A warning letter from the Food and Drug Administration was sent to St. Jude Medical over its apparent lack of progress resolving issues with its implantable defibrillators. Defibrillators manufactured by St. Jude Medical may have been implanted in patients after a recall had been issued. A defibrillator is a medical device that delivers an electric shock to help the heart return to a normal pace.
Last October, the Food and Drug Administration stated that 841 of approximately 400,000 defibrillators were returned to St. Jude Medical due to a battery issue where the device would sporadically die. Such an issue is life threatening and two patients reportedly died because of the faulty battery. The issue appeared to stem from the lithium batteries contained within the device that would drain too quickly, causing the device to shut down.
As a result of the returns, St. Jude Medical announced a recall and recommended that doctors closely monitor the devices for problems. However, removal of the device was not recommended. Because defibrillators are implanted in patients, removal due to faulty manufacturing would require surgery which would expose patients to additional risk.
St. Jude assumed the worst was over when it issued the recall October 11. However, the Food and Drug Administration has evidence that seven defective defibrillators were implanted in patients between October 14 and October 26. The cause of the inexplicable implantation was the slow approach taken by St. Jude Medical in notifying the public about the recall. The reason for the slow notification was likely financially driven. The devices accounted for nearly 1/3 of the company's sales in 2015. St. Jude Medical sold the company in January to Abbott Laboratories for $25 billion.
The warning letter, which cited that the company had not acted upon evidence that the batteries in its defibrillators were defective, could be a problem for, new owner, Abbott Laboratories if new defibrillators are not approved by the Food and Drug Administration as a result of the manufacturing issues that took place under St. Jude Medical. Further, St. Jude could still be on the hook for regulatory action.
Hospitals must not only maintain functional equipment, but they must work to keep that equipment clean and in proper working order. Any failure to do so can result in serious errors and harm to patients. The legal team at Gilman & Bedigian works closely with our staff physician to examine the details of each individual case of potential medical malpractice, including injuries and negligence which occur in a hospital setting. Call 800-529-6162 today or contact them online for a free case evaluation. They handle cases in Maryland, Pennsylvania, and Washington, D.C.