UNITED STATES DISTRICT COURT

DISTRICT OF NEW HAMPSHIRE

Karen L. Bartlett

v. Civil No. 08-cv-00358-JL

Mutual Pharmaceutical

Company, Inc.

MEMORANDUM ORDER

Plaintiff Karen Bartlett has moved for a jury instruction

stating that she does not have to prove that Sulindac had an

inadequate warning to prevail on her defective design claim, but

that such evidence may be considered by the jury as a factor in

determining whether Sulindac was unreasonably dangerous to

consumers. She relies on the following passage from Vautour v.

Body Masters Sports Industries, Inc., 147 N.H. 150 (2001):

Under a risk-utility approach, a product is

defective as designed if the magnitude of the danger

outweighs the utility of the product.... In order to

determine whether the risks outweigh the benefits of

the product design, a jury must evaluate many possible

factors including the usefulness and desirability of

the product to the public as a whole, whether the risk

of danger could have been reduced without significantly

affecting either the product’s effectiveness or

manufacturing cost, and the presence and efficacy of a

warning to avoid an unreasonable risk of harm from

hidden dangers or from foreseeable uses.

Id. at 154 (emphasis added). Nearly identical language appears

in a series of earlier New Hampshire Supreme Court cases. See

Price v. BIC Corp., 142 N.H. 386, 390 (1997); LeBlanc v. Am.

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Honda Motor Co., 141 N.H. 579, 585 (1997); Chellman v. SaabScania AB, 138 N.H. 73, 77-78 (1993).

Mutual argues, in response, that Bartlett cannot present any

evidence regarding Sulindac’s warning, because this court

recently granted summary judgment on Bartlett’s failure-to-warn

claims due to a lack of causation between the warning and her

injuries. See Bartlett v. Mut. Pharm. Co., 2010 DNH 112, at 11-

22 (finding no causation because, among other things, Bartlett’s

doctor did not read or rely upon the drug’s warning).1 In light

of that ruling, Mutual argues that Sulindac’s warning is no

longer relevant and that Bartlett, to prevail on her defective

design claim, must prove that Sulindac was unreasonably dangerous

regardless of what its warning said. 

After reviewing the relevant case law, discussing this

matter with the parties during a conference call on August 13,

2010, and reviewing their written submissions,2 this court

concludes that the warning is still relevant to Bartlett’s

1 Mutual recently withdrew its “comment k” defense, which

depended in part on the warning’s adequacy. See Bartlett, 2010

DNH 112, at 24-25 (describing the requirements of that defense)

(citing Restatement (Second) of Torts § 402A, cmt. k (1965));

document no. 332 (withdrawing the defense). Until that defense

was withdrawn, there was no dispute that evidence of the

warning’s adequacy could be presented at trial, which is why this

issue has not been resolved until now. See Bartlett v. Mut.

Pharm. Co., 2010 DNH 131, 13 n.5 (reserving judgment on this

issue); see also Bartlett v. Mut. Pharm. Co., 2010 DNH 123, 4 n.1

(same).

2 Documents no. 339, 341, 342, and 344.

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defective design claim, but not in the same way that it would be

in the context of a failure-to-warn claim. For Bartlett to

prevail on her defective design claim, she must prove that

Sulindac was unreasonably dangerous despite its warning, not

because of it. Evidence regarding the warning may be admitted

for that purpose.

I. Legal framework

The New Hampshire Supreme Court has made clear that “design

defect and failure to warn claims are separate” ways of

establishing that a manufacturer is strictly liable for a defect

in a product. See LeBlanc, 141 N.H. at 586. Our court of

appeals, applying New Hampshire law, has said the same thing. 

See Cheshire Med. Ctr. v. W.R. Grace & Co., 49 F.3d 26, 32 (1st

Cir. 1995) (stating that “manufacturing defect, design defect,

and warning defect [are] three different ways of proving product

defect, not just ... factors bearing upon one way of proving

product defect”); see also Brochu v. Ortho Pharm. Corp., 642 F.2d

652, 657 (1st Cir. 1981) (separately analyzing design defect and

failure-to-warn claims involving a prescription drug). The

standard jury instructions in New Hampshire also include a

separate section for each type of strict liability claim; there

is no mention of warnings in the design defect section. See

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Walter L. Murphy & Daniel C. Pope, New Hampshire Civil Jury

Instructions §§ 23.2 and 23.4, at 23-3 and 23-5 (2007). 

