# Appendix — Dow AgroSciences LLC v. Sleath

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Appendix
- **Published:** January 1, 2001
- **Citation:** 534 U.S. 814

## Text

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APPENDIX A — OPINION OF THE SUPREME COURT
OF THE STATE OF MONTANA DATED, DECIDED
AND FILED DECEMBER 28, 2000

No. 99-185

IN THE SUPREME COURT OF THE
STATE OF MONTANA

2000 MT 381

LIBBY SLEATH, MARY ANN HAYES, GLENDA
TRUESDELL, and MARY OWEN,

Plaintiffs/Appellants,

Vv.

WEST MONT HOME HEALTH SERVICES, INC., WEST
MONT HOME MANAGEMENT SERVICES, INC., ORKIN
EXTERMINATION COMPANY, INC., and EP CO., INC.,
and ROFAN SERVICES, INC., d/b/a DOWELANCO,

Defendants/Respondents.

APPEAL FROM: District Court of the First Judicial District,
In and for the County of Lewis and Clark,
The Honorable Jeffrey M. Sherlock, Judge
presiding.

* * *

Heard January 11, 2000
Submitted February 15, 2000
Decided December 28, 2000

* * *

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Justice James C. Nelson delivered the Opinion of the Court.

41 Appellants Libby Sleath, Mary Ann Hayes, Glenda
Truesdell, and Mary Owen brought this personal injury action
against Respondents West Mont Home Health Services, Inc.
and West Mont Home Management Services, Inc. (collectively
referred to as “West Mont”); Orkin Extermination Company,
Inc. (Orkin); and Ep Co., Inc. and Rofan Services, Inc.
d/b/a DowElanco (collectively referred to as “DowElanco”),
for injuries Appellants allegedly suffered when Orkin applied
a pesticide manufactured by DowElanco at the West Mont
building where plaintiffs worked. The District Court for the
First Judicial District, Lewis and Clark County, granted
summary judgment in favor of DowElanco on the basis that
Appellants’ claims are preempted by the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA). We reverse and
remand for further proceedings consistent with this opinion.

{2 Appellants present the following issues for review:

93 1. Whether Appellants’ failure to warn claims, pleaded
in negligence, strict liability, and breach of express warranty,
are preempted by FIFRA because they are based upon or
implicate the pesticide’s labels.

94 2. Whether the failure to warn claims in Appellants’
negligence and strict liability theories of liability are
preempted by FIFRA when Appellants were not purchasers
or users of the pesticide and were, instead, unwitting
bystanders who never saw the pesticide’s labels and who
suffered injury from the use of the pesticide by others.

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45 3. Whether Appellants’ strict liability for design defect
theory of liability is preempted by FIFRA.

{6 Because we conclude that Issue 1 is dispositive, we do
not address Issues 2 and 3.

Factual and Procedural Background

{7 Appellants worked in a building in Helena owned by their
employer, West Mont. Sometime in 1991, West Mont ordered
that all windows in the building be closed and that the
operating cranks for the windows be removed, thereby
preventing fresh air ventilation of the building. Between 1991
and 1994, Orkin applied various pesticides, collectively
referred to here as Dursban, to the interior of the West Mont
building every three to six weeks without prior or subsequent
warnings to Appellants. These pesticides were manufactured
and sold by DowElanco.

48 Each of the Appellants began suffering from various
physical ailments and were forced to leave their employment
on advice of their physicians. Appellant Hayes worked in
the West Mont building until June 28, 1993; Appellant Owen
worked until July 12, 1993; Appellant Truesdell worked until
August 24, 1993; and Appellant Sleath worked until May
1994. Appellants first learned that they were routinely
exposed to Dursban in 1995 when they requested information
from West Mont about the pesticide applications. Prior to
1995, Appellants were unaware that they had been exposed
to Dursban.

9 Dursban is DowElanco’s registered trademark for a group
of insecticides developed, manufactured, and marketed by

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DowElanco. The active ingredient in each of the Dursban
products is a synthetic chemical compound known as
chlorpyrifos which is one of a group of compounds known
as organophosphates. Organophosphates are synthetic
chemical relatives of the nerve gases used in World Wars I
and II. They are central and peripheral nervous
system poisons that inhibit the action of the enzyme
acetylcholinesterase.

410 Depending on exposure frequency and dosage levels,
the toxicity to the central and peripheral nervous systems
can cause symptoms such as headaches, dizziness, flu-like
malaise, urinary frequency, confusion and difficulties with
memory and concentration. Each of the Appellants exhibits
one or more of these symptoms, all of which are
toxicologically consistent with excessive exposure to
chlorpyrifos as contained in Dursban.

911 Dursban’s labels are registered in accordance with
FIFRA and its implementing regulations. Each of the
Dursban labels relevant to this case contains the following
statement:

DowElanco warrants that this product conforms
to the chemical description on the label and is
reasonably fit for the purposes stated on the label
when used in strict accordance with the directions,
subject to the inherent risks set forth below.

412 DowElanco markets and sells its Dursban products only
to professional applicators, distributors, and formulators.
It does not market or sell Dursban products to the general

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public. In fact, Dursban’s labels require that it be applied
by, or under the direction of, commercial applicators.

{13 On January 5, 1996, Appellants filed a complaint against
West Mont, Orkin, and DowElanco. Thereafter, on October
9, 1996, Appellants, with leave of the District Court, filed
their Second Amended Complaint wherein they alleged that
West Mont was negligent for failing to ensure that the
building in which Appellants were working was free from
hazardous chemicals and for failing to warn Appellants and
other employees about the possible health risks of the
pesticides applied in the building. Appellants also alleged
that Orkin negligently and carelessly failed to give warning
or otherwise take steps to ensure that Appellants and others
would not be exposed to the pesticide’s adverse effects.

14 As to DowElanco, the complaint alleged negligent
design and manufacture of Dursban, strict products liability
for the design and manufacture of Dursban, and breach of
express and implied warranties. Moreover, the negligence
and strict liability theories contained allegations that
DowElanco failed to provide adequate warnings about the
dangers of Dursban.

415 During the course of discovery, DowElanco served each
Appellant with an identical set of 15 interrogatories.
Appellants’ answers to these interrogatories were nearly
identical. And, in response to many of these interrogatories,
Appellants referred to Dursban’s labels.

416 On February 24, 1998, DowElanco moved for summary
judgment on the basis that all of Appellants’ claims are

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preempted by FIFRA because Appellants’ complaint and
interrogatory answers show that Appellants’ theories of
liability are all based solely upon inclusions in or omissions
from Dursban’s labels. The specific provision in FIFRA to
which DowElanco refers is 7 U.S.C. § 136v(b); which
provides:

(b) Uniformity

Such State shall not impose or continue in
effect any requirements for labeling or packaging
in addition to or different from those required
under this subchapter.

417 Appellants responded to DowElanco’s motion for
summary judgment by redacting their interrogatory answers
to exclude specific references to Dursban’s labels. Appellants
also submitted a supplemental affidavit from Robert K.
Smith, Ph.D., one of Appellants’ proposed expert witnesses,
setting forth his opinion that Dursban is defective and
unreasonably dangerous “in the context of interior workplace
application of those products.”

418 DowElanco moved to strike this supplemental affidavit,
but the District Court denied the motion. The court
determined, however, that even considering the supplemental
affidavit and excluding references to Dursban’s labels in
Appellants’ interrogatory answers, all of Appellants’ claims
are based on Dursban’s labels. Hence, the District Court
concluded that pursuant to this Court’s opinion in McAlpine
v. Rhone-Poulenc Ag. Co. (1997), 285 Mont. 224, 947 P.2d
474, all of Appellants’ claims against DowElanco are

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preempted by FIFRA. Accordingly, the District Court
granted summary judgment in favor of DowElanco.

Standard of Review

419 Our standard of review in appeals from summary
judgment rulings is de novo. Oliver v. Stimson Lumber Co.,
1999 MT 328, 9 21, 297 Mont. 336, 9 21, 993 P.2d 11, J 21
(citing Motarie v. N. Mont. Joint Refuse Disposal (1995),
274 Mont. 239, 242, 907 P.2d 154, 156; Mead v. M.S.B.,
Inc. (1994), 264 Mont. 465, 470, 872 P.2d 782, 785). When
we review a district court’s grant of summary judgment, we
apply the same evaluation as the district court based on Rule
56, M.R.Civ.P. Oliver, § 21 (citing Bruner v. Yellowstone
County (1995), 272 Mont. 261, 264, 900 P.2d 901, 903). We
set forth our inquiry in Bruner as follows:

The movant must demonstrate that no genuine
issues of material fact exist. Once this has been
accomplished, the burden then shifts to the non-
moving party to prove, by more than mere denial
and speculation, that a genuine issue does exist.
Having determined that genuine issues of fact do
not exist, the court must then determine whether
the moving party is entitled to judgment as a
matter of law. We review the legal] determinations
made by a district court as to whether the court
erred.

Oliver, ¥ 21 (quoting Bruner, 272 Mont. at 264-65, 900 P.2d
at 903).

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420 Moreover, in a summary judgment proceeding, the
evidence must be viewed in the light most favorable to the
nonmoving party, and all reasonable inferences will be drawn
therefrom in favor of the party opposing summary judgment.
Oliver, § 22 (citing Joyce v. Garnaas, 1999 MT 170, 4 8,
295 Mont. 198, J 8, 983 P.2d 369, 4 8). Consequently, we
will view the evidence in the light most favorable to the
Appellants and all reasonable inferences will be drawn in
their favor.

Issue 1.

21 Whether Appellants’ failure to warn claims, pleaded in
negligence, strict liability, and breach of express warranty,
are preempted by FIFRA because they are based upon or
implicate the pesticide’s labels.

422 The United States Constitution provides that “[t]his
Constitution, and the Laws of the United States which shall
be made in Pursuance thereof. . . shall be the supreme Law
of the Land; ... any Thing in the Constitution or Laws of
any State to the Contrary notwithstanding.” U.S. Const. art.
VI, cl. 2. “It is basic to this constitutional command that all
conflicting state provisions be without effect.” Maryland v.
Louisiana (1981), 451 U.S. 725, 746, 101 S.Ct. 2114, 2128-
29, 68 L.Ed.2d 576 (citing McCulloch v. Maryland (1819),
17 U.S. 316, 427, 4 Wheat. 316, 4 L.Ed. 579; Hines v.
Davidowitz (1941), 312 U.S. 52, 61 S.Ct. 399, 85 L.Ed. 581).

423 This preemptive power is not to be found carelessly,
however.

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[B]ecause the States are independent sovereigns
in our federal system, we have long presumed that
Congress does not cavalierly pre-empt state-law
causes of action. In all pre-emption cases, and
particularly in those in which Congress has
“legislated ... in a field which the States have
traditionally occupied,” ... 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, Inc. v. Lohr (1996), 518 U.S. 470, 485, 116 S.Ct.
2240, 2250, 135 L.Ed.2d 700 (quoting Rice v. Santa Fe
Elevator Corp. (1947), 331 U.S. 218, 230, 67 S.Ct. 1146,
1152, 91 L.Ed. 1447). See also Cipollone v. Liggett Group,
Inc. (1992), 505 U.S. 504, 516, 112 S.Ct. 2608, 2617, 120
L.Ed.2d 407. Thus, the purpose of Congress “‘is the ultimate
touchstone” in every preemption case. Medtronic, 518 U.S.
at 485, 116 S.Ct. at 2250 (quoting Retail Clerks v.
Schermerhorn (1963), 375 U.S. 96, 103, 84 S.Ct. 219, 223,
11 L.Ed.2d 179).

{24 Congress’s intent may be “explicitly stated in the
statute’s language or implicitly contained in its structure and
purpose.” Cipollone, 505 U.S. at 516, 112 S.Ct. at 2617
(quoting Jones v. Rath Packing Co. (1977), 430 U.S. 519,
525, 97 S.Ct. 1305, 1309, 51 L.Ed.2d 604). Furthermore,

[i]n the absence of an express congressional
command, state law is pre-empted if that law
actually conflicts with federal law, or if federal

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law so thoroughly occupies a legislative field as
to make reasonable the inference that Congress
left no room for the States to supplement it.

Cipollone, 505 U.S. at 516, 112 S.Ct. at 2617 (internal
quotations and citations omitted).

425 FIFRA was first enacted by Congress in 1947 to regulate
pesticides. The 1947 Act required pesticide manufacturers
to register pesticides with the Secretary of Agriculture, to
display poison warnings on the labels of highly toxic
pesticides, and to include other warning statements to prevent
injury to people, animals and plants. In 1949, the Secretary
of Agriculture, under the authority of FIFRA, issued
substantial pesticide labeling requirements. In 1970, the
authority for pesticide regulation was transferred to the newly
created Environmental Protection Agency (EPA), which now
administers the pesticide labeling requirements imposed by
the Department of Agriculture.

426 In 1972, Congress enacted sweeping amendments to
FIFRA, largely in response to public concerns over the
health risks of the pesticide DDT. The 1972 amendments
established that the primary purpose of federal pesticide
regulation is the protection of human health and the
environment from the risks posed by pesticides. While
FIFRA had previously regulated pesticides primarily through
labeling requirements, the 1972 amendments established
federal regulation of pesticide use, an area previously
regulated exclusively by the states.

927 The 1972 amendments established a program of federal-
state cooperation in regulating pesticides. Under this

:

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program, the EPA registers pesticides for a particular use
and approves pesticide labels. In doing so, FIFRA requires
that the EPA must determine whether the pesticide’s
composition is such as to warrant the proposed claims for it;
whether the labeling and other materials comply with FIFRA;
whether the pesticide will perform its intended function
without unreasonable adverse effects on the environment;
and whether the pesticide will have unreasonable adverse
effects on the environment when used in accordance with
widespread and commonly recognized practices. Pursuant
to a 1978 amendment, the EPA does not evaluate pesticide
label claims regarding efficacy or otherwise regulate efficacy
in approving pesticide labels.

28 States retain broad authority to regulate the sale and
use of pesticides. Under 7 U.S.C. § 136v(a), states may
regulate pesticide sales or use more strictly than the federal
government. Under 7 U.S.C. § 136v(c) and its accompanying
regulations, states may register pesticides for local uses in
addition to those approved by the EPA and may impose
supplemental labeling requirements regarding those
additional uses.

29 The term “label” means “the written, printed, or graphic
matter on, or attached to, the pesticide ... or any of its
containers or wrappers.” 7 U.S.C. § 136(p)(1). The term
“labeling” means “all labels and all other written, printed,
or graphic matter — (A) accompanying the pesticide . . . at
any time; or (B) to which reference is made on the label or
in literature accompanying the pesticide... .” 7 U.S.C.
§ 136(p)(2). The EPA has specific regulations concerning
content, placement, type size, and prominence of warnings

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and precautionary statements on a label. See 40 C.F.R.
§ 156.10. The final form of the printed labeling for a pesticide
must be submitted to and accepted by the EPA before
registration. 40 C.F.R. § 156.10(a)(6). Once the EPA
approves a label, the manufacturer may not change it without
the EPA’s approval. Worm v. American Cyanamid Co.
(4th Cir. 1993), 5 F.3d 744, 747.

