## Facts

- Automated Medical Laboratories, Inc. (AML) owned and operated Richmond Plasma Corporation (RPC), a commercial plasmapheresis facility subject to extensive FDA regulation, licensing, and recordkeeping requirements.
- AML maintained a compliance function that inspected RPC and prepared the facility for anticipated FDA inspections.
- The government alleged that AML personnel, acting through RPC and AML’s compliance staff, directed or encouraged falsification of required logbooks and records to conceal regulatory violations from the FDA.
- Evidence at trial indicated that employees were instructed to make record entries appear compliant even when actual procedures deviated from FDA rules, and that the practice continued over time.
- RPC employees ultimately reported misconduct to the FDA, triggering an investigation.
- A grand jury indicted AML, RPC, and individual managers for conspiracy and for making and using false documents within federal agency jurisdiction.
- After a jury trial, AML was convicted of one count of conspiracy (18 U.S.C. § 371) and three counts of making and using false documents (18 U.S.C. § 1001), and fined.

## Issues

1. Whether the preindictment delay violated due process because it caused actual prejudice and resulted from an improper prosecutorial motive.
2. Whether alleged prosecutorial misconduct (including bill-of-particulars/discovery disputes and questioning at trial) denied AML a fundamentally fair trial.
3. Whether the evidence was sufficient to support AML’s convictions, including whether employees’ acts and intent could be imputed to the corporation.

## Decision

- The Fourth Circuit affirmed AML’s convictions on all counts.
- The court held that AML failed to show actual, substantial prejudice from the preindictment delay and failed to show the delay was used to gain a tactical advantage.
- The court found no misconduct warranting reversal; any arguable misimpressions from questioning were addressed by the trial court through rulings and instructions, and the government’s disclosures were sufficient for trial preparation.
- The court held the evidence sufficient for a reasonable jury to find AML guilty beyond a reasonable doubt, including under corporate criminal liability principles.

## Legal Principles

- Preindictment delay violates due process only if the defendant shows (1) actual, substantial prejudice to the defense and (2) that the government intentionally delayed to gain a tactical advantage; investigative complexity and administrative review can be legitimate reasons for delay.
- Prosecutorial misconduct requires reversal only when it so infects the trial with unfairness that the resulting conviction denies due process; curative actions by the trial court may defeat prejudice.
- A corporation may be held criminally liable for acts of its agents when the agents act within the scope of employment and at least partly for the corporation’s benefit, including in conspiracy and false-statement prosecutions involving regulatory recordkeeping.

## Conclusion

The Fourth Circuit upheld AML’s conspiracy and false-document convictions arising from falsified FDA-regulated records, concluding that preindictment delay did not violate due process, alleged prosecutorial errors did not render the trial fundamentally unfair, and the evidence supported corporate liability based on employees’ acts within their duties and for corporate benefit.


United States v. Automated Med. Labs., Inc., 770 F.2d 399 (4th Cir. 1985)