Bartlett v. Mutual Pharmaceutical

Bartlett v. Mutual Pharmaceutical       CV-08-358-JL    1/5/11     P

                     UNITED STATES DISTRICT COURT
                       DISTRICT OF NEW HAMPSHIRE


Karen L. Bartlett

     v.                              Civil No. 08-cv-358-JL
                                     Opinion No. 

Mutual Pharmaceutical
Company, Inc.

                           OPINION & ORDER

     This products liability case arises out of severe and

permanent injuries, including blindness, that plaintiff Karen

Bartlett suffered after ingesting sulindac, a prescription drug

manufactured by the defendant. Mutual Pharmaceutical Company.

Bartlett brought claims against Mutual for strict liability

(defective design), strict liability (failure to warn), fraud,

and negligence under New Hampshire law.      This court granted

summary judgment to Mutual on nearly all of the claims.      See

Bartlett v. Mut. Pharm. Co., 

, 

, 

   (failure to warn, fraud, and part of

negligence claim); Bartlett v. Mut. Pharm. Co., 

,

, 

     (remainder of

negligence claim).    Bartlett proceeded to trial and prevailed on

her sole remaining claim, for defective design.      The jury found

in her favor and awarded her $21.06 million in compensatory

damages.
     Mutual has now renewed its motion for judgment as a matter

of law, see Fed. R. Civ. P. 50(b), arguing that Bartlett

presented insufficient evidence to support her claim and that the

claim is pre-empted by federal law.       Mutual has also moved, in

the alternative, for a new trial, see Fed. R. Civ. P. 59, arguing

that numerous errors at trial tainted the jury verdict and that

the damages award was excessive.       Both motions are denied.

Bartlett presented sufficient evidence for a reasonable jury to

conclude that sulindac's risks outweighed its benefits, making it

a defective product unreasonably dangerous to consumers.          Federal

law does not prohibit states from imposing liability on that

basis.   In light of the severe injuries that Bartlett suffered,

the damages award (though substantial) was within the acceptable

range.   And while no three-week trial is perfect. Mutual has not

identified any errors that would warrant setting aside the jury

verdict or retrying the case.

     To a large extent. Mutual's post-trial motions attempt to

escape the conseguences of its own tactical decisions.       For

example. Mutual accuses this court of expanding the scope of

manufacturer liability for injuries caused by products that

cannot be made safer.   But Mutual voluntarily withdrew an

affirmative defense, recognized by this court in its summary

judgment ruling, that would have relieved Mutual of liability if

it proved that sulindac was unavoidably unsafe and had an


                                   2
adequate warning.    See Bartlett, 

, 

.      Mutual also accuses Bartlett

of giving the jury an unbalanced view of sulindac's risks and

benefits.    But Mutual chose not to call any of its own witnesses

at trial, foregoing the opportunity to rebut Bartlett's evidence

and put sulindac in a better light.         Of course. Mutual was

entitled to employ any trial strategy it wished.         But, having

made those tactical decisions, it must live with the

consequences.    It is not entitled to another trial where it can

try a different strategy.



I.   Applicable legal standard

      "The standard for granting a Rule 50 motion [for judgment as

a matter of law] is stringent."     Malone v. Lockheed Martin Corp.,

 (1st Cir. 2010) .     Courts may set aside a jury's

verdict and award judgment as a matter of law "only when the

evidence points so strongly and overwhelmingly in favor of the

moving party that no reasonable jury could have returned a

verdict adverse to that party."       

    In making that

determination, the court must "view the evidence in the light

most favorable to the verdict, making no determination[] of [its]

own as to the credibility of witnesses or the weight of the

evidence."    Rodriguez-Garcia v. Miranda-Marin, 

(1st Cir. 2010).    It is the moving party's burden to "specify ...


                                  3
the law and facts that entitle [it] to the judgment."       Coons v.

Indus. Knife Co., 

 (1st Cir. 2010)      (quoting Fed.

R. Civ. P. 50(a)(2)).

        The standard for granting a motion for new trial under Rule

59 is more flexible.      "The district court has the power and duty

to order a new trial whenever, in its judgment, the action is

required to prevent injustice."      Rodriguez-Garcia, 

 65.    In making that determination, the court "is free to

independently weigh the evidence," including "the credibility of

the witnesses."      Jennings v. Jones, 

 (1st Cir.

2009).     But the court "cannot displace a jury's verdict merely

because [it] disagrees" with the outcome.      

   A new trial may

be granted "only if the verdict is against the law, against the

weight of the credible evidence, or tantamount to a miscarriage

of justice."     Crowe v. Marchand, 

 (1st Cir. 2007).

It is the moving party's burden to show that any "errors and

defects" at trial affected its "substantial rights."       Fed. R.

Civ. P. 61; see also Cabral v. U.S. Dep't of Justice, 

 (1st Cir. 2009) .



