The Federal Drug Administration (FDA) doesn’t let doctors implant any old screws and hardware in the backs of patients undergoing spinal surgery. They have to be designated as surgical quality by the agency and tested biomechanically by companies required to carry special liability insurance.
Then, with a little luck, the screws don’t break after being implanted, like they did in 2011 in the back of David Solomon, who had to have a second surgery in 2013, according to The Center for Investigative Reporting (CIR). Solomon sued in Los Angeles County Superior Court, claiming the hardware was manufactured illegally and used by doctors who knew better.
Solomon is just one of many spinal fusion patients who are filing lawsuits revolving around allegations that Spinal Solutions LLC of Murrieta obtained the hardware from a mom-and-pop tool shop, inflated the prices and paid kickbacks to doctors who used them. The doctors then participated in an insurance scam that may have netted $500 million. The screw cost $300 to make and may have been billed at up to $12,500.
The scam was allegedly facilitated by Democratic state Senator Ronald Calderon, who protected a loophole in legislation that let hospitals bill insurance companies for the entire cost. Calderon pleaded not guilty to corruption charges and is currently suspended from the Legislature.
Thousands of people might have the suspect hardware in their backs. Spinal fusion surgeries have become very popular in recent years. One of the many lawsuits (pdf) filed over counterfeit screws noted that the surgeries accounted for 40% of inpatient hospital charges to the California Workers’ Compensation System in 2010, up from 30% in 2001.
“Moreover, the same scheme has been perpetrated on patients whose surgeries were paid for by Medi-Cal,” according to the suit, which alleged that among its victims were “unsophisticated Latino workers” targeted by “marketers” getting kickbacks.
Spinal Solutions is out of business. Owner Roger K. Williams filed for bankruptcy but, according to CIR, the court threw out the filing after hidden assets were discovered. Williams is accused of passing the bogus hardware off as FDA-approved and destroying records which would prove that.
Former Pacific Hospital owner Michael Drobot of Corona del Mar pleaded guilty in April to federal charges of conspiracy and paying kickbacks of between $10,000 and $15,000 to doctors who referred their patients to his facility for the suspect surgery. A separate whistleblower lawsuit alleges that many of the surgeries were unnecessary.
Drobot reportedly implicated Calderon. The senator is also accused by the FBI of accepting bribes in a sting operation that had agents posing as filmmakers trying to secure a more lucrative tax credit law. His brother Tom, a former Assemblyman, has also pleaded not guilty to related crimes.
The scheme went on for years. Trent Northcutt, chief executive of Aurora Spine in Carlsbad, told CIR, “Everyone knew something funny was going on.”