Medical Device Manufacturer Pays $550K to Settle Lawsuit

A rectal therapeutic systems manufacturer and its president have agreed to pay $550,000 to settle a lawsuit accusing the company of reusing its single-use devices.

Filed in 2022, the lawsuit claimed Dover, N.H.-based The Prometheus Group and its president/sole owner Richard Poore of violating the False Claims Act by causing healthcare providers to bill Medicare for services in which the providers improperly re-used single-user rectal sensors and single-use catheters on multiple patients. 

“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.”

Prometheus manufactures and sells devices and systems used in pelvic muscle rehabilitation (PMR), a non-surgical therapy to eliminate or reduce symptoms of pelvic floor disorders, including urinary and fecal incontinence. Prometheus has manufactured and marketed the Pathway CTS 2000 Pelvic Floor Training System and the Morpheus System, both of which used a rectal pressure probe 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 and anorectal manometry catheter to be used as a single-use device. 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.”

Prometheus and Poore knew of these restrictions, but for years encouraged and instructed healthcare 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, federal prosecutors claimed. Using the devices in this manner exposed patients to unnecessary infection risk, was not reasonable or necessary, and thus was ineligible for Medicare coverage, the U.S. government alleged.

“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 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 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.”

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. 

Filed in the U.S. District Court for the Western District of Michigan, the lawsuit 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.