Wyoming Premium Farms v. Pfizer Inc et al

Filing 31

OPINION and ORDER by the Honorable Alan B Johnson granting 21 Motion for Judgment on the Pleadings.(Court Staff, sth)

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STEPHAN HARRIS CLERK
CHEYENNE

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF WYOMING

WYOMING PREMIUM FARMS, LLC, a Wyoming )
Limited Liability Company,
)
)
Plaintiff,
)
)
v.
)
)
PFIZER, INC., a Delaware Corporation, and
)
WYETH HOLDINGS CORPORATION, a Maine
)
Corporation,
)
)
Defendants.
)

No. 11-CV-282-J

OPINION AND ORDER GRANTING
MOTION FOR JUDGMENT ON THE PLEADINGS

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
1

(n.2)-756 (lOth 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 (lOth Cir. 2009), cert. denied,--- U.S.
----, 130 S.Ct. 742, 175 L.Ed.2d 515 (2009).

****

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 (lOth 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 (lOth 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

2

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~

3

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.
4

Complaint
(4)

~~

39-44.

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

5

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.

Discussion
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 ofVSTA clearly placed both interstate and intrastate vaccines
within the ambit of federal control. 21 U.S.C. § 151; S.Rep. No. 145, 99th
6

Cong., 1st Sess. 338-39-1985, 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. 1 Under this regulatory scheme, 9 C.F.R. §
1

There is no claim here that the rule-making process employed to craft
this regulatory scheme is infirm. Comments were solicited by APHIS, and were
responded to in promulgating the final rule. At 57 Fed. Reg. 38759, the agency
states: "The regulation will not be amended based on these comments because
the purpose of the Act is to assure that biologics used in the treatment of
animals are pure, safe, potent, and efficacious. The public benefits as a result
of the successful protection of animals from various diseases, including those
which are of great public concern such as rabies. Since safe and effective
(continued ... )

7

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 accomplish the purpose for which they are
intended; and
(2) The Administrator is satisfied on the basis of information before
him that:
(I) The establishment shall be operated in compliance
with the Act and applicable regulations and be under
the supervision of person(s) competent in the
preparation of biological products; and
(ii) The applicant, or the person having the
responsibility for producing biological products in the
establishment, or both, is qualified by education and
experience, and has demonstrated fitness to produce
such products in compliance with the Act and
regulations issued pursuant thereto; Provided, That,
previous violations of the Act, or such regulations or
both shall be relevant to the Administrator's
'( ... continued)

vaccines and other biologics are in the public interest, APHIS has used this term
in the regulations." There is nothing that is offered by anyone in this case that
suggests the agency's position that VSTA preempts state law was not consistent
with its previous position. APHIS has consistently maintained that state
common law causes of action pertaining to safety, potency, purity or efficacy
of veterinary biologics are preempted. This supports the notion that deference
should be given to the agency's assertion that state law is preempted.

8

determination of fitness.
(3) Written assurance is filed with Animal and Plant Health
Inspection Service that the biological products which are licensed
to be prepared therein shall not be so advertised as to mislead or
deceive the purchasers and that the packages or containers in
which the same are to be marketed shall not bear any statement,
design, or device which is false or misleading in any particular.
The APHIS regulatory scheme for animal vaccines is comprehensive. A
few provisions are here highlighted, but these of course are not exhaustive.
When evaluating biological products certain testing terminology is employed.
For instance:
(a) Standard Requirement. Test methods, procedures, and criteria
established by Animal and Plant Health Inspection Service for
evaluating biological products to be pure, safe, potent, and
efficacious, and not to be worthless, contaminated, dangerous, or
harmful under the Act.
9 C.F.R. § 101.5(a).
Information that must be included in applications for an animal vaccine
license is identified in 9 C.F.R. § 102.3, which requires, among other things, an
Outline of Production prepared in accordance with §§ 114.8 and 114.9, and
copies of 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). Labels,
packaging information and advertising matter must also be provided and

