More on Generic Drugs, Preemption, and Access to the Courts to Redress Drug-Related Injuries

We have posted several times recently (go here, here, and here) about Mutual Pharmaceutical Company v. Bartlett, a pending Supreme Court case that presents the question whether FDA approval of a generic prescription drug preempts a state-law damages claim premised on the drug's design defect. (The Supreme Court held 5-4 in PLIVA v. Mensing (2011) that FDA approval of a generic prescription drug and its labeling generally preempts a state-law damages claim premised on a failure to warn of the drug's hazards.) The drug company in Mutual has just filed its opening Supreme Court merits brief.

Relatedly, on Monday, we posted about a recent ruling of the Alabama Supreme Court that a patient who took a generic version of a drug could, as a matter of Alabama law, sue the brand-name drug manufacturer for failing to warn about the drug’s risks. That ruling may leave open an avenue of relief for people harmed by generic drugs because the Supreme Court held in Wyeth v. Levine (2008) that failure-to-warn suits against brand-name manufacturers generally are not preempted. In this regard, readers may also be interested in taking a look at Conte v. Wyeth, a 2008 decision of the California Court of Appeal, which, like the Alabama Supreme Court, held that state law authorizes someone harmed by a generic drug to hold the brand-name manufacturer responsible for failing to warn of the product's hazards.