Allegations of Fraud Surrounding Blackstone Medical, Inc.
The Food and Drug Administration (FDA) announced a recall of Blackstone Medical’s ICON Modular Fixation System due to a problem with its construction. This spinal implant was a collection of components that allowed surgeons to assemble a construct including screws, connectors, and rods. It was implanted in and near the patient’s spine and was intended to immobilize and stabilize spinal segments at the site of spinal surgery.
However, according to the recall, the construct could loosen in the early postoperative period requiring surgery to remove it. To date, approximately 4% of the 484 surgical procedures to implant the system have had loose constructs. Fortunately, no deaths or serious injuries have been reported as of yet.
In recent years, several orthotics companies have been investigated for participating in illegal kickbacks schemes. With these schemes, there have been allegations of civil conspiracy with underlying medical malpractice, specifically, violation of informed consent due to doctors and surgeons lying about test results to induce patients to consent to unnecessary surgeries.
Blackstone is now coming under fire for suspicion of illegal kickbacks schemes in which surgeons are providing patients false reports to induce them into agreeing to spinal surgery where the Blackstone devices are implanted. Both surgeons and Blackstone Medical, Inc. have been alleged to benefit financially each time one of the devices is implanted under fraudulent terms.
If you or a loved one has been involved in a spine surgery medical malpractice case, there may be more to your situation than meets the eye. What was once thought to be just a defective medical device, may now be at the center of a kickbacks scheme to profit from unnecessary surgery and unnecessary implantation of spinal devices.