FDA must prove fraud in Vioxx suits

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Dealing a severe blow to more than a 1,000 Texas product liability cases involving Merck’s Cox-2 selective inhibitor Vioxx, a Texas federal judge ruled in April that a 2003 state law allowing tort claims to proceed if a drug company withheld from FDA material risk information is pre-empted because only the agency itself, not a Texas jury, can conclude that fraud had been committed.

Relying on a 2001 landmark medical device pre-emption ruling by the US Supreme Court (Buckman vs. Plaintiffs Legal Committee), Judge Randy Wilson said it is the FDA’s “exclusive responsibility” to police fraud. He noted that other courts have also concluded that to invoke “fraud-on-the-FDA” exceptions found in many state product liability laws, the agency must first determine that it had been defrauded.

Wilson also emphasized the Supreme Court’s concern that if state tort claims were permitted, “manufacturers might ‘deluge’ the FDA with information it neither needed nor wanted in order to defend state tort claims. This could potentially impede the regulatory process.”

Most of the consolidated Vioxx product liability cases in Texas contain an allegation that Merck failed to provide adequate warnings on Vioxx-related risks, the judge noted.

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