Opinion

Indian Brand Farms, Inc. v. Novartis Crop Protection Inc.

  • 617 F.3d 207
  • 2010 U.S. App. LEXIS 16496
  • 2010 WL 3122815
Court
Court of Appeals for the Third Circuit
Filed
Aug 10, 2010
Status
Published
On the bench
Fisher, Hardiman, Stapleton
Cited by
21 cases
Authority
More cited than 8.3%

explaining that Bates “established that mere inconsistency between the duty imposed by state law and the content of a manufacturer’s labeling approved by the EPA at registration did not necessarily mean that the state law duty was preempted”

How later courts described this case

  • explaining that Bates “established that mere inconsistency between the duty imposed by state law and the content of a manufacturer’s labeling approved by the EPA at registration did not necessarily mean that the state law duty was preempted”
  • noting, .in the products liability context, than an occurrence is reasonably foreseeable if "in light of the general experience within the industry when the product was manufactured, [the occurrence] objectively and reasonably could have been anticipated” (citation omitted)
  • “[T]he remand [in Bates] established that mere inconsistency between the duty imposed by state law and the content of a manufacturer’s labeling approved by the EPA at registration did not necessarily mean that the state law duty was preempted.”
  • “the states have joint control with the federal government in regulating the sale and use of pesticides with only the exception of the EPA’s exclusive supervision of labeling”

Written by the judges who cited it.

The opinion

PRECEDENTIAL

IN THE UNITED STATES COURT

OF APPEALS

FOR THE THIRD CIRCUIT

NO. 08-4484

INDIAN BRAND FARMS, INC.; COLUMBIA

FRUIT FARMS, INC.; JOYCE CAPPUCCIO,

Individually and d/b/a WM. Cappuccio & Sons;

COLUMBIA CRANBERRY, INC.; JOSEPH

MARTINELLI, Individually and d/b/a Blu-Jay

Farms; GREGORY A. CLARK, Individually and

d/b/a Clark Farms; ANTHONY MELORA,

Individually and d/b/a/ Melora Farms; R&S

FRANCESCHINI FARMS, a partnership of

Russell Franceschini and Scott Franceschini,

Appellants

v.

NOVARTIS CROP PROTECTION INC.,

a foreign corporation

On Appeal From the United States District Court

For the District of New Jersey

(D.C. Civil Action No. 1-99-cv-02118)

District Judge: Hon. Joseph H. Rodriguez

Argued December 1, 2009

BEFORE: FISHER, HARDIMAN and STAPLETON,

Circuit Judges

(Opinion Filed: August 10, 2010)

Scott K. Attaway (Argued)

Kellogg, Huber, Hansen, Todd, Evans & Figel

1615 M Street, N.W. - Suite 400

Washington, DC 20036

and

Kathleen F. Beers

Thomas J. Vesper

R.C. Westmoreland

Westmoreland, Vesper & Quattrone

8025 Black Horse Pike - Suite 500

West Atlantic City, NJ 08232

Attorneys for Appellants

2

John P. Mandler (Argued)

Bruce G. Jones

Kristen R. Eads

Krisann C. Kleibacker Lee

Faegre & Benson

2200 Wells Fargo Center

90 South 7th Street

Minneapolis, MN 55402

and

Robert J. Machi

Morgan Melhuis Abrutyn

651 West Mount Pleasant Avenue - Suite 200

Livingston, NJ 07039

Attorneys for Appellee

OPINION OF THE COURT

STAPLETON, Circuit Judge:

For the second time in just over five years, a group of

New Jersey blueberry farmers (collectively, “Plaintiffs”) appeals

orders of the District Court granting summary judgment to

defendant Novartis Crop Protection, Inc. (“Novartis”) on

Plaintiffs’ claims for damage to their crops allegedly caused by

use of a pesticide manufactured and distributed by Novartis.

3

The principal issues on appeal are: (1) whether

Plaintiffs’ claims of negligent misrepresentation/fraud, violation

of the New Jersey Consumer Fraud Act (“NJCFA”), and failure-

to-warn are preempted by the Federal Insecticide, Fungicide,

and Rodenticide Act (“FIFRA”), a comprehensive regulatory

statute that covers the use, sale, and labeling of pesticides; (2)

whether Plaintiffs have made a sufficient showing that they

relied on the alleged misrepresentations by Novartis to avoid

summary judgment on their negligent misrepresentation/fraud

and NJCFA claims; and (3) whether Novartis was entitled to

summary judgment on Plaintiffs’ strict product liability, design

defect claim on the ground that Novartis owed no duty to test its

pesticide when mixed with fungicides.

We conclude that because Plaintiffs’ negligent

misrepresentation/fraud and NJCFA claims are based on alleged

misrepresentations in Novartis’s marketing brochure, and that

brochure does not qualify as “labeling” under FIFRA, those

claims are not preempted. We further conclude that Plaintiffs,

other than Plaintiff Indian Brand Farms, have tendered prima

facie evidence of their reliance on Novartis’s alleged written

misrepresentations. Accordingly, we will vacate the District

Court’s grant of summary judgment as to the negligent

misrepresentation/fraud and NJCFA claims as to all Plaintiffs

except Indian Brand Farms and remand for further proceedings.

We will affirm the District Court’s grant of summary judgment

to Novartis on these claims as to Indian Brand Farms.

Because Plaintiffs’ failure-to-warn claim, if successful,

would not result in a labeling requirement in addition to or

different from those required by FIFRA, the failure-to-warn

4

claim is not preempted, and further proceedings on that claim

are required. Finally, we conclude that there is a genuine issue

of material fact with respect to Plaintiffs’ design defect claim,

and summary judgment in Novartis’s favor was inappropriate.

I. Background

A.

For several years, Plaintiffs treated their blueberry plants

with two of Novartis’s pesticides, Diazinon 50 WP and

Diazinon AG500 (“50 WP” and “AG500,” respectively). Before

applying 50 WP and AG500, Plaintiffs would combine them

with fungicides called Captan and Captec in a process known as

tank mixing. Plaintiffs assert that tank mixing is a common

practice that is well known in the industry, and while using 50

WP and AG500 in this manner, they experienced no crop

damage.

In the spring of 1997,1 Plaintiffs purchased and began

1

According to Plaintiffs’ record purchase and record

application documents, Indian Brand Farms purchased AG600

on April 21, 1997, and first applied it on May 10, 1997. It is

unknown when Columbia Fruit Farms purchased AG600, but its

first application was on May 16, 1997. Wm. Cappuccio & Sons

purchased AG600 on June 3, 1997, and first applied it on June

4, 1997. Columbia Cranberries purchased AG600 on May 28,

1997, and first applied it on May 29, 1997. Blu-Jay Farms

purchased AG600 on May 29, 1997, but its first application date

is unknown. It is unknown when Clark Farms purchased

5

using Diazinon AG600 (“AG600”), a new pesticide produced

and marketed by Novartis, and Plaintiffs tank mixed AG600

with Captan and Captec in the same manner they had tank mixed

50 WP and AG500. AG600 was indicated for use on sixty-two

different plants, one of which was blueberries. Novartis did not

recommend, however, on the product label or orally, that

growers mix AG600 with Captan or Captec, and the product

label warned purchasers that unintended consequences such as

crop injury could result from the “presence of other materials, or

the manner of use or application.” App. at A545.

The AG600 product label is a twenty-one-page document

that is divided into “Directions for Use” and “Conditions of Sale

and Warranty.” The “Conditions of Sale and Warranty” are

contained in the first two paragraphs of the label, and the

“Directions for Use” take up the remainder, containing multiple

subparagraphs and charts covering various crop and pest types.

The label does not specify that AG600 contains an inert

ingredient called an ionic surfactant2 because the United States

Environmental Protection Agency (“EPA”) does not require

AG600, but its first application was on June 4, 1997. Melora

Farms purchased AG600 on May 26, 1997, and first applied it

on May 27, 1997. Finally, it is unknown when R&S

Franceschini purchased AG600, but its first application of it was

on May 24, 1997.

2

A surfactant, short for “surface-active agent,” is intended to

enhance the pesticide’s active ingredient’s ability to spread

evenly across plant tissue and adhere to the plant structure.

6

manufacturers to identify the inert ingredients of a product on

the label unless the agency has determined that a particular inert

ingredient is of toxicological concern. See 7 U.S.C. §

136h(d)(1)(C); 40 C.F.R. § 156.10(g)(1) & (7); Labeling

Requirements for Pesticides and Devices, 49 Fed. Reg. 37,960,

37,965 (1984) (“Because the identity of an inert ingredient is

protected from disclosure by FIFRA sec. 10(d)(1)(C), a

prerequisite for labeling identification of such ingredients is that

the Agency make a finding that ‘disclosure is necessary to

protect against an unreasonable risk of injury to health or the

environment.’”).

Novartis distributed advertising literature stating that

AG600 was safer and more effective than its previous products.

This literature was in the form of a seventeen-page, full-color,

marketing brochure stating that AG600 had “[t]he same

powerful product performance,” “[i]ncreased safety to users and

the environment,” and promoted “[b]etter crop safety” with

“equal performance.” App. at A533-34. The marketing

brochure contained no instructions for use of AG600. The

brochure was distributed to, among others, product retailers and

scientists at the Rutgers University Cooperative Extension, a

part of the Rutgers New Jersey Agricultural Experiment Station.

As a result of these marketing efforts, these scientists

recommended AG600 to New Jersey blueberry farmers, both at

a “twilight meeting” of farmers in May 1997 3 and via the May

3

The exact date of this “twilight meeting” is unclear. One of

Plaintiffs’ pesticide dealers, Frank Donato, recalled the date of

the meeting as around May 15, 1997. App. at A451. Dr. Gary

7

29, 1997, edition of the Blueberry Bulletin, a newsletter

published by Rutgers.

