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Supreme Court Rules that Drug Warning Claims are Not Preempted


On March 4, 2009, the U.S. Supreme Court dealt what, at first blush, appears to be a blow to the pharmaceutical industry, by holding that federal law does not preempt a claim that labeling for a prescription drug failed to adequately warn about the risks of a particular method of administration.  However, the Court’s decision leaves open the possibility that implied conflict preemption may apply where the Food and Drug Administration (FDA) has considered a specific risk and made a determination about the way to warn of that risk.

Wyeth v. Levine, no. 06-1249, underscores the importance of performing a case-specific analysis of preemption. The Court held that federal law did not preempt plaintiff’s state-law claim that labeling for the prescription drug Phenergan failed to adequately warn about the risks of a particular method of administration. Plaintiff received Phenergan intravenously to treat nausea.  She claimed that the drug’s label inadequately warned or failed to instruct clinicians to use an IV-drip method, rather than a higher risk IV-push method.  Evidence was presented to show that if the drug enters a patient’s artery, gangrene may result.  Plaintiff developed gangrene which resulted in the amputation of her forearm. Although the labeling contained certain warnings about this risk, the majority of the Court concluded that the labeling could have been strengthened based upon “accumulating data” about the risk of amputation.

Significant to the decision were the so-called “changes being effected” federal regulations which permit manufacturers to enhance warnings without prior FDA approval in certain circumstances. The Court concluded that “absent clear evidence that the FDA would not have approved a change to Phenergan’s label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements.”

Importantly, however, the Court held open the possibility that, on a different record, preemption would be upheld.  The opinion noted: “Although we recognize that some state-law claims might well frustrate the achievement of congressional objectives, this is not such a case.”  The dissenting justices observed that this case illustrates the maxim that “tragic facts make bad law.”  Some legal analysts are concerned that the decision will open the floodgates to other inadequate warnings actions against the pharmaceutical industry.  Others see this as affirming the recognition that there is a role for preemption in appropriate cases.