DePuy Sold ASR Hip Implants After FDA Rejection

A controversial DePuy Orthopaedics artificial hip system that was rejected by the United States Food and Drug Administration (FDA) in 2009 was marketed in Europe and other overseas countries despite numerous safety concerns, The New York Times reported.

According to The New York Times, the FDA told DePuy, a division of Johnson & Johnson, in August 2009 that clinical data and studies performed by the company were not enough to determine if its device, the ASR (Articular Surface Replacement) Hip Resurfacing System, was safe for use in the U.S. The FDA said it needed more data to grant approval, which could take more than a year. About the same time, medical professionals nationwide were raising concerns about the implants.

Also during that time, DePuy sold a related hip-replacement model in the United States, called the ASR XL Acetabular System total hip replacement, using a regulatory loophole that allowed the device to slip through the FDA approval, the Times reported.

It’s not clear how many people overseas received the hip replacement after the FDA decided not to approve it for the number of U.S. patients who received DePuy’s XL system. During eight years on the market, more than 93,000 patients worldwide received DePuy hip replacements. About one third of the patients were in the U.S.

DePuy Recalls Hips Replacement System in U.S., Gears Up for Lawsuits

In August 2010, DePuy issued a recall for both its ASR XL Acetabular System total hip replacement and ASR Hip Resurfacing System because of higher than normal failure rates. Studies show that five years following a DePuy ASR hip system replacement, 12 to 13 percent of patients need a second hip surgery to fix the problems with the DePuy device. The components of the metal ball-and-socket device rub together and unleash metal fragments into the joints and nearby muscles.

A DePuy spokeswoman told the Times that the company had received a “non-approval letter” from the FDA but would not release the letter or respond to questions about it.

There is no evidence that suggested Johnson & Johnson broke the law, the Times reported. Regulatory standards in other countries are less stringent than that in the U.S. and most companies are not required to disclose information when the FDA refuses to approve a product, the Times reported.

However, this underscores the mounting problems surrounding DePuy and its hip replacements. With an estimated 5,000 pending lawsuits regarding the faulty devices, the company recently set aside nearly $3 billion for anticipated medical and legal expenses associated with the recall.

A lawyer who specializes in FDA regulations told the Times that drug and medical device companies typically disclose non-approval letters if they impact the company’s finances. However, companies always remain cautious about damaging their brands and images, the attorney said.

FDA Loophole Allowed DePuy to Sell Their ASR Systems Without Approval

Also, the Times reported, the way the FDA handled the ASR approval process sheds some light on how the agency’s actions could affect patients overall. The FDA does not publicly release non-approval letters because they could contain confidential information.

According to the Times, the DePuy ASR Acetabular System products first became available overseas in July 2003. Because the company’s hip replacement procedure, called resurfacing – an alternative to standard surgery – was new to the U.S, the FDA required clinical trials.

With those trials underway in 2005, DePuy used another pathway to FDA clearance to sell a version of the ASR that was based on traditional ball-and-cup joint replacement models. The traditional ASR system was cleared for market without clinical trials.

DePuy was within weeks of getting an FDA letter in August 2009 when company executives started phasing out the ASR sales, the Times reported.  Months later, the company announced it would phase out ASR because of declining sales and withdraw its application for the resurfacing version of the device.

It’s not clear what the FDA said to DePuy regarding the joint devices. Copies of letters that could provide insight into this have been sealed by the court, pending litigation against Johnson & Johnson.  All along, DePuy has said its ASR devices are safe and maintain that device failures are due to surgeon mistakes.

Dr. Antoni Nargol, an orthopedic surgeon in England who worked on the DePuy study that was submitted to the FDA, said that DePuy never told him that its application in the U.S. was rejected. He has since become a critic of the device.