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Ex-patients sue UMMS over alleged use of counterfeit surgical hardware

Fourteen former patients of the University of Maryland Baltimore Washington Medical Center have sued the Glen Burnie hospital and the University of Maryland Medical System (UMMS) in Baltimore Circuit Court, alleging that a doctor implanted counterfeit spinal fusion hardware during surgeries and received hundreds of thousands of dollars in kickbacks from the hardware distributor.

The medical center is alleged to have purchased more than a million dollars’ worth of non-FDA-approved spinal fusion hardware from California-based Spinal Solutions LLC, including screws, rods and cages used to stabilize patients’ spines during surgeries between 2005 and 2012.

Dr. Randy Davis, who works at Baltimore Washington Medical Center, is also named as a defendant. The lawsuit, filed Monday, claims that Davis entered into a “sham” consulting agreement worth hundreds of thousands of dollars in kickbacks with Spinal Solutions to use their products, which the lawsuit claims were not regulated by the Food and Drug Administration.

Spinal Solutions gained significant attention from a June 2019 episode of the CBS “Whistleblower” program titled “The Billion-Dollar Back Surgery Scam: Patients in Pain and Peril.” The episode examined the company’s alleged use of kickbacks to persuade doctors around the country to use unregulated equipment and hardware.

Michael Schwartzberg, media relations director for UMMS, said in an email Thursday that the medical system denies the accusations and that plaintiffs’ attorney Craig M. Silverman, of the New York firm Sullivan Papain Block McGrath & Cannavo P.C., “knowingly and intentionally misrepresented the facts of the case.” Schwartzberg also said that UMMS would “vigorously” defend the lawsuit and that the medical system was confident it will be vindicated.

“Baltimore Washington Medical Center has not utilized Spinal Solutions as a vendor since 2012,” Schwartzberg said. “As cited in the Complaint, the patients in these lawsuits had their surgeries in 2010 and 2011, nearly 10 years ago. Based on our extensive review of our policies, practices and individual patient records both then and now, we strongly disagree with plaintiffs’ attorney’s claims.”

Several patients claimed in the lawsuit that they experienced no relief from their operations, and some reported that fluid had pooled internally around the area of the surgery.

The lawsuit states that Davis had to perform revision surgery for one patient. It added that the patient experienced pain caused by “sequential loosening” and “dislodgement” of a screw, a situation possibly exacerbated by the patient’s inflammatory reaction to “substandard” hardware.

Another patient suffered internal bleeding a week after surgery and required another operation to drain the blood, the lawsuit says.

Along with the allegations about counterfeit hardware, the lawsuit claims that the hospital and Davis failed to follow the regulatory practices governing medical devices laid out by the FDA.

In the suit, the plaintiffs ask for total compensatory damages in excess of $75,000, plus litigation expenses, as well as punitive damages to be determined.

 


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