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Supreme Court Vacates Ninth Circuit Ruling on Generic Ibuprofen Case

On Oct. 31, 2011, the U.S. Supreme Court vacated the Ninth Circuit Court of Appeals' holding in Perrigo v. Gaeta that a state law duty-to-warn lawsuit alleging defects in generic over-the-counter ibuprofen was not subject to federal law preemption. Despite granting certiorari, the Supreme Court remanded the case to the Ninth Circuit. In its remand, the high court requested the Ninth Circuit appeals court to reconsider its holding, given the Supreme Court's ruling that state failure-to-warn cases against generic drug manufacturers were preempted by federal law.

Landmark Federal Preemption Case, Pliva, Inc. v. Mensing

The Supreme Court's pivotal ruling on federal preemption, Pliva, Inc. v. Mensing, was issued in June 2011. The Court's rationale for finding a basis to justify federal preemption came from the Hatch-Waxman Amendments to the federal Food, Drug, and Cosmetic Act. Those amendments require generic drugs to use identical warnings to consumers as their brand name counterparts.

Generic prescription medicines derive their preemption protections from the Mensing case. Mensing stands for the proposition that state law-based failure-to-warn claims are preempted by the Supremacy Clause of the Constitution. The preemption is due to the fact that generic drug makers cannot bolster drug warnings without running afoul of federal law, and the resulting conflict between state law mandates and federal drug regulations makes compliance with both sets of laws impracticable.

Background Facts of Perrigo v. Gaeta

The underlying claims in the Perrigo case stemmed from severe injuries suffered by a child, Gaeta, that were purportedly caused by an allergic, toxic reaction to over-the-counter generic ibuprofen made by the L. Perrigo Company. The injuries mounted to the point of the pediatric patient requiring a liver transplant. He first took the generic over-the-counter medication after having dermatology surgery to remove several moles. The product liability suit was ultimately filed by Gaeta's parents against drugmaker Perrigo. The suit's chief allegation was that Perrigo's failed to warn of hepatoxic risks associated with ibuprofen when it was prescribed along with Halothane. Halothane is an anesthetic that was administered to Gaeta during his mole removal surgery.

Significance of the Supreme Court's Remand to the Ninth Circuit

In Perrigo v. Gaeta, the Supreme Court flatly directed the Ninth Circuit Court of Appeals to reconsider its prior preemption ruling adverse to a manufacturer of generic over-the-counter ibuprofen. As such, the landmark case gives both the Ninth Circuit, and quite possibly also the Supreme Court, another chance to ascertain whether generic over-the-counter medicine claims are subject to the same preemption preclusions as generic prescription drugs. The scope of federal preemption law and its precedents are now subject to additional judicial scrutiny, particularly in the specific context of over-the-counter medications.