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Johnson & Johnson Recalls its DePuy Hip Implants

More than two years after the Food and Drug Administration ("F.D.A.") began receiving complaints about the failure of a hip replacement implant device manufactured by the DePuy Orthopaedics unit of Johnson & Johnson, the company announced that it was recalling two kinds of hip implants. DePuy said its decision to withdraw the products was due to many patients requiring a second hip replacement after the company’s implants had failed.

According to The New York Times, in addition to DePuy’s recall, the F.D.A. criticized the company in a warning letter, contending that it had illegally marketed an unapproved knee device and that the company had also sold a hip implant for an unapproved use. DePuy released a statement that it was recalling two products: the ASR XL Acetabular System (a hip socket used in traditional hip replacement); and the ASR Hip Resurfacing System (a partial hip replacement that involves placing a metal cap on the ball of the femur, a method intended to preserve more bone). The traditional implant has been available worldwide, and the resurfacing implant was approved for use in countries outside the United States. About 93,000 of these devices have been implanted worldwide, said Lorie Gawreluk, a DePuy spokeswoman.

In March, The New York Times reported that for more than two years, the F.D.A. had been receiving complaints the devices failed early in some patients, which required expensive and painful operations to put in new hip replacements. Since the start of 2008, an F.D.A. spokesperson stated having received about 400 complaints involving patients in the United States who received the devices.

DePuy said that the majority of hip replacements using the ASR devices had been successful. But the company advised patients who had had hip replacements with the recalled products to visit their surgeons for an evaluation and annual monitoring. The company said it would pay reasonable and customary medical costs associated with the recalled products, including new hip replacement operations. According to a Johnson & Johnson earnings report, DePuy had sales last year of about $5.4 billion. The high early failure rate of the ASR implants was reported this year in several articles in The New York Times. These devices have come under scrutiny over the last few years because they are part of a category of implants called metal-on-metal bearings, which have the potential to generate debris from wear, which causes inflammation and tissue damage in certain patients. Late last year, DePuy said it was phasing out the implants because of slowing sales. In March, the company warned doctors that the implants might have a high failure rate in some patients. In one New York Times article, some orthopedic experts expressed dismay that DePuy did not sooner halt sales of the devices. About 12 to 13 percent of patients needed a second hip replacement within five years of receiving an ASR implant, the statement from DePuy said, citing new unpublished data from a national registry in Britain. The statement also said that previously reported follow-up data, including internal company information and clinical trials, had reported lower rates of second hip replacement comparable to similar devices by other companies.

Many medical centers in the U.S. that specialize in joint replacement surgery noticed a higher failure rate with the DePuy hip implants early on, according to Dr. Joshua J. Jacobs, the chairman of orthopedic surgery at Rush University Medical Center in Chicago. “Most major medical centers have seen issues with this device,” Dr. Jacobs said. “This does not come as a surprise.” Dr. Jacobs added that the DePuy recall pointed to the importance of having a national registry for joint implants that can serve as an early warning system for product problems. Britain, Australia and some other countries have such national registries, he said, but the reporting system currently used by the F.D.A. does not necessarily capture every device failure. DePuy President, David Floyd, said in a statement that the recall would be a concern for patients and their family members and for surgeons and that the company is “committed to assisting patients and health care providers by providing information through multiple channels and paying for the costs of doctor visits, tests and procedures associated with the recall."

Johnson & Johnson comprises more than 250 different operating companies in 60 countries. But the recent recalls and F.D.A. warning letters to several units at Johnson & Johnson raise questions about whether there may be companywide problems, according to industry analysts. Johnson & Johnson stock closed at $57.80, down 18 cents per share, after their recall announcement of its hip implant device.

If you or someone you care about underwent surgery for hip implant, and may have suffered injuries or underwent revision surgery due a hip replacement implant failure, then you need to have a strong advocate in your corner. The partners of Kentucky's top ranking law firm Gray and White Law, Mark K. Gray and Matthew L. White, along with their associates, will use their extensive experience and knowledge of personal injury and class action litigation to build your case, no matter the size or scope. Their experienced team will fight for the compensation you deserve by seeking out others who have been similarly victimized. Contact us today to schedule an evaluation of your case - dial us toll-free at 1-800-634-8767 or send a confidential email.

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