After Dismissal of the Most Serious Counts, Remaining FDA Criminal Charges Result in Mixed Verdict for Dr. Sanjeev Kumar

Memphis, Tennessee – The verdict returned this week in United States v. Sanjeev Kumar closed a federal trial that bore little resemblance to the case the public was first told it was witnessing. What began as a sensational prosecution framed around sexual misconduct and human trafficking ultimately narrowed into a dispute over medical judgment, regulatory enforcement, and the expanding criminalization of healthcare under statutes never designed for that purpose.

When the Department of Justice first announced charges against Dr. Sanjeev Kumar, a Mayo Clinic–trained gynecologic oncologist, government press releases implied predatory behavior, sexual abuse, and human trafficking. Those allegations dominated headlines and generated widespread fear among patients. Yet none of those accusations ever reached the jury. Months before trial, the court dismissed the Travel Act charges brought under 18 U.S.C. § 1952, finding them legally deficient. Still, the narrative they created endured long after the charges themselves disappeared.

By the time jurors were seated, the case had transformed into something far more technical and far more consequential for the medical community. The prosecution centered on allegations of healthcare fraud under 18 U.S.C. § 1347 and criminal enforcement of FDA adulteration and misbranding provisions under the Federal Food, Drug, and Cosmetic Act, specifically 21 U.S.C. §§ 331, 351, and 352. These statutes are historically enforced through civil or administrative processes, not felony prosecutions carrying the weight of prison sentences. The case thus became a defining example of an FDA adulteration criminal case pursued in the absence of patient injury.

Dr. Kumar took the stand in his own defense and testified for nearly seven hours. He explained his medical training, his clinical decision-making, his biopsy practices, and the sterilization and cleaning protocols used in his clinic. He walked jurors through the operation and design of the medical devices at issue and the realities of practicing gynecologic oncology, where physicians routinely confront cancer risk, abnormal pathology, and incomplete diagnostic samples. When his testimony concluded, the government declined to cross-examine him.

Other witnesses offered testimony that complicated the prosecutionʼs narrative. One referring physician testified that he had sent hundreds of patients to Dr. Kumar and that those patients consistently received exceptional care. That physician was prevented from discussing the extent of free and reduced-cost care Dr. Kumar provided to underserved members of the community, limiting the juryʼs understanding of the practice as a whole. Patient witnesses faced similar constraints. Several were barred from fully describing their treatment experiences, including why procedures were recommended and how decisions were made, resulting in testimony that critics say presented an incomplete picture of the clinicʼs operations.

As the trial progressed, concerns also emerged about witness handling. Defense filings alleged that witnesses whose early statements conflicted with the Department of Justice’s theory were re-interviewed repeatedly by investigators. In several instances, those witnesses later offered testimony that differed materially from their earlier accounts, raising questions about whether investigative pressure contributed to evolving narratives rather than newly discovered facts.

Much of the governmentʼs case rested on FDA allegations that certain medical devices were “adulteratedˮ or “misbranded.ˮ These claims invoked 21 U.S.C. §§ 351 and 352, provisions typically used in regulatory enforcement actions. Yet while prosecutors argued that Dr. Kumar violated complex FDA protocols, the defense documented that the lead FDA agent, Special Agent Brian Kriplean, violated basic evidence-preservation standards. According to motions filed during trial, Kriplean deleted the contents of his phone and failed to disclose key investigative materials until after witnesses had testified. Those actions formed the basis of motions alleging violations of Brady v. Maryland, Giglio v. United States, the Jencks Act -18 U.S.C. § 3500-, and Federal Rules of Criminal Procedure 16 and 26.2.

The contrast was striking. A physician was prosecuted criminally for alleged regulatory violations, while the investigating agency failed to preserve evidence and disclose exculpatory material in a timely manner. Observers noted that this dynamic sits at the heart of growing concerns about the overcriminalization of healthcare.

