Behrens v. United Vaccines, Inc.

• Decision Date: 22 February 2002
• Docket Number: No. CIV. 00-459(RLE).,CIV. 00-459(RLE).
• Citation: 189 F.Supp.2d 945
• Parties: Randy J. BEHRENS and Theresa M. Behrens, d/b/a Behrens' Fur Farm, Plaintiffs, v. UNITED VACCINES, INC., A DIVISION OF HARLAN SPRAGUE DAWLEY, INC., Defendant.
• Court: U.S. District Court — District of Minnesota

189 F.Supp.2d 945

Randy J. BEHRENS and Theresa M. Behrens, d/b/a Behrens' Fur Farm, Plaintiffs, v. UNITED VACCINES, INC., A DIVISION OF HARLAN SPRAGUE DAWLEY, INC., Defendant.

No. CIV. 00-459(RLE).

United States District Court, D. Minnesota.

February 22, 2002.

Todd Maurice Johnson, Scott Allen Johnson, Johnson Law Group, Minnetonka, MN, for Plaintiffs.

Robert Lowell McCollum, McCollum Crowley Vehanen Moschet & Miller, Scott Patrick Drawe, Minneapolis, MN, for Defendant.

MEMORANDUM ORDER

ERICKSON, United States Magistrate Judge.

I. Introduction

This matter came before the undersigned United States Magistrate Judge, pursuant to the consent of the parties, as authorized by Title 18 U.S.C. § 636(c), upon the Motion of the Defendant United Vaccines, Inc., for Summary Judgment. A Hearing on the Motions was conducted on September 12, 2001, at which time, the Plaintiffs, Randy and Theresa Behrens, appeared by Todd M. Johnson, Esq., and the Defendant appeared by Scott P. Drawe, Esq.

For reasons which follow, we grant the Defendant's Motion, except as to the Plaintiffs' express warranty, false representation, and Minnesota Consumer Fraud Act claims, which survive Summary Judgment, in part.

II. Factual and Procedural History

This case arises out of the Plaintiffs' use of the Defendant's vaccine in the operation of their mink ranch. In July of 1998, according to industry custom, the Plaintiffs vaccinated the majority of their mink herd against canine distemper.¹ The Defendant's vaccine, which was administered to the Plaintiffs' mink, was Biocom-DP, a "four-way mink vaccine" that "consists of two separate vaccine products." Memorandum of Law of Defendant United Vaccines, Inc. In Support of Motion for Summary Judgment ("Defendant's Brief") at 2. One part of the vaccine employs Distemink, which is a live virus "protection against distemper," and which is prepared in biscuit form. Id. The Distemink is dissolved in the second vaccine—Biocom-P— which is a "liquid inactivated vaccine for protection against enteritis, botulism and pseudomonas." Id. at 2. Since the Defendant's formulation combines an inactivated virus with a live virus, measures must be taken to ensure that the Formalin,² which is used to inactivate the virus in Biocom-P, is neutralized, so that it does not inactivate the live virus in the Distemink. Id. at 7. Each batch of both vaccines is given a serial number and, at issue in this case, is Biocom-P batch PB13, which was sold to the Plaintiffs, as part of Biocom-DP serials DB19/PB13 and DB04/PB13. See, Affidavit of Roger G. Brady.

The Plaintiffs vaccinated their mink with the Biocom-DP from lot PB13 in July of 1998. See, Affidavit of Randy Behrens at 3. However, the Plaintiffs' ranch suffered a canine distemper outbreak which, ultimately, caused the Plaintiffs to lose 7,100 kits, and 850 breeder females, out of their total of 16,000 mink. Exhibit B attached to Affidavit of William Wustenberg, at 5. Due to this substantial loss, the Plaintiffs had to "pelt" their remaining herd, and cease the operation of their business in the Fall of 1999. Affidavit of Randy Behrens at 3.

All animal biotics, such as the vaccine at issue here, are regulated by the Federal Government under the Viruses, Serums, Toxin, and Analogous Products Act ("VSTA"), Title 21 U.S.C. §§ 151-159. Under VSTA, all vaccine products, and manufacturing sites, must be licensed by the United States Department of Agriculture ("USDA"). Title 21 U.S.C. § 154. VSTA authorizes the Secretary of Agriculture 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 * * * of any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product for use in the treatment of domestic animals." Id. Through the Animal and Plant Health Inspection Service ("APHIS"), the USDA, at 9 C.F.R. §§ 101-124, has promulgated Regulations which govern the licensing of animal vaccines. A party who seeks to manufacture animal vaccines must have both a valid "Veterinary Biologics Establishment License and at least one" valid "Veterinary Biological Product License." 9 C.F.R. § 102.2(a).

