Document Library — Federal Counterfeit Drug Prosecutions

In the age of the Internet, trying and convicting drug counterfeiters often involves resource-intensive investigation across multiple jurisdictions and even when those resources are available, current laws and regulations aren't always enough to deter these criminals' activity.  Determined prosecutors employ a range of laws to bring these charges—including violations of the Food Drug and Cosmetic Act and the Federal Controlled Substances Act, and criminal codes that address fraud, counterfeiting, theft and money laundering.

In this ongoing project, PSM is gathering court documents that offer insight into how prosecutors have approached these cases. We've started with federal cases, but plan to expand into state prosecutions in the future.

Recent additions

Cases we are following

Case overview, USA v Capsulcn International Co Ltd et al

In May 2025, the U.S. District Court in the Western District of Texas unsealed an indictment against a CapsulCN International and three Chinese nationals for their alleged role in the illegal importation of pill-making equipment.

Case overview, Gilead Sciences v Heal the World et al

Gilead Sciences has filed a civil complaint against a Queens, New York-based pharmacy that allegedly sold counterfeit HIV medicine.

Case overview, USA v Xiaofei Chen

Xaiofei "Sophie" Chen pleaded guilty to illegally importing a pill press and a counterfeit pill mold in April 2025. The Chinese national worked for CapsulCN, which is under indictment for pill press trafficking.

Food and Drugs violations

Unapproved drugs / devices

Read the statutes: 21 USC §§ 331(i)(3) and 333(a)(2)


Prescription Drug Marketing Act violations

Read the statute: Pub. L. 100–293, §1(a)


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Indictment, USA v Lindsay Marie Clark, April 2021

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Sentencing Memo, USA v Lindsay Marie Clark, April 2023

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Second Superseding Indictment, USA v Bruce Holder, August 2019

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Jury Instructions, USA v Bruce Holder, April 2021

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Indictment, USA v Lazaro Hernandez, June 2022

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Factual Basis for Guilty Plea, USA v Lazaro Hernandez, April 2023

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Indictment, USA v Steven Diamantstein, June 2023

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U.S. Sentencing Memo, USA v Tien Tan Vo, October 2023

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Information, USA v Tien Tan Vo, October 2023

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Defendant’s Sentencing Memo, USA v Tien Tan Vo, October 2023

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