Document 6wL8jxQG2wOxJo82Ejj4aqoVd

*1 I I I I J 1 > t The Park Case By RICHARD A. MERRILL Mr. Merrill U Chief Counsel of the Food ond Drug Administration. ISCUSSION OK THE PARK CASE1 is an open invitation to Dhyperbole from both the critics and the defenders of Mr. Chief Justice Burger's decision. Representatives of the Food and Dtu Administration (FDA) might be expected to call forth Justice Frank furter's vivid statements of the high purposes of the Food and Drug Act. Advocates of acquittal, much in the nature of a second appeal to the jury, will invoke the `'fundamental principles of AngloAmerican jurisprudence" and the spirit of the founding fathers. This discussion will be more useful, however, if its tone is more skeptical Let me begin in this vein by wondering, only half facetiously, why the Pork decision has been marie the focus of a panel on the FDA's enforcement policies Not that the role of criminal prosecu tion in the enforcement of laws intended to protect consumers is not an important subject. But one may justifiably question how much the Pork decision has to contribute to the topic. People talk about the Park decision, in either hushed or angered tones, as if it had come as n surprise. Vet. since HW. federal law has imposed strict liability on producers of food and drugs. That policy was consciously reasserted by Congress in 193S. And in the famous Aottenccieh ease in l'MT* the Supreme Court confirmed that Com press' judgment was both sensible and constitutional. Indeed. Chief Justice Burger himself spends a good portion of his opinion in P,:nl* explaining that criminal liability without proof t>f "awnreacs- of some wrongdoing" i.. by no means m\cl. * V. S. r. Pork. 95 S. Ci. 1903 (1975b * V. S. v. Dettm.-.-irb. 520 U. sTSJ (1943). Til k takk cask rxr.r CS3 VC3130 m?<^;m.teM, pRsfactdandgOrder1/11X)0in RcMvCfinocn f9tU M 7r/l don #97-7949 14lfcJudicial District Court, Stateof Louisiana. All claims f privilege. ^ N rk product and confidentiality rejerved in i l l other mitten. j t Facts of the Case justice Burger's opinion, to be sure, contains some fine round words, but they do not account for the stir the Perl- decision has caused. Nor, I submit, do the facts of the case. Very few people have seriously suggested that Mr. I'ark was unjustly convicted of a misdemeanor. Consider what the gov ernment was able to prove at the trial: (1) FDA inspectors had, on three separate occasions, discovered serious sanitation violations in warehouses operated hv Acme Super markets. It has never been suggested that no violations of law occurred. (2) The last two inspections conducted by the FDA were of the same Baltimore warehouse . . . demonstrating either a persistent problem, or a persistent indifference to its solution. (3) Mr. Park acknowledged that not only was warehouse sani tation one of the matters for which he accepted rcs|>ousibility, but that he had specifically delegated to subordinates the job of solving the problem in Baltimore. (4) Mr. Park was aware that the problem, discovered first in Philadelphia and subsequently in Baltimore, was not being solved or, at least, was continuing. He was. in short, on notice that his "system" was not working. In the face of this evidence, under the standard announced in Dottcnvcich, it cannot be a surprise that the jury convicted or that the Supreme Court affirmed. Strict Criminol Liability 1 do not want to be understood as denigrating the efforts of the Supreme Court on our behalf. The Park opinion is a workman like product, and it reconfirms both the importance and the legitimacy of Strict criminal liability for violation* of the Federal Food. Drug and Cosmetic Act. But it is also an unsatisfactory decision in sonic ways, for it leaves troubling questions unanswered. Two that come quickly to mind arc: 01 the Court's failure to 'explain precisely what the government must show tn establish that a defendant had a "reasonable relation*' to the vhdations charged; and (2) the Court's cursory treatment what is h*cimiiig known as the "impossibility" defense. I'aok f>Rt Koon mere rosMn ir law j or ts n at.--okckmuk*. 