The Park Doctrine

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The Park Doctrine Issue Concerning FDA’s prosecution of individuals for Corporate Misconduct, Park Doctrine, how does this legal doctrine implicate those who market to Corporations that manufacture FDA regulated products? Brief Answer Lubrizol’s Corporate Officers’ overall exposure to liability under the Park Doctrine would be limited. Our role as a supplier of raw materials to corporations that manufacture FDA Regulated Products insulates us from the Park Doctrine. While we supply raw materials to corporations whose products are regulated by the FDA, we play no role in the final manufacturing and/or use of those products. Facts The Park Doctrine, U.S. v. Park 421 U.S. 658, 95 S.Ct. 1903, is used to criminally prosecute Corporate Officers of manufacturers for alleged violations of the Federal Food, Drug, and Cosmetic Act, regardless of whether the officer is aware of the existence of a violation, as long as the officer holds a position of responsibility so that that individual could have initiated preventive or corrective action and, for whatever reason, failed to do so. Discussion Park Doctrine In U.S. v. Park 421 U.S. 658, 95 S.Ct. 1903 the president, John Park, of a large national food chain was convicted in U.S. District Court of causing adulterated food which had traveled in interstate commerce and which was held for sale. The case wound its way to the United States Supreme Court. Mr. Park and Acme Markets were charged with violating 301(k) of the Federal Food, Drug and Cosmetics Act, alleging that that Acme’s Baltimore Warehouse was exposed to rodent contamination. The trial court in its jury instructions instructed that although Mr. Park had not personally participated he had ‘a responsible relationship’ to the issue. Mr. Park was convicted and upon appeal the conviction was reversed. The appeals court stated that while the statute addressed the

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