Bartlett v. Mutual Pharmaceutical CV-08-358-JL 7/30/10
UNITED STATES DISTRICT COURT
DISTRICT OF NEW HAMPSHIRE
Karen L. Bartlett
v. Civil No. 08-cv-358-JL
Opinion No. 2010 DNH 130
Mutual Pharmaceutical
Company, Inc.
MEMORANDUM OPINION
Defendant Mutual Pharmaceutical Company has moved for
reconsideration of this court's order denying Mutual's summary
judgment motion in part and granting it in part. See Bartlett v.
M ut. Pharm. C o ., 2010 DNH 112 ("Order").1 Mutual argues that
this court made a manifest error of law in ruling that Bartlett
could prevail on her strict products liability claim by proving
that the product at issue, the prescription drug Sulindac, was
"defective because its safety risks outweigh its medical
benefits, making it an unreasonably dangerous product," id. at 23
(footnote omitted), without having to prove that the product had
some other "defect" in design.
While language in the New Hampshire Supreme Court's opinion
in Buckingham v. R.J. Reynolds Tobacco Co., 142 N.H. 822 (1998),
arguably supports Mutual's view, its subseguent decision in
Vautour v. Body Masters Sports Industries, Inc.,
147 N.H. 150
1Document no. 243.
(2001), expressly holds that a plaintiff can prevail on a strict
products liability claim by proving that a product was
"unreasonably dangerous pursuant to the risk-utility balancing
test," without also having to prove "a safer, alternative
design," id. at 157. Mutual's motion does not address Vautour's
holding and, indeed, barely mentions the case.
Accordingly, as fully explained infra. Mutual's motion to
reconsider fails to demonstrate a "manifest error of fact or
law," L.R. 7.2(e)," or, so far as the court is concerned, any
error at all. The motion is therefore denied.
I. Background
The facts relevant to Mutual's motion for summary judgment
are set forth throughout the Order and need not be repeated here.
Essentially, Bartlett claims that she suffered a painful and
life-threatening condition known as Stevens-Johnson
Syndrome/Toxic Epidermal Necrolysis, or "SJS/TEN," from taking
Sulindac, a generic prescription drug manufactured by Mutual and
prescribed by her doctor. In moving for summary judgment. Mutual
argued principally that it adeguately warned the doctor of the
risk of SJS/TEN but that, even if it had not, any failure to warn
was not the cause of Bartlett's injuries because her doctor
admitted that he had not read Sulindac's warning label before
2
prescribing it to her. Mutual argued that those flaws were fatal
not only to Bartlett's failure-to-warn claims, but also to her
strict products liability claim based on defective design,
because "the primary allegation [she] relies upon to support [it]
is [her] erroneous contention that Sulindac was defective because
it lacked an adeguate warning."
In support of her strict products liability claim, though,
"Bartlett also alleges that Sulindac is defective because its
safety risks outweigh its medical benefits, making it an
unreasonably dangerous product"--as this court ultimately
observed in the Order. Thus, following oral argument on Mutual's
summary judgment motion, the court ordered both parties to brief
whether Bartlett's inability to prove causation on her failure-
to-warn claims was also fatal to her strict products liability
claim based on defective design.
Mutual maintained that it was, because "the New Hampshire
Supreme Court would recognize that in actions involving
pharmaceutical products, whether a product is defective in design
turns on whether the product was accompanied by an inadeguate
warning." According to Mutual, that proposition followed from
New Hampshire's embrace of comment k to the Restatement (Second)
of Torts § 402A (1965), which. Mutual said, provides that "an
unavoidably unsafe product is defective in design only if it is
3
not accompanied by a proper warning." Because "[w]here a product
design cannot be made safer, it is judged by the adeguacy of its
warnings," Mutual argued that a causal link between an allegedly
inadeguate warning and the plaintiff's injury was essential to a
strict liability claim based on an unavoidably unsafe product.
