Hawkins v. Leslie Pool Mart Inc ( 1999 )

Opinions of the United
1999 Decisions States Court of Appeals
for the Third Circuit
7-15-1999
Hawkins v. Leslie Pool Mart Inc
Precedential or Non-Precedential:
Docket 98-5229
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Filed July 15, 1999
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
No. 98-5229
DAWN-MARIE HAWKINS; JAMES E. HAWKINS,
Appellants
v.
LESLIE'S POOL MART, INC.
APPEAL FROM THE
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
(D.C. No. 96-cv-01869)
District Judge: The Honorable Mary Little Cooper
ARGUED March 9, 1999
BEFORE: MANSMANN, SCIRICA, and NYGAARD,
Circuit Judges.
(Filed July 15, 1999)
Gerald J. Williams, Esq. (Argued)
Williams & Cuker
1617 JFK Boulevard
One Penn Center at Suburban
Station, Suite 800
Philadelphia, PA 19103
Attorney for Appellant
William T. Corbett, Jr., Esq. (Argued)
Shanley & Fisher
131 Madison Avenue
Morristown, NJ 07962-1979
Attorney for Appellee
OPINION OF THE COURT
NYGAARD, Circuit Judge.
Appellants Dawn-Marie and James Hawkins (referred to
collectively as Hawkins) appeal the District Court's
summary judgment. It had concluded that Hawkins's
claims that Leslie's Pool Mart (1) negligently failed "to
provide adequate directions or precautions regarding the
opening, closing and/or storage of the package containing
the product" and (2) negligently failed "to package the
product in a manner adequate to prevent excessive
chemical decomposition, contamination, combustion, or
generation of fumes and gases" were preempted by the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA),
7 U.S.C. S 136 et seq. We have jurisdiction under 28 U.S.C.
S 1291 and will exercise plenary review to determine
whether "the pleadings, depositions, answers to
interrogatories and admissions on file, together with the
affidavits, if any, show that there is no genuine issue as to
any material fact" such that Leslie's Pool Mart is entitled to
judgment as a matter of law. Fed. R. Civ. P. 56; see Olson
v. General Elec. Astrospace, 101 F.3d 947, 951 (3d Cir.
1996). We will affirm in part and reverse in part.
I.
Dawn-Marie Hawkins suffered a burning sensation in her
throat and lungs, and breathing difficulty when she opened
a container of Leslie's Chlorinator Tablets 1 purchased
from Leslie's Pool Mart. Hawkins filed a diversity action in
federal court against Leslie's Pool Mart alleging negligence,
strict liability, breach of warranty and loss of consortium.
Germane to this appeal, Hawkins asserts that Leslie's Pool
Mart:
2
* failed to warn of sudden decomposition and
chemical reactions which could generate harmful
fumes;
* failed to provide adequate directions regarding the
opening, closing and/or storage of the container;
and
* failed to package the product in a manner adequate
to prevent excessive decomposition contamination,
combustion, or generation of fumes.
Compl. PP 9, 18, 21, 22 and 25; App. 2a-6a.
The District Court employed the preemption analysis
established by the Supreme Court in Cipollone v. Liggett
Group, Inc., 505 U.S. 504, 112 S. Ct. 2608 (1992), and held
that Hawkins's failure to warn claims, failure to provide
adequate directions claims and failure to adequately
package the product claims were preempted by FIFRA. The
District Court reasoned that imposing liability would
require Leslie's Pool Mart to alter the label and packaging
approved by the Environmental Protection Agency (EPA).
Hawkins appeals, relying on the Supreme Court's most
recent case on preemption, Medtronic, Inc. v. Lohr, 518 U.S.
470, 116 S. Ct. 2240 (1996).
On appeal, Hawkins first argues that FIFRA neither
requires directions for opening a package nor information
about the chemical reactivity of a pesticide be included
therein. Appellant's Br. at 12. Second, she suggests that
directions on a container's lid are neither required or
approved under FIFRA nor are they registered with the
EPA. Third, she asserts that FIFRA's regulations concerning
directions for use are general, and therefore, her claims do
not impose requirements that are in addition to, or different
from, FIFRA's. As to Hawkins's defective/negligent
packaging claim, she argues that because the EPA has
regulated packaging only in the area of child-resistant
packaging, her claim for defective packaging is not
preempted. We will affirm as to the labeling based claims
but reverse as to the packaging claim.
II.
Preemption is based on the Supremacy Clause. See U.S.
Const. art. VI, cl. 2 ("This Constitution, and the Laws of the
3
United States which shall be made in Pursuance thereof;
. . . shall be the supreme Law of the Land; and the Judges
in every State shall be bound thereby, any thing in the
Constitution or Laws of any State to the contrary
notwithstanding."). The doctrine preempts state laws that
conflict with or are contrary to federal law. See Cipollone,
505 U.S. at 516, 112 S. Ct. at 2617. There are three types
of preemption: express, implied and conflict preemption.