Contrary to these claims of crop safety, Plaintiffs contend

that AG600, when mixed with the fungicides Captan and

Captec, caused systemic injury to their blueberry plants,

including blotches, depressions, spots on the plants, and even

plant death. Plaintiffs allege that this injury was due to the

presence of an ionic surfactant, which was not an ingredient of

50 WP or AG500. Plaintiffs allege that this ingredient, about

whose inclusion in AG600 Plaintiffs were unaware, when mixed

with the fungicides, caused the damage to their plants.

B.

Plaintiffs filed suit in the United States District Court for

the District of New Jersey on May 7, 1999, seeking damages

based on claims of strict liability under the New Jersey Products

Liability Act (“NJPLA”) (in that AG600 had a latent design

defect and Novartis failed to warn that AG600 could be harmful

to crops if mixed with a fungicide); negligence (in that Novartis

was negligent in failing to test AG600 before putting it in the

stream of commerce); negligent misrepresentation/fraud (in that

Novartis marketed AG600 as controlling insects without having

adverse effects on plants, when Novartis knew or should have

Pavlis of Rutgers recalled that the date was around May 25,

1997. Id. at A399. Joyce Cappuccio of Plaintiff Wm.

Cappuccio & Sons certified that the date of the meeting was

May 21, 1997. Id. at A904.

8

known that this was false); breach of the NJCFA (in that

Novartis deceptively represented that AG600 was safe to use on

blueberry plants); and breach of express warranty (in that

Novartis warranted that AG600 would conform to the chemical

description on its label and would not injure plants).

Following discovery, Novartis moved for summary

judgment, arguing, inter alia, that Plaintiffs’ claims were

preempted by FIFRA. The District Court agreed and granted the

motion. Plaintiffs then appealed to this Court.

On appeal, this Court concluded, in light of the

intervening case of Bates v. Dow Agrosciences LLC, 544 U.S.

431 (2005), in which the Supreme Court clarified the scope of

FIFRA preemption, that Plaintiffs’ claims of strict product

liability, negligent testing of AG600, and breach of express

warranty were not preempted by FIFRA, and it reversed the

District Court’s grant of summary judgment on those claims for

that reason. Mortellite v. Novartis Crop Protection, Inc., 460

F.3d 483, 489-90 (3d Cir. 2006). With respect to Plaintiffs’

claims of negligent misrepresentation/fraud and violation of the

NJCFA, to the extent that they were based on oral

misrepresentations by Novartis, we ruled that they were not

preempted by FIFRA. However, to the extent that these claims

were based on written misrepresentations, we remanded them to

the District Court, because the preemption issue with respect to

these claims had not been fully briefed and argued on appeal.

We remanded Plaintiffs’ failure-to-warn claim as well, also

because the issue of whether they were preempted by FIFRA

was not fully briefed and argued on appeal.

9

Following remand, Novartis filed several summary

judgment motions, and in a series of rulings, the District Court

once again granted summary judgment to Novartis on all of

Plaintiffs’ claims. The District Court concluded that, to the

extent Plaintiffs’ claims of negligent misrepresentation/fraud

and violation of the NJCFA were based on written

misrepresentations by Novartis, they were preempted by FIFRA,

because the AG600 marketing brochure qualified as “labeling”

under the statute. Alternatively, the District Court concluded

that even if these claims were not preempted, summary

judgment was appropriate because “the record reflects Plaintiffs

never received and/or relied upon any written representations

outside of the product label before purchasing and using”

AG600. Indian Brand Farms, Inc. v. Novartis Crop Protection,

Inc., No. 99-2118, 2007 U.S. Dist. LEXIS 94443, at *23 n.5

(D.N.J. Dec. 20, 2007). To the extent Plaintiffs’ negligent

misrepresentation/fraud and NJCFA claims were based on

alleged oral misrepresentations by Novartis, the District Court

ruled that “there is no evidence that any oral representations

were made by Novartis regarding the use of Diazinon AG600

and/or relied upon by Plaintiffs.” Id. at *24. Regarding

Plaintiffs’ failure-to-warn claim, the District Court concluded

that success on this claim “would impose a labeling requirement

in addition to the requirements set forth in FIFRA,” and thus this

claim was preempted. Id. at *28. With reference to Plaintiffs’

design defect claim,4 the District Court concluded that tank

4

The District Court concluded that Plaintiffs’ negligent

testing claim was subsumed within their strict product liability

claim, because “claims for common law negligence are

10

mixing of AG600 was not a reasonably foreseeable use of the

product, and it was not “practical, feasible, and reasonable, as a

matter of law, to require [Novartis] to have tested its product in

combination with every fungicide for use on all plants.” 5 Indian

Brand Farms, Inc. v. Novartis Crop Protection, Inc., No. 99-

2118, slip op. at 11 (D.N.J. Oct. 10, 2008).

subsumed within the statutory cause of action, and are not viable

separately for harm caused by a defective product.” Indian

Brand Farms, 2007 U.S. Dist. LEXIS 94443, at *29 (quoting

Tirrell v. Navistar Int’l, Inc., 591 A.2d 643, 647 (N.J. Super. Ct.

App. Div. 1991)). Plaintiffs do not challenge this conclusion.

5

The District Court also granted Novartis’s motion for

summary judgment on Plaintiffs’ breach of express warranty

claim, ruling that the disclaimer on AG600’s label successfully

disclaimed all warranties (including express warranties), and

stating that “Plaintiffs do not dispute that this disclaimer

satisfies N.J. Stat. Ann. § 12A:2-316(2).” Indian Brand Farms,

Inc. v. Novartis Crop Protection, Inc., No. 99-2118, slip op. at

3 (D.N.J. Jan. 10, 2008). Thus, the breach of express warranty

claim “survived to the extent that it [was] based on statements

in the brochure.” Indian Brand Farms, Inc. v. Novartis Crop

Protection, Inc., No. 99-2118, slip op. at 11 (D.N.J. Oct. 10,

2008). Plaintiffs do not challenge the ruling regarding the

disclaimer on the label, and they expressly acknowledge that

they have “never argued that the breach of warranty claim was

based on the brochure.” Pl. Br. at 62; see also Pl. Reply Br. at

30-31. Thus, we need not address the breach of express

warranty claim.

11

Plaintiffs once again appeal.6

II. Preemption and the Alleged Waiver of

Efficacy Jurisdiction

We first briefly address an overarching contention of

Plaintiffs. They insist that there can be no FIFRA preemption

of any form of crop damage claim because Congress granted the

EPA authority to waive its jurisdiction over pesticide efficacy

issues,7 and the EPA has opted in favor of exercising that

authority. It follows, in Plaintiffs’ view, that there is no federal

regulation of product efficacy and, accordingly, no preemption.

6

The District Court had jurisdiction over this action pursuant

to 28 U.S.C. § 1332. We have jurisdiction over the District

Court’s final order under 28 U.S.C. § 1291. We review the

District Court’s grant of summary judgment de novo. DIRECTV

Inc. v. Seijas, 508 F.3d 123, 125 (3d Cir. 2007) (citing CAT

Internet Servs., Inc. v. Providence Wash. Ins. Co., 333 F.3d 138,

141 (3d Cir. 2003)).

7

7 U.S.C. § 136a(c)(5) provides in part:

In considering an application for the registration

of a pesticide, the Administrator may waive data

requirements pertaining to efficacy, in which

event the Administrator may register the pesticide

without determining that the pesticide’s

composition is such as to warrant proposed claims

of efficacy.

12

We cannot agree for a number of reasons.

First, this case does not involve the efficacy of AG600.

Plaintiffs do not allege that it fails to perform in the manner

intended with respect to targeted pests; rather, they complain

about plant damage, which in FIFRA terminology is damage to

the “environment.” 7 U.S.C. § 136(j) (“The term ‘environment’

includes . . . all plants . . . .”); 40 C.F.R. § 158.130(e)(1) (“The

information required to assess hazards to nontarget organisms is

derived from tests to determine pesticidal effects on . . .

plants.”); Kuiper v. Am. Cyanamid, 131 F.3d 656, 664 (7th Cir.

1997) (concluding that “corn is a plant and falls within this

definition”); Etcheverry v. Tri-AG Serv., Inc., 993 P.2d 366, 375

(Cal. 2000) (stating that with regard to crop damage claims, “the

EPA’s waiver of the submission of efficacy data is irrelevant,

since plaintiffs complain of phytotoxicity, not inefficacy”).

Moreover, Congress did not authorize the EPA to waive

its jurisdiction over efficacy issues, and the EPA has not done

so. The authority referred to (see footnote 7,

supra) is authority only to waive “data requirements pertaining

to efficacy” when passing on an application for initial

registration of a pesticide. If there is cause for concern about

crop damage, initially or thereafter, the EPA will respond by

requiring additional data and, if appropriate, changes in label

warnings.8 It is thus not the case that the EPA no longer

8

As the Court noted in Etcheverry, 993 P.2d at 376, Section

136d(a)(2)

13

regulates efficacy.

Finally, we held when this case was first before us, based

upon Bates, that Plaintiffs’ failure-to-warn claim was preempted

if it imposed a labeling requirement different from or in addition

to the labeling requirement imposed by FIFRA. Plaintiffs’

broad sweeping waiver of efficacy jurisdiction argument is

inconsistent with that holding and, accordingly, with the law of

the case.

III. The Negligent Misrepresentation/Fraud and NJCFA

Claims

A.

As noted, the District Court held that Plaintiffs’ claims of

requires pesticide manufacturers to submit “toxic

or adverse effect incident reports,” specifically

including data concerning “alleged effect[s]

involv[ing] damage to plants.” (40 C.F.R. §

159.184(c)(5)(iv)(1999).) Significantly, the

regulation provides that information need not be

reported for an “incident” which “concerns non-

lethal phytotoxicity to the treated crop if the label

provides an adequate notice of such a risk.” (40

C.F.R. § 159.184(b)(4), italics added.) Moreover,

upon receiving crop damage reports under the

adverse effects reporting rule, the agency’s

regulatory options are not limited to cancellation;

it can also require labeling changes.

