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United States v. Automated Medical Laboratories, Inc.

770 F.2d 399 (4th Cir. 1985)

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United States v. Automated Medical Laboratories, Inc.

United States Court of Appeals for the Fourth Circuit

770 F.2d 399 (4th Cir. 1985)

Facts

Automated Medical Laboratories, Incorporated (AML) (defendant) owned and operated Richmond Plasma Corporation, a commercial plasmapheresis center. Richmond Plasma collected and sold plasma. Hugo Partucci, Noberto Queris, and Pedro Ramos (defendants) all managed or oversaw Richmond Plasma’s compliance with Food and Drug Administration (FDA) regulations. The three men served in various roles for AML and Richmond Plasma with respect to FDA compliance. Led by Partucci, AML’s compliance team regularly inspected Richmond Plasma in advance of FDA inspections. When problems were found, the compliance team often instructed Richmond Plasma employees to falsify records in order to protect the company from the FDA finding violations. The falsification of records continued even after Partucci left AML. Eventually, Richmond Plasma employees reported the misconduct to the FDA. The FDA commenced an investigation. Soon after, compliance-team members reported the misconduct to a vice president at AML. The FDA completed its investigation, which ultimately resulted in criminal prosecution of AML, Richmond Plasma, Partucci, Queris, and Ramos. AML was convicted of one count of conspiracy and three counts of making and using false documents. AML appealed to the United States Court of Appeals for the Fourth Circuit.

Rule of Law

Issue

Holding and Reasoning (Sneeden, J.)

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