Counterfeit Equipment for Spine Surgery Spurs Lawsuits

Some sleazy California surgeons and their enablers, it seems, have pulled a General Motors: They used substandard equipment that caused, if not fatalities, at least several thousand injuries to patients undergoing spinal operations.

The Center for Investigative Reporting (CIR) discovered that the doctors implanted counterfeit screws and rods manufactured in a small machine shop, into injured workers undergoing back surgery. Many have filed lawsuits after suffering adverse outcomes.

The surgeons’ motive, of course, was money: Some who used the fake hardware took kickbacks including cash and private plane rides. Middlemen and hospitals also got a slice of the poison pie by wildly inflating the cost of the screws, according to one of the suits. Some of the screws cost $300 to make but were billed at as much as $12,500 each.

One lawsuit filed last month claims that the bogus spinal implants could cause harm by causing infection or because patients could have an adverse reaction to metal that is not surgical grade. The screws also might loosen or fail.

“It’s probably the worst example where fraud has progressed from being a financial crime to hurting people for profit,” Thomas Fraysse, an attorney on the case told the CIR. “It’s beyond unethical.”

The cases involve spinal fusion surgeries, about which we’ve raised concerns. The procedure implants rods and screws in the patient’s back to relieve pain. In this case, the patients were people who had filed back injury claims for workers’ compensation, a state system that, according to the CIR, used to pay a premium for hardware used in the surgeries until a loophole was closed by recent legislation.

One of the lawsuits says the defendants committed fraud and battery, and that the deficient hardware risked the life of Arthur Golia, who got seven of the counterfeit devices implanted in his spine.

A similar case alleges that David Solomon had medical implants from the mom-and-pop machine shop implanted in 2011. One of the screws broke, requiring Solomon to undergo a second surgery in 2013. He has ongoing pain and loss of movement.

“If you break this down to the core of right and wrong, it really is using people as pieces of meat to make money,” attorney Chris Purcell told the CIR.

A whistle-blower lawsuit charges that many of the patients with fake implants might not have needed surgery in the first place. It alleges they were damaged victims of a massive scheme to defraud insurers that involved the former owner of Pacific Hospital in Long Beach.

Michael Drobot, the owner, admitted to paying doctors kickbacks of as much as $15,000 to use his hospital for the surgeries. He also admitted to paying bribes to former state Sen. Ronald Calderon for supporting a law allowing hospitals to bill insurance providers for the full cost of spinal implants. Calderon has been charged with corruption charges, and Drobot is to be sentenced in December.

Spinal Solutions LLC, is the outfit accused of distributing and inflating the cost of the hardware in some of the lawsuits. Its owner, Roger K. Williams, is accused of passing off the counterfeit rods and screws as FDA-approved even though they were made at a local tool shop. The federal agency sent him a warning letter a couple of years ago, and recalled its products last year.

The lawsuits point up how widespread illegal palm-greasing is when it comes to lucrative spine surgeries.

To understand the risks of back surgeries, and to better assess your treatment options for back trouble, see our newsletter, “Better Care for Your Aching Back.”

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