9

approved by APHIS. No license may issue 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 accomplish the purpose for which they are
intended; and
(2) The Administrator is satisfied on the basis of information
before him that:
(I) The establishment shall be operated in
compliance with the Act and applicable regulations and
be under the supervision of person(s) competent in the
preparation of biological products; and
(ii) The applicant, or the person having the
responsibility for producing biological products in the
establishment, or both, is qualified by education and
experience, and has demonstrated fitness to produce
such products in compliance with the Act and
regulations issued pursuant thereto; Provided, That,
previous violations of the Act, or such regulations or
both shall be relevant to the Administrator's
determination of fitness.
(3) Written assurance is filed with Animal and Plant Health
Inspection Service that the biological products which are licensed
to be prepared therein shall not be so advertised as to mislead or
deceive the purchasers and that the packages or containers in
which the same are to be marketed shall not bear any statement,
design, or device which is false or misleading in any particular.

9 C.F.R. § 102.4(b).
Once a license has been issued, preparations of licensed biological

10

products cannot be changed without APHIS approval. 9 C.F.R. § 102.5. The
regulations include provisions for sampling and testing protocols, see e.g., 9
C.F.R. § 113.3-113.10. "A biological product shall with reasonable certainty
yield the results intended when used as recommended or suggested in its
labeling or proposed labeling prior to the expiration date." 9 C.F.R. § 113.6.
APHIS may cause biological products manufactured in the United States to be
examined and tested for purity, safety, potency or efficacy, and the licensee
must withhold the product from the market until a determination has been
made. 9 C.F.R. § 113.6(a). The regulations even provide:
§ 114.15 Disposal of unsatisfactory products and byproducts.

All biological products found to be unsatisfactory for
marketing, all biological products which have become worthless
subsequent to the expiration date, all refuse, other materials
deemed unsatisfactory for production purposes, all carcasses (part
or whole) of production or test animals, and any undesirable
byproducts of manufacture shall be disposed of as may be required
by the Administrator.
9 C.F.R. § 114.15. Inspections of facilities where biologic products are
manufactured are permitted by regulation at any time, day or night, to
determine whether such products are worthless, contaminated, dangerous or
harmful. 9 C.F.R. Part 115.
Against this regulatory backdrop, the defendants in this case argue that
11

the plaintiff's state law claims are preempted by federal law. The preemption
analysis begins with Article VI, cl. 2 of the United States Constitution:
Clause 2. Supreme Law of Land
This Constitution, and the Laws of the United States which shall be
made in Pursuance thereof; and all Treaties made, or which shall
be made, under the Authority of the United States, shall be the
supreme Law of the Land; and the Judges in every State shall be
bound thereby, any Thing in the Constitution or Laws of any State
to the Contrary notwithstanding.
In Kurns v. Railroad Friction Products Corp., 132 S.Ct. 1261, 1265-1266
(2012), the most recent opinion addressing preemption, the United States
Supreme Court stated:
Pre-emption of state law thus occurs through the "direct operation
of the Supremacy Clause." Brown v. Hotel Employees, 468 U.S.
491, 501, 104 S.Ct. 3179, 82 L.Ed.2d 373 (1984). Congress may,
of course, expressly pre-empt state law, but "[e]ven without an
express provision for preemption, we have found that state law
must yield to a congressional Act in at least two circumstances."
Crosby v. National Foreign Trade Council, 530 U.S. 363, 372, 120
S.Ct. 2288, 147 L.Ed.2d 352 (2000). First, "state law is naturally
preempted to the extent of any conflict with a federal statute." Ibid.
Second, we have deemed state law pre-empted "when the scope
of a [federal] statute indicates that Congress intended federal law
to occupy a field exclusively." Freightliner Corp. v. Myrick, 514
U.S. 280, 287, 115 S.Ct. 1483, 131 L.Ed.2d 385 (1995).
"The phrase 'Laws of the United States' encompasses both federal
statutes themselves and federal regulations that are properly adopted in

