MARSHALL -- In the midst of a recent Minnesota class action lawsuit over faulty defibrillator wires, Medtronic, Inc. is facing allegations in Texas that include civil theft of a previously implanted Medtronic device.
Fort Worth residents, David and Elisha Kuhn filed suit on Oct. 19 against Medtronic in the Marshall Division of the Eastern District of Texas.
David Kuhn had a Medtronic dorsal column stimulator surgically implanted to provide pain relief with stimulation through electrodes. According to the Kuhn's lawsuit, a Medtronic column stimulator implanted in Kuhn began to malfunction causing him distress and severe pain.
In January 2006, the medical device was surgically removed and sent to a Medtronic representative for evaluation. Kuhn claims he has requested to have the device returned but has been unsuccessful and now Medtronic has destroyed the device or spoiled evidence of the alleged malfunction.
Although not in possession of the column stimulator, Kuhn alleges the product was "defectively designed, manufactured, and/or marketed by the defendant." Further, the plaintiff alleges Medtronic is liable for fraud, fraudulent concealment, negligence, gross negligence, malicious behavior, and breach of express and implied warranties.
Using the Texas Deceptive Trade Practices Act, the plaintiff argues Medtronic committed a criminal offense through false, misleading and deceptive advertising regarding the safety of its product.
The suit seeks exemplary damages for medical expenses, physical pain and suffering, mental anguish, disfigurement, physical impairment, loss of earnings/ earning capacity, loss of family relations, loss of consortium and household services, property damage and attorney fees.
Dallas attorney Gil Daley II and Fort Worth attorneys Andrew T. Hawkins and Sommer L. Walker of the firm Hawkins, Walker and Reed L.L.P. are representing the plaintiffs. Federal Judge John Ward will preside in the case.
The suit comes on the heels of a class action suit filed in Minnesota over Medtronic's wiring in implantable cardiac defibrillators. Only placed in patients with life threatening heart conditions, the implantable cardiac defibrillators provide detection and correction of irregular heart rates. Within the heart, lead wires with electrodes are placed to monitor the heart rhythm and provide necessary correction through electrical shock.
Medtronic voluntarily suspended distribution and recommends against new implantation of its Sprint Fidelis leads (wires) due to potential for lead fractures. According to the Medtronic news release, worldwide approximately 268,000 Sprint Fidelis leads have been implanted. The Sprint Fidelis lead fracture may have been a contributing factor in five patient deaths. However doctors and medical experts advise against patients having the leads replaced as the risk of removal far exceeds the risk of a lead failure.
The Minnesota class action was filed on Oct. 15, the same day as the Medtronic voluntary recall. Plaintiffs Kelly Luisi and Len Stavish, individually and as class representatives, filed the class action against Medtronic for compensatory, equitable, injunctive and declaratory relief.
The suit alleges Medtronic was negligent, misrepresented, and concealed the safety and possible defects of the Sprint Fidelis leads in an effort to gain market share.
The plaintiffs seek relief for products liability, breach of implied and express warranty, negligence, intentional and negligent infliction of emotional distress, violation of consumer protection statutes, violation of the Minnesota Prevention of Consumer Fraud Act, unjust enrichment, declaratory relief, and medical monitoring.
Federal Judge Richard Kyle has referred the products liability case (Luisi et al v. Medtronic, Inc. et al. Case No.: 0:07-cv-04250) to Magistrate Judge Janie Mayeron.
A week after the Medtronic announcement shares were still falling from an October high of 57.99 to 46.89. Medtronic considers itself "a global leader in technology, - alleviating pain, restoring health, and extending the life for millions of people around the world."
Kuhn et al v. Medtronic, Inc. Case No.: 2:07-cv-00460