II .    Background

        In December 2004, Bartlett sought medical treatment for pain

in her right shoulder.      Her doctor prescribed a non-steroidal

anti-inflammatory drug ("NSAID") called Clinoril.       A nearby


                                    4
pharmacy filled the prescription with sulindac, a generic version

of the drug manufactured by Mutual.       Within weeks, Bartlett went

to the emergency room complaining of skin blisters, eye

irritation, and other symptoms.        She was soon diagnosed with

Stevens-Johnson Syndrome   ("SJS") progressing to toxic epidermal

necrolysis   ("TEN"), a serious and potentially fatal condition

characterized by necrosis of the skin and mucous membranes.           See

Borland's Illustrated Medical Dictionary 1872 (31st ed. 2007) .

Her doctors concluded that the SJS/TEN was caused by sulindac.

She spent about three months in the hospital recovering--two of

them in a medically induced coma--and emerged with permanent

injuries, including blindness.

     Bartlett brought suit against Mutual in New Hampshire

Superior Court in January 2008, asserting claims for strict

liability (defective design) , strict liability (failure to warn),

fraud, and negligence under New Hampshire law.        She had three

principal theories of liability:        (1) that Mutual failed to warn

adeguately about sulindac's risk of SJS/TEN;       (2) that Mutual

failed to survey the medical literature for information about

sulindac's risks and to report that information to the Food &

Drug Administration   ("FDA"); and (3) that sulindac's risks

outweighed its benefits, making it a defective product

unreasonably dangerous to consumers.       Mutual removed the case to

this court, see 

, which has subject-matter


                                   5
jurisdiction based on diversity of citizenship, see 

 (a) (1) .

      At first, the litigation focused primarily on Bartlett's

failure-to-warn theory.     Mutual moved for judgment on the

pleadings, see Fed. R. Civ. P. 12(c), arguing that the Hatch-

Waxman Amendments to the Federal Food, Drug, and Cosmetic Act

("FDCA"), 

 et seg., and related FDA regulations

barred a manufacturer from unilaterally changing the warning for

a generic drug, which must remain identical to that of the brand-

name drug, and therefore pre-empted Bartlett's claims.         This

court denied the motion, concluding that federal law allowed such

changes and did not pre-empt Bartlett's claims.         See Bartlett v.

Mut. Pharm. C o ., 

 (D.N.H. 2009); accord Demahy

v . Actavis, Inc., 

   (5th Cir. 2010), cert, granted, 

    (U.S. Dec. 10, 2010)   (No. 09-1501); Mensing v.

Wyeth, Inc., 

 (8th Cir. 2009), cert, granted, 

    (U.S. Dec. 10, 2010)   (No. 09-993).

      Mutual then moved for summary judgment, see Fed. R. Civ. P.

56, arguing that sulindac's warning was adeguate as a matter of

law and that, in any event, Bartlett could not prove that any

defect in the warning caused her injuries because her doctor

admittedly never read the warning before prescribing sulindac.

This court rejected the first argument, finding that the adeguacy

of sulindac's warning was for the jury to decide        (sulindac's


                                   6
label expressly mentioned SJS/TEN in its list of potential

adverse reactions, but not in its warnings section) .   See

Bartlett, 

, 

.   But this court agreed with the second argument, as to

the lack of causation, and therefore granted summary judgment to

Mutual on Bartlett's claims for strict liability (failure to

warn) and fraud, as well as her negligence claim to the extent it

was based on a failure-to-warn theory.   

, 

.

     After that ruling, this court sua sponte ordered the parties

to brief whether Bartlett had a trialworthy claim for negligence

based on her second theory:   that Mutual failed to survey the

medical literature for information about sulindac's risks and to

report that information to the FDA.   Bartlett's brief made clear

that the theory depended on speculation that the FDA, if advised

of that information, would have withdrawn its approval of

sulindac in whole or in part, contrary to what had actually

happened (sulindac remains on the market to this day, with FDA

approval).   Accordingly, this court granted summary judgment to

Mutual on the remainder of Bartlett's negligence claim.       See

Bartlett, 

, at *4-12, 

,

at *12-36.   As a result, Bartlett also lost any ability to

recover enhanced compensatory damages, since her claim for those

damages was based on her failure-to-warn and failure-to-survey


                                 7
theories.   