12

accordance with statutory authorization." City of New York v. F.C.C., 486 U.S.
57, 63, 108 S.Ct. 1637, 1642 (1988). Further, "'a federal agency acting within
the scope of its congressionally delegated authority may pre-empt state
regulation' and hence render unenforceable state or local laws that are
otherwise not inconsistent with federal law." Id., 486 U.S. at 64. The Supreme
Court continued in City of New York:
.... here the inquiry becomes whether the federal agency has
properly exercised its own delegated authority rather than simply
whether Congress has properly exercised the legislative power.
Thus we have emphasized that in a situation where state law is
claimed to be pre-empted by federal regulation, a "narrow focus on
Congress' intent to supersede state law [is] misdirected," for "[a]
pre-emptive regulation's force does not depend on express
congressional authorization to displace state law." Fidelity Federal
Savings & Loan Assn. v. De Ia Cuesta, 458 U.S. 141, 154, 102
S.Ct. 3014, 3023, 73 L.Ed.2d 664 (1982). Instead, the correct
focus is on the federal agency that seeks to displace state law and
on the proper bounds of its lawful authority to undertake such
action. The statutorily authorized regulations of an agency will
pre-empt any state or local law that conflicts with such regulations
or frustrates the purposes thereof. Beyond that, however, in proper
circumstances the agency may determine that its authority is
exclusive and pre-empts any state efforts to regulate in the
forbidden area. Crisp, 467 U.S., at 700, 104 S.Ct. at 2700; De Ia
Cuesta, supra, 458 U.S., at 152-154, 102 S.Ct., at 3022-3023. It
has long been recognized that many of the responsibilities
conferred on federal agencies involve a broad grant of authority to
reconcile conflicting policies. Where this is true, the Court has
cautioned that even in the area of pre-emption, if the agency's
choice to pre-empt "represents a reasonable accommodation of
conflicting policies that were committed to the agency's care by the
13

statute, we should not disturb it unless it appears from the statute
or its legislative history that the accommodation is not one that
Congress would have sanctioned." United States v. Shimer, 367
U.S. 374, 383, 81 S.Ct. 1554, 1560, 6 L.Ed.2d 908 (1961); see
also Crisp, supra, 467 U.S., at 700, 104 S.Ct., at 2700.
Id., 486 U.S. at 64-65.
As the Supreme Court stated, a narrow focus on the congressional intent
to preempt state law is misplaced. Even so, there is quite a bit of legislative
history to rely upon, permitting courts to conclude that the congressional
intention was to preempt state law with the enactment of VSTA and the
concomitant regulatory scheme through which APHIS implements VSTA. In
1913, in the Department of Agriculture Appropriation Act of 1914, Act March
1913, ch 145, Stat. 832, under the heading "Bureau of Animal Industry,"
Congress enacted federal legislation concerning viruses, serums, toxins, and
analogous products. In 1985, PL 99-198, December 23, 1985, 1985 HR 2100,
Section 1768 (cited as the "Food Security Act of 1985") did the same, by
amending the 1913 "Act entitled "An Act making appropriations for the
Department of Agriculture for the fiscal year ending June thirtieth, nineteen
hundred and fourteen", approved March 4, 1913 (21 U.S.C. 151)." Id. As
discussed in PL 99-198, S. Rep. 99-145, 1985 HR 2100, Sec. 1768, the 1985
amendments provide for interstate and intrastate regulation of viruses, serums,
14

toxins and analogous products. It recognized the need for uniform national
standards. PL 99-198, S. Rep. 99-145
These legislative expressions "evince[] an unquestionable congressional
intent to create national, uniform standards for the preparation and sale of
animal vaccines."

Lynn brook, 79 F.3d at 625.

The Lynn brook opinion

continues by discussing the agency's position regarding VSTA and preemption:
In reaction to the VSTA amendments, APHIS issued the declaration
of preemption relied upon by SBC. The declaration states in
relevant part:
[W]here safety, efficacy, purity, and potency of
biological products are concerned, it is the agency's
intent to occupy the field. This includes, but is not
limited to the regulation of labeling. Under VSTA,
Congress clearly intended that there be national
uniformity in the regulation of these products.