430 In the case sub judice, Appellants ask this Court to
revisit its decision in McAlpine v. Rhone-Poulenc Ag. Co.
(1997), 285 Mont. 224, 947 P.2d 474, insofar as it holds that
state law claims based on a failure to warn are preempted by
FIFRA to the extent that they expressly or implicitly
challenge the adequacy of the warnings 1n a pesticide’s label.
Appellants maintain that this Court reached its conclusion
in McAlpine by following the decisions holding that the
preemption language of FIFRA should be given the same
effect as the statute governing cigarette advertising that the
United States Supreme Court construed in Cipollone v.
Liggett Group, Inc. (1992), 505 U.S. 504, 112 S.Ct. 2608,
120 L.Ed.2d-407.

431 Appellants present three reasons why we should revisit
our decision in McAlpine. First, Appellants argue that a plain
reading of the parties’ briefs in McAlpine confirms that all
parties to that appeal simply assumed that Cipollone was
controlling on the question of FIFRA’s preemption language
and never examined the validity of that proposition.

432 Second, Appellants point out that none of the parties’
briefs in McAlpine mentioned Medtronic, Inc. v. Lohr (1996),
518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700, wherein the

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Supreme Court stated that the preemption language of the
Medical Device Amendments of 1976 (the MDA), which is
similar to FIFRA’s preemption section, does not preempt
state law failure to warn claims regarding medical devices
even though they are properly labeled pursuant to the MDA.
Medtronic, 518 U.S. at 501-02, 116 S.Ct. at 2258. Appellants
argue that Medtronic demonstrates that when a federal
regulatory statute consistently uses the term “requirement”
to mean positive legislative or administrative enactments,
and there is no indication in the statute’s legislative history
that Congress intended to preempt state common law, the
term “requirements” does not include common law damage
actions.

433 Third, Appellants point out that the United States
Department of Justice, representing the EPA, filed an amicus
curiae brief in Etcheverry v. Tri-Ag Service, Inc. (Cal. 2000),
993 P.2d 366, articulating the Government’s position that
FIFRA does not preempt any state law theories of liability,
including failure to warn claims that implicate pesticide
labels. Appellants argue that the EPA’s view of the scope of
FIFRA’s preemptive effect is entitled to substantial weight
because the EPA is charged by Congress with overseeing
the primary enforcement responsibility of the states under
FIFRA, and thus the EPA is uniquely qualified to determine
whether a particular form of state law should be preempted.
Appellants also argue that the EPA’s brief is a record of the
California Supreme Court within the meaning of Rule
202(b)(6), M.R.Evid., and that this Court may take judicial
notice of it pursuant to Rules 202(d)(2) and (f)(2), M.R.Evid.

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434 DowElanco argues on the other hand, that Congress
expressly stated its intent to preempt state law under FIFRA
when it amended § 136v(b) in 1972 to read:

[A] State shall not impose or continue in effect
any requirements for labeling or packaging in
addition to or different from those required under
this Act.

In addition, DowElanco maintains that Appellants’ argument
that this Court was inadequately advised when it decided
McAlpine has been waived by Appellants’ failure to raise
the argument in the District Court and that, even so,
Appellants’ argument is without merit. DowElanco argues
that the United States Supreme Court’s decision in
Medtronic, wherein the Supreme Court construed a different
statute, does not alter preemption analysis under FIFRA.
Moreover, DowElanco argues that even though Medtronic
was decided nearly two years before Appellants filed their
response to DowElanco’s motion for summary judgment,
Appellants did not make any argument to the District Court
based on Medtronic or even cite to Medtronic in their
response to DowElanco’s motion for summary judgment.
Hence, DowElanco contends that Appellants waived their
Medtronic argument.

935 DowElanco correctly points out that this Court has
repeatedly held that we will not address either an issue raised
for the first time on appeal or a party’s change in legal theory.
Unified Industries, Inc. v. Easley, 1998 MT 145, 4 15, 289
Mont. 255, J 15, 961 P.2d 100, 4 15. However, this Court
has never applied this rule to cases. Indeed, we have decided

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issues based on cases neither side cited. See DeTienne
Associates v. Montana Rail Link, (1993), 261 Mont. 238,
241, 862 P.2d 1106, 1107-08. Medtronic does not raise an
issue for the first time on appeal or raise a new theory of
liability. It simply represents further legal support for the
preemption issue. “In our de novo review of a district court
ruling on summary judgment, we are not bound by the legal
authority presented in the district court.” Thomas v.
Northwestern Nat. Ins. Co., 1998 MT 343, § 22, 292 Mont.
357, | 22, 973 P.2d 804, ¥ 22.

436 DowElanco also objects to Appellants’ contention that
this Court should consider and give deference to the EPA’s
brief in Etcheverry. DowElanco maintains that courts do not
give deference to an agency’s statutory interpretation which
is contrary to the plain language of a statute, as determined
by the courts. DowElanco argues that Appellants have put
the cart before the horse because the initial question is
whether Congressional intent can be ascertained by the
language of the statute and traditional tools of statutory
interpretation. Moreover, DowElanco argues that the rule of
deference to agency statutory interpretations does not apply
to an agency’s litigation position.

{37 In Chevron, U.S.A., Inc. v. Natural Resources Defense
Council, Inc. (1984), 467 U.S. 837, 844, 104 S.Ct. 2778,
2782, 81 L.Ed.2d 694, the United States Supreme Court
stated: “We have long recognized that considerable weight
should be accorded to an executive department’s construction
of a statutory scheme it is entrusted to administer... .” In
this case, because the EPA is the agency charged with
administering FIFRA, we agree with Appellants that we

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should consider the EPA’s brief in Etcheverry and that the
EPA’s interpretation of FIFRA should receive deference.

438 Moreover, the EPA was not a party in any of the
previous actions regarding FIFRA and had not previously
expressed an opinion in court on whether FIFRA preempts
state-law damages actions. As a result, we did not have the
benefit of the EPA’s position on FIFRA preemption when
we decided McAlpine. Nor did we have the benefit of the
United States Supreme Court’s decision in Medtronic.
Consequently, we take this opportunity to revisit our decision
in McAlpine insofar as it holds that state law claims based
on a failure to warn are preempted by FIFRA.

939 In McAlpine, several farmers brought a products liability
action against the manufacturer and distributor of a herbicide
alleging that they suffered damage as a result of defendants’
failure to warn them that the herbicide could damage their
crops if applied in cool weather. We held in McAlpine, that
because the plaintiffs’ negligence claim was based solely
on the insufficiencies in the product’s warning label, that
claim was preempted by FIFRA. McAlpine, 285 Mont. at
231-32, 947 P.2d at 478. We also held that FIFRA did not
preempt plaintiffs’ breach of warranty and strict liability
claims to the extent that those claims did not rely on
representations made on the product’s label. McAlpine, 285
Mont. at 232-33, 947 P.2d at 478-79.

940 We predicated our decision in McAlpine on the United
States Supreme Court’s decision in Cipollone wherein the
Supreme Court interpreted a portion of the Public Health
Cigarette Smoking Act of 1969 that provided:

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(b) No requirement or prohibition based on
smoking and health shall be imposed under State
law with respect to the advertising or promotion
of any cigarettes the packages of which are labeled
in conformity with the provisions of this Act.

Cipollone, 505 U.S. at 515, 112 S.Ct. at 2617 (quoting
15 U.S.C. § 1334(b)).

41 The plaintiff in Cipollone claimed that the defendant
tobacco company caused his mother’s death by failing to
provide adequate warnings on its cigarettes and by
misrepresenting the dangers of smoking to the public.
Cipollone, 505 U.S. at 508, 112 S.Ct. at 2613. The Supreme
Court determined in Cipollone that:

The phrase “[n]o requirement or prohibition”
sweeps broadly and suggests no distinction
between positive enactments and common law:
to the contrary, those words easily encompass
obligations that take the form of common-law
rules.

Cipollone, 505 U.S. at 521, 112 S.Ct. at 2620. On that basis,
the Supreme Court held that state law failure to warn claims
are preempted insofar as they require a showing that a
defendant’s cigarette advertising “should have included
additional, or more clearly stated, warnings.” Cipollone, 505
U.S. at 524, 112 S.Ct. at 2621.

42 In our discussion of Cipollone in McAlpine, we noted
that

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[a]ll of the circuit courts, and several state
supreme courts, that have considered the effect
of FIFRA’s preemption clause have concluded |
that it should be given the same effect as the |
preemption clause interpreted in Cipollone... .

Thus, for purposes of determining the scope of |
FIFRA preemption, Cipollone provides the
appropriate framework for our analysis.

McAlpine, 285 Mont. at 229-30, 947 P.2d at 477 (citations
omitted). Hence, we determined in McAlpine that, as in the
cigarette labeling statute at issue in Cipollone, the phrase
“requirement” in § 136v(b) of FIFRA includes state common
law damage actions. McAlpine, 285 Mont. at 230, 947 P.2d
at 477. Consequently, we concluded that FIFRA preempts
state tort claims to the extent that they arise from an omission
or inclusion in a product’s label, but that claims alleging a
product, manufacturing, or design defect; claims alleging
negligent design, testing, or manufacturing; or claims
alleging breach of warranty that do not rely on such an
omission or inclusion in the product’s label, are not
preempted. McAlpine, 285 Mont. at 230, 947 P.2d at 477.

943 However, as pointed out by Appellants in their brief on
appeal and as we noted earlier in this opinion, we did not
have the benefit of the Supreme Court’s decision in
Medtronic in making our determination in McAlpine. The
Supreme Court held in Medtronic that in spite of its earlier
decision in Cipollone, the preemption provision at issue in
Medtronic did not preempt state common law damage
actions.

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44 In Medtronic, a pacemaker recipient’s pacemaker failed
resulting in a “complete heart block” that required her to
undergo emergency surgery. According to her physician, the
likely cause of the failure was a defect in the lead that
transmits the heartbeat-steadying electrical signal from the
“pulse generator” to the heart itself. The pacemaker recipient
brought an action against the pacemaker manufacturer
asserting claims of negligence and strict liability. Medtronic,
518 U.S. at 480-81, 116 S.Ct. at 2248.

45 The preemption statute at issue in Medtronic provided:
State and local requirements respecting devices
(a) General rule

Except as provided in subsection (b) of this
section, no State or political subdivision of a
State may establish or continue in effect with
respect to a device intended for human use any

. requirement —

(1) which is different from, or in addition to,
any requirement applicable under this chapter to
the device, and

(2) which relates to the safety or
effectiveness of the device or to any other matter
included in a requirement applicable to the device
under this chapter.

Medtronic, 518 U.S. at 481-82, 116 S.Ct. at 2248-49 (quoting
21 U.S.C. § 360k(a)).

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446 A four-Justice plurality held in Medtronic that distinct
features of the MDA mandated the conclusion that Congress
intended only to preempt states from imposing positive law
“requirements” on medical devices in the form of regulations
or laws and did not intend to preempt common law damage
actions. Medtronic, 518 U.S. at 488-89, 116 S.Ct. at 2252.
The Medtronic plurality found five key differences in the
statutory schemes of the 1969 Cigarette Act and the MDA
that mandated the conclusion that Congress did not intend
the word “requirements” to mean the same thing in both
statutes.

{47 First, the preemption of state authority resulting from
the 1969 Cigarette Act prevented only “a limited set of state
requirements” — requirements imposed on advertising
regarding the health effects of cigarettes, while preemption
of common law actions as a result of the MDA would
extinguish all state law design defect claims regarding all
medical devices. Second, the MDA provided no private
damages action that would replace state common law actions.
Third, the MDA’s preemption provision, unlike the 1969
Cigarette Act’s, expressed congressional concern “with the
problem of specific, conflicting state statutes and regulations
rather than the general duties enforced by common-law
actions.” Fourth, unlike the 1969 Cigarette Act, the MDA
uses the word “requirements” in numerous provisions, and
each use clearly refers only to statutory and regulatory law,
not common law. Fifth, the legislative history of the MDA
reveals no reference in the hearings, committee reports, or
debates that suggests a congressional intent to preempt all
common- law remedies. Medtronic, 518 U.S. at 487-91, 116
S.Ct. at 2251-53.

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448 In the same way, while the term “requirements” may
encompass common law duties in some contexts, the text,
legislative history, and purposes of FIFRA demonstrate that
Congress had no intent that the use of the term
“requirements” in § 136v(b) would extinguish state common
law damage actions. As the EPA noted in its amicus brief in
Etcheverry:

When § 136v(b) was enacted in 1972, state law
actions against pesticide manufacturers for failure
to warn were a commonplace and uncontroversial
feature of the legal landscape. No evidence from
the text or legislative history of FIFRA suggests
that Congress had any intent to extinguish those
actions or that Congress even considered doing
so. Indeed, Congress amended FIFRA in 1972 out
of increasing concern for the human health and
the environmental effects of pesticides such as
DDT. Given that FIFRA establishes no private
damages remedy for those injured by pesticides,
it would be astonishing that, without any
discussion, Congress could have intended to
deprive injured persons of all means of relief.

949 FIFRA’s text demonstrates that Congress had no intent
to extinguish damages remedies under state common law.
For example, in § 136v, Congress used the term
“requirements” to mean “regulation,” a term connoting
positive commands of law, not court orders to pay damages
for the harms caused by pesticides. Section 136v(a) provides
that “[a] State may regulate” the sales or use of pesticides as
long as the state “regulation” does not permit a sale or use

22a

Appendix A

prohibited by FIFRA. Section 136v(b) forbids “[s]uch
state” from regulating labeling by imposing labeling
“requirements” in addition to or different from those required
under FIFRA. The plainest reading of the two subsections is
that a state may “regulate” pesticide sales or use, but in doing
so may not impose labeling “requirements.” In other words,
§ 136v(b)’s prohibition on state labeling “requirements”
represents an exception to § 136v(a)’s general grant of state
authority to “regulate” pesticide sales and use.

9450 The Medtronic plurality interpreted the term
“requirements” in the MDA’s preemption provision by
examining its usages throughout the MDA. In doing so, the
plurality adhered to “the normal rule of statutory construction
that identical words used in different parts of the same act
are intended to have the same meaning.” Sullivan v. Stroop
(1990), 496 U.S. 478, 484, 110 S.Ct. 2499, 2504, 110 L.Ed.2d
438 (internal quotations and citations omitted).

451 The term “requirements” appears in FIFRA 75 times.
No court considering preemption under FIFRA ever
addressed the meaning of “requirements” in the entire context
of FIFRA; courts only looked at it in terms of § 136v(b).
However, in each instance other than § 136v(b), Congress
intended the term “requirements” to mean enactments of
positive law by legislative or administrative bodies. It is
inconceivable that Congress intended that § 136v(b) would
be the only section of FIFRA in which the term
“requirements” includes the application of general rules of
common law by judges and juries.

