Physicians accused of using counterfeit implants in spine surgeries
A pair of lawsuits claim doctors in Southern California knowingly used counterfeit screws in spinal fusion surgeries, according to a report by the Center for Investigative Reporting (CIR). Additional lawsuits are expected from other patients who suspect they also received counterfeit implants.
The lawsuits claim that the screws used in the implants were manufactured illegally in a small machine shop but passed off as FDA-approved. The implants pose a risk to patients because they were constructed from non-surgical grade metal that can cause infections, adverse reactions in patients, or break.
One lawsuits also claims that doctors received kickbacks for using the counterfeit implants and hospitals benefited by inflating their costs, the CIR reported. Screws were billed at up to $12,500 each despite allegedly costing just $300 to manufacture.
The firm named in the lawsuits as the distributer of the counterfeit implants, Spinal Solutions of Murrieta, California, filed for bankruptcy last year and was cited for quality control violations by the FDA in 2012. Crowder Machine & Tool of Temecula, California, named in the lawsuits as the manufacturer of the implants, has also closed.