This court accepted Mutual's premise--that New Hampshire
would not hold the manufacturer of an important and unavoidably
unsafe product strictly liable so long as it was accompanied by
an adeguate warning, see Order at 24-25--but rejected Mutual's
conclusion that Bartlett's strict liability claim therefore
failed for want of proof that the allegedly inadeguate warning
caused her injury, id. at 23-24. Instead, the court ruled, if
Bartlett could prevail at trial on "whether Sulindac is
unreasonably dangerous and whether that defective condition
caused her injuries . . . Mutual might nonetheless be able to
avoid liability for defective design if it can prove, as an
affirmative defense, that Sulindac is unavoidably unsafe and had
an adeguate safety warning." Id. at 26. The court refused to
enter summary judgment for Mutual based on that defense, however,
because "the adeguacy of Sulindac's safety warning is a matter of
genuine dispute on this record." Id.
4
II. Analysis
As noted above. Mutual now argues that--quite apart from the
adequacy of the warning--Bartlett's strict products liability
claim fails because she cannot prove "a defect in the product."
Proving that Sulindac's safety risks outweigh its medical
benefits, making it unreasonably dangerous, is not enough. Mutual
maintains.2 Instead, Mutual says, Bartlett must also prove that
Sulindac was "defective"--a concept that Mutual does not attempt
to define, but which it insists cannot be proven here, because
Sulindac "contains a single active ingredient" and therefore
"cannot be made safer, as one would expect of a product
containing a design defect."
There are a number of problems with this argument, but the
first (and most glaring) is that the New Hampshire Supreme Court
expressly rejected it in Vautour. There, the plaintiffs appealed
from a directed verdict entered against them on their strict
2In a footnote. Mutual suggests that Bartlett cannot prove
even that, because her expert witnesses "do not compare the
utility of Mutual's Sulindac to any other medications with
respect to their ability to relieve pain and inflammation or to
treat patients with . . . any other condition" and "have not even
addressed those benefits with respect to Sulindac itself."
Because Mutual is not urging reconsideration on this point (and
in fact did not even make this argument in support of its summary
judgment motion), the court need not consider it here--but will
do so at the appropriate point in the proceedings.
5
products liability claim, arguing that "the superior court erred
by reguiring them to prove an alternative design as an
additional element in the case." 147 N.H. at 153. The
defendant, however, urged the court "to adopt the Restatement
(Third) of Torts § 2(b) (1998), which reguires a plaintiff in a
design defect case to prove that the risks of harm posed by the
product could have been reduced or avoided by a reasonable
alternative design." Id. at 154. The court declined, reasoning
that "while proof an alternative design is relevant in a design
defect case, it should be neither a controlling factor nor an
essential element that should be proved in every case." Id. at
156. Instead, the court concluded, "the risk-utility test as
currently applied protects the interests of both consumers and
manufacturers in design defect cases." Id.
Under that test, the court explained, "a product is
defective as designed 'if the magnitude of the danger outweighs
the utility of the product.'" Id. at 154 (guoting William
Prosser et a l ., Prosser and Keeton on the Law of Torts § 99, at
699 (5th ed. 1984)). Thus, because the "plaintiffs presented
sufficient evidence that the [product at issue] was unreasonably
dangerous pursuant to the risk-utility balancing test," the
superior court "erroneously granted the defendant's motion for
directed verdict upon the plaintiffs' strict liability, design
6
defect claim. Under New Hampshire law, the plaintiffs' evidence
was sufficient to establish a prima facie case." Id. at 157.
Mutual's argument flies in the face of this explicit
holding, which the motion for reconsideration simply ignores.
