Petition for Writ of Certiorari — Netland v. Hess & Clark, Inc.
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Supreme Court, U.S.
FILED
02 219 AUG - 92002
No. 02- OFFICE OF THE GLERK
IN THE
Supreme Court of the United States
KIM NETLAND,
Petitioner,
Ve
HEss & CLARK, INC.,
‘Respondent.
On Petition for a Writ of Certiorari to the
United States Court of Appeals for the Eighth-Circuit
PETITION FOR A WRIT OF CERTIORARI
ROBERT J. FEIGH BRIAN WOLFMAN
CHRISTOPHER W. HARMONING (Counsel of Record)
GRAY, PLANT, MOoTY, ALLISON M. ZIEVE
Moorty & BENNETT, P.A. SCOTT L. NELSON
1010 West St. Germain PUBLIC CITIZEN LITIGATION
Suite 600 GROUP
St. Cloud, MN 56301 1600 20th Street, NW
(320) 252-4414 Washington, DC 20009
(202) 588-1000
Counsel for Petitioner
August 9, 2002
i
QUESTION PRESENTED
Does the Federal, Insecticide, Fungicide, and
Rodenticide Act, 7 U.S.C. § 136v, preempt state-law product-
liability claims premised on a defendant pesticide
manufacturer’s failure to warn of the pesticide’s hazards and to
properly design the pesticide?
li
TABLE OF CONTENTS
QUESTION PRESENTBOD 5.005.526.5235 obs esha i
TABLE OF AUTHORITIES ............ececcececes iv
PETITION FOR A WRIT OF CERTIORARI ........... 1
OPINED. cieic en ss l
JUMEEICTOR eeae e l
STATUTE BIVOENGD i. sooo ss 1
STATEMENT OF THE CASE ...............0.0000: 2
A. The Structure Of FIFRA. ............... 2
B. Factual Background And Proceedings Below.7
1. Kim Netland’s Injuries .............. 7
4. DOWN. 5.600524 8
3. Poocpodings Bas oc. kin ccceacntss 9
REASONS FOR GRANTING THE WRIT ............ 11
A. This Court Should Resolve The
Conflicts In Appellate Authority
On The Question Presented. ........... 11
B. The Decision Below Incorrectly
Construes The Scope Of
Preemption Under FIFRA. ............. 18
ESET ORE BTS CRETE EEE 28
PI 5k on Goin ct dawn de ve cedscvoneerscces la
Eighth Circuit Decision, March 26, 2002 .....-.- la
D. Minn. Decision, April 16,2001 .........-- lla
Eighth Circuit Order Denying Rehearing,
May 13, 2002 ........- eee cree ee eeeeees 24a
iv
TABLE OF AUTHORITIES
CASES
Ackerman v. American Cyanamid Co.,
586 N.W.2d 208 (lowa 1998) ............. 15,17
American Airlines, Inc. v. Wolens, 513 U.S. 220 (1995) .. 14
American Cyanamid Company v. Geye,
ee
2002 WL 1448843 (Tex. June 6, 2002) ............ 18
Andrus v. AgrEvo USA Co.,
7S F356 9S CG Cer. 1999) 2... ccc ccc cccse 16
Brown v. Chas. H. Lilly Co.,
985 P.2d 846 (Or. App. 1999),
rev. denied, 6 P.3d 1098 (Or. 2000) ............... 12
Chemical Specialties Manufacturers Association v. Allenby,
958 F.2d 941 (9th Cir.),
cert. denied, 506 U.S. 825 (1992) ................ 28
Cipollone v. Liggett Group, Inc.,
IOS U.S. SOG CUFSE) ow ce vescce 18, 21, 22, 23, 26, 27
Didier v. Drexel Chemical Co.,
938 P.2d 364 (Wash App. 1997) ................. 16
Eide v. E.I. Du Pont De Nemours & Co.,
542 N.W.2d 769 (S.D. 1996) ................. 15,17
Vv
Etcheverry v. Tri-Ag Services, Inc.,
76 Cal. Rptr. 2d 466 (Cal. App. 3d Dist. 1998),
rev'd, 993 P.2d 366 (Cal. 2000) .....---e eee ee eres 12
Etcheverry v. Tri-Ag Services, Inc.,
993 P.2d 366 (Cal. 2000) ....--- ese r errr 12, 18
Ferebee v. Chevron Chemical Co.,
736 F.2d 1529 (D.C. Cir. 19BA) 0 ccc cceeccce: 12, 24
Frey v. Montgomery Ward & Co.,
258 N.W.2d 782 (Minn. 1977) ..------s+sseerree 25
Geier v. American Honda Motor Co., Inc.,
529 U.S. 861 (2000) ....---eeereerrreserrrtt 14
Goodyear Atomic Corp. V. Miller, 486 U.S. 174 (1988) .. 23
Grenier v. Vermont Log Buildings, Inc.,
96 F.3d 559 (Ist Cir. 1996) ...---- essere 15, 16
Higgins v. Monsanto Co.,
862 F.Supp. 751 (N.D.N.Y. a) 17
Hillsborough County v. Automated Medical Laboratories,
Inc., 471 U.S. 707 (1985)... +--+ eee reer errr 14
Kawamata Farms v. United Agri Products,
948 P.2d 1055 (Haw. 1997) ...---- essere 18
Lee v. Madigan, 358 U.S. 228 (1959) ....--2eeeeeeees 19
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) .... 10, 14, 25
vi
National Bank of Commerce v. Dow Chemical Co.,
165 F.3d 602 (8th Cir. 1999) ............ .. 10, 15,17
New York State Pesticide Coalition v. Jorling,
874 F.2d 115 (2d Cir. 1989)..................... 28
Papas v. Upjohn Co., 985 F.2d 516 (11th Cir. 1993) .... 28
Pfeifer v. EI. Du Pont de Nemours and Co. '
606 N.W.2d 773 (Neb.), cert. dismissed,
950 US. 19D OBO) oo 5s Be A hock oboe cee 16
Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984) .... 23
Sleath v. West Mont Home Health Services, Inc..,
16 P.3d 1042 (Mont. 2000),
cert. denied sub nom., Dow AgroSciences LLC vy.
Sleath, 122 S. Ct. 40 (2001) .................. 12
Taylor Ag Industries v. Pure-Gro,
54 F.3d 555 (9th Cir. 1995) .................. 11,18
Wisconsin Public Intervenor y. Mortier,
IOs Ua OOe CN bins Sa dediince sce 3
Worm v. American Cyanamid Co.,
970 F.2d 1301 (4th Ci:. ce, LETT er ea & 11,15
Worm v. American Cyanimid Co. ;
> F356 POG GOR Cie NOPE) ons ccc bo ecce snk. 16
STATUTES
USL. § U6Q) nian 20
PU TORO ooo is. os csesnenantdavdtsckd- 27
OES BIA) 651.6 Se: 6
PELREt BARIIIIAD 5... oso ccecc ths den¥een tose bss 6
ne ne: OPE e rey eer ree 6,7
oreo Pere Ee 4
PUIGC; SOMA ... . occ ssccccseddeessovses 4
Ca, ee ore 5, 20
SRERS: ADT) . .. <0 5.000.00555 008 4, 5, 20, 25
PEROT BAMA)... 5500500 cc celeceeceess 4
Ce ane 4
sc ueveavas vedenbveenses 3
ee errr rr Pore re 4
Wie BARRE ois. oscas ss caetiti eee. 20, 25
PAR ROMINA) 55... 5.00000 seth iw seeeses. 4
PUM CIID «<5 55055 Seee nse cess 4
RO RU i a acon va tbindenne soe 6, 20
DU AN ai iki osc g hdtv iced vos 7,25
St ANON ac... Soo 5, 26
CGR 00 iii ite udbles ihe 7
FUSE CISION inne insc tind eens 6,7
TUR CI nin choad 7
ee arn ath eee 7
7 U.S.C. § 136k(bX3) ........ee eens. Nieside GDR) 7
TUR PIs... cc eee a 7
99160: 6K oi iin BURRS i, 1
PUNO CIDE fois cides hc th 3, 22
USC. 606i i passim
TUB OHIO icc c ose cssc..teees a 3
1S WO. GOON i ick ai Sad oaks ccc 3,19
UNC. CAMNiiid. ihe 3
8 OE. BTID: oo vickcenndssstoitentlas ae 27
5 OE ON 5252) eae 25
USC. 68k is... CREA
ee oy ee es rr re wee y 12
WUBL. 0 ISIN. oo. cins cscs eee 9
lowa Code Ann. § 206.32 ........ccccccccccccseces 23
Md. Agric. Code § 5-210.5 .....--eeeeeee errr ereeee 23
REGULATIONS
21 C.F.R. § 801.420 0... cece eee eee eee e eee ees 3
21 CF.R. § 801.430 .. 0... eee eee eee eee nee e reece 3
91 CFR. Part 820 .... 2. cece reece cece eee cceeeees 26
40 C.F.R. § 152.112 20... cece cere cece rece eee ees 4
40 C.F.R. § 152.168(b) ...-. cece eee eee eee eee ees 6
40 C.F.R. § 152.44 2... cece cece cere ener een eee ences 6
40 C.F.R. § 152.50(€) 0... ee eee eee e rece eee eeees 4
40 C.F.R. § 156.10(a1) «0... cece eee eee eee eees 20
40 C.F.R. § 156.10(aX2) .... ee eee cece e neers 4
40 C.F.R. § 156.10(h) 2.0... cece e ee eee erence eeees 3
40 C.F.R. § 156.1011)... eee eee ees 5, 20
40 C.F.R. § 156.10(i)(2)(iii) 6. eee 5, 20
40 C.F.R. § 156.10(i)(2)iV) . 6. eee eee eens 5
40 C.F.R. § 156.10(i( 2M Vi)... eee ee eee eee 5, 20
40 C.F.R. § 156.10(i(2M{vii) «6. eee eee eee eee 5, 20
40 CER. § 156.10) 2MX) ... eee eee e eee ee eres 5, 20
X
49 Fed. Reg. 37,960 (Sept. 26, 1984) .......-+--++> 5, 20
53 Fed. Reg. 15,952 (May 4, 1988) .....-----eeeereeee 4
60 Fed. Reg. 50,338 (Sept. 28, 1995) ....-.++eeeeeeeee 8
LEGISLATIVE HISTORY
S. Rep. No. 92-838, 92d Cong., 2d Sess. (1972),
reprinted in 1972 U.S.C.C.A.N. 3993 ....--++++++: 21
See S. Rep. No. 92-970, 92d Cong., 2d Sess. (1972),
reprinted in 1972 U.S.C.C.A.N. SE apovkent ea ees 23
MISCELLANEOUS
Stedman's Medical Dictionary (25th ed. 1990) .......--- 8
Michael K. Steenson & Peter B. Knapp,
Minnesota Practice (4% ed. 1999) .........4+0005: 25
PETITION FOR A WRIT OF CERTIORARI
Petitioner Kim Netland respectfully petitions this Court
for a writ of certiorari to review the decision of the United
States Court of Appeals for the Eighth Circuit.
OPINIONS BELOW
The Eighth Circuit’s opinion affirming the grant of
summary judgment to respondent is reported at 284 F.3d 895
(8" Cir. 2002), and is reproduced in the appendix at la. The
unreported order of the Eighth Circuit denying panel rehearing
and rehearing en banc is reproduced in the appendix at 24a.
