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US Supreme Court to Decide Failure to Warn Claims in Pharmaceutical Cases

The Supreme Court of the United States heard argument in several pharmaceutical cases involving the issue of failure to warn consumers about the risks of certain drugs. The petitioners are generic drug manufacturers. The respondents are individual plaintiffs asserting state law failure to warn claims against the generic drug manufacturers. The United States, as amicus curiae, supports the respondents.

The petitioners are facing state law claims that the labels they are using fail to properly warn consumers about the risks associated with the use of their drugs. Several circuit courts of appeal held that the plaintiffs could pursue state law claims because federal law did not preempt those claims.

In front of the Supreme Court, the petitioners argued that respondents cannot pursue state law claims because federal law preempts the state law claims. According to the petitioners, federal law requires generic drugs to have the same warnings as their brand name equivalent drugs. Petitioners concede that they, and all generic drug manufacturers, have a duty to disclose to the Food and Drug Administration adverse results from the use of their drugs. However, since the Hatch-Waxman Amendments require generic drug manufacturers to have the same warnings as their brand name equivalent, generic drug manufacturers do not have a duty to request a change in the language being used on the label. This area, according to petitioners, is under the exclusive authority of the Food and Drug Administration, which is a federal agency. Therefore, state law claims are preempted as the Food and Drug Administration is the agency that controls disclosure of information and warnings provided by drug manufacturers.

Respondents argued that federal law does not preempt the state law claims because petitioners did not submit requests to the Food and Drug Administration to change the labels that were being used by the brand name equivalent drugs. Had petitioners submitted a request to change the labels and the Food and Drug Administration affirmatively rejected the request, then, according to respondents, the state law claims would be preempted. In other words, respondents contend that petitioners had a duty to request a change in the language used in the label and the Food and Drug Administration had to act upon that request before petitioners could assert preemption as an affirmative defense. According to respondents, state law requires an adequate warning to be provided to consumers and if the warning is inadequate, state law requires the petitioners to pursue a change in the label. Since petitioners failed to request a label change, state law still applies to respondents' claims.

The United States, in support of respondents, argued that the Hatch-Waxman Amendments were designed to facilitate the entry of generic drugs into the market. The Amendments were not designed to absolve a manufacturer of its responsibilities to maintain the safety of the drug and the adequacy of the label after the drug has been entered into the market. According to the United States, there is no conflict between state and federal law until the Food and Drug Administration rejects a request for a label change. It is at that point that preemption would apply. However, until the conflict between state and federal law comes into play, there is no preemption and respondents should be allowed to pursue their state law claims.


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