14

negligent misrepresentation/fraud and violation of the NJCFA

are preempted by FIFRA. We turn to that issue. FIFRA sets up

the basic system of pesticide regulation in the United States, and

it covers, inter alia, the use, sale, and labeling of pesticides.

FIFRA requires a manufacturer seeking to register a pesticide to

submit to the EPA “a complete copy of the labeling of the

pesticide, a statement of all claims to be made for it, . . . any

directions for its use,” and “a full description of the tests made

and the results thereof upon which the claims are based, or

alternatively a citation to [supporting] data that appear in the

public literature.” 7 U.S.C. § 136a(c)(1)(C), (F). “The EPA will

register the pesticide if it determines that the pesticide is

efficacious and will not cause unreasonable adverse effects on

humans and the environment, and that its label complies with

FIFRA’s prohibition on misbranding.” Mortellite, 460 F.3d at

488. Under FIFRA, a pesticide is “misbranded” if its labeling

contains statements that are “false or misleading in any

particular,” the pesticide’s labeling does not contain directions

for use which are “necessary for effecting the purpose for which

the product is intended,” or “the label does not contain a

warning or caution statement which may be necessary . . . to

protect health and the environment.” 7 U.S.C. § 136(q)(1).

Importantly for present purposes, FIFRA provides that 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

Act.” 7 U.S.C. § 136v(a). Additionally, it provides that states

“shall not impose or continue in effect any requirements for

labeling or packaging in addition to or different from those

required under this Act.” 7 U.S.C. § 136v(b). Thus, the states

15

have joint control with the federal government in regulating the

sale and use of pesticides with only the exception of the EPA’s

exclusive supervision of labeling. Novartis does not contend

that the state law relied upon by Plaintiffs permits a sale or use

prohibited by FIFRA. Accordingly, the preemption issue before

us turns not on whether Novartis’s brochure is related to the sale

or use of a pesticide, but rather on whether it constitutes labeling

within the meaning of FIFRA. Moreover, even if the brochure

constitutes labeling, the law relied upon by Plaintiffs is not

preempted unless it imposes a requirement or “requirements . .

. in addition to or different from those required under” FIFRA.

Id.; Bates, 544 U.S. at 444.

In Bates, a group of Texas peanut farmers alleged that a

newly marketed pesticide manufactured and distributed by

defendant Dow severely damaged their crops. The pesticide

bore a label stating that use of the pesticide was “recommended

in all areas where peanuts are grown,” but the farmers alleged

that Dow should have known that the pesticide would stunt the

growth of peanuts in soils with pH levels of 7.0 or greater.

Bates, 544 U.S. at 435. When the farmers applied the pesticide

to their western Texas farms, where the soil typically has a pH

level of 7.2 or higher, crops were damaged. The farmers

brought claims of strict product liability, negligence, fraud,

breach of warranty, and violation of the Texas Deceptive Trade

Practices Act, Tex. Bus. & Com. Code Ann. § 17.01, et seq. In

the course of determining whether these claims were preempted

by FIFRA, the Supreme Court articulated the following two-part

test:

For a particular state rule to be pre-empted, it

16

must satisfy two conditions. First, it must be a

requirement “for labeling or packaging;” rules

governing the design of a product, for example,

are not pre-empted. Second, it must impose a

labeling or packaging requirement that is “in

addition to or different from those required under

this subchapter.” A state regulation requiring the

word “poison” to appear in red letters, for

instance, would not be pre-empted if an EPA

regulation imposed the same requirement.

Id. at 444 (italics in original).

The Supreme Court in Bates: (1) held that plaintiffs’

claims of strict product liability, negligent testing, and breach of

express warranty were not preempted, because “[n]one of these

common law rules requires that manufacturers label or package

their products in any particular way;” (2) concluded that

plaintiffs’ claims under the Texas Deceptive Trade Practices Act

were not preempted, to the extent that statute might provide a

remedy for the breach of an express warranty; and (3) remanded

the case to the Court of Appeals to determine whether,

consistent with the Supreme Court’s reasoning, plaintiffs’ fraud

and failure-to-warn claims were preempted. Id. at 444-47.

FIFRA defines “label” as “the written, printed, or graphic

matter on, or attached to, the pesticide or device or any of its

containers or wrappers.” 7 U.S.C. § 136(p)(1). FIFRA defines

“labeling” as:

all labels and all other written, printed, or graphic

17

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

States 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 pesticides.

7 U.S.C. § 136(p)(2). It is undisputed that the AG600 marketing

brochure was not “on, or attached to” AG600, and so it cannot

qualify as a “label.” It is equally unquestionable, though, that

the brochure qualifies as “all other written, printed, or graphic

matter.” Given that the brochure is not referenced on the

AG600 “label,” and that there is no other writing accompanying

the product which references it, the question of whether the

brochure qualifies as “labeling” thus comes down to whether the

brochure was “accompanying” AG600, as that term is used in

the statute. The case law on the meaning of “accompanying” in

this and similar contexts is sparse but helpful.

The Federal Food, Drug, and Cosmetic Act of June 25,

1938, 21 U.S.C. § 301, et seq., defined “labeling” as “all labels

and other written, printed, or graphic matter (1) upon any article

18

or any of its containers or wrappers, or (2) accompanying such

article.” Kordel v. United States, 335 U.S. 345, 347-48 (1948).

The term “label” was defined as “a display of written, printed,

or graphic matter upon the immediate container of any article.”

Id. at 348 n.2. The Supreme Court was asked in Kordel to

determine whether this definition of “labeling,” similar to that

in FIFRA, covered sales literature that was not distributed with

a drug. The Court declined to read “accompanying such article”

as limited to materials “accompanying such article in the

package or container.” Rather, it was the content of the

materials, not their physical proximity, that controlled:

One article or thing is accompanied by

another when it supplements or explains it, in the

manner that a committee report of the Congress

accompanies a bill. No physical attachment one

to the other is necessary. It is the textual

relationship that is significant.

Id. at 350.

The Court acknowledged that Congress had not intended

that the labeling provisions of the Act regulate drug advertising

generally. It held, however, that advertising matter was

nevertheless “labeling” where it “performs the same function as

it would if it were on the article or on the containers or

wrappers.” Id. at 351. The Supreme Court concluded that the

particular material before it was “labeling” because it instructed

the ultimate users how to use the drugs:

It explained their uses. Nowhere else was the

19

purchaser advised how to use them. It constituted

an essential supplement to the label attached to

the package.

Id. at 348.

Justice Black’s dissenting opinion agreed with this aspect

of the Court’s decision. He summarized the Court’s holding as

follows:

I agree that a drug is misbranded within the

meaning of the statute if false and misleading

written, printed, or graphic matter is either placed

upon the drug, its container or wrappers, or used

in the sale of the drug as a supplement to the

package label to advise consumers how to use the

drug.

Id. at 352.

The decision of the Second Circuit in New York State

Pesticide Coalition, Inc., v. Jorling, 874 F.2d 115 (2d Cir.

1989), appears to be the only federal appellate decision which

speaks directly to the meaning of “accompanying” in the context

of FIFRA. It too focuses on the content of material alleged to

be labeling, rather than the manner of its distribution, and on

whether it instructs the ultimate user on how to use the product.

In Jorling, the Court resolved the question of whether a

“New York law, designed to assure public awareness that

poisonous chemicals are being utilized,” created “labeling”

20

requirements under FIFRA, and was therefore preempted. Id. at

116. The New York law at issue required all commercial

pesticide applicators to: (1) “enter into a written contract with

the owner of the premises where extermination is to occur;” (2)

“provide a list of the chemicals to be applied along with any

warnings which appear on the pesticide’s . . . label;” (3) “give

the prospective purchaser a notification ‘cover sheet’ which

provides further warnings and safety information;” (4) post

signs on the perimeter of the premises, “instructing persons not

to enter the area for a 24 hour period;” and (5) in some instances

“notify the public in newspapers of prospective use over large

tracts.” Id. at 116-17.

The plaintiffs in the case, a coalition of pesticide

applicators, argued that the New York notification requirements

constituted “labeling” under FIFRA and were therefore

preempted because those provisions required additional

“written, printed, or graphic matter” which “accompan[ies] the

pesticide or device at any time.” Id. at 118-19. The Jorling

Court disagreed, concluding that even though these notification

materials would be “present in some spatial and temporal

proximity” to the pesticides, the materials would not

“accompany” the pesticides, as that term is used under FIFRA.

Id. at 119. As the Jorling Court advised, “‘[l]abeling’ is better

understood by its relationship, rather than its proximity, to the

product.” Id. The Court instructed that “FIFRA ‘labeling’ is

designed to be read and followed by the end user.” Id. It then

concluded:

In enacting § 24(b), Congress clearly sought to set

minimum standards for pesticide labeling, see

21

Cox v. Velsicol Chemical Corp., 704 F. Supp. 85,

86-87 (E.D. Pa. 1989), not to prevent states from

regulating the “sale and use” of the poisonous

chemical substances through mandatory written,

printed, or graphic materials revealing the

ingredients.

[The District Court] properly noted that

FIFRA’s prohibition of state labeling “in addition

to or different from” that approved by the EPA

has as “its main focus . . . preserving the force of

the information contained in the FIFRA label.”

Notification requirements such as cover sheets,

signs, and newspaper advertisements do not

impair the integrity of the FIFRA label. Rather,

they serve to further the purpose of the statute by

enlisting state aid to prevent “unreasonable

adverse effects [of pesticide use] on the

environment.” 7 U.S.C. § 136a(c)(5).

To hold otherwise would preempt a wide

range of state activities which Congress did not

subject to the jurisdiction of the EPA.

Id. at 119-20.

