A Call to Restore the Rights of Generic Drug Consumers

Warning labels on generic drugs have garnered a lot of attention recently, and for good reason.  In PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court held that federal drug regulations applicable to generic drug manufacturers, which require that generic drug manufacturers use safety labels identical to those used by the brand name drug manufacturers, pre-empt state law failure-to-warn claims.[1]  The state tort laws at issue “require a drug manufacturer that is or should be aware of its product’s danger to label that product in a way that renders it reasonably safe.”[2]  In finding that the state tort law claims were pre-empted by federal law, the Court reasoned that it was impossible for the generic drug manufacturers to comply with both the state tort laws and regulations promulgated by the U.S. Food and Drug Administration (“FDA”), as the federal regulations prevent the generic drug manufacturers from independently changing their safety labels even if they learn of risks not included on those labels.[3]

Among other “absurd consequences,” the dissent in Mensing emphasized that the decision would “strip[ ] generic-drug consumers of compensation when they are injured by inadequate warnings.”[4]  Indeed, although consumers can maintain failure-to-warn claims against brand name drug manufacturers, which are governed by different federal statutes and regulations, courts across the country have cited Mensing when dismissing injured consumers’ lawsuits against generic drug companies.

Mensing has stark implications for consumer safety.  The vast majority of prescriptions filled in the United States each year are filled with generic drugs.  As time passes and generic competition increases, brand name manufacturers have less incentive to monitor the adequacy of their safety labeling, even though significant drug-related risks are often discovered only when drugs are used by a broader population following initial FDA approval.  Thus, preventing failure-to-warn lawsuits against generic drug manufacturers deprives the consuming public of an effective way of incentivizing the manufacturers to ensure that safety risks are fully disclosed.

There is, thankfully, mounting pressure to undo the effects of the Mensing decision.  In August 2011, Public Citizen filed a Citizen Petition (the “Citizen Petition”) requesting, in part, that the FDA authorize generic drug manufacturers to revise generic drug labeling through certain procedures that the FDA currently interprets as applying only to brand name manufacturers. Early last month, the American Association for Justice submitted comments in support of the Citizen Petition.  And, on March 26, 2012, Senator Leahy announced plans to introduce legislation “that permits generic manufacturers to improve the warning information for their products in the same way as brand manufacturers, providing adequate warnings to consumers.

At the conclusion of the Court’s opinion in Mensing, Justice Thomas reminded the reader:  “As always, Congress and the FDA retain the authority to change the law and regulations if they so desire.”[5]  Let’s hope that one of those entities seizes the opportunity to remedy this dangerous and unjust result.