The informations were based on § 301 of that Act (21 U.S.C. § 331), paragraph (a) of which prohibits "The introduction or delivery for introduction into interstate commerce of any … drug … that is adulterated or misbranded." "Any person" violating this provision is, by paragraph (a) of § 303 (21 U.S.C. § 333), made "guilty of a misdemeanor." Three counts went to the jury — two, for shipping misbranded drugs in interstate commerce, and a third, for so shipping an adulterated drug.

The jury disagreed as to the corporation and found Dotterweich guilty on all three counts. “For some unexplainable reason” (see United States v. Buffalo Pharmacal Co.) the jury disagreed as to the corporation's guilt. 

The Circuit Court of Appeals, one judge dissenting, reversed the conviction on the ground that only the corporation was the "person" subject to prosecution unless, perchance, Buffalo Pharmacal was a counterfeit corporation serving as a screen for Dotterweich. On that issue, after rehearing, it remanded the cause for a new trial. 

The Supreme Court addressed whether the president/general manager of a corporation, as well as the corporation itself, could be liable under the Food, Drug, and Cosmetics Act of 1938 (the Act), which imposed criminal liability on ‘[a]ny person’ shipping adulterated or misbranded drugs.

The Supreme Court disagreed with the federal appellate court, and held that the offense is committed by all who have a responsible share in the furtherance of the transaction which the statute outlaws, namely, to put into the stream of interstate commerce adulterated or misbranded drugs.

Central to the court's holding was that the Act was public welfare legislation and the statute imposed strict liability. Specifically, it was noted that Food and Drugs Act of 1906 was an exertion by Congress of its power to keep impure and adulterated food and drugs out of the channels of commerce, and that by an Act of 1938, Congress extended the range of its control over illicit and noxious articles and stiffened the penalties for disobedience.

The Supreme Court also emphasized that the Act allowed for criminal conviction without proof of awareness of some wrongdoing, and thus put the burden of acting at hazard upon a person otherwise innocent but standing in responsible relation to a public danger.

The Supreme Court further explained why Dotterweich, and not just the corporation, was liable: “The statute makes ‘any person’ who violates § 301 (a) guilty of a ‘misdemeanor.’ It specifically defines ‘person’ to include "corporation." But the only way in which a corporation can act is through the individuals who act on its behalf.” In addition, “[i]f, then, Dotterweich is not subject to the Act, it must be solely on the ground that individuals are immune when the "person" who violates [the Act] is a corporation, although from the point of view of action the individuals are the corporation.”

Using this reasoning, the court found that Dotterweich had a responsible share in the furtherance of the transaction which the statute outlaws, namely, to put into the stream of interstate commerce adulterated or misbranded drugs. This was held despite the fact that he had no personal connection with either shipment of misbranded and adulterated drugs and was simply in general charge of the corporation's business and had given general instructions to its employees to fill orders received from physicians.