Former DePuy Orthopaedics president, David Floyd, testified in California state court in the first of some 10,000 lawsuits brought about over the now-recalled DePuy ASR hip device.
According to his testimony, Floyd said that the hip implant’s failure rate should not exceed one percent annually, according to Bloomberg Businessweek. When the ASR was recalled in August 2010, Johnson and Johnson—the parent company of DePuy Orthopaedics—cited a 12 percent failure rate in five years. More recent data from an Australian joint registry found the failure rate exceeded 40 percent.
Senior Litigation Counsel, Daniel C. Burke, with national law firm, Parker Waichman LLP, pointed out that, “While Floyd testified that failure rates should not be higher than 1 percent a year, the ASR has been shown to have revision rates much higher than that.” Burke noted that, “When this information came to light, DePuy decided to place the blame on surgeons instead of taking responsibility for their own design.” Parker Waichman LLP advises hip replacement patients to speak with their surgeons if they experience symptoms such as:
· Difficulty walking, or a change in the ability to walk
· Popping, creaking, or other sounds emanating from the area of the implant
· Metallosis, high levels of metal ions
· Early failure, revision surgery
The first lawsuit being heard was brought about by Loren Kransky, 65, who alleges the recalled DePuy ASR hip implant caused a number of serious complications that forced him to undergo revision surgery, a painful, complex process that involves removing the defective device and undergoing re-implantation with another, different device.
Floyd also testified that a failure rate of 10 percent “would be an unacceptably high failure rate at one year, but at 10 years, it would not be,” according to Bloomberg Businessweek. The New York Times has referred to the DePuy ASR recall as one of the biggest medical device failures in recent history.
Floyd, who served as DePuy president from September 2007 to March 2011, said that three surgeons complained of high revision rates in August 2008. Floyd also testified that DePuy attributed the issue to the way in which surgeons were implanting the device, stating that they have implanted the cup at an angle greater than 40-45 degrees. Kransky’s attorneys, however, state that DePuy failed to test the cup at different angles and that the company only tested one of several sizes.
Johnson & Johnson is faced with over 10,000 lawsuits in the United States alleging that the ASR is defective and caused injuries. The international recall of 93,000 ASRs sparked concerns about the implant, as well as metal-on-metal hip implants as a class of medical devices. In addressing reports of high failure rates and complications associated with metal ion debris, the U.S. Food and Drug Administration (FDA) issued new guidelines to patients implanted with the ASR and other all-metal hip replacements. Among other things, the agency advised that physicians conduct physical examinations, diagnostic imaging, and metal ion tested, as needed. The agency also proposed stricter regulations that would require manufacturers to prove the implants are safe and effective before selling them.