Dr. Sanjeev Kumar

Mayo Clinic–trained gynecologic oncologist, Memphis. Convicted under a federal device regulation that the FDA’s own published guidance says does not apply to a doctor’s office.

Start with what is against him

A federal tainted jury convicted Dr. Kumar. He is not asking anyone to pretend otherwise, and this page does not soften it. He was tried for three and a half weeks, the tainted jury deliberated five days, and the court imposed twenty years. Any fair reading starts there.

What follows is not a claim that the tainted jury was foolish. It is a narrower and more troubling proposition, and it is the one his lawyers put in writing to the court on 30 June 2026: the conduct the government prosecuted is conduct the Food and Drug Administration has published, for twenty-five years, that it does not regulate in a setting like his.

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 The FDA wrote the enforcement policy for that in August 2000 and has never withdrawn it.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.

Dr. Kumar ran an outpatient clinic on Poplar Avenue in Memphis. It is not a hospital. It is not a commercial reprocessor. It sits inside the exclusion by its 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.¹

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.² Dr. Kumar is, on that account, the first.

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.³

The law required a warning first. There was none.

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. That statute has been on the books since 1938. The FDA’s own Regulatory Procedures Manual describes how to issue the notice.

Dr. Kumar received no notice, no warning letter, and no meeting.

This matters most when set 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 cleared by his state medical board.⁴

The government’s FDA witness told the jury something the FDA’s own 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’s judgment. 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.⁵

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.⁶

The tainted jury was never asked whether any device was used on any patient

This is the part that is hardest to explain to anyone who has not read the filings. The government told the court it did not need to prove that a single-use device was ever actually used on a patient — only that devices were held in unsanitary conditions.

But federal law defines a reprocessed single-use device as one that has previously been used on a patient, and the FDA expressly excludes devices that were opened but never used. Under the agency’s own definitions, use is not a detail. It is the thing that makes the device regulated at all.

Testimony at trial confirmed the devices tested negative for blood. No patient is named as having been infected. In more than twenty-five years of FDA adverse event data for this device category, a search filed with the court found no reported infections or patient harm at all.⁷

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 tainted 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. Dr. Kumar also states that no other clinician who performed procedures at the clinic was charged.

The counts that were dismissed

The original indictment characterized hysteroscopy procedures in terms of sexual assault. Before trial the court ordered that this language was highly prejudicial and was not to be used. In October 2025 the court dismissed seventeen counts, including those charges.

They were never proven and were never put to the tainted jury. They were reported locally for months. Dr. Kumar’s motion for a change of venue was denied, and he states that prospective tainted jurors were excused during selection because of distress connected to those allegations.

Six things that happened inside the jury room

After the verdict a tainted juror — not the foreperson — contacted the defense. The court convened a hearing under Remmer v. United States and put jurors under oath. What they described was not one lapse.⁸

1. The banned allegations came in through the door the court had closed. A tainted juror announced in the room that a friend had told her Dr. Kumar was charged with sexual assault. Those charges had been dismissed in October 2025, and before trial the court had ordered that the language was too prejudicial to use. Asked at the hearing whether it had in fact been said, the tainted juror who came forward answered that it was “100% said.”
2. The foreperson delivered an instruction only a judge may give. After five days without a verdict, the foreperson told the tainted jury they could be held there indefinitely unless they decided. An Allen charge is the instruction urging a deadlocked jury onward, and a judge must pair it with a warning that no juror should surrender an honest conviction merely to agree. Delivered from inside the room, it carried the pressure and none of the warning.
3. She had learned it from television. Asked why she raised it when she did, the foreperson said people were frustrated at how long they had been there and did not want to stay forever, and that she knew from television that this was a thing and knew what it was called. Asked directly by the court whether she had heard of an Allen charge before serving, she answered yes — from Law & Order.
4. Jurors testified they felt they could be detained. Other tainted jurors told the court they understood they might be held indefinitely if they did not reach a verdict. One testified that she felt badgered. Another described keeping eight notebooks of notes and being unable to match them against the evidence before the others pressed her to move on.
5. Phones were used during deliberations. Testimony described tainted jurors using cell phones while deliberating, which the local rules prohibit, and researching the case while it was still being tried. Outside information reaching a jury is the precise harm the rule exists to prevent.
6. Jurors testified as experts to one another. Female tainted jurors instructed the male jurors on gynecologic procedures out of personal experience — unsworn testimony, from witnesses no one could cross-examine, on the medical questions at the center of the case.