However, these "categories are not `rigidly distinct.' " Gade
v. National Solid Wastes Management Ass'n, 505 U.S. 88,
104 n.2, 112 S. Ct. 2374, 2386 n.2 (1992) (quoting English
v. General Elec. Co., 496 U.S. 72, 79 n.5, 110 S. Ct. 2270,
2275 n.5 (1990)). Here, the language of FIFRA expressly
preempts state law.
The preemptive provision of FIFRA states:
S 136v. Authority of States
(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.
(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.
7 U.S.C. S 136v.
Even though "the pre-emptive language of [section 136v]
means that we need not go beyond that language to
determine whether Congress intended [FIFRA] to pre-empt
at least some state law, we must nonetheless `identify the
domain expressly pre-empted.' " Medtronic, 518 U.S. at 484,
116 S. Ct. at 2250 (quoting Cipollone, 505 U.S. at 517, 112
S. Ct. at 2618). To do so, we "begin with [the statute's] text"
as "informed by two presumptions about the nature of
preemption." Id. at 484-85, 116 S. Ct. at 2250 (citing Gade,
505 U.S. at 111, 112 S. Ct. at 2389-90 (Kennedy, J.,
concurring in part and concurring in judgment)). Thefirst
presumption is " `that the historic police powers of the
4
States [are] not to be superseded by the Federal Act unless
that was the clear and manifest purpose of Congress.' " Id.
at 485, 116 S. Ct. at 2250 (quoting Rice v. Sante Fe
Elevator Corp., 331 U.S. 218, 230, 67 S. Ct. 1146, 1152
(1947)). The second long-standing presumption is that " `the
purpose of Congress is the ultimate touchstone' in every
pre-emption case." Id., 116 S. Ct. at 2250 (quoting Retail
Clerks v. Schermerhorn, 375 U.S. 96, 103, 84 S. Ct. 219,
222 (1963)). Therefore, a proper analysis of a statute's
preemptive scope "rest[s] primarily on`a fair understanding
of congressional purpose' " as "discerned from the language
. . . and the `statutory framework.' " Id. at 485-86, 116 S.
Ct. at 2250-51 (quoting Cipollone, 505 U.S. at 530 n.27,
112 S. Ct. at 2624 n.27, and Gade, 505 U.S. at 111, 112
S. Ct. at 2390 (Kennedy, J., concurring in part and
concurring in judgment)).
A proper analysis must also consider "the `structure and
purpose of the statute as a whole,' as revealed not only in
the text, but through the reviewing court's reasoned
understanding of the way in which Congress intended the
statute and its surrounding regulatory scheme to affect
business, consumers, and the law." Id. at 486, 116 S. Ct.
at 2251 (quoting Gade, 505 U.S. at 98, 112 S. Ct. at 2383).
In Wisconsin Public Intervenor v. Mortier, the Supreme
Court concluded that section 136v of FIFRA resulted in a
"narrow preemptive overlap" and that Congress did not
intend "to occupy the entire field of pesticide regulation."
501 U.S. 597, 613, 111 S. Ct. 2486 (1991). The Supreme
Court observed, albeit in dicta, that although FIFRA was "a
comprehensive regulatory statute," the preemption
provision was narrow and preempted state regulation of
labeling. Id. at 601, 111 S. Ct. at 2480 (quoting
Ruckleshaus v. Monsanto Co., 467 U.S. 986, 991, 104 S. Ct.
2862, 2867 (1984)). This conclusion is supported by the
House Committee Report on the 1972 amendments to
FIFRA. The Report notes that "[i]n dividing the
responsibility between the States and the Federal
government for the management of an effective pesticide
program, the Committee has adopted language which is
intended to completely preempt State authority in regard to
labeling and packaging." H.R. Rep. No. 92-511, at 16
(1971).
5
However, the pre-emptive effect of FIFRA is dependent on
agency regulations. See id. at 1 (explaining that "[t]he
Federal Government sets the program standards the States
must meet. State authority to change Federal Labeling and
packaging is completely preempted" and noting that the
EPA has "[g]eneral authority . . . to write regulations to
carry out the Act and recognize the use of specialty
chemicals"); 7 U.S.C. S 136v(a) (permitting state regulation
of pesticides "but only if and to the extent the regulation
does not permit any sale or use prohibited by this
subchapter"); id. S 136v(b) (prohibiting state imposed
labeling or packaging requirements that are "in addition to
or different from those required under this subchapter").
We therefore begin by noting that FIFRA expressly
preempts state imposed requirements in the areas of
labeling and packaging that are "in addition to or different
from those required" by the EPA. 7 U.S.C. S 136v(b). We
also note that the term "requirements" in section 136v
includes not only state statutory law but also state
common-law damages claims. See Medtronic, 518 U.S. at
487-88, 116 S. Ct. at 2251; see also Cipollone, 505 U.S. at
521, 112 S. Ct. at 2620 (concluding that the term
"requirements" "sweeps broadly" and"easily encompass[es]
obligations that take the form of common-law rules" and
that an award of damages can be " `a potent method of
governing conduct and controlling policy' " (quoting San
Diego Bldg. Trades Council v. Garmon, 359 U.S. 236, 247,
79 S. Ct. 773, 780 (1959))). However, that does not in turn
automatically preclude all state common-law damages
claims. As the Supreme Court observed in Medtronic, "if
Congress intended to preclude all common-law causes of
action, it chose a singularly odd word with which to do it."