, at *12-13, 

, at *36-40.1

     Those rulings left Bartlett with only one theory for trial:

that sulindac's risk outweighed its benefits, making it a

defective product unreasonably dangerous to consumers.   Mutual

challenged that theory as well   (albeit not until a motion for

reconsideration of this court's summary judgment ruling), arguing

that New Hampshire law reguires a plaintiff to prove, in addition

to the product's risks outweighing its benefits, some other

"defect" in design.    See Buckingham v. R.J. Reynolds Tobacco Co.,

 (1998).   But this court disagreed, explaining that

under more recent New Hampshire Supreme Court cases "a product is

defective as designed if the magnitude of the danger outweighs

the utility of the product," Bartlett v. Mut. Pharm. Co., 

, 

, at *3, 

, at

*7 (guoting Vautour v. Body Masters Sports Indus., Inc., 

 (2001)), and "the plaintiff is not reguired to present

evidence of a safer alternative design, " Bartlett v. Mut. Pharm.

Co., 

, at *1, 

, at *3




     1Using a similar sua sponte procedure, this court also
granted summary judgment to Bartlett on certain of Mutual's
affirmative defenses that were based on the alleged misconduct of
Bartlett and her doctor, concluding that the defenses were not
sufficiently supported by the necessary expert testimony.   See
Bartlett v. Mut. Pharm. Co., 

, 

(document no. 340).

                                  8
(document no. 336)   (quoting Kelleher v. Marvin Lumber & Cedar

Co., 

 (2005)).

     Nevertheless, this court agreed with Mutual that if a drug

cannot be redesigned to make it safer, the manufacturer's

liability must be limited.   Following the view set forth in the

Restatement   (Second) of Torts § 402A, cmt. k (1965), this court

ruled that Mutual could "avoid liability for defective design if

it can prove, as an affirmative defense, that sulindac is

unavoidably unsafe and had an adequate safety warning."

Bartlett, 

, 

; see also 1 Louis R. Frumer & Melvin I. Friedman,

Products Liability §8.07[5], at 8-296 (2010)     (noting that because

comment k "is traditionally viewed as an exception and a defense

to strict liability, courts generally place the initial burden of

proving the various ... factors on the defendant").       Mutual,

however, voluntarily withdrew that "comment k" defense on the eve

of trial, without explanation.    See document no. 332.

     With Bartlett's failure-to-warn theory and Mutual's "comment

k" defense out of the case, the adequacy of sulindac's warning

(meaning whether it reasonably informed doctors of the drug's

risks, see Brochu v. Ortho Pharm. Corp., 

 (1st

Cir. 1981))2 was no longer an issue for trial.     Mutual argued


     2Brochu is one of just a handful of decisions, all of them
by federal courts, that have applied New Hampshire products
liability law to prescription drugs.   It is also one of the
that this court should therefore exclude all warning-related

evidence and instruct the jury to analyze sulindac's risks and

benefits "without regard to the warning."   But since a warning

can affect a drug's risks and benefits   (e.g., by explaining how

to use the drug safely, or by identifying certain patients who

should not take it), this court concluded that the proposed

instruction would provide no real guidance to the jury; either

the drug's risks and benefits must be weighed as if it had no

warning at all,3 or they must be weighed in light of the warning

that actually accompanied it.   See Bartlett v. Mut. Pharm. Co.,

, at *3, 

, at *10

(document no. 345).

     Following a line of New Hampshire Supreme Court cases, which

expressly stated that the jury in a defective design case may

consider "the presence and efficacy of a warning to avoid an

unreasonable risk of harm," Vautour, 

, this court

ruled that warning-related evidence could be admitted at trial

for a limited purpose:   if the jury found that sulindac's risks




leading cases establishing that drug manufacturers can be held
liable not only on a failure-to-warn theory, but also on a
defective design theory.  

 (rejecting the view
"that under New Hampshire's balancing test no drug can ever be
classified as unreasonably dangerous").

     3Mutual would not accept this approach as a means of keeping
warning-related evidence out of the case.   Instead, Mutual wanted
the jury to assume that sulindac had the best possible warning,
which was contrary to the evidence.

                                10
outweighed its benefits, then it could consider whether the

warning--regardless of its adeguacy--reduced those risks or

increased those benefits to such an extent that it eliminated the

unreasonable danger.    In other words, the warning could operate

only to Mutual's benefit.    Bartlett needed to prove that

sulindac's risks outweighed its benefits "despite its warning,

not because of it."    Bartlett, 

, at *1, 

, at *4.

     This court also ruled on many other evidentiary and

procedural issues in advance of trial, including nearly 50

challenges to expert witnesses and testimony, see Bartlett v.

Mutual Pharm. Co., 

, 

, at *1, 

 (ruling that "[t]he parties'

experts have sufficient gualifications and a sufficient

foundation to support most of their proffered opinions"), and

nearly 50 motions in limine, see Bartlett v. Mut. Pharm Co., 

, 

    (document no. 278)    (ruling on Bartlett's

limine motions); Bartlett v. Mut. Pharm. Co., 

, 

, 

 (ruling on Mutual's

limine motions), as well as Mutual's motion to bifurcate the

trial into separate liability and damage phases, see Bartlett v.

