Takeaway
In short, this case established that the FDCA can impose strict criminal liability on corporate officials who stand in a responsible relation to the distribution of adulterated or misbranded products, placing consumer protection ahead of a traditional requirement of personal knowledge or intent.
Buffalo Pharmacal Company, a drug jobber, bought drugs from manufacturers, repackaged them under its own label, and shipped them in interstate commerce. The Government charged both the corporation and its president and general manager, Joseph Dotterweich, with introducing misbranded and adulterated drugs into interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).
Three counts went to the jury: two involving misbranded drugs and one involving an adulterated drug. The jury failed to reach a verdict as to the corporation but convicted Dotterweich on all three counts. The Court of Appeals found the evidence sufficient to establish adulteration and misbranding, but reversed Dotterweich's conviction. It concluded that the Act ordinarily made only the corporate entity liable, absent proof that the corporation was merely Dotterweich's alter ego. The Supreme Court granted certiorari and reversed.
Issue #1
Whether the evidence was sufficient to support findings that the drugs were adulterated or misbranded.
Holding
Yes. The Court accepted the Court of Appeals' conclusion that the evidence adequately supported those findings.
Reasoning
The Supreme Court treated the factual sufficiency question as settled by the Court of Appeals' determination that the record supported the verdicts of adulteration and misbranding. Its analysis therefore focused on whether Dotterweich, as a corporate officer, could be criminally liable for the unlawful shipments.
Issue #2
Whether § 305 of the FDCA required the Administrator to give Dotterweich an opportunity to present his views before the Government could prosecute him.
Holding
No. A pre-prosecution opportunity to present views was not a prerequisite to prosecution.
Reasoning
The Court relied on United States v. Morgan, which had construed materially similar provisions in the 1906 food and drug law. The legislative history of the 1938 Act showed that Congress changed the wording without intending to alter that established rule.
Issue #3
Whether the jury's failure to convict Buffalo Pharmacal barred Dotterweich's conviction for the same shipments.
Holding
No. The verdicts could stand despite their apparent inconsistency.
Reasoning
Under Dunn v. United States, a jury's acquittal or failure to convict one defendant does not invalidate its conviction of another. The different results may reflect compromise, carelessness, or a judgment that the responsible individual, rather than the corporation, should bear the punishment; none of those possibilities defeats the individual conviction.
Issue #4
Whether a corporate president and general manager may be convicted under the FDCA for causing adulterated or misbranded drugs to enter interstate commerce, even without proof that he knew of the violations or personally participated in the shipments.
Holding
Yes. A corporate officer who has a responsible share in furthering an unlawful distribution may be criminally liable under the FDCA, even though the statute does not require awareness of wrongdoing.
Reasoning
The FDCA makes any "person" who violates its prohibition on introducing adulterated or misbranded drugs into interstate commerce guilty of a misdemeanor. Although the Act expressly includes corporations within the definition of person, corporations can act only through natural persons. The Court therefore rejected the view that corporate status immunizes the individuals through whom the corporation carries out the prohibited distribution.
reasoning_placeholder