The opinion of the United States District Court for the District
of Minnesota granting respondent’s motion for summary
judgment is reported at 140 F. Supp. 2d 1011 (D. Minn. 2001),
and is reproduced in the appendix at 1 1a.
JURISDICTION
The judgment of the Eighth Circuit was entered on
March 26, 2002. Petitioner filed a timely petition for rehearing
en banc on April 8, 2002, which the Eighth Circuit treated as a
petition for panel rehearing and for rehearing en banc and
denied on May 13, 2002. This Court has jurisdiction under 28
U.S.C. § 1254(1).
STATUTE INVOLVED
7 U.S.C. § 136v provides in pertinent part:
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
2
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.
STATEMENT OF THE CASE
Petitioner Kim Netland alleges that he has suffered
severe and permanent injuries from exposure to Bovinol, a
pesticide marketed by respondent Hess & Clark. The Eighth
Circuit held that, as a matter of federal law, petitioner is barred
from pursuing his Minnesota state-law product-liability claims.
Specifically, that court ruled that all of petitioner’s damages
claims are preempted by the Federal Insecticide, Fungicide, and
Rodenticide Act (“FIFRA”), a statute enacted to protect people
and the environment from pesticide hazards. As explained in
more detail below, this Court should grant review because the
federal and state courts are in conflict on the question presented
and because the Eighth Circuit’s decision is at odds with
FIFRA’s text and purpose.
Because an understanding of FIFRA is necessary to
evaluate the preemption issue, Part A describes the structure of
the Act. Part B explains the factual background of this case and
the decisions below.
A. The Structure Of FIFRA.
The Eighth Circuit ruled that FIFRA’s preemption
provision, 7 U.S.C. § 136v(b), preempts all of petitioner’s
damages claims. That provision can be construed properly only
3
in the context of FIFRA’s substantive requirements. FIFRA is
the federal component of a tripartite scheme in which pesticides
are regulated at the federal, state, and local levels. Wisconsin
Public Intervenor v. Mortier, 501 U.S. 597 (1990). FIFRA
requires that the federal Environmental Protection Agency
(“EPA”) make certain regulatory decisions regarding pesticides,
but the Act rarely forbids a state or local government from
supplementing EPA decisions. For example, a pesticide
generally may not be sold or used in the United States without
an EPA registration. 7 U.S.C. § 136a(a). Although state and
local governments generally may not permit the sale or use of
any pesticide not registered with EPA, they may regulate or ban
outright the sale and use of a federally registered pesticide. 7
U.S.C. § 136v(a). For instance, Minnesota may restrict the use
of dichlorvos, the active pesticide ingredient at issue in this
case, or ban its use entirely. In this way, federal pesticide
regulation establishes a floor that may be exceeded by
additional state regulations. Moreover, FIFRA gives states the
lead role in enforcing pesticide use restrictions. 7 U.S.C. §
136w-l.
Unlike federal statutes governing cigarette and
smokeless tobacco labels, FIFRA does not mandate precise
wording for pesticide labels. Cf. 15 U.S.C. §§ 1333,
4402(a)(1). Nor do EPA’s regulations dictate any specific
language to be used for the majority of pesticide labels.’
Compare 21 C.FR. §§ 801.420, .430 (FDA regulations
demanding specific label warnings for particular medical
devices). Rather, as part of an application for a pesticide
IEPA requires signal words (“warning” or “caution”) for four
toxicity categories and precise precautionary statements for three. 40
C.F.R. § 156.10(h). The warnings and precautionary statements in
connection with these categories generally must appear verbatim on
the label.
4
registration, the manufacturer submits not only health and
environmental data, but also a draft label. 7 U.S.C.
§ 136a(c)(1)(C); 40 C.F.R. § 152.50(e). EPA has made clear
that “[t]he registrant must take responsibility for quality control
of the product’s composition and for adequate labeling
describing the product, its hazards and uses.” 53 Fed. Reg.
15,952, 15,956 (May 4, 1988).
EPA will register a pesticide if the manufacturer meets
FIFRA’s requirements. 40 C.F.R. § 152.112. The statute
requires that the pesticide’s composition warrant the claims —
made for it, that its labeling and other materials comply with
FIFRA’s requirements, that it will perform its intended function
without unreasonable adverse effects on the environment, and
that it will not generally cause unreasonable adverse effects on
the environment when used in accordance with widespread and
commonly recognized practice. 7 U.S.C. § 136a(c)(5)(A)-(D).
As to the product label, FIFRA and EPA establish
certain minimum requirements: Pesticide labels must contain
an EPA registration number, the registrant’s name and address,
the pesticide’s name, brand, or trademark, the net weight or
other measure of content, the use classification of the pesticide,
an ingredient statement, directions for use, a warning or
cautionary statement that is adequate to protect health and the
environment, and, for pesticides that are highly toxic to
humans, specific signal words and a description of appropriate
first-aid treatment. 7 U.S.C. § 136(q)(1)(D),(G) & (2)(A)-(D);
40 C.F.R. § 156.10(a)(1); see supra note 1. Any information
required under FIFRA to be on a pesticide’s label must be
prominently and conspicuously placed in comparison to other
labeling information that is not federally mandated. 7 U.S.C.
§ 136(q)(1)(E); 40 C.F.R. § 156.10(a)(2).
With respect to directions for use, FIFRA contains only
5
very general requirements: Pesticide labels must contain
directions necessary to effectuate the product’s intended
purpose and adequate to protect against fraud, personal injury,
and unreasonable health and environmental effects. 7 US.C.
§ 136(q\(1)(F); 40 C.F.R. § 156.10(i(1)@). Thus, EPA
regulations provide that directions for use must specifically
identify the crops or animals to be treated, the dosage rate
associated with each site and pest, instructions for dilution,
other application instructions needed to obtain effective results,
and “[a]ny limitations or restrictions on use to prevent
unreasonable adverse effects.” Id.
§ 156.10(i)(2)(iii),(iv),(vi),(vii), (x).
A registrant’s use of the label submitted with its
registration application does not necessarily satisfy the
registrant’s FIFRA (or other) obligations. To the contrary, a
pesticide is misbranded if, notwithstanding EPA’s registration
of the pesticide and acceptance of the label, it fails to contain
whatever additional warnings are necessary to protect against
unreasonable adverse health and environmental effects. 7
U.S.C. § 136(q)(1)(F)-(G). Indeed, EPA has recognized that
“(flor liability reasons, companies often voluntarily provide
additional information on the label, particularly in the area of
precautionary statements.” 49 Fed. Reg. 37,960, 37,971 (Sept.
26, 1984). Neither FIFRA nor EPA regulations prohibits the
inclusion of additional label information or warnings, provided
that the information does not violate any specific statutory or
regulatory requirement. Jd.
Because EPA depends so heavily on manufacturer
submissions, FIFRA imposes continuing obligations on
registrants to submit complete, up-to-date information to EPA.
Registrants have ongoing obligations to provide to EPA all
factual information that they have regarding unreasonable
adverse environmental effects, 7 U.S.C. § 136d(a)(2), and
6
ongoing obligations to ensure that their labeling complies with
FIFRA’s requirements. 7 U.S.C. §§ 136(q)(1), 136j(a)(1)(E).
Thus, FIFRA anticipates that a manufacturer may have to make
labeling changes after registration of its product. FIFRA
provides that “[i]f the labeling or formulation for a pesticide is
changed, the registration shall be amended to reflect such
change if the Administrator determines that the change will not
violate any provision of this [Act].” 7 U.S.C. § 136a(f)(1). In
other words, the onus for deciding whether a label change is
necessary falls on the registrant, which must draft the revised
label and submit it to EPA for review. 40 C.F.R. § 152.44.
Although section 136v(b) preempts state “labeling or
packaging” requirements “in addition to or different from”
FIFRA requirements, the submitted labeling is limited to “the
written, printed, or graphic matter on, or attached to, the
pesticide or device or any of its containers or wrappers,” or
other detached written matter accompanying the pesticide, such
as an instructional booklet, that serves the same purpose as a
label. 7 U.S.C. § 136(p)(1) & (2)(A). The Act expressly leaves
manufacturers of registered pesticides many other unrestricted
means of conveying information to purchasers and users. For
example, EPA’s regulations identify the following means of
conveying information: “[b]rochures, pamphlets, circulars and
similar material offered to purchasers at the point of sale or by
direct mail; [n]Jewspapers, magazines, newsletters and other
material in circulation or available to the public; [b]roadcast
media such as radio and television; [t]elephone advertising; and
[billboards and posters.” 40 C.F.R. § 152.168(b). Unlike
labeling, manufacturers do not submit such materials to EPA
for review and approval as part of the registration process.
If a pesticide label contains false or misleading ~
statements or lacks directions for use and warnings that are
adequate to protect health and the environment, the pesticide is
7
misbranded. 7 US.C. §§ 136(qX(1), 136j(a)(1)(©),
136j(a)(2)(C) & (M). In an administrative action to cancel a
pesticide’s registration or to seize or bar use or sale, EPA
registration is not a defense. 7 U.S.C. § 136a(f)(2) (although if
no cancellation proceedings are in effect, registration is prima
facie evidence of compliance with FIFRA’s registration
provisions). Violations warranting EPA action include labeling
that lacks required information and products that cause
unreasonable environmental effects even when used as directed
on the label. 7 U.S.C. §§ 136) & 136k(b)(3); see also id. § 1361
(authorizing civil and criminal penalties for FIFRA violations).
FIFRA does not provide a remedy for individuals who
sustain injuries from pesticide use, and thus state-law damages
actions provide the only means of compensation for such
injuries.
B. Factual Background And Proceedings Below.
1. Kim Netland’s Injuries. In the summer of 1994,
petitioner Kim Netland was 17 years old and preparing to enter
his senior year in high school. That summer, petitioner sprayed
respondent’s pesticide, Bovinol, to control flies on his family’s
three horses. Petitioner’s mother, Margaret Netland, purchased
the Bovinol at a local feed store and gas station because she
wanted to minimize the risk of injury to her son from the
horses’ unpredictable behavior when they were annoyed by
flies. Mrs. Netland asked the sales clerk whether Bovinol
would work on horses, and he said that it would. Using a spray
bottle prepared by his mother, Kim sprayed Bovinol on his
horses three to four times per week for six weeks. He would
spray each horse with eight to 10 squirts and then ride one of
the horses. Kim did not wear any protective clothing or
equipment when he used the pesticide and did not read the label
(though his mother had read it when she prepared the spray
8
bottle). He believes that Bovinol got on his skin while riding
the horses because his clothes were damp after riding. See Pet.
App. 2a. He also inhaled the Bovinol spray. See, e.g., Dep. of
Harry S. Jacob, M.D., at 61, 67.
In mid-August 1994, Kim started high school football
practice and became very fatigued and began bruising easily.
On September 28, 1994, he collapsed on his way to school and
was taken to his family physician, who realized that he had a
severe blood problem and transferred him to a hematologist in
Fargo, North Dakota. The hematologist diagnosed Kim with
acquired aplastic anemia, a defective functioning of the bone
marrow in which the body fails to produce all types of blood
cells. Pet. App. 3a; see Stedman's Medical Dictionary 72 (25"
ed. 1990). Over the next year, Kim took large doses of steroids
and had approximately 35 blood transfusions. As a result of the
treatments, one of his hips had to be replaced with a prosthetic
hip and the other hip is at risk of failure. Pet. App. 3a.
