More on….McNeil-PPC and Two of Its Officers (J&J)

More on….McNeil-PPC and Two of Its Officers (J&J)

United States v. Park, 421 U.S. 658 (1975)

More on….McNeil-PPC and two of its officers for failing to comply with current good manufacturing practice requirements as required by federal law.  The U.S. Supreme Court reversed a decision by the Court of Appeals in which the president of Acme Markets, Inc. was charged with causing “interstate food shipments being held in Acme’s Baltimore warehouse to be exposed to rodent contamination.”  Acme, but not the president, pleaded guilty.  “The trial court, inter alia, instructed the jury that, although respondent need not have personally participated in the situation, he must have had “a responsible relationship to the issue.”  To learn more about the impact this decision may have on McNeil-PPC’s two vice presidents, please review the additional summary below.  Please also post your comments.  Do you believe the FDA is overstepping its boundaries when it charged these two individuals?

United States v. Park

U.S. Supreme Court

No. 74-215

Argued March 119, 1975

Decided June 9, 1975

421 U.S. 658

Syllabus

Acme Markets, Inc., a large national food chain, and respondent, its president, were charged with violating § 301(k) of the Federal Food, Drug, and Cosmetic Act (Act) in an information alleging that they had caused interstate food shipments being held in Acme’s Baltimore warehouse to be exposed to rodent contamination. Acme, but not respondent, pleaded guilty. At his trial, respondent conceded that providing sanitary conditions for food offered for sale to the public was something that he was “responsible for in the entire operation of the company,” and that it was one of the many phases of the company that he assigned to “dependable subordinates.” Evidence was admitted over respondent’s objection that he had received a Food and Drug Administration (FDA) letter in 1970 concerning insanitary conditions at Acme’s Philadelphia warehouse. Respondent conceded that the same individuals were largely responsible for sanitation in both Baltimore and Philadelphia, and that, as Acme’s president, he was responsible for any result that occurred in the company. The trial court, inter alia, instructed the jury that, although respondent need not have personally participated in the situation, he must have had “a responsible relationship to the issue.” Respondent was convicted, but the Court of Appeals reversed, reasoning that, although this Court’s decision in United States v. Dotterweich, 320 U. S. 277, had construed the statutory provisions under which respondent had been tried to dispense with the traditional element of “awareness of some wrongdoing,'” the Court had not construed them as dispensing with the element of “wrongful action.” The Court of Appeals concluded that the trial court’s instructions

“might well have left the jury with the erroneous impression that [respondent] could be found guilty in the absence of ‘wrongful action’ on his part,”

and that proof of that element was required by due process. The court also held that the admission in evidence of the 1970 FDA warning to respondent was reversible error.

Held:

1. The Act imposes upon persons exercising authority and

Page 421 U. S. 659

supervisory responsibility reposed in them by a business organization not only a positive duty to seek out and remedy violations, but also, and primarily, a duty to implement measures that will insure that violations will not occur, United States v. Dotterweich, supra; in order to make food distributors “the strictest censors of their merchandise,” Smith v. California, 361 U. S. 147, 361 U. S. 152, the Act punishes “neglect where the law requires care, or inaction where it imposes a duty.” Morissette v. United States, 342 U. S. 246, 342 U. S. 255. Pp. 421 U. S. 670-673.

2. Viewed as a whole and in context, the trial court’s instructions were not misleading, and provided a proper guide for the jury’s determination. The charge adequately focused on the issue of respondent’s authority respecting the conditions that formed the basis of the alleged violations, fairly advising the jury that, to find guilt, it must find that respondent “had a responsible relation to the situation”; that the “situation” was the condition of the warehouse; and that, by virtue of his position he had “authority and responsibility” to deal therewith. Pp. 421 U. S. 673-676.

3. The admission of testimony concerning the 1970 FDA warning was proper rebuttal evidence to respondent’s defense that he had justifiably relied upon subordinates to handle sanitation matters. Pp. 421 U. S. 676-678.

499 F.2d 839, Reversed by U.S. Supreme Court.

BURGER, C.J., delivered the opinion of the Court, in which DOUGLAS, BRENNAN, WHITE, BLACKMUN, and REHNQUIST, JJ., joined. STEWART, J., filed a dissenting opinion, in which MARSHALL and POWELL, JJ., joined, post, p. 421 U. S. 678.

Page 421 U. S. 660

The full text may be found at the Web Site listed below:

http://supreme.justia.com/us/421/658/case.html