In a letter published this week in the New York Times, the president of DePuy Orthopaedics denied allegations that his company knew about problems with its ASR metal-on-metal hip replacements but failed to alert doctors and health officials. Andrew Ekdahl’s letter was published in response to a New York Times investigation which found that DePuy knew about problems with the ASR hip replacements at least two years before the devices were recalled by the company.
Although DePuy recalled the ASR hip replacements in 2010, documents uncovered in lawsuits filed against the company have alleged that DePuy received numerous reports of problems with the hip replacements from doctors and patients that it failed to make public. Subsequent studies have found that the recalled DePuy hip replacements are significantly more likely to fail prematurely than other models.
In his letter, Ekdahl denied charges that the DePuy ASR hip replacements were not properly tested for safety because of a Food and Drug Administration regulatory loophole. The FDA has since moved to close this loophole because of the risk that it could allow unsafe medical devices to go onto the market.
More than 10,000 DePuy lawsuits have been filed by patients who suffered complications after undergoing hip replacement surgery, including those who were forced to undergo revision surgery to replace problems with their implant. Health and legal experts predict that DePuy could be facing additional lawsuits in the coming years as more of the company’s metal hip replacements continue to fail prematurely.