452 Throughout FIFRA, the term “requirements” refers
exclusively to positive enactments of statutory and regulatory

23a

Appendix A

law. Accordingly, the term “requirements” should be given
the same reading in § 136v(b). Simply because the term
“requirement” was found in Cipollone to encompass common
law actions for damage, does not preclude this Court from
reaching a contrary result in this case. “Only mischief can
result if [the same words appearing in different statutes] are
given one meaning regardless of the statutory context.”
Lee v. Madigan (1959), 358 U.S. 228, 231, 79 S.Ct. 276,
278, 3 L.Ed.2d 260.

53 Moreover, subsections (a) and (c) of § 136v demonstrate
that Congress intended to authorize states to take actions
that may indirectly prompt pesticide manufacturers to change
their labels. Indirect pressure on pesticide manufacturers to
change their labels, which may result from liability in damage
actions, cannot be characterized as labeling “requirements.”
A state court award of damages for failure to warn does not
mandate any change in labeling. Rather, it merely requires
that a pesticide manufacturer pay money to an injured person.
While a damage award may prompt a pesticide manufacturer
to seek the EPA’s approval for a change in labeling, it does
not directly command such a change. As the EPA points out,
such indirect pressure cannot reasonably be characterized
as imposing labeling requirements.

54 Indeed, indirect pressure to change a pesticide label does
not frustrate Congress’s purpose of establishing nationally
uniform pesticide labels. The EPA approves only one label
per pesticide. In approving a labeling change, the EPA
substitutes a new nationally uniform label. This process is
the same whether the labeling change is prompted by state
damage liability or state regulation authorized by FIFRA.

24a

Appendix A

455 In addition, FIFRA’s legislative history does not
demonstrate a Congressional intent to extinguish actions for
damages. As the EPA noted in its amicus brief, when
§ 136v(b) was enacted, common law actions against pesticide
manufacturers for failure to warn were a “well-recognized
and uncontroversial feature of the legal landscape.” Common
law actions for inadequate, misleading, or false
representations regarding pesticides were available as early
as 1884. And, in the first part of this century, dozens of
reported decisions recognized the availability of actions for
false or inadequate representations regarding pesticides,
including actions based on pesticide labels. After FIFRA was
enacted in 1947, the federal government issued substantial
labeling regulations, but state and federal courts uniformly
concluded that the federal pesticide labeling regulations did
not alter the availability of state law damage actions for
inadequate labeling. By 1972, when § 136v(b) was enacted,
nearly every state and federal jurisdiction recognized
pesticide manufacturer and dealer liability both for personal
injuries and crop damage resulting from the failure to provide
adequate warnings.

56 FIFRA’s legislative history reveals no intent to alter
the availability of common law remedies. In 1971 and 1972,
three House and Senate committees devoted 25 days to
hearings on proposed pesticide legislation. In the thousands
of pages of transcripts of the hearings and floor debates, there
is no suggestion that the 1972 amendments to FIFRA would
preempt state tort law.

457 For instance, in the committee hearings, testifying on
behalf of the Administration and the EPA, which drafted the

;

25a

Appendix A

bill that formed the basis of the 1972 amendments, the EPA’s
General Counsel, John Quarles, testified as follows:

I would like to emphasize that the States have
played a major and continuing role in pesticides
regulation. ... We wish to encourage and not
supplant these efforts by providing that States may
prohibit the use of a particular pesticide within
their jurisdiction even if the pesticide is registered
under the Federal authority. States thus are not
precluded from imposing stricter standards or
added requirements, but they may not permit any
sale or use of a pesticide which is prohibited under
the authority of the Act.

The EPA’s brief in Etcheverry at 24-25 (quoting the Federal
Pesticide Control Act of 1971: Hearings Before the House
Committee on Agriculture, 92d Congress (1971) at 8).

458 These hearings reveal that Congress had no intent to
preempt state tort law. Quarles testified as the first witness
in the first hearing, stating unequivocally: “The bill does
not affect tort liability.” EPA’s brief at 28 (quoting House
Ag. Comm. Hearing at 42). No one disagreed and no witness
or member of Congress suggested that FIFRA would alter
common law duties or affect the availability of tort damages.

459 In addition, the four House and Senate Committee
reports describe in detail the changes that the 1972
amendments would bring to federal pesticide regulation.
Each report summarizes the changes made by the bill, but
none mentions any intent to preempt state damage actions.

26a

Appendix A

460 Furthermore, the House and Senate debated the 1972
FIFRA amendments over 5 days. Like the committee
hearings and reports, the floor debates reveal no suggestion
of a Congressional intent to preempt state tort law. The
preemption provision was not mentioned on the floor of the
Senate. The preemption provision was debated at length on
the floor of the House, but nowhere in the debate is there a
suggestion that the preemption provision would affect state
tort law.

461 Therefore, as pointed out by EPA, rather than reveal an
intent to extinguish state common law damage remedies, the
legislative history of the 1972 FIFRA amendments is replete
with evidence that Congress understood and intended that
state damage actions would remain available. Moreover,
there is a presumption against preemption of common law
remedies. Medtronic, 518 U.S. at 485-86, 116 S.Ct. at 2250;
Cipollone, 505 U.S. at 518, 523, 112 S.Ct. at 2618, 2621.
That long standing presumption can only be overcome by
evidence of a “clear and manifest” intent of Congress to
preempt state law. See Wisconsin Public Intervenor v.
Mortier (1991), 501 U.S. 597, 610, 111 S.Ct. 2476, 2484,
115 L.Ed.2d 532. In the absence of evidence that Congress
intended to alter then existing law, FIFRA should not be
interpreted to do so.

62 Furthermore, preemption of state tort law would conflict
with FIFRA’s purposes. The 1972 FIFRA amendments were
enacted to address growing public concern with the
environmental and public health effects of pesticides such
as DDT. The fact that there is no federal private damage
remedy, that Congress was aware of state damage remedies,

27a

Appendix A

and that Congress decided to give the states the primary
enforcement authority under FIFRA, all strongly imply that
Congress did not intend to preempt state common law
damage remedies. Given that the 1972 amendments to FIFRA
were intended to provide increased public protection against
the harms caused by pesticides, it would make no sense to
infer that Congress intended to close off all avenues of
judicial relief for those injured by pesticides.

63 The Medtronic plurality adopted similar arguments in
interpreting the MDA. Absent a federal private cause of
action, preemption of state common law damage actions
would effectively bar relief to persons injured by defective
medical devices and “have the perverse effect of granting
complete immunity from design defect liability to an entire
industry that, in the judgment of Congress, needed more
stringent regulation. . . .” Medtronic, 518 U.S. at 487, 116
S.Ct. at 2251. “It is to say the least, ‘difficult to believe that
Congress would, without comment, remove all means of
judicial recourse for those injured by illegal conduct,’ and it
would take language much plainer than the text of § 360k to
convince us that Congress intended that result.” Medtronic,
518 U.S. at 487, 116 S.Ct. at 2251 (quoting Silkwood v. Kerr-
McGee Corp. (1984), 464 U.S. 238, 251, 104 S.Ct. 615, 623,
78 L.Ed.2d 443). In the same way, FIFRA’s preemptive force
should not be interpreted to undermine the statutory purpose
to provide increased protection from harmful pesticides.

164 We conclude that Congress intended the term
“requirements” in § 136v(b) of FIFRA to mean enactments
of positive law by legislative or administrative bodies, not
State law damage actions. Consequently, we overrule our
prior decision in McAlpine for holding otherwise.

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Appendix A

465 Accordingly, we hold that Appellants’ claims are not
preempted by FIFRA and that the District Court erred in
granting summary judgment in favor of DowElanco on that
basis.

466 Reversed and remanded for further proceedings
consistent with this opinion.

s/ James C. Nelson
Justice

s/ J.A. Turnage
Chief Justice

s/ William E. Hunt, Sr.
s/ Jim Regnier

s/ Terry N. Trieweiler
Justices

Hon. Thomas M. McKittrick, District Judge
sitting for Justice W. William Leaphart

s/ Thomas M. McKittrick
District Judge

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Appendix A

Justice Karla M. Gray, dissenting.

67 I dissent from the Court’s opinion. We resolved the
dispositive issue in this case, whether failure to warn claims
— pleaded in negligence, strict liability and breach of express
warranty — are preempted by FIFRA, a scant three years
ago in McAlpine, holding such claims are preempted to the
extent they expressly or implicitly challenge the adequacy
of the warnings in a pesticide’s label. 1 would hold that
McAlpine is controlling and affirm the District Court.

168 Stare decisis, which means to abide by or adhere to
decided cases, is of fundamental and central importance to
the rule of law. State v. Gatts (1996), 279 Mont. 42, 51, 928
P.2d 114, 119 (citations omitted). It is a “ ‘fundamental
doctrine which reflects our concerns for stability,
predictability and equal treatment... .’”” Gatts, 279 Mont.
at 51,928 P.2d at 119 (quoting Formicove, Inc. v. Burlington
Northern, Inc. (1983), 207 Mont. 189, 194, 673 P.2d 469,
472). The doctrine is meant to keep courts from lightly
overruling past decisions, in order to heed the necessity for
stability and predictability in the law. See Gatts, 279 Mont.
at 51, 928 P.2d at 119 (citing Morayne v. States Marine Lines
(1970), 398 U.S. 375, 403, 90 S.Ct. 1772, 1789, 26 L.Ed.2d
339, 358). At the same time, stare decisis is not a mechanical
adherence to the latest decision and, of course, court
decisions are not sacrosanct. Gatts, 279 Mont. at 51, 928
P.2d at 119 (citation omitted). A decision which is manifestly
wrong need not be followed. Gatts, 279 Mont. at 51, 928
P.2d at 119 (citation omitted). It is my view that, in overruling
McAlpine, the Court is merely substituting a result it finds
preferable to that announced in our well-reasoned McA lpine

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Appendix A

decision. The Court makes no showing of manifest
incorrectness here and, indeed, neither the EPA’s amicus
brief in Etcheverry nor the United States Supreme Court’s
decision in Medtronic provides an appropriate basis on which
to resolve the present case by overruling McAlpine.

469 Starting with the U.S. Department of Justice’s brief on
behalf of EPA in the recent California Etcheverry case,
I would give it no deference. This is not an internal policy
or regulatory statement of the EPA regarding its
administration of FIFRA of the type to which courts give
deference. It is a brief prepared for litigation, part of the
government’s litigation strategy. Moreover, as the California
Supreme Court observed,

[e]ven though the question presented in this case
has been addressed by nine of the federal circuit
courts of appeals, the United States failed to file
amicus curiae briefs in any of the cases and
permitted those courts to proceed upon a
fundamental assumption that it now characterizes
as mistaken.

Etcheverry, 993 P.2d at 374. In addition, the matter on which
the EPA rests its contention that FIFRA does not preempt
failure to warn claims relates to its waiver of review of
pesticide efficacy claims. As was the situation in Etcheverry,
however, the case before us does not relate to pesticide
efficacy, that is, whether the pesticide will control the target
pest(s). See Etcheverry, 993 P.2d at 374. The case before us
involves the indoor application of Dursban without
ventilation. Thus, as in Etcheverry, the EPA’s argument is

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Appendix A

irrelevant to the case before us. See Etcheverry, 993 P.2d at
375. Under these circumstances, the Court’s decision to give
this johnny-come-lately litigation brief significant weight is
a perilously slim basis on which to premise overruling our
well-reasoned decision in McAlpine.

470 Nor dol find Medtronic either useful or persuasive here
and this no doubt explains why it was not called to our
attention in McAlpine. As the Court notes several times, the
portion of Medtronic on which it relies is a four-Justice
plurality, clearly not controlling authority even if the MDA
and FIFRA contained more similar preemption language.
Indeed, it is my view, as it was the view of the California
Supreme Court in Etcheverry, that Medtronic is
distinguishable on the basis that Congress gave the Food
and Drug Administration a unique role in determining the
scope of preemption under the MDA. Congress did not give
the EPA an analogous role in implementing FIFRA.
See Etcheverry, 993 P.2d at 373 (citations omitted).

971 I would hold that Medtronic does not undermine our
conclusion in McAlpine that FIFRA preempts state failure
to warn claims. In doing so, I would join the overwhelming
majority of courts which have examined the question in the
wake of Medtronic. See, e.g., Grenier v. Vermont Log Bidgs.,
Inc. (1* Cir. 1999), 96 F.3d 559; Oliver v. Reckitt & Colman.
Inc. (M.D. Fla. 1998), 12 F.Supp.2d 1287; Hawkins v.
Leslie's Poolmart (D.N.J. 1997), 965 F.Supp. 566; Kuiper
v. American Cyanamid Co. (E.D. Wis. 1997), 960 F.Supp.
1378; Koch v. Shell Oil Co. (D. Kan. 1997), 173 F.R.D. 288;
Etcheverry, 993 P.2d at 373; Ackerman v. American
Cyanamid Co. (lowa 1998), 586 N.W.2d 208; Ackles v.

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Appendix A

Luttrell (Neb. 1997), 561 N.W.2d 573, cert. denied, 522 U.S.
928 (1997); Didier v. Drexel Chemical Co. (Wash. App.
1997), 938 P.2d 364; Lewis v. American Cyanamid Co. (N.J.
1998), 715 A.2d 967; Sherman v. Claire Mfg. Co. (N.Y. App.
Div. 1997), 657 N.Y.S.2d 453.

472 In my view, no showing has been made that McAipine
is “manifestly wrong.” See Gatts, 279 Mont. at 51, 928 P.2d
at 119. Therefore, | would apply stare decisis here, reaffirm
McAlpine and affirm the District Court. I dissent from the
Court’s failure to do so.

s/ Karla M. Gray
Justice

33a

APPENDIX B — ORDER OF THE MONTANA FIRST

JUDICIAL DISTRICT COURT, LEWIS AND CLARK

COUNTY ON MOTION FOR SUMMARY JUDGMENT
DATED JANUARY 8, 1999

MONTANA FIRST JUDICIAL DISTRICT COURT
LEWIS AND CLARK COUNTY

Cause No. BDV 96-18

LIBBY SLEATH, MARY ANN HAYES, GLENDA
TRUESDELL, and MARY OWEN,

Plaintiffs,
Vv.
WEST MONT HOME HEALTH SERVICES, INC., WEST
MONT HOME MANAGEMENT SERVICES, INC., ORKIN
EXTERMINATION COMPANY, INC., and EP CO., INC.,
and ROFAN SERVICES, INC., d/b/a DOW ELANCO,

Defendants.

ORDER ON MOTION FOR
SUMMARY JUDGMENT

This matter is before the Court on the motion of Ep Co.,
Inc., and Rofan Services, Inc., d/b/a Dow Elanco, (hereinafter
Dow) for summary judgment. The crux of Plaintiffs’
complaint against Dow is that Dow manufactured various
formulations of Dursban insecticides that were applied
between 1991 and 1994 by Orkin Extermination Company
at the office building of West Mont Home Health Services

34a

Appendix B

in Helena, Montana. During that period of time, Plaintiffs
worked in the West Mont building.

