These BUSINESS LAW case problems must be completed by a someone with professional business law experience. Each question must be answered with clarity and detail and proper grammar. Total word count for all questions combined should equal 300 words. Case 34.1 Food Regulation Barry Engel owned and operated the Gel Spice Co., Inc. which specialized in the importation and packaging of various food spices for resale. All the spices Gel Sice imported were unloaded at a pier in New York City and taken to a warehouse on McDonald Avenue. Storage and repackaging of the spices took place in the warehouse. During three years, the McDonald Avenue warehouse was inspected four times by investigators from the Food and Drug Administration (FDA). The investigators found live rats in bags of basil leaves, rodent droppings in boxes of chili peppers, ad mammalian urine in bags of sesame seeds. The investigators produced additional evidence which showed that spices packaged and sold from the warehouse contained insects, rodent excreta pellets, rodent hair, and rodent urine. The FDA brought criminal charges against Engel and Gel Spice. Are they guilty? United States v. Gel Spice Co., Inc., 601 F.Supp. 1205, Web 1984 U.S. Dist. Lexis 21041 (United States District Court for the Eastern District of New York) Case 34.2 Regulation of Drugs Dey Laboratories, Inc. was a drug manufacturer operating in the state of Texas. Dey scientists created an inhalant known as ASI. The only active ingredient in ASI was altropine Sulfate. The inhanlant was sold to physicians, who then prescribed the medication for patients suffering from asthma, bronchitis, and other pulmomary diseases. Dey filed a new drug application with the Food and Drug Administration. Four months later, Dey was advised that its application would nmot be approved. In spite of the lack of FDA approval, Dey began marketing ASI. The United States filed a complaint for forfeiture of all ASI manufactured by Dey. The inhalant was seized, and Dey sued to have the FDA’s seizure declared illegal. Who wins? United States v. Atropine Sulfate 1.0 Mg. (Article of Drug), 843 F.2d 860, Web 1988 U.S. App Lexis 5817 (United States Court of Appeals for the Fifth Circuit) Case 34.3 Cosmetics Regulation FBNH Enterprises, Inc., was a distributor of a product known as “French Bronze Tablets.” The purpose of the tablets was to allow a person to achieve an even tan without exposure to the sun. When ingested, the tablets imparted color to the skin through the use of various ingredients one of which is canthaxanthin, a coloring agent. Canthaxanthin had not been approved for use by the Food and Drug Administration as a coloring additive. The FDA became aware that FBNH was marketing the tablets and that each contained 30 milligrams of canthaxanthin. The FDA filed a lawsuit seeking the forfeiture and condemmation of eight cases of the tablets in the possession of FBNH. FBNH challenged the government’s right to seize the tablets. Who wins? United States v. Eight Unlabeled Cases of an Article of Cosmetic, 888 F.2d 945, Web 1989 U.S. App. Lexis 15589 (United States Court of Appeals for the Second Circuit) 34.6 Clean Air Act Pilet Petroleum, Associates, Inc. and various affiliated companies distributed gasoline to retail gasoline stations in the state of NY. Pilot owned some of these stations and leased them out to individual operators who were under contract to purchases gasoline from Pilot. The EPA took samples of gasoline from five different service stations to which Pilot had sold unleaded gasoline. These samples showed the Pilot had delivered “unleaded gasoline that contained amounts of lead in excess of that permitted by the Clean Air Act and EPA regulations.” The US brought criminal charges against Pilot for violating the act and EPA regulations and sought fines from Pilot. Who wins? United States v. Pilot Petroleum, Associates, Inc., 712 F.Supp 1077, Web 1989 U.S. Dist. Lexis 6119 (United States District Court for the Eastern District of New York) 34.9 Clean Water Act The Reserve Mining Company owned and operated a mine in Minnesota that was located on the shores of Lake Superior and produced hazzardous waste. In 1947, Reserve obtained a permit from the state of Minnesota to dump its wasts into Lake Superior. The permits prohibited discharges that would “result in any clouding of discoloration of the water outside the specific discharge zone” or “result in any material adverse affects on public water supplies.” Reserve discharged its wastes into Lake Superior for years. Evidence showed that the discharges caused discoloration of surface waters outside the zone of discharge and contained carcinogens that adversely affect public water supplies. The United States sued Reservde for engaging in unlawful water pollution. Who wins? United States v. Reserve mining Co., 543 F.2d 1210 Web 1976 U.S. App. Lexis 6503 (United States Court of Appeals for the Eighth Circuit) 34.10 Hazardous Waste Douglas Hoflin was the director of the Public Works Departmemt for Ocean Shores. Washington. During a period of seven years, the department purchased 3,500 gallons of paint for road maintenance. As painting jobs were finished, the 55-gallon drums that had contained the paint were returned to the department’s yard. Paint contains hazardous substances such as lead. When 14 of the drums were discovered to still contain unused paint, Hoflin instructed employees to haul the paint drums to the city’s sewage treatment plant and bury them. The employees dug a hole on the grounds of the treatment plant and dumped the drums in. Some of the drums were rusted and leaking. The hole was not deep enough, so the employees crushed the drums with a front-end loader to make them fit. The refuse was them covered with sand. Almmost two years later, one of the city’s employees reported the incident to state authorities, who referred the matter to the EPA. Investigation showed that the paint had contaminated the soil. The United States brought criminal charges against Hoflin for aiding and abetting the illegal dumping of hazardous waste. Who wins? Uited States v. Hoflin, 880 F.2d 1033, Web 1989 U.S. App. Lexis 10169 (United States Court of Appeals for the Ninth Circuit)
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