January 24, 2013 — Documents unsealed on an ongoing state court trial in California reveal that Johnson & Johnson was aware of serious problems with the ASR hip implant in 2008, but failed to issue a recall for another two years.
Pre-trial testimony revealed that the company received clinical data showing “extreme” levels of metal ions in patients implanted with the ASR. By the time the ASR was recalled in 2010, about 93,000 patients worldwide received an ASR, including 37,000 Americans.
Although elevated metal ions are one of the first indications of hip implant failure, DePuy did not immediately recall the ASR. Instead, one DePuy official said:
“I believe it means that we need to start any ASR upgrade sooner than our previous plans had suggested.”
In 2009, DePuy officials decided to phase out production of all-metal hip implants. The remaining stock of ASR implants was recalled in 2010. In 2011, an internal company analysis conducted by Johnson & Johnson estimated that 37% of the ASR hip implants would fail within five years, but this information was not disclosed publicly. At the same time, the New York Times reports that the company was publicly downplaying similar results from a British joint registry.
The information revealed is just a tiny fraction of what could be unearthed as more than 10,000 lawsuits move forward against DePuy Orthopedics, a subsidiary company of Johnson & Johnson. Approximately 2,000 of these lawsuits are centralized in California Superior Court, Los Angeles County. The first trial involves plaintiff Loren Kransky, a man who was injured by the ASR hip implant and now has cancer. The rest of the lawsuits are pending in a federal Multi-District Litigation (MDL) in the U.S. District Court, Northern District of Ohio. The first federal trials are scheduled to begin in May 2013.
As the ASR litigation heats up, concern is growing about the entire class of metal-on-metal hip implants. The devices consist of a metal ball which rotates inside a metal cup, which was originally intended to be more durable for younger, more active hip implant recipients. Unfortunately, according to the FDA, all-metal hip implants convey unique risks in addition to the risks found in plastic or ceramic devices. Metal hip implants can shed particles of cobalt and chromium, which can destroy tissue and bone and elevate metal levels in a patient’s bloodstream.
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