Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

A patient affected by Medtronic’s 2007 recall of defibrillator leads is suing the company, claiming unnecessary shocks led to post-traumatic stress syndrome that required psychiatric treatment.

Plaintiff Donald Jackson received an implantable cardioverter defibrillator containing a Sprint Fidelis lead in 2006, which he says gave him unexpected and medically unnecessary shocks, causing excruciating pain.

The shocks caused “great physical, emotional and psychological suffering and extreme anxiety,” placing Jackson in “imminent apprehension of death,” the complaint says. It adds that Jackson is now prescribed mood-stabilizing drugs. And, as a result of problems with the lead, he has an increased risk of death or major heart problems.

The complaint, filed Jan. 18 in the U.S. District Court in the Eastern District of Texas, alleges Medtronic misrepresented the safety of the leads and negligently manufactured, marketed and sold the leads as safe, effective devices. Because such acts were “intentional, reckless and grossly negligent,” the plaintiff is seeking punitive damages.

February 4th, 2008 by Staff with FDA News

This entry was posted on Monday, February 4th, 2008 at 1:35 pm and is filed under News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.