WYOMING PREMIUM FARMS, LLC, a Wyoming Limited Liability Company, Plaintiff,
PFIZER, INC., a Delaware Corporation, and WYETH HOLDINGS CORPORATION, a Maine Corporation, Defendants.
OPINION AND ORDER GRANTING MOTION FOR JUDGMENT ON THE PLEADINGS
ALAN B. JOHNS, District Judge.
The defendants' Motion for Judgment on the Pleadings (Docket Entry 21), the plaintiffs' response in opposition to the motion (Docket Entry 27), and the defendants' further reply (Docket Entry 28) have come before the Court for consideration. The Court has considered the parties' submissions, all pleadings of record, the applicable law and FINDS and ORDERS that the defendants' motion should be granted and that judgment should be entered accordingly in favor of the defendants.
Review of the motion is informed by Bixler v. Foster, 596 F.3d 571, 755 (n.2)-756 (10th Cir. 2010), in which the appellate court stated:
Our standard of review for rulings under Rule 12(b)(6) and Rule 12(c) is the same-de novo. Corder v. Lewis Palmer Sch. Dist. No. 38 , 566 F.3d 1219, 1223 (10th Cir. 2009), cert. denied, ___ U.S. ___ , 130 S.Ct. 742, 175 L.Ed.2d 515 (2009).
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We review de novo the district court's Rule 12(b)(6) dismissal. See Christy Sports, LLC v. Deer Valley Resort Co. , 555 F.3d 1188, 1191 (10th Cir. 2009). "To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to state a claim for relief that is plausible on its face."' Ashcroft v. Iqbal, ___ U.S. ___ , 129 S.Ct. 1937, 1949, 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly , 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). "[W]e assume the factual allegations are true and ask whether it is plausible that the plaintiff is entitled to relief." Gallagher v. Shelton , 587 F.3d 1063, 1068 (10th Cir. 2009). "[T]he tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions. Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice." Iqbal , 129 S.Ct. at 1949.
The plaintiff's (hereafter plaintiff is referred to most often as "WPF") complaint in this action arises out of the purchase and sale of a vaccine for circovirus in pigs known as Suvaxyn. WPF's manager contacted a representative of Fort Dodge Animal Health, which is a division of defendant Wyeth. The complaint alleges that the defendants' representative recommended the Suvaxyn vaccine, and based on the representative's recommendation and WPF's review of advertisements and literature of Fort Dodge Animal Health, the decision was made to purchase that vaccine. Complaint ¶ 13. Fort Dodge required that WPF purchase the vaccine through its own veterinarian, Anthony Scheiber. Complaint ¶ 14. Through him, between January and July of 2007, WPF purchased 493 bottles of Suvaxyn circovirus vaccine (123, 500 doses) for $184, 875.00. Complaint ¶ 15. WPF began vaccinating its pigs and by late summer and early fall of 2007, determined the pig mortality rate was not decreasing. Complaint¶ 17. WPF then told Fort Dodge Animal Health of its concerns, and Fort Dodge's representatives requested tissue samples from pigs that had died after vaccination to be used in lab testing, which WPF provided. WPF alleges that it was told there was no live virus in the vaccine, but was never told if the samples had been tested for circovirus and, if testing had been done, it was not told of the findings. Complaint¶ 18.
Suvaxyn was to be manufactured using killed virus. WPF asserts that the vaccine "may contain live virus and that instead of controlling the virus, the administration of the vaccine may instead be introducing it. To assure that the vaccine contained no live virus, in October, 2007, WPF's veterinarian Anthony Scheiber, at the direction of WPF, sent samples of the vaccine to the Veterinary Diagnostic laboratory at Iowa State University. The results showed that the vaccine contained no live virus." Complaint¶ 19. Thereafter WPF continued to vaccinate pigs with the Suvaxyn vaccine through mid-February 2008. The pig mortality rate continued to be abnormally high, so WPF's veterinarian began to search for and found another circovirus vaccine from a different pharmaceutical company. By May of 2008, WPF asserts the new vaccine had successfully controlled the circovirus and mortality rates returned to normal. Complaint ¶¶ 20, 21.
