24 June 2013

Law in Plain English: Mutual Pharmaceutical Co. v. Bartlett

This is one in a series of posts designed to describe court decisions in plain English. For more detail and background on the legal issues, see the link to the case below. For similar posts, click here.

Mutual Pharmaceutical Co. v. Bartlett

Bartlett took a generic version of Clinoril (sulindac, manufacturered by Mutual Pharmaceutical) and suffered serious injuries associated with a rare side effect. Generally, products liability claims are not preempted for branded pharmaceuticals (Wyeth v. Levine), but are preempted for generic versions (PLIVA, Inc. v. Mensing), because branded manufacturers can make changes to the product's lablel, but generic manufacturers cannot. Bartlett's case is similar to PLIVA in all respects except that PLIVA was a negligence claim, and Bartlett's is a strict liability claim. Bartlett filed claims in New Hampshire state court, which Mutual removed to federal court. The federal jury found for Bartlett, and the First Circuit affirmed, holding that federal law does not preempt state law. The rationale was that the Supreme Court had adopted a general no-preemption rule in Wyeth (for both failure-to-warn and design defect claims), and that PLIVA was a narrow exception to that rule for failure-to-warn claims against generic manufacturers, but not necessarily for design defect claims. The question before the Court was whether the First Circuit Court of Appeals erred when it held that federal law does not preempt state law design-defect claims targeting generic pharmaceutical products because the conceded conflict between such claims and the federal laws governing generic pharmaceutical design allegedly can be avoided if the makers of generic pharmaceuticals simply stop making their products. In a 5-4 decision, the Supreme Court ruled that State-law design-defect claims that turn on the adequacy of a drug’s warnings are preempted by federal law under PLIVA. As a result, Bartlett's state law claim fails. The practical impact of this decision affirms that because federal law prevents generic manufacturers from changing their labels, they are prohibited from taking the remedial action required to avoid liability (and thus, can't be subject to such liability).
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