Indeed, its only references to the case, express or implied, are
in (1) a string citation with a parenthetical that describes the
case as "involving [the] guestion of whether location of safety
stops constituted a defective condition making eguipment
unreasonably dangerous" and (2) a footnote that, in what appears
to be a tacit acknowledgment of Vautour, states that "[e]ven
though plaintiff might not be reguired to establish that a safer
alternative design exists, she must still prove that a defect
exists." First, while Vautour certainly "involved" the guestion
of the location of the safety stops on a leg press machine, the
plaintiff presented no evidence that changing the location of the
stops would have prevented his injury. 147 N.H. at 153. The New
Hampshire Supreme Court, however, specifically ruled that no such
evidence was necessary because, again, "the plaintiffs presented
sufficient evidence that the leg press machine was unreasonably
dangerous pursuant to the risk-utility test."
Id. at 157. So
Vautour reguires the rejection of Mutual's argument that, even if
Bartlett can adduce sufficient evidence that Sulindac's risks
outweigh its benefits, her strict products liability claim still
7
fails because she cannot prove that "a change in design would
have avoided the injury" she suffered.
Second, Mutual does not attempt to reconcile its view that a
plaintiff must prove that a product is "defective"--and cannot do
so by proving only that its risks outweigh its benefits--with its
concession that a plaintiff "need not prove that a safer
alternative design exists." This cries out for an explanation as
to how else a plaintiff proves that a product is defective in
design. Mutual offers none. Vautour, however, does. Again, it
expressly states that "a product is defective as designed if the
magnitude of the danger outweighs the utility of the product."
147 N.H. at 154 (guotation omitted). That is precisely how this
court articulated Bartlett's strict liability claim in the
summary judgment Order--"Sulindac is defective because its safety
risks outweigh its medical risks." Order at 23. So Mutual's
reguest for reconsideration rings hollow, particularly in the
absence of any effort to meaningfully address the Vautour
decision.3
3This court also notes that Mutual's view appears to be
inconsistent with comment k of the Restatement (Second) of Torts
§ 402A (1965), which allows manufacturers to avoid strict
liability for defective design if they can prove that their
product is important, unavoidably unsafe, and had an adeguate
warning. See Order at 24-26. There would be no need for comment
k if, as Mutual argues, the fact that a product cannot be more
safely designed is itself fatal to a strict products liability
In fairness to Mutual, the case on which it relies,
Buckingham, did reject the argument that " ’
'defect' is not a
'separate and distinct element of proof' from the 'unreasonably
dangerous' element" in affirming the dismissal of a plaintiff's
strict products liability claim against cigarette manufacturers.
142 N.H. at 825. The court reaffirmed that it recognizes "the
tort of strict liability as set out in the Restatement (Second)
of Torts § 402A," which "imposes liability for selling 'any
product in a defective condition unreasonably dangerous to the
user or consumer' when the product causes injury to the user or
consumer." Id. The court reasoned that if "a product is per se
defective if it is unreasonably dangerous, then it would be
redundant for section 402A to include both the terms 'defective'
and 'unreasonably dangerous.'" Id. at 826. The court found
further support for this reading in comment i to § 402A, which
states that it applies "'only when the defective condition of the
product makes it unreasonably dangerous to the user or consumer'"
and "cites several products, such as tobacco, whiskey, and
claim for defective design under New Hampshire law (regardless of
the product's importance or the adequacy of its warning).
Despite the fact that Mutual argued in moving for summary
judgment that "New Hampshire courts evaluate a design defect
claim involving a pharmaceutical product under comment k," its
motion for reconsideration does not address this apparent
inconsistency or mention comment k.
butter, that may be dangerous in their intended form . . . but
liability will not be imposed absent an additional ingredient
which the ordinary consumer would not expect to be present." Id.
Thus, the court ruled, "because the plaintiff has failed to
allege separately that cigarettes are ''defective' and
'unreasonably dangerous,' he has failed to state a claim upon
which relief may be granted."4 Id. Mutual, however, makes no
attempt to reconcile this holding with the New Hampshire Supreme
Court's subseguent decision in Vautour, which, again,
specifically held that a product is defective if its risks
outweigh its benefits so as to make it unreasonably dangerous.