Plaintiffs, in their second amended complaint, allege
three causes of action against Dow. The first is a cause of
action for negligence; the second is a breach of warranty;
and the final one is a claim of strict liability.

The issue currently before the Court is whether or not
Plaintiffs’ claims are barred by the Federal Insecticide,
Fungicide and Rodenticide Act (hereinafter FIFRA) found
at U.S.C. § 136, et seq.

STANDARD OF REVIEW

Summary judgment is proper only when no genuine issue
of material fact exists and the moving party is entitled to
judgment as a matter of law. Rule 56(c), M.R.Civ.P. It
encourages judicial economy through the elimination of
unnecessary trial, delay, and expense. Bonawitz v. Bourke,
173 Mont. 179, 182, 567 P.2d 32, 33 (1977). However,
summary judgment is not to be utilized to deny the parties
an opportunity to try their cases before a jury. Brohman v.
State, 230 Mont. 198, 202, 749 P.2d 67, 70 (1988).

The movant has the initial burden to show that there is a
complete absence of any genuine issue of material fact. To
satisfy this burden, the movant must make a clear showing
as to what the truth is so as to exclude any real doubt as to
the existence of any genuine issue of material fact. Minnie
v. City of Roundup, 257 Mont. 429, 431, 849 P.2d 212, 214
(1993). The burden then shifts to the party opposing the

35a

Appendix B

motion to show that there are genuine issues for trial.
Brinkman and Lenon v. P & D Land Enter., 263 Mont. 238,
242, 867 P.2d 1112, 1114 (1994). The party Opposing the
summary judgment is entitled to have any inferences drawn
from the factual record resolved in his or her favor. Rule
56(c), M.R.Civ.P. Rule 56(c) permits the court to render
judgment if the pleadings, admissions, and any affidavits
filed show that there is no genuine issue as to any material
fact and that the moving party is entitled to a judgment as a
matter of law. Poulsen’s, Inc. y. Wood, 232 Mont. 4] 1, 415,
756 P.2d 1162, 1165 (1988).

DISCUSSION

Four products manufactured by Dow were applied at the
West Mont facility; Dursban 4E, Dursban LO, Empire 20
and Dursban granules. Each of these products is registered
with the Environmental Protection Agency (EPA) as directed
by FIFRA. See Robert F. Bischoff Aff.

The labels for the assorted Dursban products contain
various instructions on the manner in which the individual
products should be used. See Bischoff Aff. Exs. A, B and C.
All parties agree that the Montana Supreme Court’s decision
in McAlpine v. Rhone-Poulenc Ag. Co., 285 Mont. 224, 947
P.2d 474 (1997), governs the case at bar. In McAlpine, the
Montana Supreme Court held:

Under FIFRA, “a State shall not impose or
continue in effect any requirements for labeling
or packaging in addition to or different from those
required under this subchapter.” 7 U.S.C.

36a

Appendix B

§ 136v(b). We determine that, as in the cigarette
labeling statute, the phrase “requirement” in
7 U.S.C. § 136v(b) includes state common law
damage actions. Therefore, FIFRA preempts state
tort claims to the extent they arise from an
omission or inclusion in the product’s label.
Claims alleging a product, manufacturing or
design defect, claims alleging negligent design,
testing or manufacturing, or claims alleging [a]
breach of warranty that do not rely on such an
omission or inclusion in the product’s label are
not preempted.

285 Mont. at 230, 947 P.2d at 477.

The McAlpine decision is in accord with what one legal
analyst has called a “tsunami of authority.” See, e.g.
Louisiana-Pacific Corp. v. Koppers Co., 32 Cal. App. 4th
599, 38 Cal. Rptr. 2d 257 (1995); Taylor AG Industries vy.
Pure-Gro, 54 F.3d 555 (9th Cir. 1995); MacDonald v.
Monsanto Co., 27 F.3d 1021 (Sth Cir. 1994); Worm vy.
American Cyanamid Co., 5 F.3d 744 (4th Cir. 1993); King
v. EJ. DuPont de Nemours & Co., 996 F.2d 1346 (1st Cir.
1993); Shaw v. Dow Brands, Inc., 994 F.2d 364 (7th Cir.
1993); Papas v. Upjohn Co., 985 F.2d 516 (11th Cir. 1993)
(Papas II); Arkansas-Platte & Gulf v. Van Waters & Rogers,
Inc., 981 F.2d 1177 (10th Cir. 1993) (Arkansas-Platte II);
Kuiper v. American Cyanamid Co., 131 F.3d 656 (1997).

Plaintiffs’ admission that their express warranty claim
is preempted by FIFRA eases this Court’s burden somewhat.
See Pls’ Resp. at 3. However, the Court still must consider

37a

Appendix B

Plaintiffs’ complaint, interrogatory answers and affidavits
on file to determine if Plaintiffs’ remaining claims are based
upon an omission or inclusion in the products’ labels.

Prior to addressing these remaining claims, the Court
needs to consider two disputes that have arisen between the
parties. First, Dow submitted contention interrogatories to
Plaintiffs, many of which were answered with reference to
the products’ labels. Plaintiffs now suggest that the Court
should read these interrogatories and omit any reference to
the products’ labels. Plaintiffs note that these interrogatories
were submitted prior to the Montana Supreme Court’s
decision in McAlpine and were in response to Dow’s request
that Plaintiffs set forth any and all grounds for liability.
Contrarily, Dow suggests that the Court’s modification to
Plaintiffs’ answers to the interrogatories not be allowed.
However, for purposes of this motion, the Court feels it
appropriate to eliminate any specific references to the
products’ labels that were contained in Plaintiffs’ answers
to the interrogatories.

Second, Dow contends Dr. Robert K. Simon’s
supplemental affidavit should be stricken. Dow’s contention
is that Dr. Simon changed his opinion in his second affidavit,
and that this change violates the expert disclosure rule. The
Court rejects this argument, holding that Dr. Simon’s
supplemental affidavit was a necessary response for Plaintiffs
to counter the affidavits filed by Dow pursuant to their motion
for summary judgment.

At the hearing on the motion for summary judgment,
Plaintiffs’ attorney indicated that, in essence, his clients’

38a
Appendix B

claim against Dow was a design defect strict liability case.
This seemly abandons Plaintiffs’ claims against Dow for
negligence and breach of implied warranty. However, since
nothing is in writing on this particular issue, the Court feels
it prudent to address the negligence and implied warranty
arguments.

Negligence

Plaintiffs’ negligence claim is contained in Count IV of
the complaint at paragraph 31. The following allegation is
made: “Defendants EP Co., Inc., and Rofan Services, d/b/a
DOW ELANCO, and its agents or employees were negligent
in failing to provide adequate warning of the known, harmful
and inherently dangerous properties of Chlorpyrifos
[Dursban] to the public. .. .” If, as Plaintiffs’ suggest, Dow
was negligent in that it had knowledge of the harmful effects
of its products, but failed to provide a warning, this claim
must be classified as a failure to warn claim. How, we must
ask ourselves, could Dow protect itself from liability for this
allegedly negligent activity? Clearly, what Dow would have
to do would be to place some warning on its label. As
previously noted, a multitude of courts, including the
Montana Supreme Court, have held that FIFRA does preempt
state law causes of action predicated on a failure to warn.
This comes about, primarily, because the failure to warn is
an attack on the EPA-approved label for the product.

Breach of Implied Warranty

The interrogatories expanding on Plaintiffs’ claim of
breach of implied warranty start with Interrogatory No. 2.
In Plaintiffs’ Answer No. 2c, they aver that Dursban is:

39a

Appendix B

“not fit to be used in unventilated areas or without
limits on the applications. . .. When used according
to Defendant DowElanco’s instructions, Dursban
and/or Chlorpyrifos exposed plaintiff to manufac-
turing impurities and caused cholinesterase
inhibition in plaintiff which may have been
avoided by proper warnings and instructions.”

The omitted language from Interrogatory No. 2 was the
specific mention of the label. However, the remaining
information clearly shows that Plaintiffs’ complaint deals
with the use and application instructions on the product. The
labels for all of the Dursban products do have limits on the
application and use of the products. Therefore, Plaintiffs are
once again, pursuant to their answer to Interrogatory No. 2,
challenging the label. Reference can also be made to
Interrogatories No. 10 and 12 which refer to “inadequate
warnings on its Dursban/Chlorpyrifos products” and
“application and use standards.” Again, these issues are dealt
with on the label. Such being the case, Plaintiffs’ claim for
breach of implied warranty is, in reality, an attack on the
instructions contained on the EPA-approved label.

Dow should be granted summary judgment on both the
claim of negligence and breach of implied warranty.

Strict Liability

At oral argument, Plaintiffs Suggested that their real
claim against Dow was one for a design defect. Strict liability
claims, as other common law tort claims, may be preempted
by FIFRA. See McAlpine, 285 Mont. at 230, 947 P.2d at

40a

Appendix B

477; Quest Chem. Corp. v. Elam, 898 S.W.2d 819, 821 (Tex.
1995); Worm v. America Cyanamid Co., 5 F.3d 744 (4th Cir.
1993); Grenier v. Vermont Log Bldgs, Inc., 96 F.3d 559 (1st
Cir. 1996); Shaw v. Dow Brands, Inc., 994 F.2d 364 (7th
Cir. 1993). However, this area of FIFRA preemption does
prove problematic for the Court. The courts have dropped
hints as to the type of strict liability claims that could survive
FIFRA preemption. For example, a claim that the product
was unfit for any use might survive the present motion.
Grenier, 96 F.3d at 564. Also, if a plaintiff can assert factual
grounds for a strict liability claim other than those based on
inadequate warnings, FIFRA would not preempt his claim.
See Quest, 898 S.W.2d at 821.

The Worm court noted that “the line between a claim
for mislabeling and a claim for a defective product may not
always be clear.” 5 F.3d at 747. However, the distinction
may become less blurred by considering, zs one factor,
whether it was reasonably foreseeable that the manufacturer,
in seeking to avoid liability, would choose to alter the product
or the label. Jd.

The labels on the various products involved here discuss
the type of buildings in which the Dursban products may be
applied and also discuss the frequency of application of the
products. See Bischoff Aff. Exs. A, B and C. At issue here is
that Plaintiffs’ answer to Interrogatory No. 4, which alleges
that Dursban causes health problems in humans when used
without adequate ventilation and without appropriate limits
on applications. Notably, Defendants’ labels provide no such
instruction. Plaintiffs’ answer goes on to state that there are
no warnings on the label for the dangers of Dursban and that

4la

Appendix B

repeated use of Dursban in a closed building without
adequate ventilation can cause a toxic buildup of the product.
Even in omitting the word “label” in the aforementioned
answer, it seems clear that the answer to Interrogatory No. 4
is questioning the label instructions for the various Dursban
products that are shown on the attachment to Bischoff’s
affidavit. The label instructions discuss the type of buildings
in which Dursban can be applied, and also mention
reapplication rates. Thus, at least as far as the interrogatory
answer goes, it appears that Plaintiffs’ strict liability claim
against Dow is, in reality, a label-based claim.

Finally, the Court must review the affidavits of Dr.
Simon. Specifically, we must refer to his supplemental
affidavit that is attached to Plaintiffs’ reply brief in
Opposition to Dow’s motion for summary judgment. In
paragraph 3, Dr. Simon states that the design defect making
Dursban products unreasonably dangevous to the ultimate
consumer in the context of interior workplace application of
those products. In paragraph 5 of his supplemental affidavit,
Dr. Simon indicates that the known impurities, degradation
products and impurities in Dursban cause the products to be
unreasonably dangerous, again, in the context of interior
workplace application. Again and again in his supplemental
affidavit, Dr. Simon refers to the “context of interior
workplace application.” In his original affidavit, Dr. Simon
discusses air flow and ventilation in the West Mont building
as being a factor in this problem. See Simon Aff., J 8.2. Also
in his original affidavit, paragraph 8.5 again talks about the
“excessive application of pesticides.” All of what Dr. Simon
Says may well be true. However, underlying his conclusion
that these products are unreasonably dangerous is their

42a

Appendix B

application “in the context of interior workplaces” and at
the reapplication rate and ventilation rate in those interior
areas. These are all topics that are discussed on the various
labels of these products. See Bischoff Aff. Exs. A, B and C.
Plaintiffs must, therefore, be contesting the label directions
and warnings related to interior workplace application,
ventilation and reapplication of the products. Consequently,
their strict liability claim must also be preempted under
McAlpine.

CONCLUSION
Therefore, based on the above, IT IS HEREBY
ORDERED, ADJUDGED AND DECREED that the motion
for summary judgment filed by Dow is GRANTED.

DATED this 8 day of Jan. 1999.

s/ Jeffrey M. Sherlock
JEFFREY M. SHERLOCK
District Court Judge

43a

APPENDIX C — FINAL JUDGMENT OF THE
MONTANA FIRST JUDICIAL DISTRICT COURT,
LEWIS AND CLARK COUNTY PURSUANT TO
RULE 54(b) M.R.C.P. DATED FEBRUARY 22, 1999

MONTANA FIRST JUDICIAL DISTRICT COURT
LEWIS AND CLARK COUNTY

Cause No. BDV 96-018

LIBBY SLEATH, MARY ANN HAYES, GLENDA
TRUESDELL, and MARY OWEN,

Plaintiffs,
V.

WEST MONT HOME HEALTH SERVICES, WEST MONT

HOME MANAGEMENT SERVICES, INC., ORKIN

EXTERMINATION COMPANY, and EPCO, INC., and
ROFAN SERVICES INC., d/b/a DOWELANCO,

Defendants.

FINAL JUDGMENT PURSUANT TO
RULE 54(b) M.R.C.P.

Based upon Plaintiffs and Defendant EPCO, Inc. and
Rofan Services, Inc., d/b/a DowElanco (hereinafter
DowElanco) motion and the lack of objection by the
remaining Defendants and for good cause shown, the
Court, pursuant to Rule 54(b), M.R.Civ.P., enters this
Final Judgment in this matter, in favor of Defendant

44a

Appendix C

DOWELANCO, and makes the following findings in support
of this certification and entry of a Final Judgment:

A. The District Court’s Order makes a final ruling as to
DowElanco in this proceeding. The claims of Plaintiffs
against the other Defendants are not final, indeed none of
the other claims are in a status where a definitive ruling will
be reached with regard to any of the other non-DowElanco
Defendants in the near future and there is no reason to delay
entry of a final judgment in favor of DowElanco.

B. The claims against DowElanco are based upon
product liability law, and relate to manufacture of DowElanco
products, whereas the claims against the remaining
Defendants are upon different theories of liability relating
to the application of DowElanco products. Thus the claims
are distinct and a ruling as to the one class of the Defendants
represented by DowElanco will not affect the proceedings
against the remaining Defendants. To the contrary, no result
of appellate review of the claims against DowElanco will
have any effect on the claims or proceedings against
remaining Defendants. Finally, there are no claims or
counterclaims which could result in a setoff of this judgment.

C. There is no reason to delay the entry of a final
judgment in favor of DowElanco and entry of a final judgment
will facilitate further handling of the issues in this litigation.

