Jury Buys Plaintiff’s Argument That Drug Manufacturer Should Have Distributed Dear Doctor Letter Sooner, Without Prior FDA Approval

Dear Doctor letters were front and center in the just-tried case of Tietz v. Abbott Laboratories, Inc., et al., No. 12-L-002715. On Thursday, May 9, 2013, a Chicago jury returned a $2.2 million verdict in favor of the plaintiff who alleged his wife was injured by Abbott’s failure to adequately warn of risks related to its arthritis drug, Humira.

The verdict has significant implications for the future of failure to warn litigation involving prescription drugs. Tietz has opened the door to the argument that a drug manufacturer has a duty to send a Dear Doctor letter to provide new drug warnings before the letter is approved by the Food and Drug Administration (FDA), despite regulations and guidance that arguably require such approval.

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