A number of participants in a failed study involving the Stryker CerviCore spinal implant are now pursuing lawsuits against the medical device manufacturer, alleging that they suffered grave harm as a result of the company’s negligence during the human trials.
The complaint (PDF) was filed last month in the U.S. District Court for the Southern District of Illinois in East St. Louis, on behalf of nine former test subjects and five of their spounses. The product liability and personal injury lawsuit was brought against Howmedica Osteonics Corp., which does business as Stryker.
The plaintiffs were all participants in a human trial involving the Stryker CerviCore, which Howmedica allegedly told them was a safe and effective implant that could be an alternative to spinal fusion.
There were 400 participants in the study, about 200 of whom received the Stryker Cervicore implant. Plaintiffs allege that the company told them it would continue the study and monitor their health, yet the manufacturer abandoned the projected and, curtailed monitoring and has refuesed to provide on-going care, according to the complaint.
Plaintiffs claim that they have suffered a number of different complications and injuries as a result of participation in the CerviCore study. According to the complaint, the former test subjects have shown signs of metallosis, which is a form of metal blood poisoning that has been associated with metal-on-metal hip replacements.
“At certain points, Howmedica portrayed CerviCore as a device made entirely of titanium,” the lawsuit states. “In contrast to its portrayal of the metals in CerviCore, Howmedica used cobalt, chromium, molybdenum, titanium, and nickel to construct many or all of the CerviCore units implanted in Plaintiffs.”
The lawsuit alleges that the company either won’t do the proper blood tests or have done them and are keeping the results a secret. They also say the company lied about the failure rate, saying it was only 2% when other information suggests the failure rate was much higher, with at least five patients who needed revision surgery or other intervention going unreported.
Plaintiffs report suffering neck, arm and back pain, headaches, unexpected bone growth, and other problems. Some say they have asked Howmedica to remove the spine implant, but the company has refused.
Patients Report Interference By Howmedica Representatives
One of the plaintiffs, Colleen Jaeger, reported that a Howmedica representative, Flor Mendoza, attended all of her doctor appointments. When she said she intended to complain about severe pain from the device, Mendoza reportedly told her she could not see her doctor unless she signed more waivers for Howmedica, which were addendums to the study agreement she had already signed. She refused and Mendoza allegedly not only tried to stop her from seeing her doctor, but threatened to throw her out of the study.
When Jaeger finally got to see her doctor, she claims Mendoza repeatedly tried to pressure her to sign the addendum and once Jaeger banned her from future appointments tried to get her doctor to pressure her to sign the agreement. Jaeger claims Mendoza quizzed her in an attempt to help her company build a case against future legal claims.
Once Mendoza was banned from Jaeger’s appointments, her doctor was able to determine that a bone mass was pushing on her esophagus and determined that the CerviCore was the problem and needed to be removed.
Jaeger’s doctor found a silvery fluid around the implant and sent it to the FDA for analysis. Neither the FDA nor Howmedica has returned inquiries to what the fluid was, the lawsuit claims. Jaeger still suffers pain, may have to go through more surgeries, and is showing signs of bone deterioration consistent with metallosis.
Jaeger says that Howmedica’s representatives violated the Medical Bill of Rights meant to protect patients.
Another plaintiff, Angela Moneymaker, had the CerviCore shift in her body, causing excruciating pain. Her doctor filed an adverse event report with the FDA, saying that the implant failed after just one month and ordered the device removed.
Moneymaker indicates that she suffered so much nerve damage that she has been forced into early retirement.
The lawsuits charge Howmedica with manufacturing and designing a defective implant, failing to adequately warn test subjects of the risks, negligence and gross negligence, fraud, fraudulent misrepresentation, negligent misrepresentation, breach of warranty, and inflicting emotional distress, as well as loss of consortium on behalf of the spouses. The plaintiffs seek both punitive and compensatory damages.