Document KnR5X3ZnXLZGzeQzx5LRnXKK

',**!*** The Park Case By RICHARD A. MERRILL Mr. Merrill Is Chief Counsel of the Food and Drug Administration. DISCUSSION OF THE PARK CASE1 is ail open invitation to hyperbole from both the critics and the defenders of Mr. Chief Justice Burner's decision. Keprcscntatives of the Food and Drug 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 tltc 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 ha been marie the focus of a panel on the FDA's enforcement policies Not that the role o: 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 a surprise. Yet. since lf*0fi. federal law has imposed strict liability on producers of food and drugs. That policy was consciously reasserted by Congress in 19.18. And in the famous tioUemvirh ease in 1^.1.5 the Supreme Court confirmed that Con gress' judgment was both sensible and constitutional. Indeed. Chief Justice Burger himself spends a good portion of his opinion in Park explaining that criminal liability without proof *f "awarcnc." of some wrongdoing" i> hv no means novel. * U. S. r. Pori. 95 S. Ct. 1903 0975). ' V. S. V. (1W3). 320 U. S. 277 T1IIC TAkK CASF. rAr.r CP3 a'Sw *S3 Ba C J i*Ch y* m rt S C VC31 t } t Facts of the Case Justice Burger's opinion, to be sure, contains some fine round words, but they do not account fur the stir the Park 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 whai the government was able to prove at the trial: (1) FDA inspectors had, on three separate occasions, discovered serious sanitation violations in warehouses operated by Acme Super markets. It has never been suggested that no violations of bw 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 lie accepted responsibility, 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 Dottenvcich, it cannot be a surprise that the jury convicted <t that the Supreme Court affirmed. 2 Strict Criminal Liability I 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 violations of the Federal Food. Drug and Cosmetic Act. But it is also an unsatisfactory decision in some ways, for it leaves troubling questions unanswered. Two that come quickly to mind arc: flf the Court's failure to `explain precisely what the government must show t<> establish that a defendant had a "reasonable relation" to the violations charged; and (2) the Court's cursory treatment of what is becoming known as the "impossibility" defense. rAr.KfiSl toon user. COSMn ir i.au joi'kxai.--hm*k.mi:kk. 1075 VC3131 Two cases now before the Ninth Circuit Court of Appeals, Starr and Mata, 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. It may not, however, be iiossible 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 wc recognize that the uncertain scope of the Pari: decision--indeed, of the Act it self--imposes on us an obligation to deploy this ultimate sanction with great care. ProducedunderOrder l/l 1A)0in Romy.Comop #9(M8J7g*wUndan 097-7949 H ill Judicial District Court, State of Louisiana. All claims of privilege, mirk product ind confidentiality reserved in all other mailer*. % Basic Ground Rules The government's brief in the Park case identifies certain basic ground rules. First, wc almost always will include one or more indi viduals as defendants: corporations alone do not commit crimes, tjie 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 tl.c element." of 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 cases 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 criteria may sound too flexible but. in practice, they pro duce a high degree of continuity and consistency in our recommenda tions. Moreover, it is important to recognize that the prosecutorv function inevitably entails the exercise of judgment. The scope of our discretion under Park is not. I submit, notably different than th.1t, exercised by most local prosecutors. J This leaves the central issue of whether strict, though not abso lute. criminal liability is an appropriate feature of a scheme for regu- TIIK AVK CASK tact. 6SS VC313? PrefacedimdeeOfdert/1 I/nOinKnau Cnnnra JQrUWO^itt Mutton&7-T949 14th judicial District Court, State of Louisiana. All claims of privilege, work product and confidentiality reserved in all other matters. lating foods, pharmaceuticals, and medical equipment. In my view, the answer is self-evident. The other sanctions provided by the Act-- or providable 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 194S on behalf 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 the criminal liability provisions of the Act. a bill inspired by reaction to the Doltcmvich 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 essentia! ingredient of the oiTcnse. If yon make it so. you simply nullify, in effect, the practical value of these laws." Congress wisely listened to Mr. Dunn then. The jury is still out On whether Congress will e,\hibit the same wisdom this time around. The proposed Consumer Food Act. recently reported hv the Senate Commerce Committee, includes a provision that woc'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 Committee on Interstate and Foreign Commerce will be invited, and possibW persuaded, to amend the device bill so as to limit criminal liability to en>es in which the FD.\ 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 oi the Act's basic purposes, 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 commitment necessary to guarantee that their products are *afc. [The End] J PACE CPC pooo Oki e cosmetic law journal--dkckmHint, 1975 V/C3133