DATED this 22nd day of February, 1999.

s/ JEFFREY M. SHERLOCK
District Judge

45a

APPENDIX D — ORDER OF THE SUPREME COURT
OF THE STATE OF MONTANA DENYING
PETITION FOR REHEARING DATED
AND FILED FEBRUARY 1, 2001

IN THE SUPREME COURT OF THE
STATE OF MONTANA

No. 99-185

LIBBY SLEATH, MARY ANN HAYES, GLENDA
TRUESDELL, and MARY OWEN,

Plaintiffs and Appellants,
v.

WEST MONT HOME HEALTH SERVICES, INC., WEST

MONT HOME MANAGEMENT SERVICES, INC., ORKIN

EXTERMINATION COMPANY, INC., and EP CO., INC.,
and ROFAN SERVICES, INC., d/b/a DOW ELANCO,

Defendants and Respondents.

ORDER

IT IS ORDERED that the Petition for Rehearing filed

with this Court by respondents EP CO, Inc., and Rofan
Services, Inc., d/b/a Dow Elanco, is DENIED.

46a

Appendix D
DATED this Ist day of February, 2001.

s/ Karla M. Gray
Chief Justice

s/ James C. Nelson

s/ Jim Regnier

s/ W. William Leaphart
Justices

Justice Terry N. Trieweiler would also deny the petition for
rehearing.

47a

APPENDIX E — BRIEF AMICUS CURIAE FOR THE
UNITED STATES IN ETCHEVERRY, et al. v. TRI-AG
SERVICE, INC., et al., SUPREME COURT OF
CALIFORNIA, NO. S072524 DATED MARCH, 1999

No. S072524
IN THE SUPREME COURT OF CALIFORNIA
MONIQUE ETCHEVERRY, et al.,

Plaintiffs-Appellants,

¥.

TRI-AG SERVICE, INC., BAYER CORP., et al.,

Defendants-Respondents.

ON APPEAL FROM THE COURT OF APPEAL,
THIRD APPELLATE DISTRICT

BRIEF AMICUS CURIAE FOR THE UNITED STATES
IN SUPPORT OF PLAINTIFFS-APPELLANTS

OF COUNSEL: LOIS J. SCHIFFER
GARY S. GUZY Assistant Attorney General
Acting General Counsel
JARED A. GOLDSTEIN
ROBERT G. DREHER ANNE R. TRAUM
Deputy General Counsel Attorneys

: Environment and Natural
JONATHAN J. FLEUCHAUS Resources Division

Attorney U.S. Department of Justice
United States Environmental Washington, D.C. 20530
Protection Agency (202) 514-5316

Washington, D.C. 20044

48a

Appendix E
TABLE OF CONTENTS

QUES TIN PREGOINEGD oa iviccewewencccsees

INTEREST OF THE UNITED STATES......... :

FIFRA’S STATUTORY AND REGULATORY
et | errr errr rey eee eer e

SUMMARY OF ARGUMENT ................

PRION oo So tahoe nbd iu nbbeeadineinees |

I. FIFRA DOES NOT PREEMPT STATE
COMMON LAW DAMAGES ACTIONS

“ee 6 688 6 6 6 06.680 8 € 6. 629 F.8O OR 2 6.44 2 6 4 2. 2 Oo

A. As the Supreme Court’s Decisions in
Cipollone and Medtronic Demonstrate,
FIFRA’s Preemption Provision Must Be
Read in its Statutory Context ........

B. The Text of FIFRA Demonstrates That
Congress Did Not Intend to Preempt
Common Law Actions .............

1. Under section 136v, the term
“requirements” refers to state
commands regarding labeling
enn ar CS et

[70a]

[72a]

[75a]

49a
Appendix E

FIFRA’s other references to
“requirements” all refer to direct
commands imposed by law, not the
indirect pressure resulting from tort
liebility soi 63 iee ei k ee

Section 136v addresses state
commands regarding labeling, not
state actions that indirectly pressure
pesticide manufacturers to change
Sg ROOT ees Pee

C. The History of FIFRA Demonstrates No
Congressional Intent to Extinguish
Actions for Damages...............

1.

When section 136v(b) was enacted,
common law actions against
pesticide manufacturers for failure
to warn were a well-recognized and
uncontroversial feature of the legal
MMIII ig fk Fig dau dees dares

FIFRA’s legislative history reveais
no intent to alter the availability of
common law remedies. .........
a. The committee hearings-....

b. The committee reports .....

c. The floor debates..........

[77a]

[82a]

[84a]

[85a]

[89a]

[91a]

50a

Appendix E

D. Preemption of State Tort Law Would
Conflict with the Purposes of the 1972
FIFRA Amendments ............... [101la]

II. SECTION 136V(B) DOES NOT PREEMPT "
COMMON LAW ACTIONS ADDRESSING
MATTERS SUCH AS PESTICIDE
EFFICACY UNREGULATED BY EPA... [104a]

A. EPA Does Not Evaluate Pesticide
SOY i ccc ise tee [107a]

B. Congress Did Not Intend to Leave
Pesticide Efficacy Unregulated ...... [114a]}

II. FIFRA DOES NOT PREEMPT STATE
DAMAGES ACTIONS CHALLENGING

OFF-LABEL STATEMENTS ........... [115a]
CONMCIIIIN oo e are [117a]
CERTIFICATE OF SERVICE................. [118a]

ADDENDUM: Pesticide Regulation (PR) Notice 96-4

S5la

Appendix E
TABLE OF AUTHORITIES

CASES

American Airlines, Inc. v. Wolens,
SES TB. 2 eee ba veciecieeviwiws [103a]

Arkansas Electric Cooperative Corp. v. Arkansas
Public Service Comm'n,
461 08 SIS GOED 67s) hexoses. [1143]

Arkansas-Platte & Gulf Partnership v. Van Waters
& Rogers, Inc.,
961: F.26 1177 (10s Car. 1993) 2.5. ec ccecene [107a]

Arkansas-Platte & Gulf v. Van Waters & Rogers, Inc.,
ie Se Bees fe |: ) [71a]

Bean v. Diamond Alkali Co..,
Be |) re [89a]

Burke v. Dow Chemical Co.,
797 F. Supp. 1128 (E.D.N.Y. 1992) .......... [64a]

Cipollone v. Liggett Group, Inc.,
A UES GW ol bw av kvic pccecwcvaces passim

Corprew v. Geigy Chemical Corp.,
ROP et WU Ere EOE hs Sh eee c i ceceees [89a]

Daniels v. Atlantic Refining Co.,
295 F. Supp. 125 (D. Del. 1968) ............. [89a]

52a

Appendix E

Diamond Alkali Co. v. Godwin,
112 S.E.2d 365 (Ga. Ct. App. 1959) .......... [89a]

Dole v. Dow Chemical Co.,
316 N.Y.S.2d 348 (N.Y. Sup. Ct. 1970) ....... ~ [89a]

Eaton Fruit Co. v. California Spray-Chemical Corp.,
445 P26: 457 (Aris, 19GE) dsc ie csi ec ss [89a]

Ebers v. General Chemical Co.,
17. WA FPO CR, IDG o's vc cen cdvnecs [86a]

Gonzalez v. Virginia-Carolina Chemical Co.,
239 F. Supp. 567 (D.S.C. 1965)........... [88a, 89a]

Goodyear Atomic Corp. v. Miller,
SOG US: TP CIRO 6 isc adaiads ikexees - [85a]

Grenier v. Vermont Log Buildings, Inc.,
G6 F356 S50 Ci Cae Pe ooo ene lasaeess [71a]

Grey v. Hayes-Sammons Chemical Co.,
S10 FG ore Cet CE: BE 6 od Sn eeiieends [89a]

Griffin v. Planters Chemical Corp.,
302 F. Sepp. 937 (DSA. TSG 665i civ wees [88a]

Hubbard-Hall Chemical Co. v. Silverman,
340 F.2d 402 (Ist Cir. 1965) ............. [88a, 89a]

Ingersoll-Rand Co. v. McClendon,
O56 US. 155 COGN cal eniiandiiies ere [103a]

53a

Appendix E

International Association of Machinists v. Wisconsin
Employment Relations Comm'n,
427 U.S. 132 (1976). oo sv ocasi stcesereee [114a]

Jones v. George,
Gi Tom, SO9 CIT: oon cckiccaskessecewes {86a}

King v. E.J. DuPont de Nemours,
996 F.2d 1346 (ist Cir. 1993) ............... [107a]

Lee v. Madigan,
SOS UI Ca CRO Sika vn ne chk cadet ed ia [75a]

McClanahan v. California Spray-Chemical Co.,
To Gee TEA OCG: BOO in ce SiR eae ee [88a, 89a]

McCrossin v. Noyes Brothers & Cutler,
SFm Ee. Seer Ce, TBI So 6 ics ns tia sens [86a]

Medtronic v. Lohr,
gh k Bey | ere er Ae eee passim

Mossrud v. Lee,
7g 8 ge, Yi. Bh. | Aes yp nee [86a]

Muncy v. Magnolia Chemical Co.,
437 S.W.2d 15 (Tex. Ct. App. 1968).......... [88a]

Oneida County, N.Y. v. Oneida Indian Nation,
gp gl Mee Fh...) Baran pra ero ae [103a]

54a

Appendix E

Oubre v. Entergy Operations, Inc.,
118 S. Cr B38 Ce i hie ews [85a]

Papas v. Upjohn Co.,
985 F.2d 316 (11th Cir. 1993) ...........006. [71a]

Perry Creek Cranberry Corp. v. Hopkins Ag.
Chemical Co., ,
139 N.W.2d 96 (Wisc. 1966) ............. [88a, 89a]

Retail Clerks v. Schemerhorn,
37S US. FOCI) koe cee ae [71a]

Rice v. Santa Fe Elevator Corp.,
S31 02.5. ZI CST) os vaste cd sek ceeeasee [70a]

Rose v. Buffalo Air Service,
104 N.W.2d 431 (Neb. 1960)............055. [89a]

Rumsey v. Freeway Manor Minimax,
423 S.W.2d 387 (Tex. Ct. App. 1968)......... [88a]

Silkwood v. Kerr-McGee Corp.,
464 U.S. 238 (1984) ....... Seveea bee ks Cees [104a]

Stull’s Chemicals, Inc. v. Davis,
263 S.W.2d 806 (Tex. Ct. App. 1953)......... [89a]

Sullivan v. Stroop,
496 U.S. 478 (1990)

55a

Appendix E

Taylor AG Industrial v. Pure-Gro,
54 F.3d 555 (9th Cir. 1995) ............. [7la, 107a]

United States National Bank of Ore. v. Independent
Insurance Agents of America, Inc.,
SOB US. 499.(1993) ... ccsccsedsahitetnda [72a]

United States v. Texas,
FOl Us SAMENOOE) veectictiddcidiavesedes [85a]

Weichert v. American Cyanamid Inc.,
~ Eo a) er eer rere [71a]

West Disinfecting Co. v. Plummer,
44 App. D.C. 345 (D.C. Cir. 1916) ........... [86a]

White v. National Bank of Commerce,
278 P. 915 (Cal. D. Ct. App. 1929) ........... [86a]

Wisconsin Public Intervenor v. Mortier,
ts | BP eee ee eee [64a]

Wise v. Hayes,
ee aE BPS COPE EPOED cievcvuccscavetees [89a]

Worm v. American Cyanamid Co.,
Prades Fe CE GMs CPHOP cvienieesivévece [7la, 107a]

56a

Appendix E
STATUTES, RULES AND REGULATIONS

Federal Insecticide, Fungicide and Rodenticide

Act (FIFRA):

7 Us BEE ode cd oct cacesinswsle eee [86a]
7 Ueda: RHMIEEDS wn ccnbcnssbbidennesstas [77a]
peif Soe 0 | Rr erre rer rer rer passim
paik tem: os; |) rarer ree [78a]
7 UA. TIO 6 oa chert ccdcnceedn [78a]
7 U.S.C. 136a(c)(2)(B)(vili)(I)(A) .:.......... [78a]
7 U.S.C. 136a(c)(2)(B)(vitip(II]) ............. [78a]
7 Ue SE ob 608 ccs chawligides bee [78a]
4 Rs RII 8 oie nc aksutatncdednae [78a]
7 Un SE i heUSb6 ae os connecayasl [78a]
F Us MEE 6 60 5 cdleeccasa cones [78a, 81a]
7 Mes CN 6 hub dee Nase dNnkn bacee [78a, 80a]
7 UBL. EAGAN avin cba ddveecesawsis [78a]
FULDA. SEs 6 cick eccnuvecevens [78a]
F Gees SEE cn hb ods dua nedeveduens [78a]
7 Ul SD 6 8p :8 Kiba cravadasenin [78a]
pps Fae rer perce ys oy [78a]
FU es RE ck ov cus nusndaceeusas [78a, 79a]
peak op rr rer rrr oe [78a, 79a]
pei Fame ON Pere re or rrr ey [78a]
F ses ED n.b.n kd do eeein ceushes [78a]
F OBA, TARR oo 6:0:k0 640 sn btetivxes [78a]
pRi ek eer rer we Pr [78a]
Aik fee Ul rere err [78a] -
7 U.S.C. 136a-1(eK4KAMiv) ........222000. [78a]
F Sb MIE ia nes eedenaveseone (78a, 79a]
pees Food TL Ur rae [78a]

FURL, CS sooo odes [78a]

7 US.C.
7 U.S.C.
7 U.S.C.
7 U.S.C.
7 U.S.C.
7 U.S.C.
7US.C.
7 U.S.C.
7 U.S.C.
7 USS.C.
7 U.S.C.
7 U.S.C.
7 U.S.C.
7 USS.C.
7 U.S.C.
7 US.C.
7 U.S.C.
7 U.S.C.
7 U.S.C.
7 USS.C.
7 U.S.C.
7 U.S.C.
7 U.S.C.
7 U.S.C.
7 U.S.C.
7 U.S.C.
7 U.S.C.
7 US.C.
7 U.S.C.
7 U.S.C.
7 US.C.
7 U.S.C.

