Twenty-six hundred and eighty-two cases later, Medtronic, Inc. of Fridely, Minn. will pay out $114 million – all related to a battery problem in an electrical line of its implanted cardioverter defibrillator (ICD), the Associated Press reported. Plaintiffs received $95.6 million, while attorneys will net $18 million.
In November 2006 a federal judge denied a defense motion to dismiss 350 product-liability lawsuits against Medtronic. Two years earlier, the company had voluntarily recalled its ICD heart device, reported CNNMoney.com. Implantable defibrillators are the size of stop-watches and pacemakers that “shock” an abnormally beating heart back into rhythm, according to the Medtronic web site.
"We are pleased to settle these cases and put the matter behind us," said Pat Mackin, president of Medtronic Cardiac Rhythm Disease Management. "We prefer to focus our resources on areas that are beneficial to physicians and patients, rather than prolong this litigation."
CNN reported the U.S. Food and Drug Administration did not take regulatory enforcement action but classified Medtronic's action as a Class II recall.
Plaintiffs said Medtronic knew about the potential battery problem but continued to sell stock without advising cardiac patients safer devices were available and approved. But the company maintained it reported the problem and sought FDA approval in 2003 to make changes in its battery design.
Medtronic is the largest ICD maker. Other manufacturers include Boston Scientific Corp. (BSX) and St. Jude Medical Inc. (STJ).
This fall, Medtronic pulled the wires from the market, a step that affected 235,000 patients who had those leads implanted in their chests. That move prompted a 16%-drop in ICD sales. The Sprint “Fidelis” lead, used to connect defibrillators to the patient's heart, has been fracturing at a rate of 2.3% in a 30-month period, more than twice that of an older Medtronic lead, the Sprint “Quattro.” CNNMoney.com reported.
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