A Mississippi woman’s alleged injuries, pain, high cobalt and chromium levels, and early revision surgery led to a lawsuit brought against device maker, DePuy Orthopaedics and its Pinnacle hip implant. DePuy Orthopaedics is a unit of Johnson & Johnson.
The woman received DePuy Pinnacle hip replacement devices in both hips and alleges that the all-metal devices are defective and led to a number of injuries that forced her to have to undergo early revision surgery.
The national law firm, Parker Waichman LLP, filed the lawsuit on March 19, 2013 in the U.S. District Court for the Northern District of Texas. The case is one of many other cases pending in the multidistrict litigation (MDL) entitled In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation (MDL No. 3:11-md-02244).
According to the complaint, the woman was implanted with the DePuy Pinnacle on her left side in January 2007; the second Pinnacle was implanted on her right side in December 2008. After that, the lawsuit alleges, she suffered from extreme pain, weakness, and elevated cobalt and chromium levels due to the Pinnacle’s defects. The lawsuit also alleges that the woman was unaware that her injuries were related to her defective metal-on-metal hip implants because the defendants neglected to adequately warn about the risks, and that she would not have had the Pinnacle implanted if she had been fully informed about the device’s risks.
The lawsuit points out that the Pinnacle hip implant, like most metal-on-metal hip systems, was approved with little to no clinical testing. This is because the devices are approved through the 510(k) route, which exempts the need for clinical safety and efficacy tests if the manufacturer can prove that the product is “substantially equivalent” to a previously approved device.
Congress gave the U.S. Food and Drug Administration (FDA) authority over medical devices in 1976 and allowed it a quick review process for new devices it deemed were substantially equivalent to already approved medical devices. The expedited process became known as a 510(k) review. In 1976, medical devices played a much smaller role in medicine. In recent years, the 510(k) process has been criticized because the complexity of the thousands of devices on the current market has rendered the expedited process inadequate.
In stark contrast to the more intense process for drug approvals, the FDA only mandates that medical device makers demonstrate that a device does what the maker says it does, and that the device poses no undue safety risks. Unlike a new drug, a device approved under 501(k) rules does not have to be shown to be effective.
The DePuy Pinnacle and other metal-on-metal hip implants has raised safety concerns due to reports suggesting that such devices have a tendency to fail early in the post-operative period. In light of these reports, the FDA has sought to propose stricter guidelines for approving all-metal hip implants. The new regulations would require device makers to show that their implants are safe and effective before selling them.