M ut. Pharm. C o ., 

    (document no. 320)   (denying the

motion because bifurcation would result in duplication of

evidence and other inefficiencies).


                                  11
     Trial began in August 2010 and lasted nearly three weeks.

Bartlett presented testimony from herself, her sister (Barbara

Mourikas), two friends who were with her on the day she fell ill

(Lynda Mailhot and Rebecca Padulo), eight doctors who treated her

for various different injuries resulting from SJS/TEN (primary

care physician Leo Lane, burn surgeons Nam Kim, Colleen Ryan, and

John Schulz, eye surgeons Claes Dohlman and James Chodosh,

pulmonologist Bijan Sadrnoori, and gynecologist Steven Pliskow),

two Mutual employees   (Robert Dettery and Andria Werynski), two

retained expert witnesses who opined about sulindac's risks and

benefits   (pharmacologist Randall Tackett and burn surgeon Roger

Salisbury), and two retained experts who opined about Bartlett's

economic damages   (economist Thomas Barocci and life care planner

Carol Hyland).

     Mutual cross-examined Bartlett's witnesses, but chose not to

present any witnesses of its own (aside from designating

additional testimony by certain unavailable fact witnesses whose

testimony Bartlett presented by deposition).   At the close of

evidence. Mutual moved for judgment as a matter of law, see Fed.

R. Civ. P. 50(a)(2), which this court orally denied.    On the

fourth day of deliberations, the jury returned a verdict in

Bartlett's favor, finding that she had proven her claim for

strict liability (defective design) by a preponderance of the

evidence and awarding her $21.06 million in damages, consisting


                                 12
of $1.25 million for past medical expenses      (to which the parties

had stipulated),    $2,377 million for future medical expenses,

$933,000 for lost wages, and $16.5 million for pain, suffering,

and loss of enjoyment of life.     See document no. 381.

       This court entered judgment in accordance with the verdict

and the earlier summary judgment rulings.       See document no. 389.

Mutual then renewed its motion for judgment as a matter of law,

see Fed. R. Civ. P. 50(b), arguing that Bartlett presented

insufficient evidence to support her claim and that the claim is

pre-empted by federal law.     Mutual also moved, in the

alternative, for a new trial, see Fed. R. Civ. P. 59, arguing

that numerous errors at trial tainted the jury verdict and that

the amount of damages was excessive.       The execution of judgment

has been stayed pending the resolution of those post-trial

motions and any subseguent appeal.       See Bartlett v. Mut. Pharm.

C o ., 

, 

    (document no.

406)   (applying Fed. R. Civ. P. 62).    This court will now analyze

each of Mutual's arguments in turn.



Ill.   Analysis

A. Sufficiency of the evidence

       i.   Risks outweighing benefits

       The first issue raised by Mutual's Rule 50 motion is whether

Bartlett presented sufficient evidence for a reasonable jury to


                                  13
find that sulindac's risks outweighed its benefits.     The New

Hampshire Supreme Court has stated that, "barring a determination

that the utility of the product completely outweighs the risk

associated with its use or that the risk of harm is so remote as

to be negligible," the weighing of risks and benefits is a

"guestion[] of fact to be decided by the jury."    Price v. BIC

Corp., 

 (1997)   (citing Thibault v. Sears,

Roebuck & C o ., 

 (1978)).4 As explained below,

this court cannot make either of those risk-benefit

determinations as a matter of law in light of the evidence that

Bartlett presented.   Mutual's challenge to the sufficiency of

that evidence is therefore rejected.

      As an initial matter. Mutual argues that Bartlett's experts

(Drs. Tackett and Salisbury) were not gualifled to testify at all

about sulindac's risks and benefits, because neither works

directly with sulindac and other NSAIDs.   "It is not reguired,"

however, "that experts be 'blue-ribbon practitioners' with

optimal gualifications," United States v. Vargas, 

   (1st Cir. 2006), or that they have "an intimate level of

familiarity with every component of a [product] as a prereguisite

to offering expert testimony," Crowe, 

.     They need

only be "gualified as an expert by knowledge, skill, experience,


      4State law governs the sufficiency inguiry in a diversity
case.   See, e.g., Soto-Lebron v. Fed. Express Corp., 

 (1st Cir. 2 008).

                                  14
training, or education."    Fed. R. Evid. 702; see also Levin v.

Dalva Bros., Inc., 

 (1st Cir. 2006)          ("Rule 702 has

been interpreted liberally in favor of the admission of expert

testimony.").

     Both of Bartlett's experts easily met that standard.           Dr.

Tackett has been a pharmacologist for more than 30 years and is a

pharmacology professor at the University of Georgia.          Dr.

