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.
Video 2010 DePuy Hip Recall
Background
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.
Lawsuits
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. Shine Lawyers commenced an Australian class action in the Federal Court of Australia on September 27, 2011, against DePuy International Pty Ltd and Johnson and Johnson Medical Pty Ltd. Both lawsuits claim 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.
As of 2014, Johnson & Johnson have continued to deny culpability and settlements are starting at a base of $250,000.
Maps 2010 DePuy Hip Recall
References
Further reading
- 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 Investigative Journalism report into ASR Hip Replacements, Quentin McDermott, 16 May 2011, Australian Broadcasting Corporation
- 4 Corners Follow Up Report on ASR Hip Replacements, Quentin McDermott and Peter Cronau, 26 May 2014, Australian Broadcasting Corporation
External links
- ASR Hip Replacement Recall site
Source of the article : Wikipedia
0 Comments