U.S. Supreme Court Hands Down Influential Ruling for Generic Drug Manufacturers in Mutual Pharmaceutical Co., Inc. vs. Bartlett
In an important decision potentially affecting all makers of federally-regulated products, the United States Supreme Court today held in Mutual Pharmaceutical Co., Inc. v. Bartlett that manufacturers of generic drugs cannot be held liable for failing to “stop selling” their products, even if allegedly defectively designed or labeled.
In a 2011 decision, PLIVA, Inc. v. Mensing, the U.S. Supreme Court ruled that, because federal law required generic drug makers to use exactly the same product labeling that was approved by the FDA for the corresponding “brand-name” drug, state tort failure-to-warn claims alleging that a generic manufacturer was required to provide a more vigorous warning in the generic’s label were barred under the doctrine of “conflict” or “impossibility” preemption. A New Hampshire plaintiff allegedly harmed by a generic substitute argued that its manufacturer should still be liable for her injuries, Mensing notwithstanding, because the company could have simply “stopped selling” a drug it knew or should have known to be dangerous. Reversing lower court holdings to the contrary, the Supreme Court in Bartlett explicitly rejected the “stop selling” argument as inconsistent with its prior pre-emption decisions and held that plaintiff’s claims were pre-empted under Mensing.
The Bartlett decision is potentially significant to all product manufacturers subject to federal design, manufacture, labeling or testing standards. For more information on Bartlett and federal preemption, our pharmaceutical and medical device product liability defense group, or our products team generally, please feel free to contact Scott Smith (firstname.lastname@example.org) and/or Tracy Van Steenburgh (email@example.com) at your convenience.