US sues medical device manufacturer over reuse of disposable accessories

by Ben Vernia | May 22nd, 2022

On May 17, the Department of Justice announced that it had filed a civil lawsuit in Michigan against the manufacturer of a medical device, alleging that the company instructed providers that single-use accessories could be reused, resulting in the submission of false claims to federal healthcare programs. According to DOJ’s press release:

The United States has filed a lawsuit against The Prometheus Group (Prometheus), a New Hampshire manufacturer of pelvic muscle therapeutic systems and related rectal probes, and Richard Poore, its president and sole owner. The complaint, filed in the U.S. District Court for the Western District of Michigan, 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. The United States alleges that the reuse of these devices on multiple patients unnecessarily exposed vulnerable Medicare beneficiaries to the risks of serious bacterial, fungal and viral infections.

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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 another company’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. This reuse, which exposed patients to unnecessary risk of infections, was not reasonable or necessary, and thus was ineligible for Medicare coverage. In addition to the safety risks, Prometheus allegedly made no attempt to determine if the probes worked effectively when re-used under those conditions.

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The case apparently arose from a government investigation, rather than a whistleblower’s lawsuit.

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