518 U.S. at 487, 116 S. Ct. at 2251. The word
" `requirement' appears to presume that the State is
imposing a specific duty upon the manufacturer." Id., 116
S. Ct. at 2251. If Congress's true intention was to preclude
all common law causes of action, it could have stated that
all remedies, rather than requirements, under state law
pertaining to pesticides, fungicides and rodenticides are
precluded. Cf. id. at 487-88, 116 S. Ct. at 2251.
A. Labeling Claims
Although FIFRA's language is fairly general as to some
aspects of pesticide regulation, EPA rules and regulations
6
set forth specific labeling requirements. See 40 C.F.R.
S 156.10; Lewis v. American Cyanamid Co. , 715 A.2d 967,
973 (N.J. 1998) (noting that "[a]lthough FIFRA does not
prescribe the exact contents of labels, manufacturers are
not free . . . to create pesticide labels in any manner they
choose. . . . FIFRA cannot impose a specific requirement for
warning labels like the 1969 Cigarette Act because FIFRA
regulates a wide variety of products that cannot be serviced
by a single statement."). The EPA requirements address,
inter alia, label contents and proper label placement.
Required warning and precautionary statements are based
in part, on the toxicity of the pesticide. The EPA has
established "typical precautionary statements" for the
different categories of toxicity. 40 C.F.R.S 156.10(h)(2)(i)(B).
However, "[t]hese statements must be modified or expanded
to reflect specific hazards." Id. Thus, Hawkins's claim that
Leslie's Pool Mart failed to warn of sudden decomposition
and sudden reactivity of the pesticide is, on its face,
preempted by the pesticide-specific labeling requirements
established by the EPA.
Hawkins contends that her "claims based on failure to
provide adequate directions for opening and closing the
container are not preempted because they do not impose
requirements that are different from or in addition to
federal requirements." Appellant's Br. at 6. We disagree.
First, " `labeling' means all labels and all other written,
printed, or graphic matter . . . accompanying the pesticide or
device at any time." 7 U.S.C. S 136(p)(2) (emphasis added).
Thus, a plain reading of the statute reveals that Congress
intended the term "labeling" to include all printed matter--
whether appearing on a front or back "label" or some other
portion of the container. Hawkins attempts to make the
distinction that her claim is based not on the label, but on
instructions placed on the lid of the container. We reject
such a hair-splitting reading of the statute, and instead
conclude that, under a literal reading of FIFRA, labeling
requirements include any and all printed matter that
"accompan[ies] the pesticide." Id.
Hawkins also argues that "[t]he applicability of
[Medtronic's] logic to this case is inescapable" because the
language of FIFRA "is virtually identical" to that of the
7
Medical Device Amendments.1 Appellant's Br. at 11.
However, even assuming that FIFRA is analogous to the
Medical Device Amendments addressed by the Supreme
Court in Medtronic, contrary to Hawkins's assertions, we do
not read that case as standing for the overarching premise
that tort claims fall outside "preempted requirements."
Further, the Court's holding in Medtronic does not alter our
analysis as to Hawkins's labeling-based claims. In
Medtronic, the Food and Drug Administration approved a
pacemaker device without performing an extensive
evaluation. See 518 U.S. at 480, 116 S. Ct. at 2248. In
stark contrast, here the EPA withheld approval of the
chlorinator tablets and accompanying labels until Leslie's
Pool Mart incorporated specific labeling language mandated
by the EPA. For example, in 1975, the EPA approved the
following language for Leslie's chlorinator tablets 1 labels
and warning:
DANGER: KEEP OUT OF REACH OF CHILDREN.
Corrosive, causes eye damage. May be fatal if
swallowed. Do not get in eyes, on skin or on clothing.
Irritating to nose and throat. Avoid breathing dust. May
cause burns to broken skin. Wash hands after
handling.
DANGER: STRONG OXIDIZING AGENT.
_________________________________________________________________
1. The preemptive provision of the Medical Device Amendments Act
states in pertinent part:
(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 form, or in addition to, any requirement
applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the ddAdevice
or
to any other matter included in a requirement applicable to the
device under this chapter.
21 U.S.C. S 360k(a). Subchapter (b) then lists the exempted
requirements. See id. S 360k(b).
8
Mix only with water. Use clean dry utensils.
Contamination by moisture, organic matter, or other
chemicals may liberate hazardous gases. Store in cool,
dry, well-ventilated area away form heat or openflame.
Decomposes at 350F with liberation of harmful gases.
In case of decomposition, if possible, isolate container
in open air. Flood with large amounts of water. Keep
container tightly closed when not in use. Rinse empty
container thoroughly with water to dissolve all material
before discarding.
