FREE Case Review (866) 588-0600

DePuy Hip Phaseout Prompted by FDA Safety Data Inquiry

In 2009, Johnson & Johnson made the decision to phase out its ASR hip replacement just weeks after the FDA sent a letter to the company requesting additional safety information about the device.

In 2009, Johnson & Johnson made the decision to phase out its DePuy ASR hip replacement just weeks after the U.S. Food & Drug Administration (FDA) sent a letter to the company requesting additional safety information about the device. In the letter, the FDA told J&J that it had received multiple reports of “high concentration of metal ions” in ASR recipients. The DePuy hip was manufactured and implanted in patients between August 2005 through August 2010, when it was recalled nationwide.

DePuy Hip Update 1/23/13: Newly disclosed court documents have revealed that a 2011 internal investigation conducted by Johnson & Johnson on its much-troubled DePuy ASR hip implant estimated that the device would fail within five years in nearly 40% of recipients. For reasons still unclear, the company failed to make this information public while simultaneously downplaying the potential health complications associated with its metal-on-metal hip. Click here to learn more.
Free DePuy Hip Lawsuit Evaluation: If you or a loved one has suffered a serious injury after being implanted with a DePuy hip replacement device, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against Johnson & Johnson and we can help.

What’s the problem?

March 22, 2012 – The FDA’s 2009 nonapprovable letter to DePuy stated that it was turning down the company’s application to sell its articular surface replacement (ASR) hip device in the United States. The letter’s main emphasis focused on problems with data submitted by DePuy to support its claim that the ASR was safe and effective. The FDA also requested additional safety information from the company if it wanted to continue to pursue its application.

It took more than a year for DePuy to recall the device after the FDA’s letter was submitted to the company. But in September 2009, just weeks after it received the letter, DePuy began implementing a strategy to phase out the ASR while selling their remaining stocks for use in patients in the United States and overseas.

To phase out the ASR, DePuy initiated a so-called ‘rationalization procedure’ to end the model’s production and sell off its existing inventory while urging doctors to switch to other hip replacement devices sold by the company.

DePuy publicly announced the rationalization plan in November 2009, initially setting a completion date of late 2010. But an internal e-mail indicates that the program would not end at a fixed date, but when the remainder of the hip implants ‘are depleted.’

In its eight years on the market, it has been estimated that approximately 93,000 patients were implanted with the DePuy ASR, about a third of whom underwent the procedure in this country.

In addition to being reported to fail at an alarmingly high rate, hundreds of ASR recipients have suffered severe injuries caused by particles of cobalt and chromium shed by the metal-on-metal implants.

“We are almost out of ASR, and the few doctors still using ASR are threatening to leave DePuy anyhow,” wrote a company executive in May 2010, nine months after the FDA’s letter. To date, thousands of DePuy ASR hip lawsuits have been filed in courthouses around the country, and many more are expected in the near future.

Need More Info?

Click on the links below if you’d like additional information on these topics from Schmidt & Clark, LLP:

Do You Have a DePuy Hip Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in DePuy hip lawsuits. We are handling individual litigation nationwide and currently accepting new metal poisoning, soft tissue damage, bone loss, aseptic fibrosis and local necrosis cases in all 50 states.

Free DePuy Hip Lawsuit Evaluation: If you or a loved one has suffered a serious injury after being implanted with a Depuy hip device, you should contact our law firm immediately. You may be entitled to compensation by filing a DePuy hip injury suit and we can help.

Free Confidential Case Evaluation

Verified 100% Secure SiteTo contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 588-0600.
*
*
*

Awards & recognition