Mutual v. Bartlett Further Shields Generic Drug Manufacturers From Liability

This morning the Supreme Court issued its ruling in the much-anticipated Mutual Pharms. Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). As we predicted, the Court reversed the First Circuit's decision and held that "[s]tate-law design defect claims that turn on the adequacy of a drug's warnings are pre-empted by federal law under PLIVA."1

BARTLETT'S BACKGROUND

Bartlett's facts are undeniably tragic. The plaintiff, Karen Bartlett, took generic sulindac (manufactured by Mutual) for shoulder pain. She developed Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and suffered permanent injury and disfigurement. By the time of trial, the only remaining claim for the jury to decide was whether sulindac was defectively designed. The jury found in Bartlett's favor and awarded her $21.06 million in compensatory damages.

The First Circuit affirmed, holding that because Mutual "certainly c[ould] choose not to make the drug at all," there was no impossibility preemption. Mutual petitioned for a writ of certiorari, which the Supreme Court granted in December 2012. In addition to the parties' briefs, the Solicitor General filed a brief arguing that all "duty to recall" claims should be rejected. The Supreme Court heard oral argument in March.

Questioning at oral argument focused on two main issues: (1) whether design-defect claims can be independent of failure-to-warn claims; and (2) whether this case represented anything other than a challenge to the FDA's authority to allow drugs to be sold on the market.

The decision today squarely addressed both issues.

MUTUAL'S DUTIES UNDER NEW HAMPSHIRE LAW CONFLICT WITH ITS DUTIES UNDER FEDERAL LAW

Justice Alito authored the opinion for the Court, joined by Chief Justice Roberts and Justices Scalia, Kennedy, and Thomas (the same five Justices who ruled for preemption in Mensing). In its impossibility preemption analysis, the Court began by "identifying [Mutual's] duties under state law." First, the Court rejected the notion that New Hampshire recognized an "absolute-liability regime," i.e., one that makes drug manufacturers insurers of their products.

Second, the Court analyzed design defect under New Hampshire law, which imposes liability "only where the design of the product created a defective condition unreasonably dangerous to the user."2

Factors to be considered include: (1) the usefulness of the product to the general public; (2) whether the risk at issue could have been reduced without significant impact to the product's efficacy or manufacturing cost; and (3) "the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or foreseeable uses."3

The Court concluded that the first two factors would require...