App. at 15a (emphasis added). In 1988, the EPA notified
Leslie's Pool Mart that its labeling was unacceptable and
needed to be revised to read as follows:
Danger: corrosive. Causes eye and skin damage. Do
not get in eyes, on skin or on clothing. Wear goggles
and rubber gloves when handling. Harmful if
swallowed. Avoid breathing dust. Wash thoroughly with
soap and water after handling.
App. 35a (emphasis added). Finally, in 1994, the EPA again
changed the wording requirements to read:
CORROSIVE: Causes irreversible eye damage and skin
burns. May be fatal if absorbed through skin. May be
fatal if inhaled. Do not breathe dust or spray mists.
Irritating to nose and throat. Harmful if swallowed. Do
not get in eyes, on skin, or on clothing. Wear goggles
or face shield, protective clothing and rubber gloves
when handling this product. Wash thoroughly with
soap and water after handling and before eating,
drinking or using tobacco. Remove contaminated
clothing and wash before reuse.
App. 58a (emphasis added).
Additionally, in 1994, the EPA approved the following
language concerning the storage and disposal of the
chlorinator tablets:
STORAGE AND DISPOSAL: Do not contaminate water,
food, or feed by storage or disposal. Keep product dry
in tightly closed container when not in use. Store in cool
dry, well ventilated area away from heat or openflame
. . .
9
app. at 38a (emphasis added), and the following
precautionary statements under the heading "Physical or
Chemical Hazards: Strong Oxidizing Agent":
Mix only with water. Use clean dry utensils. Do not add
this product to any dispensing device containing
remnants of any other product. Such use may cause a
violent reaction leading to fire or explosion.
Contamination with moisture, organic matter, or other
chemicals may start a chemical reaction, with
generation of heat, liberation of hazardous gases, and
possible generation of fire and explosion. In case of
contamination or decomposition, do not reseal container.
If possible isolate container in open air or well
ventilated area. Flood with large volumes of water if
necessary.
Id. (emphasis added). The Record shows that each time the
EPA evaluated the labels and made recommendations
pertaining to the language on the labels, Leslie's Pool Mart
cooperated with the EPA and changed the labels as
instructed.
"In sum, the EPA's requirements for labeling pesticides
are sufficiently specific to mandate preemption of claims
based on state statutes or common law." Lewis, 715 A.2d
at 973; see also Taylor AG Indus. v. Pure-Gro, 54 F.3d 555,
560 (9th Cir. 1995) ("[U]nder 7 U.S.C. S 136a(c)(5), the EPA
approves each label only after a careful review of the
product data and the draft label. FIFRA cannot impose a
specific language requirement for warning labels like the
1969 Cigarette Act because FIFRA regulates a wide variety
of products that cannot be serviced by a single statement.").
The EPA categorizes each pesticide according to its toxicity
and then sets forth the warning language required on the
pesticide's label. See Lewis, 715 A.2d at 973. FIFRA
disallows any changes to an EPA-approved label unless the
EPA approves the change. This absolute control of labeling
regulation indicates that Hawkins's claim that labeling
different from that approved by the EPA should have been
included on the container is preempted.2
_________________________________________________________________
2. This conclusion "comports with the decisions of an overwhelming
majority of federal and state courts that have interpreted the extent of
10
Moreover, Hawkins mischaracterizes the EPA labeling
requirements concerning directions for use. We agree that
the General Requirements are just that--general. 3 The
_________________________________________________________________
FIFRA preemption in light of Medtronic." Lewis, 715 A.2d at 973 (citing
Kuiper v. American Cyanamid Co., 131 F.3d 656, 662 (7th Cir. 1997),
and Grenier v. Vermont Log Bldgs., Inc., 96 F.3d 559, 563-64 (1st Cir.
1996)); see, e.g., Taylor AG Indus., 54 F.3d at 561; Welchert v. American
Cyanamid, Inc., 59 F.3d 69, 73 (8th Cir. 1995); Lowe v. Sporicidin Int'l,
47 F.3d 124, 129 (4th Cir. 1995); MacDonald v. Monsanto Co., 27 F.3d
1021, 1025 (5th Cir. 1994); Papas v. Upjohn Co. , 985 F.2d 516, 518
(11th Cir. 1993); Arkansas-Platte & Gule Partnership v. Van Waters &
Rogers, Inc., 981 F.2d 1177, 1179 (10th Cir. 1993).
3. The General Requirements mandate:
(i) Adequacy and clarity of directions. Directions for use must be
stated in terms which can be easily read and understood by the
average person likely to use or to supervise the use of the
pesticide.
When followed, directions must be adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment.
(ii) Placement of directions for use. Directions may appear on any
portion of the label provided that the are conspicuous enough to be
easily read by the user of the pesticide product
. . .
(2) Contents of Directions for Use. The directions for use shall
include the following, under the headings "Directions for Use"
(i) The statement of use classification . . .
(ii) Immediately below the statement of use classification, the
statement "It is a violation of Federal law to use this product in
a
manner inconsistent with its labeling"
. . .