***

APHIS ... does not agree that States should be
allowed to add various restrictions ... based upon a
need to protect domestic animals or the public health,
interests or safety. Any restrictions, other than those
which are necessary to address a local disease
condition, should be Federally imposed so that they are
uniform nationwide.

***

States are not free to impose requirements which
are different from, or in addition to, those imposed by
USDA regarding the safety, efficacy, potency, or purity
of a product. Similarly, labeling requirements which are
different from or in addition to those in the regulations
under the Act may not be imposed by the States. Such
15

additional or different requirements would thwart the
Congressional intent regarding uniform national
standards, and would usurp USDA's authority to
determine which biologics are pure, safe, potent and
efficacious.
57 Fed.Reg. 38758, 38759 (August 27, 1992) (emphasis added).
We find that APHIS acted rationally and within the scope of
the authority granted to it by Congress in issuing the above
statement seeking to preempt state law. Congress granted the
USDA and APHIS the broad regulatory power to promulgate and
enforce "such rules and regulations as may be necessary" to
prevent the production and sale of any "worthless, contaminated,
dangerous or harmful" animal vaccines. Congress also delegated to
the USDA and APHIS the responsibility to eliminate "undue
burdens" on commerce hi this area, and toward that end, to
establish a national, uniform regulatory scheme. It is apparent that
APHIS' congressional mandate is to ensure safe and effective
vaccines while at the same time minimize undue burdens on
interstate commerce that often accompany varied state regulation.
Given these powers and responsibilities, APHIS was acting
rationally, and well within its congressionally delegated discretion,
in creating a complex statutory scheme governing the safety,
efficacy, purity, and potency of animal vaccines and in pronouncing
this scheme to be the exclusive law in the area. The Supreme Court
has held that:
if the agency's choice to preempt "represents a
reasonable accommodation of conflicting policies that
were committed to the agency's care by the statute,
we should not disturb it unless it appears from the
statute or its legislative history that the
accommodation is not one that Congress would have
sanctioned."
City of New York, 486 U.S. at 64, 108 S.Ct. at 1642 (quoting
16

United States v. Shimer, 367 U.S. 374, 383, 81 S.Ct. 1554,
1560-61, 6 L.Ed.2d 908 (1961)); de Ia Cuesta, 458 U.S. at 154,
102 S.Ct. at 3023. The instant case of preemption reflects a prime
example of such an accommodation. Nothing in the legislative
history of either VSTA or its amendments indicates that APHIS'
actions would not be congressionally sanctioned. On the contrary,
the course chosen serves only to further VSTA's purposes-further
indicating that the agency was acting within its authority and not
acting arbitrarily. See de Ia Cuesta, 458 U.S. at 159, 102 S.Ct. at
3025. Thus we decline to disturb the agency's judgment to preempt
state law.
Id. at 625-626.
The Lynnbrook court also considered a 1995 letter by the Acting
Administrator of APHIS regarding the agency's position on preemption of state
law. 2 The letter indicated that the intent of the agency "in promulgating the

2

In In re Universal Service Fund Telephone Billing Practice Litigation, 619
F.3d 1188 (10th Cir. 2010), the appellate court stated that an agency's
conclusion that state law is preempted is not necessarily entitled to deference,
citing Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 1201 (2009). Wyeth did
recognize that agencies do have a "unique understanding of the statutes they
administer and an attendant ability to make informed determinations about how
state requirements may pose an obstacle to the accomplishment and execution
of the full purposes and objectives of Congress." Id. Universal Service Fund,
stated that the "Wyeth decision made clear '[t]he weight we accord the
agency's explanation of state law's impact on the federal scheme depends on
its thoroughness, consistency and persuasiveness." 619 F.3d at 1200, quoting
Wyeth, 129 S.Ct. at 1201. The regulatory scheme here is comprehensive and
thorough, has been consistent over an extensive period of time, and may be
considered persuasive. There is no indication that the agency's position
regarding preemption of state law in the area of veterinary biological products
has ever been otherwise.
17

