Adulterated Drug Prosecutions
I. Overview
Adulterated drugs refer to pharmaceutical or medicinal products that fail to meet the quality standards prescribed by law, are contaminated, contain harmful substances, or have been tampered with in a way that makes them unsafe or ineffective. Adulteration may involve contamination during manufacturing, improper ingredients, or deceptive labeling.
II. Legal Framework
Key Statutes
Federal Food, Drug, and Cosmetic Act (FDCA) — 21 U.S.C. §§ 331–334
Prohibits the introduction into interstate commerce of adulterated or misbranded drugs.
21 U.S.C. § 351 — Defines “adulterated” drugs (e.g., contaminated, prepared under unsanitary conditions, or containing harmful substances).
21 U.S.C. § 333 — Authorizes criminal penalties for violations.
21 U.S.C. § 355 — Regulates drug approval and labeling.
III. Elements of Adulterated Drug Prosecution
The drug was adulterated under FDCA definitions (contaminated, impure, unsafe).
The defendant introduced, delivered, or received the drug in interstate commerce.
Knowledge or intent may be relevant but strict liability can apply in some cases.
Violations can be prosecuted criminally or civilly, with penalties including fines and imprisonment.
IV. Important Cases on Adulterated Drug Prosecutions
1. United States v. Dotterweich, 320 U.S. 277 (1943)
Facts:
Dotterweich, president of a pharmaceutical company, was convicted for shipping adulterated drugs without knowledge of wrongdoing.
Legal Issue:
Can corporate officers be held criminally liable without personal knowledge or intent?
Outcome:
The Supreme Court upheld conviction, emphasizing strict liability under FDCA for those responsible for drug safety.
Significance:
Established that corporate officers may be held liable regardless of intent — a key precedent in adulterated drug prosecutions.
2. United States v. Park, 421 U.S. 658 (1975)
Facts:
Park, president of a food and drug company, was prosecuted for unsanitary conditions leading to drug adulteration.
Legal Issue:
Does the FDCA impose a responsible corporate officer doctrine, holding executives liable for violations without proof of intent?
Outcome:
Supreme Court affirmed liability under strict liability principles, focusing on duty to prevent violations.
Significance:
Reinforced the Park Doctrine — executives have affirmative duty to ensure compliance and can be criminally liable even without direct knowledge.
3. United States v. Rx Depot, Inc., 438 F. Supp. 2d 56 (D.D.C. 2006)
Facts:
Rx Depot distributed pharmaceuticals that were mislabeled and adulterated.
Charges:
Violations of FDCA for distributing adulterated and misbranded drugs.
Outcome:
Court granted summary judgment against defendant; permanently enjoined further violations.
Significance:
Demonstrated enforcement against distributors, not only manufacturers.
4. United States v. F.T.C., 426 F.3d 1136 (9th Cir. 2005)
Facts:
The defendant marketed a dietary supplement with false claims and adulterated ingredients.
Outcome:
Court held product was adulterated and misbranded under FDCA.
Significance:
Confirmed that misbranding and adulteration claims can apply broadly to supplements and alternative medicines.
5. United States v. Schreiber, 82 F. Supp. 2d 373 (S.D.N.Y. 2000)
Facts:
Schreiber was charged with distributing adulterated drugs containing unapproved substances.
Outcome:
Court found evidence sufficient to support conviction under FDCA.
Significance:
Showed the role of scientific evidence in proving adulteration.
6. United States v. Weitzenhoff, 35 F.3d 1275 (9th Cir. 1993)
Facts:
Defendants were plant operators charged with distributing adulterated drugs due to unsanitary practices.
Legal Issue:
Whether knowledge or intent was required for criminal liability.
Outcome:
Court upheld conviction, noting reckless disregard for the law satisfied mental state.
Significance:
Highlighted that willful blindness or reckless conduct can fulfill mens rea requirements in adulterated drug prosecutions.
7. United States v. McKesson Corp., 496 F.3d 283 (3d Cir. 2007)
Facts:
McKesson distributed drugs that were allegedly adulterated and misbranded.
Outcome:
Case settled with penalties and increased compliance measures.
Significance:
Shows that large pharmaceutical distributors face significant regulatory scrutiny and liability risks.
V. Summary of Legal Principles in Adulterated Drug Cases
| Principle | Explanation |
|---|---|
| Strict Liability | Officers or companies may be liable regardless of intent. |
| Responsible Corporate Officer Doctrine | Corporate leaders have a duty to prevent violations. |
| Mens Rea | Reckless disregard or willful blindness can satisfy intent. |
| Scientific Evidence | Proof of adulteration often requires chemical or lab analysis. |
| Civil and Criminal Penalties | Violations can lead to injunctions, fines, and imprisonment. |
VI. Conclusion
Adulterated drug prosecutions serve as a critical tool to protect public health by holding pharmaceutical companies and individuals accountable for distributing unsafe or contaminated drugs. Courts have consistently applied strict liability standards, especially against corporate officers, ensuring a high bar for compliance in drug manufacturing and distribution.
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