(ix) specific directions concerning the storage and disposal of the
pesticide and its container . . . . These instructions shall be
grouped
and appear under the heading "Storage and disposal." This heading
must be set in type of the same minimum sizes as required for the
child hazard warning
(x)(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
40 CFR S 156.10.
11
record, however, makes clear that the EPA scrutinized
Leslie's Pool Mart's proposed labels, and withheld approval
until the required language was incorporated. Therefore, we
agree with Leslie's Pool Mart's observation that"[h]ad the
EPA felt that additional language on the opening, closing,
storage or use of the tablets was necessary, it would have
required that Leslie's include such language." Appellee's Br.
at 19 n.7.
Finally, Hawkins asserts that her labeling claims relate to
areas not addressed by FIFRA or the EPA regulations
because "[n]owhere do the regulations address the
appropriate directions for opening a package in any given
condition." Appellant's Br. at 12. We disagree. The EPA-
mandated and approved language on the labels specifically
instructed the user on protective actions to take when
opening the container and using the pesticide. Among the
federal requirements are directions for the proper storage
and disposal of the product and the potential reactivity of
the product. These instructions necessarily implicate
"opening instructions." Although the approved instructions
and warnings do not specify how the user is to pry the lid
off the container, they do instruct the user to avoid
breathing any fumes and to wear protective clothing and a
face shield or eye goggles. Again, the comprehensiveness of
the regulations leads us to conclude that Hawkins's
labeling claims are preempted. To hold otherwise would be
to impose labeling requirements additional to those
mandated by the EPA. See Welchert v. American Cyanamid,
Inc., 59 F.3d 69, 73 (8th Cir. 1995) ("Where Congress has
so clearly put pesticide labeling regulation in the hands of
the EPA, [a] claim challenging the accuracy of the . . .
label's federally-mandated and approved statement cannot
survive. To hold otherwise would be to allow state courts to
sit, in effect, as super-EPA review boards that could
question the adequacy of the EPA's determination of
whether a pesticide registrant successfully complied with
the specific labeling requirements of its own regulations.").
B. Defective Packaging Claims
Hawkins also alleges that Leslie's Pool Mart "negligent[ly]
fail[ed] to package the product in a manner adequate to
prevent excessive chemical decomposition, contamination,
12
combustion, or generation of fumes and gases." Compl.
P 18(c); App. at 4a. During oral argument, Hawkins
contended that Leslie's Pool Mart's failure to individually
wrap the chlorinator tablets facilitated the generation of
fumes. The District Court read section 136v as preempting
all state law claims based on packaging and labeling.
Accordingly, the District Court granted summary judgment
for Leslie's Pool Mart. On appeal, Hawkins asserts that
because the only area of packaging the EPA has regulated
is child-resistant packaging, her claims alleging inadequate
packaging would not impose a requirement in addition to,
or different from, federal packaging requirements.
Therefore, Hawkins argues, the preemption doctrine does
not apply.
Leslie's Pool Mart responds that the EPA's limited
exercise of authority is of no consequence to the broad
preemptive scope of FIFRA. Leslie's Pool Mart argues that
because section 136v specifically mentions state imposed
labeling and packaging requirements, these areas are the
"exclusive domain" of the federal government and any state
requirement concerning labeling or packaging is preempted.
Thus, our task is to determine whether the scope of federal
preemption of packaging claims under FIFRA is limited to
the discrete area of child-resistant packaging when the EPA
has not evaluated and approved the packaging methods in
dispute.
Once again, we begin our preemption analysis by
identifying the domain preempted. When identifying the
domain preempted, we first acknowledge that the text of
FIFRA makes it clear that the EPA has authority to regulate
all aspects of packaging. See 7 U.S.C. S 136q(e) (stating that
the Administrator of the EPA "shall . . . promulgate
regulations for the design of pesticide containers that will
promote safe storage and disposal of pesticides"); id.
S 136w(a)(1) (authorizing the Administrator of the EPA "to
prescribe regulations to carry out the provisions of[FIFRA]";
id. S 136w(c)(3) (authorizing the Administrator of the EPA
"to establish standards . . . with respect to the package,
container, or wrapping in which a pesticide or device is
enclosed for use or consumption, in order to protect
children and adults from serious injury or illness resulting
13
from accidental ingestion or contact with pesticides or
devices regulated by this subchapter as well as to
accomplish the other purposes of this subchapter"). We
also consult FIFRA's legislative history to glean Congress's
intent. The legislative history notes that "Subsection (b) [of
section 136v] preempts any State labeling or packaging
requirements differing from such requirements under the
Act." Sen. Rep. No. 92-838 (1972) reprinted in 1972
U.S.C.C.A.N. 3993, 4021 (emphasis added). It also allows
for the inference that state and federal labeling and
packaging requirements might coexist. See id. at 4111
(commenting that "[t]he amended language would prohibit
local governments from imposing requirements as to
labeling and packaging which differ from those imposed by
Federal and State authorities (emphasis added)). Finally, we
must also consider the appropriate EPA regulations
because, as explained supra, the preemptive reach of FIFRA
is dependent on agency regulations.
