GRAND RAPIDS, Mich. — The United States has filed a lawsuit against The Prometheus Group (Prometheus) and its president and owner, Richard Poore, for allegedly violating the False Claims Act.
The lawsuit alleges that Prometheus and its owner caused health care providers to bill Medicare for services where the providers re-used single-user rectal sensors and single-use catheters on multiple patients.
“The Medicare Program is designed to serve an already-vulnerable population,” said Mark Totten, United States Attorney for the Western District of Michigan. “Device manufacturers must not train providers who bill Medicare for services to use devices in a way that fails to protect patient health.”
Prometheus manufactures pelvic muscle therapeutic systems that incorporate these single-use rectal probes and catheters.
The United States alleges that the reuse of their single-use devices unnecessarily exposed vulnerable Medicare beneficiaries to the risks of serious bacterial, fungal and viral infections.
“By encouraging the improper reuse of medical devices for financial gain, this manufacturer significantly endangered the health and safety of patients,” said Special Agent in Charge Mario Pinto with the Department of Health and Human Services, Office of the Inspector General (HHS-OIG). “HHS-OIG is committed to working with our law enforcement partners to hold accountable any medical device manufacturers who exploit Federal health care programs and threaten the health and safety of beneficiaries.”
In a previous case against Prometheus' Director of Clinical Services, Denise D'Andrea, a U.S. Attorney alleged that D'Andrea "trained medical practitioners in the Western District of Michigan to reuse a single-user rectal pressure sensor on multiple patients by covering it with a surgical glove between uses."
D'Andrea was charged with causing the adulteration of a medical device and pleaded guilty in December of 2020.
Additional criminal charges were brought on individuals in relation to the re-use of the single-use rectal pressure sensor in 2020.
Owner and operator of Urological Solutions of Michigan, Dr. Roger D. Beyer, was found guilty of healthcare fraud and adulteration of a medical device in May of 2020. Dr. Beyer agreed to pay a share of $1.26 million as part of a civil settlement and is currently serving 57 months in prison.
Two of Dr. Beyer's employees, Susan Wright and an unnamed office manager, were also charged in the case. Wright was convicted of healthcare fraud and sentenced to three years of probation and over 3,000 hours of community service. Wright and the unnamed office manager were also ordered to pay a share of the $1.26 million civil settlement with Dr. Wright.
The United States Food and Drug Administration (FDA) approved the Prometheus rectal pressure sensor and the anorectal manometry catheter to be used as single-use devices. Both devices were said to be clearly labeled with instructions indicating “This sensor is restricted for single person use only," or “Do not re-use.”
The claims asserted in the current lawsuit are allegations only and there has been no determination in liability.
The lawsuit is being handled by the Civil Division’s Commercial Litigation Branch (Fraud Section) and the U.S. Attorney’s Office for the Western District of Michigan.
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