Salisbury has been a burn surgeon for more than 35 years and has

treated more than 400 patients with SJS/TEN.          Both have

demonstrated familiarity with the medical literature on

sulindac's risks and benefits, as well as NSAIDs and SJS/TEN more

generally.    They were gualified to testify on those topics.         See

Bartlett, 

, at *13, 

    (deeming Drs. Tackett and Salisbury gualified before

trial); Lofton v. McNeil Consumer & Specialty Pharms., No. 05-cv-

1531, 

, at *9-10, 

, at

*28-30   (N.D. Tex. July 25, 2008)        (allowing them to testify in a

similar case involving an NSAID that allegedly caused SJS/TEN,

citing their "extensive experience").

     Mutual also argues that Bartlett's experts should have been

prohibited from testifying about sulindac's risks and benefits

because their expert reports--like much of the early litigation--

focused primarily on Bartlett's failure-to-warn theory, not her

defective design theory.    See Fed. R. Civ. P. 26(a)(2)(B)(I)


                                     15
(requiring pre-trial disclosure of "all opinions that the witness

will express").     But the reports were filled with opinions about

sulindac's risks and benefits, which were clearly relevant to the

defective design theory as well.       "The purpose of expert reports

is to ... convey the substance of the expert's opinion ... so

that the opponent will be ready to rebut [and] cross examine."

Metavante Corp. v. Emigrant Sav. Bank, 

      (7th

Cir. 2010).    Bartlett's expert reports accomplished that purpose,

as evidenced by Mutual's "able cross-examination" of the experts

at trial.     

     Mutual notes that Bartlett's experts never opined that

sulindac was "unreasonably dangerous," which is the ultimate

issue in a defective design case.       That is true; this court

prohibited them from using that particular phrase at trial

because they had not used it in their expert reports.       But they

did expressly state in their reports, and testify at trial, that

sulindac's risks outweighed its benefits, which is what the

phrase "unreasonably dangerous" means in this context.       See

Vautour, 

.     There is no requirement that experts

utter the magic words "unreasonable danger" for a plaintiff to

recover for defective design.5     C f . Kelleher, 

     5Indeed, before this court granted summary judgment on
Bartlett's negligence claim. Mutual argued--successfully--that no
expert should be allowed to utter the word "negligent." See
Bartlett, 

, at *12, 

.

                                  16
(rejecting "the defendant's assertion that the plaintiff was

required to use the exact phrase,    'unreasonably dangerous,' to

adequately plead" a defective design claim).

     As for the opinion that sulindac's risks outweighed its

benefits. Mutual argues that it was merely a "passing reference,

without support."   But Bartlett's experts supported the opinion

with a litany of specific facts, most of them drawn directly from

the medical literature or published FDA analyses.    They

testified, for example, to the following:

•    Causation of SJS/TEN.   Sulindac is one of many drugs,
     including nearly every NSAID and nearly every antibiotic,
     that can cause SJS/TEN.   This causal link has been confirmed
     by positive re-challenges, i.e., cases where patients who
     had previously developed SJS/TEN after taking sulindac
     developed it again after re-administration of the drug.
     See, e.g., Glen D. Park et al.. Serious adverse reactions
     associated with sulindac, 142 Archives of Internal Medicine
     1292-94 (1982).6

•   Background rate of SJS/TEN.   The background rate of SJS
     associated with drug therapy is 1.2 to 6 per million
    prescriptions, and the background rate of TEN (the more
     serious form of the disease) is 0.4 to 1.2 per million
    prescriptions, according to FDA estimates.   See Letter from
     Steven K. Galson, Director, FDA Center for Drug Evaluation &
     Research, to Dr. Salisbury, at 5 (June 22, 2006) (document
     no. 310-1) (citing medical literature).

•   Group risk of SJS/TEN. While no controlled study has
    measured its individual risk of SJS/TEN, sulindac is part of
     a group of NSAIDs, known as acetic acid NSAIDs, that has
    been shown to have a greater risk of SJS/TEN than another


     6Bartlett's experts were permitted to express opinions based
on the medical literature, see Fed. R. Evid. 703, but the
articles themselves were not admitted as exhibits because they
were hearsay not subject to any identified exception, see Fed. R.
Evid. 801-803.

                                17
     group, known as propionic acid NSAIDs, in a controlled
     study.  See Maja Mockenhaupt et al., SJS and TEN: assessment
     of medication risks with emphasis on recently marketed
     drugs; the EuroSCAR-study, 128 Journal of Investigative
     Dermatology 35, 41 (2008).  In addition, sulindac is one of
     the NSAIDs with longer half-lives, which are suspected of
     having a greater risk of SJS/TEN because they stay in the
     body longer.  See, e.g., Pierre E. Wolkenstein et al.. Druginduced TEN, 16 Clinics in Dermatology 399, 403 (1998).

    Adverse event reports of SJS/TEN.1 From 1980 to 1997, the
    FDA's adverse event reporting database--which collects
    spontaneous reports of drug side effects from doctors,
    manufacturers, patients, etc.--received 89 reports of
    SJS/TEN attributed to sulindac, more than the number of
    reports for any other NSAID on the market and all but four
    drugs of any kind.   See Maja Mockenhaupt et al.. The risk of
    SJS and TEN associated with NSAIDs: a multinational
    perspective, 30 Journal of Rheumatology 2234 (2003)
     (document no. 230-4). Through 2004, the number of SJS/TEN
    reports attributed to sulindac had increased to 134.8 In 39


     Consistent with a pre-trial ruling, this court allowed
Bartlett's experts to "testify based on the [adverse event]
reports," Bartlett, 

, at *1, 

, at *1-4, but excluded the reports themselves from
evidence because they were hearsay not subject to any identified
exception, see Fed. R. Evid. 801-803.   The pre-trial ruling left
open the possibility that the reports themselves could be
admitted to show notice to Mutual (i.e., not for their truth),
but that became irrelevant once Bartlett's negligence claim was
dismissed. Mutual seems to misunderstand that ruling as limiting
the experts' reliance on adverse event reports to notice issues,
which by its plain language it did not.

     8Bartlett's experts originally miscounted the number of
reports at 17 6, which included many duplicates.  They corrected
the number at trial.   This court instructed the jury that it
could draw an inference against Dr. Tackett's credibility because
he failed to disclose the errors before trial. Mutual argues
that this court should have gone further and excluded all of the
experts' testimony as unreliable.   But, as this court explained
in rejecting Bartlett's pre-trial motion to exclude one of
Mutual's experts who made a computational error, such errors
generally go to the weight, not the admissibility, of expert
testimony.   See Bartlett, 

, at *11, 

 (citing cases). Moreover, even

                               18
     of those cases, the patient died. According to FDA
     estimates, more than 90 percent of adverse events go
     unreported.

     Reporting rate of SJS/TEN.  Sulindac's rate of SJS/TEN
     reports from 1980 to 1997, per million prescriptions, was
     the highest of any NSAID, according to an unpublished
     manuscript (document no. 230-2) prepared for the drug
     company Pharmacia by the authors of the Journal of
     Rheumatology article just mentioned (one of whom was
     Mutual's own expert, dermatologist Robert Stern).9

     Risks other than SJS/TEN. According to a recent FDA
     analysis, there is no evidence that any one NSAID--including
     sulindac--is more or less risky than other NSAIDs with
     regard to various other known side effects, including
     gastrointestinal bleeding, renal toxicity, hepatic enzyme
     elevation, bronchospasm, fluid retention, and edema.   See
     John K. Jenkins, Director, FDA Office of New Drugs, Analysis
     and recommendations for Agency action regarding NSAIDs and
     cardiovascular risk 12 (Apr. 6, 2005) (document no. 309-
     1) .10

     Benefits.  Sulindac has been approved by the FDA for
     treatment of acute painful shoulder and various arthritic


without their own count, Bartlett's experts had an independent
and reliable basis for testifying about sulindac's high number of
SJS/TEN reports:  the Journal of Rheumatology article.  If
anything, the errors helped Mutual by giving it a way to counter
that evidence (which is presumably why Mutual waited until trial
to expose the errors, rather than seeking exclusion when it, too,
noticed them before trial).

     9Mutual argues that Bartlett's experts failed to disclose
this opinion in their expert reports.   See Fed. R. Civ. P.
26(a)(2)(B)(i). But Dr. Tackett expressly stated in his report
that the authors of the Journal of Rheumatology article "found
when analyzing the number of reports per physician office visits
with a prescription, sulindac had significantly and substantially
higher rates of reported SJS/TEN reactions ... compared to other
NSAIDs." So the opinion was disclosed.

     10This court admitted the FDA analysis into evidence as a
full exhibit, since it was a self-authenticating public record
available on the FDA's website.   See Fed. R. 803(8) (hearsay
exception) and 902 (self-authentication) .

                               19
     conditions (acute gouty arthritis, rheumatoid arthritis,
     osteoarthritis, and ankylosing spondylitis). It is the only
     NSAID approved to treat the first two conditions.
     Nevertheless, according to a recent FDA analysis, there is
     no evidence that any one NSAID--including sulindac--provides
     greater relief of pain and inflammation than other NSAIDs.
     See Jenkins, supra, at 2.11

     Risk/benefit profile. The FDA has recommended that five
     NSAIDs be removed from the market due, in part, to their
     risk of SJS/TEN as demonstrated by adverse event reports
     (sometimes fewer than 15). While sulindac has not been
     removed from the market, it has a similar "risk/benefit
     profile" to valdecoxib (known by the brand name Bextra), one
     of the removed NSAIDs, in that neither drug has a
     demonstrated advantage over other NSAIDs with regard to
     their benefits or various known risks other than SJS/TEN,
     see id. at 2, 12, both drugs had a higher reporting rate of
     SJS/TEN than other NSAIDs, see id. at 17, and sulindac had
     more reported deaths from SJS/TEN (39) than did Bextra (7),
     see id.12

