New York Attorney General Eliot Spitzer has filed a law suit in N.Y.S. Supreme Court (Manhattan) against the medical device maker Guidant Corp., alleging that it covered up problems with one of their implantable heart defibrillators, a device that uses electric shocks to normalize the heart beat in patients with abnormal, and potentially fatal, heart rhythms.
The 11-page complaint states that Guidant’s Ventak Prizm defibrillators were flawed thereby causing 28 of them to stop working without warning. As a result of this serious malfunction, one patient died of cardiac arrest when his defibrillator short-circuited and failed to deliver the jolt of electricity that could have saved his life.
The complaint also alleges that Guidant failed to alert medical professionals to the flawed devices despite the fact that it was fully aware of the problem since 2002.
The 13,900 recalled Ventak Prizms were all made prior to April of 2002. Warnings have been issued for 88,000 defibrillators and 200,000 pacemakers because of reported malfunctions. To date, doctors have replaced many of the faulty defibrillators. Many patients, however, are torn between having additional surgery and gambling that their device is not one of the defective ones.
In May, Guidant disclosed the information about the flaw just prior to the publication of a New York Times article regarding the defect. While Guidant has offered $2,500 to cover the cost of replacing recalled units, the actual cost of replacing a heart defibrillator through surgery is considerably higher than that amount.
“Concealment of negative facts that might influence a consumer to purchase another manufacturer’s product is the essence of fraud,” said Spitzer in an issued statement. Spitzer, who has gained a reputation for his tenacious enforcement of consumer and shareholder rights, is seeking damages for harm suffered by patients and their health plans.
This is just the latest lawsuit to be brought against the company but it may turn out to be the most significant one to date since Johnson & Johnson is already contemplating abandoning its planned $25.4 billion acquisition of Guidant. Several private lawsuits were previously filed against the manufacturers over the defibrillators.