57a

Appendix E ree,
136a-1(g)(2)(E)(ii). «2. eee eee eee eee [78a]
136a-1(§) 6. cec sc cives seu ebares [78a]
1S6AQO M2). ice vn cas [79a, 80a, 113a]}
1960(IMSMD) «0a sii eee ens [79a]
196Q(1NE) 25005 eo ETA [79a]
SORES os hhcs ie esdasceeeee [79a, 80a]
IS6QfOM A) i... 6 ike REI. [79a]
SOO kc vk es ieee eee [79a]
CGA ios sess 6 SAS [79a, 80a]
SOOT ick os on ce aes [79a, 80a]
kg rr er ee Poe ree re [79a]
RMD s a'0c cccv abyss eedabd beta) [79a]
SDGetOMIMA) 5 5. 5 is GS: [79a]
LN os i 6 6 ERE E EES oe . [79a]
EIGER o:-v.0 C4 VG Be [79a, 81a]
RD 68 obs Leeks [79a, 80a]
fo || ans eae wee [79a, 80a]
+ «| sy RESO ee a ater Ya [79a, 80a]
Tn 8} eee yer errr re ee [79a, 80a]
RU ik oikn cs ki eeeiea [79a, 80a]
SED GR aos 05 ie SEEs Kees [79a, 80a]
TFIIB) 6 obs es [79a, 80a]
Se) 8 6 isk hades dee esersa [79a]
SD a5 stan ei tabad ea eek [79a]
ee rere ee me ee [79a, 80a]
SAEED chi 3 bed os se Kara [77a, 81a]
Ley ae ne SIA [77a, 81a]
eer Tf ner e Meee een [65a]
Ses kis Soe PRE eda Ts ees passim
RPE Ci buch Wevehae bake peed [79a]
5 RGR er ee Pe we ee mT 7 ery [79a]
SEE Sc wac canon ceeeekeaaesd [80a]

58a

Appendix E
7 USBG. 19GWERIGED oc dcteskscdiaesta [79a, 80a]
0 BK. SIONS si ccacnscoaceseuges [65a, 79a, 102a]
7 UBL. SIGH oc co cvvecsdcvcssseubusees [79a]
F OA BIE oc ccccccévudeaseseveveen [79a]
O Cake ERS oi ccccccccccebunsbeaser [79a, 80a]
FIFRA Regulations:
F CPB. BEBE CII c kee cncccccedcwinssaet [87a]
pets B® RG. | Br, ee [87a]
T Gate CGR CEE é cvicdenccssdiseeabecass [87a]
7 CBee. HERBS CRD oc cccccccnssstoboces [87a]
TCH. SERRE CID 0c cccccsswvessscesan [87a]
F Cite COR OENOTED s cc ccccavbsvedcocess [87a]
T Cae SERRE CR 0 oc ocbcccdvadecseses [87a]
het s Rot, | err rrr [87a]
7 CHa. CGR AED CRP ccc cccccdcctdeoccese [87a]
7 CHR. BGR AOG Gi e boc kc dcckddéddcaseus [87a]
40 C.F.R. 1SG.1QEMAMEMC) 2 occcccccccssecs [112a}
BOC Fs RE aed cvcvsscssvai {[104a,110a,113a} —
GO CF Be ISSUED sc cccccccescs [104a, 110a, 111la}
SOC ks TREE 0c cccccacdicdévecenes [110a]
pet A ee Rl, ee [113a]
pe sk err rr [66a, 82a, 99a]
Other:
44 Fed. Reg. 27932 (May 11, 1979) .......... [110a}
47 Fed. Reg. 40659, 40661 (Sept. 15, 1982).... [110a]
47 Fed. Reg. 53192 (Nov. 24, 1982) .......... [110a]

49 Fed. Reg. 42856 42873-42874 (1984) ...... [112a]

59a |
Appendix E
LEGISLATIVE HISTORY

Bills:
H.R. 10729, 92d Cong., 2d Sess. § 24(1972)... [95a]

H.R. 4152, 92d Cong., Ist Sess. (1971) ....... [92a]
S. 660, 92d Cong., Ist Sess. (1971)........... [92a]
Hearings:

Federal Environmental! Pesticide Control Act:
Hearings Before the Subcomm. on Ag.
Research of the Sen. Comm. on Ag. and
Forestry, 92d Cong., 1* Sess. (1971) [1971
Sen. Ag. Comm. hearing]............... passim

Federal Pesticide Control Act of 1971: Hearings
Before the House Comm. On Ag., 92d Cong.,
1* Sess (1971) [House Ag. Comm. hearings]

“e*eeeeeneeeeeeeneeneneeeeneeneeneneneeneeneeeneeenene

Federal Environmental Pesticide Control Act of
1971: Hearings Before the Subcomm. on the
Environment of the House Comm. on
commerce, 92d Cong., 2d Sess. (1972)
[Sen. Commerce Comm. hearing] ........

eo eve ewww eeneeneneenenwn err eee eh eh eh eh

60a

Appendix E

Federal Environmental Pesticide Control Act:
Hearings Before the Subcomm. on Ag.
Research of the Sen. Comm. on Ag. and
Forestry, 92d Cong., 2d Sess. (1972)

[1972 Sen. Ag. Comm. hearing]... [90a, 95a, 96a]

Committee Reports:

H.R. Conf. Rep. No. 1540, 92d Cong., 2d Sess.
tigre) a> ae [90a, 98a]

S. Rep. No. 838, 92d Cong., 2d Sess. 3 (1972)
a Rs PPT e reer ee passim

S. Rep. No. 970, 92d Cong., 2d Sess. 9 (1972)
[Sen. Commerce Comm.]........ [64a, 90a, 97a]

H.R. Rep. No. 511, 92d Cong., Ist Sess. (1971)
[House Ag. Comm.] ............ [64a, 97a, 98a]

Floor Debates:

117 Cong. Rec. 39,975-39,981 (Nov. 8, 1971)
(House debate)................ [90a, 99a, 100a]

117 Cong. Rec. 40,020-40,068 (Nov. 9, 1971)
(House debate and passage) ...... ear per

118 Cong. Rec. 32,448-32,263 (Sept. 26, 1972)
(Sen. debate and passage)............ [90a, 99a]

6la

Appendix E

118 Cong. Rec. 33,920-33,924 (Oct. 5, 1972)
(Sen. passage of conference report).... [90a, 99a]

118 Cong. Rec. 35,543-35547 (Oct. 12, 1972)
(House passage of conference report) .. [90a, 99a]

MISCELLANEOUS

“Liability of Manufacturer or Seller for Injury
Caused by Animal Feed or Medicine, Crop Sprays,
Fertilizers, Insecticides, Rodenticides, and Similar
Products,” 81 A.L.R. 2d 147 (1962) .......... [87a]

Restatement (Second) of Torts §§ 286-288C ..... [83a]

Robert L. Rabin, “A Sociolegal History of the
Tobacco Tort Litigation,” 44 Stan. L. Rev. 853
(PR hae sacedkks fh eswksapayediehatcidss [85a]

62a

Appendix E
No. 8072524

IN THE SUPREME COURT OF CALIFORNIA
MONIQUE ETCHEVERRY, et al.,
Plaintiffs-Appellants,
v.
TRI-AG SERVICE, INC., BAYER CORP., et al.,
Defendants-Respondents.

ON APPEAL FROM THE COURT OF APPEAL,
THIRD APPELLATE DISTRICT

BRIEF AMICUS CURIAE FOR THE UNITED STATES
IN SUPPORT OF PLAINTIFFS-APPELLANTS

INTEREST OF THE UNITED STATES

This appeal addresses the preemptive effect of 7 U.S.C.
136v, the provision of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) that establishes the authority of
state governments to regulate pesticides. The preemptive
effect of FIFRA implicates at least two important federal
interests. First, the United States has a general interest in
the preemptive force of federal statutes and in properly
delineating the regulatory authorities of the state and federal
governments. Pursuant to that interest, the United States
seeks to ensure that federal law does not deprive individuals

63a

Appendix E

of otherwise available state-law remedies unless Congress
clearly manifested an intent to do so. Second, the United
States Environmental Protection Agency (EPA) is the
primary agency charged by Congress with the administration
of FIFRA. Because FIFRA establishes a broad program of
joint federal-state regulation, EPA’s authority over pesticides
is necessarily affected by the scope of state authority.
Believing that state tort law would be available as a check
on inadequate or false manufacturer statements regarding
pesticide efficacy, EPA approves pesticide labels without
evaluating those claims. Accordingly, the United States has
institutional and programmatic interests in the resolution of
this appeal.

FIFRA’S STATUTORY AND REGULATORY
FRAMEWORK

First enacted in 1947, P.L. 80-103, 61 Stat. 163, FIFRA
established a federal program for the regulation of pesticides.
The 1947 Act required the registration of pesticides with the
Secretary of Agriculture, the display of poison warnings on
the labels of highly toxic pesticides, and the inclusion of
other warning statements to prevent injury to people, animals,
and plants. In 1949, pursuant to his authority under FIFRA,
the Secretary issued substantial pesticide labeling
requirements. See 7 C.F.R. Part 162 (1949). In 1970,
authority for pesticide regulation was transferred to the
newly-created EPA,' which administered the pesticide
labeling requirements imposed by the Department of
Agriculture. See 7 C.F.R. Part 2762 (1971).

1. See Reorganization Plan No. 3 of 1970, section 2(8)(i),
5 U.S.C. Appendix at 610 (1970).

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Appendix E

In 1972, largely in response to public concerns over the
pesticide DDT,” Congress enacted sweeping amendments to
FIFRA. Those amendments establish that the primary
purpose of federal pesticide regulation is the protection of
human health and the environment from the risks posed by
pesticides.’ While FIFRA had previously regulated pesticides
primarily through labeling requirements, the 1972 amendments
established federal regulation of pesticide use, an area
previously regulated exclusively by states.‘

As amended by the 1972 amendments, FIFRA
establishes a broad program of federal-state cooperation in

2. See, e.g., Burke v. Dow Chemical Co., 797 F. Supp. 1128,
1134 (E.D.N.Y. 1992) (“The statute was completely overhauled in
1972 * * * in light of concerns over the health risks of DDT and
other chemical pesticides.”); 118 Cong. Rec. 32,259 (statement of
Sen. Neson) (Sept. 26, 1972); id. at 32,262 (statement of Sen.
Tunney); 118 Cong. Rec. 40,038 (statement of Rep. Dow) (Nov. 9,
1971); S. Rep. No. 970, 92d Cong., 2d Sess. 9 (1972); Federal
Environmental Pesticide Control Act: Hearings Before the
Subcomm. on Ag. Research of the Sen. Comm. on Ag. and Forestry,
92d Cong., Ist Sess. 141 (statement of Sen. Nelson) (1971).

3. See Wisconsin Public Intervenor v. Mortier, 501 U.S. 597,
601 (1991) (“In 1972, growing environmental and safety concerns
led Congress to undertake a comprehensive revision of FIFRA.”);
S. Rep. No. 838, 92d Cong., 2d Sess. 3 (1972) (“This bill provides
for the more complete regulation of pesticides in order to provide
for the protection of man and his environment and the enhancement
of the beauty of the world around him.”).

4. See Mortier, 501 U.S. at 601; H. Rep. No. 511, 92d Cong.,
Ist Sess. 4 (1972).

65a
Appendix E

regulating pesticides. Under this program, EPA registers
pesticides for particular uses and approves pesticides labels.
7 U.S.C. 136a(5). FIFRA requires that, in registering
pesticides and approving their labels, EPA must determine
(a) that the pesticide’s “composition is such as to warrant
the proposed claims for it,” (b) that the labeling and other
materials “comply with the requirements” of FIFRA, (c) that
the pesticide “will perform its intended function without
unreasonable adverse effects on the environment,” and
(d) that “when used in accordance with widespread and
commonly recognized practice” the pesticide will not have
unreasonable adverse effects on the environment. /bid.
Pursuant to a 1978 amendment, EPA does not evaluate
pesticide label claims regarding efficacy or otherwise
regulate efficacy in approving pesticide labels. bid.

Under FIFRA, state governments have a substantial role
in regulating pesticides. As the Supreme Court stated, FIFRA
“leaves ample room for States and localities to supplement
federal efforts.” Mortier, 501 U.S. at 613. FIFRA gives states
the lead role in enforcing pesticide use restrictions. 7 U.S.C.
136w-1; see also 7 U.S.C. 136u.

States further retain broad authority to regulate the sale
and use of pesticides:

(a) In general. A state may regulate the sale or
use of any federally registered pesticide or device
in the State, but only if and to the extent the
regulation does not permit any sale or use
prohibited by this subchapter.

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Appendix E

(b) Uniformity. Such State shall not impose or
continue in effect any requirements for labeling
or packaging in addition to or different from those
required under this subchapter.

(c) Additional uses. (1) A State may provide
registration for additional uses of federally
registered pesticides formulated for distribution
and use within that State to meet special local
needs in accord with the purposes of this
subchapter and if registration for such use has not
previously been denied, disapproved, or canceled
by the Administrator.

7 U.S.C. 136(v). Under subsection (a), states may regulate
pesticide sales or use more strictly than the federal
government. Under subsection (c) and accompanying
regulations, states may register pesticides for local uses in
addition to those approved by EPA and may impose
supplemental labeling requirements regarding those
additional uses. See 40 C.F.R. 162.153(e). Under subsection
(b), which is at issue in this appeal, states may not impose
pesticide labeling “requirements” that are “in addition to or
different from” requirements imposed under FIFRA.

SUMMARY OF ARGUMENT

The majority of courts that have examined the question
presented by this case have concluded that FIFRA preempts
all state-law failure to warn actions and all other state-law
tort actions that implicate federally approved pesticide labels.
The United States was not a party in any of those actions

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Appendix E

and has not previously expressed an opinion in court on
whether FIFRA preempts state-law damages actions.’ In June
1996, recognizing that the decisions holding that FIFRA
preempts state tort law reflect a widespread misunderstanding
of EPA’s role in regulating pesticides, EPA issued Pesticide
Regulation Notice 96-4 (PR 96-4), which details the process
for registering pesticides under FIFRA. See Addendum. As
PR 96-4 explains, EPA’s approval of a pesticide does not
involve evaluation of pesticide label statements regarding
the product’s efficacy. EPA waived review of efficacy
statements pursuant to express authorization by Congress,
7 U.S.C. 136a(c)(5), and it did so based on its conclusion
that state tort law provides an effective means of ensuring
the adequacy of statements regarding efficacy. Having
published PR 96-4, the United States submits this brief to
more fully inform the Court of its views on the preemptive
force of FIFRA.

FIFRA does not preempt state-law actions for damages.
Section 136v(b) prohibits states from imposing labeling
“requirements” in addition to, or different from, those
imposed under FIFRA. While the term “requirements” may
encompass common law duties in some contexts, the text,
legislative history, and purposes of FIFRA demonstrate
that Congress had no intent that the use of the term

“requirements” in section 136v(b) would extinguish state law

5. The United States’ brief in Mortier stated that “Congress
clearly preempted all but federal regulation of labels.” Brief for the
United States as Amicus Curiae, Wisconsin Public Intervenor v.
Mortier, No. 89-1950 (Oct. Term 1990). The brief did not, however,
take any position on whether state damages actions impose
“requirements” under section 136v(b).

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Appendix E

damages actions. When section 136v(b) was enacted in 1972,
state law actions against pesticide manufacturers for failure
to warn were a commonplace and uncontroversial feature of
the legal landscape. No evidence from the text or legislative
history of FIFRA suggests that Congress had any intent to
extinguish those actions or that Congress even considered
doing so. Indeed, Congress amended FIFRA in 1972 out
of increasing concern for the human health and the
environmental effects of pesticides such as DDT. Given that
FIFRA establishes no private damages remedy for those
injured by pesticides, it would be astonishing that, without
any discussion, Congress could have intended to deprive
injured persons of all means of relief.

