Bribed surgeons implanted counterfeit spinal hardware into the backs of potentially thousands of patients as part of a vast scheme overseen by Michael D. Drobot, the former hospital executive who as part of a plea deal admitted to bribing indicted California state Sen. Ron Calderon, according to a new lawsuit.
The federal case against Calderon, who has been suspended from the state Senate, includes charges that the Montebello Democrat accepted money to try to preserve workers’ compensation rules that helped Drobot. In the years leading up to being indicted for fraud, Drobot was a prolific donor to California Democrats.
While Calderon’s case remains unresolved, Drobot has struck a plea deal in which he admitted to funneling bribes to Calderon. He also acknowledged overstating the price of medical implants for which he sought reimbursements and paying kickbacks to doctors and marketers who brought patients to Drobot’s hospitals.
Now one of those patients has sued doctors, hospitals and medical device distributors allegedly wrapped up in the scheme. Mary Cavalieri underwent multiple spinal surgeries at Drobot’s Pacific Hospital and said knockoff devices were inserted into her spine.
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Cavalieri’s suit includes lurid details about bribes the purveyors of allegedly fake screws and plates paid to surgeons. According to the suit, a device distributor plied doctors with cash, sports memorabilia and free air travel that came with some onboard entertainment.
“Flights were provided to a large number of spinal surgeons,” the complaint alleges, and “transported medical devices and/or instruments, cash, and prostitutes or other ‘adult entertainers’ for the spinal surgeons’ enjoyment.”
Cavalieri’s experience, according to the lawsuit, illuminates a broader pattern in which doctors paid off by Drobot used fake, dangerous imitations of approved implants.
“The conspiratorial plot to secure fraudulent profits … included a plan to manufacture, distribute, sell and implant counterfeit medical devices used in spinal fusion surgeries of patients,” says the complaint, filed in Los Angeles Superior Court.
The federal case that led to Drobot accepting a plea deal did not include any allegations of counterfeit medical devices. An attorney for Drobot rejected the new lawsuit’s claims. “Any allegation involving the use of counterfeit devices is baseless,” attorney Donald Norris said in an emailed statement.
But Calavieri’s complaint alleges that Drobot deployed a “ ‘sham’ distributorship of implantable medical devices.”
As part of his deal with Drobot, the lawsuit alleges, Cavalieri’s surgeon agreed to implant devices sourced from a company that produced non-FDA-approved screws, rods and cages out of a machine shop in Temecula. In addition to arguing that Cavalieri specifically has suffered as a result, the lawsuit depicts systemic abuse.
“Cavalieri is among thousands of spinal fusion surgery patients in Southern California and elsewhere who had such counterfeit, non-FDA approved medical devices implanted into their bodies as a consequence of the systematic pattern of fraud and deceit,” the lawsuit states.
The lawsuit describes how manufacturers connected to Drobot’s network did their best to make knockoff screws look like legitimate, medically sanctioned devices.
“The Hospital Defendants accepted the counterfeit, non-FDA approved ‘knock-off’ spinal implants with the sole intent to fraudulently inflate the cost so that false billing statements could be prepared and submitted to insurers,” the complaint states. “At all times herein relevant, the safety and effectiveness of the material supplied by the Distributor Defendants was of no concern to the Hospital Defendants.”
When they were confronted by federal regulators, the document states, manufacturers tried to conceal their use of fake devices by destroying evidence and lying.
Cavalieri is seeking unspecified damages that cover her medical expenses and lost earnings, “punitive damages to deter and make an example of the Defendants” and forfeit of profits doctors and manufacturers allegedly reaped.