In order to obtain a Product License from APHIS, a manufacturer must submit an "Outline of Production," which details how the product will be developed and tested, including "test reports and research data sufficient to establish purity, safety, potency, and efficacy of the product." 9 C.F.R. § 102.3(b)(2)(ii). Once its Outline of Production is approved, a manufacturer is licensed to produce that biotic. 9 C.F.R. § 102.5. Since the Regulations mandate that "[n]o biological product shall be released prior to the completion of tests prescribed in a filed Outline of Production," a manufacturer must test each batch of the biotic prior to its sale. 9 C.F.R. § 113.1—113.5(a). Manufacturers are required to report only the test results to APHIS, which is accomplished by completing Form 2008, and they are not required to furnish the raw data that was employed to calculate those results. See, 9 C.F.R §§ 112—113. A manufacturer must also submit samples of each serial, together with all packaging and accompanying inserts. Id. APHIS may then grant a license based solely upon the manufacturer's data, it may test the sample itself, or it may request and review the manufacturer's raw data. 9 C.F.R. § 113.6. Only when APHIS has approved a serial, may the manufacturer sell it.

The Defendant is licensed to manufacture animal biotics, and it was, in 1989, granted a Product License to produce and sell Biocom-DP. Defendant's Brief at 5. The Defendant performed a viricidal activity test³ on serial PB13, as required. For Biocom-P, the viricidal activity test required a comparison of titers⁴ of Distemink, which had been dissolved in sterile water, with Distemink which had been dissolved in Biocom-P. 9 C.F.R. § 113.36(c). "If the titer of the [Distemink] rehydrated with the [Biocom-P] is more than 0.7 Log below the titer of the [Distemink] rehydrated with sterile purified water, the product is unsatisfactory for use." 9 C.F.R. § 113.36(d). When a test proves a product to be unsatisfactory, the Regulations allow for "one retest to rule out faulty techniques." 9 C.F.R. § 113.35(e).

When the Defendant tested PB13, the titer of the Distemink, which had been dissolved in sterile water, was 3.3 Logs, and when dissolved in Biocom-P it was 3.5 Logs, or .2 Logs greater—a result that the Defendant reported, on its Form 2008, as being "not viricidal." Defendant's Brief at 7-8. APHIS received the Form on June 29, 1998, and issued a conditional license,⁵ "releas[ing] Biocom-P, serial number PB13 for sale." Affidavit of Christina Furseth, at unnumbered 3. Pursuant to a telephone order, which was also placed on June 29, 1998, the Plaintiffs were shipped 16,000 doses of Biocom-DP containing serial PB13. See, Exhibit C attached to Affidavit of Roger G. Brady.

On January 6, 2000, after receiving complaints from several mink farmers, see Exhibit J, attached to Affidavit of Todd M. Johnson, the USDA directed the Defendant to "[i]mmediately stop distribution and sale" of PB13, and it quarantined the remaining inventory of any product containing that serial. Exhibit K, at TH01364, attached to Affidavit of Todd M. Johnson. In its letter to the Defendant, the USDA explained, that the viricidal activity test results "should have been reported on APHIS Form 2008 as `NO TEST' and repeated." Id. Thus, the Plaintiffs maintain that by reporting the vaccine as being non-viricidal when, in fact, it should have reported a "No test," the Defendant "presented false information in the process of obtaining conditional approval to sell its product" and, therefore, unlawfully sold its product to the Plaintiffs. Plaintiffs' Memorandum in Opposition to Motion for Summary Judgment ("Plaintiffs' Brief") at 2 and 10-13; see also, 9 C.F.R. § 113.5(d) ("When the initial or any subsequent test is declared a `No test,' the reasons shall be reported in the test record, the results shall not be considered as final, and the test may be repeated.") After ordering the Defendant to stop distribution and sales of the PB13, the USDA attempted to correlate the Defendant's test results in its own lab. Id. at 17; see also Exhibit C, at 36, attached to Affidavit of Todd M. Johnson To this date, the USDA has never re-released PB13 for sale. Id. at 2-3.

The Plaintiffs filed this diversity action against the Defendant, claiming a breach of express warranties, a breach of implied warranties, strict liability, negligence, false representations, and a violation of Minnesota's Consumer Fraud Act. The Plaintiffs have alleged a loss in excess of one million dollars, which they attribute to the failure of the Defendant's distemper vaccine. In response, the Defendant has filed a Motion for Summary Judgment, which claims that the Plaintiffs' State law claims are preempted by Federal law.

III. Discussion

Summary Judgment is not an acceptable means of resolving triable issues, nor is it a disfavored procedural shortcut when there are no issues which require the unique proficiencies of a Jury in weighing the evidence, and in rendering credibility determinations. See, Celotex Corp. v. Catrett, 477 U.S. 317, 327, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). Summary Judgment is appropriate when we have viewed the facts, and the inferences drawn from those facts, in a light most favorable to the non-moving party, and we have found no triable issue. See, Duffy v. McPhillips, 276 F.3d 988, 991 (8th Cir.2002); Schoolhouse Inc. v. Anderson, 275 F.3d 726, 728 (8th Cir.2002); Krentz v. Robertson Fire Protection Dist., 228 F.3d 897, 901 (8th Cir. 2000); Curry v. Crist, 226 F.3d 974, 977 (8th Cir.2000); Carter v. St. Louis Univ., 167 F.3d 398, 400 (8th Cir.1999). For these purposes, a disputed fact is "material" if it must inevitably be resolved and the resolution will determine the...