With these guideposts, we now turn to the pertinent
federal statutes and regulations. In contrast to the
numerous regulations and statutes governing pesticide
labeling requirements, only one EPA regulation governs
pesticide packaging. See 40 C.F.R. S 157.20. Section 157.20
states in pertinent part:
This subpart prescribes requirements for child-resistant
packaging of pesticide products and devices. The
requirements are established under the authority of
FIFRA section 25(a)(1)4, which authorizes the
Administrator to issue regulations to carry out the
purposes of the Act, and FIFRA section 25(c)(3) 5, which
authorizes the Administrator to establish standards
with respect to the package, container or wrapping in
which a pesticide or device is enclosed in order to
protect children and adults from serious injury or
illness resulting from accidental ingestion or contact
with pesticides or devices regulated under the Act.
Id. Accordingly, despite a potentially broad scope of
_________________________________________________________________
4. FIFRA section 25(a)(1) can be found at 7 U.S.C. S 136w(a)(1).
5. FIFRA section 25(c)(3) can be found at 7 U.S.C. S 136w(c)(3).
14
authority, the EPA has thus far limited its exercise of power
to the area of child-resistant packaging. We conclude that
this limited exercise of power is significant and seriously
undermines Leslie's Pool Mart's argument. In sum, we hold
that where, as here, a preemption provision is dependent
on government regulations, we cannot extend the reach of
that provision to areas not actively regulated by the federal
government. In other words, the EPA's failure to promulgate
packaging regulations outside the area of child-resistant
packaging is fatal to Leslie's Pool Mart's preemption
argument. When no federal packaging requirements have
been established, logic dictates that a state law packaging
requirement cannot be different from or in addition to the
absent federal requirement. We believe this decision is
consistent with the Supreme Court's recent pronouncement
on preemption in Medtronic, 518 U.S. at 470, 116 S. Ct. at
2240 (1996).6
In Medtronic, the Court analyzed the preemptive effect of
the Medical Device Amendments of 1976 on state law
claims for common-law negligence and strict liability
brought against the manufacturer of an allegedly defective
pacemaker. See id. at 474, 116 S. Ct. at 2245. The Court
concluded that defective design claims were not preempted
even though the Food and Drug Administration approved
the pacemaker. See id. at 492, 116 S. Ct. at 2254. The
Court reached its decision after noting that the Food and
Drug Administration "did not `require' Medtronic's
pacemaker to take any particular form for any particular
reason; the agency simply allowed the pacemaker, as a
device substantially equivalent to one that existed before
1976, to be marketed without running the gauntlet of the
[premarket approval] process." Id. at 494-95, 116 S. Ct. at
2254. As such, the federal requirements did not reflect "an
unambiguous conclusion" that was reached after a
deliberate weighing of competing interests. Id. at 501, 116
S. Ct. at 2258. Rather, the requirements "reflect[ed]
important but entirely generic concerns about device
_________________________________________________________________
6. Our reliance on Medtronic should not be read as implying that the
Supreme Court effectively overruled Cipollone. To the contrary, Cipollone
remains good law and provides the basic background for preemption
analysis.
15
regulation generally." Id., 116 S. Ct. at 2258. Therefore, the
recipient's manufacturing and labeling based claims were
not preempted. We read Medtronic as instructing that only
when the "Federal Government has weighed the competing
interests . . . [and] reached an unambiguous conclusion
about how those competing considerations should be
resolved in a particular cases . . . and implemented that
conclusion via a specific mandate" are general state
common-law claims preempted. Id., 116 S. Ct. at 2258.
Here, the record reveals no evidence that the EPA
considered the packaging methods at issue. Additionally, it
is undisputed that no federal requirements exist in the area
of pesticide packaging, exclusive of child-resistant
packaging. Accordingly, we will not infer that the EPA
approved the packaging for the chlorinator tablets after
weighing the competing interests and reaching an
"unambiguous conclusion." Therefore, in keeping with the
reasoning underlying the Supreme Court's decision in
Medtronic, we conclude that allowing Hawkins's defective
packaging claims would not impose state law requirements
that are in addition to or different from federal regulations.
We recognize that our holding might be viewed as
conflicting with Lowe v. Sporicidin International, 47 F.3d
124, 129 (4th Cir. 1995), Worm v. American Cyanamid Co.,
5 F.3d 744, 747 (4th Cir. 1993), and Papas v. Upjohn Co.,
985 F.2d 516, 518 (11th Cir. 1993). However, none of these
cases was decided after the Supreme Court's decision in
Medtronic. Moreover, these cases do not stand for the
blanket proposition that all packaging claims are
preempted. In Lowe, the Fourth Circuit Court of Appeals
limited its mention of defective packaging based claims to
the comments that "any state law claim that would require
the defendant to alter its EPA-approved warning label,
labeling, or packaging to avoid liability is preempted." 47
F.3d at 129. In Worm, the court focused on failure to warn
and labeling requirements, not design requirements.