While, as the District Court stressed, these precedents do

rule out physical proximity to the product as the controlling

factor, they also speak persuasively to the necessity of

constraining the scope of “accompanying” if Congress’s intent

is to be served. As the Jorling Court stressed, “Congress

22

explicitly preserved the states’ right to regulate the ‘sale and

use’ of pesticides while reserving ‘labeling’ to federal control.”

Id. at 118. The labeling provisions of FIFRA were thus clearly

not intended to regulate sales literature generally and the legal

obligations that can arise therefrom. Congress’s objective was

much narrower. It sought to impose uniformity of labeling

throughout the country, Bates, 544 U.S. at 542,9 and to protect

the integrity of that uniform labeling. Jorling, 874 F.2d at 119.

Novartis’s AG600 marketing brochure cannot be read as

providing a supplement to the AG600 label. Its function is to

point out the advantages of the new product to wholesalers and

retailers, as well as farmers. Importantly, it contains no

instructions for the use of AG600. If we were to construe the

term “labeling” as including the AG600 brochure, then all sales

and marketing materials would necessarily be included within

the scope of that term. We are confident that such was not the

intent of Congress.

In light of the foregoing, the District Court erred when it

concluded that Novartis’s marketing brochure qualified as

“labeling” under FIFRA. Plaintiffs’ claims of negligent

9

Bates reminds us that the “legislative history of the 1972

amendments [to FIFRA] suggests that Congress had conflicting

state labeling regulations in mind when crafting” the labeling

provisions. Bates, 544 U.S. at 452 n.26. By contrast, “the

lengthy legislative history is barren of any indication that

Congress meant to abrogate most of the common- law duties

long owed by pesticide manufacturers.” Id.

23

misrepresentation/fraud and violation of the NJCFA are not

preempted by FIFRA.

B.

The District Court, however, as an alternative basis for its

summary judgment ruling on the claims of negligent

misrepresentation/fraud and violation of the NJCFA, concluded

that “the record reflects Plaintiffs never received and/or relied

upon any written representations outside of the product label

before purchasing and using” AG600. Indian Brand Farms,

2007 U.S. Dist. LEXIS 94443, at *23 n.5. Thus, the District

Court ruled that even if these claims were not preempted by

FIFRA, and even if the statements in the marketing brochure

were fraudulent misrepresentations, Plaintiffs could not prevail

because they failed to show that they relied on the statements to

their detriment. We are unpersuaded by this alternative analysis.

In New Jersey, a successful claim of fraud requires proof

of five elements: “(1) a material misrepresentation of a

presently existing or past fact; (2) knowledge or belief by the

defendant of its falsity; (3) an intention that the other person rely

on it; (4) reasonable reliance thereon by the other person; and

(5) resulting damages.” Gennari v. Weichert Co. Realtors, 691

A.2d 350, 367 (N.J. 1997). “Negligent misrepresentation is . .

. [a]n incorrect statement, negligently made and justifiably relied

upon, [and] may be the basis for recovery of damages for

economic loss . . . sustained as a consequence of that reliance.”

H. Rosenblum, Inc. v. Adler, 461 A.2d 138, 142-43 (N.J. 1983).

Regarding the reliance element, it is enough for a

24

plaintiff to show “indirect reliance.” The New Jersey Supreme

Court has explained this concept in the following manner:

Indirect reliance allows a plaintiff to prove a fraud

action when he or she heard a statement not from

the party that defrauded him or her but from that

party’s agent or from someone to whom the party

communicated the false statement with the

intention that the victim hear it, rely on it, and act

to his or her detriment.

Kaufman v. I-Stat Corp., 754 A.2d 1188, 1195 (N.J. 2000)

(citing Judson v. Peoples Bank & Trust Co., 134 A.2d 761 (N.J.

1957); Metric Inv., Inc. v. Patterson, 244 A.2d 311 (N.J. Super.

Ct. App. Div. 1968)).

“[T]o state a claim under the [NJCFA], a plaintiff must

allege each of three elements: (1) unlawful conduct by the

defendants; (2) an ascertainable loss on the part of the plaintiff;

and (3) a causal relationship between the defendants’ unlawful

conduct and the plaintiff’s ascertainable loss.” N.J. Citizen

Action v. Schering-Plough Corp., 842 A.2d 174, 176 (N.J.

Super. Ct. App. Div. 2003). The proscribed unlawful conduct

includes, inter alia, “any unconscionable commercial . . . fraud,

false pretense, [or] misrepresentation” and “the knowing . . .

omission of any material fact with intent that others rely upon

such . . . omission.” N.J. Stat. Ann. § 56:8-2. While the

required “causal relationship” may be shown under some

circumstances without evidence that would satisfy the reliance

requirement of common law fraud, evidence of the kind of

indirect reliance which satisfies the common law requirement

25

would clearly satisfy the causal relationship requirement of the

NJCFA. See Varacallo v. Mass. Mut. Life Ins. Co., 752 A.2d

807, 817 (N.J. Super. Ct. App. Div. 2000).

Plaintiffs concede that “there was no credible evidence

that [they] directly relied on the brochure” before purchasing

and applying AG600. Pl. Reply Br. at 16. Plaintiffs contend,

though, that they have made a sufficient showing of indirect

reliance to avoid summary judgment, given the evidence

regarding the recommendations of AG600 by Rutgers scientists

at a “twilight meeting” in May 1997, and the Blueberry Bulletin

that was published on May 29, 1997. We agree with Plaintiffs

as to all Plaintiffs except Indian Brand Farms.

Dr. Sridhar Polavarapu of Rutgers testified that he relied

on the marketing brochure in recommending to the farmers at

the twilight meeting that they purchase and use AG600 on

blueberries:

Q: At one of these Twilight meetings, did you

talk about the new product, AG600?

A: Yes, I do recall talking about the new

product.

Q: And do you remember which meeting that

was, Doctor?

A: That’s more than likely the May meeting,

yeah.

26

Q: Do you remember what you said about it?

A: I probably said what I said in the

newsletter, which is, you know, this is a

newer product that is coming here and it is

purportedly to be safer to the environment

and because it doesn’t have solvents.

Basically, I would have said what is

provided to me vis-a-vis the information,

as per the information from the

manufacturer.

***

Q: Okay. So, as we sit here today, what you

do recall is that you did say something to

the effect that it was purported to be a

safer product, the AG600?

A: It’s based on – based on what I learned

from the literature.

Q: Yes.

A: I would have said something like that.

App. at A428-30. Further, Dr. Polavarapu testified that he relied

on the marketing brochure in writing the Blueberry Bulletin

article recommending the use of AG600 on blueberries:

Q. And as you sit here today, you do recall

27

reading something [regarding better crop

safety] that was sent to you by Novartis

back before you had the Twilight meeting

with the farmers?

A: Yes.

Q: And this written material that was sent to

you by Novartis did say specifically

something to the effect that it was better

for crop safety?

A: Yes.

***

Q: And again, the only things you can think of

now that were given to you by Novartis as

you sit here today that you relied upon to

make that statement [regarding crop safety

in the Blueberry Bulletin] was the

brochure of three or four pages?

A: Correct.

Id. at A432-35.

Plaintiffs, in turn, certified and/or testified that they relied

upon the “twilight meeting” recommendation of Dr. Polavarapu

28

and the Blueberry Bulletin in purchasing and mixing AG600.10

In light of this evidence, Plaintiffs have made a sufficient

showing that they indirectly relied upon the AG600 marketing

brochure in making their decision to purchase or apply AG600.

Novartis raises an issue, however, based on the dates of

Plaintiffs’ purchase and use of AG600, as to whether Plaintiffs

could have indirectly relied on the brochure. Novartis points out

that most Plaintiffs purchased or used AG600 prior to the May

29, 1997, publication date of the Blueberry Bulletin. See

footnote 2, supra. However, this does not resolve whether the

two Plaintiffs who clearly purchased and used AG600 after May

29, 1997 – Wm. Cappuccio & Sons and Clark Farms – did so in

reliance on the Blueberry Bulletin. Nor does it negate the

possibility that Plaintiffs relied on Dr. Polavarapu’s

recommendation at the earlier “twilight meeting.” The

10

See, e.g., App. at A114-15, A904 (deposition and

certification of Joyce Cappuccio, of Plaintiff Wm. Cappuccio &

Sons); A176-79, A922 (deposition and certification of Gregory

Clark, of Plaintiff Clark Farms); A173-74, A915 (deposition and

certification of Anthony DiMeo, of Plaintiff Columbia Fruit

Farms, Inc.); A126, A909 (deposition and certification of

Michael DiMeo, of Plaintiff Indian Brand Farms); A250-52,

A927 (deposition and certification of Anthony Melora, of

Plaintiff Melora Farms); A936 (certification of Russell

Franceschini, of Plaintiff R&S Franceschini Farms); A942

(certification of Joseph Martinelli, of Plaintiff Blu-Jay Farms);

A946 (certification of Gene Martinelli, of Plaintiff Columbia

Cranberries.).

29

testimony in the record indicates different dates for the “twilight

meeting,” 11 but construing this testimony in a light most

favorable to Plaintiffs, Plaintiffs (with the exception of Indian

Brand Farms) have demonstrated that a genuine issue of

material fact exists as to whether the farmers indirectly relied on

the representations in the marketing brochure in their decision

to purchase and mix AG600.

The problem for Plaintiff Indian Brand Farms is that it

purchased AG600 on April 21, 1997, and it applied AG600 on

May 10, 1997, before either the “twilight meeting” or the

publication of the Blueberry Bulletin. Thus, Indian Brand Farms

is the only plaintiff that is temporally excluded from having

indirectly relied on the AG600 marketing brochure.

In light of the foregoing, the District Court’s grant of

summary judgment to Novartis on the claims of negligent

misrepresentation/fraud and violation of the NJCFA based on

written representations will be reversed as to all Plaintiffs except

Indian Brand Farms. The District Court’s grant of summary

judgment on these claims as to Plaintiff Indian Brand Farms will

be affirmed.

