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Johnson & Johnson’s Orthopedic Implant Woes Continue
Johnson & Johnson subsidiary DePuy Orthopaedics Inc. has recalled over 8,000 medical device units in response to the FDA finding that it sold the devices without the required approvals. The recall was disclosed on August 16, 2012, and is in response to a December letter where the FDA accused DePuy of marketing 14 various knee, hip, and ankle devices without proper approval. DePuy tried to exercise a loophole saying the devices were customized to the needs of individual patients, but the FDA disagreed. Despite receiving the warning in December, it took DePuy over 8 months to comply with the FDA request.
DePuy recently announced the company had settled three lawsuits in Nebraska over its now-recalled ASR hip implant systems. The three cases were scheduled for trial later this year, and the Plaintiffs are estimated to each receive approximately $200,000 in the settlement. The 2010 ASR hip implant recall included 93,000 hip implant devices, including 37,000 in the United States. Thousands of lawsuits are pending across the United States related to the defective ASR metal-on-metal hip implant.
This is hardly the first bad news for Johnson & Johnson in recent months. Johnson & Johnson’s subsidiary Ethicon removed four types of vaginal mesh implants from the market after it was found that serious complications associated with the devices were “not rare” in women who were implanted with the mesh products. The FDA also recalled another Johnson & Johnson medical implant after it discovered the company had sold the product for three years without proper FDA approval. It is obvious from these stories that Johnson & Johnson takes it bottom line much more seriously than the health of patients who receive their products.