2. Bovinol. Bovinol is registered with the EPA and its
label was approved by the EPA. Its active ingredient is
dichlorvos, an organophosphate whose purpose is to interfere
with neural transmission. Dichlorvos can be absorbed into the
human body by ingestion, by inhalation, and through the skin.
Pet. App. 3a. Despite its EPA registration, the dangers of
dichlorvos have not gone unnoticed. In 1988, the EPA notified
registrants that it was instituting a “special review” of
dichlorvos. Plaintiff's Statement of Material Disputed Facts,
35-36. In doing so, the agency stated that exposure to
dichlorvos may pose serious adverse health risks to individuals.
Id. 937. In 1995, the EPA preliminarily proposed to cancel use
of dichlorvos-containing products in all residential areas and to
prohibit all hand-held applications to farm livestock (except
poultry). Id. | 43; see 60 Fed. Reg. 50,338, 50,369 (Sept. 28,
1995). Numerous peer-reviewed articles link dichlorvos to
9
autoimmune disease, including aplastic anemia. See, e.g., Aff.
of Harry S. Jacob, M.D., 15 (listing and describing articles).
The Bovinol label indicates that the product may be
used on cattle, in animal buildings, including specifically horse
barns, and for certain outdoor uses (such as on picnic grounds,
refuse areas, and around service stations). The label does not
expressly state that Bovinol may be used on horses or that it
should not be used on horses, although it does state that it
should not be used on dogs. See Pet. App. 3a-4a.
3. Proceedings Below. On July 1, 1999, petitioner
filed a three-count complaint in the United States District Court
for the District of Minnesota alleging that respondent (1) was
strictly liable because Bovinol was defectively designed and
unreasonably dangerous, including specifically that it exposes
users unreasonably to immune system damage such as that
caused by aplastic anemia, Complaint, f¥ 12-13; (2) failed to
warn users of Bovinol’s dangerous characteristics, id. 4 15; and
(3) was negligent and breached its warranty that Bovinol was
safe for its ordinary purposes by failing to use reasonable care
in the design, manufacture, and sale of the product. Id. ¥ 18.
See generally Pet. App. 4a-Sa. The district court’s jurisdiction
was premised on diversity of citizenship under 28 U.S.C. §
1332(aX(1). Complaint, { 1.
In January 2001, respondent moved for summary
judgment, asserting that FIFRA preempts all of petitioner’s
state-law claims. Respondent also sought summary judgment
on the ground that petitioner had not offered proof of causation
linking Bovinol to his injuries and it simultaneously moved to
exclude the testimony of several of petitioner’s experts.
The district court granted respondent’s motion for
summary judgment solely on preemption grounds. Pet. App.
10
lla. The district court concluded that each of petitioner's
claims, even those based on defective design of the product, is
an attack on Bovinol’s labeling and thus preempted by FIFRA’s
preemption provision, 7 U.S.C. § 136v(b), which, as discussed
above, bars states from imposing certain types of pesticide
labeling and packaging requirements. See Pet. App. 19a-22a.
The Eighth Circuit affirmed. The court relied on its
prior decision in National Bank of Commerce v. Dow Chemical
Co., 165 F.3d 602 (8 Cir. 1999), which held that “FIFRA
preempts state common law claims for ‘inadequate labeling or
failure to warn.” Pet. App. 6a (quoting National Bank of
Commerce, 165 F.3d at 608). Petitioner acknowledged the
Eighth Circuit’s precedent, but urged the panel to reverse
course in light of this Court’s decision in Medtronic, Inc. v.
Lohr, 518 U.S. 470 (1996), the views of the United States on
the issue, and recent precedent from state appellate courts in
Montana and Oregon. The panel refused to consider those
arguments because of its rule that circuit precedent may only be
overruled by a decision of the full court sitting en banc. Pet.
App. 7a. The panel also held that petitioner’s design-defect
claim is preempted because it constitutes “an impermissible
challenge to the pesticide’s label.” Pet. App. 9a.
2The district court did not reach the causation and
admissibility issues. Petitioner’s experts testified that, given the
chronology of events, petitioner’s injuries, the medical literature
linking dichlorvos and other organophosphates with autoimmune
disease, including aplastic anemia, and the absence of other causal
explanations, the only plausible explanation for petitioner’s aplastic
anemia was his exposure to Bovinol. See, e.g., Aff. of Harry S.
Jacob, M.D., #f G.1- G.11; Aff. of Richard L. Lipsey, Ph.D., Fj 25-
27. Although respondent disagreed, these issues have never been
decided in this case; preemption was the only issue decided below
and is the only issue before this Court.
11
Petitioner sought rehearing en banc, asking the full court
to reconsider its prior FIFRA preemption holdings on the basis
of more recent precedent. The petition was denied on May 13,
2002.
REASONS FOR GRANTING THE WRIT
The petition should be granted for two reasons. First,
this Court should grant review to resolve conflicts in appellate
authority regarding the question presented: whether FIFRA
preempts state-law damages claims premised on 4a
manufacturer’s failure to warn of a pesticide’s hazards and on
defects in the pesticide’s design. Second, the majority of
decisions on the question presented, including the decision
below, have seriously erred in interpreting FIFRA and its
preemption provision, and have thereby eliminated injured —
persons’ rights to compensation under state law contrary to
Congressional intent.
A. This Court Should Resolve The Conflicts In
Appellate Authority On The Question Presented.
1. Petitioner acknowledges that a large majority of
FIFRA preemption decisions, including decisions of most of the
federal circuit courts, hold that state damages actions are among
the "requirements" within the preemptive reach of 7 U.S.C. §
136v(b). See, e.g., Taylor Ag Industries v. Pure-Gro, 54 F.3d
555 (9th Cir. 1995); Worm v. American Cyanamid Co., 970
F.2d 1301 (4th Cir. 1992); Pet. App. 6a (citing Eighth Circuit
decisions to that effect). Those decisions also hold that
damages actions alleging that the defendant failed to warn of a
pesticide’s dangers are preempted by 7 U.S.C. § 136v(b), under
which states are prohibited from issuing certain “requirements”
concerning pesticide “labeling or packaging” that are “in
addition to or different from” FIFRA requirements.
12
Several decisions, however, directly conflict with the
majority view, and hold that state damages actions are not
“requirements” within the meaning of section 136v(b). Those
rulings include the early decision of the District of Columbia
Circuit in Ferebee v. Chevron Chemical Co., 736 F.2d 1529
(D.C. Cir. 1984), and the relatively recent decisions of the
Montana Supreme Court in Sleath v. West Mont Home Health
Services, Inc., 16 P.3d 1042 (Mont. 2000), cert. denied sub
nom., Dow AgroSciences LLC v. Sleath, 122 S. Ct. 40 (2001),
and the Oregon Court of Appeals in Brown v. Chas. H. Lilly
Co., 985 P.2d 846 (Or. App. 1999), rev. denied, 6 P.3d 1098
(Or. 2000). In addition, the California Court of Appeal held in
1998 that FIFRA does not expressly preempt state-law damages
actions. Etcheverry v. Tri-Ag Services, Inc., 76 Cal. Rptr.2d
466 (Cal. App. 3d Dist. 1998). Although the California
Supreme Court reversed that decision, it did so by a narrow
four-to-three margin, over two forceful dissents. See
Etcheverry v. Tri-Ag Services, Inc., 993 P.2d 366 (Cal. 2000).
Petitioner believes that the minority position better comports
with the text of section 136v, the structure of FIFRA, and
Congressional intent. See Part B infra. For present purposes,
however, the question is not which position is correct, but that
there is a division among the courts under which state-law
damages claims may (or may not) go forward based solely on
geographical happenstance. This Court should grant certiorari
to establish uniformity on the question presented.
In Sleath, this Court denied review despite the clear conflict
in appellate authority. However, as the respondent in Sleath had
argued, the Montana state courts had not issued a “final judgment”
and thus this Court did not have jurisdiction under 28 U.S.C. §
1257(a). See Respondent’s Brief in Opposition, at 3-11, in Dow
AgroSciences LLC, et al. v. Sleath, et al., No. 00-1674 (U.S. filed
July 3, 2001).
13
The need for review is underscored by the position taken
by the EPA, which has stated that section 136v(b) does not
preempt any state-law damages action. The agency has filed
amicus curiae briefs in private appellate litigation to express its
concern that the courts have misinterpreted federal law and
regulations and FIFRA’s legislative history. The agency’s most
comprehensive brief — signed by the EPA’s general counsel as
well as by an Assistant Attorney General — was filed in the
Etcheverry litigation in California, in which the Justice
Department also presented oral argument. See Brief Amicus
Curiae for the United States in Support of Plaintiffs-Appellants,
in Etcheverry v. Tri-Ag Service, Inc., No. $072524 (Cal. S. Ct.
filed March 1999) (hereafter “U.S. Etcheverry Br.”). Copies of
that brief have been lodged with this Court, as have copies of
the EPA/Justice Department brief in a case from the Fifth
Circuit, which takes the same position. See Brief Amicus
Curiae for the United States in Support of Appellants in Hart
v. Bayer Corp., No. 98-60496 (Sth Cir. filed March 1999).
The EPA’s Etcheverry brief explains why the text,
structure, and history of FIFRA do not support preemption of
state damages claims and why the EPA has an interest in
assuring that the courts do not undermine the ability of state tort
systems to provide compensation to growers whose crops have
been damaged by pesticides and individuals who have sustained
personal injuries from pesticides. U.S. Etcheverry Br. at 8-33.
The United States summarized its views as follows:
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 damages
actions. When section 136v(b) was enacted in
id
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 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 would have intended to
deprive injured persons of all means of relief.
Id. at 5-6.
The EPA’s position is important because this Court has
sometimes given weight to an agency’s views of the preemptive
scope of the statute that it is charged with implementing, both
as expressed in agency regulations, see Medtronic, 518 U.S. at
496-97; id. at 505-06 (opinion of Breyer, J.); Hillsborough
County v. Automated Medical Laboratories, Inc., 471 U.S. 707,
714-15 (1985), and in the form of briefs filed in private
litigation. See Geier v. American Honda Motor Co., Inc., 529
U.S. 861, 883 (2000); American Airlines, Inc. v. Wolens, 513
U.S. 220, 232-34 (1995). The EPA’s position is not, of course,
dispositive on the merits and should only be accorded the
weight that its persuasive power deserves, but it provides a
further compelling reason to grant review. The majority view
in the lower courts effectively abrogates traditional state
damages remedies based on an interpretation of a federal statute
that is flatly at odds with the interpretation of the agency
authorized by Congress to enforce that statute. That situation
15
should not persist without this Court’s blessing.
2. The courts are also in tension with one another over
the scope of FIFRA preemption regarding state-law damages
claims premised on duties other than a failure to warn, such as
design defect, manufacturing defect, and breach of warranty.
Those kinds of claims allege that the pesticide product itself is
defective in some way — for instance, that it is unreasonably
dangerous because its risks outweigh its benefits or because
safer and more effective alternative prod icts were available.
