FDA Faults Medical Company’s Handling of Recall and Cyber Security

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The U.S. Food and Drug Administration recently criticized medical device company St. Jude Medical (not to be confused with St. Jude Children’s Research Hospital) over a couple of issues that it found the company had handled poorly. The issues involve defective medical devices and cybersecurity.

Last year, an investment group publicly stated that one of St. Jude’s home medical monitoring devices was vulnerable to hacking. The company denied those charges, and even sued the investment group for defamation. However, the FDA and the U.S. Department of Homeland Security later confirmed the cybersecurity issues. Eventually St. Jude released a software patch, that was supposed to address the problem. Last month, the FDA sent the company a warning label stating that the company was unable to prove that it had taken steps to ensure the patch would work before its release.

The other issue with St. Jude involves defibrillators. Last year, the company recalled 400,000 defibrillators because of a battery problem that could cause the device to short circuit without issuing any battery indicator warnings. Two patient deaths were linked to the problem. In the FDA’s letter to the company, it asserted that the company had for years underestimated the true extent of the problem, and faulted the company for failing to institute proper controls once the recall was initiated.

Companies that sell medical devices must take steps to ensure that their devices are safe. If you or a loved one has been harmed by a defective medical device, you have legal rights. You may choose to sue the company that sold the device for damages. Call the Houston defective medical device attorneys at Kennedy Hodges at 855-847-0707, or visit us on Twitter to learn more. 

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