from youarewithinthenorms.com

NORMAN J CLEMENT, RPH., DDS, NORMAN L. CLEMENT, PHARM-TECH, MALACHI F. MACKANDAL, PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO, ESQ., INC., SPIRIT OF REV. IN THE SPIRIT OF WALTER R. CLEMENT BS., MS, MBA. HARVEY JENKINS, MD, PH.D., IN THE SPIRIT OF C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., M.B.A., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., EVELYN J. CLEMENT, IN THE SPIRIT OF WALTER F. WRENN III., MD., JULIE KILLINGSWORTH,  RENEE BLARE, RPH, DR. TERENCE SASAKI, MD LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, IN THE SPIRIT OF WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., IN THE SPIRIT OF FOREST TENNANT, MD., IN THE SPIRIT OF RICHARD KAUL, MD., IN THE SPIRIT OF LEROY BAYLOR, JAY K. JOSHI MD., MBA, AISHA GARDNER, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

 “..WE ARE NOT POWERLESS, AND THROUGH OUR VIDEOS, WRITINGS, AND PHOTOGRAPHS, WE WILL EXPOSE THE ABUSES AND TYRANNY ……JUST AS THE VIDEO WAS RECORDED BY THE CELL PHONE CAMERA OF YOUNG Darnella Frazier, BORE WITNESS TO THE MURDER OF GEORGE FLOYD, THE BLOG youarewithinthenorms.com bears WITNESS, AND BOTH ALLOWS THE SYSTEM TO BE HELD ACCOUNTABLE..”

FOR IMMEDIATE RELEASE

July 1, 2026

Justice at Odds: The FDA Safe Harbor Defense

Sworn Declarations from Former FDA Counsel and Renowned Device Regulation Expert Expose Clear Regulatory Carve-Outs for Outpatient Clinics; Emergency Motion Seeks to Strike Verdict Before July 7 Sentencing

MEMPHIS, Tenn. – National experts in FDA regulation and medical device law are expressing profound shock and dismay that the Department of Justice obtained a criminal conviction against Dr. Sanjeev Kumar—a Mayo Clinic-trained gynecologic oncologist and prominent Memphis robotic surgeon—despite the FDA’s own published guidance explicitly creating safe harbors for exactly this type of outpatient physician practice.

On June 30, 2026, Dr. Kumar filed a sweeping emergency post-conviction motion in the U.S. District Court for the Western District of Tennessee (Case No. 25-cr-20032) asking the Court to strike the jury’s verdict. The motion argues that the government’s theory of prosecution under the Federal Food, Drug, and Cosmetic Act directly conflicts with the FDA’s own regulatory framework governing single-use devices (SUDs), violating due process, the rule of lenity, and principles of entrapment by estoppel arising from reasonable reliance on official FDA guidance.

National Experts Highlight FDA’s Explicit Safe Harbors

Central to the motion are sworn declarations from two of the nation’s most respected authorities on FDA medical device regulation:

• Stephen D. Terman, former Associate Chief Counsel for Enforcement at the FDA (1976–1987), with 50 years of experience representing device manufacturers, reprocessors, and trade associations before the agency.

• Edward R. Teitel, M.D., J.D., a board-certified surgeon with extensive endoscopy experience and deep regulatory expertise in reprocessing and single-use device compliance, now a regulatory attorney at a leading FDA law firm.

Quote from Dr. Edward R. Teitel’s Sworn Declaration – The Four FDA Carve-Outs

In his declaration filed with the motion, Dr. Teitel quotes directly from the FDA’s August 14, 2000 Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals:

“This guidance document is applicable to third party and hospital reprocessors. The enforcement priorities set forth in this guidance do not apply to: (emphasis added)

1. Permanently implantable pacemakers. The reuse of permanent pacemakers is addressed in Compliance Policy Guide 7124.12…

2. “Opened-but-unused” SUDs (see Definitions in Appendix B);

3. Health care facilities that are not hospitals; or

4. Hemodialyzers. …

Dr. Teitel then concludes under oath: “Physician’s offices and clinics, such as Dr. Kumar’s facility, are exactly the type of facilities that are ‘Health care facilities that are not hospitals’ and fit squarely within the safe harbor carved out by the FDA in their guidance. This safe harbor extends beyond just using the SUDs in the clinic to include the other requirements of hospitals and third party reprocessors that include such things as labeling them as reprocessed to inform users that the devices used in their procedures are reprocessed.”