Our discussion of the District Court’s alternative holding

11

See App. at A451 (Donato recalling the date of the “twilight

meeting” as around May 15, 1997), A399 (Dr. Pavlis recalling

the date of the “twilight meeting” as around May 25, 1997),

A904 (certification of Joyce Cappuccio identifying the date of

the “twilight meeting” as May 21, 1997).

30

regarding Plaintiffs’ claims of negligent misrepresentation/fraud

and violation of the NJCFA has thus far been limited to claims

based on written representations. As noted in Part I.B above,

the District Court also granted summary judgment to Novartis

on the negligent misrepresentation/fraud and NJCFA claims to

the extent they were based on alleged oral misrepresentations.

We will affirm this grant of summary judgment, because we

agree with the District Court that Plaintiffs have failed to

“identif[y] with any certainty any oral representations made by

Novartis [regarding the use of AG600] that they relied on.”

Indian Brand Farms, 2007 U.S. Dist. LEXIS 94443, at *24.

IV. The Failure-to-Warn Claim

Plaintiffs seek to impose liability on Novartis for failing

to warn of dangers to their crops from tank mixing AG600 with

the fungicides Captan and Captec. Plaintiffs contend that

FIFRA requires labels to contain sufficient warnings, see 7

U.S.C. § 136(q)(1), and, accordingly, that their failure-to-warn

claim would only impose labeling requirements equivalent and

parallel to those of FIFRA, not labeling requirements in addition

to or different from those of FIFRA.

We note at the outset that prior to the Supreme Court’s

decision in Bates, several of our sister Courts of Appeals held

that failure-to-warn claims based on inadequate labeling were

pre-empted by FIFRA, on the reasoning that “[i]n order to

prevail on . . . failure to warn claim[s], [plaintiffs] would have

to prove that [product] labels [approved by the EPA] contained

insufficient information and that different labels were

warranted,” and so “[a]warding damages on the[se] . . . claim[s]

31

would therefore be tantamount to allowing the state[s] . . . to

regulate pesticide labeling indirectly, an action which is

specifically prohibited by § 136v(b).” Taylor AG Indus. v.

Pure-Gro, 54 F.3d 555, 560 (9th Cir. 1995); see also Bice v.

Leslie’s Poolmart, Inc., 39 F.3d 887, 888 (8th Cir. 1994)

(holding that failure-to-warn claims are preempted by FIFRA

because “actual agency approval eliminates any possible claims

under state tort law for failure to comply with federal [labeling]

requirements”) (internal quotation omitted); MacDonald v.

Monsanto Co., 27 F.3d 1021, 1025 (5th Cir. 1994) (holding that

“the express language of FIFRA clearly indicates that Congress

intended that the federal act preempt conflicting state law,

including state common law tort claims” of failure-to-warn);

Ark.-Platte & Gulf P’ship v. Van Waters & Rogers, Inc., 981

F.2d 1177, 1179 (10th Cir. 1993) (“To the extent that state tort

claims in this case require a showing that defendants’ labeling

and packaging should have included additional, different, or

alternatively stated warnings from those required under FIFRA,

they would be expressly preempted.”); Worm v. Am. Cyanamid

Co., 5 F.3d 744, 748 (4th Cir. 1993) (“The [plaintiffs’] argument

that their state law claims are based on duties not inconsistent

with those imposed by FIFRA has no merit . . . , [because] to

argue that the warnings on the label are inadequate is to seek to

hold the label to a standard different from the federal one.”).

However, Bates introduced a different analysis of FIFRA

preemption, one that compels us to depart from this pre-Bates

precedent.

As we have earlier explained, the Bates Court made clear

that failure-to-warn claims were not preempted unless they

would impose a requirement “in addition to or different from”

32

those required by FIFRA. Bates, 544 U.S. at 447. It stressed

that it was thus endorsing a “‘parallel requirements’ reading of

§ 136v(b)” which preserved state law duties that are consistent

with those imposed by FIFRA, whether or not state law provides

a remedy that FIFRA did not provide.12 Id. The Court noted

that “[p]rivate remedies that enforce federal misbranding

requirements would seem to aid, rather than hinder, the

functioning of FIFRA.” Id. at 451.

Also, as earlier noted, the Bates Court, because of

insufficient briefing, remanded the case to the Court of Appeals

to determine whether the plaintiffs’ failure-to-warn claim would

impose any requirements in addition to or different from the

requirements under FIFRA. In doing so, it provided guidance

which we find helpful here. First of all, the remand established

that mere inconsistency between the duty imposed by state law

and the content of a manufacturer’s labeling approved by the

EPA at registration did not necessarily mean that the state law

12

The Court also excluded from preemption state law

requirements that are in fact narrower than those required by

FIFRA, because “[w]hile such a narrower requirement might be

‘different from’ the federal rules in a literal sense, such a

difference would surely provide a strange reason for finding pre-

emption of a state rule insofar as it duplicates the federal rule.”

Bates, 544 U.S. at 448 n.23 (quoting Medtronic, Inc. v. Lohr,

518 U.S. 470, 495 (1996)).

33

duty was preempted.13 We must look to the requirements

imposed by FIFRA. Accordingly, the Court suggested that, on

remand, the Court of Appeals look to whether the failure-to-

warn claim was “not equivalent to FIFRA’s misbranding

standards.” Id. at 453 n.27. If equivalency is found between the

claim and the statutory text, the Court should determine whether

there are “any EPA regulations that further refine those general

standards in any way that is relevant to petitioners’ allegations.”

Id.14 “To the extent that EPA [has] promulgate[d] such

regulations . . . , they will necessarily affect the scope of pre-

emption under § 136v(b).” Id. at 453 n.28.

FIFRA’s misbranding provisions require “warning[s] or

caution statement[s] which may be necessary . . . to protect

health and the environment.” 7 U.S.C. § 136(q)(1)(G). The

“term ‘environment’ includes water, air, land, and all plants and

man and other animals living therein . . . .” 7 U.S.C. § 136(j);

Kuiper, 131 F.3d at 664; Etcheverry, 993 P.2d at 375. The

13

Indeed, FIFRA expressly provides that while “registration

of a pesticide shall be prima facie evidence that the pesticide, its

labeling and packaging comply with the registration provisions

of the Act,” “in no event shall registration be construed as a

defense for the commission of any offense under the Act.” 7

U.S.C. § 136a(f)(2).

14

As the Bates Court noted, “[a]t present, there appear to be

relatively few regulations that refine or elaborate upon FIFRA’s

broadly phrased misbranding standards.” Bates, 544 U.S. at 453

n.28.

34

NJPLA imposes liability on a manufacturer where “the product

causing the harm was not reasonably fit, suitable or safe for its

intended purpose because it . . . failed to contain adequate

warnings or instructions.” N.J. Stat. Ann § 2A:58C-2. This

provision has been interpreted as consistent with Section 2 of

The Restatement (Third) of Torts: Product Liability, i.e.,

liability is imposed for inadequate warnings “when the

foreseeable risks of harm posed by the product could have been

reduced or avoided by the provision of reasonable . . . warnings

. . . and the omissions of the . . . warnings renders the product

not reasonably safe.” In the context of this case, this does not

appear to us to impose a duty inconsistent with or in addition to

the duty imposed by the text of the warning provisions of

FIFRA’s misbranding requirements. Moreover, Novartis does

not purport to have identified any duty imposed by New Jersey

law that does not come within this statutory text. Nor has

Novartis identified any EPA regulations that “further refine

those general standards in any way that is relevant” to Plaintiffs’

allegations. Bates, 544 U.S. at 453 n.27. And we have found

none.15 Rather, Novartis’s response to Plaintiffs’ “parallel

15

40 C.F.R. § 156.10 provides in relevant part:

(a) General – (1) Contents of the label.

Every pesticide product shall bear a label

containing the information specified by the Act

and the regulations in this part. The contents of a

label must show clearly and prominently the

following: . . .

(vii) Hazard and precautionary statements

35

requirements” interpretation of the state law and FIFRA is an

EPA “Notice” of “Revised Policy on Label Claims for Tank

Mixing” issued in January 1982. As its title indicates, the

revised policy is directed to applications for registration where

the proposed label, unlike that of AG600, claims that the

product is suitable for tank mixing. Under the revised policy,

the “EPA will usually approve tank mix label claims without

supporting compatibility and residue data if” certain specified

conditions are met, including:

(2) The chemical characteristics of all products to

be used in the mix are such that no incompatibility

or potentiation is likely to occur. (The Agency

reserves the right to request appropriate data if it

determines that a problem could arise.)

as prescribed in subpart D of this part for human

and domestic animal hazards and subpart E of this

part for environmental hazards.

Subpart E, § 156.80, et seq., provides in part:

(a) Requirement. Each product is required

to bear hazard and precautionary statements for

environmental hazards, including hazards to non-

target organisms, as prescribed in this subpart.

Hazard statements describe the type of hazard that

may be present, while precautionary statements

direct or inform the user of actions to take to

avoid the hazard or mitigate its effects.

36

Pesticide Registration (PR) Notice 82-1 (Jan. 12, 1982).

While this policy revision was not applicable to AG600,

Novartis finds it to be of controlling significance because its

discussion of the “Background” of the policy revision contains

the following statements:

In the past, the Agency has required that

applications for new registration or for amended

registration involving claims for tank mixing the

pesticide product with another pesticide product

be supported by compatibility data and, if the

mixture is to be used on a food or feed crop, by

residue data demonstrating that the mixture would

not result in residues higher than the tolerance

established for each active ingredient. However,

in cases where the pesticide labels are silent on

the matter of tank mixing, applicators have been

permitted to use tank mixes at their own risk if the

sites or crops on which the mix is to be used are

registered sites and crops for all the pesticides

contained in the mix and if all pertinent

limitations, use directions, and precautions are

followed.

