Wiring Defect in Heart Implant Jolts Manufacturer
Why You Need a Florida Medical Device Defect Attorney
Greg Jessee, 50, was knocked unconscious by a series of shocks from his heart defibrillator. The implant, made by St. Jude Medical, has been under fire since a study in North Ireland revealed problems with the device's wiring. The life-saving "lead" is connected to the heart to release an electrical jolt that disrupts a heart attack and restores the normal beating of the heart.
When functioning properly, these defibrillators vastly reduce the risk of sudden death and can actually improve heart function. In Jessee's case, however, a problem with the wiring caused the device to short-circuit, sending multiple shocks to the heart. Rather than preventing a heart attack, the implant actually contributed to abnormal heart rhythms that knocked Jessee unconscious.
Up to 1 in 3 St. Jude Heart Implant Patients in Danger
Jessee is not the first patient to complain about the implant. A study in North Ireland detected flawed wiring in 15-30 percent of the patients tested. This product defect could kill or seriously injure some of the 128,000 patients implanted with the device. The problem stems from the gradual deterioration of the lead coating that insulates the wires.
After several years, as the devices age, the insulation wears thin, causing the wires to protrude. When this happens, the device can short-circuit, sending electric shocks to the heart in rapid succession. The problem is tricky because it is extremely dangerous to remove the wires and equally risky to leave them in.
Patients allege that St. Jude Medical, one of the nation's largest heart device manufacturers, should have done more to investigate the safety issue and warn patients of the problem. Heart device experts contend that St. Jude downplayed the severity of the defect and failed to respond to the concerns of medical investigators.
In fact, they allege that St. Jude estimated the rate of abrasion was only .47 percent when the speed of deterioration was much greater. The manufacturer had a duty to warn of defects involving the silicone insulation, exposed wire, and potential electrical malfunction. St. Jude is not the only maker to be blamed for flawed products. Its two major competitors have both had problems with defective heart devices that killed or injured patients.
Denying Any Negligence on Their Part
St. Jude denies allegations that it has been less than forthright in warning doctors of the problem. The maker admits that 20 people have experienced fatal episodes of electric malfunction, but claims such incidents are comparable to those of other implants. In most cases, the exposed wires still function and have never been the actual cause of death.
However, these assurances have not inspired enough confidence in investors to give St. Jude the jolt it needs. The company's stock has fallen sharply and St. Jude has recently announced that it would be pulling its two older heart devices, the Riata and Riata ST, off the market. The manufacturer marketed a new lead, the Durata, which has an extra coating of insulation that prevents the problems related with the Riata.
This new product does not seem to be providing the reliability St. Jude Medical was hoping for. In 2012 the Durata manufacturing process was investigated by the FDA. They found that St. Jude was testing their leads only once instead of the company-written policy of five tests minimum. In total, the FDA found 11 problems with their manufacturing-only 5 of which were being addressed by St. Jude.
Have questions? Call our Florida Durata lawsuit attorneys today: (888) 554-2030.