Under those theories of liability, the fact that the pesticide was
marketed in a defective condition requires the manufacturer to
compensate people injured by it, whether or not the product was
accompanied by the appropriate warnings. The courts generally
have recognized that such claims are not preempted by FIFRA
because 7 U.S.C. § 136v(b) concerns only the “labeling or
packaging” of pesticides. See, ¢.g,, National Bank of
Commerce v. Dow Chemical Co., 165 F.3d 602, 609 (8" Cir.
1999) (“defectively manufactured or designed products properly
labeled under FIFRA may still be subject to state regulation in
the form of common law or other claims”); Grenier v. Vermont
Log Bldgs., Inc., 96 F.3d 559, 564 (1* Cir. 1996) (FIFRA does
not expressly preempt design and manufacturing claims); Worm
v. American Cyanamid Co., 970 F.2d 1301, 1307 (4" Cir. 1992)
(FIFRA does not preempt “state-imposed standard of care
relating to product design, manufacture, testing, and the like”);
Ackerman v. American Cyanamid Co., 586 N.W.2d 208, 215
(Iowa 1998) (FIFRA does not preempt negligent design and
testing claims); Eide v. E.J. Du Pont De Nemours & Co., 542
N.W.2d 769, 772 (S.D. 1996) (FIFRA does not preempt
defective design, manufacture, and production claims).
Courts have nevertheless held some claims preempted,
even if pleaded as defect claims, on the ground that they are
“disguised” failure-to-warn claims that, in effect, challenge the
16
warnings on the product label. See, e.g., Grenier, 96 F.3d at
565 (referring to manufacturing and design defect claim as
“disguised labeling claim”); Worm v. American Cyanimid Co.,
5 F.3d 744, 747-48 (4% Cir. 1993); Pfeifer v. E.I. Du Pont de
Nemours and Co., 606 N.W.2d 773, 778 (Neb.), cert.
dismissed, 530 U.S. 1300 (2000); Pet. App. 8a. In applying that
standard, a number of courts, including the Eighth Circuit
below, have asked “whether in seeking to avoid liability for any
error, would the manufacturer choose to alter the label or the
product.” Pet. App. 8a (citing Worm, 5 F.3d at 747-48); see
also, e.g., Andrus v. AgrEvo USA Co., 178 F.3d 395, 399 (5™
Cir. 1999); Didier v. Drexel Chemical Co., 938 P.2d 364, 369
(Wash App. 1997) (“the test for preemption is whether a
manufacturer, in seeking to avoid liability, would reasonably
choose to alter the product or the label”).
That is not the proper preemption inquiry for two related
reasons. First, when a plaintiff seeks recovery on a product-
defect theory, there is no preemption under the plain language
of 7 U.S.C. § 136v(b), and the question whether liability should
be imposed is solely a matter of state law. For instance,
petitioner’s first claim for relief alleges that Bovinol “was
defectively designed and unreasonably dangerous for its use, in
that it exposes users to a foreseeable risk of permanently
damaging the user’s immune system, including exposing the
user to acquiring aplastic anemia.” Complaint, { 12. That
allegation, which has nothing to do with whether the product
was accompanied by appropriate warnings, poses a question
solely under state law; it does not raise a preemption issue
because it does not challenge the product’s “labeling or
packaging.” Second, the question whether the defendant
manufacturer would or would not choose to change its label is
irrelevant to the preemption question. To be sure, in response
to a jury finding that a pesticide was defectively designed, the
manufacturer might include additional warnings on its label,
17
rather than modifying or ceasing to sell the product (or doing
nothing at all), but that does not alter the nature of the
plaintiffs claim or the basis of the jury’s decision. Both are
based solely on the product’s defective design.‘
In contrast to courts that ask- whether the defendant
would alter its label in response to a finding of liability, other
courts look to the underlying nature of the plaintiff's claims and
hold that allegations of liability on bases other than a failure to
warn are not preempted by FIFRA, without asking how the
defendant might react to a jury verdict in favor of the plaintiff.
See, e.g., National Bank of Commerce, 165 F.3d at 609;
Ackerman, 586 N.W.2d at 214 (noting the Worm test, but
allowing design and testing claims to go forward if they
challenge the production of the production and not its labeling);
Eide, 542 N.W.2d at 772; Higgins v. Monsanto Co., 862
F.Supp. 751, 757-60 (N.D.N.Y. 1994). A grant of review
‘For this reason, the Eighth Circuit’s reliance on the
testimony of one of petitioner’s experts that Bovinol could have been
used safely if the label warnings had been appropriate, Pet. App. 9a,
is irrelevant to the preemption question, even though it might be
relevant as a matter of state law to at least some of petitioner's
claims. That same expert also repeatedly stated that the product was
defective, in particular because safer and more effective products
were available. Dep. of Richard L. Lipsey, Ph.D, at 257-61; see also
Aff. of Richard L. Lipsey, Ph.D., § 20 (noting that because of
dangers of dichlorvos his former company had substituted “more
effective and safer pesticide chemicals for the Dichlorvos”). That
testimony underscores the fact that petitioner's design-defect claim
is not a “disguised” attack on the product’s label, see Pet. App. 8a,
but rather is a claim that the product should not have been marketed
at all.
18
would resolve this confusion in the case law as well.°
B. The Decision Below Incorrectly Construes The
Scope Of Preemption Under FIFRA.
1. The decision below, like the decisions of most other
courts to have addressed the scope of FIFRA preemption, is
flawed because it erroneously holds that FIFRA’s express
preemption provision applies to state-law damages claims. The
courts that have found preemption of damages claims under 7
U.S.C. § 136v(b) have relied almost exclusively on a rote
application of this Court’s decision in Cipollone v. Liggett
Group, Inc., 505 U.S. 504 (1992). Cipollone held that the word
“requirement,” as used in the preemption provision of the
Public Health Cigarette Smoking Act of 1969, could include
common-law claims for damages, including claims for failure
to warn. 505 U.S. at 520-24. The courts have erroneously
‘The appellate courts are also divided on a related FIFRA
preemption question: whether FIFRA preempts a pesticide user’s
state-law failure-to-warn claim that the product was not effective for
its intended use, e.g., a claim by a farmer alleging that a FIFRA-
registered pesticide’s ineffectiveness resulted in crop damage.
Compare American Cyanamid Company v. Geye,__ S.W.3d __.,
2002 WL 1448843 (Tex. June 6, 2002) (no preemption of crop-
damage claims because EPA does not review product labels for
efficacy and noting conflict); Kawamata Farms v. United Agri
Prods., 948 P.2d 1055, 1076-77 (Haw. 1997) (some such claims not
preempted and citing other authority), with Etcheverry, 993 P.2d 366
(crop-damage claims preempted); Taylor Ag Industries v. Pure-Gro,
54 F.3d 555 (9th Cir. 1995) (same); see also U.S. Etcheverry Br. at
33-42 (explaining that efficacy claims are not preempted by FIFRA
because, among other reasons, EPA does not conduct efficacy review
for pesticides). A grant of certiorari here would, if resolved in
petitioner’s favor, necessarily resolve the conflict in the crop-damage
cases.
19
concluded that this holding — concerning the use of a particular
word in one statute enacted by Congress in 1969 — necessarily
means that “requirement” as used by Congress in 1972 in
FIFRA’s preemption provision reaches common-law damages
claims. A fair reading of FIFRA’s preemption provision,
however, reveals that Congress did not intend preemption of
damages claims at all. See US. Etcheverry Br. at 9
(acknowledging that in some contexts “‘requirements’ may
encompass obligations imposed through common law damages
actions[,]” and explaining that 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
[and] does not include state damages actions”); see also Lee v.
Madigan, 358 U.S. 228, 231 (1959) (“Only mischief can result
if those terms [appearing in different statutes] are given one
meaning regardless of the statutory context.”).
In Cipollone, the statute at issue set forth the specific
warning to be included on each label, that is, Congress itself
drafted the required warning language. See 15 U.S.C. § 1333
(stating exact warnings to appear on cigarette packages and
advertisements). It was Congress’ very specific and unusual
action — and only that specific action — that the preemption
provision sought to protect from conflicting state regulation.
Congress had dictated the warnings, and thus the Act preempted
challenges to the adequacy of those warnings.
By contrast, with regard to preemption under FIFRA,
petitioner’s common-law claims in no way challenge a
congressional determination, or even an agency determination,
that the label should state certain cautionary language and no
other. Quite the contrary, the label is drafted by the registrant,
i.e., the pesticide manufacturer. Although FIFRA specifies
warning “signal words” and precautionary statements for certain
20
toxicity categories, those warnings have nothing to do with the
types of warnings that might have prevented petitioner’s -
injuries here: for instance, that the product not be used on
horses or that it not be applied with a spray bottle. And even
where specific warnings are required, pesticide manufacturers
must include additional warnings or cautionary statements on
the labels as are needed to adequately protect health and the
environment. 7 U.S.C. § 136(q\(1)(F), (G); 40 C.F.R. §§
156.10(a)(1); 156.10(i)(1)(i). Whether or not one of the
specific toxicity warnings is required, the label must state "[a]ny
limitations or restrictions on use to prevent unreasonable
adverse effects." 40 C.F.R. § 156.10(i)(2)(x). FIFRA places
full responsibility on the manufacturer to provide adequate
warnings and directions for use on its product’s label. 7 U.S.C.
§ 136a(c)(5). FIFRA prescribes only general requirements for
pesticide labels and leaves it to the manufacturer to devise a
label that will adequately protect against adverse effects,
including damage to people, animals, and crops. Jd. §§ 136(),
136a(c)(5); 40 C.F.R. § 156.10(i)(2)(iii),(vi),(vii),(x). If a
registrant learns of inadequacies in the label after the EPA has
registered its pesticide, the registrant must promptly inform the
EPA of the inadequacies and revise its label to provide adequate
warnings and directions for use. 7 U.S.C. § 136a(f)(1).
Accordingly, respondent was not only free at any time to
provide information to purchasers and users that would have
enabled petitioner to avoid injury, it was obligated under FIFRA
to do so.
Indeed, one manifestation of FIFRA’s registrant-driven
scheme of labeling, as EPA has acknowledged, is that, “[flor
liability reasons, companies often voluntarily provide additional
information on the label, particularly in the area of
precautionary statements.” 49 Fed. Reg. 37,960, 37,971 (Sept.
26, 1984). The understanding that the federal regulatory system
and state-law tort compensation would co-exist makes sense in
21
the FIFRA context where registrants draft pesticide labels and
are subject to general, continuing duties to provide adequate
warnings.
2. The legislative history of the provision at issue in
Cipollone and the one at issue here also differ dramatically. In
Cipollone, the Court focused on a comparison of the 1969
preemption provision with its predecessor from the 1965
Cigarette Act. 505 U.S. at 520-23. Whereas the 1965 version
preempted only “statements,” the 1969 version preempted
“requirements or prohibitions.” The Court determined that the
change in language must have some significance, and, on that
basis, found that common-law claims could come within the
scope of the preemption provision of the 1969 Act. 505 U.S. at
522-23. The Court’s opinion makes clear that the dispositive
factor was the contrast between the 1965 and 1969 provisions,
not simply the use of the word “requirement” in the 1969
provision. Indeed, although the 1965 Act preempted any
“statement relating to smoking and health . . . required” in
cigarette advertising, the Court held that it did not preempt any
common-law claims. /d. at 518-20.
