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Blackstone Medical, Inc.

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.

Most recently, the company being investigated is Blackstone Medical, Inc., a medical technology manufacturing company whose products represent three major categories: cervical, thoracolumbar, and biologics (spine devices). Blackstone Medical only manufactures devices to help those with spine problems. The company works very closely with surgeons who use the equipment to treat patients with serious spine injuries.

In August 2006, Orthofix International, NV announced that it had signed an agreement to acquire the independent spinal implant developer for $333 million in cash. Previously, Orthofix manufactured non-operative orthopedic devices such as braces and stimulators. By acquiring Blackstone Medical, Inc., Orthofix’s focus was now on spinal implants, a fairly new area of medical equipment.

Product Recall

In April 2006, 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 the News Again

With a history of recalled equipment (a 2005/2006 voluntary recall of its ICON Modular Fixation System due to loose construction of the system), 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.

Blackstone Medical, Inc. is currently under investigation by the Office of Inspector General (OIG), a government agency that investigates allegations of Medicare/Medicaid fraud. The agency’s website states that the mission of the OIG is:

  • “…to conduct independent audits, inspections, and investigations that advance the missions of the Department of State and the Broadcasting Board of Governors.”

The OIG also conducts investigations of criminal, civil, and administrative misconduct related to organizational programs and operations. Investigations examine allegations, reports, and other information indicating possible violations of law or regulation.

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.

If you feel you may have been the victim of a fraudulent medical scheme or you have suffered due to a defective medical device in Orlando or anywhere in Florida, please contact the attorneys at Colling Gilbert Wright, The Florida Firm, today to schedule your initial consultation.

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