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.

Please see full alert below for more information.

LOADING PDF: If there are any problems, click here to download the file.

Topics:  Abbott Laboratories, Dear Doctor Letters, Drug Manufacturers, Failure To Warn, FDA, Pharmaceutical, Prescription Drugs

Published In: Civil Remedies Updates, Products Liability Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Morrison & Foerster LLP | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »