The Amended Complaint presents eight counts. In Counts I and
VII, Plaintiff asserts that SBC is liable, under a strict
liability theory, for the defective, dangerous, and inefficacious
nature of *CattleMaster 4 and Ultrabac7/Somubac, respectively.
Counts II and III contain allegations that SBC breached implied
warranties of fitness for a particular purpose and
merchantability under the Illinois Uniform Commercial Code, 810
ILCS 5/1-101, et seq. Count IV states a claim for fraudulent
misrepresentation. Count V alleges that SBC violated the Illinois
Consumer Fraud and Deceptive Business Practices Act, 815 ILCS
505/1, et seq., through the advertising and promotion of
*CattleMaster4. In Counts VI and VII, Plaintiff contends that the
*CattleMaster4 and Somubac vaccines were defective in that the
product labeling on the vaccines failed to warn against certain
alleged dangers arising out of their use.
Conclusions of Law
Summary judgment will be granted "if the pleadings,
depositions, answers to interrogatories, and admissions on file,
together with the affidavits, if any, show that there is no
genuine issue as to any material fact and that the moving party
is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(c).
Once the moving party has borne its burden of identifying those
portions of the pleadings, answers to interrogatories, etc., that
demonstrate there is no genuine issue of material fact, the
nonmoving party must come forward with specific facts showing
that there is a genuine issue for trial. Matsushita Elec. Indus.
Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586-87, 106 S.Ct.
1348, 1356, 89 L.Ed.2d 538 (1986). Where the record taken as a
whole could not lead a rational trier of fact to find for the
nonmoving party, there is no genuine issue for trial. Id. at 587,
106 S.Ct. at 1356 (citations omitted). When considering a motion
for summary judgment, courts must give the benefit of all
inferences to the party opposing the motion and examine the
record in the light most favorable to that party. United States
v. Diebold, Inc., 369 U.S. 654, 655, 82 S.Ct. 993, 994, 8 L.Ed.2d
176 (1962); Sarsha v. Sears, Roebuck & Co., 3 F.3d 1035, 1038
(7th Cir. 1993).
In this matter, the Court gives the benefit of all inferences
to the Plaintiff, for purposes of the Motion for Summary
Judgment, regarding Plaintiff's allegations that it purchased the
vaccines, *CattleMaster4 and Ultrabac7/Somubac, for use on its
cattle; that it properly utilized these vaccines; and that its
cattle contracted debilitating disease and either died or had to
be disposed of at a loss. All this being true, however, will not
permit the Plaintiff to survive summary judgment if the
Virus-Serum-Toxins Act ("VSTA") preempts Plaintiff's state common
law and statutory claims.*fn1 In the event that this Court finds
VSTA to preempt state law, Plaintiff, for all the injury
sustained by it, will have no remedy at law.
The presumption against preemption, especially where the
state law being usurped is a traditional state police power, is
well established. California v. ARC America Corp., 490 U.S. 93,
100, 109 S.Ct. 1661, 1665, 104 L.Ed.2d 86 (1989); Maryland v.
Louisiana, 451 U.S. 725, 746, 101 S.Ct. 2114, 2129, 68 L.Ed.2d
576 (1981) ("Consideration under the Supremacy Clause starts with
the basic assumption that Congress did not intend to displace
state law"); Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230,
67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947) ("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") (citations omitted). The same
presumption applies when an agency acts to preempt the field.
Hillsborough County, Fla. v. Automated Medical Laboratories,
Inc., 471 U.S. 707, 715, 105 S.Ct. 2371, 2376, 85 L.Ed.2d 714
(1985). In instances where agency preemption is alleged, however,
a "narrow focus on Congress' intent to supersede state law [is]
misdirected," as "[a] preemptive regulation's force does not
depend on express congressional
authority to displace state law." Fidelity Federal Sav. and
Loan Ass'n v. de la Cuesta, 458 U.S. 141, 154, 102 S.Ct. 3014,
3023, 73 L.Ed.2d 664 (1982).
Congress may act to preempt state law in three ways. Express
preemption exists where Congress has legislated in clear and
unequivocal terms, found within the text of the statute, that an
act preempts state law. See, e.g., Cipollone v. Liggett Group,
Inc., ___ U.S. ___, ___ - ___, 112 S.Ct. 2608, 2617-20, 120
L.Ed.2d 407 (1992). Implied preemption may be found (1) where
state law actually conflicts with an act of Congress, or (2)
where federal legislation is so pervasive as to make reasonable
the inference that Congress left no room for the States to
supplement it. Hines v. Davidowitz, 312 U.S. 52, 67, 61 S.Ct.
399, 404, 85 L.Ed. 581 (1941). Finally, state law may be
preempted by federal regulations, Hillsborough, supra, at 713,
105 S.Ct. at 2375, where a federal agency, acting within the
scope of its congressionally delegated authority, acts to preempt
state law. Fidelity Federal Sav. and Loan Ass'n v. de la Cuesta,
458 U.S. 141, 153-54, 102 S.Ct. 3014, 3022-23, 73 L.Ed.2d 664
(1982) (citations omitted); City of New York v. F.C.C.,
486 U.S. 57, 63-64, 108 S.Ct. 1637, 1642, 100 L.Ed.2d 48 (1988) (citing
Louisiana Public Service Com'n v. F.C.C., 476 U.S. 355, 367-71,
106 S.Ct. 1890, 1898-99, 90 L.Ed.2d 369 (1986)).*fn2
In the case at bar, Defendants have eschewed the express and
implied preemption arguments, relying solely upon agency
preemption to support its Motion for Summary Judgment. (Tr. of
2/24/95 Oral Argument at 3-4). Thus, this Court must determine
first whether the agency which regulated cattle vaccines, APHIS,
was acting within its congressionally delegated authority. City
of New York, supra, at 63-64, 108 S.Ct. at 1641-42. Once this
Court finds that APHIS was acting within its grant of authority,
it must determine whether the language APHIS chose in
promulgating its regulations is sufficiently broad to preempt
each of Plaintiff's claims. Id. at 66, 108 S.Ct. at 1643.
Under VSTA, all animal vaccines sold in the United States,
and all establishments at which animal vaccines are produced,
must be licensed by the USDA. 21 U.S.C. § 154 (West Supp. 1994).
Within USDA, licensure of animal vaccines and vaccine-producing
establishments is regulated by the USDA's APHIS. 9 C.F.R. §
101.1, et seq. This Court finds that Congress has delegated broad
authority to the USDA and APHIS to promulgate and enforce "such
rules and regulations as may be necessary" for the preparation
and sale of animal vaccines in the United States. 21 U.S.C. § 154
(West Supp. 1994).
In 1980 and 1981, several federal court opinions issued which
found that the breadth of VSTA was limited to "interstate"
commerce. See Animal Health Institute v. U.S. Dept. of
Agriculture, 487 F. Supp. 376 (D.Colo. 1980); Grand Laboratories,
Inc. v. Harris, 644 F.2d 729 (8th Cir. 1981), on rehearing,
660 F.2d 1288 (8th Cir. 1981), cert. denied, 456 U.S. 927, 102 S.Ct.
1972, 72 L.Ed.2d 442 (1982). These decisions found that the USDA
did not have the authority to regulate the production and sale of
products made within a single state. Animal Health Institute, 487
F. Supp. at 379; Grand Laboratories, 644 F.2d at 731; 660 F.2d at
1289. Congress responded to these cases by amending VSTA to
eliminate any distinction between "intrastate" and "interstate"
manufacture and distribution of animal vaccines. S.Rep. No.
99-145, 99th Cong., 1st Sess. at 338-339 (1985), reprinted in
1985 U.S. Code Congressional & Administrative News, 1676,
2004-2005. This congressional action placed the manufacture and
sale of all animal vaccines under the control of the United
States federal government. 21 U.S.C. § 151.
The legislative history surrounding the 1985 amendments to
VSTA indicates Congress' intent to create a national, uniform
standard for the preparation and sale of animal vaccines. S.Rep.
No. 99-145. In this
excerpt of legislative history, Congress noted that an
"intrastate/interstate" distinction no longer exists for
comparable products such as animal drugs, food additives, medical
devices, or pesticides. Id. Congress concluded that due to the
drastic changes in animal agriculture since 1913, including the
presence of "truly national markets," a uniform regulatory
standard would better serve "livestock owners, veterinarians, and
the American public." Id.
As a basis for comparison, this Court studied the decision in
City of New York, in which the Supreme Court decided whether the
Federal Communications Commission ("FCC") had properly acted
within its congressionally delegated power in preempting state
and local cable television quality standards. 486 U.S. at 66, 108
S.Ct. at 1643. The Court turned to both the Cable Communications
Policy Act of 1984, 47 U.S.C. § 521-559 (1982 ed., Supp. IV),
and the Communications Act of 1934 to analyze the breadth of
power the FCC had been granted by Congress. Id. at 60-62, 108
S.Ct. at 1640-41. In an earlier decision, Capital Cities Cable,
Inc. v. Crisp, the Court had found that Congress authorized the
FCC "to regulate all aspects of interstate communication by wire
or radio." 467 U.S. 691, 700, 104 S.Ct. 2694, 2701, 81 L.Ed.2d
580 (1984). According to the Crisp Court, this authority extended
to "all regulatory actions `necessary to ensure the achievement
of the Commission's statutory responsibilities.'" Id. (quoting
F.C.C. v. Midwest Video Corp., 440 U.S. 689, 706, 99 S.Ct. 1435,
1444, 59 L.Ed.2d 692 (1979)). Shortly after the Crisp decision,
Congress enacted the 1984 Cable Act, which states that Congress
intended to "establish a national policy concerning cable
communications" and to "minimize unnecessary regulation that
would impose an undue economic burden on cable systems."
47 U.S.C. § 521(1), (6) (1982 ed., Supp. IV).
The language in the 1985 amendments to VSTA are no less broad
than the grant of authority to the FCC in the 1934 and 1984 Acts.
The language Congress chose in enacting the 1985 amendments to
VSTA indicates its intent to grant the USDA broad powers
"necessary to prevent and eliminate burdens on . . . commerce and
to effectively regulate . . . commerce." 21 U.S.C. § 159.
Congress gave the Secretary of Agriculture the power to "make and
promulgate from time to time such rules and regulations as may be
necessary to prevent the preparation, sale . . . or shipment . .
. of any worthless, contaminated, dangerous or harmful virus,
serum, toxin, or analogous product. . . ." 21 U.S.C. § 154.
Having found that the congressional grant of power to USDA's
APHIS was broad enough to include the authority to preempt state
laws, this Court must now turn to the second prong of this
analysis, which is whether the language that APHIS chose in
promulgating its regulations is sufficiently broad to preempt
each of Plaintiff's claims. de la Cuesta, supra, at 153-54, 102
S.Ct. at 3022-23. "[W]here Congress has directed an administrator
to exercise his discretion, his judgments are subject to judicial
review only to determine whether he has exceeded his statutory
authority or acted arbitrarily." Id.
SBC asserts that APHIS has expressly construed the 1985
amendments to VSTA as reserving to the federal government the
exclusive responsibility for the safety, efficacy, purity,
potency, and labeling of animal vaccines. Further, SBC seeks to
invoke the rule that unless an agency's decision to preempt state
law is arbitrary or capricious, it must be given controlling
weight by the reviewing court. Chevron, U.S.A., Inc. v. Natural
Resources Defense Council, Inc., 467 U.S. 837, 845, 104 S.Ct.
2778, 2783, 81 L.Ed.2d 694 (1984).
In the August 27, 1992 Federal Register, APHIS articulated
its interpretation of the 1985 amendments, in relevant part, as
Where 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 [the 1985 amendments to 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
[S]tates 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
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
57 Fed.Reg. 38758, 38759 (August 27, 1992).
The Court must turn to the analysis set out in Chevron to
determine whether or not this interpretation of the 1985
amendments is to be given controlling weight. 467 U.S. 837,
842-43, 104 S.Ct. 2778, 2781. As Congress has not directly spoken
to the issue of preemption, the Court must decide whether APHIS'
declaration of preemption is based upon a permissible
construction of VSTA. Chevron, 467 U.S. at 843-44, 104 S.Ct. at
2781-82. APHIS' interpretation can be found to be based upon a
permissible construction, thus entitled to controlling weight, if
it is not arbitrary, capricious or manifestly contrary to VSTA.*fn3
The language of the amendments, including those sections
aforementioned which grant the Secretary of Agriculture the
authority to "make and promulgate . . . such rules and
regulations as may be necessary to prevent the preparation, sale,
barter, exchange or shipment . . . of any worthless contaminated,
dangerous or harmful . . . serum, toxin, or analogous product,"
21 U.S.C. § 154, "to prevent and eliminate burdens on
[interstate] commerce and to effectively regulate such commerce,"
21 U.S.C. § 159, allow the permissible interpretation that APHIS
may preempt state law. The choice to preempt state law represents
"a reasonable accommodation of conflicting policies that were
committed to the agency's care by the statute," United States v.
