FDA intervenes in drug liability cases

To the horror of the litigation lobby, the Food and Drug Administration has begun intervening in liability lawsuits urging courts not to second-guess design and marketing issues already contemplated and resolved by the federal regulatory agency. For many years now it has been commonplace for lawyers suing over side effects to claim that a drug’s […]

To the horror of the litigation lobby, the Food and Drug Administration has begun intervening in liability lawsuits urging courts not to second-guess design and marketing issues already contemplated and resolved by the federal regulatory agency. For many years now it has been commonplace for lawyers suing over side effects to claim that a drug’s marketer should have, e.g., given a stronger warning even though the FDA had considered and rejected the idea of its doing so. Agency general counsel Daniel Troy is credited with the new policy, which is based on the longstanding principle that state government action should not undercut comprehensive federal regulatory schemes. (“FDA stepping into liability lawsuits on side of drug makers”, Newhouse/Seattle Times, May 11).

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