New York, June 25, 2026—Physicians Nicole Fleischmann and Robert Simon each have agreed to pay more than $1.1 million, for a total of more than $2.2 million, for their roles in alleged fraud involving implants of Medtronic’s InterStim system to relieve incontinence. A former Medtronic employee brought the lawsuit under the False Claims Act, the law that allows whistleblowers to receive up to 30 percent of a financial settlement for reporting fraud against the government. Phillips & Cohen LLP represented the whistleblower. The whistleblower filed the complaint in 2020 in the Southern District of New York.
Medtronic’s InterStim system is a device implanted in patients’ lower back to reduce symptoms of incontinence by stimulating the patient’s sacral nerve. According to a 2001 Medicare decision, sacral nerve stimulation therapy works on only some patients. Accordingly, Medicare covers the implantation of the InterStim system only if the patient first undergoes a pre-implantation stimulation test for three or more days and the test results show greater than 50% improvement in the patient’s symptoms.
According to the whistleblower’s allegations, both Dr. Fleischmann and Dr. Simon implanted InterStim systems without performing the full test required by Medicare. Both allegedly often implanted two InterStim devices, one on each side of the patient’s spine, without first testing to determine whether dual devices (or even any devices) were necessary. The whistleblower alleged that Dr. Simon also performed excessive replacements and revisions of implanted InterStim devices.
As a result, Medicare patients received numerous unnecessary surgical implantations and surgical replacements of InterStim devices despite the absence of the required test showing that those devices would alleviate their symptoms. Medicare pays thousands of dollars to doctors and hospitals or surgical centers for the services associated with each test and implant.
“These doctors targeted some of the most vulnerable people enrolled in Medicare. They ignored Medicare rules put in place to protect the health and safety of patients, without even bothering to test whether these invasive and painful surgeries would be effective,” said Stephen Hasegawa, a partner with Phillips & Cohen. “This whistleblower bravely stepped forward to protect those patients and bring these unnecessary surgeries to an end.”
Hasegawa thanked Assistant United States Attorney Allison Rovner of the Southern District of New York for her work on the case.
Phillips & Cohen is the nation’s most successful law firm representing whistleblowers. The firm’s cases have helped recover more than $13 billion in civil settlements and criminal fines. Phillips & Cohen represents whistleblowers in qui tam lawsuits as well as whistleblower claims under other reward programs, including the SEC, CFTC, and IRS whistleblower programs.