Supreme Court Decision Opens Door For Possible Implied Conflict Preemption Of Over-The-Counter Drugs

The United States Supreme Court's most recent pronouncement on federal preemption, decided in the context of generic prescription drugs, appears destined to be at the forefront in future battles over unsettled questions regarding preemption in the context of nonprescription, over-the-counter (OTC) drugs. In PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court held that federal law preempted state law failure to warn claims asserted against generic drug manufacturers. The Court's preemption holdings, couched in terms of "impossibility" borne out of federal regulatory requirements of "sameness," could arguably have similar applicability in the context of OTC drugs regulated under the FDA's "monograph" regime.

The doctrine of federal preemption is based on the Supremacy Clause of the United States Constitution. The Supremacy Clause provides that federal law is "the supreme Law of the Land; . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const. art. VI, cl. 2. As such, any state law that conflicts with the exercise of federal power is preempted and has no effect. See Maryland v. Louisiana, 451 U.S. 725, 747 (1981).

State law is preempted under the Supremacy Clause where Congress has expressly preempted state law. See, e.g., Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, (1992). Preemption may also be implied to the extent that state law actually conflicts with federal law. English v. Gen. Elec. Co., 496 U.S. 72, 79 (1990). "Implied" or "conflict" preemption exists where (1) it is impossible for a private party to comply with both state and federal requirements; or (2) state law obstructs accomplishing and executing Congress' full purposes and objectives. See Mensing, 131 S. Ct. 2567 (citing Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995)). In Mensing, the Supreme Court addressed implied preemption based on impossibility.

Impossibility-Based Federal Preemption as Articulated by Supreme Court in Mensing

Mensing involved state law failure to warn claims asserted against generic prescription drug manufacturers, and alleged the manufacturers failed to provide adequate warning labels. Plaintiffs claimed that state law required the manufacturers to use a different, safer label.

However, the Mensing Court determined that, under FDA regulations, generic drug manufacturers have an ongoing federal duty of "sameness" regarding their labels – namely, that the generic drug's labeling must at all times be the same as the brand name drug's labeling because the brand name drug is the basis for generic drug approval. Specifically, the Court found that the generic drug manufacturers could not strengthen their labels through the FDA's...

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