DePuy Orthopaedics’ global vice president of clinical research took the stand Monday, as the nation’s first Pinnacle hip replacement trial continued this week in Texas federal court. According to Reuters, the witness was grilled by the Plaintiff’s attorney about the clinical testing performed on a metal-on-metal version of the Pinnacle hip system.
Among other things, the witness stated that the Pinnacle hip had not been subjected to any human tests aimed at measuring the health impacts of metal debris exposure prior to 2001. But the lawyer for the Plaintiff countered that research as early as 1974 suggested that metal-on-metal hips could be dangerous because of toxic metal ions that may be shed from the devices.
More than 6,000 hip replacement lawsuits involving an all-metal version of the Pinnacle are currently pending in the multidistrict litigation underway in U.S. District Court, Northern District of Texas. This bellwether trial could provide valuable clues as to how juries hearing similar Pinnacle claims might decide those cases.
According to court documents, the case at trial was filed on behalf of a 58-year old Montana woman who received two Pinnacle hips in 2009. She underwent revision surgery in 2011 after experiencing serious complications, including blood cobalt levels that were 85 times higher than normal. She alleges that DePuy Orthopaedics, a division of Johnson & Johnson, was negligent and didn’t subject the metal-on-metal Pinnacle hip implant to enough testing to ensure its safety.
Like other metal-on-metal hip replacements, the Pinnacle device at the center of this trial was brought to market via the U.S. Food & Drug Administration’s (FDA) 510k program, which does not require human testing if a device maker can show it is “substantially equivalent” to a product already on the market.
Metal-on-metal hip implants, in which the acetabular cup and femoral ball are made of a chromium/cobalt alloy, have been the subject of safety concerns for several years now. In January 2013, the FDA warned that such devices might be more vulnerable to premature failure than those made of other materials. The agency has proposed new rules that would make all-metal hips ineligible for the 510k program.
In May 2013, DePuy announced it would cease sales of metal-on-metal hips, including the Pinnacle device involved in litigation. However, the company blamed slowing sales of all-metal hip replacements, and said the move was not related to safety issues.
In addition to the litigation involving the Pinnacle implants, DePuy has also been named in more than 12,000 hip replacement lawsuits over its ASR line of artificial hips. Those metal-on-metal devices were recalled in 2010, after data indicated they were associated with an unacceptable early failure rate. In November 2013, the company agreed to settle around 8,000 of those claims for $2.5 billion.