Bizarre Counterfeit Spinal-Hardware Has Insurance Companies Suing Doctors

August 31, 2015 | Crandall & Pera Law
Bizarre Counterfeit Spinal-Hardware Has Insurance Companies Suing Doctors

A civil complaint has been filed on behalf of dozens of insurance companies. The complaint alleges a huge national health care fraud scheme involving the use of, and billing for, fake surgical hardware, and implicates fifteen surgeons and seventeen hospitals across the country.

According to the complaint, Spinal Solutions, LLC, of California, engaged in the production and distribution of fake spinal implants as long ago as 2007. The company would then sign an agreement to have doctors implant their non-FDA approved devices and pay kickbacks to those who participated.

The doctors involved allegedly entered into “sham agreements” with Spinal Solutions. For example, “...Maryland surgeon Dr. Randy Davis entered into a ‘sham agreement’ with Spinal Solutions and was paid $458,962 in kickbacks in exchange for getting the... products used in surgeries at the University of Maryland’s Baltimore Washington Medical Center,” according to Aljazeera America.

What may be worse is the level of conscious participation these agreements required. The fake spinal parts were delivered via private jet, and the surgeons participating in this counterfeit ring are alleged to have received cash, vacations, free plane trips, and other kickbacks for implanting the fake medical devices.

The healthcare facilities that are implicated participated by falsely justifying surgeries and deliberately ignoring the activities of surgeons and their supply chain. These hospitals then billed insurance companies as if the parts were from an approved source, sometimes marking up the false products as much as 250%.

On top of this, patients who were implanted with the fake devices may have a difficult time finding out. Paper trails were complicated and, allegedly, intentionally obscured. Scott Lederhaus, the president of the Association for Medical Ethics, said, “This has got to end. The spine industry is corrupt and it needs a washing from top to bottom.”

Participation in this counterfeit ring is gross negligence to the highest degree. Medical facilities and surgeons agreed, with intent and knowledge aforethought, to put patients at risk by using untested, unapproved medical devices purely for financial gain. The fact that they betrayed the trust of their patients and did not consider the potential lifelong ramifications of implanting fake medical devices shows the degree of their negligence, and those affected deserve to be compensated.

If you or someone you know has been affected by the quality of an implanted medical device, or has had a breach of trust with a healthcare facility or provider, please contact Crandall & Pera Law today for a free consultation in one of our Ohio or Kentucky office locations.