Here, in contrast, the legislative history of FIFRA
provides no evidence that Congress intended to preempt state
damages actions. Aside from technical changes, section
136v(b) has not been amended since its enactment in 1972 and
nothing analogous to the interpretive guide provided by the
amendments to the 1965 Cigarette Act is present in the history
of section 136v(b). Furthermore, FIFRA’s extensive legislative
history does not mention preemption of state damages claims.
See, e.g., S. Rep. No. 92-838, 92d Cong., 2d Sess. (1972),
reprinted in 1972 U.S.C.C.AN. 3993; see also U.S. Etcheverry
Br. at 22-31 (explaining that FIFRA’s legislative history
involving 25 days of hearings and numerous committee reports
does not even hint at intent to preempt any state damages
22
actions). As the United States has noted, the conclusion that
Congress did not enact “tort reform” in 1972 is underscored by
the fact that, in nearly a century of case law prior to FIFRA’s
passage, the courts uniformly held that pesticide manufacturers
had a duty to warn under state law. Jd. at 19-22.
3. Another fundamental problem with the lower courts’
FIFRA preemption analyses premised on Cipollone is that they
overlook the placement of subsection 136v(b). That provision
is part of a section entitled “Authority of States,” which —
with an anti-preemption clause:
A State may regulate the sale or use of any
federally registered pesticide or device in the
State, but only to the extent the regulation does
not permit any sale or use prohibited by this
subchapter.
7 U.S.C. § 136v(a). The preemption clause, which follows
immediately, 7 U.S.C. § 136v(b), begins with the words “Such
State,” thus tying the preemption provision to the activities of
the state discussed in section 136v(a), quoted above. Section
136v(a) addresses states’ general authority to “regulate” the sale
and use of pesticides, not the states’ authority to award
compensation through damages remedies. As this Court has
stated, the use of the word “regulate” refers not to common-law
damages remedies, but rather to positive-law enactments of
legislative and regulatory bodies. See Cipollone, 505 U.S. at
519, 523 (in 1965 Cigarette Act, “‘regulation’ most naturally
refers to positive enactments” of legislatures and agencies, “not
to common-law damages actions”). It follows, therefore, from
the structure and wording of section 136v, that subsection (b)
also does not encompass damages liability because it refers to
states only in their regulatory, not adjudicatory, capacity.
23
This conclusion is consistent with other decisions of this
Court, which have noted that Congress can, and does, rationally
distinguish state positive law and common law, preempting the
former but not the latter. See Cipollone, 505 U.S. at 518 (“there
is no general, inherent conflict between [express] federal
preemption of state [regulatory] warning requirements and the
continued vitality of state common-law damages actions”);
Goodyear Atomic Corp. v. Miller, 486 U.S. 174, 185-86 (1988)
(“The effects of direct regulation ... are significantly more
intrusive than the incidental effects of such an award provision.
...Congress may reasonably determine that incidental regulatory
pressure is acceptable, whereas direct regulatory authority is
not.”); Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 256
(1984) (despite federal preemption of state regulatory authority,
state-law punitive damages awards not preempted even though
“regulatory in the sense that a nuclear plant will be threatened
with damages liability if it does not conform to state
standards”).
US.C.C.AN. 4092, 4111-12 (“Local governments could,
however, prohibit or restrict the sale or use of pesticides within
their jurisdiction.”). Indeed, states have done so. See, ¢.g.,
Iowa Code Ann. § 206.32 (banning sale, purchase, application,
and use of chlordane); Md. Agric. Code § 5-210.5 (restricting
24
use of various pesticides). A state could require that pesticide
manufacturers submit results of safety and efficacy testing to a
state environmental agency. Or a state could require that
pesticide manufacturers include warnings about risks to people
or the environment in any advertising within that state.
Indeed, a state could require that manufacturers, as a
condition to marketing in that state, compensate consumers for
damage to people, land, or crops caused by their products. The
state could do so without imposing any requirement on product
labels. Such a requirement would reflect a state’s decision that,
' “if it must abide by EPA’s determination that a label is
adequate, [the state] will nonetheless require manufacturers to
bear the risk of any injuries that could have been prevented had
[the state] been allowed to require a more detailed label or had
[the company] persuaded EPA that a more comprehensive label
was needed.” Ferebee, 736 F.2d at 1541. Or the state might
decide, based on the principle of strict liability, that
manufacturers should be held liable for damage caused by their
products, without regard to fault. Under either rationale, a
plaintiff's verdict would not require the manufacturer to change
its label. It would only require, consistent with subsection (a)’s
grant of authority to states to regulate pesticide “use,” that the
manufacturer pay damages associated with the use of its
product. The federal labeling requirements and the state use
requirement would not conflict, and the state requirement would
not run afoul of section 136v(b)’s proscription against “any
requirements for labeling or packaging in addition to or
different from those required” under FIFRA.
4. Even if it could be said that the state-law
“requirements” referred to in section 136v(b) encompass duties
that give rise to liability for damages, section 136v(b) would not
preempt petitioner’s claims because those claims would not be
based on duties in addition to or different from the duties
25
imposed by FIFRA. As discussed above, FIFRA requires
pesticide registrants to ensure that their labels and directions for
use are adequate to protect against unreasonable adverse effects
to health and the environment. 7 U.S.C. § 136a(c)(5).
Pesticides that lack adequate warning labels are misbranded,
even if EPA has approved the label. Jd. §§ 136(q)(1)(G),
136a(f)(2).
Petitioner alleges that respondent “failed to adequately
warn the user of the dangerous characteristics” of Bovinol.
Complaint, 15. Minnesota common law requires that sellers
provide adequate instructions for safe use and warn of dangers
inherent in improper use of the product. See, e.g., Frey v.
Montgomery Ward & Co., 258 N.W. 2d 782, 787 (Minn. 1977);
see also 4A Michael K. Steenson & Peter B. Knapp, Minnesota
Practice, CIVJIG 75.25, at 126-34 (4" ed. 1999) (standard jury
instruction on duty to warn). The common-law duties on which
those allegations were based thus mimic the manufacturer’s
duties under FIFRA, which places the burden of testing,
identifying, and labeling as to risks to people and the
environment on the registrant. To the extent that the claims
alleged here are based on duties that parallel requirements
imposed under FIFRA, see Medtronic, 518 USS. at 496-97, they
are not “in addition to or different from” FIFRA’s requirements
and, thus, are not preempted.
This conclusion is consistent with the Court’s analysis
in Medtronic. Looking to the general language of the
preemption provision of the federal Medical Device
Amendments (“MDA”), 21 U.S.C. § 360k(a) — which is
similar to the language of 7 U.S.C. § 136v(b) — the Court
identified an “overarching concer that pre-emption occur only
where a particular state requirement threatens to interfere with
a specific federal interest.” Medtronic, 518 U.S. at 500. More
specifically, in considering negligent manufacturing and failure-
26
to-warn claims, Medtronic made “a careful comparison between
the allegedly pre-empting federal requirement and the allegedly
pre-empted state requirement to determine whether they fall
within the intended pre-emptive scope of the statute and
regulations.” Jd. at 500. The Court concluded that the federal
manufacturing and labeling requirements were “important but
entirely generic” regulatory concerns, not the type of concerns
that section 360k(a) was designed to protect from potentially
contradictory state requirements. Similarly, the state common-
law duties at issue in Medtronic were general duties, not
developed specifically with respect to devices. Thus, the Court
found that those duties were not the kind of requirements that
Congress or the FDA feared might impede the FDA’s
implementation and enforcement of the MDA. Id. at 500-01.
Like the good manufacturing requirements and general
labeling requirements at issue in Medtronic, FIFRA’s labeling
requirements are general. (Indeed, the FDA’s good
manufacturing requirements are more comprehensive than the
EPA’s labeling regulations, see 21 C.F.R. Part 820, yet
Medtronic found that the MDA did not preempt manufacturing
claims.) The registrant, not the EPA, devises a label in
accordance with FIFRA’s general standards. And, as noted
earlier, in contrast to the statutorily prescribed warnings of the
1969 Cigarette Act, see Cipollone 505 U.S. at 508, pesticide
registrants are obliged under FIFRA to update their labels to
protect against adverse health and environmental effects. See
7 U.S.C. § 136d(a)(2).
5. Even if section 136v(b) preempts common-law
claims challenging the adequacy of a pesticide’s label, it does
not preempt failure-to-warn claims based on the theory that a
defendant should have warned through means other than
labeling. This conclusion follows directly from the language of
section 136v(b), which only preempts state requirements “for
27
labeling or packaging,” and from the Court’s ruling in
Cipollone.
The 1969 Act at issue in Cipollone preempted state-law
requirements “with respect to advertising or promotion.” 15
U.S.C. § 1334(b). Cipollone held that, although the 1969 Act
preempts failure-to-warn claims based on advertising or
promotion, claims based on the theory that the defendants
should have warned through other means were not preempted.
505 U.S. at 524-25 (failure-to-warn claim not preempted to
extent based on “actions unrelated to advertising or
promotion”).
Under FIFRA, “labeling” does not include oral
statements, point-of-sale signs or pamphlets, or advertising and
promotional material. See 7 U.S.C. § 136(p) (defining “label”
and “labeling”).° Thus, consistent with Cipollone, petitioner’s
claims cannot be preempted to the extent that they challenge
respondent’s failure to advise about the risks of Bovinol
7 U.S.C. § 136(p), provides in full:
Label and labeling.—
(1) Label.—The term "label" means the written, printed, or
graphic matter on, or attached to, the pesticide or device or any of its
containers or wrappers.
(2) Labeling —The term "labeling" means all labels and all
other written, printed, or graphic matter—
(A) accompanying the pesticide or device at any time; or
(B) to which reference is made on the label or in literature
accompanying the pesticide or device, except to current official
publications of the Environmental Protection Agency, the United
State Departments of Agriculture and Interior, the Department of
Health and Human Services, State experiment stations, State
agricultural colleges, and other similar Federal or State institutions
or agencies authorized by law to conduct research in the field of
28
through non-label means. That conclusion is consistent with
decisions of two circuits that have held that even direct state
regulation of communications by pesticide manufacturers are
not preempted by section 136v(b) where the state regulations
affirmatively require communications by means other than
labeling. See Chemical Specialties Manufacturers Ass'n v.
Allenby, 958 F.2d 941, 946 (9" Cir.) (“labeling” under FIFRA
does not include point-of-sale signs required under California's
Proposition 65), cert. denied, 506 U.S. 825 (1992); New York
State Pesticide Coalition v. Jorling, 874 F.2d 115, 119 (2d Cir.
1989) (“labeling” under FIFRA does not include posting of
signs to warn of impending use of dangerous chemicals,
required by New York law). Contra Papas v. Upjohn Co., 985
F.2d 516, 519 (11" Cir. 1993). The decision below is erroneous
for this reason as well.’
CONCLUSION
For the reasons stated above, the petition for a writ of
certiorari should be granted.
Respectfully submitted,
Brian Wolfman
(Counsel of Record)
Allison M. Zieve
Scott L. Nelson
Public Citizen Litigation Group
1600 20" Street, N.W.
Washington, D.C. 20009
(202) 588-1000
"For the reasons stated above (at 16-17), the court below also
erred in granting summary judgment as to petitioner’s product-defect
claims.
August 9, 2002
29
Robert J. Feigh
Christopher W. Harmoning
Gray, Plant, Mooty, Mooty
& Bennett, P.A.
