Less than a week after its recall of a pair of hip implants, DePuy Orthopaedics was hit with another series of lawsuits over the devices, this time alleging that the Johnson & Johnson (NYSE: JNJ) subsidiary knowingly sold defective products.
Warsaw, Indiana-based DePuy pulled its ASR hip replacement system off the market last week after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants.
The recall of the ASR XL Acetabular and ASR Hip Resurfacing systems was prompted by new data showing “a five-year revision rate of approximately 12 percent for the ASR Hip Resurfacing System and approximately 13 percent for the ASR XL Acetabular System,” according to a DePuy press release announcing the recall.
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The ASR devices had already generated a slew of lawsuits even before the recall. DePuy discontinued the cup and had phased it out by March of this year, sending a letter to doctors that month warning that data from the Australian medical device registry showed a “higher-than-expected” failure rate in traditional hip replacements, especially in smaller patients or those with weak bones.
Those moves followed two years of reports that the implant was prone to early failure, according to the New York Times. Dr. Stephen Graves, the director of the Australian database, told the newspaper that the company was too slow in pulling the device from the market. The Food & Drug Administration received about 300 complaints about the ASR cup since 2008, according to the Times, with most complainants undergoing revision surgeries to replace the device. And the device’s co-developer, Dr. Thomas Schmalzried, said he and DePuy officials realized that the ASR cup might be more of a challenge to implant properly than competing cups.
The latest suits, filed in the California Superior Court in San Francisco, allege that the ASR implant wasn’t adequately tested before it hit the market and that DePuy continued to market the product despite knowing of its problems.
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The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