1075 VC3131 .I <I II 1 1 Two cases now before the Ninth Circuit Court of Appeals, Storr and Hota, will soon speak to the latter issue. Therefore, 1 shall not explore it further. On the former issue, which is really the heart of the matter, the Court says essentially that the facts proved by the government in Park clearly demonstrated such a relationship and that the jury instructions, though perhaps lacking in specificity, were adequate to focus the jury's attention on the facts before it. Jt may not, however, be possible to do much better with this issue. We struggle very hard in reviewing proposed prosecutions to satisfy ourselves that the evidence of individual involvement--of op portunity to know and ability to prevent or correct--is adequate enough to justify prosecution. We are attempting to articulate and publish criteria for recommending prosecution, because we recognize that the uncertain scope of the Park -decision--indeed, of the Act it self--imposes on us an obligation to deploy this ultimate sanction with great care. Basic Ground Rules The government's brief in the Park ease identifies certain basic ground rules. First, we almost always will include one or more indi viduals as defendants: corporations alone do not commit crimes. ^ the same time, we will not include individuals who lack authority to prevent or correct violations or who could not be expected to have been aware of violations in the reasonable exercise of their corporate duties. And. even if investigation discloses the element:* *{ liability, ordinarily we do not recommend prosecution unless the defendant, after learning of the violations, fails to correct them or to make changes to prevent their recurrence. Our standards for reference of eases to the Department of Justice focus on continuing violations, on violations of an obvious and fla grant nature and on intentionally false or fraudulent violations. These criicria may sound too flexible but. in practice, they pro duce a high degree of continuity and consistency in otir recommenda tions. Moreover, it is important to recognize that the pmseeutory function inevitably entails the exercise of judgment. The scope of our discretion under Park is not. 1 submit, notably different than thglexercised by most local prosecutors. This leaves the centra! issue of whether strict, though not abso lute. criminal liability is an appropriate feature of a scheme for regu- TIIK f-AKK CASK FAGF. 6S5 VC313? ) ) lating foods, pharmaceuticals, and medical equipment. In my view, the answer is self-evident. The other sanctions provided by the Act or provitiablc by Congress--would not by themselves assure the degree of punctilious concern for product integrity and safety to which con sumers are entitled and too often fail to receive. Testimony Before Congress The point has since been more eloquently, but never more force fully, stated than by Charles Wesley Dunn, who testified before Congress in 19-IS on brhalf of the Grocery Manufacturers of America, the American Pharmaceutical Manufacturers Association and the New York State Bar Association, The occasion was a hearing to consider a bill to amend tlie criminal liability provisions of the Act. a bill inspired bv reaction to the Dottcnveich decision. On that oc casion, Mr. Dunn declared: "It has always been the situation under the Food and Drug Law . . . that intent is not an essential ingredient of the olTcnsc. If you make it so. you simply nullify, iu effect, the practical value of these laws." Congress wisely listened to Mr. Dunn then. The jury is atilt out on whether Congress will exhibit the same wisdom this time around. The proposed Consumer Fi/od Act. recently rcjtortcd by the Senate Commerce Committee, includes a provision that wou'd re quire the FDA to prove that a defendant charged with violating the food provisions of the Act did so knowingly, willfully or negligently. And it is widely rumored that the House Cominiitri* mi Interstate and Foreign Commerce will be invited, and possihh persuade.!, to amend the device hill so as to limit criminal liability to cn>e$ in which the FDA could prove that the defendant acted knowingly or willfully. The latter of these proposals would, in Mr. Dunn's words, "sim ply nullify . . . the practical value" of the Federal Food. Drug and Cosmetic Act. The former, though less destructive of the Act's haste purjsnscs. represents a fundamental shift in Congressional philosophy respecting consumer safety. And only Congress could then answer for the practical effect of its adoption on the willingness of individuals engaged in the production of food, drugs, devices and cosmetics to make the cninnmmem necessary to guarantee that their jm<tucls are safe (The End] PAGE 6% roou OKl'C. COSMETIC LAW JOO'RN'AI.--DKCKMHint, 1975 VC.3133 Froduced>ulcrOvderlAtitX>inEfiBU^2IUXS *90-4837dw]ja&lD 4*97-7949 i4 ih Judicial District Court, State of Louisiana. A il claims o f privilege, w o rt product and confidentiality reserved in all other matters.