1010 West St. Germain, Suite 600
St. Cloud, MN 56301
(320) 252-4414
Attorneys for Petitioners
la
United States Court of Appeals
for the Eighth Circuit
No. 01-2182
Kim Netland,
Appellant,
V.
Hess & Clark, Inc.,
Appellee.
Appeal from the United States
District Court for.the
- District of Minnesota.
Submitted: December 14, 2001
- Filed: March 26, 2002
Before McMILLIAN, JOHN R. GIBSON, and MAGILL,
Circuit Judges.
MAGILL, Circuit Judge.
Kim Netland brings this action against Hess & Clark,
Inc. (“Hess”), the manufacturer of the pesticide KenAg Bovinol
2a
(“Bovinol”), claiming damages for injury resulting from
Netland’s use of Bovinol on his horses. The district court!
granted Hess’s motion for summary judgment holding that
Netland’s claims are preempted by the Federal Insecticide,
Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. § 136 et
seq,, because they are an impermissible challenge to Bovinol’s
label. For the reasons stated below, we affirm.
I.
Netland, in the summer of 1994, following his junior
year of high school, used Bovinol to control flies on his
family’s three horses. Margaret Netland, Netland’s mother,
purchased the pesticide in June 1994, from a local retail feed
store for the purpose of minimizing the risk of injury to Netland
from the unpredictable behavior of horses due to the annoyance
of flies. The sales clerk informed Mrs. Netland that the
pesticide would work for horses. Prior to giving Netland the
pesticide, Mrs. Netland read the warning label and wore plastic
gloves to pour the pesticide into a bathroom cleaner spray
bottle. Thereafter, Netland sprayed the pesticide on his horses
three to four times a week over a six-week period. Prior to
riding, Netland sprayed each horse with eight to ten squirts of
the pesticide and would normally ride the horse within a minute
after spraying it with the pesticide. Netland did not wear any
protective clothing or equipment when he used the pesticide
and did not read the Bovinol label. Netland believes that he got
the pesticide on his skin by touching the horses because his
clothes were damp after riding.
\'The Honorable Ann D. Montgomery, United States
District Judge for the District of Minnesota.
3a
In mid-August 1994, Netland began high school football
practice and began to experience fatigue and bruising. On
September 28, 1994, Netland collapsed on his way to school
and was taken to his family physician, Dr. Thabes. Realizing
that Netland had a severe blood problem, Dr. Thabes transferred
Netland to a hematologist in Fargo, North Dakota, where he
was diagnosed with acquired aplastic anemia.” Over the next
year, Netland’s treatment consisted of large doses of steroids
and approximately thirty-five blood transfusions. As a result of
this treatment, one of Netland’s hips failed and was replaced
with a prosthesis. Netland’s other hip is also at risk.
Bovinol is a registered insecticide with the
Environmental Protection Agency (“EPA”) under FIFRA and
carries an EPA-approved label. Dichlorvos (“DDVP”), the
active ingredient in Bovinol, is an organophosphate, which is
absorbed into the human body by ingestion, inhalation, and skin
absorption. The Bovinol label describes the approved and
lawful uses of the pesticide, including use on cattle, in animal
buildings (horse barns, shelter sheds, dairy barns, milk sheds),
in poultry houses, dog kennels, and outdoor uses (picnic
grounds, loading docks, outdoor latrines, parking areas, refuse
areas, around service stations, open-air drive-ins, outdoor ice
cream stands, and garbage collection and disposal areas). The
label does not expressly state that Bovinol may be used on
horses. The Bovinol label also contains a precautionary
2 Aplastic anemia is an anemia characterized by defective
function of the bone marrow, such that there is a failure to
properly form all types of blood cells.
ty be eR NERY tre Pr
4a
instruction and warning.’
On July 1, 1999, Netland filed a three-count complaint
against Hess alleging (1) strict liability in that Bovinol was
*Specifically, the warning contained on the Bovinol
label states:
PRECAUTIONARY STATEMENTS
HAZARDOUS TO HUMANS
AND DOMESTIC ANIMALS
WARNING
May be fatal if swallowed, inhaled or absorbed
through the skin or eyes. Rapidly absorbed
through skin and eyes. Do not get into eyes, on
skin or on clothing. Do not breathe vapor or
spray mist. Wash thoroughly with soap and
water after handling and before eating or
smoking. Do not contaminate feed, water,
foodstuffs, milk or milking utensils. Wear clean
natural rubber gloves, protective clothing, and
goggles, faceshield or equivalent. Wear a
pesticide respirator jointly approved by the
Mining Enforcement and Safety Administration
(MESA) and the National Institute for
Occupational Safety and Health (NIOSH) under
the provisions of 30 CFR Part 11. Wear
impervious footwear or protective covers as
shoes, boots and other articles made of leather
or similar porous materials may be dangerously
contaminated.
5a
defectively designed and unreasonably dangerous, (2) failure to
warn users of the dangerous characteristics inherent in the
Bovinol product, and (3) negligence and breach of warranty in
that Hess failed to use reasonable care in the design,
manufacture, and sale of Bovinol. On January 19, 2001, Hess
moved for summary judgment asserting federal preemption
under FIFRA and also that Netland failed to offer admissible
proof of causation. Hess also filed a motion to exclude the
opinion testimony of several of Netland’s expert witnesses.
The district court granted Hess’s motion for summary
judgment without reaching the issue of causation or the
admissibility of the testimony of Netland’s expert witnesses. In
particular, the district court found that each of Netland’s claims
is essentially an attack on Bovinol’s EPA-approved label, and
therefore is preempted by FIFRA. Netland v, Hess & Clark,
Inc., 140 F. Supp. 2d 1011, 1017-19 (D. Minn. 2001). Netland
timely appealed.
Il.
A grant of summary judgment is reviewed de novo.
Nat’] Bank of Commerce v, Dow Chem. Co,, 165 F.3d 602, 606
(8th Cir. 1999). Summary judgment is appropriate if, after
viewing the facts and all reasonable inferences in the light most
favorable to the nonmoving party, here Netland, the record
demonstrates that there is no genuine issue as to any material
fact and that the moving party is entitled to judgment as a
matter of law. Id, See also Fed. R. Civ. P. 56(c); Celotex Corp.
v. Catrett, 477 U.S. 317, 322-23 (1986). In addition, preemption
is a question of law reviewed de novo. Nat’] Bank, 165 F.3d at
607.
A.
Under FIFRA, all pesticides sold in the United States
must be registered with the EPA. See 7 U.S.C. § 136a(a)
(1994). When applying for registration, manufacturers must
submit draft label language addressing a number of topics
6a
including ingredients, directions for use, and any information of
which they “are aware regarding unreasonable adverse effects
of the pesticide on man or the environment.” 40 C.F.R. §
152.50(f)(3) (2001). Prior to registering a pesticide, the EPA
must find that its labeling complies with FIFRA’s requirements,
such as a determination that the pesticide is not misbranded,
and that when the pesticide is used in accordance with its
labeling that it will perform its intended function without and
unreasonable adverse effect on the environment. See 7 U.S.C.
§ 136a(c)(5) (1994). Finally, FIFRA contains an express.
preemption clause, which provides that a state “shall not
impose or continue in effect any requirements for labeling . . .
in addition to or different from those required under this
subchapter.” 7 U.S.C. § 136v(b) (1994).
In National Bank, we held that once a label is approved,
FIFRA expressly provides a defense, arising from preemption,
against certain state law claims. 165 F.3d at 608. Specifically,
we held that FIFRA preempts state common law claims for
“inadequate labeling or failure to warn.” Id, (quoting Bice v,
Leslie’s Poolmart, Inc., 39 F.3d 887, 888 (8th Cir. 1994)).
Moreover, we stated: —
It is immaterial whether an inadequate labeling
or failure to warn claim is brought under a
negligence or products liability theory. If a state
law claim is premised on inadequate labeling or
a failure to warn, the impact of allowing the
claim would be to impose an additional or
different requirement for the label or packaging.
Id. (footnote omitted). Common law claims for breach of
express warranty also are preempted by FIFRA. Id. (citing
Welchert v. Am. Cyanamid, Inc., 59 F.3d 69, 73 (8th Cir.
1995)).
Netland concedes that our decision in National Bank
preempts his state law claims based on labeling or packaging
requirements in addition to or different from those required
Ta
under FIFRA. Nevertheless, Netland asks us to revisit our prior
decisions insofar as they hold that state law claims based on
failure to warn are preempted by FIFRA. Netland maintains that
a revisiting is necessitated by the Supreme Court’s decision in
Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and an amicus
curiae brief submitted by the United States Department of
Justice, representing the EPA, filed in Etcheverry v. Tri-Ag
Serv.. Inc., 993 P.2d 366 (Cal. 2000), which articulated the
government’s position that FIFRA does not preempt any state
law theories of liability, including failure to warn claims that
implicate pesticide labels. In addition, Netland draws our
attention to two recent state court decisions finding failure to
warn claims not preempted in light of these recent
developments. See
16 P.3d 1042, 1053 (Mont. 2000); Brown v. Chas. H. Lilly Co.,
985 P.2d 846, 853 (Ore. 1999). The law is well established,
however, that this court may not overrule one of its prior
decisions unless it does so en banc. Minn. Citizens Concerned
for Life v. FEC, 113 F.3d 129, 131 (8" Cir. 1997). Thus, until
modified or overruled by the court en banc, National Bank is
the law of this circuit. Accordingly, Netland’s failure to warn
and breach of warranty claims are preempted by FIFRA.‘
4At least two of our sister circuits have concluded that
the established interpretation of the FIFRA preemption clause
is unchanged by the Supreme Court’s decision in Medtronic,
Inc. v. Lobr, 518 U.S. 470 (1996). See, ¢.g., Grenier v, Vi. Log
Bidgs., Inc,, 96 F.3d 559, 563 (ist Cir. 1996) (“It. . . is now
settled by the Supreme Court in Cipollone [v. Liggett Group,
Inc., 505 U.S. 504 (1992)] and Lohr, that ‘requirements’ in this
context presumptively includes state causes of action as well as
laws and regulations.”); Hawkins v. Leslie’s Pool Mart, Inc.,
184 F.3d 244, 250 (3d Cir. 1999) (“even assuming that FIFRA
is analogous to the [MDA] addressed by the Supreme Court in
- Medtronic, contrary to [plaintiffs] assertions, we do not read
that case as standing for the overarching premise that tort
claims fall outside ‘preempted requirements’.”).
ee
8a
B.
Next, Netland contends that his claims alleging strict
liability and negligence fall outside the state law causes of
action that are preempted by FIFRA. He argues that FIFRA
preempts only state law claims that directly challenge the
product label; therefore, FIFRA does not preempt his claims
that Bovinol was defectively designed and unreasonably
dangerous. The district court disagreed because it concluded
that Netland failed to produce any evidence of errors in the
manufacture of Bovinol other than the adequacy of the warning.
Netland, 140 F. Supp. 2d at 1017. Moreover, the district court
found that Netland’s liability expert, Dr. Lipsey, testified that
Bovinol is safe if properly used and distributed with appropriate
labeling, and therefore, Netland failed to produce any evidence
demonstrating that Bovinol is unreasonably dangerous. Id, at
1017-18. Thus, the district court concluded that Netland’s
claims alleging strict liability and negligence were nothing more
than a challenge to Bovinol’s label for failure to warn against
using the pesticide on horses before riding them. Id, at 1017-19.
