In 2009, a year before recalling their metal on metal DePuy ASR artificial hip, an executive, Ms Plouhar, at Johnson & Johnson reported in an internal e-mail that the Food and Drug Administration had refused to approve the device, after reviewing company studies that showed it had failed prematurely in “significant” numbers, requiring repeat surgeries for patients.
Before recalling the device due to rising failure rates in 2010, Johnson & Johnson claimed it was safe and insisted that its internal studies demonstrated that the device was not flawed.
The device turned down by the F.D.A. was only sold abroad, but a companion version that was recalled at the same time by Johnson & Johnson was used in 30,000 patients in the United States.
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.
To win approval, a new 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 releases metallic debris as it grinds, particularly cobalt and chromium particles that have damaged tissue in some patients or caused crippling injuries. This serious and life threatening side effect is known as metallosis.
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’s decision not to publicize the agency’s findings to doctors, patients and others while continuing to market the device may weaken its defense in the 5,000 related lawsuits pending against it and has certainly damaged its reputation.
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 chosen by DePuy, including some who had developed the implant and received royalties or consulting fees in connection with it.
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.
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.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.