Clinical Director for The Prometheus Group Pleads Guilty for Role in Causing the Reuse of Single-User Rectal Pressure Sensors on Multiple Patients

          GRAND RAPIDS, MICHIGAN — U.S. Attorney Andrew B. Birge announced today that Denise D’Andrea pleaded guilty to one count of causing the adulteration of a medical device. In the criminal information, the government alleged that Ms. D’Andrea, the Director of Clinical Services at The Prometheus Group ("Prometheus"), a device manufacturer headquartered in Dover, New Hampshire, 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. The rectal pressure sensor is a component part of Prometheus’s Pathway CTS 2000 Pelvic Floor Training System used in a form of therapy known as pelvic muscle rehabilitation. FDA cleared this system for introduction into the market in 2000, but restricted use of the rectal pressure sensor to single-patient use only. As part of that clearance, FDA also approved instructions for use submitted by Prometheus for the rectal pressure sensor that prominently stated: "This sensor is restricted for single person use only. Use by another person is strictly prohibited by Federal Regulations."

          The government charged Ms. D’Andrea under the criminal provisions of the Federal Food, Drug & Cosmetic Act ("FDCA"), alleging that Ms. D’Andrea caused medical practitioners to engage in conduct that resulted in the rectal pressure sensors being adulterated. Under the FDCA, a device is adulterated if it was "prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health." As part of her guilty plea, Ms. D’Andrea acknowledged the government’s evidence that reusing the rectal pressure sensor on multiple patients, even when covered with a glove, resulted in the adulteration of the device given the risk of cross-contamination of viral and bacterial diseases. She faces up to a year in prison.

          Ms. D’Andrea’s guilty plea follows the May 2020 convictions of Dr. Roger Beyer and Susan Wright who, in addition to convictions related to healthcare fraud, both pleaded guilty to counts of adulteration involving the reuse of the Prometheus rectal pressure sensor on multiple patients at Dr. Beyer’s practices. On October 29, 2020, U.S. District Judge Janet T. Neff sentenced Dr. Beyer to 57 months of incarceration, and she previously sentenced Ms. Wright to three years of probation and over 3,000 hours of community service. Dr. Beyer and Ms. Wright, along with an office manager, paid separate civil settlements under the Federal False Claims Act totaling over $1.25 million.

          "The Federal Food, Drug & Cosmetic Act plays an important role in protecting the public health and safety," stated U.S. Attorney Birge. "When device manufacturer representatives and medical practitioners flaunt the rules, they jeopardize the wellbeing of patients in our community. My office is committed to working with FDA and other law enforcement to hold any other responsible parties accountable for this or other similar misconduct."

          "The FDA requires medical device manufacturers to provide healthcare professionals with the important safety information, including single-use and single-user designations, that is required to protect patients’ health. When manufacturers and their representatives blatantly disregard this safety information, they put patients’ health at risk," said Special Agent in Charge Lynda M. Burdelik, FDA Office of Criminal Investigations Chicago Field Office. "We will continue to aggressively investigate and bring to justice those who threaten the health and safety of Americans."

          This case was the result of an investigation by FDA’s Office of Criminal Investigations, the U.S. Department of Health and Human Services, Office of Inspector General, and the Federal Bureau of Investigation, in coordination with the U.S. Attorney’s Office for the Western District of Michigan. Assistant U.S. Attorney Raymond E. Beckering III and Trial Attorney Ross S. Goldstein of the Justice Department’s Consumer Protection Branch are prosecuting the criminal case against Ms. D’Andrea, with subject-matter expertise and assistance from FDA’s Office of Chief Counsel and Assistant U.S. Attorney Andrew J. Hull.

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