John D.W. Partridge

Partner, Washington, D.C.

+1 303.298.5931

John Partridge, a Co-Chair of Gibson Dunn's FDA and Health Care Practice Group and Chambers-ranked white collar defense and government investigations lawyer, focuses on government and internal investigations, white collar defense, and complex litigation for clients in the life science and health care industries, among others. John has particular experience with the Anti-Kickback Statute, the False Claims Act, the Foreign Corrupt Practices Act, and the Federal Food, Drug, and Cosmetic Act, including defending major corporations in investigations pursued by the U.S. Department of Justice (DOJ) and the U.S. Securities and Exchange Commission (SEC). In its rankings, Chambers & Partners has reported that John's clients regard him as a "smart and strategic tactician," "incredibly responsive and thorough," and "extremely knowledgeable." In 2022, John was recognized by BTI as a Client Service All-Star.

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Introducing Biotech Briefings

March 3, 2025 | Posted by Branden C. Berns; Aaron K. Briggs; Jane M. Love, Ph.D.; Mary Beth Maloney; Ryan A. Murr; Melanie E. Neary; John D.W. Partridge; Karen A. Spindler; Eric J. Stock; Todd J. Trattner; Stephen Weissman; Topic(s): Trends and Insights

Dear friends and colleagues,

We are excited to introduce Biotech Briefings, providing Gibson Dunn’s commentary and perspectives on the legal, business, and regulatory issues shaping the life sciences industry.

From groundbreaking developments in biopharma, medical devices, and diagnostics to the evolving landscape of IP, FDA and SEC regulation, Biotech Briefings delivers timely insights for companies, investors, and industry stakeholders.

Stay tuned for expert analysis on:

Key FDA, FTC & SEC developments
M&A, financing & strategic partnerships
Market dynamics shaping investment & innovation

We invite you to follow along for actionable insights at the crossroads of law, business, and science.

The Gibson Dunn Life Sciences Team

False Claims Act Risks for Cyber Device Manufacturers Arising under New Requirements Subject to FDA Enforcement Beginning October 1, 2023

October 16, 2023 | Posted by Gustav W. Eyler; John D.W. Partridge; Topic(s): False Claims Act; FDA Guidance

The False Claims Act (FCA) is one of the government’s chief tools to address false claims involving government funds, imposing liability on “any person who… knowingly presents, or causes to be presented, a false or fraudulent claim for payment” to the federal government or who “knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim.”[1] Through its qui tam provisions, the FCA also allows private citizens to file suit on behalf of the government for statutory violations.[2]

FDA Publishes Proposed Rule Asserting Medical-Device Jurisdiction over Laboratory-Developed Tests

October 9, 2023 | Posted by Gustav W. Eyler; John D.W. Partridge; Topic(s): FDA Guidance

On September 29, 2023, the U.S. Food and Drug Administration (FDA) released its highly anticipated proposed rule on laboratory-developed tests (LDTs) (“LDT Proposed Rule”), which was officially published in the Federal Register on Tuesday, October 3, 2023.[1] In the LDT Proposed Rule, FDA announced plans to formally classify LDTs as medical devices under its regulations, subjecting these tests to extensive premarket review and postmarket compliance requirements. If finalized, the LDT Proposed Rule would result in a significant impact to the growing laboratory testing industry.

FDA Draft Guidance Sheds Light on Agency’s Evaluation of Prescription Drug Use-Related Software

September 29, 2023 | Posted by Gustav W. Eyler; John D.W. Partridge; Topic(s): FDA Guidance

The U.S. Food and Drug Administration (FDA) recently published a draft guidance document proposing to regulate end-user output of prescription drug use-related software (PDURS) as labeling.[1] The draft guidance sets forth review pathways that could benefit prescription drug application sponsors, including by allowing sponsors to incorporate information about PDURS in the FDA-approved labeling and to seek premarket review for certain PDURS functions that meet the definition of a medical device. But by proposing to regulate PDURS-related information as labeling, the draft guidance poses potential enforcement risks for sponsors under the Federal Food, Drug, and Cosmetic Act (FDCA), the False Claims Act (FCA), and other laws, including through possible off-label promotion claims. Interested parties should consider submitting comments to FDA on the draft guidance. FDA has invited comments through December 18, 2023.