Symens v. Smithkline Beecham Corp.

• Decision Date: 07 October 1997
• Docket Number: Civ. No. 94-1036.
• Citation: 19 F.Supp.2d 1062
• Parties: Richard SYMENS and Joyce Symens, Husband and Wife, Plaintiffs, v. SMITHKLINE BEECHAM CORPORATION, a Pennsylvania Corporation; Defendant.
• Court: U.S. District Court — District of South Dakota

19 F.Supp.2d 1062

Richard SYMENS and Joyce Symens, Husband and Wife, Plaintiffs, v. SMITHKLINE BEECHAM CORPORATION, a Pennsylvania Corporation; Defendant.

Civ. No. 94-1036.

United States District Court, D. South Dakota, Northern Division.

October 7, 1997.

Order Denying Reconsideration December 15, 1997.

Danny R. Smeins, Britton, South Dakota, James Allen Davis, James Allen Davis & Associates, Fremont, Nebraska, for plaintiffs.

William F. Day, Sioux Falls, South Dakota, Alan R. Peterson, Lynn, Jackson, Schultz & Lebrun, Scott A. Smith, Patrick A. Reinken, Hinshaw & Culbertson, Minneapolis, Minnesota, for defendant.

ORDER ON MOTION FOR SUMMARY JUDGMENT

KORNMANN, District Judge.

BACKGROUND

[¶ 1] Plaintiffs are engaged in the feedlot business near Claremont, Marshall County, South Dakota. Beginning in July of 1992, and continuing until December of 1992, plaintiffs injected their cattle with the vaccine Bovishield 4 which was manufactured, tested and marketed by defendant. Plaintiffs contend that, despite vaccination, plaintiffs' cattle and cattle belonging to others which cattle were in plaintiffs' feedlot, contracted a disease resulting in weight loss or death. Plaintiffs instituted this diversity action, claiming that defendant's Bovishield 4 vaccine is defectively designed and manufactured and unreasonably dangerous (Count I), that defendant breached implied warranties of fitness for a particular purpose and merchantability, (Counts II and III), that defendant falsely advertised and promoted the vaccine (Counts IV and V), that defendant failed to warn of foreseeable dangers associated with the use of the vaccine (Counts VI and VII), and that defendant knowingly supplied false information to the United States Department of Agriculture ("USDA") in its applications for a license for the vaccine (Count 8). Defendants deny the material allegations of the complaint and have moved for summary judgment, Doc. 52, claiming plaintiffs' claims are all preempted by the Virus-Serum-Toxin Act (VSTA), 21 U.S.C. §§ 151-159.

DISCUSSION

[¶ 2] Summary judgment is proper where there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law. Fed. R.Civ.P. 56(c), Donaho v. FMC Corp., 74 F.3d 894, 898 (8th Cir.1996). The issue of federal preemption is one of law for the court to decide. Defendant requested oral argument. Defendant has briefed this issue numerous times before numerous other federal and state courts and almost all of the issues have been adequately addressed by the parties and by other courts. Pursuant to D.S.D. LR 7.1, the motion will be decided without oral argument. Jetton v. McDonnell Douglas Corp., 121 F.3d 423, 426-427 (8th Cir. 1997). Defendant's motion for oral argument has been considered and denied.

[¶ 3] The issue presented by defendant's motion for summary judgment has been analyzed by at least five federal and state courts. See Lynnbrook Farms v. Smithkline Beecham Corp., 79 F.3d 620 (7th Cir.1996), cert. den. ___ U.S. ___, 117 S.Ct. 178, 136 L.Ed.2d 118 (1996); Garrelts v. SmithKline Beecham Corp., 943 F.Supp. 1023 (N.D.Iowa 1996); Gresham v. Boehringer Ingelheim Animal Health, Inc., Civ. 95-3376, 1996 WL 751126 (N.D.Ga. August 7, 1996); Murphy v. SmithKline Beecham Animal Health Group, 898 F.Supp. 811 (D.Kan.1995); and Brandt v. SmithKline Beecham Corp., 540 N.W.2d 870 (Minn.App.1995). The issue presented was best stated by Judge Bennett in Garrelts as "whether the regulations promulgated by the ... VSTA ... preempt plaintiffs' state tort claims, because plaintiffs' claims are allegedly premised on inadequate labeling of a product whose label had been approved by the agency under its regulations." Garrelts v. SmithKline Beecham, 943 F.Supp. at 1028. Garrelts and Gresham decided that the VSTA did not preempt some state law claims. Lynnbrook, Murphy, and Brandt held that the VSTA completely preempted state law claims.

