The Philadelphia product liability lawyers at Messa & Associates, experienced with cases regarding defective medical devices, recently discovered a report by the New York Times that revealed that Johnson & Johnson executives were aware of problems with an all-metal hip implant manufactured by its subsidiary, DePuy Orthopaedics, long before the defective medical product was recalled. The Food and Drug Administration raised some valid concerns with the defective product more than a year before an official recall was announced. The manufacturer continued to sell the product internationally, as well as distribute a similar product in the United States.
In August 2009, the Food and Drug Administration (FDA) sent a confidential letter to DePuy rejecting an application to sell the hip implants in the United States. The letter focused on health and safety concerns, citing reports from other countries where the devices were not performing well or failing at significant rates within a few years rather than lasting the expected 15 years. In addition, blood tests of some patients showed a high level of metal ions (specifically, cobalt and chromium) in their bloodstreams. The FDA also asked DePuy to submit additional safety data before the FDA would consider their application.
However, according to the Times’ article, DePuy chose not to recall the device in question or a sister model that was being used in the United States. Instead, just a few weeks after receiving the letter, DePuy executives devised a strategy to phase out the flawed hip device. They decided to stop production and sell the remaining inventory while encouraging surgeons to use other DePuy hip replacement products. The company claimed the phase out was started due to declining sales of the devices rather than any safety issues. In August 2010, a worldwide recall was initiated.
Although the executives from the company have defended their actions and the timing of the recall, the disclosed documents revealed by the New York Times seem to imply that DePuy knew that their product was potentially dangerous and defective for at least a full year before it was recalled. It has been questioned whether the company continued to sell a defective product in order to avoid losing money.
It is not known how many patients received the defective hip device from the time DePuy knew about the legitimate concerns raised by the FDA to the date of the official recall of their products. According to the New York Times, about 93,000 patients worldwide have had the defective hip device implanted over an eight-year span. In addition to early failure rates, many patients have suffered crippling and debilitating injuries due to metallic particles being generated when the metal on metal product grinds against each other. The metal shavings are released into the patients’ bodies having the potential to cause adverse reactions. Many patients have been forced to undergo revision surgeries. Numerous lawsuits involving the metal on metal hip implant devices have been filed against DePuy.
The Philadelphia product liability lawyers at Messa & Associates are experienced at handling personal injury cases involving dangerous and defective medical devices. Our extremely skilled team of personal injury lawyers and medical experts are dedicated to ensuring you receive proper compensation for your personal injuries. If you or a loved one has suffered personal injuries as a result of a recalled DePuy hip implant or other medical product, contact our Philadelphia product liability lawyers for a free consultation. To discuss a potential claim with one of our experienced attorneys, call Messa & Associates toll-free at 1-877-637-7252 or submit a free online inquiry.