147 N.H. at 154. A federal court exercising diversity
jurisdiction over a state-law action, like this court here, "must
apply the most recent statement of state law by the state's
highest court." Vitkus v. Beatrice Co.,
127 F.3d 936, 941-42
(10th Cir. 1997); see also, e.g., Brunner v. Hampson,
441 F.3d
457, 465 (6th Cir. 2006); Lamargue v. Mass. Indem. & Life Ins.
C o .,
794 F.2d 194, 196 (5th Cir. 1986); Middle Atl. Utils. Co. v.
S,M. Dev. Corp.,
392 F.2d 380, 384 (2d Cir. 1968); cf. Smith v.
4To like effect is the decision by another judge of this
court in Gianitsis v. Am. Brands, Inc., 685 F. Supp. 853, 856-57
(D.N.H. 1988) (Loughlin, D.J.), cited by both the New Hampshire
Supreme Court in Buckingham and Mutual here. Like Buckingham,
however, Gianitsis was decided prior to Vautour.
10
F .W . Morse & C o ., 76 F.3d 413, 429 (1st Cir. 1996) (following the
more "recently decided" New Hampshire Supreme Court case that
"speaks directly to the question," rather than an older opinion).
Insofar as Buckingham and Vautour are in conflict, then--a point
on which, again. Mutual offers no argument at all5--this court
must follow Vautour, as the New Hampshire Supreme Court's more
recent articulation of its strict products liability rule. See
also Kelleher v. Marvin Lumber & Cedar Co.,
152 N.H. 813, 831
(2005) ("'a product is defective as designed if the magnitude of
the danger outweighs the utility of the product'") (quoting
Vautour, 147 N.H. at 154).6
5Mutual does not argue, for example, that Buckingham, rather
than Vautour, applies here.
6Moreover, even assuming (contrary to the express holding of
Vautour, as followed in the Order and again here) that New
Hampshire law required Bartlett to prove a safer alternative
design, this court is skeptical of Mutual's argument, raised
repeatedly throughout this litigation, that because Sulindac is a
single "molecule and the molecule cannot be changed," no safer
alternative design could possibly exist. See, e.g.. Brown v.
Super. C t ., 751 P.2d 470, 478 (Cal. 1988) (expressing "serious[]
doubt" about such an argument, despite ruling as a matter of
California public policy that drug manufacturers should be
shielded from strict liability based on defective design). Even
in such cases, a plaintiff "might be able to prove that other,
less harmful drugs were available to prevent" the indicated
condition (here, for example, other NSAIDs), so "the benefit of
such alternate drugs could be weighed against the advantages of
[the defendant's drug] in making the risk/benefit analysis."
Id.
That has been one of Bartlett's main arguments from the
beginning.
11
Ill. Conclusion
New Hampshire law allows a plaintiff to recover in strict
products liability by showing that a product is defective in
design because its risks outweigh its benefits, and that the
plaintiff suffered injury as a result. See Vautour, 147 N.H. at
154. As our court of appeals has observed, this test applies not
just to "mass-produced items sold over the counter," but also to
prescription drugs. Brochu v. Ortho Pharm. Corp.,
642 F.2d 652,
655 (1st Cir. 1981) (applying New Hampshire law). That is the
law this court applied in the summary judgment Order, and will
continue to apply here. For the foregoing reasons. Mutual's
motion for reconsideration7 is DENIED.
SO ORDERED.
lante
United States District Judge
Dated: July 30, 2010
cc: Keith M. Jensen, Esq.
Bryan Ballew, Esq.
Patrick J. O'Neal, Esq.
Eric Roberson, Esq.
Christine M. Craig, Esq.
Timothy P. Beaupre, Esq.
Document no. 2 63.
12
Joseph P. Thomas, Esq.
Paul J. Cosgrove, Esq.
Jeffrey D. Geoppinger, Esq.
Linda E. Maichl, Esq.
Stephen J. Judge, Esq.
13
