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Preemption and Generic Drug Liability

By Alan Minsk and Kelley Nduom

To quote Michael Corleone from the forgettable The Godfather: Part III, “Just when I thought I was out, they pull me back in.” In 2011, we thought we had heard the last from the courts on whether preemption prevented generic drug manufacturers from being held liable under state failure-to-warn statutes. The answer was yes ' preemption exists because manufacturers cannot comply simultaneously with their state duty to adequately warn on the labels and their federal obligation to have the same label as their branded drug counterpart. See PLIVA v. Mensing, 131 S. Ct. 2567 (2011).

The 2011 decision followed the Court's 2009 holding that, regarding branded drug manufacturers, state failure-to-warn lawsuits were not preempted by federal law because branded manufacturers may strengthen the warnings in labels on their own initiative. See Wyeth v. Levine, 555 U.S. 555 (2009). Now, the trilogy continues with Fulgenzi v. PLIVA (6th Cir. No. 12-3504, March 13, 2013). While this case has not reached the Supreme Court, it attempts to further define preemption and potential product liability claims against generic drug companies. In short, preemption might not apply in certain cases, as discussed below. The Sixth Circuit pulls us back in. (One month before the Sixth Circuit decision, the Fifth Circuit ruled in a strikingly similar case (same generic drug manufacturer and drug product, but slightly different state-law claims) and rejected the argument that a generic manufacturer could be held liable for failing to update the generic drug label to match a revised brand-name label. Morris v. PLIVA, (5th Cir. No. 12-30319, Feb. 14, 2013). This article focuses on the Fulgenzi ruling.)

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