rule was, and continues to be, to preempt States from imposing other
requirements either through statutes, regulations, or other means that are
different from, or in addition to those imposed by USDA regarding the safety,
efficacy, potency, or purity of a product." Id. at 625. The letter further stated
the agency "did not intend to preempt common law actions for damages arising
from noncompliance with USDA regulatory standards." Id. The Lynnbrook
court continued:
We must agree with SBC that the correspondence confirms the
interpretation that APHIS intended certain state tort claims to be
preempted. Contrary to Lynnbrook's argument that APHIS only
intended to preempt positive enactments, the agency included in
its preemptive scope additional requirements dictated by States via
"regulations, statutes, or other means." The phrase "or other
means" clearly encompasses state tort claims. Moreover, APHIS'
letter signals that state tort claims are available when APHIS
regulatory standards are violated or disregarded. The natural
conclusion to draw from this statement is that when APHIS
regulations are heeded, state tort claims involving the safety,
efficacy, potency, or purity of an animal vaccine do not survive.
This dichotomy follows from the preemption language chosen by
APHIS, as it is precisely when APHIS regulations have been
satisfied that a common law action imposes requirements in
addition to, or different from, those mandated by APHIS. [FNS
omitted] Where noncompliance is involved, a common law action
could simply serve to impose the standards of APHIS. Thus, it is
evident that APHIS intended to preempt common law claims
relating to areas under its regulatory control (namely the safety,
purity, potency, and efficacy of vaccines) which would impose
additional or different requirements on vaccines, i.e., common law
claims involving regulated areas in cases where the manufacturer

18

has complied with all APHIS regulations and standards.
Id. at 629-630. Where the claims relate to safety, purity, potency and efficacy,
seeking to impose additional or different requirements in these areas, the
Lynnbrook court concluded they are preempted. Id. This preemption analysis
encompassed claims for strict products liability, breach of implied warranties of
fitness

for

a

particular

purpose

and

of

merchantability,

fraudulent

misrepresentation and false advertising under Illinois law, where APHIS had
already declared the products safe and efficacious. Id.
In Symens v. SmithKiine Beecham Corp., 152 F.3d 1050, 1055 (8th Cir.
1998), the Eighth Circuit's analysis was similar. It stated that "common law
claims are not preempted to the extent that they seek relief for alleged
violations of the federal substantive standards," generally discussed in the case
law as claims asserting non-compliance with the federal regulatory standards.
This case also cited and relied upon the letter from the APHIS Acting
Administrator in reaching its conclusion.
Plaintiff WPF has relied on Behrens v. United Vaccines, Inc., 189 F.
Supp.2d 945 (D.Minn. 2002), to challenge the argument that its state law
claims are preempted by federal law. In that case owners of a mink ranch
brought suit against the manufacturer of an ineffective canine distemper
19

vaccine that had been given to their minks.

That court found their strict

liability, negligence and breach of implied warranty claims against the
manufacturer of the vaccine were preempted.
considered

the

However, the Behrens court

plaintiffs' express warranty claims,

alleging

that the

manufacturer's representative had stated the vaccine was 95 percent effective.
The Behrens court found the express warranty claim was not preempted by
VSTA. This, WPF contends, at least permits a finding that some state common
law claims are not preempted.

The promotional statement made by the

defendant in Behrens that the vaccine was 95 percent effective was, in that
court's view, distinguishable from the representations in Cooper, discussed
below, in that its representations were express and beyond what was required
by federal law:
Here, the Defendant's promotional statement, that its product
would be "95 per cent effective," was not required by any APHIS
labeling requirement, at least as disclosed in this Record, and we
are unable to conclude, as the Court did in Cooper, that the
representation was "not 'substantially different"' from the
statements "set forth in the APHIS-approved labeling and
packaging that accompanied Biocom-DP." Cooper v. United
Vaccines. Inc., supra at 872. [FN14 omitted] To assure consumers,
that a product is effective in preventing distemper-to the extent
of a finite, quantified percentage-is starkly different from assuring
that the product "aids in the prevention of," or "produces a
significant effect."

