The Supreme Court ruled yesterday that federal law does not prevent people injured as a result of inadequate warnings on drug labels from suing the drug makers in state court, even if labels were approved by the Food & Drug Administration.

The 6-3 ruling by the court in Wyeth v. Levine is not the first case concerning state law preemption of medical products lawsuits decided by the Supreme Court in recent years. In February 2008, the court in an 8-1 decision ruled that state cases against medical device makers are preempted once their devices have been approved by the FDA.

In the drug company case, Wyeth had argued that it would have been impossible to comply with the state-law duty to modify the labeling of the drug in question without violating federal law requiring FDA label approval. The drug company argued further that recognition of state tort action creates an unacceptable "obstacle to the accomplishment and execution of the full purposes and objectives of Congress" by substituting a lay jury's decision about drug labeling for the expert judgment of the FDA.

Justice Stevens, who authored the Supreme Court opinion, addressed the first argument, noting that there is an FDA regulation–"changes being effected [CBE] regulation"–allowing certain label changes before receiving FDA approval. These include label changes that "add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product."

In the underlying case, Diana Levine had sued Wyeth after she received an injection of an anti-nausea drug–a method that put her at risk of infection and ultimately lead to the amputation of her forearm.

She alleged that the labeling was defective because Wyeth failed to instruct clinicians to use a safer method (IV-drip). The trial court that heard the case noted there were 20 reports of amputations similar to Ms. Levine's since the 1960s.

"Wyeth's cramped reading of the CBE regulation and its broad assertion that unilaterally changing the [drug] label would have violated federal law…are based on the fundamental misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling," Judge Stevens wrote in the Supreme Court opinion published Tuesday.

"It is a central premise of the Food, Drug and Cosmetic Act (FDCA) and the FDA's regulations that the manufacturer bears responsibility for the content of its label at all times," he wrote.

Wyeth's second argument–that requiring it to comply with a state-law duty to provide a stronger warning would interfere with Congress' purpose of entrusting an expert agency with drug labeling decisions–"is meritless," Judge Stevens said, "because it relies on an untenable interpretation of congressional intent and an overbroad view of an agency's power to preempt state law."

"The history of the FDCA shows that Congress did not intend to preempt state-law failure-to-warn actions," he wrote.

"If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express preemption provision at some point during the FDCA's 70-year history," he wrote. "But despite its 1976 enactment of an express preemption provision for medical devices…Congress has not enacted such a provision for prescription drugs."

Later he noted, "In keeping with Congress' decision not to preempt common-law tort suits, it appears that the FDA traditionally regarded state law as a complementary form of drug regulation." He said the agency has "limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs."

He continued, "State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come for-ward with information."

He added that failure-to-warn actions, in particular, "lend force to the FDCA's premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times."

Special Reports /

High Court Rules Drug Cos. Not Immune To State Courts

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