Medtronic loses bid to drop suits
Claims over Medtronic defibrillators with potential battery problemscancontinue on to trialNov 28, 2006 | Star Tribune
The ruling by U.S. District Judge James Rosenbaum means that more than 300 cases filed by patients and their families can move forward and that new claims may be filed against the Fridley medical technology giant.
"This is an important day for those patients and our clients who have been affected by a Medtronic device," said a plantiff's attorney. Patients may now "seek compensation for the injuries they have sustained due to the defective devices sold to them by Medtronic."
Medtronic said it will seek the court's permission to appeal the order.
The company issued a safety alert to doctors for 87,000 implantable cardioverter defibrillators (ICDs) in February 2005, saying the devices could have faulty batteries. Defibrillators are one of the company's most lucrative devices, selling for about $30,000. The stopwatch-size devices shock abnormally beating hearts back into rhythm.
The Food and Drug Administration (FDA), which regulates medical devices, later classified the company's advisory as a recall. Medtronic said in a statement Tuesday that there have been no confirmed serious injuries or deaths related to the February 2005 alert.
Hundreds of lawsuits subsequently filed in state and federal courts seeking class-action status were consolidated in Minneapolis before Rosenbaum.
Medtronic argued that medical devices regulated by the FDA face such rigorous testing and standards that state laws governing negligence and product liability do not apply. The company urged the court to dismiss the lawsuits.
But the plaintiffs countered that Medtronic bore a congressionally imposed duty to disclose information about a possible device malfunction to the FDA. The company, they said, knew that the defibrillator battery could lose its charge nearly two years before it alerted doctors about the problem.
Although Medtronic began to redesign the battery, plaintiffs' lawyers said the company still sought and obtained approval from the FDA for three additional defibrillator models, all using the old, and potentially faulty, battery, which court documents called a "medical Trojan horse."
According to court documents, Medtronic claimed it didn't notify the FDA because it had seen the battery depletion problems only during routine lab testing, not in patients.
However, between February and April 2004, the company began to receive reports of premature battery depletion among patients, according to Rosenbaum's order. While the company notified the FDA about the problem at the time, it did not alert doctors until nearly a year later.
"We firmly believe that we took the right actions at the right time through this process, including all the appropriate and timely notifications to the FDA," Medtronic spokesman Rob Clark said Tuesday. "We are confident that those facts will prevail."