In its June 24, 2013, decision in
Mutual Pharmaceutical Co., Inc. v. Bartlett, the United States Supreme Court elucidated a new aspect of drug regulation in which the federal Food, Drug, and Cosmetic Act ("FCDA") preempts state drug regulation. As
the Court described in its opinion,
New Hampshire law imposes a duty on manufacturers to ensure that the drugs they market are not unreasonably unsafe, and a drug’s safety is evaluated by reference to both its chemical properties and the adequacy of its warnings.
The
Court held that
State-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law...
A recent trend has witnessed the FDCA used to justify the preemption of state laws that attempt to regulate drugs. Although
the Court noted that not all state drug regulation is preempted, both states and plaintiffs are left guessing where the borders of preemption lie.
