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 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."
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