In January of 2008, WPF's veterinarian sent tissue samples from a 13 week old pig vaccinated with Suvaxyn to a laboratory in South Dakota for testing. Analysis revealed the presence of circovirus. Autopsies on other pigs also showed the presence of circovirus. WPF alleges that the lab results and autopsies, along with the successful results from the use of the other vaccine, showed "that the Fort Dodge Animal Health Suvaxyn circovirus vaccine was not effective and had not controlled circovirus in WPF's pigs." Complaint¶ 22. WPF now seeks to recover for its financial losses.
In the complaint several causes of action are asserted:
(1) Breach of Express Warranty. Complaint¶¶ 24-28.
(2) Breach of Implied Warranties of Merchantability and Fitness for a Particular Purpose. Complaint ¶¶ 29-38.
(3) Strict Products Liability - § 402A, Restatement (Second) of Torts. Complaint ¶¶ 39-44.
(4) Misrepresentation - § 402B, Restatement (Second) of Torts). Complaint¶¶ 43-49.
(5) Negligence. Complaint ¶ 50-54.
The defendants' motion seeks judgment on the pleadings pursuant to Rule 12(c) of the Federal Rules of Civil Procedure. They argue that the state law claims asserted by WPF in its complaint are preempted by federal law. They assert that the WPF claims are barred by conflict preemption because imposing additional or different state law requirements on the efficacy of veterinary biologics obstructs the congressional objective of implementing uniform standards of efficacy. Defendants argue that the WPF claims are also barred by the impossibility conflict preemption doctrine because defendants could not simultaneously comply with applicable federal law and the state tort duties plaintiff has asserted. Finally, defendants contend that field preemption bars WPF's claims because Congress has occupied the field of veterinary biologics licensure.
Plaintiff opposes the motion, disputing that its claims are preempted by the "purposes and objectives" conflict and impossibility conflict doctrines and that there is no evidence of congressional intent to preempt state law. WPF asserts that defendants are unable to show compliance with the applicable federal regulations cannot be accomplished concurrently with Wyoming tort and contract law. WPF further argues that Congress has shown no intent to occupy the field with respect to animal vaccines.
The Court finds that all of the plaintiff's state law claims are preempted by federal law and that judgment should be entered in favor of defendants. This determination is made following a review of the regulatory scheme governing animal vaccines.
Suvaxyn, the porcine circovirus vaccine at issue in this case, was licensed by the United States Department of Agriculture ("USDA") and the Animal and Plant Health Inspection Services agency ("APHIS") of the USDA. Animal biologic products, which include vaccines, are regulated through the Virus-Serum-Toxin Act ("VSTA"), 21 U.S.C. §§ 151-159. VSTA authorizes the 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. The 1985 amendment of VSTA clearly placed both interstate and intrastate vaccines within the ambit of federal control. 21 U.S.C. § 151; S.Rep. No. 145, 99th Cong., 1st Sess. XXX-XX-XXXX, reprinted in 1985 U.S.C.C.A.N. 1676, 2004-05. "The need for uniform national standards has become recognized widely in recent years." S. Rep. No. 145, 99th Cong., 1st Sess. 338-39 (1985, reprinted in 1985 U.S.C.C.A.N. 1676, 2005). "The amendments reflect the Congressional finding that federal regulation was necessary to prevent and eliminate burdens on commerce and to effectively regulate such commerce.' 21 U.S.C. § 159." Lynnbrook Farms v. SmithKiine Beecham Corp. , 79 F.3d 620, 625 (7th Cir.), reh. and suggestion for reh. denied (1996), cert. denied, 519 U.S. 867 (1996).
APHIS is the agency in the USDA responsible for administering VSTA. 9 C.F.R. § 101.2. APHIS has "promulgated an extensive regulatory scheme governing the design, manufacture, distribution, testing, and labeling of animal vaccines." Symens v. Smith Kline Beecham Corp. , 152 F.3d 1050, 1052 (8th Cir. 1998), quoting Lynnbrook Farms v. SmithKiine Beecham Corp. , 79 F.3d at 624, and citing 9 C.F.R. §§ 101-124. Under this regulatory scheme, 9 C.F.R. § 102.4, provides in part:
(b) A license shall not be issued unless:
(1) In the opinion of the Administrator, the condition of the establishment, including its facilities, and the methods of preparation of biological products are such as reasonably to assure that the products shall ...