Statement Regarding ASR Hip System Verdict in Los Angeles, CA
In the first ASR™ Hip System case to go to trial in the United States, a jury in the California Superior Court, Los Angeles County, returned a mixed verdict after a five week trial. The jury found that the ASR XL was defectively designed. The jury rejected the plaintiff’s claim that DePuy Orthopaedics, Inc. failed to adequately warn of the risks associated with ASR XL.
“We believe ASR XL was properly designed, and that DePuy’s actions concerning the product were appropriate and responsible,” said Lorie Gawreluk, a spokeswoman for DePuy. “We plan to appeal the jury’s decision on design defect pending the outcome of post-trial motions. We believe we have a number of valid grounds for appeal, notably that the court didn’t let the company tell the jury about the Food and Drug Administration’s review and clearance of the device.”
The jury rejected plaintiff’s claim for punitive damages and awarded $8,338,000 in compensatory damages.
For additional information on the ASR Hip System, please visit: www.ASRHipInfo.com
ASR Hip System Recall Information
In 2010, the company received new information from the National Joint Registry of England and Wales reporting that some ASR patients were undergoing a second hip replacement surgery sooner than expected. After receiving this information, the company acted quickly by voluntarily recalling the product in every country where it was sold. Before August 2010, the totality of the data available to the company showed ASR was performing consistent with the class of monoblock metal-on-metal hip implants.
93,000 ASR implants were sold worldwide.
Within days of the recall, the company set up a Help Line for patients that is now available in dozens of countries and has served tens of thousands of callers. The company created a worldwide reimbursement program for ASR patients that, so far, has resulted in thousands of payments to patients for testing and treatment and other out-of-pocket expenses. DePuy also set up a process to provide information to surgeons and to work with surgeons so that they could get information to their patients.
“DePuy is committed to improving patients’ lives, and the company regrets that the ASR Hip System did not perform as expected for some patients. Since the recall, DePuy has worked to provide patients and surgeons with the information and support they need,” added Gawreluk. “Joint replacement surgery is one of the greatest medical advances of our time, and we remain dedicated to serving patients who need this important treatment.”
DePuy believes the ASR Hip System was properly designed, physicians were properly informed of the product’s risks, and the company’s actions concerning the product were appropriate.
As of December 30, 2012, in the U.S. there were approximately 10,750 plaintiffs with direct claims in pending lawsuits with respect to the ASR™ XL Acetabular System.
Cases filed in federal courts in the United States have been organized as a multi-district litigation in the United States District Court for the Northern District of Ohio. The first case as part of the multi-district litigation is scheduled for May 2013.
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