A plaintiff who alleged harm from the use of a generic drug has had her claim preempted as a result of recent U.S. Supreme Court rulings.
The Fourth Circuit ruled in Drager v. Pliva Tuesday that a generic drugmaker “may not unilaterally change its labeling or change its design or formulation, and cannot be required to exist the market or accept state tort liability.”
It is just the latest of similar rulings around the country after the U.S. Supreme Court held in Pliva v. Mensing and Mutual Pharmaceutical Co. v. Bartlett that it would be impossible for generic drugmakers to comply both with state-law tort duties and federal regulatory requirements. Thus, drug companies cannot be required to unilaterally change their labeling, to change their generic products’ design or formulation or to exit the marketplace in order to avoid state-law liability.
Shirley Gross, whose case was continued by her estate after her death, claimed that metoclopramide, a treatment for gastroesophageal reflux, caused her to have permanent movement disorders.
While the plaintiff conceded that failure-to-warn claims are preempted by the Food, Drug and Cosmetic Act, the plaintiff argued that her claims of negligent testing, inspection, and post-market surveillance, breach of express and implied warranties about the safety of metoclopramide, as well as a claim of strict liability “for introducing its product into the stream of commerce in its defective condition,” were not preempted.
The plaintiff argued that Bartlett, which involved a New Hampshire plaintiff, did not control the strict-liability claim because “Maryland assesses the unreasonableness of the danger of a product using a consumer-expectations test while New Hampshire … uses a risk-utility approach.” But the Fourth Circuit said that that did not make a difference because “regardless of the way in which Maryland assesses the unreasonableness of a products’ risks, if Pliva’s metoclopramide is unreasonably unsafe, there is no apparent action that Pliva can take in compliance with FDCA restrictions to avoid strict liability.”
Judge Allyson K. Duncan wrote the opinion in which Judges Dennis W. Shedd and Andre M. Davis joined.
Louis Martin Bograd, of the Center for Constitutional Litigation, argued the case for the plaintiff. Michael David Shumsky, of Kirkland and Ellis, argued the case for the drugmaker defendant.