Attempt in US Congress to stop FDA pre-emption

Two senior members of the US House of Representatives have launched an attempt to overturn, by legislation, a Supreme Court of the USA (SCOTUS) ruling in favor of regulatory pre-emption by the Food and Drug Administration. The proposed law would also seek to overturn a ruling by the Court on Levine versus Wyeth, expected before the end of the year, which concerns a claim on behalf of a Vermont patient who was awarded $6.8 million in compensation after suffering a limb amputation, when an anti-nausea drug was allegedly incorrectly delivered (Marketletters passim). Mark Herrmann, an attorney in Chicago, Illinois, told the Associated Press that the Wyeth case could "potentially apply to all law suits against all manufacturers of prescription drugs."

Reps Henry Waxman (Democrat, California) and Frank Pallone (Democrat, New Jersey), respectively the Chairmen of the House Oversight and Government Reform Committee and the House Energy and Commerce Subcommittee on Health, introduced the Medical Device Safety Act of 2008 to restore tort liability. A similar draft law was due to be launched by Senators Edward Kennedy (Democrat, Massachusetts) and Patrick Leahy (Democrat, Vermont). Although both chambers of the Congress are controlled by a Democratic party majority, without some backing from Republicans, even if only by supporting a vote, such legislation has little chance of approval before the end of the congressional session at the end of 2008.

Lawyers want law suits