The FDAʼs core theory—that Dr. Kumar reused “adulteratedˮ devices—also weakened under scrutiny. Evidence at trial showed that actual reuse of many seized devices was physically impossible. Certain cannulas were designed with safety mechanisms that prevent reuse altogether. One device highlighted by investigators was found in a cupboard without a battery and could not function. Forceps and graspers cited by the FDA did not fit the scopes they were allegedly associated with. Many items had been staged for disposal, not use.

Dr. Kumar conducted a live demonstration in court, showing that the devices collected by investigators were inoperable and could not be “held for saleˮ or used on patients. Other devices were shown to be sitting in CDC-approved high-level disinfectant solutions, consistent with federal guidance on medical device reprocessing and sterilization. Investigators, however, collected select items set for disposal while ignoring hundreds of sterile, packaged devices, documented cleaning logs, and protocols consistent with published Centers for Disease Control and Prevention sterilization guidance.

No patient contracted an infection. No disease outbreak occurred. No evidence showed that any device was reused on a patient.

Yet under the jury instructions permitted by the court, prosecutors were not required to prove actual use on a patient. Under this interpretation of FDA adulteration statutes, criminal liability can attach if a device is merely present in a medical office, even if it is inoperable, never reused, and never touches a patient. For hospitals and clinics that rely on trained staff to clean, stage, and dispose of equipment in accordance with CDC guidance, the implications are far-reaching and place unprecedented pressure on compliance operations.

The healthcare fraud allegations raised similar concerns. The government did not allege that any patient lacked consent. Biopsies are elective procedures, and every patient involved consented to treatment. The jury appeared troubled by the governmentʼs theory, hanging on most of the counts charged under 18 U.S.C. § 1347, reflecting skepticism about the breadth of the healthcare fraud prosecution advanced at trial.

How those counts were constructed became a central issue.

Prosecutors selected 26 patients with the highest number of biopsies—a slanted, non-random sample— and had an expert review those cases. The expert agreed with many of Dr. Kumarʼs clinical findings. The government then narrowed the group to eight patients. Only then did the expert testify that repeating a biopsy within six months was inappropriate and that an insufficient biopsy sample should be repeated in a hospital setting at a cost exceeding $20,000.

Under oath, the expert could not identify a single medical standard, peer-reviewed study, or professional guideline supporting those opinions. No literature from the American College of Obstetricians and Gynecologists – ACOG – articulated such a rule, nor did any published standard require that insufficient biopsy samples be repeated exclusively in hospital settings. The standards applied at trial reflected one expert’s subjective views, imposed retrospectively on a selectively chosen patient group.

Perhaps most consequential was what the prosecution did not dispute. Dr. Kumarʼs cleaning protocols and standards of care had been reviewed and approved by the Tennessee Medical Board, which inspected his practice and found it appropriate. That approval was unrebutted. Nevertheless, a government expert was permitted to substitute personal judgment for CDC guidance, Medical Board oversight, and widely accepted medical practice.

Taken together, the case illustrates a broader shift in federal enforcement strategy: the transformation of regulatory disputes into criminal prosecutions, the reliance on subjective expert opinion untethered from published standards, and the expanding criminal prosecution of physicians for compliance issues traditionally addressed through professional discipline or administrative review.

Dr. Kumar maintains his innocence and has indicated he will pursue post-trial remedies, including appeal. The issues preserved during trial—alleged Brady and Giglio violations, failure to preserve evidence, disputed jury instructions, and the scope of criminal liability under the Federal Food, Drug, and Cosmetic Act—are likely to receive close appellate scrutiny.

For healthcare professionals nationwide

For physicians, hospital administrators, and compliance professionals nationwide, the case raises an unsettling question: whether medical care will continue to be judged by established standards, regulatory guidance, and real patient outcomes, or by hypothetical harms imagined after prosecutors have already decided whom to charge.

Related FDA Charges Guides

• FDA Criminal Defense FAQ
• Defending FDA Criminal Cases
• The DOJ-FDA Strike Force
• FDA Adulteration and Misbranding Charges