Supreme Court Holds Failure to Warn Suits Against Generic Drug Manufacturers Are Preempted By Federal Law

Jun 30, 2011   

On June 23, 2011, the Supreme Court ruled in Pliva, Inc. v. Mensing that federal law preempts state tort law suits against generic drug manufacturers for failure to provide adequate warning labels. The decision comes two years after Wyeth v. Levine in which the Court held that federal drug laws did not preempt such suits against brand-name manufacturers. As a result of its decision in Pliva, generic drug manufacturers have greater protection against state tort suits than their brand-name manufacturing counterparts. Also, as a result of this decision, consumers are left with fewer remedies for injuries caused by taking generic drugs than their brand-name counterparts.

In Pliva, Mrs. Mensing and Mrs. Demahy brought state-law tort claims against generic manufacturers claiming that the labels warning of the dangers associated with the long term use of their drugs were inadequate. As a result of the long term use of the generic drugs, Mrs. Mensing and Mrs. Demahy alleged that they developed a severe neurological disorder whose risk of development was known by the generic manufacturer to be greater than that indicated on the label.

Responding to the plaintiffs’ claims, the generic manufacturers argued that because federal law requires a generic drug to bear the same label as its brand-name counterpart, it was impossible to also comply with a state law duty to revise its labels. Thus, the Court addressed “whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, these state-law claims.”

In determining conflict preemption applied and that Mrs. Mensing’s and Mrs. Demahy’s state tort law claims were barred, the Court focused its analysis on “whether the private party could independently do under federal law what state law requires of it.” The Court found that under federal law brand-name and generic drug manufacturers have different labeling duties. While a brand-name manufacturer is responsible for the accuracy and adequacy of its label, a generic manufacturer’s duty is to ensure that its warning label is the same as the brand-name drug’s.

Consequently, the Court rejected the victims’ argument that, like the brand-name manufacturers in Wyeth, generic drug manufacturers could provide additional warning labels before receiving agency approval through the FDA’s “change being effected” (“CBE”) regulations. In reaching this conclusion, the Court relied heavily upon the FDA’s interpretation of its CBE regulations. The FDA asserted, and the Court agreed, that the CBE regulations only permit generic drug manufacturers to change its label: 1) to match an updated brand-name label, or 2) to follow the FDA’s instructions.

Furthermore, though all manufacturers bear responsibility for the content of their labels at all times to ensure adequate and accurate labeling, the “requirement of sameness” in generic labeling prohibits the unilateral change of a generic label. Instead, the Court adopted the FDA’s position that “generic drug manufacturers that become aware of safety problems must ask the [FDA] to work toward strengthening the label that applies to both the generic and brand-name equivalent drug,” rather than unilaterally changing a label.

However, the Court also rejected the argument that in order for state tort claims against manufacturers of generic drugs to be preempted by federal law, the generic drug manufacturer must first ask the FDA for help in strengthening the brand-name label and thus its own. In rejecting this argument, the Court found that even if a generic drug manufacturer complied with its obligation under federal law to communicate with the FDA about the possibility of a safer label, such actions would not satisfy its state law duty to provide adequate labeling. The Court stated: “state law demanded a safer label; it did not instruct the Manufacturers to communicate with the FDA about the possibility of a safer label.” The Court went on to hold that “when 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.”

Therefore, because state tort law requires all drug manufacturers to  adequately and safely label their products, but federal drug regulations prevent generic manufacturers from unilaterally changing their generic drug products’ safety labels, “it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.” As such, the Court found that state law was preempted by the federal drug regulatory regime.

Given that the Court previously found in Wyeth that “Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness,” this case raises the interesting question of whether the Court’s decision leaves a gap in consumer protection. The practical result of the Court’s opinion is that the ability of an individual to bring a state tort suit for failure to warn of dangers regarding drug products now hinges on whether that drug product is brand-name or generic. However, the Court’s last line of Pliva is telling: “as always, Congress and the FDA retain the authority to change the law and regulations if they so desire.” Fuerst Ittleman will continue to monitor the progress of these issues. For more information, contact us at