On appeal, Netland argues that the district court’s
decision was in error because his complaint asserts a claim for
defective design, and therefore is not preempted by FIFRA. We
agree with Netland that defectively manufactured or designed
products properly labeled under FIFRA remain subject to state
regulation, in the form of common law or other claims.
Nevertheless, “if the state law claim is premised on inadequate
labeling or a failure to warn,” which results in the imposition of
additional or different labeling requirements, the claim is
nonetheless preempted regardless of the guise under which the
claim is presented. Nat’] Bank, 165 F.3d at 608. Thus, our task
is to determine whether Netland’s claims are essentially a
challenge to Bovinol’s label or the overall design of the
pesticide. To guide our analysis, we must ask whether in
seeking to avoid liability for any error, would the manufacturer
choose to alter the label or the product. See Worm v. Am.
Cyanamid Co,, 5 F.3d 744, 747-48 (4th Cir. 1993) (line
between mislabeling and defective design may not always be
9a
clear but may be resolved by asking whether manufacturer
would alter the product or the label). After careful review of the
entire record, we agree with the district court and hold that
Netland’s claims are preempted by FIFRA because they are an
impermissible challenge to the pesticide’s label.
Netland contends that his claim is not preempted based
on Dr. Lipsey’s expert testimony that Bovinol was defectively
designed and unreasonably dangerous because it contained
DDVP as one of the active ingredients in its formula. In
particular, Netland asserts that Dr. Lipsey testified that a safer
and more effective alternative exists to DDVP, that being
pyrethrum. We disagree with Netland’s characterization of Dr.
Lipsey’s testimony. Dr. Lipsey did not testify that the inclusion
of DDVP makes Bovinol defective or unreasonably dangerous.
In fact, Dr. Lipsey testified that Bovinol is an EPA-registered
and approved product that can be safely used under appropriate
circumstances. Dr. Lipsey’s testimony merely indicated that Dr.
Lipsey personally sprays his horses prior to riding them with
pyrethrum, that he personally recommends pyrethrum for
horses, and that most people use pyrethrum for horses. It is
illogical to conclude that Bovinol is defectively designed or
unreasonably dangerous because a substitute product might be
the preferred pesticide for horses.
Dr. Lipsey’s remaining complaints with Bovinol all
directly challenge the pesticide’s label. First, Dr. Lipsey stated
“{a] prudent manufacturer would have put the fact that
[Bovinol] can affect bone marrow; that this . . . can cause
leukemia [on the label].”° Dr. Lipsey’s second complaint is that
the label is not specific about the parameters of using the
product on horses. In particular, Dr. Lipsey testified, “[the label
does not say] ‘Do not apply to horses.’ They said okay to horse
*Elaborating on this point, Dr. Lipsey further testified
that the label should include information about chronic health
effects so that the user could decide whether they wanted to use
it and could handle it in a safe manner.
10a
barns and okay to pests that get on horses, but they didn’t
exclude horses, so you can assume that you can apply it to
horses.” Dr. Lipsey’s final complaint with Bovinol also
concerns the pesticide’s label, but in this instance, he opines
that the label’s instructions to the user to use personal
protective equipment is “overkill,” and the label should merely
state “avoid breathing the vapors” or “avoid getting it on your
skin.” While Dr. Lipsey’s complaints with Bovinol may indeed
create genuine issues of fact, they nonetheless are insufficient
to avoid summary judgment because they fail to offer any
evidence of a design defect unrelated to the label. Thus,
Netland’s claims are preempted by FIFRA.
iil.
Because we find that the premise of each of Netland’s
claims is Bovinol’s label and is therefore preempted by FIFRA,
we affirm the well-reasoned and thorough opinion of the district
court granting summary judgment in favor of Hess.
A true copy.
Attest:
CLERK, U.S. COURT OF APPEALS, EIGHTH CIRCUIT.
lla
United States District Court,
D. Minnesota.
Kim NETLAND, Plaintiff,
v.
HESS & CLARK, INC., Defendant.
No. CIV.99-1032 ADM/RLE.
April 16, 2001.
MEMORANDUM OPINION AND ORDER
MONTGOMERY, District Judge.
I. INTRODUCTION
On February 1, 2001, the undersigned United States
District Judge heard Defendant Hess & Clark’s Motion for
Summary Judgment [Doc. No. 31]. Defendant seeks summary
judgment on Plaintiff Kim Netland’s claims for: (1) “strict
liability”; (2) “failure to warn”; and (3) “negligence and breach
of warranty.” Compl. 44 12, 15,18. Defendant argues that
the Federal Insecticide, Fungicide, and Rodenticide Act
(“FIFRA”), 7 U.S.C. § 136 ef seg., preempts all common law
actions against manufacturers of EPA-registered pesticides that
are based upon claims directly or indirectly relating to labeling,
including any failure to warn theory. For the reasons set forth
below, Defendant’s motion is granted.
II. BACKGROUND’
Plaintiff Kim Netland (“Netland”) alleges that he
developed aplastic anemia after using Defendant Hess &
Clark’s (“Defendant”) insecticide product, KenAg Bovinol
(“Bovinol”),” to spray his horses. Defendant’s Statement oi
Material Undisputed Facts (“SMF”) J 12-18, 24-26. Bovinol
is an organophosphate insecticide, registered with the United
States Environmental Protection Agency (“EPA”). SMF ¥ {
5-11. The product label describes all of its approved uses,
none of which include use on horses. SMF 9 J 19-21. Under
FIFRA, it is a violation of federal law to use a pesticide product
in a manner inconsistent with its labeling. See 7 U.S.C. §
136(ee). The Bovinol label lists various warnings and
precautions, including instructions to use specific personal
protective gear when spraying Bovinol. SMF { 22. Part of
the label reads:
Hazardous to Humans and Domestic Animals
Warning
May be fatal if swallowed, inhaled or absorbed
through the skin or eyes. Rapidly absorbed
through skin and eyes. Do not get into eyes, on
' In passing on a motion for summary judgment, the
court must review the facts in the light most favorable to the
party opposing the motion, and must give that party the benefit
of all reasonable inferences to be drawn from the evidence.
See Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475
U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986).
? Bovinol’s active ingredient is Dichlorvos, also known
as DDVP or Vapona. SMF ¥ 4.
13a
skin or on clothing. Do not breathe vapor or
spray mist. Wash thoroughly with soap. and
water after handling and before eating or
smoking. Do not contaminate feed, water,
foodstuffs, milk or milking utensils.
Wear clean natural rubber gloves, protective
clothing, and goggles, faceshield or equivalent.
Wear a pesticide respirator jointly approved by
the Mining Enforcement and Safety
Administration (MESA) and the National
Institute for Occupational Safety and Health
(NIOSH) under the provisions of 30 C.F.R. Part
11. Wear impervious footwear or protective
covers as shoes, boots and other articles made of
leather or similar porous materials may be
dangerously contaminated.
Bovinol Label, SMF 4 22.
In June 1994, Margaret Netland, Netland’s mother,
purchased Bovinol from a Bagley, Minnesota retailer, Marty
Brothers. SMF J 12. Margaret Netland purchased Bovinol
for her son’s use in keeping flies away from his horses. SMF §
§ 12-13. She was concerned about the risk of injury to
Netland if the horses reacted unpredictably to the flies. M.
Netland Dep., at 71. After reading the label, Margaret Netland,
using plastic gloves for protection, poured the Bovinol into a
“Lysol Basin, Tub & Tile” cleaner spray bottle. SMF 9 15-
17. She kept the spray bottle next to the large container of
Bovinol in the barn and told Netland to use the spray in the
bottle. Jd. Margaret Netland refilled the spray bottle at least
once, if not twice. M. Netland Dep., at 73. Netland admits he
did not read the Bovinol label. SMF ¥ 23.
14a
Netland alleges that he used Bovinol approximately
three to four times per week for a period of approximately six
weeks in the summer of 1994. SMF 4 24. During each use,
Netland testified that he sprayed one or two horses, with eight
to ten squirts from the spray bottle for each horse. Jd. Netland
rode the horses within minutes after spraying them. Netland
believes Bovinol contacted his skin as a result of his touching
the horses and the fact that his clothing was damp with Bovinol
after riding the horses. See K. Netland Dep., at 87-92, 94.
In late August and September of 1994, Netland began
feeling more fatigued each week. Jd. at 123-24. On September
28, 1994, Netland collapsed and was taken to his family
physician, Dr. Thabes, who referred him to a hematologist, Dr.
Kobrinsky. See Thabes Dep., at 18, 28, 41. Netland was
diagnosed with acquired aplastic anemia.’ SMF § 25.
Netland’s Complaint alleges theories of “strict liability,”
“failure to warn,” and “negligence and breach of implied
warranty.” Compl. § § 12, 15, 18. Netland’s liability expert is
Dr. Richard L. Lipsey. SMF § 37. Dr. Lipsey opined “the
only possible cause of [Netland’s] aplastic anemia has to be the
[Bovinol] product. Because he had a strong spatial correlation
[sic]. | He was there, he used it, he had no protective
equipment.” SMF § 45. Dr. Lipsey testified that the
Bovinol’s label was insufficient and that a prudent
manufacturer should have warned users to “avoid breathing the
vapors,” and “avoid getting it on your skin.” SMF 4 57. Dr.
Lipsey further testified that Bovinol is safe as long as it is used
3 Aplastic anemia is an anemia characterized by
defective function of the bone marrow, such that there is a
failure to properly form all types of blood cells.
15a
properly and is distributed with appropriate warnings so that the
user avoids breathing the spray mist. SMF J {J 56-61.
III. DISCUSSION
A. Summary Judgment Standard
Federal Rule of Civil Procedure 56(c) provides that
summary judgment shall issue “if the pleadings, depositions,
answers to interrogatories, and admissions on file, together with
the affidavits, if any, show that there is no genuine issue as to
any material fact and that the moving party is entitled to a
judgment as a matter of law.” A genuine issue of material fact
does not exist “[w]here the record taken as a whole could not
lead a rational trier of fact to find for the non-moving party.”
Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475
U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). The
movant has the burden of showing that no genuine issue of
material fact exists. See Celotex Corp. v. Catrett, 477 U.S.
317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).
Once the movant meets its Rule 56(c) burden, the non-
movant “must set forth specific facts showing that there is a
genuine issue for trial.” Fed.R.Civ.P. 56(e). “The mere
existence of a scintilla of evidence in support of the [non-
movant’s] position will be insufficient; there must be evidence
on which the jury could reasonably find for the [non-movant].”
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252, 106 S.Ct.
2505, 91 L.Ed.2d 202 (1986). When weighing the evidence
offered by the parties on a motion for summary judgment, this
Court must review the evidence and all inferences drawn from
that evidence in the light most favorable to the party opposing
the motion. See Matsushita, 475 U.S. at 587, 106 S.Ct. 1348.
The nonmovant, however, “must do more than simply show
16a
that there is some metaphysical doubt as to the material facts.”
Id. at 586, 106 S.Ct. 1348.
B. Preemption
Preemption is based on the Supremacy Clause of
Article VI of the United States Constitution. U.S. Const. art.
