Medical Device Manufacturer And Its Owner Agree To Pay $550,000 To Resolve False Claims Act Allegations

          GRAND RAPIDS – The United States has reached a settlement agreement with The Prometheus Group (Prometheus), a New Hampshire manufacturer of rectal therapeutic systems and probes, and Richard Poore, its president and sole owner, to resolve a civil lawsuit filed against them. The lawsuit alleges that the defendants violated the False Claims Act by causing health care providers to bill Medicare for services in which the providers improperly re-used single-user rectal sensors and single-use catheters on multiple patients.  As part of the settlement, Prometheus and Poore will pay $550,000 to resolve the claims against them.  

          “Medicare beneficiaries deserve treatment that is reasonable and safe,” said Acting U.S. Attorney for the Western District of Michigan Andrew B. Birge. “Device manufacturers and medical practitioners cannot flaunt the rules and jeopardize the wellbeing of patients in our community.”

          “Manufacturers and providers must ensure that medical devices are utilized in a manner that ensures the safety of patients and complies with Federal laws and regulations,” said Mario M. Pinto, Special Agent in Charge of the U.S. Department of Health and Human Services, Office of Inspector General – Chicago Region.  “Our agency, working in conjunction with our law enforcement partners, will always work to hold those accountable who jeopardize patient safety or submit false claims to Federal health care programs.”

          “The FBI is committed to investigating bad actors and protecting the public from healthcare professionals and top executives who exploit the trust of patients by prioritizing greed and convenience over safe health practices,” said Cheyvoryea Gibson, Special Agent in Charge of the FBI in Michigan. “The FBI remains dedicated to safeguarding public health and maintaining the integrity of the medical system.”

          Prometheus manufactures and sells device systems for use in pelvic muscle rehabilitation (PMR), a non-surgical therapy to eliminate or reduce symptoms of pelvic floor disorders, including urinary and fecal incontinence. Specifically, Prometheus has manufactured and marketed the Pathway CTS 2000 Pelvic Floor Training System and the Morpheus System.  Both systems required the use of a rectal pressure probe that is inserted into a patient’s rectum during therapy. Prometheus manufactured its own sensor for use with the Pathway System and encouraged its customers to use a competitor’s anorectal manometry catheter with the Morpheus System.

          The U.S. Food and Drug Administration (FDA) cleared the Prometheus rectal pressure sensor to be used as a single-user device and the anorectal manometry catheter to be used as a single-use device.  For example, the instructions for use identify the rectal pressure sensor as “a potential bio-hazard” and state: “This sensor is restricted for single person use only. Use by another person is strictly prohibited by Federal Regulations.” Similarly, the anorectal manometry catheter was cleared by the FDA as a disposable single-use device, with packaging that states: “Do not re-use.”

          According to the United States’ complaint, the defendants knew of these restrictions, but for years encouraged and instructed health care providers to reuse the rectal pressure sensors and anorectal manometry catheters on multiple patients, using a glove or condom to cover the probes, as a way to reduce the overhead costs associated with Prometheus’s systems.  The government alleged that using the devices in this manner, which exposed patients to unnecessary risk of infections, was not reasonable or necessary, and thus was ineligible for Medicare coverage. 

          The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section, and the United States Attorney’s Office for the Western District of Michigan, with assistance from the Department of Health and Human Services, Office of Inspector General, the FDA’s Office of Criminal Investigations, and the Federal Bureau of Investigation.

          The investigation and resolution of this matter illustrates the government’s emphasis on combating healthcare fraud.  One of the most powerful tools in this effort is the False Claims Act.  Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).

          The lawsuit, which was filed in the U.S. District Court for the Western District of Michigan, is captioned United States v. The Prometheus Group., et al., No. 22-cv-446 (W.D. Mich.).  The lawsuit was handled by Senior Trial Counsel Jay D. Majors and former Assistant U.S. Attorney Andrew J. Hull. 

The claims resolved by the settlement are allegations only, and there has been no determination of liability. 

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