Attorneys In Pre-Emption Case Seek To Add Documents Indicating Two FDA Officials Objected To Rules Aimed At Pre-Empting Lawsuits

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Litigation / Medical Malpractice;  Pharma Industry / Biotech Industry
Article Date: 03 Nov 2008 - 0:00 PDT

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Plaintiff attorneys in Wyeth v. Levine, a U.S. Supreme Court case that could determine whether patients have the ability to file product liability lawsuits against pharmaceutical companies in state courts, on Thursday requested that the court add to the case record documents from FDA officials who expressed opposition to pre-emption, Dow Jones reports. Supporters of pre-emption, a legal principle under which federal laws supersede state laws, maintain that FDA approval of medication labels pre-empts the ability of consumers to file lawsuits against pharmaceutical companies under state product liability laws.

In 2006 and 2008, FDA issued rules that increased agency responsibility for medication labels in support of pre-emption. In addition, FDA has filed a friend-of-the-court brief in support of pre-emption in the case (Mundy, Dow Jones, 10/30).

However, according to internal documents released on Wednesday by House Oversight and Government Reform Committee Chair Henry Waxman (D-Calif.), two FDA officials objected to the rules. According to the documents, the two FDA officials in memos said that FDA approval of medication labels is not completely reliable or based on full disclosure of safety risks by pharmaceutical companies (Kaiser Daily Health Policy Report, 10/30).

Plaintiff attorney David Frederick on Thursday in the letter to the court wrote, "The internal communications of the FDA's expert staff undermine the factual bases of the contention that the Solicitor General and the petitioner Wyeth have made in their submissions in their case." Wyeth declined to comment on the issue (Dow Jones, 10/30).

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