Medical device manufacturer to pay $550K to settle lawsuit
The lawsuit was filed in 2022 in the U.S. District Court for the Western District of Michigan. According to a release from the U.S. Attorney's Office for the Western District of Michigan, the complaint accused The Prometheus Group, a New Hampshire-based manufacturer of rectal therapeutic systems, of telling health care providers to reuse its products on multiple patients — even though the U.S. Food and Drug Administration had only approved the products for single users.
'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,'' the release says. 'Similarly, the anorectal manometry catheter was cleared by the FDA as a disposable single-use device, with packaging that states: 'Do not re-use.''
The complaint alleged that The Prometheus Group knew about the rules but told health care providers to reuse the products anyway, using a glove or condom to cover them, to reduce costs. According to the attorney's office, the health care providers then billed Medicare for the services — but they were actually not eligible for Medicare coverage because they had misused the devices and risked infecting their patients. That's why the manufacturer and its owner were accused of violating the False Claims Act.
'Medicare beneficiaries deserve treatment that is reasonable and safe,' said Acting U.S. Attorney for the Western District of Michigan Andrew B. Birge in a statement. 'Device manufacturers and medical practitioners cannot flaunt the rules and jeopardize the wellbeing of patients in our community.'
Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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