St. Jude Medical defibrillators were implanted in patients even after a formal recall of the defective devices last year, according to a warning letter from the Food and Drug Administration (FDA). The warning letter to St. Jude indicated the agency isn’t satisfied with the medical technology company’s response to problems at its Sylmar, California, plant.
The problems with the device began years ago, as St. Jude Medical played down the failure of some batteries in the defibrillators. These devices were shipped for years before the recall occurred last fall. St. Jude Medical also failed to tell its own management and medical advisory board that the battery problems had led to the death of a patient, and they failed to inform the FDA about this fatality (which is mandatory).
Last October, St. Jude Medical admitted two patients died as a result of premature battery depletion and 10 other patients fainted. However, 3 months later, the company continued to state there were no deaths or serious injuries resulting from defibrillator battery failures.
Not only are these devices potentially dangerous, but they can’t be safely removed without posing further problems to the patient, as this process would require invasive surgery. The FDA recommends any patient who had these defibrillators installed be monitored closely for problems with the device. According to an FDA spokesperson, nearly 200,000 people in the United States have a defibrillator included in the recall.
Doctors at Duke University reported 2 cases of battery errors in the devices in 2014, and another team at the University of Illinois reported the same problem the next year. While St. Jude fixed the issue in newer models, they didn’t recall the older devices or alert doctors or patients about the potential problem until late 2016. Defibrillators account for almost a 3rd of St. Jude’s sales in 2016 ($1.6 billion).
The company who now owns St. Jude Medical, Abbott Laboratories, has 15 days to respond to the letter. If Abbott fails to correct the violations, the FDA will serve the company with an injunction, seizure, or monetary fine.
If you or a loved one have been harmed by a defective medical device, don’t hesitate to call our skilled San Francisco defective medical device attorneys. Kaiser Gornick LLP has more than 50 years of combined legal experience to offer your case, and you might be entitled to compensation for your medical bills, lost wages, and pain and suffering. Let us see what we can do for you.
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