Representing Jefferson County resident Cheryl Fisk, the law firm Provost and Umphrey has filed another lawsuit against Medtronic's implantable cardioverter defibrillator (ICD).
Fisk claims the medical device has caused "frightening episodes of unnecessary shocks" which have required additional medical care.
The product liability suit was filed against the ICD's manufacturer and distributer Medtronic, Medtronic Puerto Rico and Medtronic Puerto Rico Operations Co. on July 31 in the Beaumont Division of the Eastern District of Texas.
The implantable cardioverter defibrillators are only placed in patients with life threatening heart conditions and provide detection and correction of irregular or rapid heart rates. The heart rhythm is monitored through lead wires with electrodes that are placed in the heart to provide necessary correction through electrical shock.
According to the plaintiff's original complaint, on Jan. 19, 2006, Fisk was implanted with an ICD that includes the recalled Sprint Fidelis lead wire system (model number 6949).
Medtronic voluntarily suspended distribution of several models of the Sprint Fidelis leads because of a potential for lead factures.
In a FDA statement on the voluntary recall, the FDA states, "When a defibrillator lead is slightly more prone to fracture, it doesn't mean that every lead will break. Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered."
Doctors and medical advisors advice against patients seeking replacement of the leads as the risks associated with removal far exceed the risk of a lead failure.
The plaintiff is seeking claims of relief for products liability, breach of implied warranty, negligence, and violation of consumer protection statutes, breach of express warranties, unjust enrichment, declaratory relief, and medical monitoring.
The complaint claims the lead wires were "unreasonably dangerous" when used in "reasonably expectable ways of handling and consumption" and were "defective, unmerchantable, and unfit for ordinary use."
Despite Medtronic's voluntary notice of increased fracture risk of the Sprint Fidelis leads to the FDA, Fisk argues Medtronic had a duty to notify the FDA of design flaws and of the devices' "defective nature."
The plaintiff is seeking damages for medical expenses, loss of earnings, loss of earning capacity, physical pain and suffering, mental anguish, disfigurement, physical impairment, pre and post-judgment interest.
Beaumont attorney Christopher T. Kirchmer of Provost and Umphrey is representing the plaintiff.
U.S. District Judge Marcia A. Crone will preside over the litigation.
Case No: 1:09cv00732