Internal DePuy Email Discussed ASR Hip Implant Problems Year Before RecallFeb 22, 2012 | Parker Waichman LLP
An email from a DePuy Orthopaedics vice president written a full year before the company’s ASR hip implant devices were pulled from the market in a worldwide recall shows that executives at the Johnson & Johnson subsidiary knew in 2009 that clinical trials of an ASR model used in hip resurfacing procedures indicated it was prone to premature failures. Throughout the following year, however, DePuy would continue to insist in public statements that the ASR Hip Resurfacing System and the ASR Acetabular System, a device used in traditional hip replacements, were safe.
The email, dated August 21, 2009, was written by a by Pamela Plouhar, vice president for worldwide clinical affairs at DePuy, and sent to several other executives at the company. It discusses the U.S. Food & Drug Administration's (FDA) issuance of a non-approval letter for the ASR hip resurfacing device. In the email, which was obtained by The New York Times, Plouhar reports that the device had not met FDA approval standards and that a major concern was its high rate of early failure, or “revision,” during clinical trials. She also acknowledges that the ASR device had been the subject of overseas complaints.
“This comes at a time when ASR data from national registries (Australia and UK) is being closely scrutinized because of higher revision rates,” she wrote, according to the Times.
In the FDA non-approval letter, the agency says it will need additional information from more clinical trials before it can approve the ASR Hip Resurfacing System. But Plouhar expresses concern that even with additional data, the FDA will not approve the device.
“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,” she wrote.
DePuy never submitted additional information to the FDA on the ASR Hip Resurfacing System, and it was never marketed in the U.S. However, it was marketed overseas. According to the Times, regulators abroad were never informed of the concerns expressed in the FDA non-approval letter.
Another ASR model, the ASR Acetabular Hip Replacement System, was approved by the FDA, and hit the U.S. market in 2005. DePuy managed to get FDA approval for the device because it was deemed eligible for 510(k) clearance protocols. That process does not require human testing if a device is shown to be substantially equivalent to products already on the market. The FDA did, however, require human clinical trials for the ASR resurfacing system because resurfacing was a new procedure, according to the Times.
A year after Plouhar discussed early failures of the resurfacing device in her email, DePuy issued a worldwide recall of both ASR models. The August 2010 recall was issued after the National Joint Registry of England and Wales reported that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it. At the time of the recall, DePuy had sold more than 93,000 units of the hip replacement devices, including 30,000 in the U.S.
In the year between Plouhar’s email and the recall, DePuy and Johnson & Johnson continued to insist that the ASR device was safe. Only months before the recall, the company had maintained its internal studies refuted complaints by surgeons and regulators abroad that the device was defective, according to the Times. Instead, the company countered that doctors were implanting the devices incorrectly.