Id. (emphasis added).

For Novartis, this statement establishes that the EPA

regards FIFRA as imposing no label requirements for a warning

of an unreasonable risk of plant damage from tank mixing so

long as no tank mixing claim is made. Novartis therefore

37

concludes that Plaintiffs’ failure-to-warn claim imposes a

labeling requirement not required by FIFRA. We are not

persuaded.

Bates teaches that there is a strong presumption against

preemption of state law:

Even if Dow had offered us a plausible

alternative reading of § 136v(b) – indeed, even if

its alternative were just as plausible as our reading

of that text – we would nevertheless have a duty

to accept the reading that disfavors pre-emption.

“[B]ecause the States are independent sovereigns

in our federal system, we have long presumed that

Congress does not cavalierly pre-empt state-law

causes of action.” Medtronic, 518 U.S. at 485. In

areas of traditional state regulation, we assume

that a federal statute has not supplanted state law

unless Congress has made such an intention

“‘clear and manifest.’” New York State

Conference of Blue Cross & Blue Shield Plans v.

Travelers Ins. Co., 514 U.S. 645, 655 (1995)

(quoting Rice v. Santa Fe Elevator Corp., 331

U.S. 218, 230 (1947)).

Bates, 544 U.S. at 449. Given this admonition, we would be

most reluctant to base a preemption holding on a background

observation of the kind relied upon by Novartis.

More importantly, however, this observation does not

relate to the labeling requirements for manufacturers. Rather, it

38

is addressed to what applicators have been permitted to do

where the manufacturers’ label makes no claim concerning tank

mixing. The duty of manufacturers under FIFRA is to avoid

misbranding, and that duty is not limited to the claims they make

for their products. Indeed, the fact that the EPA does not share

Novartis’s view of the limitation on its duty to warn is apparent

from the fact that, after Plaintiffs’ crop damage was called to the

attention of the EPA, it required that a warning of risk of tank

mixing be added to the AG600 label, even though the label

continued to contain no claim of tank mixing.

The NJPLA imposes a requirement for a warning of risk

to property which is consistent with Section 2 of the

Restatement (Third) of Torts: Products Liability. That

requirement is thus not an extraordinary one. It is consistent in

scope with the generally accepted commercial expectation.

Moreover, we note that FIFRA expressly endorses a concept

quite similar to New Jersey’s duty to warn of risks associated

with objectively foreseeable uses. Section 136a(c)(5) provides

in part as follows:

(5) Approval of registration

The Administrator shall register a pesticide

if the Administrator determines that, when

considered with any restrictions imposed under

subsection (d) –

(A) its composition is such

as to warrant the proposed claims

for it;

(B) its labeling and other

39

material required to be submitted

comply with the requirements of

this Act;

(C) it will perform its

intended function w ithout

unreasonable adverse effects on the

environment; and

(D) when used in

accordance with widespread and

commonly recognized practice it

w ill not generally cause

unreasonable adverse effects on the

environment.

7 U.S.C. § 136a(c)(5) (emphasis added). We find it significant

that Congress found it advisable to include the provisions of (D)

in addition to the “intended function” provisions of (C).

Given that Congress in FIFRA imposed a generalized

duty to include in one’s labeling any warning statement

necessary to protect plant life and the fact that the EPA has not

seen fit to narrow that duty, we find no basis for concluding that

New Jersey law imposes a duty to warn different than or in

addition to the scope of the requirement imposed by FIFRA.

The District Court’s judgment regarding Plaintiffs’ failure-to-

warn claim will be reversed.16

16

In addition to arguing that Plaintiffs’ failure-to-warn claim

is preempted by FIFRA, Novartis contends that it had no duty to

warn about the dangers of tank mixing AG600 because there

40

V. The Design Defect Claim

The final question before us is whether Novartis was

entitled to summary judgment on Plaintiffs’ design defect claim.

The NJPLA provides that:

A manufacturer or seller of a product shall be

liable in a product liability action only if the

claimant proves by a preponderance of the

evidence that the product causing the harm was

not reasonably fit, suitable or safe for its intended

purpose because it: . . . was designed in a

defective manner.

N.J. Stat. Ann. § 2A:58C-2. Plaintiffs insist that AG600 was

“designed in a defective manner,” because it contained the ionic

surfactant that Plaintiffs allege caused the damage to their crops

when AG600 was mixed with certain fungicides.

To succeed under a strict liability design defect theory in

New Jersey, “a plaintiff must prove that (1) the product was

defective; (2) the defect existed when the product left the hands

was, as a matter of law, no duty to test AG600 in combination

with fungicides. However, as we explain in the next section, see

infra Part V, there remains a genuine issue of material fact as to

whether Novartis had a duty to perform reasonable testing

regarding AG600’s compatibility with fungicides, as well as

whether tank mixing was a reasonably foreseeable use of

AG600.

41

of the defendant; and (3) the defect caused the injury to a

reasonably foreseeable user.” Jurado v. W. Gear Works, 619

A.2d 1312, 1317 (N.J. 1993). “Because this case involves a

design defect, as distinguished from a manufacturing defect,

plaintiff must show specifically that the product ‘is not

reasonably fit, suitable and safe for its intended or reasonably

foreseeable purposes.’” Id. (quoting Michalko v. Cooke Color

& Chem. Corp., 451 A.2d 179, 183 (N.J. 1982); Suter v. San

Angelo Foundry & Mach. Co., 406 A.2d 140, 149 (N.J. 1979)).

“The decision whether a product is defective because it

is ‘not reasonably fit, suitable and safe’ for its intended purposes

reflects a policy judgment under a risk-utility analysis” that

“seeks to determine whether a particular product creates a risk

of harm that outweighs its usefulness.” Id. Under this analysis,

a manufacturer is not liable for damages where a person misuses

the product, unless that misuse was “objectively foreseeable.”

See Port Auth. of N.Y. & N.J. v. Arcadian Corp., 189 F.3d 305,

314 (3d Cir. 1999) (stating that the “unforeseeable misuse of a

product may not give rise to strict liability,” because “where ‘the

use of the product is beyond its intended or reasonably

anticipated scope,’ an injury resulting from that use is ‘not . . .

probative of whether the product was fit, suitable, and safe’”)

(quoting Suter, 406 A.2d at 144). Thus, the first step of the risk-

utility analysis is for the jury to “determine whether the plaintiff

used the product in an objectively foreseeable manner.” Jurado,

619 A.2d at 1319.

Novartis contends that tank mixing, as a matter of law,

was not a reasonably foreseeable use of AG600. We conclude

that there is a genuine issue of material fact with respect to that

42

issue. The evidence in the summary judgment record would

support a finding of fact that Plaintiffs’ “misuse” of AG600 was

objectively, that is reasonably, foreseeable. First, the economics

and utility of tank mixing make it almost inevitable that such

mixing will occur. See, e.g., App. at A702 (testimony of

Plaintiff Gene Martinelli) (“If you apply more than one chemical

and it is compatible, that’s one less time you have to go through

the fields.”), A886 (Expert Report of Dr. Carl Whitcomb) (“The

tank mixing of insecticides with . . . fungicides is common

practice as it allows the farmer to address several problems with

one spray application . . . thereby saving time and equipment

expense . . . .”). Second, several Plaintiffs testified that tank

mixing was a well-known and common practice among farmers.

See, e.g., App. at A204 (Plaintiff Russell Franceschini) (stating

that the prior versions of Diazinon “and Captan has been mixed

for years”), A708 (Plaintiff Anthony Melora) (“[W]e always –

I always mixed the fungicide with insecticide.”). Third, several

Plaintiffs testified that pesticide dealers and Rutgers personnel

recommended tank mixing AG600 with fungicides, which

indicates industry practice. See, e.g., App. at A115 (Plaintiff

Joyce Cappuccio), A126-27 (Plaintiff Michael DiMeo), A165

(Plaintiff Anthony DiMeo), A216-17 (Plaintiff Joseph

Martinelli). Finally, Novartis’s own representatives testified

that they were aware that farmers frequently mixed pesticides

and fungicides. See, e.g., App. at A716-17, A723-24. This

evidence is sufficient for a jury to conclude that tank mixing

pesticides and fungicides was a reasonably foreseeable practice.

Novartis relies upon this Court’s decision in Arcadian in

arguing that tank mixing was not a reasonably foreseeable use

of AG600. In Arcadian, the plaintiff sought to hold the

43

defendants, manufacturers of fertilizers, liable for massive

damage resulting from the 1993 terrorist bombing of the World

Trade Center in New York because the terrorists used the

defendants’ fertilizers in constructing the explosive device.

Arcadian, 189 F.3d at 308. One of plaintiff’s claims was a

products liability claim under New Jersey law, and he argued

that defendants owed a duty to plaintiff, even though “there is

no allegation that the fertilizer products were dangerous in and

of themselves.” Id. at 314. With reference to whether building

an explosive was a foreseeable use of the fertilizer, we first

explained that in New Jersey, foreseeability means objective

foreseeability, which:

means reasonable foreseeability. The standard

“does not affix responsibility for future events

that are only theoretically, remotely, or just

possibly foreseeable, or even simply subjectively

foreseen by a particular manufacturer.” . . . Rather

it “applies to those future occurrences that, in

light of the general experience within the industry

when the product was manufactured, objectively

and reasonably could have been anticipated.”

Id. at 315 (quoting Oquendo v. Bettcher Indus., Inc., 939 F.

Supp. 357, 361 (D.N.J. 1996) (quoting Brown v. U.S. Stove Co.,

484 A.2d 1234, 1241 (N.J. 1984))). We then agreed with the

District Court’s conclusion that:

No jury . . . reasonably could conclude that one

accidental explosion 50 years ago, one terrorist

act in this country almost 30 years ago, and

44

scattered terrorists incidents throughout the world

over the course of the last 30 years would make

an incident like the World Trade Center bombing

anything more than a remote or theoretical

possibility.

