Stryker (NYSE:SYK) can’t slip a personal injury lawsuit filed over its Trident hip implant because the case asserts a "parallel" claim that isn’t preempted by federal law, a federal judge in Massachusetts ruled this week.
Raymond Chasse Jr. and Stephen Miele sued Kalamazoo, Mich.-based Stryker in December 2012 in the U.S. District Court for Massachusetts, alleging that the medical device company was negligent in its manufacture and distribution of the Trident hip replacement system, according to court documents.
Stryker moved to dismiss the case, arguing that it is preempted by federal law, but Judge Patty Saris disagreed, dismissing the Stryker motion on the grounds that the case parallels but does not add to federal regulation of medical devices.
Chasse and Miele argued that Stryker was negligent under Massachusetts law, including Current Good Manufacturing Practice regulations. Saris cited prior appeals court decisions that allowed CGMP regulations to serve as parallel claims.
"The two Circuits to have addressed the precise issue have rejected efforts to dismiss substantially similar common law claims against Stryker, holding that CGMPs are ‘legally binding requirements’ that can serve as the basis of a ‘parallel’ claim when they are alleged to have caused the plaintiff’s specific injury," Saris wrote, according to court documents.
Chasse and Miele brought the purported class action lawsuit on behalf of all Massachusetts residents who "have undergone total hip arthroplasty since 2003 using the defendants’ Trident System containing Trident Hemispherical Acetabular Shells, and who have experienced a failure of said Trident System as evidenced by the following: an audible ‘squeaking’ emanating from the replaced hip joint area; pain and/or discomfort in the replaced hip joint area; and/or the necessity for revision surgery of the replaced hip joint," according to court documents.
Miele’s double hip replacement in May 2004, according to the documents, with Chasse undergoing a left hip replacement in 2005. Stryker recalled the Trident devices in January 2008 after an investigation found "deviations between specifications and processes for manufacturing required by the FDA whereby, among other failures, excessive bioburden and manufacturing residuals were found in the final rinse tank thereby contaminating the devices," according to the lawsuit.
Miele began experiencing discomfort and pain in February 2010 and eventually had revision surgeries for both hips in 2012, according to the documents.
"The Trident Systems implanted into plaintiff Miele failed and became ‘grossly loose’ because bone ingrowth was inhibited on plaintiff Miele’s devices due to contamination as a result of defendants’ failure to comply with the FDA’s standards and requirements established and approved through the PMA process for the Trident system," according to the complaint.
For Chasse the trouble allegedly began in January 2012 and also led to a revision surgery in August of that year, according to the lawsuit.
"The Trident System implanted into plaintiff Chasse failed and exhibited striping and improper wear marks due to dimensional mismatching caused by defendants’ failure to comply with the FDA’s standards and requirements established and approved through the PMA process for the Trident system," the complaint states.