The U.S. Food and Drug Administration recently published a warning letter that it sent to St. Jude Medical, stating that the company likely downplayed the risks associated with its defibrillator batteries last fall. A defibrillator is a device that provides an electric shock to the heart in the event it begins to beat irregularly or cease beating entirely. The device is implanted in the patient’s chest and is battery powered.
The letter also indicates that St. Jude may have failed to notify management officials within the company, in addition to its medical advisory board, that these battery-related issues resulted in the death of a patient.
The letter also indicates that the agency has determined that St. Jude Medical has not taken sufficient or adequate measures to resolve the issue with the batteries. The company has 15 days to provide the FDA with a revised reporting plan.
In October 2016, St. Jude Medical announced a recall of the devices. At the time, the FDA suggested that physicians should implement close monitoring of patients with affected devices and report any problems to St. Jude Medical promptly. The FDA reported that 841 of the nearly 400,000 affected devices had been returned to the company for testing because the battery stopped working unexpectedly.
The issues associated with the defibrillator device batteries pose serious health consequences for heart patients. If the batteries cease working unexpectedly, patients could face severe health complications, including death. Removing a defective defibrillator also requires major open-heart surgery that can be risky for patients with certain medical conditions. After the October 2016 recall, St. Jude Medical argued that the risks associated with the replacement surgery may outweigh the risks associated with the defective batteries.
As of January 2017, two patients lost their lives as a result of a battery failure. Dozens of additional patients have reported suffering serious health consequences. Although many individuals have criticized the FDA for not encouraging St. Jude Medical to initiate a recall at an earlier date, the agency has said that it was relying on information from the company. Now, according to the warning letter, the agency believes that the company made various misrepresentations about the risks associated with the devices.
More specifically, the letter alleges that St. Jude Medical downplayed the risks of failing batteries by stating that reports describing such incidents were unconfirmed. Conversely, the manufacturer of the batteries concluded that the battery was the source of the malfunction in these reported instances.
If you or someone you love has suffered injuries as a result of a faulty defibrillator or another medical device, you may be entitled to compensation. At Moll Law Group, our group of trial lawyers has assisted many victims and their families with investigating a potential claim. We understand how daunting it can be to go up against a major medical device manufacturer. Proudly serving clients in Texas, California, Illinois, Florida, and elsewhere, we offer a free consultation to help you learn about your legal rights. Call us now at 312-462-1700 or contact us online to get started.