The Supreme Court ruled yesterday that federal law does notprevent people injured as a result of inadequate warnings on druglabels from suing the drug makers in state court, even if labelswere approved by the Food & Drug Administration.

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

In the drug company case, Wyeth had argued that it would havebeen impossible to comply with the state-law duty to modify thelabeling of the drug in question without violating federal lawrequiring FDA label approval. The drug company argued further thatrecognition of state tort action creates an unacceptable "obstacleto the accomplishment and execution of the full purposes andobjectives of Congress" by substituting a lay jury's decision aboutdrug 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 FDAregulation–"changes being effected [CBE] regulation"–allowingcertain label changes before receiving FDA approval. These includelabel changes that "add or strengthen an instruction about dosageand administration that is intended to increase the safe use of thedrug product."

In the underlying case, Diana Levine had sued Wyeth after shereceived an injection of an anti-nausea drug–a method that put herat risk of infection and ultimately lead to the amputation of herforearm.

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

"Wyeth's cramped reading of the CBE regulation and its broadassertion that unilaterally changing the [drug] label would haveviolated federal law…are based on the fundamental misunderstandingthat the FDA, rather than the manufacturer, bears primaryresponsibility for drug labeling," Judge Stevens wrote in theSupreme 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 bearsresponsibility for the content of its label at all times," hewrote.

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

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

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

Later he noted, "In keeping with Congress' decision not topreempt common-law tort suits, it appears that the FDAtraditionally regarded state law as a complementary form of drugregulation." He said the agency has "limited resources to monitorthe 11,000 drugs on the market, and manufacturers have superioraccess to information about their drugs."

He continued, "State tort suits uncover unknown drug hazards andprovide incentives for drug manufacturers to disclose safety riskspromptly. They also serve a distinct compensatory function that maymotivate injured persons to come for-ward with information."

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