Dr. Sanjeev Kumar

The rule he was convicted of breaking excludes his own clinic

The charges rest on the reprocessing of single-use medical devices. The FDA wrote the enforcement policy for that in August 2000 and has never withdrawn it. The policy names four categories it does not reach. One of them is health care facilities that are not hospitals. Another is devices that were opened but never used.

Here is the facility.

A three-story suburban office building off a parking lot. No emergency room. No inpatient ward. No operating theatre. No overnight bed. Inside: a leased suite on the fourth floor, and an exam room with a table, a stool and a chair.

The clinic sits inside the exclusion by the policy’s plain terms, and the FDA’s current Compliance Policy Guide — still linked from the agency’s own web page — still says the policy does not apply to health care facilities other than hospitals. The CDC guidance the FDA links to says the same thing, in the same words, and adds the same carve-out for opened-but-unused devices.

The trade association that represents the regulated reprocessing industry put this in a signed declaration: it is aware of no FDA enforcement action, ever, against any facility that is not a hospital or a commercial reprocessor.

A separate FDA regulation, 21 C.F.R. § 884.1690, classifies hysteroscope accessories — the graspers, forceps and cannulas named in the indictment — as Class I devices exempt from the premarket requirements the charges were built on. Two device-regulation experts say so under oath.

FDA Compliance Policy Guides Manual, Sec. 300.500; FDA, Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals (14 August 2000); CDC, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008, updated June 2024), p. 81; declarations of Daniel J. Vukelich, Bernard Grisoni PhD and Stephen D. Terman, ECF 411-3, 411-7, 411-1.

The law required a warning first. They skipped it.

Before the FDA reports a violation for criminal prosecution, 21 U.S.C. § 335 requires that the person be given notice and an opportunity to present his views. The provision is titled Hearing before report of criminal violation. It has been on the books since 1938. The FDA’s own Regulatory Procedures Manual describes how to issue it, and states that warning letters exist because the agency expects most people to comply once told.

Nobody ever gave him the chance to comply, because compliance was never the point. This matters most against the two cases the government relied on to convict him. In one, FDA investigators sat down with the physician, told him their concerns, and he kept going anyway — and admitted it. In the other, the defendant admitted reuse and had also submitted forged affidavits and committed identity theft.

Those are the precedents. Dr. Kumar admitted nothing, was warned about nothing, and had already been investigated and closed out by his state medical board.

The government’s own FDA witness told the jury something the FDA’s paperwork contradicts

The government’s FDA reviewer testified that the agency had never cleared a hysteroscope for anything other than sterilization. The prosecution repeated it in closing.

The manufacturer’s FDA-cleared Instructions for Use for the Olympus hysteroscope in this case permit either sterilization or high-level disinfection, and leave the choice to the physician. FDA and CDC guidance both classify these instruments as semi-critical — the category for which high-level disinfection is the accepted standard. The reviewer who gave that testimony has since left the agency.

The clinic owned more than thirty reusable hysteroscopes, an automatic endoscope reprocessor built for exactly this purpose, a drying and storage cabinet, and a service contract with the manufacturer that included staff training. A physician who has bought that equipment has already paid for the compliant method.

He was also not quiet about it. In April 2022 — two years before anyone knocked on the door — the clinic’s own Instagram account posted that at least two medical assistants cleaned every room thoroughly after every patient, with the clinic’s phone number attached and hashtags for Memphis and Germantown.

People concealing something do not post it with hashtags.

His own emails instructing staff to use multi-use devices and to run them through high-level disinfection were excluded from evidence. So was the CDC guideline itself. The jury that convicted him was never allowed to read the document that says the rule does not apply to him.

He beat seventeen counts. Thirteen days later they charged him with twenty-seven more.

The new counts rested on no new evidence. They covered the same devices, seized on the same day, that the Department had held for a year and a half and had already tested at two federal laboratories. Nothing had been discovered. Nothing had changed except one thing: he had won.

What the new counts did change was the arithmetic. From a maximum of thirty-nine years to a maximum of eighty-one.

Motion to dismiss the second superseding indictment for vindictive prosecution, ECF 144 (3 November 2025), citing United States v. Goodwin, 457 U.S. 368 (1982); United States v. Ladeau, 734 F.3d 561 (6th Cir. 2013); United States v. Zakhari, 85 F.4th 367 (6th Cir. 2023).