[¶ 4] The United States Supreme Court has "recognized that the Supremacy Clause, U.S. Const., Art. VI, may entail preemption of state law either by express provision, by implication, or by a conflict between federal and state law." New York State Conference of Blue Cross & Blue Shield Plans v. Travelers Ins., 514 U.S. 645, 654, 115 S.Ct. 1671, 1676, 131 L.Ed.2d 695 (1995); Freightliner Corp. v. Myrick, 514 U.S. 280, 287, 115 S.Ct. 1483, 1487, 131 L.Ed.2d 385 (1995). The Eighth Circuit recognizes an additional method of preemption where the subject matter of the legislation concerns "a field in which the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject." Heart of America Grain Inspection Service, Inc. v. Missouri Department of Agriculture, 123 F.3d 1098, 1103-04 (8th Cir. 1997) (citations omitted). The Eighth Circuit has characterized the exceptions as follows:

Preemption traditionally comes in four "flavors": (1) "express preemption," resulting from an express Congressional directive ousting state law (Morales v. Trans World Airlines, Inc., 504 U.S. 374, 112 S.Ct. 2031, 119 L.Ed.2d 157 (1992)); (2) "implied preemption." resulting from an inference that Congress intended to oust state law in order to achieve its objective (Hines v. Davidowitz, 312 U.S. 52, 67, 61 S.Ct. 399, 404, 85 L.Ed. 581 (1941)); (3) "conflict preemption." resulting from the operation of the Supremacy Clause when federal and state law actually conflict, even when Congress says nothing about it (Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 143, 83 S.Ct. 1210, 1218, 10 L.Ed.2d 248 (1963)); and (4) "field preemption," resulting from a determination that Congress intended to remove an entire area from state regulatory authority (Fidelity Fed. Savs. & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153, 102 S.Ct. 3014, 3022, 73 L.Ed.2d 664 (1982)).

Kinley Corp. v. Iowa Utilities Bd., Utilities Div., Dept. of Commerce, 999 F.2d 354, 358 n. 3 (8th Cir.1993).

[¶ 5] The ultimate touchstone of statutory preemption is congressional intent. Medtronic, Inc. v. Lohr, 518 U.S. 470, 484-86, 116 S.Ct. 2240, 2250, 135 L.Ed.2d 700 (1996); Kinley Corp. v. Iowa Utilities Bd., 999 F.2d 354, 357 (8th Cir.1994). "In all preemption cases ... we `start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.'" Medtronic v. Lohr, 518 U.S. at 484-85, 116 S.Ct. at 2250 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947)). "The historic police powers of the State include the regulation of matters of health and safety." De Buono v. NYSA-ILA Medical and Clinical Services Fund, 520 U.S. 806, ___, 117 S.Ct. 1747, 1751, 138 L.Ed.2d 21 (1997), citing Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 715, 105 S.Ct. 2371, 2376, 85 L.Ed.2d 714 (1985). Defendant therefore "bears the considerable burden of overcoming `the starting presumption that Congress does not intend to supplant state law.'" Id. at ___, 117 S.Ct. at 1751 (quoting Travelers, 514 U.S. at 654, 115 S.Ct. at 1676).

[¶ 6] The Federal act in question here is the VSTA. The VSTA was promulgated in 1913 and authorizes the Secretary of the Department of Agriculture ("USDA") to issue regulations for the preparation and sale, and the issuance of licenses for the sale of viruses serums and toxins for domestic animals. As amended in 1985, the VSTA provides, inter alia:

The Secretary of Agriculture is authorized to make and promulgate from time to time such rules and regulations as may be necessary to prevent the preparation, sale, barter, exchange, or shipment as aforesaid of any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treatment of domestic animals, or otherwise to carry out this paragraph, and to issue, suspend, and revoke licenses for the maintenance of establishments for the preparation of viruses serums, toxins, and analogous products, for use in the treatment of domestic animals, intended for sale, barter, exchange, or shipment as aforesaid.

21 U.S.C. § 154. The agency within the USDA responsible for administering the VSTA is the Animal and Plant Health Inspection Service ("APHIS"). 9 C.F.R. § 101.2. APHIS promulgated extensive rules to implement the VSTA. 9 C.F.R. Parts 101-123.

[¶ 7] Defendant recognizes that the VSTA does not expressly preempt state law tort claims but it argues that a federal agency may preempt state law even without congressional authorization and that APHIS expressly declared its intent to preempt state law damages actions. Defendant argues that Congress did not specifically preserve state tort law remedies in the VSTA, that Congress knows how to do so, and that the broad based directive to APHIS and APHIS action carries the day for defendant. This Court disagrees.

[¶ 8] Judge Bennett pointed out in Garrelts, "[t]he phrase `Laws of the United States' in the Supremacy Clause, the Supreme Court has held, encompasses both federal statutes and statutorily authorized federal regulations." Garrelts v. SmithKline Beecham, 943 F.Supp. at 1036 citing City of New York v. FCC, 486 U.S. 57, 63, 108 S.Ct. 1637, 1642, 100 L.Ed.2d 48 (1988). Judge Bennett applied a two-fold analysis of agency preemption: first, "did the agency intent to preempt the state law in question;" second, "if so, was that action within the scope of the agency's delegated authority?" Garrelts v. SmithKline Beecham, 943 F.Supp. at 1038. Agency intent to preempt state law may be either express or implied. Id., citing City of New York v. FCC, 486 U.S. at 64, 108 S.Ct. at 1642.

[¶ 9] Defendant argues that APHIS declared its intent to preempt all state law requirements which are different from or in addition to those imposed by APHIS's regulation when it published the background to a final rule on August 27, 1992,...