclose that safer designs exist.

Justice Breyer asked whether persons who could have been saved if the manufacturer had told the FDA that a better product was available were persons whose harm was “avoidable.” Sullivan’s reference to comment k appeared not to persuade Justice Sotomayor, who expressed deep concern for compensating persons whose injuries were “avoidable in its normal sense.”

Sullivan emphasized the potential costs of defending against design-defect claims, which requires “shadowboxing against an infinite number of theories about how there could have been a safer vaccine.” Justice Ginsburg contested Sullivan’s suggestion that petitioners’ interpretation of the Act affords manufacturers no protection, arguing that vaccine court prevents all but a small number of claims from reaching state court. Sullivan emphasized the five thousand claimants who allege a link between autism and vaccinations and may ultimately pursue state-law remedies.

Benjamin Horwich, the Assistant to the Solicitor General arguing on behalf of the United States, sought to turn the Court’s attention to the Centers for Disease Control and Prevention, which he described as perhaps the “most important federal agency” involved in the case. (The no-fault remedy and preemption provisions of the NCVIA apply only to categories of vaccines recommended by the CDC for “routine administration to children.”) After Justice Breyer pressed him on the federal government’s definition of “unavoidable,” he assured Justice Breyer that “the nature of vaccine research” makes it “very unlikely” that a manufacturer would uniquely possess knowledge of design defects. And he represented to Justice Sotomayor that when the CDC recommends a vaccine, it seeks, in her words, the “most efficacious drug with the least adverse effects.” Chief Justice Roberts inquired whether the CDC alerts people of its preferences that certain vaccines be manufactured. Horwich assured him that it does, and that the CDC compares vaccines, in the Chief’s words, “both with respect to losses…and with respect to efficiency.” Horwich thought it “extraordinary” to suggest that Congress would permit juries to second-guess those decisions.

Frederick’s rebuttal focused on the CDC issue. He confirmed to Justice Alito that on the Bruesewitzes’ view, a lay jury could hold a manufacturer liable for producing a vaccine recommended by the CDC. But he emphasized the government’s failure to cite any regulations requiring the CDC to “do the kind of comparative analysis for safety that is provided under State law design defect claims,” noting that the CDC does not distinguish between the six DTap vaccines now on the market. When Chief Justice Roberts pressed him on whether the CDC publishes comparative analyses, he responded that he was “not aware that the CDC does the kind of granular comparisons that would go to the level of safety that is at issue in this kind of case. And that’s what’s important here.”

Recommended Citation: Matthew Scarola, Argument recap: Court considers vaccine design-defect liability, SCOTUSblog (Oct. 14, 2010, 11:08 AM),