Fourteen Former Patients Sue Maryland Hospital Alleging Use Of Counterfeit Surgical Hardware

The University of Maryland Baltimore Washington Medical Center and the University of Maryland Medical System (UMMS) have been sued by fourteen former patients who allege in their lawsuit filed on January 6, 2020 in the Circuit Court for Baltimore City that an orthopedic surgeon who works at the hospital used counterfeit spinal fusion hardware on them and received hundreds of thousands of dollars in illegal kickbacks from the hardware supplier. The orthopedic surgeon is also named as a defendant.

The patients’ lawsuit alleges that the hospital purchased in excess of one million dollars of the non-FDA-approved spinal fusion hardware between 2005 and 2012 from Spinal Solutions LLC, which is based in California. The counterfeit hardware includes screws, rods, and cages that were used in patients’ spines during surgeries intended to stabilize their spines.

The plaintiffs allege that the defendant spine surgeon entered into a sham consulting agreement with Spinal Solutions LLC that paid the defendant hundreds of thousands of dollars in illegal kickbacks in exchange for using the non-FDA-approved spinal hardware.

The plaintiffs allege in their lawsuit that several of them received no relief from their surgeries, and others allege that they suffered harm from their surgeries, including pain due to sequential loosening and dislodgement of a screw and inflammatory responses to the counterfeit hardware implanted in them. One of the plaintiffs alleges that the defendant surgeon had to perform a revision surgery and another alleges that surgery had to be performed after internal bleeding began one week after the initial surgery.

The lawsuit further alleges that the defendants failed to follow the regulatory practices regarding medical devices as established by the FDA.

The plaintiffs are seeking compensatory damages in excess of $75,000, plus punitive damages and their litigation expenses.

A spokesperson for UMMS stated in response to the filing of the lawsuit, “Baltimore Washington Medical Center has not utilized Spinal Solutions as a vendor since 2012. 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.”

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UMMS states on its website that the defendant orthopedic surgeon “received his medical degree from the Johns Hopkins University School of Medicine and completed his residency at the Johns Hopkins Hospital. He is an Associate Professor of Orthopedics and Neurosurgery at Johns Hopkins University and an Associate Professor of Orthopedics at The University of Maryland. He performs all aspects of spinal surgery involving the cervical, thoracic and lumbar spine.”

Source

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This entry was posted on Monday, February 17th, 2020 at 5:28 am. Both comments and pings are currently closed.

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