The hospital paid out over 100 million to settle the cases and now additional previously sealed whistleblower complaint filed against EBI Inc. are up on the block filed by 8 patients to seek money to be returned to the government, although they will stand to get one quarter of the payout.
“Wright Medical Technology Inc. based in Arlington, Tenn., made Allomatrix, a bone fusion material that failed to work properly during two experimental studies performed on rats and rabbits. A third study, using pig-tailed macaques, rare primates native to Southeast Asia, showed "questionable" benefits.
EBI Inc., a subsidiary of Biomet Inc. in Parsippany, N.J., made spine stimulating devices King used during his surgeries. EBI allegedly paid King a bonus each time he inserted one of their "Ionic Spacers" into a patient's spine.”
Patients were never informed they would be receiving an experimental device and there appears no consent forms were signed and the suit is also investigating kickbacks given to the surgeon and there was no investigational device exemption from the FDA for the spacers used in the spinal surgeries. The surgeon lost his medical license and his location now is not known and the physician’s assistant is also named in the case. You wonder how this was able to get by the hospital administration in not following clinical trial processes. BD
A whistleblower complaint accuses former osteopathic surgeon Dr. John A. King of experimenting on 26 of his patients.
The federal complaint says King used medical devices in ways that hadn't been approved by the FDA and received illegal kickbacks for doing it.
"King and David McNair [King's physician assistant] were conducting clinical research and human patient experimentation when they performed the anterior lumbar inter-body fusions" on eight patients, the "qui tam," or whistleblower, complaint states.
"King and McNair took studies that failed in laboratory animals, and then, without any reasonable basis to conclude that they would be successful, began to experiment on humans," the complaint says.