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The Ever Shifting Landscape in Prescription Drug Design Defect Litigation

By Andrew K. Solow, Evan Anziska and Daniel Meyers

Aside from preemption, it is quite possible that no legal doctrine has caused more angst to both sides of the pharmaceutical product liability bar, and in turn, the courts, than the interplay of negligence versus strict liability and the viability of a design defect claim against manufacturers of FDA-approved prescription drugs. At the heart of this debate is “comment k” of the Restatement (Second) of Torts, a provision written almost 50 years ago by the American Law Institute (ALI). See Restatement (Second) of Torts ' 402A, comment k (1965).

In the past year, two much-anticipated decisions, one from the U.S. Supreme Court and one from the Supreme Court of Pennsylvania, stand at opposite ends of the spectrum on the viability of design defect claims against manufacturers of prescription drugs. In June 2013, the U.S. Supreme Court decided Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013), holding that state law design defect claims against generic manufacturers of prescription drugs are preempted under federal law. This past January, the Pennsylvania Supreme Court decided Lance v. Wyeth, 2014 Pa. LEXIS 205 (Pa. Jan. 21, 2014), holding that design defect claims grounded in negligence can proceed against manufacturers of prescription drugs, side-stepping 20-year-old precedent barring strict liability design defect claims under Pennsylvania law.

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