A year before it issued a worldwide recall for the ASR Hip Resurfacing System and the ASR Acetabular Hip Implant System, DePuy Orthopaedics heard from the U.S. Food & Drug Administration (FDA) that the resurfacing device failed prematurely in “significant” numbers of patients. In an internal email from August 21, 2009 that was obtained by The New York Times, an executive at DePuy, a division of Johnson & Johnson, reported that the FDA had declined to approve the ASR Hip Resurfacing System, after the agency reviewed company studies that indicated many patients underwent revision surgeries following early failure of the device.
The ASR Hip Resurfacing System was never approved for sale in the U.S., however it was marketed abroad. The ASR Acetabular Hip Implant System was approved by the FDA for sale here in 2005, and was eventually implanted in 30,000 U.S. patients. DePuy was able to obtain approval for the ASR Acetabular Hip Replacement System because the FDA allowed the device to be cleared through its 510(k) protocols, a more streamlined process that 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.
In August 2010, both devices were subject to a worldwide recall 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. Since issuing the ASR hip implant recalls, DePuy and Johnson & Johnson have been named in more than 5,000 U.S. product liability lawsuits filed on behalf of people who allegedly suffered early failures of their implants
According to The New York Times, the information disclosed by the August 21, 2009 email could undercut DePuy’s defense of those lawsuits. The missive, composed by Pamela Plouhar, vice president for worldwide clinical affairs at DePuy, and sent to several other executives at the company, contrasts with public statements made by DePuy about the performance of the all-metal ASR hip implant device in the years leading up to the recall. In the email, 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 expressed concern that even if DePuy conducted more clinical trials and provided the FDA with additional data on the implant, the agency might still fail to approve it.
“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,” Plouhar wrote.
The email 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.
Publically, however, DePuy and Johnson & Johnson continued to insist that the ASR was safe. As late as 2010, in the months before the recall, the company maintained its internal studies refuted complaints coming from overseas regulators that the device was defective, according to the Times. DePuy blamed surgeons for the hip implants failures, insisting they were not positioning the device correctly.
The FDA non-approval letter for the ASR Hip Resurfacing System was never made public, and regulators in countries where the device was already on the market were never informed of the FDA decision. However, none of that is illegal, as overseas regulatory standards are less stringent than those in the U.S., and usually do not require companies to provide notification when the FDA refuses to approve a product that is being used abroad, the Times said. For its part, the FDA says it has a policy of not publically releasing non-approval letters because they might contain confidential business information.
Just weeks after Plouhar wrote the August 2009 email, other internal emails obtained by the Times indicate that DePuy executives had decided to phase out sales of the ASR devices. An official announcement was made in November, with DePuy stating that the decision was made because of declining sales.