Lawyers for Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics asked a California judge to file a summary judgment to close a lawsuit accusing the device maker of negligence in manufacturing its ASR metal-on-metal hip implants.
Effective on January 1, 2013, J&J and DePuy issued a motion to dismissing accusations that the companies are on the hook for negligence, defects and recall management issues that plaintiff Loren Kransky filed in December 2010, just weeks after DePuy originally pulled its ASR hip replacement and resurfacing devices off the shelves.
"There is no evidence that Mr. Kransky’s ASR XL hip implant was negligently manufactured," according to court documents filed late last month.
DePuy lawyers added that the company isn’t liable for Kransky’s alleged pain and suffering following the hip implant because "the ASR XL hip implant Instructions for Use specifically warned that metal ions may be released into the body, that metal debris may be released into surrounding tissue and that additional surgery may be required."
The lawsuit against DePuy claims that the company knew as early as 2007 that the ASR XL implants resulted in high revision rates among patients but that DePuy ignored the data and continued to "aggressively market" the devices as a safe and effective hip replacement system.
"For more than 2 year, Defendants have known that there is a likelihood that their hip replacement prosthesis – the ASR XL Acetabular System – may become unstable and fail within months after surgical implantation despite the fact that such hip implant devices are supposed to last more than 15 years," according to Kransky’s complaint. "Had Defendants recalled the devices in 2007/2008 when dozens of complaints began being made to the FDA regarding the device’s failures (before such time as Plaintiff had the device surgically implanted), Plaintiff would not have suffered from unnecessary pain, inflammation and infection, debilitation, partial or complete immobility, and the need to undergo subsequent revision surgery."
DePuy voluntarily recalled the ASR in August 2010 after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants. The company said it was pulling the ASR XL Acetabular and ASR Hip Resurfacing systems from the market "due to the number of patients who required a second hip replacement procedure, called a revision surgery." More than 96,000 patients were affected by the massive global recall.
Metal-on-metal hips as a class have become a magnet for lawsuits, even for devices that have not been recalled.
Orthopedic device maker Smith & Nephew (FTSE:SN, NYSE:SNN) may be the next to see patient complaints, as adverse event reports gathered from the FDA’s MAUDE database may progress into lawsuits and then into a collective legal action against the company’s Birmingham metal-on-metal hips, which have not been subjected to a recall.
Fellow device maker Biomet has already blazed that trail, with a raft of personal injury lawsuits against its M2A Magnum MoM hips consolidated in a federal court in Indiana, despite the fact that those devices have not been recalled.
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