An article in the publication “Outpatient Surgery” describes a lawsuit in California against a number of doctors and clinics, as well as a local machine shop, for making and using “knock-off” screws and other spine hardware. It is alleged that the doctors received part of the profits from implanting an orthopedic screw and charging $12,500 when the counterfeit cost only $300 to make. Of course, the counterfeits were not FDA-approved.

Numerous patients have now joined in a lawsuit, claiming that they had serious medical issues when some of the hardware failed after being implanted. The article states that thousands of patients in the Long Beach, California area may have claims related to this practice.

The business of making and selling spine “hardware” or other orthopedic devices is a huge one in the U.S., involving billions of dollars. Scandals occasionally arise when it is found that a doctor is using a particular brand and getting some benefit in return. An example is a Seattle-area spine surgeon who was indicted by the U.S. Attorney in Texas for getting kickbacks for using a particular brand of spine implant devices. The surgeon was in the Army at the time these events allegedly occurred, so it was a violation of a federal fraud law.