The Food and Drug Administration (FDA) has claimed St. Jude Medical downplayed potential risks caused by its pacemakers. St. Jude Medical was bought by Abbot Laboratories earlier this year for $25 billion. According to a letter sent by the FDA to Abbot Laboratories, St. Jude Medical shipped hundreds of thousands of pacemakers for years before finally recalling the devices in late 2016. The letter claims St. Jude continued to ship these devices after calculating the low odds of the device failing. However, FDA adverse event reports show the pacemaker defect may have harmed dozens of consumers.
Lithium clusters can form in the batteries used by the pacemakers and cause short-circuits. These clusters lead to increased battery depletion, meaning the pacemakers can stop working. The pacemakers are designed to gently vibrate when the battery needs to be replaced. However, the rapid depletion of the batteries may not give patients enough notice.
Pacemakers are implanted to prevent abnormal heart rhythms. If a patient’s heart rhythm is too slow, the defibrillator helps provide pacing. These devices also provide shocks to prevent dangerously fast heart beats.
Has This Pacemaker Defect Caused Injuries or Deaths?
Abbot Laboratories claims St. Jude Medical fixed the defect with a design update. However, more than 200,000 Americans are still using defibrillators included in the recall. Two deaths have been linked to the faulty device, including one in the United States. There are also many adverse event reports that mention fainting and dizziness.
Patients may undergo risky “revision surgeries” to replace or remove defective medical devices. With faulty pacemakers, it may be riskier to perform a revision surgery than it would be to keep using the devices.
Patients harmed by the pacemakers or their families may have legal options available. The New Jersey defective medical device attorneys at Keefe Law Firm can help you explore which options may be available.