Shimer, 367 U.S. 374, 382, 81 S.Ct. 1554, 1560, 6 L.Ed.2d 908
(1961), in that it would be difficult to prevent or eliminate
burdens on interstate commerce if each of the 50 states could
impose different regulations on animal vaccines. Thus, APHIS'
reading is neither arbitrary nor capricious. Further, it is
congruous with VSTA's purpose of regulating the safety, efficacy,
purity, potency, and labeling of animal vaccines.
Finally, the Court must analyze the various claims of
Plaintiff to determine whether the legal duty that is the
predicate of the common law damages counts, Cipollone, supra, at
___, 112 S.Ct. at 2621, would impose a requirement upon the
Defendants which is "different from, or in addition to, those
imposed by the USDA regarding the safety, efficacy, potency, or
purity of a product." Cipollone, supra, at ___, 112 S.Ct. at
2621; 57 Fed.Reg. 38758, 38759 (August 27, 1992).
It is noteworthy that several Courts of Appeal, including the
Seventh Circuit, have previously addressed language similar to
that of APHIS' regulations in the Federal Insecticide, Fungicide
and Rodenticide Act ("FIFRA"), 7 U.S.C. § 136, et seq. Section
136v(b) of FIFRA, entitled Authority of the States, provides as
Such State shall not impose or continue in effect
any requirements for labeling or packaging in
addition to or different from those required by
7 U.S.C. § 136v.
The majority of circuits to consider FIFRA's preemptive
reach, including the Seventh Circuit, find this language to
both positive enactments and common law. MacDonald v. Monsanto
Co., 27 F.3d 1021 (5th Cir. 1994); Bice v. Leslie's Poolmart,
Inc., 39 F.3d 887 (8th Cir. 1994); King v. E.I. Dupont De Nemours
and Co., 996 F.2d 1346 (1st Cir. 1993), cert. dismissed, ___ U.S.
___, 114 S.Ct. 490, 126 L.Ed.2d 440 (1993); Worm v. American
Cyanamid Co., 5 F.3d 744 (4th Cir. 1993); Shaw v. Dow Brands,
Inc., 994 F.2d 364 (7th Cir. 1993); Arkansas-Platte & Gulf
Partnership v. Van Waters & Rogers, Inc., 981 F.2d 1177 (10th
Cir. 1993), cert. denied, ___ U.S. ___, 114 S.Ct. 60, 126 L.Ed.2d
30 (1993); Papas v. Upjohn Co., 985 F.2d 516 (11th Cir. 1993),
cert. denied by Papas v. Zoecon Corp., ___ U.S. ___, 114 S.Ct.
300, 126 L.Ed.2d 248 (1993).
Applying this logic, Counts I and VII of Plaintiff's Amended
Complaint, which allege the two vaccines were defective,
dangerous, and inefficacious, would impose a duty on SBC
regarding the safety, efficacy, potency, or purity of the cattle
vaccines which would be in addition to or different from those
regulations promulgated by the USDA and enforced by APHIS.
Similarly, Counts II and III allege that SBC breached implied
warranties of fitness of a particular purpose and
merchantability, respectively. These allegations implicate the
safety and efficacy of SBC's cattle vaccines and, as such, are
preempted by VSTA.
Counts IV and V state claims for fraudulent misrepresentation
and false advertising, alleging that Defendants knew the vaccine
*CattleMaster4 was dangerous and lacked efficacy. These claims
are inherently failure to warn claims which, if not preempted,
would allow a jury to determine that the vaccine was unsafe
and/or inefficacious. Thus, a requirement different from or in
addition to those set out by APHIS would be imposed upon SBC.
These Counts are both preempted.
With regard to the failure to warn claims, Counts VI and
VIII, APHIS has expressly stated that "labeling requirements
which are different from or in addition to those in the
regulations under the Act may not be imposed by the States." 57
Fed.Reg. at 38759. Thus, to the extent that Plaintiff's failure
to warn claims would require SBC to alter the labels of its
cattle vaccines, they are also preempted.
All this being said, the Court is troubled by the absence of
a federal remedy. Based on the breadth of APHIS' congressional
grant of authority, the express language of the regulations, and
the agency's permissible interpretation of VSTA, however, this
Court can come to no other viable conclusion.
For the reasons set forth herein, the Court GRANTS the
Defendants' Motion for Summary Judgment in favor of Defendants
Smithkline Beecham and Norden Laboratories and against Plaintiff,
Lynnbrook Farms, and finds the Motion to Dismiss DENIED as moot.