The fraud counts

Six of the forty counts are health care fraud. The charged period runs five years, 2019 to 2024. The government put a single calendar year to the jury — 2021, the height of the pandemic — and twelve documented procedures out of roughly 9,000. Eleven were called unnecessary. The other four years were never examined at all.

The clinical indication for every disputed procedure was documented in the patient’s chart. The government’s chart reviewer — the witness who told the jury the procedures were unnecessary — does not perform office hysteroscopy in his own practice.

And the lead investigating agent testified under oath that the billing records matched the procedures actually performed.

That is the whole fraud case. Billing for procedures that did not happen is what health care fraud means. The government’s own case agent told the jury the billing was accurate. What was left was a disagreement about medical judgment, prosecuted as a felony.

What the state medical board found, and when

The Tennessee Board of Medical Examiners investigated these allegations and closed the matter without a finding of wrongdoing. That letter is dated 17 September 2024. It predates the trial, and the board did not have the evidence the jury later heard. It is not a substitute for the verdict.

It is, however, the answer to a question a clemency reviewer should ask: did anyone with medical expertise look at this practice before the Justice Department did?

Someone did, and reached the opposite conclusion. No other clinician who performed procedures at the clinic was charged — and more than a thousand procedures at Poplar Avenue Clinic were performed by other clinicians.

One of the most egregious cases of weaponized lawfare in the United States

Memphis gynecologist sentenced to 20 years despite following CDC and FDA guidelines.

What follows is this page’s summary of the case as the court file shows it.

Recent court documents reveal widespread misinformation surrounding the case of Dr. Sanjeev Kumar, MD, a Mayo Clinic–trained robotic cancer surgeon and prominent Memphis gynecologic oncologist. Media reports claiming Dr. Kumar performed more than 15,000 biopsy procedures with “adulterated devices” on Medicare and Medicaid patients are not supported by accurate data.

Government data under scrutiny

Court records show the government released opaque datasets containing no patient names and lacking accountability. One exhibit attributes numerous procedures to patients who never existed at Poplar Avenue Clinic. Prosecutors also counted denied claims, crossover claims, rejected claims, and simple clerical insurance errors as “procedures,” inflating the numbers used in dramatic headlines.

Sterile single-use devices used for biopsies

Endometrial biopsies at Poplar Avenue Clinic were performed with single-use sterile endometrial pipelles. Clinic records document the purchase of more than 40,000 of these sterile, disposable devices. Multiple witnesses testified that a new sterile pipelle was used for every biopsy. The jury was never asked to evaluate the actual use of any specific device on any specific patient.

Hysteroscopes reused according to FDA and CDC guidance

Dr. Kumar and Poplar Avenue Clinic purchased more than 30 multi-use hysteroscopes and accessories cleared by the FDA. Defense evidence showed these instruments were reprocessed according to CDC and FDA regulatory guidance for high-level disinfection — a standard practice in office-based hysteroscopy worldwide. High-level disinfection is explicitly permitted under the devices’ Instructions for Use.

Problematic expert testimony

• Government expert Dr. Matt McDonald, paid $750 per hour, did not perform in-office hysteroscopy yet was admitted as an expert.
• Dr. Jona Bandyopadhyay, Deputy Chief Medical Officer for TennCare, had not seen patients in a clinic for over five years and had been recommended by the Tennessee State Medical Board for a re-entry pathway or administrative license.
• Government witness Dr. Ben Abdu testified that insurance companies were “the real criminals,” admitted reusing single-use devices himself, and stated he did not believe his own device use constituted a crime. He received immunity and later joined a competing Memphis clinic.

FDA testimony and evidence issues

Court documents indicate that FDA lead reviewer Poulomi Nandy provided testimony implying the agency had never cleared a hysteroscope for high-level disinfection — a claim contradicted by existing clearances. An FDA agent on the case destroyed evidence from his phone, and a lead reviewer later left the agency.

Clinic devices kept under FBI custody under filthy conditions

Devices shown to the jury had been held in FBI custody for more than a year under filthy conditions; many were broken, non-functional, or not hysteroscopes but cystoscopes. Several contained built-in kill switches that prevent reuse.

Independent review found no wrongdoing

A comprehensive investigation by the Tennessee State Medical Board found no wrongdoing. No other clinicians who performed more than 1,000 procedures at Poplar Avenue Clinic were charged.

Context and impact

Dr. Kumar, elected a Top Doctor in 2024 according to court documents, operated a multi-specialty clinic that expanded access to in-office hysteroscopy with sampling — a procedure capable of detecting endometrial cancer early. The 20-year sentence in United States v. Sanjeev Kumar is cited by supporters as an example of overzealous prosecution that punishes physicians serving patients in underserved communities under contested interpretations of medical device regulations.

