Problems With Spine Implant Blamed On Stryker. Fourteen lawsuits have been filed in Ohio, claiming the CerviCore artificial discs made by Stryker are so dangerous that the company abandoned a clinical trial of the device and abandoned plans to obtain pre-market approval.
Judge James D. Bates of Lucas County, Ohio ordered all 14 lawsuits be made public, Qmed reports, denying Stryker’s request to seal case documents, Qmed reports.
Manufactures, doctors, and hospitals are required to report device-related injuries to the Food and Drug Administration (FDA). So far only two reports related to the CerviCore can be found in the MAUDE database (Manufacturer and User Facility Device Experience), according to Qmed. In 2008, a patient wrote,
“I have severe metal poisoning, tumors and metallosis and early signs of leukemia.” The patient said the surgeon “refuses to follow up or report any of the adverse effects because it will raise red flags that he implanted a device that did not have . . . approval from the FDA.”
A recent U.S. Senate report on the failure of the FDA’s device surveillance system in the case of medical scopes linked to a series of outbreaks of antibiotic-resistance infections, calls this “just one example of the fallacy of a system that is primarily reliant on hospitals and device manufacturers to self-report information to FDA,” according to Qmed.
Defective Design and Manufacturing Problem of Clinical Device
The most recent CerviCore suit was brought by a Florida man who claims he was injured in a clinical trial for the device. He says the device is “unreasonably dangerous,” that it had a defective design and manufacturing problems, and that he was not adequately warned about the risks.
The suit claims that the CerviCore releases four times as much metal debris as Stryker initially told the FDA, also notes reports of problems with the titanium coating shearing off the CerviCore device.
About 200 patients were initially implanted with the device as part of the clinical trial and 60 more were added later. An additional 200 additional patients were involved in the trial as control subjects.
The Florida plaintiff says Stryker did not inform him that it halted the CerviCore study in late 2011. The following year Stryker stopped providing care related to CerviCore. The plaintiff says his health has worsened and he has possible signs of metal poisoning.
The suit alleges that Stryker halted the clinical trial in part because of “horrendous manufacturing mistakes,” Qmed reports. Another patient claims the CerviCore design was defective and the device dislodged in her neck. She suffered such extensive nerve damage that she was forced to take early retirement.
Years after the clinical trial began, patients started to complain of problems such as metal poisoning from the chromium, cobalt, molybdenum, and titanium debris shed by the device-similar to the problems reported by patients with metal-on-metal hip implants. Five years after the start of the trial, the Stryker was still having difficulty convincing FDA to approve CerviCore.
The latest lawsuit claims the company sought to extend the duration of the trial from five to eight years while excluding results from the patients exhibiting the most severe signs of metallosis. The suit claims Stryker failed to warn patients of mounting evidence that CerviCore could cause metal poisoning and other problems.
Stryker could not abandon the clinical trial until it secured FDA approval to do so. To obtain the necessary approval, Stryker agreed to disclose the known risks of metallosis with CerviCore, Qmed reports. The lawsuit claims those risks are so severe that reasonable physicians would not use the device if they knew of the risks.