Following the U.S. Supreme Court’s five–four decision in PLIVA, Inc. v. Mensing,1 it appears doubtful that many state-law-based claims against generic drug manufacturers remain viable. In Mensing, the Supreme Court held that state law claims based upon a failure-to-warn theory against generic drug manufacturers are federally preempted by the U.S. Constitution’s Supremacy Clause. In framing the issue, Justice Clarence Thomas, writing for the Court, asked “whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt . . . state-law claims.” Ultimately, the Court found conflict preemption existed insofar as it was impossible for the defendant generic drug manufacturers to simultaneously comply with both the federally-imposed duty to warn and duties imposed by state laws.
The Mensing Decision
The Mensing case analyzed the inherent tensions between state-law-based failure-to-warn claims of risks inherent in prescription drugs and federal regulations implementing the Hatch-Waxman amendments to the federal Food, Drug and Cosmetic Act (FDCA). hose regulations require a generic drug’s warnings to be “the same as” those of its bioequivalent branded pharmaceutical counterpart. To attain Food and Drug Administration (FDA) approval of abbreviated new drug applications (ANDAs) permitted by Hatch-Waxman and federal regulations, generic drug companies always needed to ensure that their drug labeling mirrored the brand’s label. Recognizing this, the Court in Mensing extended the inquiry further: “What is in dispute is whether, and to what extent, generic manufacturers may change their labels ater initial FDA approval.” he Court concluded that under existing federal regulations generic warning labels must always be “the same as” their branded counterparts’ labels—both before and ater ANDA review and FDA’s marketing approval.
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