     Safer alternative products.  Two alternatives to sulindac,
     aspirin and acetaminophen (known by the brand name Tylenol),




     “ Mutual argues that Bartlett's experts failed to disclose
this opinion and the one discussed in the previous paragraph.
See Fed. R. Civ. P. 26(a)(2)(B)(I). But both experts expressly
cited the FDA's analysis in their reports and guoted its
statement that Bextra, another NSAID, lacked "any demonstrated
advantage over other NSAIDs." Their reports then stated that
sulindac had a similar "risk/benefit profile" to Bextra.   So
Mutual was on notice that Bartlett's experts would testify, based
on the FDA's analysis, that sulindac also lacked any demonstrated
advantage over other NSAIDs.

     “ Mutual argues that this Bextra comparison should have been
excluded as unreliable because, as Bartlett's experts
acknowledged, Bextra had been on the market for a much shorter
period of time (about 3.5 years, compared to sulindac's then-27)
and had more SJS/TEN reports (189) than sulindac (133). But
those differences went to the weight of the comparison, not its
admissibility.   The jury could weigh both the similarities and
the differences between Bextra and sulindac.

                                20
     carry no risk of SJS/TEN, at least in adults,13 and are
     equally effective as sulindac, at least in treating
     conditions like shoulder pain (for which Bartlett took
     sulindac). While they carry some additional risks that
     sulindac does not (e.g., aspirin can cause Reye's syndrome)
     and may not be equally effective in treating every condition
     that sulindac treats, they also provide additional benefits
     that sulindac does not.   Overall,they are safer alternative
     products.

     Mutual faults Bartlett's experts for focusing primarily on

sulindac's risk of SJS/TEN and failing to consider all of its

other risks and its benefits.    As just mentioned, however,

Bartlett's experts   (while acknowledging sulindac's approved uses)

testified broadly that there is no evidence that sulindac has any

greater benefit than other NSAIDs, or any lesser risk of various

known side effects other than   SJS/TEN.    They based that testimony

on a recent FDA analysis, see Jenkins,     supra, at 2, 12, which

resulted from what the FDA called "a comprehensive review of the

risks and benefits, including the risks of SJS and TEN, of all

approved NSAID products," Galson, supra, at 2, and which was

admitted into evidence as a full exhibit.     So their risk/benefit

analysis was sufficiently comprehensive.14



     13Dr. Tackett acknowledged on cross-examination that a
recent study indicated a possible link between Tylenol and
SJS/TEN in children.   See Natacha Levi et al.. Medications as
risk factors of SJS/TEN in children:   a pooled analysis, 12 3
Pediatrics 297 (2009).

     14Bartlett's experts also relied on another piece of
evidence that contained an extensive summary of sulindac's risks
and benefits, and that was admitted into evidence as a full
exhibit:   sulindac's label, or "package insert." The label
described in detail each of sulindac's approved uses, including

                                 21
     Mutual argues that this court should have prohibited

Bartlett's experts from relying on the FDA's analysis, in light

of their testimony that the FDA has insufficient resources to

monitor the safety of all drugs, which is how Bartlett's experts

attempted to downplay the FDA's approval of sulindac.      See Wyeth

v. Levine, 129 S. C t . 1187, 1202 (2009)   (noting that "FDA has

limited resources to monitor the 11,000 drugs on the market" and

that, as discussed in Part III.B.i, infra, FDA approval does not

preclude state tort liability).    That was indeed a theoretical

tension in Bartlett's case, and one that Mutual highlighted for

the jury during closing argument.15    But it went to the weight,

not the admissibility, of the experts' opinions.     A reasonable

jury could have agreed with Bartlett's experts that the FDA was

right about some things, but wrong about others.16



the benefits it had been shown to have in controlled studies, and
each of its known side effects other than SJS/TEN, including
their estimated rates of occurrence.

     150f course. Mutual faced the opposite theoretical tension:
attacking the FDA's recent analysis of NSAIDs as unreliable,
while simultaneously emphasizing the FDA's approval of sulindac
to suggest it was not unreasonably dangerous.

     16Mutual also argues that Bartlett's experts lacked a
reliable basis for testifying about the FDA's limited resources.
But their testimony was based primarily on two government
reports, see U.S. Gov't Accountability Office, GAO-06-402,
Improvement Needed in FDA's Postmarket Decision-making and
Oversight Process (2006); H. Subcomm. on Science and Technology,
FDA Science and Mission at Risk (2007), which were admitted into
evidence as full exhibits, see Fed. R. Evid. 803(8) (hearsay
exception) and 902 (self-authentication); see also Fed. R. Evid.
703 (permissible bases of expert testimony).

