Plaintiff Melinda Killen filled a lawsuit against Stryker’s spinal division on allegations that the company’s experimental CerviCore device caused her to need multiple revision and fusion surgeries and left her with severe pain, discomfort, numbness and weakness, among other symptoms.
Unlike fusion surgery, the CerviCore metal-on-metal vertebral implant was designed to "allow a patient to maintain normal ranges of motion in their cervical spine following implantation" and could purportedly reduce recovery time following surgery, according to court documents.
In June 2007 Killen agreed to participate in an investigational device exemption study of Stryker’s CerviCore implant. The program, the 1st human trials of the artificial disc, was to enroll 400 patients for random assignment to receive either the metal implant or traditional spinal fusion surgery.
Killen landed in the CerviCore arm of the trial, but within weeks of the procedure she began to experience increasing pain, a sore throat and flu-like symptoms, according to the complaint.
Within 2 years, the plaintiff "noticed a ‘scraping sound’ when she turned her neck from side to side and began to experience difficulty swallowing," for which her doctor recommended Valium and muscle relaxants, telling her that her problems were "unlikely related to the artificial disc."
After more trips to the doctor and growing pain and discomfort, Killen’s physician recommended removal of the CerviCore implant, finding an "extraordinary" amount of scarring at the surgical site. Subsequent tests found evidence of metallosis, degeneration in the vertebral body and "gray-brownish gelatinous tissue" in the spine.
Killen filed a lawsuit against Stryker, accusing the company of negligence, liability, fraud, negligent misrepresentation and breach of implied and express warranties related to the CerviCore implant and trials.
The complaint alleges, among other things, that the devices were flawed in design, that the materials used were prone to wear, the components were not properly heat-treated to prevent wear and that the company didn’t provide adequate warnings of potential adverse effects.
"The false information supplied by defendants to plaintiff and/or plaintiff’s physician was that its CerviCore implants were safe for human clinical trials and that the company had performed those tests, research and inspections that are perquisite to human clinical trials," according to the complaint. "Those misrepresentations and concealments by Stryker were made with the intent to obtain participants for its CerviCore clinical trials."
U.S. District Judge Joy Flowers of the Western District of Pennsylvania late last month granted Stryker’s call to dismiss many of the claims against the company, but upheld the plaintiff’s claims to argue for manufacturing defects, alleged intentional misrepresentations about Killen’s care, the alleged breach of implied warranty and kept intact Killen’s claim for punitive damages.
The judge ruled that Killen’s arguments regarding fraud and misrepresentation in connection with the testing, research and inspections conducted on the CerviCore were preempted, but similar claims about the patient’s follow-up care were preempted by law.
Stryker in 2004 obtained CerviCore technology, as well as the FlexiCore lumbar artificial disc, when it acquired SpineCore for $120 million in cash and an additional $240 million in milestone payments set on commercialization of the products in the U.S., according to a press release.
At the time Stryker said it would submit an application for pre-market approval of CerviCore in 2008.