Medical device manufacturer, St. Jude Medical, failed to report battery failures with nearly 400,000 of its defibrillators. Even though the manufacturer was aware of the issues, it continued to ship the product to hospitals and healthcare providers, allowing them to implant the devices in patients. The company had been notified that the defibrillator’s defect led to the death of at least two patients, and still it failed to take action.
The Food and Drug Administration (FDA) issued a warning letter just this month. The warning letter outlines how St. Jude Medical, now owned by Abbott Laboratories, failed to act even when confronted with the device issues. The FDA’s warning also states that the company has not taken sufficient action to remedy the battery problem. Because of the failure to act and lack of action, the product recall of almost 400,000 defibrillators was slow, allowing them to keep people at serious, medical risk. The FDA has now ordered that Abbott Laboratories come up with a new reporting plan immediately, disallowing new management from continuing on in this irresponsible manner.
A defibrillator is an apparatus, which delivers an electric shock to the heart so that the muscle may re-establish a normal electrical impulse, returning to a healthy heartbeat. Defibrillation itself is a procedure that is used when the heart is in life-threatening states of abnormal beats. When the heart goes into these abnormal states, the defibrillator issues an electric shock so that the heart returns to a safe pace.
Implanting a defibrillator typically requires a surgical procedure in a hospital. Before the procedure, a patient is normally given anesthesia so that they go to sleep. The implantation involves a threading of the defibrillator’s wires through a vein so that it affects the correct place in the heart. The surgery usually takes a few hours and is considered low risk. However, these risks grow exponentially when the defibrillator is defective and may require additional surgery and anesthesia to remedy the problem.
This is not the first time we have seen a medical device manufacturer favor dollars over patient lives. Even though St. Jude Medical knew that defective defibrillators are particularly problematic because surgery is necessary to remove them, they still did not take the required steps to get them off the market. Because of this failure at least two patients died and hundreds of thousands are at risk for complications and future surgeries
One huge part of the problem is that the manufacturer failed to report the defect. Therefore, doctors kept implanting defective defibrillators into patients unknowingly. And now with nearly 400,000 included in the national recall, hundreds of thousands of patients could potentially require a risky surgical procedure in order to remove the product. It isn’t just one model of defibrillator that is defective, it is at least three models, including the Unify, Fortify and Assura defibrillator lines.
So, why didn’t Abbott Laboratories do anything about the defibrillators when it purchased St. Jude Medical in January of this year? Experts say that St. Jude Medical not only misrepresented the danger to the American public and FDA, but to Abbott as well. And, considering that medical defibrillators accounted for roughly one-third of St. Jude’s sales and made the company over $1 billion a year, sadly, this isn’t too hard to believe.
St. Jude Medical misrepresented the risks that its defibrillators posed. It downplayed them, and even went as far as to say that claims about battery failures were “unconfirmed”. St. Jude also covered up at least one of the patient deaths. The company claimed that the death was unrelated to a defibrillator battery failure, and so it did not disclose the information to its own management and medical advisory boards. And, just a few months ago the FDA warned St. Jude that the defibrillators had a security issue, which could allow hackers to deliver shocks to patients. The company failed to address these concerns, as well. All in all, the company covered up dangerous, even lethal, product defects for as long as it could, refusing to report information even when people were losing their lives and becoming injured.
Other medical device manufacturers have faced federal criminal charges because of failures to warn the public of product defects that could result in injuries or deaths. This is not the first time that St. Jude Medical has faced accusations of failures to report or recall malfunctioning products. Manufacturers must be held responsible for putting individuals at risk and face consequences for valuing money over patient’s lives and wellbeing. We can only hope that with a nationwide recall in place, no one else loses his or her lives because of St. Jude’s actions and that the company will be held accountable.
If you, a family member or friend had a procedure with a defibrillator and have experienced complications or unusual side effects, please contact your doctor’s office or hospital in regard to your injury. In order to determine whether you have a right to compensation for your injuries from this medical device, please call the knowledgeable Philadelphia personal injury attorneys at Galfand Berger, LLP. With offices located in Philadelphia, Reading and Bethlehem, we serve clients throughout Pennsylvania and New Jersey. To schedule a consultation, call us at 800-222-8792 or complete our online contact form.