BERKELEY, Cali. — The Center for Investigative Reporting published a scathing report on a medical firm profiting from knockoff spinal screws. Lawsuits are now moving forward as thousands of patients were put in harm’s way due to the bogus counterfeit medical devices.
Spinal Solutions’ Scam
In June 2014, the Center for Investigative Reporting discovered the medical device manufacturing firm Spinal Solutions LLC was producing knockoff spinal screws and rods. The southern California firm was producing low-grade versions of the screws that were not made with the original high-grade titanium materials, as required by the original company, Ortho Sol. Furthermore, the counterfeit screws had uneven threads that were at a much higher risk of backing out or breaking; these threads were laser-etched to make them look like the authentic screws.
Ortho Sol’s precision screws were created for the most delicate of surgical reconstruction procedures, spinal fusion. The screws are placed in the vertebrae of patients who suffered devastating spinal injuries. As it turns out, Spinal Solutions was selling medical kits to surgeons that had a mixture of authentic and counterfeit spinal screws and rods. The company made millions of dollars off these screws before it went bankrupt in 2013. Spinal Solutions wined, bribed, and dined doctors in their efforts to sell the counterfeit products – often flying the doctors on private jets to lavish vacations and paying large consulting fees.
Ortho Sol discovered the counterfeit screws in 2009, but Spinal Solutions’ fraud was only revealed to the FDA in 2011 by a whistleblower. The Center for Investigative Reporting could not get a lot of information on the FDA investigation, but considering how the company was still in operation until 2013, it is safe to say that not much was done. Spinal Solutions instead received an agency warning letter in 2012 telling it to fix its “quality control” issues. The agency did conduct an investigation, but it allowed Spinal Solutions to continue selling its counterfeit products: “If the agency found evidence of counterfeiting, it didn’t mention it in documents provided to CIR under the Freedom of Information Act.” Spinal Solutions only shut down its activities after it went completely bankrupt due to poor money management and crippling debt.
It is believed thousands of these counterfeit screws were placed in unsuspecting patients suffering from devastating spinal injuries. Patients are already suffering pain from the screws. Additionally, experts believe that because of the low non-surgical grade material used, there is the risk of device failure or infection. Most of the victims are spinal fusion patients suffering from workplace injuries. Lawsuits have since been filed to compensate victims for their pain and suffering.
The threat of counterfeit or defective medical products is often unknown to patients and their doctors. If you believe you or a loved one has been harmed by counterfeit or defective medical devices, such as Spinal Solutions’ spinal screws, please contact an experienced defective medical device attorney.
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