Supreme Court Rules on Generic Drug Labeling Preemption

On June 23, 2011, the Supreme Court rendered its decision in Pliva, Inc. v. Mensing holding that FDA regulations governing generic drug products directly conflict with and preempt state laws that would require generic drug manufacturers to modify the FDA-authorized labeling for their products to provide ​“adequate warnings” as defined by state law. The Court distinguished its earlier decision in Wyeth v. Levine, 21 U.S.C. 555 (2009), which held that similar state law requirements were not preempted by federal drug regulations that apply to brand-named prescription drug products. Justice Thomas authored the majority opinion, which reverses rulings by the Fifth and Eighth Circuits, and Justices Ginsburg, Breyer, and Kagan joined Justice Sotomayor’s dissenting opinion.

The consolidated cases involve two women who were initially prescribed the brand-name drug Reglan, a metoclopramide tablet designed to speed the movement of food through the digestive tract. Reglan received FDA approval in 1980, and, five years later, manufacturers began producing generic metoclopramide. Both women received the generic metoclopramide from their pharmacists. They took the generic drug as prescribed for several years and subsequently developed tardive dyskinesia, a severe neurological disorder. Subsequent evidence showed that up to 29% of metoclopramide users develop the disorder after long-term use. In response, warning labels were strengthened and clarified several times.

The plaintiffs separately sued the generic drug manufacturers under state tort law in Minnesota and Louisiana. The laws in both states impose a duty to warn of the dangers associated with use of a drug on all drug manufacturers, regardless of whether the product is a brand-name drug or generic drug. Prior to the ruling, state law required the metoclopramide manufacturers to attach a safer label to their drug if they had actual or constructive knowledge of dangers associated with its use.

The Act requires manufacturers seeking FDA approval to market a new brand-name drug to prove that the drug is safe and effective, and that the proposed label is accurate and adequate. Generic drugs, on the other hand, can gain FDA approval simply by showing equivalence to a brand-name drug that has already received FDA approval. Federal regulations require, though, that the generic drug have the same warning label as the brand-name drug. A brand-name drug manufacturer can change the warning label without first seeking FDA approval. However, the FDA permits changes to generic drug labels only to the extent that the changes are being made to match an updated brand-name label or to follow FDA instructions. The generic drug maker can seek a labeling change from the FDA but cannot make the change until the change is made to the brand-name drug with FDA approval. Because generic drug manufacturers could not change their labels without FDA approval, the Court concluded that the manufacturers could not independently satisfy their state law duties to strengthen their labels without being in violation of Federal law.

“To be sure, whether a private party can act sufficiently independently under federal law to do what state law requires may sometimes be difficult to determine. But this is not such a case. Before the Manufacturers could satisfy state law, the FDA - a federal agency - had to undertake special effort permitting them to do so. . . . [W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for preemption purposes. *** Here, state law imposed a duty on the Manufacturers to take a certain action, and federal law barred them from taking that action. The only action the Manufacturers could independently take - asking for the FDA’s help - is not a matter of state law concern. [Plaintiffs] tort claims are pre-empted.”

The ruling protects generic drug manufacturers from suits under state tort law for failure to strengthen warning labels if doing so would require a label change that is prohibited by Federal law.

Kelley Drye & Warren LLP

Kelley Drye’s team of Food and Drug lawyers strives to integrate our clients’ business strategies with FDA compliance and to help resolve regulatory enforcement matters when they arise. Working side-by-side with business development and marketing professionals, we provide comprehensive regulatory counseling and assist in developing products, labels, and promotional materials that achieve our clients’ goals without running afoul of regulatory requirements. With close knowledge of FDA’s enforcement priorities and deep experience with the FTC’s regulation of advertising, our team can provide comprehensive legal advice with an eye towards giving clients a competitive edge.

For more information about this Client Advisory, please contact:

Mark L. Austrian
(202) 342-8495
maustrian@​kelleydrye.​com