More than two dozen lawsuits related to the distribution and use of counterfeit spinal screws and hardware implanted in patients were filed Friday in Los Angeles Superior Court, claiming a former hospital executive and his business partners were in on the conspiracy.
The lawsuits, which are focused on several Southern California hospitals, claim the group conspired with doctors who were financially rewarded for using the counterfeit devices that were allegedly manufactured at a California auto shop in surgeries performed at certain hospitals, Southern California Public Radio reported.
The cases are part of a bigger story reported by the Center for Investigative Reporting last week that points a finger directly at Spinal Solutions, a now-defunct California medical device supplier that had been warned by the FDA in 2009. The company, burdened by crushing debt attributed to its president's lavish lifestyle, went out of business in 2013, the CIR said.
Michael Drobot, a former hospital executive named in the civil suits, was indicted earlier this year for his part in bribing a state senator to protect what was a $500 million insurance fraud scheme. Drobot took a plea deal and agreed to cooperate with a federal law enforcement investigation.
In addition to Drobot, Pacific Hospital of Long Beach, Riverside Community Hospital, Spinal Solutions, Orthopedic Alliance, Crowder Machine & Tool Shop and doctors Jack Akmakjian, Sunny Uppal and Khalid Ahmed were named in the lawsuits, according to SCPR.
"There is absolutely no indication or evidence that Spinal Solutions ... screws were ever used at Pacific Hospital," Terree Bowers, Drobot's attorney, told public radio. "It is false and patients who went to that facility do not have to be alarmed."
According to the lawsuits, there are "thousands of spinal fusion surgery patients in Southern California and elsewhere who [have] such counterfeit, non-FDA approved medical devices implanted into their bodies as a consequence of the systematic pattern of fraud and deceit."
The suits--as well as the CIR story--claim Spinal Solutions was behind the manufacture of the fake screws.
The FDA said the investigation into Spinal Solutions is ongoing and declined to comment on the matter to FierceMedicalDevices.
- read the SCPR story
- check out the CIR story