Nevertheless, as our court of appeals has observed, “New

Hampshire case law supports the proposition that evidence

concerning the existence and adequacy of a warning is relevant

not only to a warning defect claim, but also to a design defect

claim.” Cheshire, 49 F.3d at 32 (citing Reid v. Spadone Mach.

Co., 119 N.H. 457, 463 (1979)); see also Duford v. Sears, Roebuck

& Co., 833 F.2d 407, 411-12 (1st Cir. 1987) (“The jury might have

based liability solely on the inadequacy of the warnings .... 

Alternatively, or perhaps in conjunction with a belief that the

warnings were only marginally sufficient, the jury might have

found” the product unreasonably dangerous). Since that

observation, three more New Hampshire Supreme Court cases have

expressly stated that one of many factors the jury may consider

in a defective design case is “the presence and efficacy of a

warning to avoid an unreasonable risk of harm.” Vautour, 147

N.H. at 154; see also Price, 142 N.H. at 390; LeBlanc, 141 N.H.

at 585.

II. Analysis

The question here, which has not been answered in any of the

previous cases, is whether a warning’s adequacy is still relevant

to a defective design claim where the court has granted summary

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judgment on the plaintiff’s failure-to-warn claim due to a lack

of causation between the warning and the plaintiff’s injuries. 

See Bartlett, 2010 DNH 112, at 11-22. Mutual argues that if an

inadequate warning is part of the reason why a product is deemed

to be unreasonably dangerous, and the warning did not cause the

plaintiff’s injuries, then the design defect claim too must fail

for lack of causation. Mutual’s reasoning is that the warning

would then constitute part of the product’s defective condition,

and it is black-letter law that the defective condition must

cause the plaintiff’s injuries. See Vautour, 147 N.H. at 154.

This court agrees with that reasoning, at least to some

extent. Bartlett cannot be allowed to circumvent this court’s

summary judgment ruling by using Sulindac’s warning to establish

that the drug is unreasonably dangerous (i.e., arguing that

Sulindac is unreasonably dangerous because of its warning), where

this court has already ruled that any inadequacy in the warning

did not cause Bartlett’s injuries. That would effectively turn

this case back into a failure-to-warn case, rendering the summary

judgment ruling meaningless.

But that is not how the New Hampshire Supreme Court seems to

have envisioned the warning’s role in a design defect case. 

Instead, the cases suggest (on a close reading) that the jury, if

it determines that the product would be unreasonably dangerous

without any warning, may consider “the presence and efficacy of a

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warning to avoid an unreasonable risk of harm.” Vautour, 147

N.H. at 154 (emphasis added); Price, 142 N.H. at 390; LeBlanc,

141 N.H. at 585; cf. also Bellotte v. Zayre Corp., 116 N.H. 52,

55 (1976) (distinguishing “the initial question of whether the

product was unreasonably dangerous” from the question of the

“adequacy of warning of a product unreasonably dangerous without

warnings”). In other words, the plaintiff must prove that the

product was unreasonably dangerous despite any warning in place

at the time of its sale.

Under that approach, the inadequacy of the warning is not a

part of the product’s defective condition and thus need not be

causally connected to the plaintiff’s injuries. Indeed, the

adequacy of the warning is not really the issue that the jury is

being asked to decide. The issue is whether the warning,

adequate or not, avoids the product’s otherwise unreasonable

danger. The jury could conclude that a product is unreasonably

dangerous even if its warning is adequate, or better than

adequate. See, e.g., Duford, 833 F.2d at 411 (“a suitable

warning is not necessarily a conclusive defense in a defective

design case”); accord LeBlanc, 141 N.H. at 586.

Mutual argues that unless Bartlett can show that “no warning

accompanying the product would have removed [its] unreasonable

danger,” then her defective design claim effectively turns on the

strength of Sulindac’s warning, making it a failure-to-warn claim

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for which Bartlett cannot prove causation. But that argument is

problematic for at least two reasons. 