Id. at 35 (quoting Port Auth. of N.Y. & N.J. v. Arcadian Corp.,

991 F. Supp. at 402-03).

Arcadian holds that not all misuses that would be

perceived as possible by a reasonable seller are reasonably

foreseeable misuses that can lead to seller liability. Virtually all

misuses are foreseeable as possibilities. Given that the ultimate

objective of the risk-utility analysis is to determine whether a

particular product creates a risk of harm that outweighs its

usefulness, all possible misuses clearly cannot be the basis for

liability on the part of the seller. This does not mean, however,

that misuses which a reasonable seller would believe likely to

occur in the normal course of events need not be taken into

account. Such misuses are “objectively foreseeable” and must

be considered. Here, unlike in Arcadian, there is a genuine

issue of material fact as to whether a reasonable manufacturer

in Novartis’s position would have anticipated that Plaintiffs’

mixing was likely to happen in the normal course of events.17

17

While, as we have noted, a risk-utility analysis ultimately

involves a policy judgment, we, unlike the dissent, do not

understand the concept of “objective or reasonable

foreseeability” under New Jersey law to be devoid of factual

content regarding the perceptions of a reasonable seller and

45

After determining that the plaintiff used the product in an

objectively foreseeable manner, the next step of the risk-utility

analysis requires the fact-finder to determine whether the

reasonably foreseeable risk of harm posed by the reasonably

foreseeable use of the product could have been reduced or

avoided by a reasonable alternative design. Lewis v. Am.

Cyanamid Co., 715 A.2d 967, 980 (N.J. 1998). In making this

determination, the jury is, of course, called upon to assess what

risks of harm were reasonably foreseeable.

On remand from this Court’s prior decision in this case,

the District Court granted summary judgment to Novartis on

Plaintiffs’ defective design claim because it determined that the

risk of harm to Plaintiffs’ crops posed by AG600 when mixed

with certain fungicides was not foreseeable. It concluded that

it could not “find it practical, feasible, and reasonable, as a

matter of law, to require the Defendant to have tested its product

in combination with every fungicide for use on all plants.”

Indian Brand Farms, No. 99-2118, slip op. at 11 (D.N.J. Oct.

10, 2008). However, while it is correct to say that a

manufacturer in Novartis’s position has no duty to test every

possible combination of ingredients for every possible misuse of

determinable solely on the basis of “fairness and public policy.”

Evidence tending to show common knowledge in a marketplace

regarding a likely misuse is not irrelevant to whether that misuse

is objectively or reasonably foreseeable. Where, as here, there

is such evidence regarding the practice of mixing, we are

unwilling to hold that there is no reasonable foreseeability as a

matter of law.

46

a pesticide, it is not correct to say that a manufacturer is never

chargeable with knowledge of the risks of harm that reasonable

testing would have revealed. The issue boils down to what a

reasonably prudent manufacturer would have done in the way of

testing before introducing the product to the market. See

Restatement (Third) of Torts: Products Liability § 2 cmt. m

(stating that “a seller bears responsibility to perform reasonable

testing prior to marketing a product” and “is charged with

knowledge of what reasonable testing would reveal,” and so

“[i]f testing is not undertaken, or is performed in an inadequate

manner, and this failure results in a defect that causes harm, the

seller is subject to liability,” if there was a reasonable alternative

design;)18 Feldman v. Lederle Labs., 479 A.2d 374, 387 (N.J.

1984) (stating that “a reasonably prudent manufacturer will be

deemed to know of reliable information generally available or

reasonably obtainable in the industry or in the particular field

involved”).

Here, the evidence would permit a finding of fact that a

reasonably prudent manufacturer would have appreciated the

significant risk of crop damage from the use of the ionic

surfactant and that a reasonable alternative with less risk was

available. Plaintiffs produced two experts, Dr. James Witt and

18

New Jersey generally follows the rule of Section 2 of the

Restatement (Third) of Torts: Products Liability. See, e.g.,

Cavanaugh v. Skil Corp., 751 A.2d 518, 520-21 (N.J. 2000);

Myrlak v. Port Auth. of N.Y. & N.J., 723 A.2d 45, 52 (N.J.

1999); Lewis, 715 A.2d at 975, 979, 983; Mathews v. Univ. Loft

Co., 903 A.2d 1120, 1126-27 (N.J. Super. Ct. App. Div. 2006).

47

Dr. Carl Whitcomb, who testified that the presence of the ionic

surfactant in AG600 should have raised a “red flag” that the

pesticide would be physically incompatible with fungicides. See

App. at A764, A885-87. Novartis contends that there is a

distinction between physical compatibility and whether the

mixture would result in plant damage, but Dr. Witt specifically

stated that the incompatibility caused by the ionic surfactant

“can cause . . . crop damage,” id. at A885, and Dr. Whitcomb

specifically stated that “it appears that the incompatibility and in

turn the damage to the blueberry crops resulted from a

compound(s) added to the [AG600] other than the primary

active ingredient.” Id. at A886. In addition, Dr. Pavlis of

Rutgers testified that while physical incompatibility does not

necessarily result in crop damage, “it’s a good indication,”

because “[i]f you get a problem in the jar [testing for

compatibility], then you most likely will get a problem in the

field.” Id. at A367.

In addition, there is evidence that such incompatibility

could have been discovered by conducting a simple bottle-

shaking test (in which a pesticide and fungicide are mixed in a

bottle to test compatibility), id. at A376, A765, and Dr. Witt

testified that there was no need to test every combination of

pesticides and fungicides for stability, only combinations

commonly used in the areas designated for sale. Id. at A764-65.

In contrast, the record contains no expert testimony to

support Novartis’s claim that it would have required testing of

almost 3,000,000 combinations of pesticides and fungicides in

order to determine that there was a significant risk of crop

damage. In addition, there is evidence that Novartis did not

48

conduct any compatibility testing at all before marketing and

distributing AG600. See id. at A748, A753. It was only after

the damage to the blueberry crops was reported that Novartis

tested the pesticide with twenty-five other chemicals and found

that several of the mixes were in fact incompatible. Id. at A895.

The evidence of record raises a genuine issue of material

fact as to whether the risk of harm to Plaintiffs’ crops was

foreseeable, and whether such risk of harm could have been

reduced or avoided by a reasonable alternative design, i.e., a

pesticide not containing an ionic surfactant.19 Accordingly, the

District Court erred when it granted summary judgment to

Novartis on Plaintiffs’ design defect claim.

VI. Conclusion

We will affirm the judgment of the District Court in

Novartis’s favor on Indian Brand Farms’ claims of negligent

misrepresentation/fraud and violation of the NJCFA. We will

also affirm the judgment in Novartis’s favor on Plaintiffs’

negligent misrepresentation/fraud and NJCFA claims to the

extent that they rely on oral representations by Novartis. In all

other respects, the judgment of the District Court will be

reversed, and this case will be remanded for further proceedings

on all of Plaintiffs’ other claims.

19

Plaintiffs posit as a reasonable alternative design “old

Diazinon,” which did not contain the ionic surfactant. Pl. Br. at

50.

49

Indian Brand v. Novartis

No. 08-4484

HARDIMAN, Circuit Judge, dissenting in part.

I am pleased to join Judge Stapleton’s opinion for the

Court in most respects. Unlike my colleagues, however, I would

hold that Novartis had no duty to test AG600 for tank-mixing

compatibility with the fungicides used by Plaintiffs. I therefore

would affirm the District Court’s summary judgment on

Plaintiffs’ design defect claim under the New Jersey Products

Liability Act. And because it follows a fortiori that Novartis

had no duty to warn Plaintiffs about the results of a test it had no

legal duty to conduct, I would affirm the District Court’s

summary judgment on Plaintiffs’ implied failure-to-warn claim

as well. Accordingly, I respectfully dissent from Parts IV and

V of the Court’s opinion.

I.

The extensive factual background and tortuous

procedural history of this case are aptly recounted in Judge

Stapleton’s thorough opinion, so I shall briefly mention only a

few points relevant to my dissent.

Plaintiffs’ fourth amended complaint includes two claims

brought pursuant to the New Jersey Products Liability Act

(NJPLA), N.J. Stat. Ann. § 2A:58C-1 et seq. First, Plaintiffs

allege that AG600 was defectively designed because it

contained an undisclosed ionic surfactant that harmed Plaintiffs’

crops when “tank mixed” with certain fungicides regularly used

by Plaintiffs, such as Captan and Captec. Although Novartis did

not recommend—and in fact warned against—combining

AG600 with fungicides during the application process, Plaintiffs

contend that Novartis had a duty to test AG600 for adverse

interactions with other agricultural chemicals before distributing

it. Second, Plaintiffs aver that AG600 was defective because

Novartis failed to warn of the dangers inherent in tank mixing

the pesticide with Plaintiffs’ fungicides.

In Parts IV and V of its opinion, the Court holds that the

District Court erred in granting Novartis summary judgment on

both of Plaintiffs’ NJPLA claims. Because I believe Plaintiffs’

practice of combining AG600 with various fungicides during the

tank mixing process was not objectively foreseeable to Novartis,

I disagree.

A.

