Stryker CerviCore and FlexiCore Lawsuit Investigation
Stryker Spine is a manufacturer of medical devices. In the last decade, it purchased two devices, CerviCore and FlexiCore, from a company called SpineCore, both of which were designed to correct damaged spinal discs and were supposed to provide an alternative to traditional spinal fusion surgery.
What is Stryker CerviCore?
CerviCore is designed to be installed in between two vertebrates in the cervical spine (the neck). It is made of an upper and lower plate that each grip into the bone above and below with a set of teeth. The plates are designed to move (“articulate”) against each other and theoretically allow the patient greater mobility than a spinal fusion surgery would allow.
Beginning in 2006, Stryker Spine ran a study in which it took 400 people who needed traditional spinal fusion surgery and implanted the CerviCore unit in half of them. The company had hoped it could demonstrate the CerviCore was a better solution than fusion surgery because the device was designed to leave the patient with a better range of motion. A few years later, Stryker decided not to seek approval for the CerviCore device and abandoned the study.
What is Stryker FlexiCore?
FlexiCore is very similar in design, except its purpose is to be installed in the lumbar spine (the lower back) It also has an upper and lower piece and each piece connects to the bone above and below and the device similarly. The pieces then articulate against each other.
As with CerviCore, Stryker began a human study to prove the device was viable. And, as with CerviCore, Stryker changed its mind about whether it wanted to seek approval for sale in the United States and then abandoned the study.
How the Devices Harmed Patients
CerviCore and FlexiCore patients report a series of very serious and remarkably similar problems. These include allegations that:
- The CerviCore or FlexiCore device shifted after it was installed, and, in some cases, pinched the larynx;
- The CerviCore and FlexiCore devices were improperly designed and did not properly stay in place;
- Stryker Spine did not properly disclose the metal makeup of the CerviCore and FlexiCore units. It told some people that the devices were only titanium and steel. It told other patients the device was properly coated with titanium. It issued metal detector cards, though, that include steel, titanium, cobalt, and chrome. When writing articles, some of the study doctors also listed molybdenum and nickel.
- The CerviCore and FlexiCore devices were improperly designed and manufactured in a way that caused the two pieces to strip metal ions off each other, which released chromium, cobalt, titanium, nickel, molybdenum, and steel into patients’ blood streams;
- Patients who have had CerviCore units explanted have tested positive for serious tissue and bone damage caused by leaking metals;
- Patients are suffering from metallosis and that is causing severe illness;
- Stryker Spine abandoned the studies once it realized the products were not commercially viable and failed to provide the study participants with the health care it promised them;
- Stryker Spine refused to provide follow-up monitoring and care to patients even though it knows who is at risk now that the study has failed;
- Stryker Spine did not fully disclose the terms of the human study and violated the terms in how it conducted the study and treated the participants;
- And, Stryker Spine refused to remove CerviCore and FlexiCore units even after it knew the units were dangerous and were potentially harming the people who had been willing to be volunteers in the human study.
Litigation: Lawsuits Related to CerviCore and FlexiCore
In April 2014, Zoll & Kranz, LLC filed a suit on behalf of 14 plaintiffs (nine who had CerviCore units installed and five of their spouses). McGrew et al. v. Howmedica Osteonics Corp., No. 3:14-cv-430 (S.D. Ill).
We also represent other plaintiffs who have been injured by CerviCore and FlexiCore and who have not yet filed suit. While we are the leading firm in the litigation, it also partners with other firms who have clients injured by these devices.
Do you have a CerviCore or FlexiCore Unit?
Zoll & Kranz attorneys are available to discuss your options if you were part of the failed CerviCore or FlexiCore studies. Call 1-800-841-9623 to speak to an attorney.