A group of health insurers has filed a class action lawsuit against St Jude Medical seeking to recover costs of replacing defective implantable cardiac defibrillators. The suit says that St. Jude knew about problems with the device’s batteries for years before the FDA prompted a recall in 2016. The company recalled about 400,000 of the devices because batteries in some units died suddenly and without sufficient warning. The FDA says that the defects caused two deaths and injured dozens of people.
A defibrillator delivers a shock to the heart to restore its normal rhythm. The batteries are supposed to last for an extended period of time and emit warnings when they are running low. The device is designed to run for at least three months after emitting a beep to let the user know that the battery needs to be replaced. But, in some cases, the defective batteries failed within 24 hours. Patients were unaware that their devices were not working.
Another Defribillator Lawsuit
Attorneys for the plaintiffs allege that St. Jude knew about the problems since 2011. The recalled devices are St. Jude’s Cardiac Resynchronization Therapy Defibrillator and Implantable Cardiac Defibrillator, including the Fortify, Unify and Assura models.
In urging the 2016 recall, the FDA said St. Jude downplayed the problems. The company ignored information from the actual manufacturers of the batteries that some of the units were indeed failing. The FDA also said that the company kept reports of a patient’s death in 2014 from its own medical advisory board.
The case is similar to the recalls and lawsuits involving Guidant defibrillators and pacemakers. Guidant paid $300 million in fines and pled guilty to federal criminal charges in 2011 stemming from charges it concealed defects.
If you have been the victim of a defective medical device, contact the medical device recall attorneys at Martinez Manglardi. We have offices serving Orlando, Apopka, Orange County, Seminole County, Lake County, Polk County, Kissimmee, Osceola County, Palm Bay, Brevard County and Ocala.
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