- In 2005, the FDA approved DePuy's ASR™ XL Acetabular total hip replacement system without clinical trials because it resembled devices already on the market. Testing was required for DePuy's ASR™ hip resurfacing system, but DePuy dropped its request for approval when problems were revealed. Even without FDA approval, DePuy recommended the hip resurfacing system to U.S. doctors and continued selling it outside the U.S.
- In September 2007, DePuy and three other companies paid $311 million in fines—without admitting any wrongdoing—to resolve U.S. Department of Justice allegations that they paid physicians kickbacks to use their artificial hip and knee products. The settlement agreement allowed the companies to enter into product development agreements with doctors, compensating them with royalties based on future sales, paid on an hourly basis with a cap of $500 an hour. In 2009, DePuy paid nearly $48 million to doctors; through September 2010, nearly $33 million.
- Between 2007 and 2009, the Australian National Joint Replacement Registry warned DePuy 17 times about ASR problems, including a revision rate twice the normal expectancy rate of 15 years. Orthopedists questioning DePuy were told that their surgical techniques were at fault. DePuy device problems were reported at the 2007 Annual Fall Meeting of the American Association of Hip and Knee Surgeons and the 2008 British Orthopedic Association Conference.
- DePuy voluntarily removed the ASR from the Australian market in late 2009, citing decreased demand, but left it on the market in other countries.
- In August 2010, DePuy voluntarily recalled more than 93,000 ASR devices worldwide while maintaining that DePuy devices were performing at the same rates as similar devices.
- In March 2011, the British Hip Society and British Orthopedic Association reported that revision rates for the ASR at four years were 21%; after six years, 49%.
- With funding from orthopedists, prosthetic manufacturers, insurance companies, and hospitals, the American Joint Replacement Registry was founded in 2011 to track the 700,000 total hip and knee replacements performed each year in the U.S.
- BMO Capital Markets reported that the worldwide hip replacement market would increase from $5.28 billion in 2010 by 3.2 percent in 2011.
- In September 2012, the Australian National Joint Registry reported that DePuy ASR Hip Implants had a 44% revision rate at seven years as opposed to the 6% revision rate at ten years of all other total hip replacement devices.
Settlement Amounts Approved In Australian DePuy Litigation Suggest U.S. Settlements Approaching; RD Legal Funding Supports DePuy Attorneys With Post-Settlement Financing
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