Fifteen surgeons and even more hospitals nationwide have been named in allegations that they were involved in a counterfeit spinal hardware ring.
A civil complaint obtained by America Tonight showed that patients received non-FDA approved spinal hardware as a result of the counterfeiters' actions, according to Al Jazeera America. The claim was filed on behalf of dozens of insurance companies, and details a colossal health care fraud scheme focused around fake spinal implants manufactured by California-based company Spinal Solutions, LLC. The counterfeit products - created with a combination of knock-off and genuine parts - were implanted into patients in California, Texas, Maryland, Wisconsin and Nevada hospitals.
Hospitals and doctors accused of facilitating use of fake spinal devices
The defendants in the case began a five-year relationship with Spinal Solutions to market the parts, manufactured in a machine and tool shop in California starting in 2007. The fake rods and cages were distributed through a scheme in which surgeons would receive kickbacks to use them in surgeries. One doctor was paid $458,962 to ensure that the counterfeit parts were used in surgeries in at the University of Maryland's Baltimore Washington Medical Center.
Another medical professional, once considered a trailblazer, then disgraced, then sent to federal prison in 2013 and recently released, has also been named in the counterfeiting scheme. Dr. Cully White was one of the doctors accused of using the fake parts. The lawsuit also named the hospitals where he worked, claiming that the facilities didn't properly check Dr. White or the implant supplier properly before allowing him to use the spinal hardware in surgery. White surrendered his medical license after his federal conviction, and prior to his latest allegation, wasn't allowed to reapply until 2016.
"Medical hardware, like medications, are often replicated by counterfeiters."
Two doctors discover counterfeits at trade shows
Medical hardware, like medications, are often replicated by counterfeiters. Last year, Dr. Brian Biesman, from the Nashville Center for Laser and Facial Surgery, and Dr. Neelam Patel, from the Vanderbilt University School of Medicine, authored a letter to Lasers in Surgery and Medicine, later published online, warning of the presence of counterfeit devices online and at medical trade shows. The knock-off products discussed by the two doctors typically target goods manufactured by Zeitiq and Ulthera. The doctors ultimately noted 29 devices targeting Zetiq, and five fake Ulthera items, for sale on the Internet or through legitimate trade shows.
They noted that while there are certainly financial reasons for choosing these fake devices, they're not safe or reliable, and place patients in danger, something that medical professionals are liable for should anything happen. Medical malpractice insurance carriers are not allowed to cover litigation involving non-approved medical devices, such as the ones Dr. Biesman and Dr. Patel warned about or those used by Dr. White and others named in the lawsuit.
Doctors and medical facilities alike have been accused of turning a blind eye to, or facilitating the use of counterfeit devices in recent years, and like the fake drugs that litter the supply chain, this hardware can ultimately prove dangerous for patients.