First, it would mean that, because Bartlett’s doctor did not

read Sulindac’s warning, Mutual would not only be shielded from

liability for having an inadequate label (i.e., failure-to-warn),

but also would get credit for having the best possible warning

for purposes of the defective design analysis, even though this

court has ruled that the warning’s adequacy is a matter of

genuine dispute on the current record. See Bartlett, 2010 DNH

112, at 8-11. Indeed, under Mutual’s reasoning, it would get

credit for having the best possible warning even if its warning

were gibberish. 

Second, it assumes that a warning, even a legally adequate

one, which fails to avoid a product’s unreasonable danger

automatically becomes the product’s defect (and hence must be

causally connected to the plaintiff’s injuries) if the jury can

imagine “any warning [that] would have removed the unreasonably

dangerous nature of the product.” Assume, for example, that the

jury found that Sulindac had a legally adequate warning, but that

the product was still unreasonably dangerous. Under Mutual’s

reasoning, if the jury could imagine some hypothetical “superwarning” that would have avoided the unreasonable danger (e.g.,

sending a personal messenger to every doctor’s home and office in

America), the legally adequate warning would thereby become the

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product’s defect. This court cannot accept either of those

propositions.

Mutual alternatively suggests that the jury could be

instructed to determine whether Sulindac was unreasonably

dangerous “without regard to the warning.” But that strikes the

court as an empty and artificial instruction. To the extent that

a warning affects a product’s level of dangerousness and/or

utility, it is impossible to analyze whether a product is

unreasonably dangerous “without regard to the warning,” unless

that means analyzing the product “as if there were no warning.” 

Mutual is unwilling to accept that sort of instruction as a means

of keeping the warning out of the case (even if that were

permissible, which is an issue on which this court expresses no

opinion).

For all of these reasons, this court concludes that the best

course, and the one most faithful to New Hampshire precedent, is

to give a jury instruction that tracks the language of the New

Hampshire Supreme Court cases (i.e., that the jury, if it

determines Sulindac would be unreasonably dangerous without any

warning, may consider “the presence and efficacy of a warning to

avoid an unreasonable risk of harm”) and to allow evidence and

argument about Sulindac’s warning, provided it is properly

directed at whether the warning in place at the time of

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Bartlett’s prescription avoided an otherwise unreasonable danger

(and not whether it created unreasonable danger).3 

Bartlett’s motion for a jury instruction4 is therefore

DENIED, without prejudice to any objections or counter-proposals

that either party may make in response to this court’s proposed

jury instructions.

SO ORDERED.

____________________________

Joseph N. Laplante

United States District Judge

3 Bartlett argues that “if the evidence of Sulindac’s

inadequate label is relevant ... such relevance makes all the

relevant evidence admissible, not a small portion” of it. If she

means, by that tautology, that any evidence relevant to her

former failure-to-warn claim is automatically relevant to her

defective design claim, then she is incorrect. Much of that

evidence (especially the evidence relating to causation) is no

longer relevant. Indeed, Bartlett seemed to acknowledge that

point in withdrawing her prescribing doctor Tahsin Ergin as a

witness, saying that she is “unaware of any relevant testimony he

may give” now that the failure-to-warn claims and Mutual’s thirdparty apportionment defense are no longer part of the case. 

Document no. 334. 

To give another example not tied to Dr. Ergin, whether

Mutual hypothetically could or should have filed a citizen’s

petition with the FDA regarding Sulindac, and how the FDA

hypothetically would have responded to such a petition, have no

relevance to whether Sulindac’s warning in place at the time of

Bartlett’s prescription avoided an otherwise unreasonable danger,

or to any other issue remaining in the case. Conversely, the

fact that FDA actually required changes to all NSAID labels

shortly after Bartlett’s injuries, and the fact that it

instituted a “black box” warning for Bextra, are relevant to that

issue.

4 Document no. 339.

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Dated: August 15, 2010

cc: Bryan Ballew, Esq.

Keith M. Jensen, Esq.

Patrick J. O’Neal, Esq.

Christine M. Craig, Esq.

Timothy P. Beaupre, Esq.

Jeffrey D. Geoppinger, Esq.

Joseph P. Thomas, Esq.

Paul J. Cosgrove, Esq.

Linda E. Maichl, Esq.

Stephen J. Judge, Esq.

Pierre A. Chabot, Esq.

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