VI, cl. 2 (“This Constitution, and the Laws of the 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 Supremacy
Clause invalidates state laws that interfere with or are contrary
to federal law. Wisconsin Public Intervenor v. Mortier, 501
U.S. 597, 604, 111 S.Ct. 2476, 115 L.Ed.2d 532 (1991);
Hillsborough County v. Automated Medical Labs., Inc., 471
U.S. 707, 712, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985);
‘Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 6 L.Ed. 23 (1824).
Such state laws may include legislative enactments and
executive pronouncements, i.e. positive law, as well as common
law claims recognized by state courts. See Cipollone v. Liggett
Group, Inc., 505 U.S. 504, 521-22, 112 S.Ct. 2608, 120
L.Ed.2d 407 (1992).* Given Congress’ power to preempt state
laws with federal regulation, the question is whether Congress
‘ The plurality’s judgment in Cipollone has been
embraced fully by the Supreme Court. See CSX Transp., Inc.
v. Easterwood, 507 U.S. 658, 113 S.Ct. 1732, 1737, 123
L.Ed.2d 387 (1993); Freightliner Corp. v. Myrick, 514 U.S.
280, 115 S.Ct. 1483, 131 L.Ed.2d 385 (1995) (acknowledging
the possibility that tort claims may be impliedly preempted even
if not expressly preempted under an applicable statutory
provision).
17a
intended such federal regulation to supercede state laws.
“Congress’ 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. 2608. In the case at
hand, FIFRA contains an express preemption clause. See 7
U.S.C. § 136v(b).
FIFRA creates a comprehensive scheme for the
regulation of the sale, labeling, packaging, and use of
pesticides. Ruckelshaus v. Monsanto Co., 467 U.S. 986, 991-
92, 104 S.Ct. 2862, 81 L.Ed.2d 815 (1984); Welchert v.
American Cyanamid, Inc., 59 F.3d 69, 71 (8th Cir.1995).
FIFRA requires that all pesticides to be sold and distributed in
the United States must be registered with the EPA. See 7 U.S.C.
§ 136a(a). FIFRA establishes a complex process of EPA
review that results in the approval of a pesticide label under
which the product may be marketed. Welchert, 59 F.3d at 71.
Manufacturers must propose draft label language addressing a
various number of topics, including ingredients, directions for
use, and adverse effects. Jd; 7 U.S.C. § 136a(c). The EPA’s
rules and regulations set forth specific labeling requirements.
See 40 C.F.R. § 156.10. The final label must be approved by
the EPA prior to registration. See 40 C.F.R. § 156.10(a)(6).
Under FIFRA, the EPA may not register a pesticide or
approve its labeling unless, inter alia, it finds that the product
“will perform its intended function without unreasonable
adverse effects on the environment [and] when used in
accordance with widespread and commonly recognized
practice, it will not generally cause unreasonable adverse effects
on the environment.” 7 U.S.C. § 136a(c)(5). As defined in
FIFRA, the term “environment” includes “water, air, land, and
all plants and man and other animals living therein.” 7 U.S.C.
§ 136(j) (emphasis added). Thus, the EPA must conclude that
18a
the product and its labeling are satisfactory to protect human
safety when the product is used in accordance with the
approved directions for use on the label.
Once a label is approved, FIFRA expressly provides for
a defense, based upon preemption, against certain state law
claims. National Bank of Commerce v. Dow Chemical Co., 165
F.3d 602, 608 (8th Cir.1999). The preemptive provision of
FIFRA states:
§ 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. § 136v.
Thus, 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. § 136v(b). The term “requirements” in § 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.
2240; Cipollone, 505 U.S. at 521, 112 S.Ct. 2608 (concluding
that the term “requirements” sweeps broadly and “easily
encompasses] 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
19a
Diego Bldg. Trades Council v. Garmon, 359 U.S. 236, 247, 79
S.Ct. 773, 3 L.Ed.2d 775 (1959))). The legislative history
confirms that Congress intended § 136v(b) to completely
preempt state law with regard to labeling and packaging. See
H.R. Rep. 92-511, 92d Cong., 1st Sess. 16 (1971). Indeed, it
was Congress’ intent that § 136v(b) preempt “any State
labeling or packaging requirements differing from such
requirements under the Act.” S. Rep. 92-838, 92d Cong., 2d
Sess., reprinted in 1972 U.S.C.C.A.N. at 4021. At all times
relevant to this case, the parties agree that the Bovinol product
was properly registered with the EPA pursuant to FIFRA and
carried the label approved by the EPA. SMF § 11.
1. “Failure to warn” claim
Netland alleges a failure to warn claim. State common
law claims for “inadequate labeling” or “failure to warn” are
preempted by FIFRA. National Bank of Commerce, 165 F.3d at
608. “It is immaterial whether an inadequate labeling or failure
to warn claim is brought under a negligence or products liability
theory.” Jd. Such claims attempt to impose liability for the lack
of warning labels “in addition to or different from those
required” by the EPA. See Welchert, 59 F.3d at 73 (“Where
Congress has so clearly put pesticide labeling regulation in the
hands of the EPA, [a] claim challenging the accuracy of the
[pesticide] 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. In such case,
state court consideration of the label statement would be an
‘additional’ requirement.”) (internal citations omitted).
Netland’s failure to warn claim is preempted by FIFRA.
20a
2. “Negligence and breach of warranty” claim
Netland claims “negligence and breach of warranty,”
alleging that Defendant “failed to use reasonable care in the
design, manufacture, and sale of the [Bovinol] product.”
Compl. 4 18. To the extent that this claim also is predicated
on failure to warn and inadequate labeling, it too is preempted
by FIFRA. National Bank of Commerce, 165 F.3d at 608. A
claim of negligence for defective manufacture or design, which
does not directly attack the EPA-approved labeling, may escape
FIFRA’s preemption. Jd. at 609. However, merely alleging that
a claim is a design or manufacturing defect claim does not
automatically avoid FIFRA’s express preemption clause. See
Grenier v. Vermont Log Bldgs., Inc., 96 F.3d 559, 564 (ist
Cir.1996). Netland’s liability expert, Dr. Lipsey, testified that
Bovinol is safe as long as it is used properly and is distributed
with appropriate labeling. Netland has not produced any
evidence of errors in the manufacture of Bovinol by Defendant
other than the adequacy of the warning. See National Bank of
Commerce, 165 F.3d at 609 (holding that plaintiff's defective
manufacturing or design claims fail because they lack sufficient
evidentiary support to avoid summary judgment). Netland’s
only elaborated theory under the negligence claim is that
Bovinol was defectively designed or manufactured because it
was foreseeable that it would be used on horses and it was unfit
for this use. This semantically reworked claim is essentially
nothing more than a repeat salvo on the label’s failure to warn
against use on horses before riding. See Johnson v. Monsanto
Chemical Co., 129 F.Supp.2d 189, 194-95 (N.D.N.Y.2001)
(“Claims of misdesign or mismanufacture which the Court
regards as thinly veiled labeling or failure to warn claims will
not stand.”). FIFRA preempts Netland’s “negligence” claim.
See Grenier, 96 F.3d at 564-65.
2la
Netland’s breach of an express warranty claim is
necessarily based on the EPA- approved label. The Eighth
Circuit has held that FIFRA preempts common law claims for
breach of express warranty. See Welchert, 59 F.3d at 73.
Similarly, FIFRA preempts Netland’s breach of an implied
warranty claim. National Bank of Commerce, 165 F.3d at 608.
To allow Netland’s warranty claims would result in additional
or different requirements for the Bovinol label or package. Jd.
Summary judgment is thus appropriate for Netland’s warranty
claims. |
3. “Strict liability” claim
To establish a strict liability claim, Minnesota law
requires a plaintiff to prove that: (1) the defendant’s product
was in a defective condition unreasonably dangerous for its
intended use, (2) the defect existed when the product left the
defendant’s control, and (3)the defect was the proximate cause
of the injury sustained. Marcon v. Kmart Corp., 573 N.W.2d
728, 730 (Minn.App.1998) (citing Bilotta v. Kelley Co., 346
N.W.2d 616, 623 n. 3 (Minn.1984)). In determining whether a
product is defective, Minnesota courts apply a “reasonable care
balancing test.” Drager by Gutzman v. Aluminum Industries
Corp., 495 N.W.2d 879, 882 (Minn.App.1993). A
manufacturer is obligated to exercise a degree of care in its
design that avoids any unreasonable risk of harm to anyone who
is likely to be exposed to the danger when the product is used
in the manner for which it was intended or in a manner that was
reasonably foreseeable. Id.
Netland cannot elude FIFRA’s preemption provision
simply by alleging a strict liability claim. See Grenier, 96 F.3d
at 564. The evidence must be examined to determine whether
Netland’s strict liability claim is premised on something other
22a
than the label and whether the claim indirectly attempts to
impose label requirements in addition to or different than those
required by the EPA. See id. ; National Bank of Commerce, 165
F.3d at 608-09. Netland argues that because the Bovinol label
indicates an intended use for the control of insects in livestock
barns, including horse barns, Netland’s use of Bovinol on his
horses before he rode them was intended or reasonably
foreseeable. See Mem. In Oppos., at 9. However, Netland’s
liability expert testified that Bovinol is safe as long as it is used
properly and is distributed with appropriate labeling.
Moreover, as required by FIFRA, the EPA determined that
Bovinol would perform its intended function without
unreasonable adverse effects on humans and, when used in
accordance with widespread and commonly recognized
practice, it would not generally cause unreasonable adverse
effects on humans. See 7 U.S.C. § § 136a(c)(5), 136().
Because Netland fails to present evidence showing that Bovinol
was unreasonably dangerous, Netland cannot meet the first
element of a strict liability claim. See National Bank of
Commerce, 165 F.3d at 609 (finding plaintiff did not present
evidence proving that the product was unreasonably dangerous
and whether the defective condition proximately caused the
harm).
Essentially, Netland’s strict liability theory is that
Bovinol was in a defective condition unreasonably dangerous
for its intended use because it was foreseeable that it would be
sprayed on horses before riding them and it was unfit for this
use. This claim is simply another condemnation of the label’s
failure to warn against using Bovinol on horses before riding
them. See Grenier, 96 F.3d at 564-65. Netland’s strict liability
claim indirectly attempts to impose label requirements in
addition to or different than those imposed by the EPA. FIFRA
preempts such claims, regardless of the form in which they
appear.
Because FIFRA preempts Netland’s claims, the Court
does not reach Defendant’s arguments that Netland is unable
prove causation.
IV. CONCLUSION
Based upon the foregoing, and all of the files, records
and proceedings herein, IT IS HEREBY ORDERED that
Defendant Hess & Clark’s Motion for Summary Judgment
[Doc. No. 31] is GRANTED.
LET JUDGMENT BE ENTERED ACCORDINGLY.
24a
UNITED STATES COURT OF APPEALS
FOR THE EIGHTH CIRCUIT
No. 01-2182
Kim Netland,
Appellant,
Vv.
Hess & Clark, Inc.,
Appellee.
Order Denying Petition for
Rehearing and for Rehearing
En Banc
The petition for rehearing en banc is denied. The
petition for rehearing by the panel is also denied.
Judge Melloy took no part in the consideration of this
matter.
(5128-010199)
May 13, 2002
Order Entered at the Direction of the Court:
Clerk, U.S. Court of Appeals, Eighth Circuit
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.