Flawed DePuy Hip Implant Had Early F.D.A. Notice

Hip Maker Discussed Failures (continued)
By BARRY MEIER, February 21, 2012

The e-mail at issue was written in August 2009 by a vice president of a Johnson & Johnson subsidiary, DePuy Orthopaedics, just days after the F.D.A. confidentially notified the device maker that it would not approve one version of the hip for sale in this country. In the e-mail, the executive, Pamela Plouhar, explained the reasons for the agency’s decision to three other top executives, including DePuy’s president at the time, David Floyd.

Ms. Plouhar reported that the device had not met F.D.A. approval standards and that a major concern was its high rate of early failure, or “revision,” during clinical trials. She also cautioned that providing the F.D.A. with more data might not change its stance and that it might take years to conduct new studies of the hip, known as the ASR, or articular surface replacement.

“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 wrote.

To win approval, a novel medical device like the DePuy hip must be shown to be reasonably safe and effective. One way to prove that is to show that it is at least as effective as, or not inferior to, a traditional hip implant.

In her e-mail, Ms. Plouhar said there had been “a significant number of revisions in the ASR group” compared with “very few in the control group.”

Many artificial hips last 15 years or more before they wear out and need to be replaced. But by 2008, data from orthopedic databases overseas showed that the ASR was failing at high rates in patients after just a few years. The device also sheds metallic debris as it wears, particles that have damaged tissue in some patients or caused crippling injuries.

A DePuy spokeswoman, Mindy Tinsley, declined to respond to specific questions about the e-mail. In a statement, she said that the e-mail was “simply a notification to senior management about the F.D.A. feedback as the company appropriately continued to study data” about the implant so that it could make responsible decisions on the behalf of patients.

Last week, Andrew Ekdahl, the current president of DePuy, said in a statement issued in response to an earlier article in The New York Times that any implication that the F.D.A. had determined there were safety issues with the device was “simply untrue.”

In her 2009 e-mail, Ms. Plouhar referred to complaints about early failures of the ASR from doctors and regulators abroad. Regulators in Australia were then pressuring DePuy to withdraw the artificial hip from the market there or face having 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,” she wrote.

DePuy does not appear to have violated any laws by not publicly releasing the F.D.A. ruling, which was contained in a so-called nonapprovable letter. The F.D.A., as a matter of policy, does not release such decisions, saying that they may contain confidential business information.

But DePuy’s decision not to publicize the agency’s findings to doctors, patients and others while continuing to market the device may undercut its defense in the 5,000 related lawsuits pending against it and could also tarnish its reputation.

Throughout the episode, DePuy blamed orthopedic surgeons for the model’s failures, saying that doctors were not positioning a component properly. But the clinical findings rejected by the F.D.A. came from A.S.R. studies run by surgeons hand-picked by DePuy, including some who had developed the implant and received royalties or consulting fees in connection with it.

The e-mail containing Ms. Plouhar’s report about the F.D.A. decision is among thousands of company documents released to lawyers suing the company under a court-ordered seal.

It is not known how many patients received the implant in the year between the F.D.A. decision and the recall. But during the device’s eight years on the market, it was used in an estimated 93,000 people, about one-third of them in the United States.

The version of the device rejected by the F.D.A. was developed by DePuy for use in a hip replacement procedure called resurfacing, which is a bone-sparing alternative to standard surgery. The company started selling the implant abroad around 2003 but because resurfacing was a new procedure, the F.D.A. required DePuy to run clinical trials before selling the device in the United States.

However, while those studies were under way, DePuy used a regulatory loophole in 2005 to start marketing a version of the implant in the United States for use in standard hip replacement surgery. Both versions of the device used the same critical component, a solid metal cup that replaced a patient’s hip socket. Experts say the component was flawed in design. In the wake of the F.D.A.’s 2009 decision to reject the resurfacing version of the device, DePuy executives wrote in internal e-mails that the device’s fate appeared sealed.

“Can’t imagine we would go any further in the U.S.,” one executive wrote.

In September 2009, just weeks after the F.D.A. decision, other documents indicate that top DePuy executives decided to phase out the device. The company announced the move that November.

Company executives said then that the move reflected declining sales of the implant, rather than safety issues. In his statement last week, Mr. Ekdahl, the company’s president, reiterated that position.

“This was purely a business decision,” Mr. Ekdahl stated.