Can Hip Replacements Be Deadly?
In a recent piece from The New York Times, the dangers associated with metal-on-metal hip implants are explored and discussed. Dr. Stephen Tower, an orthopedic surgeon, specifically asked his surgeon for a metal-on-metal device called the ASR XL that was manufactured by Johnson & Johnson when he needed a hip replacement. Since Dr. Tower focused on complex hip replacement surgeries, he was familiar with the procedure and the options available. However, even with his extensive knowledge of hip replacement surgeries, Dr. Tower still suffered from excruciating side effects.
Just five years after Dr. Tower’s replacement hip was implanted, he had a follow-up surgery to remove it and insert a new one. When Dr. Tower’s surgeon cut into his hip, he noticed black tissue and material that looked like “dirty oil.” The metal-on-metal hip was defective—it had leaked cobalt into the tissues around the hip. The metallosis that developed wreaked havoc on Dr. Tower’s tendons, ligaments, and muscles. It also injured his brain and heart.
Dr. Tower took action, warning his fellow physicians and employees at Johnson & Johnson about his experience. However, Johnson & Johnson kept the device on the market and continued its advertising for metal-on-metal hips. Eventually, Johnson & Johnson pulled the ASR XL model in 2010, but it continued selling a similar device, called the Pinnacle. The Pinnacle remained on the market for another 3 years before it was finally removed as well.
Thousands of plaintiffs have filed claims against Johnson & Johnson, seeking compensation for the injuries they have suffered as a result of their defective hip implant. In November of 2017, six plaintiffs in New York won a $247 million award at trial. The jury concluded that Johnson & Johnson failed to warn both patients and doctors about the possible dangers the Pinnacle hip presented. These lawsuits, in addition to other claims that have been filed, are shining light on a disturbing trend—how many medical devices make it onto the market without uniform regulation and testing.
Roughly 32 million patients in the United States have at least one medical device in their bodies. These include nerve stimulators, birth control devices, pacemakers, surgical mesh, artificial joints, cardiac stents, defibrillators, and even replacement lenses in the eyes. Certainly, many of these devices are lifesaving and offer substantial benefits to patients. However, many of these devices cause grave injuries—or even death—in patients every year. Patients and their physicians generally only have information about the device that has been provided directly by the manufacturer. Frighteningly, medical mistakes are the third leading cause of death in America, and some estimate that faulty medical devices have a significant role in this statistic.
The general public assumes that the United States Food and Drug Administration demands detailed testing from manufacturers before it will stamp its approval onto a medical device, just as it does for medications. However, many devices, such as implants, have not undergone any clinical testing.
With medications, the FDA generally requires at least two controlled, randomized clinical trials. There is no similar standard for medical devices. In fact, medical devices were not regulated by the FDA until the 1970s, and at that point, devices that were already on the market were simply given approval. Under a regulation called 510(k), manufacturers that have created new devices can skirt clinical testing if the device is “substantially equivalent” to one that is already on the market.
Medical device manufacturers that sell even the riskiest devices are able to avoid testing if they tell the FDA that they only made minor changes to a device that obtained FDA approval in the past. This is called the supplement pathway. In 2009, a study in The Journal of the American Medical Association revealed that the overwhelming majority—around 95 percent—of high-risk implanted cardiac devices did not even partially meet drug testing standards.
Aside from metal-on-metal hip implants, a variety of other devices have exhibited serious complications. For example, Medtronic recalled lead wires in one of its defibrillator models in 2007 after they began misfiring and fracturing. Patients were injured and even killed because of the malfunctioning wires. The defibrillators had not been tested and had obtained approval via the supplement pathway. However, the change that the manufacturer had claimed was minor was not minor at all—the new wire was thinner than the wire in previous models, which ultimately made it more vulnerable to breaking.
By the time Medtronic and the FDA realized what was going on, more than 260,000 leads had been surgically implanted in patients around the world. Though many patients had their devices replaced, the subsequent surgical procedures caused serious complications in around 15 percent of patients.
Additionally, the FDA fails to recognize serious signs of danger in clinical trials at times. For example, in 1997, Cyberonics submitted a vagus nerve stimulator device for approval. An adviser for the FDA commented that the device seemed to be associated with a high rate of death. However, the FDA provided conditional approval—which meant that safety studies would be completed after the vagus nerve stimulator was already on the market. Patients were not even told that there was a high death rate associated with the device, and Cyberonics was able to get away with omitting death data from its five safety studies. The FDA’s response? It had not asked Cyberonics to tally deaths, just to “characterize” them instead. Some still are not clear as to what the difference is.
In recent years, the number of device recalls has increased. In 2003, there were just 8 Class 1 device recalls, which are the most serious type of recall. With a Class 1 recall, there is a “reasonable probability” that a device will “cause serious adverse health consequences or death.”
By 2016, there were 117 Class 1 recalls.
Many organizations, such as the National Academy of Medicine, have called on the FDA to change its approval processes. Since President Ronald Reagan declared that the FDA commissioner position would be a political appointee instead of a civil servant, most presidents have appointed individuals who seem to favor the industry. Clearly, the FDA should serve the public and keep them safe from dangerous medical devices, but for now, it appears that consumers are largely on their own.
You can file a claim against a medical device manufacturer for your injuries
Medical device manufacturers should be held accountable when their products injure consumers. With the assistance of an experienced medical device injury attorney, you will ensure that your legal rights are protected throughout your claim. Medical device injury attorneys know what types of evidence to submit in your claim to support your allegations against the medical device manufacturer. Without an attorney, you may unknowingly forfeit money you are entitled to under the law. Time is of the essence—if you have been injured, make an appointment with an attorney as soon as possible.
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