Medical Devices: An FDA Afterthought Despite Known Injuries and Death

This month, the New York Times online and print editions both ran a piece on the surprisingly unregulated medical device industry. Although now under the purview of the Food and Drug Administration, devices only became their responsibility in 1976. Bogged down with prescription drug approvals, the government organization made the decision to allow all previously marketed medical devices to continue to be sold under something called a 510(k) provision. A secondary provision called a PMA Supplement (Premarket Approval) gives companies the ability to pay a fee for an ‘FDA review’ of a new product that promises to be similar to a company’s previously marketed device. By calling it a supplement and not a new product, they are able to bypass already lax rules for medical devices. Again, no studies or testing required. It seems unbelievable that devices implanted in hips, hearts, knees, eyes, uteri, and just about every other part of the body are able to exist with such minimal supervision and regulation. Unfortunately it’s the truth.

Perhaps it is worth noting that there are devices that have indeed saved lives. Many heart attack patients are enjoying healthy lives thanks to stent placements. Millions of those who struggled to walk and move around are now freely mobile due to hip, knee, and other joint replacements. But what about those devices that haven’t lived up to their intended purpose?

Doctors and Patients Left in the Dark About Known Complications
The NY Times article begins with the story of Dr. Stephen Tower, an orthopedic surgeon who had his own hip replaced 12 years ago. Dr. Tower’s artificial hip was a DePuy (a Johnson & Johnson subsidiary) product called ASR XL, a device he selected for himself after doing many hip replacements on his own patients. What Dr. Tower didn’t know was the ability of the ASR XL device to leak cobalt into the body, a complication that lead to debilitating pain and a surgery to replace the device. During the second operation, Dr. Tower’s surgeon found that surrounding tissues, muscles, and ligaments were black and severely damaged and that his heart and brain had also been harmed as a result of his ASR XL implant.

Dr. Tower refused to keep quiet. He warned his patients, fellow surgeons, and told DePuy/Johnson & Johnson that their product was defective. His complaints to the medical manufacturing giant were met with deaf ears. But it turns out Dr. Tower wasn’t the only recipient of an ASR XL device to suffer.  In 2010, the company stopped sales of the device due to lagging sales (so they claimed). Its replacement, the Pinnacle, easily breezed through FDA approval as a PMA Supplement and had 3 years of solid sales before the walls caved in. Recipients of the Pinnacle began complaining to the company, the FDA, and the media that the device was dangerous. Reports of tissue death causing significant impairment to mobility and other issues came to light before the device was finally recalled. It is estimated that at least 1 million patients received a DePuy Pinnacle hip replacement during the 3 year period between 2010 and 2013.

Several major court cases have taken place, with a $247 million dollar award being handed out in Dallas to 6 Pinnacle victims in November 2017. The large verdict is in part due to the coverup of risks and known previous injuries by DePuy and Johnson & Johnson. Even after evidence proved the devices were harmful, the company’s sales reps kept touting their benefits and scrubbed into surgeries with unknowing doctors and patients. The odds are they, too, were left in the dark by DePuy and Johnson & Johnson.

Nearly 8 Years Experience Handling DePuy Hip Replacement Lawsuits
Since ASL recalls first began in 2010, our attorneys have been working with victims to recover monetary compensation for injuries sustained as a result of the defective products. Our own Steven Levin was interviewed by Lawyers and Settlements magazine in 2010 for his insight into ASR lawsuits. Mr. Levin, founding partner of Levin & Perconti, has spent nearly 3 decades litigating cases involving products liability, personal injury, medical malpractice, nursing home abuse, birth injuries, car and truck accidents, and other serious cases involving injury and wrongful death.

If you were fitted with a DePuy ASR or Pinnacle hip implant and have injuries resulting from the device, please contact the injury attorneys of Chicago’s Levin & Perconti. While FDA regulation for these devices may be lacking, companies have been complicit in the coverup of known defects and injuries, making them liable for any injuries you may have. Please, contact us for a free consultation today. There is a statute of limitations on cases such as these in Illinois, so please do not wait.



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