Medtronic Inc. continued selling flawed cardiac defibrillators for two years after learning that some of them may suddenly quit working, according to documents filed in a California lawsuit.
“Medtronic has been taking products they know are not quite right and putting them into people rather than take the loss,” said Hunter Shkolnik, a New York lawyer, who said in a Feb. 13 interview that he represents more than 200 people whose Medtronic devices were recalled.
According to an article at Bloomberg, after Medtronic last year recalled the devices, 19,000 people had to have surgery for a replacement, said Medtronic spokesman Rob Clark. At least one of them died from post- surgical complications, according to the man’s widow. Defibrillator patients are vulnerable to potentially fatal heartbeat irregularities, which the $20,000 devices detect and correct using electrical shocks.
The company’s recalled Marquis, Maximo and Protect defibrillators haven’t been linked to failures that led to deaths or serious injuries, according to Medtronic spokesman Clark. He declined to comment on any individual cases.
“There is not enough FDA safety oversight,” said Shkolnik, who is on a steering committee of trial lawyers suing Medtronic. “It seems as though the FDA is being led by the companies instead of the companies being led by the FDA.”
The agency does inspect device maker factories regularly, said FDA spokesman Susan Bro in an interview yesterday. “The safe use of these important devices requires the involvement of many, including the companies,” Bro said. “Safety oversight is something that is always undergoing important improvements and is best carried out when all cooperate in a timely and prudent manner.”
The company offered each patient who opted to switch defibrillators a free replacement and reimbursement of as much as $2,500 for expenses. Medical insurance providers and the government’s Medicare health program were to cover the rest. Patients who elected to keep their defibrillators were offered as much as $1,000 for medical costs.
Clark said most replacements are outpatient procedures that take less than an hour. In May the company estimated the entire recall would cost $35 million.