Similarly, the Eleventh Circuit Court of Appeals in Papas
limited its discussion of defective packaging to labels
and/or warnings located on the package and concluded
that "to the extent [those] claims require a showing that
[the defendant's] labeling or packaging `should have
included additional, or more clearly stated, warnings, those
16
claims are pre-empted.' " 985 F.2d at 518 (quoting
Cipollone, 505 U.S. at 524, 112 S. Ct. at 2621). 7
Except for these cases that peripherally mention
preemption of packaging claims, no courts of appeal have
addressed the preemptive reach of FIFRA to allegations of
inadequate packaging. Despite Leslie's Pool Mart's
contention that all packaging claims are preempted, we
conclude that unless the EPA has specifically considered
the packaging methods for a pesticide product, the domain
preempted is the narrow area of child-resistant packaging.
As such, Hawkins's claims for defective packaging are not
preempted.
III.
The preemption provision of FIFRA, attendant EPA rules
and regulations, and the Supreme Court's decision in
Medtronic guide our analysis of whether the labeling and
packaging based claims are preempted. Hawkins's claim
that Leslie's Pool Mart failed to adequately warn about the
sudden decomposition of chlorinator tablets is expressly
preempted by EPA regulations. Further, Hawkins's claim
that Leslie's Pool Mart failed to provide appropriate
directions concerning the opening of the container falls
within the realm of pesticide labeling. Because the EPA
carefully reviewed all printed matter that accompanied the
chlorinator tablets and even mandated specific language,
allowing this claim would impose a state requirement in
addition to or different from federal labeling regulations.
In contrast, the EPA has chosen to regulate only the area
of child-resistant packaging. We are unwilling to hold that
_________________________________________________________________
7. As an alternative argument, Leslie's Pool Mart contends that although
Hawkins couches her claim as "defective packaging," it is actually a
challenge to the sufficiency of the precautionary and warning statements
contained on the labels and packaging and is therefore preempted by
FIFRA. Appellee's Br. at 24. This argument is unavailing and Leslie's
Pool Mart's interpretation of Hawkins's claim is misleading. The
Complaint specifically accuses Leslie's Pool Mart of failing to package
the
product in a manner adequate to prevent excessive decomposition,
contamination, combustion, or generation of fumes. See Compl. P 18(c);
App. 4a.
17
an area is preempted when the government has not acted
in that particular area. Therefore, we will not construe the
preemption provision of FIFRA so broadly as to preclude
Hawkins's packaging based claims. Accordingly, we affirm
that portion of the District Court's order that the labeling
claims are preempted by FIFRA and reverse as to the
packaging claims.
18
MANSMANN, Circuit Judge, dissenting.
Although I join in Parts I (except as to its affirmance as
to labeling-based claims) and II(B) of the majority's opinion
and agree with the majority's holding in Part II(A) that
claims based on labeling actually reviewed and approved by
the Environmental Protection Agency and claims based on
matters addressed therein are preempted under the Federal
Insecticide, Fungicide and Rodenticide Act, I must
nonetheless dissent from the majority's determination that
Plaintiffs-Appellants' (collectively, "Hawkins") claims based
on opening directions on the top of the package are also
preempted.
Hawkins contends that Mrs. Hawkins was injured as a
result of following allegedly faulty opening instructions
provided on the top of the container of pool chlorinator
tablets supplied by Defendant-Appellee Leslie's Pool Mart
("Leslie's").1 The majority rejects Hawkins's attempt to
distinguish these instructions from other package labeling
as "hair-splitting" because, under FIFRA,"labeling"
includes all "written, printed or graphic matter"
accompanying the product, wherever it appears on the
container.2 While it is undoubtedly true that the
instructions on the top of the package constitute labeling
and are subject to EPA regulation under FIFRA, I believe
that the majority has misconstrued Hawkins's argument.
Hawkins contends that claims based on the package top
opening instructions escape preemption not because of the
instructions' location but because they were never reviewed
and approved by the EPA.
The majority appears to have rejected Hawkins's real
argument concerning the opening instructions on factual,
rather than legal, grounds. According to the majority, "[t]he
_________________________________________________________________
1. The printed material on top of the container begins with the following:
TO OPEN:
PLACE COIN IN GROOVE -
PRY AND LIFT LID OFF
2. See Majority Opinion at p. 7 (rejecting Hawkins's "attempt[ ] to make
the distinction that her claim is based not on the label, but on
instructions placed on the lid of the container").
19
record . . . makes clear that the EPA scrutinized Leslie's
Pool Mart's proposed labels . . . ." Majority Opinion at pp.
11-12; see also Majority Opinion at p. 17 ("[T]he EPA
carefully reviewed all printed matter that accompanied the
chlorinator tablets . . . .").3 There is, however, no
demonstration in the record that the EPA reviewed and
approved the package top instructions at issue. As the
party with the burden of proof on its affirmative defense of
preemption,4 Leslie's is responsible for this deficiency in the
record. Cf. Anderson v. Liberty Lobby, Inc., 477 U.S. 242,
254 (1986) (on motion for summary judgment, evidence is
to be read in light most favorable to the non-moving party).5
Moreover, Hawkins expressly asserts that the top opening
instructions were not part of the EPA approved labeling,6
and Leslie's has not disputed this assertion.7
_________________________________________________________________
3. But see Majority Opinion at p. 12 (acknowledging that "the approved
instructions and warnings do not specify how the user is to pry the lid
off the container").
