Source: http://openjurist.org/152/f3d/1050/symens-v-smithkline-beecham-corporation-sjovall
Timestamp: 2015-08-05 04:45:19
Document Index: 554311637

Matched Legal Cases: ['§ 151', '§ 1292', '§ 154', '§ 101', '§ 101', '§ 102', '§ 102', '§ 113', '§ 102', '§ 101', '§ 112', '§ 114', '§ 113', '§ 113', '§ 113', '§ 113']

152 F3d 1050 Symens v. Smithkline Beecham Corporation Sjovall | OpenJurist
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152 F3d 1050 Symens v. Smithkline Beecham Corporation Sjovall 152 F.3d 1050
Prod.Liab.Rep. (CCH) P 15,330Richard SYMENS; Joyce Symens, Plaintiffs--Appellees,v.SMITHKLINE BEECHAM CORPORATION, Defendant--Appellant.Ivan SJOVALL, Plaintiff--Appellee,v.SMITHKLINE BEECHAM CORPORATION, Defendant--Appellant.
Nos. 98-1055, 98-1056.
Submitted June 8, 1998.Decided Aug. 27, 1998.
Scott A. Smith, Minneapolis, MN, argued (Patrick A. Reinken and Duana J. Grage, Minneapolis, MN, and William F. Day, Jr. and R. Alan Peterson, Sioux Falls, SD, on the brief), for defendant-appellant.
James A. Davis, Fremont, NE, argued (Michael Dowd, Omaha, NE, and Danny R. Smeins, Britton, SD, on the brief), for plaintiffs-appellees.
Before LOKEN, GODBOLD,* and HEANEY, Circuit Judges.
In the last half of 1992, cattle feedlot operators Richard and Joyce Symens and Ivan Sjovall vaccinated their cattle with "BoviShield 4" and "Ultrabac-7/Somubac," vaccines manufactured by SmithKline Beecham Corporation (SBC). They commenced these diversity actions, alleging that the cattle "contracted debilitating and mortal infections and diseases" from the vaccines, and asserting South Dakota common law claims for strict liability, breach of implied warranties, false advertising, failure to warn, and fraud on the licensing agency. SBC moved for summary judgment, arguing that plaintiffs' claims are preempted by the Virus-Serum-Toxin Act (VSTA), 21 U.S.C. §§ 151-59. The district court denied the motion and certified the issue for interlocutory appeal under 28 U.S.C. § 1292(b). We reverse in part and remand.
VSTA authorizes the United States Department of Agriculture (USDA) to license and regulate the preparation and sale of "viruses, serums, toxins, and analogous products, for use in the treatment of domestic animals." 21 U.S.C. § 154. USDA has delegated this authority to its Animal and Plant Health Inspection Service (APHIS). See 9 C.F.R. § 101.2. APHIS in turn has "promulgated an extensive regulatory scheme governing the design, manufacture, distribution, testing, and labeling of animal vaccines." Lynnbrook Farms v. SmithKline Beecham Corp., 79 F.3d 620, 624 (7th Cir.1996), cert. denied, --- U.S. ----, 117 S.Ct. 178, 136 L.Ed.2d 118 (1996), citing 9 C.F.R. §§ 101-24.
APHIS licenses all animal vaccines and vaccine manufacturers. See 9 C.F.R. §§ 102.1, 102.2. The application for an animal vaccine license must include an"Outline of Production" that details the vaccine's composition, manufacture, preparation, testing, and packaging. See 9 C.F.R. §§ 102.3(b)(2)(i), 114.8-.9. The regulations detail ingredient requirements, such as the types of cell lines that must be used to produce biologics. See 9 C.F.R. §§ 113.50-.55. APHIS-mandated testing procedures ensure the "purity, safety, potency, and efficacy" of the vaccine. See 9 C.F.R. §§ 102.3(b)(2)(ii), 113.25-.55, 113.64-.332. APHIS approves all product labels and package inserts; even minor changes in label size and color must be resubmitted for review and approval. See 9 C.F.R. §§ 101.4, 112.5. Packaging must contain instructions, warnings, the license number, and prescribed storage temperatures. See 9 C.F.R. § 112.2(a). Once approved, the Outline of Production may not be changed without resubmission to APHIS. See 9 C.F.R. § 114.8(d). Before marketing, the manufacturer must test a licensed vaccine to ensure that it is "pure, safe, potent, and efficacious." 9 C.F.R. § 113.5. Any serial (lot) that does not pass the prescribed premarket tests may not be sold. See 9 C.F.R. § 113.6(b). The manufacturer must forward samples of each serial and subserial to APHIS. See 9 C.F.R. § 113.3. APHIS may test the product for "purity, safety, potency, or efficacy" before it is marketed. See 9 C.F.R. § 113.6(a).
BoviShield 4 and Ultrabac-7/Somubac are APHIS-licensed vaccines. SBC's records reflect that each serial of the vaccines administered to plaintiffs' cattle was tested by SBC before release. The test results were "satisfactory," and those results were reviewed by APHIS. After the Symens's cattle sickened, they complained to APHIS. The agency tested two BoviShield 4 serials and concluded they met purity standards and were not contaminated.
The Preemption Question.
Under the Supremacy Clause of the Constitution, federal legislation may preempt state law. Congress may express an intent to preempt in the federal statute. An intent to preempt may also be implied, for example, when federal and state laws directly conflict, when state law stands as an obstacle to accomplishing the purposes of federal law, or when federal law is so pervasive that it reflects an intent to occupy a regulatory field. See Heart of Am. Grain Inspection Serv., Inc. v. Missouri Dep't of Agric., 123 F.3d 1098, 1103 (8th Cir.1997). Congress may also delegate the preemption question--expressly or by implication--to the agency it authorizes to administer or enforce a federal statute. When agency preemption is at issue, the inquiry focuses on whether the agency intended to preempt state law and whether it had the statutory authority to do so. See City of New York v. F.C.C., 486 U.S. 57, 63-64, 108 S.Ct. 1637, 100 L.Ed.2d 48 (1988). This appeal raises an issue of agency preemption. VSTA does not expressly address the preemption question, but it delegates broad powers to APHIS, and the agency has expressed a clear intent to preempt inconsistent state "requirements." We must consider whether APHIS has the power to preempt, and if so,