STORY FROM: Drugs & Medical Devices

Post-Recall Communications Subject to FDA Regulation, Texas Federal Judge Rules in Preemption Case

HOUSTON — Negligence claims asserted against Medtronic in connection with its recalled Sprint Fidelis lead are federally preempted, a Texas federal judge has ruled, rejecting the plaintiff’s argument that post-recall communications are not subject to Food and Drug Administration regulation.

In a June 29 order, Judge Robert Pitman of the U.S. District Court for the Western District of Texas held that devices approved by a premarket approval supplement are subject to federal requirements, and that post-recall communications, including those related to implanted devices, are federally regulated.

In April 2006, William Gates had a Medtronic implantable cardioverter defibrillator (ICD) and ...

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