Lawsuits Say Calif. Doctors Used Unapproved Screws in Surgeries

Various lawsuits filed across the state allege that Southern California physicians implanted counterfeit screws and rods into the spines of thousands of injured individuals, the Center for Investigative Reporting reports.

The cases are centered on spinal fusion surgeries, during which rods and screws are implanted into the spine of individuals in order to relieve pain.

The lawsuits allege that now-closed Spinal Solutions distributed such hardware at inflated prices and said the products were FDA-approved when they were not.

Background

In 2012, FDA cited Spinal Solutions for various quality control violations.

In 2013, the agency announced that the company was recalling spinal implant products, as issues with such hardware "could cause patient harm due to implant breakage, movement or inadequate sterilization."

Details of Lawsuits

The latest lawsuit -- filed in mid-June -- states that the counterfeit spinal implants could harm patients by causing infections or adverse reactions.

Law firms in the Bay Area and Los Angeles plan to continue to file lawsuits on behalf of individuals affected by the counterfeit hardware, CIR reports.

In addition, one lawsuit filed in Sacramento also alleges that some physicians who used the counterfeit hardware accepted kickbacks, while middlemen and hospitals profited by significantly inflating the cost of the hardware. According to the CIR, records show that some of the non-medical grade screws cost $300 but were billed at as much as $12,500 each.

Further, a separate whistleblower lawsuit filed in May 2012 alleges that many of the affected spinal implant patients may not have needed surgery at all.

Response From Spinal Solutions

A contractor for Spinal Solutions and an attorney for the owner of the tool shop that allegedly produced the counterfeit screws and rods denied the allegations, CIR reports.

Alan Mohill, an attorney for the shop's owner, said the tool shop made "prototypes" for Spinal Solutions and was not aware of how the company would use them (Jewett/Evans, Center for Investigative Reporting, 7/3).