I begin with Plaintiffs’ claim for defective design. Under

the NJPLA, a plaintiff asserting a claim for defective design

must prove by a preponderance of the evidence that “the product

causing the harm was not reasonably fit, suitable or safe for its

intended purpose because it . . . was designed in a defective

manner.” N.J. Stat. Ann. § 2A:58C-2. When a product is used

for something other than its specifically intended purpose, a

plaintiff nonetheless may prevail on a design defect claim under

the NJPLA by demonstrating that such use was “reasonably

foreseeable” to the manufacturer. Jurado v. Western Gear

Works, 619 A.2d 1312, 1317 (N.J. 1993) (citations and

quotation marks omitted). Because it is undisputed that

Novartis designed AG600 as a stand-alone pesticide and did not

recommend applying it in conjunction with fungicides, Plaintiffs

2

bear the burden of demonstrating that their tank mixing practice

was a reasonably foreseeable misuse of the pesticide. Id. at

1317-18.1

To determine whether the misuse of a product was

reasonably foreseeable under the NJPLA, we apply an objective

test. Id. at 1317. We do not ask whether a manufacturer was

aware of previous instances in which its product had been

similarly misused because such evidence “tends to show only

subjective foreseeability,” which is irrelevant to the objective

foreseeability analysis. Port Auth. of New York and New Jersey

v. Arcadian Corp., 189 F.3d 305, 315 (3d Cir. 1999) (quoting

Oquendo v. Bettcher Indus., Inc., 939 F. Supp. 357, 363 (D.N.J.

1996)); see also Brown v. U.S. Stove Co., 484 A.2d 1234, 1241

(N.J. 1984). Instead, whether the misuse of a product is

objectively foreseeable—and thereby imposes a duty on the

manufacturer to take steps to ensure that the product is safe for

that use—is ultimately “a question of fairness and public

policy.” Arcadian, 189 F.3d at 315. For that reason, we have

emphasized that “[f]airness, not foreseeability alone, is the test”

for reasonable foreseeability under the NJPLA. Id. at 316

(quoting Kuzmic v. Ivy Hill Park Apartments, Inc., 688 A.2d

1018, 1020 (N.J. 1997)).

It is in this assessment of the objective foreseeability of

Plaintiffs’ tank mixing of AG600 with fungicides where I part

1

Under the NJPLA, use of a product for anything other

than its intended purpose is termed “misuse.” See Jurado v.

Western Gear Works, 619 A.2d 1312, 1317 (N.J. 1993).

3

ways from my colleagues. The Majority marshals a

considerable amount of evidence to support its conclusion that

tank mixing was a reasonably foreseeable misuse of AG600.

According to the Majority, individual plaintiff farmers, pesticide

dealers, and Rutgers University crop-treatment scientists all

testified that tank mixing pesticides with fungicides was a

common and well-known industry practice among blueberry

farmers. Furthermore, Novartis sales representatives themselves

acknowledged a general awareness that farmers often engage in

tank mixing.

Although such evidence suggests a subjective awareness

on the part of Novartis and others that Plaintiffs would tank mix

AG600 with different fungicides, it sheds no light on the

question of whether this subjectively foreseeable misuse is

objectively reasonable. For a duty to attach under the NJPLA,

the misuse of a product must be objectively foreseeable to the

manufacturer—a determination which, as explained above, turns

on questions of fairness and public policy, not Novartis’s

subjective awareness of past tank mixing by Plaintiffs. See

Jurado, 619 A.2d at 1317; Arcadian, 189 F.3d at 315. Because

the deposition testimony cited by the Majority does not indicate

whether it would be either fair or sound public policy to charge

Novartis with responsibility for ensuring that Plaintiffs’ practice

of tank mixing AG600 with various fungicides was safe, that

evidence would seem irrelevant to the question of whether

Plaintiffs’ misuse of AG600 was objectively foreseeable under

the NJPLA.

Unlike the Majority, I am not convinced that Plaintiffs

have carried their burden of demonstrating that their misuse of

4

AG600 was reasonably foreseeable to Novartis. As the

Majority’s foreseeability analysis demonstrates, Plaintiffs can

point to no relevant evidence in the record that suggests tank

mixing was an objectively foreseeable misuse of AG600.

Instead, Plaintiffs—like the Majority—rely almost entirely on

evidence of subjective foreseeability. Because the burden of

demonstrating reasonable foreseeability rests on Plaintiffs, see

Jurado, 619 A.2d at 1317, I would affirm the District Court’s

conclusion that Novartis had no duty under the NJPLA to test

AG600 for compatibility with various fungicides.

In contrast to Plaintiffs’ failure to introduce relevant

evidence on the issue of reasonable foreseeability, Novartis has

cited persuasive evidence which strongly suggests that it would

be neither fair nor prudent public policy to impose a duty on

Novartis to test AG600 for compatibility with fungicides such

as Captan and Captec. When viewed as a whole, this evidence

compels the conclusion that Plaintiffs’ practice of tank mixing

was not an objectively foreseeable misuse of AG600.

Evidence suggests that the burden such testing would

impose on Novartis would be substantial to say the least. The

AG600 label indicates that the pesticide is approved for use not

just on the blueberries that Plaintiffs raise but on 62 different

types of plants. See App. at 548-574. Novartis has

represented—and Plaintiffs have not disagreed—that there are

approximately 98 different registered fungicides and 141

different registered insecticides that growers of those 62 types

of plants could elect to tank mix with AG600. Appellee’s Br. at

13-14, 27-28. This yields over 850,000 tank-mix/plant

combinations that Novartis would be required to test for

5

compatibility before marketing AG600. 2 Evidence also

indicates that such extensive testing would be time consuming:

a single test conducted by Rutgers University scientists

involving AG600, Captan, Captec, and blueberry plants took

two full years to complete. See App. at 614-620.3

The Majority points to the deposition testimony of Dr.

James Witt, who testified that Novartis need not test AG600 for

every possible tank-mix combination. Instead, Dr. Witt opined

that Novartis could have looked to “what some of the common

and usual practices are, and the areas where [AG 600] is going

2

Novartis cites a higher figure, claiming that the

Majority’s holding will require it to test “at least 2,963,220

different three-product use combinations” before distributing

AG600. See Appellee’s Br. at 27. Novartis’s calculation seems

to assume erroneously that farmers will combine AG600 with

multiple fungicides and multiple insecticides at the same time.

The record, however, indicates only that farmers will combine

AG600 with, at most, one fungicide and one insecticide during

any given application. Accordingly, I use the smaller figure of

850,000 as a more accurate reflection of the testing burden

facing Novartis.

3

The Majority notes that Plaintiffs introduced evidence

suggesting that Novartis could detect potential compatibility

problems with a simple “jar test” of AG600 and a given

fungicide. Accepting this as true, I believe it would be an

unreasonable burden to require a manufacturer such as Novartis

to perform over 850,000 separate jar tests.

6

to be sold and used” and limited its testing accordingly. App. at

764-765. According to the Majority, Dr. Witt’s testimony

suggests the testing burden is not nearly as onerous as Novartis

claims.

With additional information, Dr. Witt’s testimony could

be a helpful means of evaluating the testing burden that the

Majority’s holding imposes on Novartis. Despite their burden

of demonstrating the objective foreseeability of tank mixing,

however, Plaintiffs have cited no additional evidence indicating

where AG600 is commonly used and sold and no evidence

suggesting what the “common and usual practices” of farmers

who use AG600 actually are. Without such information, Dr.

Witt’s testimony provides us with no basis for concluding that

the Majority’s holding will require Novartis to test anything less

than the approximately 850,000 potential tank-mix combinations

discussed above. The notion that far fewer tests would be

required is based, I believe, on the fallacy that the manufacturer

knows in advance which of the many potential

AG600/insecticide/fungicide/crop combinations the end user

will choose.

In my view, the considerable burden that the Majority’s

holding will impose on manufacturers is unsound public policy.

Requiring Novartis to test AG600—and, apparently, all other

pesticides—in innumerable tank mixing combinations would

stifle the development of agricultural pesticides and increase

substantially their cost of production. This would, in turn, drive

up the cost of food, since pesticide manufacturers and farmers

would inevitably pass on at least a portion of their escalating

costs to consumers. As a matter of policy, then, it seems both

7

logical and prudent to lay the responsibility for ensuring tank-

mixing compatibility on end users such as Plaintiffs, who have

actual knowledge of the specific types of fungicides that they

wish to combine with AG600 and the various crops they wish to

treat with the mixture.

Nor would requiring Novartis to test AG600 for tank mix

compatibility be particularly fair, either. Because the

Environmental Protection Agency has not approved AG600 for

mixing with fungicides such as Captan and Captec, any such

mixture would be considered an “off-label” use of the pesticide.

Federal law prohibits Novartis from recommending or

marketing AG600 for off-label uses. See 7 U.S.C. §

136j(a)(1)(B). Furthermore, Novartis explicitly cautions farmers

against mixing AG600 with other chemical substances. See

App. at 545. Accordingly, the Majority’s holding will require

Novartis to undertake extensive and expensive testing to ensure

that AG600 is fit to be used in a manner that it warns against

and is explicitly prohibited from advocating.

In sum, the record evidence suggests that requiring

Novartis to test AG600 for tank mix compatibility with

fungicides such as Captan and Captec is both unfair and

unsound as a matter of public policy. Accordingly, I would

conclude that Plaintiff’s misuse of AG600 in the tank mixing

process was not objectively foreseeable to Novartis, despite

Plaintiffs’ evidence suggesting that the company was

subjectively aware of the practice. Because Novartis had no

duty to test AG600 for compatibility with the fungicides

employed by Plaintiffs, I would affirm the District Court’s

8

summary judgment on Plaintiffs’ defective design claim under

the NJPLA.

B.

The District Court also granted summary judgment on

Plaintiffs’ failure-to-warn claim brought pursuant to the NJPLA

after concluding that the claim was preempted. In Part IV of its

thorough opinion, the Majority persuasively explains why this

holding was error, and I agree fully with its preemption analysis.

Notwithstanding the District Court’s flawed preemption

reasoning, I do not believe it necessary to reverse the District

Court’s dismissal of Plaintiffs’ failure-to-warn claim. For the

reasons explained herein, I would hold that Novartis had no duty

to test AG600 for tank mix compatibility with the fungicides

used by Plaintiffs. It follows a fortiori that Novartis had no duty

to warn Plaintiffs. Accordingly, I would affirm the District

Court’s summary judgment on Plaintiffs’ implied failure-to-

warn claim as well.

9

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.

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