Wyeth v. Levine and Preemption

For drugs and biologics, the key test of preemption, Wyeth v. Levine, goes before the court in November. The case, in which Wyeth is challenging a Vermont ruling which awarded $6.8 million in damages to a woman injured by Wyeth anti-nausea drug Phenargan, could determine the viability of “failure to warn” claims, which constitute the bulk of tort suits against drug manufacturers.

The FDA has asserted that its decisions trump those of state courts, because companies cannot add warnings to labeling beyond those approved by the agency to guard against “overwarning” that might scare patients away from needed medications. “The plaintiff's lawyers' theory that FDA warnings are only a floor, not a ceiling, is blown out of the water if FDA says manufacturers are not permitted to put additional warnings in the label,” said. Richard Samp, chief counsel for the Washington Legal Foundation. Samp said the court has typically shown deference to federal agencies in similar cases, and that the Michigan and Medtronic cases offer little insight into how the court will handle Wyeth v. Levine.

If the court does uphold pre-emption, rendering “failure to warn” arguments moot, plaintiff's lawyers will still have two avenues for product liability suits: defective design claims, asserting that the risk/benefit profile of a product was so lousy it should have never been manufactured, and negligent manufacture of a product of sound design.

Scott Drake and Jan Schlichtmann discuss the implications in this video