Even if FIFRA could be read to preempt some state
damages actions, it cannot be read to preempt tort actions
addressing the efficacy of pesticides. Pursuant to express
congressional authorization, EPA has waived review of
pesticide label statements regarding the efficacy of
pesticides. Congress encouraged EPA to waive efficacy
review in order to streamline the process for federal approval
of pesticides. In authorizing the waiver, Congress anticipated
that the states would fill the regulatory gap. No evidence
suggests that Congress intended to leave the subject of
pesticide efficacy unregulated by both the state and federal
governments. A finding that FIFRA preempts state damages
actions for efficacy-related claims would have a consequence
unintended by Congress: in the area of pesticide efficacy,
there would be not only an absence of federal labeling
regulation but also preemption of state damages claims.

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Appendix E

Even if FIFRA could be read to preempt state damages
actions challenging the claims on pesticide labels regarding
efficacy, it does not preempt damages claims challenging
off-label statements. FIFRA only prohibits states from
imposing “labeling” requirements; damages actions alleging
harm from pesticide advertising, or from oral statements of
pesticide manufacturers, do not impose any “labeling”
requirements. The Supreme Court has repeatedly instructed
that express preemption provisions like section 136v(b) must
be interpreted narrowly and should not be interpreted to
preempt traditional areas of state regulation uniess Congress
manifested a clear intent to effect such preemption. Here,
Congress has only preempted state labeling requirements; it
has not expressed any intent to regulate pesticide
manufacturer statements that do not appear on the label.

The courts that have concluded that FIFRA preempts
state-law damages actions have done so, we respectfully
submit, without fully examining the text, regulatory
background, legislative history, and purposes of FIFRA.
Many important factors not considered by the courts persuade
the United States that FIFRA was not intended to preempt
state-law actions for damages: (1) that Congress did not
establish a federal damages remedy to replace state damages
remedies and that preemption would thus leave individuals
injured by pesticides largely, or entirely, without a remedy;
(2) that Congress drafted section 136v(b) against the existing
regulatory background of FIFRA, which, since 1949, has
included a well-developed body of federal pesticide labeling
requirements, suggesting that Congress only intended to
prevent states from imposing similar labeling requirements;
(3) that Congress drafted section 136v(b) against the existing

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Appendix E

common law background, which, since 1884, has authorized
the imposition of damages for false or inadequate statements
regarding pesticides; (4) that the voluminous legislative
history of section 136v(b) overwhelmingly demonstrates that
Congress was exclusively concerned with preventing
conflicting state regulations of pesticide labeling by state
administrative agencies and that no member of Congress ever
mentioned an intent to preempt state damages actions;
(5) that Congress gave EPA authority to waive review of
pesticide efficacy based on its expectation that states would
fill the regulatory gap; and (6) that, pursuant to congressional
authorization, EPA has waived regulatory review of pesticide
label claims regarding product efficacy when it approves
pesticide labels. Because no court has examined those
factors, the United States believes that its views will assist
this Court in determining FIFRA’s preemptive force.

ARGUMENT

I. FIFRA DOES NOT PREEMPT STATE COMMON
LAW DAMAGES ACTIONS

The Supreme Court has repeatedly emphasized that there
is a “presumption against the pre-emption of state police
power,” Cipollone v. Liggett Group, Inc., 505 U.S. 504, 518
(1992), and that the determination of whether federal law
preempts traditional areas of state authority must therefore
“start with the assumption that the historic police powers of
the States [are] not to be superseded by * * * Federal Act
unless that [is] the clear and manifest purpose of Congress.”
Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947).
The presumption against preemption derives from core
principles of federalism, which guarantee states the freedom

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Appendix E

to regulate as independent sovereigns within their traditional
spheres. Medtronic v. Lohr, 518 U.S. 470, 485 (1996).
Moreover, in every preemption case, “[t]he purpose of
Congress is the ultimate touchstone.” /bid. (quoting Retail
Clerks v. Schemerhorn, 375 U.S. 96, 103 (1963)).

The text and history of FIFRA reveal no “clear and
manifest” congressional intent to extinguish state-law actions
for damages.® On the contrary, the text and history
demonstrate that Congress intended only to prevent state
administrative bodies from issuing labeling regulations that
conflicted with federal requirements. No evidence suggests
that Congress ever intended to deprive injured persons of
state-law damages remedies. Moreover, given that FIFRA
establishes no federal damages remedy, preemption of state
tort law would strongly conflict with the central purpose of
the 1972 FIFRA amendments — providing increased public
protection against pesticides.

6. While this case addresses pesticide manufacturers’ liability
for failure to warn, other courts have held that FIFRA preempts any
claim that challenges the adequacy of a pesticide label, including
implied breach of warranty, see, e.g., Worm v. American Cyanimid
Co., 5 F.3d 744, 748 (4th Cir. 1993), Papas v. Upjohn Co., 985
F.2d 516, 518 (11th Cir. 1993); express breach of warranty, see,
e.g., Grenier v. Vermont Log Buildings, Inc., 96 F.3d 559, 563-565
(1st Cir. 1996); Welchert v. American Cyanamid Inc., 59 F.3d 69,
71-73 (8th Cir. 1995); Taylor AG Indus. v. Pure-Gro, 54 F.3d 555,
561 (9th Cir. 1995); strict liability, see, e.g., Papas, 985 F.2d at
518, Arkansas-Platte & Gulf v. Van Waters & Rogers, Inc., 981
F.2d 1177 (10th Cir. 1993); negligence, see, e.g., Papas, 985 F.2d
at 518; Arkansas-Platte, 981 F.2d 1177; design defect, see, e.g.,
Grenier, 96 F.3d at 563-565, Worm, 5 F.3d at 748; and negligent
testing, see, e.g., Taylor, 54 F.3d at 563; Worm, 5 F.3d at 748.

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Appendix E

A. As the Supreme Court’s Decisions in Cipollone
and Medtronic Demonstrate, FIFRA’s Preemption
Provision Must Be Read in Its Statutory Context

FIFRA prohibits states from imposing “requirements”
on pesticide labels in addition to those imposed under the
Act. 7 U.S.C. 136v(b). The central issue here is whether the
term “requirements” under section 136v(b) includes state
common law damages actions. The United States does not
dispute the contention that in some contexts the word
“requirements” may encompass obligations imposed through
common law damages actions. The text, legislative history,
and purposes of FIFRA demonstrate, however, that, as it is
used in section 136v(b), the term “requirements” means
direct commands imposed by law regarding the contents of
labels. In this context, the term “requirements” does not
include state damages actions because such actions do not
mandate any changes in labeling.

The Supreme Court has long recognized that the terms
of federal statutes must not be read in isolation but must be
understood in their statutory context.’ In Cipollone v. Liggett
Group. Inc., 505 U.S. 504 (1992), and Medtronic v. Lohr,
518 U.S. 470 (1996), the Supreme Court interpreted two
express preemption provisions that prohibited states from
imposing certain types of “requirements.” Examining the

7. See United States Nat. Bank of Ore. v. Independent Ins.
Agents of America, Inc., 508 U.S. 439, 455 (1993) (quoting United
States v. Heirs of Boisdore, 49 U.S. (8 How.) 113, 122 (1849))
(“ ‘In expounding a statute, we must not be guided by a single
sentence or member of a sentence, but look to the provisions of the
whole law, and to its object and policy.’ ”).

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Appendix E

different statutory contexts, the Court reached different
conclusions as to whether Congress intended the term
“requirements” to encompass state damages actions.

In Cipollone, the Court found that the Public Health
Cigarette Smoking Act of 1969 (the 1969 Cigarette Act)
preempted state common law damages actions for inadequate
labeling. The 1969 Cigarette Act barred states from imposing
any “ requirement or prohibition based on smoking and health
* ** with respect to the advertising or promotion of any
cigarettes.” That provision superseded the preemption
provision of the 1965 Federal Cigarette Labeling and
Advertising Act (the 1965 Cigarette Act), which barred states
from mandating that any “statement” appear on cigarette
advertising. The Court held that the 1965 Cigarette Act’s
bar on promotional “statements” did not preempt state
damages actions. 505 U.S. at 518-520. A four-Justice
plurality concluded that the 1969 Cigarette Act, which
expanded the bar to include promotional “requirements,” did
preempt certain obligations imposed by state common law.
In reaching its conclusion, the plurality credited the
broadening of the statutory language with expressing a
congressional intent to expand the preemptive force of federal
cigarette laws.

In contrast, in Medtronic, the Court found that the
Medical Devices Amendments of 1976 (MDA) did not
preempt state common law damages actions. Like the
preemption provision of the 1969 Cigarette Act, the MDA
prohibited states from imposing “requirements” on medical
devices in addition to federal requirements imposed under
the Act. 21 U.S.C. 360k(a). The Court ruled, however, that

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Appendix E

the MDA did not preempt state common law damages
actions. A four-Justice plurality found that distinct features
of the MDA mandated the conclusion that Congress intended
only to preempt states from imposing positive law
“requirements” on medical devices in the form of regulations
or laws and did not intend to preempt common law damage
actions.* 518 U.S. at 488-89.°

8. The Medtronic plurality found five key differences in the
statutory schemes of the 1969 Cigarette Act and the MDA that
mandated the conclusion that Congress did not intend the word
“requirements” to mean the same thing in both statutes. First, the
preemption of state authority resulting from the 1969 Cigarette Act
prevented only “a limited set of state requirements” — requirements
imposed on advertising regarding the health effects of cigarettes,
while preemption of common law actions as a result of the MDA
would extinguish all state law design defect claims regarding all
medical devices. /d. at 488. Second, the MDA provided no private
damages action that would replace state common law actions. Third,
the MDA’s preemption provision, unlike the 1969 Cigarette Act’s,
expressed congressional concern “with the problem of specific,
conflicting State statutes and regulations rather than the general duties
enforced by common-law actions.” /d. at 489. Fourth, unlike the 1969
Cigarette Act, the MDA uses the word “requirements” in numerous
provisions, and each use clearly refers only to statutory and regulatory
law, not common law. Fifth, the legislative history of the MDA
reveals no reference in the hearings, committee reports, or debates that
suggests a congressional intent to preempt all common-law remedies.

9. Agreeing that the meaning of the term “requirements”
depends on the statutory context, Justice Breyer concurred on the
ground that, as used in the MDA, the word “requirements” is
ambiguous and therefore the Food and Drug Administration, which
administers the MDA, is entitled to deference for its view that state
law is not preempted. 518 U.S. at 503-508.

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Appendix E

Cipollone and Medtronic may appear to be in some |
tension but in fact teach the same lesson: that the term
“requirements” must be interpreted in its statutory context.
As the Supreme Court has said, “Only mischief can result if
[the same words appearing in different statutes] are given
one meaning regardless of the statutory context.” Lee v.
Madigan, 358 U.S. 228, 231 (1959). An examination of the
text, legislative history, and purposes of the 1972 FIFRA
amendments reveals that, by preempting state labeling
“requirements,” Congress did not intend to preempt
traditional state damages actions against pesticide
manufacturers for failure to warn.

B. The Text of FIFRA Demonstrates that-Congress
Did Not Intend to Preempt Common Law Actions

FIFRA’s text demonstrates that Congress had no intent
to extinguish damages remedies under state common law.
First, in section 136v, Congress used the term “requirements”
to mean “regulation,” a term connoting positive commands
of law, not court orders to pay damages for the harms caused
by pesticides. Second, the term “requirements” appears in
FIFRA 75 times, and each time refers to direct commands
of law, which state damages actions do not impose. Third,
subsections 136v(a) and (c) demonstrate that Congress
intended to authorize states to take actions that may indirectly
prompt pesticide manufacturers to change their labels;
indirect pressure on pesticide manufacturers to change their
labels, which may result from liability in damages actions,
cannot be characterized as labeling “requirements.”

76a
Appendix E

1. Under section 136v, the term “requirements”
refers to state commands regarding labeling
content.

Section 136v(b)’s bar on state-imposed labeling
“requirements” must be interpreted in its context as a
subsection of section 136v, the provision of the 1972
amendments entitled “Authority of States.” Without section
136v, state regulation of pesticide use might have been
eliminated by the 1972 amendments. Prior to 1972, the
federal government regulated pesticides primarily through a
registration process requiring federal approval of pesticide
labels. S. Rep. No. 838, 92d Cong., 2d Sess. 3 (1972). The
1972 amendments expanded federal regulation to include
pesticide use, an area previously regulated exclusively by
states. Ibid.

Section 136v clarifies the continuing role of state
governments in pesticide regulation, authorizing states to
regulate pesticides more stringently than EPA. Section
136v(a) thus provides that “[a] State may regulate” the sales
or use of pesticides as long as the state “regulation” does
not permit a sale or use prohibited by FIFRA. Section 136v(b)
forbids “[s]uch state” from regulating labeling by imposing
labeling “requirements” in addition to or different from those
required under FIFRA. The plainest reading of the two
subsections is that a state may “regulate” pesticide sales or
use, but in doing so may not impose labeling “requirements.”
In other words, section 136v(b)’s prohibition on state labeling
“requirements” represents an exception to section 136v(a)’s
general grant of state authority to “regulate” pesticide sales
and use. Congress could only have intended that the term

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Appendix E

“requirements” in section 136v(b) refers to a subset of state
“regulation” in section 136v(a). As a majority of the Court
held in Cipollone, “the term ‘regulation’ most naturally refers
to positive enactments by those bodies, not to common-law
damages actions.” 505 U.S. at 519. Section 136v clearly
preempts state labeling commands, but suggests no
congressional intent to preempt state damages actions.

2. FIFRA’s other references to “requirements”
all refer to direct commands imposed by law,
not the indirect pressure resulting from tort
liability.

The Medtronic plurality interpreted the term
“requirements” in the MDA’s preemption provision by
examining its usages throughout the MDA. In doing so, the
plurality adhered to “the normal rule of statutory construction
that identical words used in different parts of the same act
are intended to have the same meaning.” Sullivan v. Stroop,
496 U.S. 478, 484 (1990) (internal quotation marks omitted).
Throughout FIFRA, the term “requirements” refers
exclusively to positive commands of law. Accordingly, the
term “requirements” should be given the same reading in
section 136v(b).

The term “requirements” appears seventy-five times in
FIFRA, and each time refers only to positive law requirements."