The motion further notes that numerous devices charged in Counts 17–32 (including CooperSurgical Disposable Alligator Grasper Forceps, CooperSurgical Endosee PX Cannula, and LiNA OperaScope Biopsy Forceps) are Class I hysteroscopy accessories expressly exempt from many FDA premarket and labeling requirements under 21 C.F.R. § 884.1690. The government’s theory—that mere “insanitary conditions” or lack of reprocessing labeling creates criminal adulteration/misbranding even without proof of actual patient use—directly contradicts the FDA’s own definitions and enforcement policies, which require prior patient use for a device to qualify as “reprocessed.”

Dr. Kumar’s outpatient clinic was investigated and cleared by the Tennessee Medical Board. The government itself acknowledged at trial that practices at the clinic changed after execution of the search warrant. Dr. Kumar never admitted reuse, and the jury was never asked to determine whether any single-use device had actually been used on a patient.

Relief Requested and Next Steps

The motion asks the Court to strike the jury’s verdict as a miscarriage of justice and remit the matter to the FDA, or in the alternative, to allow Dr. Kumar to remain on bond pending appeal and/or a 2255 habeas corpus proceeding. Counsel has requested an expedited hearing prior to the July 7, 2026 sentencing enhancements hearing, noting that resolution will conserve judicial resources.

“This case presents an unusual question concerning the relationship between the Department of Justice’s criminal theory and the FDA’s own regulatory framework governing medical devices,” the motion states. “And this motion concerns a single question: whether the Department of Justice may obtain a criminal conviction under the Federal Food, Drug, and Cosmetic Act using a theory that conflicts with the FDA’s own published regulatory framework governing single-use medical devices. It can’t.”

Patient advocates, legal scholars, and regulatory experts across the country are closely watching this case, warning that allowing the DOJ to override the FDA’s carefully constructed safe harbors for outpatient physicians threatens the rule of law and chills legitimate medical innovation and access to care in community settings nationwide.

About Dr. Sanjeev Kumar

Dr. Sanjeev Kumar is a Mayo Clinic-trained gynecologic oncologist and prominent Memphis robotic surgeon specializing in gynecologic cancer surgery and minimally invasive procedures for the early detection and treatment of uterine and endometrial cancers, as well as benign conditions such as fibroids and polyps. He has dedicated his career to expanding access to advanced diagnostic care for patients in Memphis, Tennessee, including a majority Black patient population historically underserved by sophisticated gynecologic oncology services.

Media Contact: 

Sanjeev Kumar, MD Board Certified Gynecological Oncologist & Pelvic Surgeon, Poplar Ave Clinic, PLLCGynecological Oncology & Pelvic SurgeryE: sanje45@gmail.comC: 248-924-17916584 Poplar Ave, Suite 400, Memphis TN, 38138P: 901-300-6713 | F: 901-881-0337pac-md.com

“drug dealers in white coats” for what may actually be good-faith medical disagreements or errors..”

…from Ruan vs. United States Case 21-1014

🔓 🔓 🔓 

ALL WATCHED OVER BY MACHINES OF LOVING GRACE

ALL WATCHED OVER BY MACHINES OF LOVING GRACE

BE SURE TO DONATE TO THE MARK IBSEN GOFUNDME DEFENSE FUND, WHERE THE SON ALWAYS RISES!!!

FOR NOW, YOU ARE WITHIN

THE NORMs

REFERENCES:

FDA DOCUMENT U.S. VS. KUMAR

1. This document details internal communications and investigative updates from the FBI Laboratory and the Department of Health and Human Services. Forensic logs indicate that specific DNA testing requests were declined because the biological samples were not suitable for the laboratory’s standard processing requirements. Additional records from the Office of Inspector General highlight an ongoing investigation into the reuse of adulterated medical devices by a specific healthcare provider. While initial screenings by the FDA suggested the presence of contaminants, subsequent laboratory analysis failed to detect human hemoglobin on the analyzed swabs. Ultimately, the records track the chain of custody and the evidentiary challenges faced during this multi-agency inquiry into medical equipment safety.

U.S. VS. KUMAR CDC Guideline for Disinfection and Sterilization in Healthcare Facilities

2.This comprehensive CDC guideline provides a rigorous, evidence-based framework for the cleaning, disinfection, and sterilization of medical equipment and environmental surfaces within healthcare settings. By employing the Spaulding classification scheme, the text categorizes medical items as critical, semicritical, or noncritical based on their infection risk, thereby dictating whether they require absolute sterilization or varying levels of chemical disinfection. The document details the efficacy and application of numerous germicides, such as glutaraldehyde and hydrogen peroxide, while addressing the specific challenges posed by emerging pathogens, antibiotic-resistant bacteria, and complex instruments like endoscopes. Ultimately, the guide serves as a vital safety manual intended to prevent healthcare-associated infections by ensuring that medical personnel strictly adhere to standardized reprocessing protocols and regulatory requirements.

“Timid women prefer the calm of Despotism to the tempestuous Sea of Liberty”

….norman j clement dds.