Who is making these arguments

Not a publicist. The declarations filed on 30 June 2026 come from:

Four of them are telling a federal court that the agency they used to work for, advise, or represent does not regulate what the Justice Department sent a physician to prison for twenty years for doing.

Why this is wrong

Strip this case to what it is.

A federal agency guideline about how to clean an instrument. In a building the guideline says on its face it does not cover. With no patient named as harmed, no infection reported in twenty-five years of national adverse-event data, and no warning letter of the kind the statute has required since 1938.

That is a regulatory dispute. There is an entire apparatus for regulatory disputes: warning letters, untitled letters, inspections, consent decrees, civil penalties, license proceedings. The Tennessee medical board used part of it and closed the matter.

This has a name, and it is not unique to him

What happened here is the fifth of seven documented forms of weaponized justice: regulatory weaponization — conduct a licensing board or a regulator used to handle, charged instead as a federal felony, often under a statute written for something else, and often without the government having to prove the defendant knew he was breaking any law.

Read that definition against this case. A state medical board did handle it, and closed it without a finding. The statute was written for commercial reprocessors and hospitals. And the jury was never required to find that Dr. Kumar knew any rule applied to him — because the FDA’s own published guidance says it does not.

The pattern is documented independently of anyone on this site. In 2010 the Heritage Foundation and the National Association of Criminal Defense Lawyers jointly published Without Intent, finding that a majority of the non-violent federal offenses proposed in a single Congress lacked an adequate guilty-mind requirement. In April 2025 the Deputy Attorney General issued a memorandum directing prosecutors to stop bringing exactly this kind of case, titled Ending Regulation by Prosecution.

A person decided which way to point every single one of these

The law did not require the Department to prosecute a cleaning guideline as a felony at all. The FDA’s own manual says warning letters exist because most people comply once told. Nobody told him.

The law did not require it to headline a press release the way it did, or to leave that release standing uncorrected after the counts behind it were dismissed, in the city where the jury would be drawn.

The law did not require it to return twenty-seven new counts thirteen days after losing seventeen, on evidence it had held for a year and a half, doubling his exposure from thirty-nine years to eighty-one.

The law did not require it to tell the court it need not prove any device was ever used on a patient.

The law did not require it to seek twenty years for a physician with no record, in a case where its own indictment alleges not one infection, not one complication, not one injured patient.

Every one of those was a choice. A person made it. And every one of them pointed the same way.

Here is what nobody can defend

Not one ruling. The sum.

Twelve people were asked to decide whether a cancer surgeon was a criminal. They were told nothing about the FDA guidance that says the rule does not reach an outpatient clinic, because it was excluded. Nothing about the CDC guideline that says the same thing, because it was excluded. Nothing about his own emails instructing staff on disinfection, because they were excluded. They were never required to find that a single device had been used on a single patient, because the government said it did not have to prove it.

They deliberated five days and could not agree. Then a juror told them they could be held there indefinitely, having learned the device from a television drama. Three hours later it was over. And a rule of evidence means most of what those jurors later said under oath can never be weighed by any court, ever.

And the conduct they convicted him of — measured against hospitals where inspectors photographed dried blood and tissue on uncovered instrument trays — produced, everywhere else in this country, a plan of correction.

That is not a trial anyone would defend if it were their own.

It is only defensible one ruling at a time — which is exactly how it was built, and exactly why it cannot be undone one ruling at a time either.

That is what clemency is for. Not mercy. Not forgiveness. Somebody with the authority to look at the whole of it at once, instead of one piece at a time.

And this is the door now

The women who were 400 pounds and had been turned away everywhere else do not have that surgeon now. Neither does the state whose Medicaid patients filled his waiting room. Neither do the residents he was teaching.

Endometrial cancer is the most common gynecologic cancer in the United States and the fastest-rising cancer in American women. The instrument that catches it early is the one at the center of this case.

And every gynecologist in America who read the coverage learned something from it. Dr. Kumar’s own conclusion, said out loud, is that his single greatest mistake was accepting Medicare and Medicaid at all.

The marquee still says same-day appointments.

The record

Filings in this case

United States v. Kumar, No. 2:25-cr-20032-SHL, Western District of Tennessee.

Government and regulatory sources

Independent research cited on this page

Others who have looked at the case

These are commentary, not news reporting, and their authors are sympathetic to Dr. Kumar.

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