After the DePuy ASR Hip Replacement Recall: New Information Surfaces in Leaked E-Mail from Company Exec
A little less than two years from when DePuy Orthopaedics issued its ASR hip replacement recall of August 2010, the truth finally came out the implant’s safety hazards, by way of a leaked internal e-mail sent by an executive of its parent company, Johnson & Johnson.
According to a New York Times report, the 2009 e-mail was sent by Pamela Plouhar, a vice president for Johnson & Johnson, and detailed the Food and Drug Administration (FDA)’s initial refusal to approve the implant before the DePuy ASR hip replacement recall,which was issued in August 2010. The agency made its decision based on early failure rates of the implant, which required patients to undergo repeat surgeries.
“The team’s concern is that given the revision rate in the ASR group that we will still not be able to demonstrate non-inferiority, with additional downside risk,” Ms. Plouhar said in the e-mail.
Although one version of the ASR hip was rejected by the FDA, that didn’t stop DePuy from marketing a companion version, which was implanted into 30,000 patients in the U.S.
It was also sold overseas, where the company received more flack. Around the time Plouhar sent the e-mail, regulatory agencies in the United Kingdom and Australia were voicing their concerns over the ASR hip, and pressuring DePuy to either voluntarily recall the device or have it forced off.
“This comes at a time when ASR data from national registries (Australia and UK) is being closely scrutinized because of higher revision rates,” Plouhar wrote.
Despite its knowledge of the side effects associated with the ASR hip, DePuy continued to market the device until the artificial hip recall of August 2010. While its omission of the FDA’s findings may not be considered illegal at this time, it is likely that plaintiffs who have filed lawsuits over the device will use this information as ammunition to win their cases.
In federal court, there are approximately 4,000 DePuy ASR lawsuits pending in a multidistrict litigation currently underway in the U.S. District Court for the Northern District of Ohio. Another 2,000 are awaiting trial dates in state courts in New Jersey and around the U.S.