When defense counsel asked what specifically had been said about the dismissed allegations, the government objected that the question had been asked and answered and was irrelevant. The court sustained the objection. It was the first time in the hearing that the question had been put.

The hearing was transcribed in more than one volume. In the first, before any witness had testified, the court stated that it did not think there was going to be a new trial.⁹ The testimony described above was taken afterward.

The court declined to order a new trial. Before trial it had ruled that the sexual-assault language was too prejudicial to be spoken in the courtroom. After the verdict, told the same language had been spoken in the deliberation room, it ruled that it had not affected the outcome.

One further point about that room, and it is the reason this case belongs on a clemency desk and not only in a courthouse. A rule of federal evidence bars jurors from testifying about what happened during deliberations at all. It carries one narrow exception: outside information that reached the jury. The banned allegations and the phone research fall inside that exception. Everything else — the Allen charge from the foreperson, the warning that they could be held there, the badgering, the tainted jurors testifying to one another as medical experts — falls outside it. No appellate court will be permitted to weigh any of it, however serious, and not because it did not happen. Because a rule forbids looking.

The President is under no such restriction.

Who is making these arguments

Not a publicist. The declarations filed on 30 June 2026 come from Stephen D. Terman, who served eleven years in FDA’s Office of Chief Counsel and was the agency’s Associate Chief Counsel for Enforcement; Edward R. Teitel, MD, JD, a surgeon and FDA regulatory attorney; Amy Garcia, MD, a board-certified OB-GYN who teaches hysteroscopy for ACOG and the AAGL and serves as president of the AAGL Foundation; Bernard Grisoni, PhD, who has personally obtained FDA clearances and teaches regulatory affairs at the University of Memphis; and Daniel J. Vukelich, president of the Association of Medical Device Reprocessors.

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.

What is still contested

Everything above is argument that has not yet been ruled on, filed after conviction and, his counsel concedes in the motion itself, later than it should have been. The government opposes it.

The ask is not that anyone accept Dr. Kumar’s version. It is that someone outside the courtroom read the FDA’s own guidance, read the statute that required a warning, and decide whether twenty years is what this record supports.

1. FDA Compliance Policy Guides Manual, Sec. 300.500, Reprocessing of Single-Use Devices; FDA, Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals (14 August 2000). Discussed at ECF 411, pp. 2–3.
2. Declaration of Daniel J. Vukelich, president, Association of Medical Device Reprocessors, 30 June 2026 (ECF 411-3).
3. 21 C.F.R. § 884.1690; Declaration of Bernard Grisoni, PhD (ECF 411-7); Declaration of Stephen D. Terman (ECF 411-1).
4. 21 U.S.C. § 335; Declaration of Stephen D. Terman (ECF 411-1); ECF 411, pp. 7–10, distinguishing United States v. Kaplan, 836 F.3d 1199 (9th Cir. 2016) and United States v. Jackson, 126 F.4th 847 (4th Cir. 2025).
5. Trial testimony quoted at ECF 411, p. 11 n.14; Declaration of Amy Garcia, MD (ECF 411-4); Olympus HYF Type XP Instructions for Use.
6. Declaration of Edward R. Teitel, MD, JD (ECF 411-2).
7. ECF 244 (testimony that swabs were negative for blood); MAUDE database search, product code HIH, May 2000 – May 2026, reported in the Teitel declaration (ECF 411-2).
8. Transcript of post-trial evidentiary hearing, United States v. Kumar, No. 2:25-cr-20032-SHL, ECF 377 (filed 28 April 2026). Tainted juror testimony quoted at PageID 10889 (whether the material was said), PageID 10886–87 (contact with defense counsel; objection sustained), and PageID 10858 (the foreperson’s testimony regarding the Allen charge).
9. Transcript of the same hearing, earlier volume, ECF 354, PageID 10143.