2010 DePuy Hip Recall
||The neutrality of this article is disputed. (February 2012)|
The 2010 DePuy Hip Replacement Recall was instituted when DePuy Orthopaedics, Inc., a division of Johnson and Johnson, recalled its ASR XL Acetabular metal-on-metal hip replacement system on August 24, 2010.
The DePuy ASR XL Acetabular System first became available in 2005 in the United States. Johnson & Johnson was given special clearance from the FDA in 2005 to market the ASR devices without first performing clinical trials—tests to determine the safety of the products. Since 2008, the FDA has received approximately 400 complaints from patients who received ASR hip replacements. In March 2010, J&J acknowledged that ASR products had a higher-than-normal failure rate after data revealed that approximately 12% of patients who received an ASR device needed “revision surgery.” In August 2010, DePuy issued a voluntary recall of both ASR devices, more than a year and a half after the first lawsuit was filed. Many experts agree that a recall should have been issued sooner, due to the high volume of complaints about the devices.
The recall came after data from a study indicated that the five year failure rate of this product is approximately 13%, or 1 in 8 patients. Even if the defective device is replaced, it can leave behind dangerous, possibly deadly fragments that may not be discovered for years. DePuy identified reasons for the failure of the hip replacement system as component loosening, component malalignment, infection, fracture of the bone, dislocation, metal sensitivity and pain. Additional complications from the hip replacement system may include increased metal ion levels in the blood, bone staining, necrosis, swelling, nerve damage, tissue damage and/or muscle damage.
At the beginning of 2010, DePuy Orthopaedics said they were phasing out the ASR Hip Implant because of declining sales, but never mentioned the high failure rate data from an Australian implant registry. In March 2010, the New York Times reported that DePuy issued its first warning to doctors and patients about the high early failure rate. However, at this point, they still had not issued a recall of the product. In fact, they claimed any statements referencing a recall were false.
It remains to be seen how DePuy’s recent recall, which affects the ASR XL Acetabular System and the ASR Hip Resurfacing System, will affect the company financially. Patients are suing the manufacturer for the costs associated with the “revision” surgery, as well as for pain and suffering in some instances. 93,000 persons worldwide received an ASR implant, making it likely that DePuy will face many thousands of lawsuits.
The first lawsuit in the United States against DePuy Orthopaedics was filed on June 15, 2010. The lawsuit claims that the DePuy ASR hip replacement was defectively designed, that DePuy knew that there were problems with the implant early on but didn't do anything to let patients or their surgeons know about the possible problems. The United States Judicial Panel on Multidistrict Litigation filed a ruling on December 7, 2010 that determined the fate of the thousands of lawsuits regarding DePuy Hip Recalls in the United States. Its ruling stated that all cases filed across the country, "are transferred to the Northern District of Ohio and, with the consent of that court, assigned to the Honorable David A. Katz for coordinated or consolidated pretrial proceedings."
On January 26, 2011, Judge Katz entered an order in the multidistrict litigation naming the leadership counsel for both the plaintiffs and the defendants. Ben Gordon, Eric Kennedy, Ellen Relkin, Mark Robinson, Christopher Seeger, and Steven Skikos were named on the plaintiffs' Executive Committee. Robert Tucker and Susan Sharko were named as defendants' Co-Lead Counsel. Discovery of documents from Johnson & Johnson and DePuy Orthopaedics has commenced.
- Barry Meier (March 9, 2010). "With Warning, a Hip Device Is Withdrawn". New York Times. Retrieved 2010-12-17. "A unit of Johnson & Johnson, just months after saying it was phasing out an artificial hip implant because of slowing sales, has warned doctors that the device appears to have a high early failure rate in some patients."
- Barry Meier (December 15, 2010). "The Implants Loophole". New York Times. Retrieved 2010-12-17. "A recently recalled artificial hip made by a unit of Johnson & Johnson, designed to last 15 years or more, is failing worldwide at unusually high rates after just a few years."
- Farrell, Greg. "J&J Hip Failure Rate as High as 49 Percent, U.K. Doctors Say". Bloomberg. Retrieved 24 February 2012.
- "Re: DuPay ASR Hip Cup (Cease and Desist Letter)". Kramer Levin Naftalis & Frankel LLP. April 1, 2010. Retrieved 12 November 2013.
- Hansen, David. [edit "IN RE: DePUY ORTHOPAEDICS, INC., ASR HIP IMPLANT PRODUCTS LIABILITY LITIGATION"]. Panel on Multidistrict Litigation.
- Medical Device Alert: DePuy ASR TM acetabular cups used in hi pre surfacing arthroplasty and total hip replacement, Medicines and Healthcare products Regulatory Agency, MDA/2010/044, 25 May 2010
- Medical Device Alert: All metal-on-metal (MoM) hip replacements, Medicines and Healthcare products Regulatory Agency, MDA/2012/008, 28 February 2012
- 4 Corners Investigate Journalism report into ASR Hip Replacements, Quentin McDermott, 16 May 2011, Australian Broadcasting Corporation