10. See 7 U.S.C. 136(q)(1)(F) (a pesticide is “misbranded” if
its label does not contain “requirements” imposed under FIFRA);
7 U.S.C. 136(q)(1)(G) (same); 7 U.S.C. 136a(b)(2) (unregistered
pesticides may be transferred in accordance with “the requirements

(Cont’d)

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Appendix E

(Cont'd)
of an experimental use permit”); 7 U.S.C. 136a(c)(2)(A) (EPA may
establish “standards for data requirements for the registration of
pesticides with respect to minor uses”); 7 U.S.C. 136a(c)(2)(B)(iv)
(suspended pesticide shall be reinstated upon a showing that the
registrant “has complied fully with the requirements that served as
a basis for the notice of intent to suspend”); 7 U.S.C.
136a(c)(2)(B)(viii)(I)(A) (“data requirements” imposed by federal
and state authorities); 7 U.S.C. 136a(c)(2)(B)(vili)(IIL) (“the
Administrator shall develop a process to identify and assist in
alleviating future disparities between Federal and State data
requirements.”); 7 U.S.C. 136a(c)(2)(E) (criteria under which EPA
“may waive otherwise applicable data requirements”); 7 U.S.C.
136a(c)(5)(B) (EPA shall register pesticides if, inter alia, “its labeling
and other material required to be submitted comply with the
requirements of this subchapter”); 7 U.S.C. 136a(c)(6) (denial of
registration for failing to satisfy FIFRA’s “requirements”);
7 U.S.C. 136a(c)(9)(B) (labeling “requirements”); 7 U.S.C.
136a(g)(1)(A) (EPA must follow “the procedures and substantive
requirements of section 136d”); 7 U.S.C. 136a(h) (imposing
“{rjegistration requirements for antimicrobial pesticides”); 7 U.S.C.
136a(h)(3)(A)(ii) (establishing “requirements” for proposed
regulations addressing antimicrobial pesticides); 7 U.S.C.
136a(h)(3)(B)(iii) (establishing “requirements” for final regulations);
7 U.S.C. 136a(h)(3)(C); 7 U.S.C. 136a(h)(4)(B) (data requirements);
7 U.S.C. 136a-1(a)(1) (data requirements); 7 U.S.C. 136a-1(a)(2)
(“requirements of section 136a(c)(5)”); 7 U.S.C. 136a-1(b)(4) (data
requirements); 7 U.S.C. 136a-1(c)(1)(C) (data requirements);
7 U.S.C. 136a-1(e)(1)(A) (“requirements of section 136a”); 7 U.S.C.
136a-1(e)(1)(B) (same); 7 U.S.C. 136a-1(e)(1)(D) (same); 7 U.S.C.
136a-1(e)(4)(A)(iv) (same); 7 U.S.C. 136a-1(f)(1) (data
requirements); 7 U.S.C. 136a-1(f)(1)(B) (same); 7 U.S.C.
136a-1(g)(2)(C) (“requirements of section 136a(c)(5)”); 7 U.S.C.
136a-1(g)(2)(E)(ii) (requirements of the Federal Food, Drug, and
Cosmetic Act); 7 U.S.C. 136a-1(j) (exemption from “the requirements
(Cont'd)

79a

Appendix E

FIFRA establishes “data requirements,”'' “time

(Cont'd)

of subsections (d), (e), (f), and (i)”); 7 U.S.C. 136d(b)(2) (time
requirements); 7 U.S.C. 136d(f)(3)(D) (“data and other requirements”);
7: U.S.C. 136d(f)(4) (data requirements); 7 U.S.C. 136f(a)
(recordkeeping requirements); 7 U.S.C. 136g(c)(1) (civil and
criminal proceedings for failing to comply with requirements of
subchapter); 7 U.S.C. 136i(a)(1) (requirements on state certification
of pest applicators); 7 U.S.C. 136i-1(a) recordkeeping requirements
for certified applicators); 7 U.S.C. 136i-1(e) (requirements of this
section do not affect state or federal laws); 7 U.S.C. 136j(b)(1)
(exemption from penalties for certain persons who comply with
requirements of this subchapter); 7 U.S.C. 136k(b)(3) (seizure of
pesticides that cause harm but comply with requirements of this
subchapter); 7 U.S.C. 136m(a)(2)(A) (indemnity unless registrant
should have known pesticide did not meet requirements for
registration); 7 U.S.C. 136q(a)(1) (data requirements); 7 U.S.C.
136q(a)(1)(B) (label requirements for transportation); 7 U.S.C.
136q(a)(2)(A) (EPA authority to issue regulatory requirements;
7 U.S.C. 136q(a)(2)(B) (same); 7 U.S.C. 136q(a)(2)(C) (same);
7 U.S.C. 136q(a)(3)(A) (same); 7 U.S.C. 136q(a)(3)(B) (same);
7 U.S.C. 136q(a)(3)(C) (same); 7 U.S.C. 136q(f)(1)(B)(iv)
(requirements under Solid Waste Disposal Act); 7 U.S.C.
136q(f)(1)(C) (exemptions from requirements of this subchapter);
7 U.S.C. 136q(f)(3) (requirements of Solid Waste Disposal Act);
7 U.S.C. 136q(h) (same); 7 U.S.C. 136v(b) (state labeling requirements);
7 U.S.C. 136w(a)(2)(C) (time requirements) 7 U.S.C. 136w(b)
(exemption from requirements of this subchapter); 7 U.S.C. 136w(d)
(time requirements); 7 U.S.C. 136w-1(b) (requirements of section
136i); 7 U.S.C. 136w-2(a) (referral to state officials for investigation
consistent with requirements of this subchapter); 7 U.S.C. 136w-5
(state minimum requirements for training applicators).

11. See, e.g., 7 U.S.C. 136a-1(a)(1); 7 U.S.C. 136a-1(b)(4);
7 U.S.C. 136a-1(f)(1); 7 U.S.C. 136d(f)(4); 7 U.S.C. 136q(a)(1).

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Appendix E

9912 6

requirements, registration requirements,”'? and
“recordkeeping requirements.”'* FIFRA refers to
“requirements” imposed under other federal and state laws.'°
All of these references to “requirements” clearly encompass
commands imposed by statute or regulation.

FIFRA’s many usages of the term “requirements,”
including section 136v, demonstrate that Congress
understood “requirements” to be a subset of “regulations.”
For example, EPA “may by regulation * * * issue
requirements” regarding pesticide storage and
transportation.'® EPA may “by regulation * * * issue
requirements” for disposing of certain pesticides,'’ pesticide
containers,'* and pesticide container rinsing agents.'°

12. See, e.g., 7 U.S.C. 136d(b)(2); 7 U.S.C. 136w(a)(2)(C);
7 U.S.C. 136w(d)(1).

13. See, e.g., 7 U.S.C. 136a(h).

14. See, e.g., 7 U.S.C. 136f(a); 7 U.S.C. 136i-1(a).

15. See, e.g., 7 U.S.C. 136a-1(g)Z2)E); 7 U.S.C.
136q(f)(1)(B)(iv); 7 U.S.C. 136i-1(e); 7 U.S.C. 136q(h); 7 U.S.C.
136w-5.

16. 7 U.S.C. 136q(a)(2)(A) (emphasis added). See also
7 U.S.C. 136q(a)(3)(A).

17. 7 U.S.C. 136q(a)(2)(B), (C) (emphasis added).
18. 7 U.S.C. 136q(a)(3)(B).

19. 7 U.S.C. 136q(a)(3)(C).

8la

Appendix E

Furthermore, each reference to labeling “requirements”
refers to statutory or regulatory commands. For example,
FIFRA mandates that EPA register a pesticide only if its
labeling complies with the labeling “requirements” imposed
under FIFRA.” FIFRA defines a pesticide to be
“misbranded” if its label does not meet the various
“requirements” imposed under FIFRA.”' Since FIFRA refers
exclusively to labeling “requirements” imposed by regulation,
section 136v(b) cannot be read to encompass voluntary
labeling changes resulting from a state damages action.

As the Medtronic plurality concluded with respect to
the uses of the term “requirements” in the MDA, the uses of
the term “requirements” throughout FIFRA demonstrate that
“its focus is * * * positive law by legislative or administrative
bodies, not the application of general rules of common law
by judges and juries.” 518 U.S. at 489. Specifically, FIFRA’s
usage of the term “requirements” demonstrates (1) that
Congress used the term “requirements” to denote a subset
of “regulations,” a term connoting positive commands of law,
and (2) that Congress understood labeling “requirements”
to refer to labeling con:mands imposed by statute and regulation.

20. 7 U.S.C. 136a(c)(5).

21. 7 U.S.C. 136(q)(1)(F),(G). See also, e.g., 7 U.S.C.
136a(c)(9)(B) (entitled “Requirements,” establishes that pesticide
labels must not “conflict with or detract from any statement required
by law or the Administrator as a condition of registration”) 7 U.S.C.
136a(c)(9)(B); 7 U.S.C. 136q(a)(1)(B) (the Administrator may
impose regulations mandating that “the labeling of a pesticide
contain requirements and procedures for the transportation, storage,
and disposal of the pesticide”).

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Appendix E

3. Section 136v addresses state commands
regarding labeling, not state actions that
indirectly pressure pesticide manufacturers
to change their labels.

A state court award of damages for failure to warn does
not mandate any change in labeling. Rather, it merely
requires that a pesticide manufacturer pay money to an
injured person. While a damages award may prompt a
pesticide manufacturer to seek EPA approval for a change
in labeling, it does not directly command such a change.” In
several provisions of FIFRA, Congress authorized states to
apply indirect pressure on pesticide manufacturers to change
their labels. For instance, pursuant to section 136v(a), a state
may prohibit pesticide use or restrict Pesticide sales for any
reason, including the adequacy of warnings. Pesticide use
or sales restrictions may pressure pesticide manufacturers
to seek EPA approval to alter a pesticide label. Alternatively,
a pesticide manufacturer may request EPA approval to
change a pesticide label in order to promote additional
pesticide uses approved by states under section 136v(c) that
have not been approved by EPA pursuant to section
136a(c)(5).7? Damages awards, like use or sale prohibitions,

22. In contrast, an injunction imposed against a manufacturer
to change its label would represent a state-mandated labeling
requirement and would therefore be preempted.

23. Pursuant to their authority under section 136v(c), states
may directly impose supplemental labeling requirements regarding
state-approved local uses. 40 C.F.R. 162.153(e). If the pesticide
manufacturer seeks to alter the label nationally, however, it must
obtain EPA approval.

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Appendix E

and state-approved additional uses, may indirectly pressure
pesticide manufacturers to change their labels. But such
indirect pressure cannot reasonably be characterized as
imposing labeling requirements.

Moreover, indirect pressure to change a pesticide label
does not frustrate Congress’s purpose of establishing
nationally uniform pesticide labels. EPA approves only one
label per pesticide. In approving a labeling change, EPA
substitutes a new nationally uniform label. This process is
the same whether the labeling change is prompted by state
damages liability or state regulation authorized by FIFRA.

The concern that state damages awards would impose
requirements that conflict with EPA’s determinations is
unfounded. Damages awards do not impose labeling
“requirements” as that term is used in FIFRA. Furthermore,
in state-law damages actions, EPA’s evaluation and approval
of pesticide label statements may be evidence of the adequacy
of the label or a pesticide manufacturer’s conduct. For
example, where a pesticide manufacturer shows that it
requested EPA approval of a particular label statement and
EPA rejected the request, tort law ordinarily will preclude
the imposition of liability for failing to include the statement.
See Restatement (Second) of Torts §§ 286-288C.** Because
pesticide manufacturers remain free to seek alterations of
their labels, however, EPA approval of a pesticide label
should not completely shield a pesticide manufacturer from
state law liability.

24. In addition, a state judgment imposing liability for failing
to include a label statement that EPA rejected may result in an actual
conflict between state and federal law and may therefore be
precluded as a result of implied preemption analysis.

seer ae

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Appendix E

C. The History of FIFRA Demonstrates No
Congressional Intent to Extinguish Actions for
Damages

When section 136v(b) was enacted in 1972, common
law actions against pesticide manufacturers for failure to
warn were widely available and had been held not to conflict
with federal labeling requirements. The legislative history
of the 1972 FIFRA amendments include no suggestion of an
intent to extinguish common law damages actions.”* Indeed,
the legislative history overwhelmingly demonstrates that
Congress enacted section 136v(b) to preclude state
administrative bodies from imposing commands on the
content of pesticide labels, not to alter existing tort remedies.

25. In Medtronic the plurality refused to accept that Congress
intended to preempt common-law damages actions where the
legislative history was devoid of such intent:

There is, to the best of our knowledge, nothing in the
hearings, the committee reports, or the debates
suggesting that any proponent of the legislation intended
a sweeping pre-emption of traditional common-law
remedies against manufacturers and distributors of
defective devices. If Congress intended such a result,
its failure even to hint at it is spectacularly odd.

Medtronic, 518 U.S. at 491. That Congress could intend FIFRA
preemptive force to be so sweeping is no less incredible, given the
total absence of legislative history evincing such intent.

85a

Appendix E

1. When section 136v(b) was enacted, common
law actions against pesticide manufacturers
for failure to warn were a well-recognized
and uncontroversial feature of the legal
landscape.

Section 136v cannot be understood without an
appreciation for the common law in 1972. A court must
“presume that Congress is knowledgeable about existing law
pertinent to the legislation it enacts.” Goodyear Atomic Corp.
v. Miller, 486 U.S. 174, 185 (1988). A court should interpret
a statute to alter existing law only if Congress intended that
result.” Because common law actions for failure to warn
about pesticides were widely available in 1972 and no
evidence hints that Congress intended to eliminate those
actions, a court should not read section 136v to do so.?’

26. See United States v. Texas, 507 U.S. 529, 540-541 (1993)
(Stevens, J., dissenting) (“We presume that Congress understands
the legal terrain in which it operates, * * * and we therefore expect
Congress to state clearly any intent to reshape that terrain.”);
cf. Oubre v. Entergy Operations, Inc., 118 S. Ct. 838, 845-846
(1998) (“[C]ommon-law doctrines ‘ought not to be deemed repealed,
unless the language of a statute be clear and explicit for this
purpose.” ”) (quoting Fairfax’s Devisee v. Hunter’s Lessee, 11 U.S.
(7 Cranch) 603, 623 (1812)).

27. The widespread availability of failure to warn actions
against pesticide manufacturers at the time section 136v was enacted
contrasts sharply with the unavailability of damages actions against
cigarette manufacturers at the time of the enactment of the federal
cigarette labeling statutes at issue in Cipollone. See Robert L. Rabin,
“A Sociolegal History of the Tobacco Tort Litigation,” 44 Stan. L.
Rev. 853 (1992).

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Appendix E

Common law actions for inadequate, misleading, or false
representations regarding pesticides were available at least
as early as 1884.”* In the first part of this century, dozens of
reported decisions recognized the availability of actions for
false or inadequate representations regarding pesticides,
including actions based on pesticide labels.”” After FIFRA
was enacted in 1947, the federal government issued
substantial labeling regulations,” but state and federal courts

28. See Jones v. George, 61 Tex. 345 (1884) (action against
the seller of “Royall’s Patent or Receipt for Killing Worms,” which
was represented as effective against cotton worms but which failed
to control the worms).

29. See, e.g., White v. National Bank of Commerce, 278
P. 915 (Cal. D. Ct. App. 1929) (crop damage action against seller
of “Volck Concentrate,” falsely represented to control pests without
harming citrus trees); West Disinfecting Co. v. Plummer, 44 App.
D.C. 345 (D.C. Cir. 1916) (personal injury action against maker of
“Kil-Bug” for allegedly inade

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386014_1768%3A2. Public record. Not legal advice.
