Statement Regarding ASR Hip System Verdict in Tulsa, OK
A jury returned a mixed verdict today in a trial concerning the ASR™ Hip System in the Tulsa County District Court, Civil Division. The jury found that the ASR XL was defectively designed. The jury also found that DePuy was not negligent and properly informed the plaintiff’s physician of the known 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 Mindy Tinsley, a spokeswoman for DePuy. “We plan to appeal the jury’s decision on design defect.”
The jury awarded $2.5 million in compensatory damages and rejected the plaintiff’s claim for punitive damages.
“The damages are not consistent with the facts in this case, and we believe we have strong grounds for appeal,” Tinsley added.
For additional information on the ASR Hip System, please visit: www.ASRHipInfo.com.
ASR Hip System Recall Information
In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new information from the National Joint Registry of England and Wales as part of the company’s ongoing surveillance of post-market data concerning the ASR Hip System. After reviewing these data, DePuy decided it was in the best interests of patients to voluntarily recall the ASR Hip System.
The ASR Hip System was designed in conjunction with expert surgeons to respond to a medical need for an implant option with reduced risk for dislocation that supported the active lifestyles of younger patients. Before the ASR Hip System was launched, it was thoroughly tested, and after it was on the market, DePuy continued studying and closely watching how the device was performing, as we do with all our devices. There was extensive discussion within DePuy on product performance and decisions were made based on the company’s knowledge at the time.
Since the recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need. DePuy has been committed to working with patients and their health insurers to address medical costs directly associated with the recall. DePuy has also addressed recall-related patient out-of-pocket expenses, such as co-pays, deductible expenses, lost wages and travel costs. Through the ASR Help Line, tens of thousands of ASR patients have been assisted.
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.
In November 2013, DePuy and the Court-appointed committee of lawyers representing ASR Hip System plaintiffs announced a settlement agreement to compensate eligible ASR patients in the United States who had surgery to replace their ASR hip, known as revision surgery, as of August 31, 2013. The settlement program is moving forward and most eligible patients have opted into the program. However, some lawsuits in the U.S. remain. DePuy will continue to defend against remaining claims and believes its actions related to the ASR Hip System have been appropriate and responsible.
The Smith case is the third ASR Hip System case to go to trial in the United States. In a trial in the Circuit Court of Cook County, Illinois, that ended in April 2013, the jury returned a verdict in favor of DePuy Orthopaedics, Inc. In a trial in the California Superior Court, Los Angeles County, that ended in March 2013, the jury rejected the plaintiff’s claim that DePuy Orthopaedics, Inc. failed to adequately warn of the risks associated with ASR XL but did find that the ASR XL was defectively designed. The jury rejected plaintiff’s claim for punitive damages and awarded compensatory damages. The company has appealed the jury's verdict regarding design defect.
As of September 28, 2014, in the U.S. there were approximately 12,300 plaintiffs with direct claims in pending lawsuits with respect to the ASR XL Acetabular System, as reported in Johnson & Johnson’s 3rd quarter 2014 10-Q filing.
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