4. See, e.g., Williams v. Ashland Eng'g Co., 45 F.3d 588, 592 n.7 (1st
Cir.), cert. denied, 516 U.S. 807 (1995) (recognizing that federal
preemption is affirmative defense as to which defendant has burden of
proof).
5. See also Avirgan v. Hull, 691 F. Supp. 1357, 1368 (S.D. Fla. 1988)
(when defendant moving for summary judgment bears burden of proof
because he is asserting affirmative defense, "he must establish beyond
peradventure all of the essential elements of the . . . defense to warrant
judgment in his favor").
6. See Brief of Appellants at 12 (alleging that front and back EPA-
registered labels do not refer to opening or closing, while the package
lid
instructions - not registered with the EPA - do). Hawkins specifically
asserts that "The allegedly defective directions on the lid are neither
required nor approved under FIFRA, nor registered with EPA." Id.
7. Indeed, the documentation provided by Leslie's in its Appendix
appears to support Hawkins's assertion. See Appendix at 13a-16a
(Affidavit of Cynthia G. Watts, Leslie's Vice President and General
Counsel, attaching as Exhibit A "a true and accurate copy of the original
label for Leslie's Chlorinator Tablets 1 approved by the EPA in
August
1975"). Exhibit A consists of two pages (15a-16a)- the front and back
labels of the container, each stamped as "ACCEPTED" under FIFRA on
August 19, 1975; Appendix at 37a-39a (a portion of Exhibit C,
correspondence from the EPA during Leslie's process of modifying and
reregistering its labels, showing that Leslie's Certification with Respect
to
Citation of Data submitted in its application for registration attached
two
labels only - front and back); Appendix at 60a-62a (Exhibit E, the EPA's
Notice of Reregistration issued on June 20, 1994, which again contains
two labels only - front and back).
20
In the present posture of this case, i.e., on review of
summary judgment, I believe we must assume that the
package top instructions were not reviewed and approved
by the EPA. Thus, EPA approval gave rise to requirements
only with respect to the storage and general handling
instructions on the approved labels. Because no statutory
or regulatory provision governs the content of opening
instructions, I would hold that in the absence of agency
review and approval there is no applicable federal
"requirement" to which a state law duty as to claims for
faulty opening instructions may be different or additional,
and therefore there is no preemption under FIFRA. 8
Moreover, as the majority indicates and as Leslie's
concedes, the inclusion of unapproved labeling material -
unilaterally added by the manufacturer - is itself a violation
of FIFRA and its implementing regulations.9 State law
causes of action which provide a remedy for conduct that
violates FIFRA are not preempted. See, Worm v. American
Cyanamid Co., 5 F.3d 744, 748 (4th Cir. 1993) ("If a state
elects to recognize that a breach of a FIFRA-created duty
forms the basis for a state remedy, . . . it is permitted to do
so by 7 U.S.C. S 136v(b).").10 Cf. Medtronic, 518 U.S. at 495
_________________________________________________________________
8. See Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (holding that
preemption depends upon agency promulgation of a relevant
requirement); see also Majority Opinion at p. 6 (explaining that "pre-
emptive effect of FIFRA is dependent on agency regulations"); 7 U.S.C.
S136v(b) (prohibiting state imposed labeling or packaging requirements
that are "in addition to or different from those required under this
subchapter").
9. See Brief of Appellee at 11 (citing 7 U.S.C. S 136j(a)(2)(A) and
observing
that "Thus, no one in the chain of commerce is free to add additional
warnings, information or instructions on its own after a particular label
has been approved by the EPA."); see also Majority Opinion at p. 10
("FIFRA disallows any changes to any EPA-approved label unless the
EPA approves the change.").
10. See also Moss v. Parks Corp., 985 F.2d 736, 741 (4th Cir. 1993)
(following Worm in concluding that FHSA does not preempt claim for
non-compliance with federally mandated labeling requirements); Nat'l
Bank of Commerce of El Dorado v. Kimberly-Clark Corp., 38 F.3d 988,
993 (8th Cir. 1994) ("We agree with the conclusions of the Worm and
Moss courts and of the district courts cited above that when a statute
only preempts state requirements that are different from or in addition
to those imposed by federal law, plaintiffs may still recover under state
tort law when defendants fail to comply with federal requirements.").
21
("The presence of a damages remedy does not amount to
the additional or different `requirement' that is necessary
under the statute; rather, it merely provides another reason
for manufacturers to comply with identical existing
`requirements' under federal law.").
For these reasons, I believe that Hawkins should be
permitted on remand to pursue claims based on the
opening instructions if indeed they were not reviewed and
approved by the EPA. I express no opinion on whether
Hawkins would be able to establish that a defect in those
instructions caused her injuries. Because I conclude,
however, that FIFRA does not preempt such a claim in
these circumstances, I respectfully dissent from this aspect
of the majority's opinion.
A True Copy:
Teste:
Clerk of the United States Court of Appeals
for the Third Circuit
22