20

Behrens, 189 F. Supp.2d at 965 (footnote omitted).
The Cooper case, 117 F. Supp.2d 864 (E. D. Wis.2000), cited in Behrens,
also involving mink vaccinations produced by the same company as in Behrens,
found

the

breach

of express

warranty

claim

was

preempted.

The

representations made by the company's representatives regarding effectiveness
of the vaccine concerned the efficacy of the vaccine. The representations did
not include any representations similar to those in Behrens, such as 95 percent
effective. For Cooper to have prevailed at trial, the jury would have had to find
the vaccine ineffective. "'However, APHIS has already declared the products
safe and effective [through the approval process]."' Cooper, 117 F. Supp.2d
at 872, quoting Lynnbrook Farms, 79 F. 3d at 630. The express warranty claim
was preempted.
The representations alleged in WPF's complaint do not meaningfully differ
from those in the Cooper case and clearly implicate the efficacy of the Suvaxyn
circovirus vaccine. APHIS has already declared the vaccine safe and effective
through the approval process. A "different standard would be enforced if [WPF]
prevailed on [its] express warranty claim." Id., 117 F. Supp.2d at 872. The
Court finds that the express warranty claim is preempted by federal law.
As to the remainder of the plaintiff's claims, for all the reasons discussed
21

above, the Court finds that they are also preempted by federal law.

This

includes strict liability, breach of implied warranties of merchantability and
fitness for a particular purpose, misrepresentation (§ 402B), and negligence
claims. Such claims would pose material impediments or thwart federal policy
designed to achieve uniform national standards in the area of animal biological
products, such as the Suvaxyn circovirus vaccine.

These state law claims

conflict with federal law in this preempted field.
The Court recognizes that, as did Lynnbrook court, that the conclusion
reached in this Order and Opinion leaves WPF with no remedy for the injuries
and losses they claim to have suffered. However, this Court is "not at liberty
to reverse the judgments of an agency acting within its congressionally
delegated authority. It is evident not only that APHIS intended claims such as
those brought by [WPF] to be preempted, but also that Congress granted APHIS
the power to act on those intentions." Lynnbrook, 79 F.3d at 630.
It is opportune to once again consider this matter in light of the United

States Supreme Court's 2012 discussions in Kurns. Here it is not difficult to
conclude that all of the state law claims asserted by WPF concern the efficacy
of the Suvaxyn circovirus vaccine and are preempted to the extent they conflict
with federal law.

Further, upon review of the federal law, including the
22

agency's regulatory scheme, it is not difficult to conclude that Congress has
intended federal law to occupy the field exclusively. Allowing WPF's state law
claims to proceed would interfere with APHIS's authority to determine whether
the vaccine at issue is pure, safe, potent and efficacious, and not worthless,
contaminated, dangerous, or harmful. The plaintiff's argument that VSTA does
not contain an express preemption provision reflecting congressional intent is
not persuasive, particularly in light of Kurns. Congressional intent is clear that
pursuant to VSTA, all matters concerning the safety, purity, potency, and
efficacy of animal vaccines have been assigned to the USDA, with authority to
promulgate regulations being properly designated to APHIS, for the purpose of
achieving uniform national standards of safety, purity, potency and efficacy for
veterinary biological products. The efficacy of the Suvaxyn circovirus vaccine
had already been declared safe and effective through the APHIS approval
process. The state law claims asserted by plaintiff here all concern the efficacy
of the Suvaxyn circovirus vaccine. The Court now finds and concludes that
these state law claims are all preempted by federal law.
Therefore, accepting all allegations in plaintiff's complaint as true, the
Court finds and concludes that all state law claims asserted by WPF are
preempted by federal law and that the defendants' motion for judgment on the

23

pleadings should be granted. Accordingly, it is therefore

ORDERED that defendants' motion for judgment on the pleadings shall
be, and is, GRANTED.
Judgment shall be entered accordingly.

/

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2013.

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ALAN B. JOHNS
UNITED STATES DISTRICT JUDGE

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