Court documents indicate that Judge Kinkeade will preside over the bellwether cases which are brought by two Montana residents against DePuy Orthopedics, Inc., a subsidiary of Johnson & Johnson Inc. The first bellwether lawsuit states that the plaintiff received a DePuy Pinnacle metal-on-metal implant for her right hip in September 2006 and an implant for her left hip in April 2007. According to the DePuy Pinnacle complaint, the woman had her first surgery in 2010 to remove the implants and had additional surgeries afterward. The plaintiff in the second bellwether lawsuit alleges that she experienced severe pain shortly after receiving a DePuy Pinnacle all-metal hip implant in 2009. According to the lawsuit, the woman had the left hip implant removed in April 2011. Both lawsuits contend that the plaintiffs had high levels of cobalt and chromium in their blood and metallosis due to the failure of the metal-on-metal hip implant. The bellwether hip replacement lawsuits also purport that the design of the DePuy Pinnacle hip replacement system is defective and the DePuy failed to provide adequate warning of the safety risks associated with the all-metal hip implants.
According to the U.S. Food & Drug Administration (FDA) metal is released from hip implant components during walking or running. Tiny metal particles that wear off can fall around the implant and cause damage to the bone or soft tissue surrounding the implant and joint. Soft tissue damage may lead to the medical device failing and elevating metal ion levels in the implant recipient’s bloodstream. In January 2013, the FDA issued a safety communication that included cautionary guidelines for physicians and patients regarding metal-on-metal hip implant systems. The federal agency recommended that physicians choose an all-metal implant for their
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