                                  22
     If Mutual had evidence to refute the FDA's analysis, such as

evidence that sulindac is more beneficial than other NSAIDs or

that it has less risk of certain side effects other than SJS/TEN,

then Mutual could have presented that evidence at trial in its

own case (or, at the very least, confronted Bartlett's experts

with it).   A plaintiff bringing a claim for defective design

cannot be expected to sing the praises of the allegedly defective

product, or to put the product in the best possible light.      So

far as this court can tell. Mutual chose not to present its own

experts because it feared that they would actually strengthen,

not weaken, Bartlett's case.17

     Next, Mutual argues that Bartlett presented insufficient

evidence for the jury to evaluate sulindac's risk of SJS/TEN.        As

just mentioned, however, Bartlett's experts testified at length

on that issue, opining that sulindac has been confirmed to cause

SJS/TEN; that the background rate of SJS/TEN is as many as six

cases per million prescriptions; that sulindac is part of two

groups of NSAIDs   (acetic acid NSAIDs and longer half-life NSAIDs)

believed to have a higher risk of SJS/TEN; that the FDA received

133 reports of SJS/TEN attributed to sulindac over the last 25

years; that 39 of those reported cases resulted in death; that




     17Indeed, one of Mutual's designated experts. Dr. Stern, co­
authored the Journal of Rheumatology article, on which Bartlett's
experts relied, that noted sulindac's high number and rate of
SJS/TEN reports.

                                 23
sulindac had both a higher number, and a higher rate, of reported

cases than any other NSAID from 1980 to 1997   (and the fifth-most

of any drug); and that some alternatives to sulindac carry no

risk of SJS/TEN.

     Mutual argues that this court should have prohibited

Bartlett's experts from relying on adverse event reports, since

such reports are anecdotal, sometimes unverified or incomplete,

and can be influenced by non-random factors.18   "To be sure,

[both parties] agree that adverse event reports--whether

published in safety databases or the medical literature--have

significant limitations."   In re Neurontin Mktg., Sales Practices

& Prods. Liab. Litig., 

 (D. Mass. 2009)

(Saris, J.).   For precisely the reasons that Mutual cites, they

"do not provide as much information as controlled epidemiological

studies do."   

 (guoting McClain v. Metabolite Int'l, Inc., 

   (11th Cir. 2005), and also citing In re Baycol

Prods. Litig., 

 (D. Minn. 2007), both

of which excluded expert testimony based on adverse event

reports).




     18One such influence, which Bartlett's experts acknowledged
at trial, is known as the "Weber effect." See J.C.P. Weber,
Epidemiology of adverse reactions to NSAIDs, 6 Advances in
Inflammation Research 1-7 (1984) (finding that adverse event
reporting peaks about two years after a drug enters the market).

                                 24
     As in many cases involving rare side effects, however, no

controlled study of sulindac's SJS/TEN risk is currently

available.   Under such circumstances, "[c]ourts may, and often

do, rely on ... adverse event data" to inform the analysis of a

drug's risks.     

 at 153 (citing In re PPA Prods. Liab. Litig.,

 (W.D. Wash. 2003)); see also, e.g.. In

re Fosamax Prods. Liab. Litig., 

(S.D.N.Y. 2009)    (noting that the admissibility of such data "may

depend on case-specific circumstances," and stressing the

"rarity" of the disease and the "relatively high number" of

reports as reasons for admitting it).       Despite its limitations,

such data has significant probative value and is "reasonably

relied upon by experts in the [pharmacological] field in forming

opinions and inferences."    Fed. R. Evid. 703.

     Indeed, Mutual's own designated expert Dr. Stern (and his

co-authors) expressly relied on adverse event data in their peer-

reviewed Journal of Rheumatology article on "The risk of SJS/TEN

associated with NSAIDs," which served as the basis for much of

Bartlett's expert testimony on this issue.       See, e.g.,

Mockenhaupt 2003, supra, at 2238       ("To identify NSAID[s] widely

used in the US ... that have risks of SJS and TEN comparable to

those of piroxicam [which had a "high risk" in a controlled

study], we compared spontaneous reporting rates for all

NSAID[s]," per million prescriptions, and "identified four


                                  25
NSAID[s]    ... with spontaneous reporting rates comparable to those

of piroxicam:    diflunisal, sulindac, oxaprozin, and etodolac.")

(emphasis added) .19

     The FDA also expressly relied on adverse event data in its

recent risk/benefit analysis of NSAIDs.     See, e.g., Jenkins,

supra, at 17 (noting that the "reporting rate of [SJS/TEN]

appears to be greater for Bextra than other" NSAIDs).     This court

is not prepared to deem it unreasonable, as a matter of law, for

Bartlett's experts to have done the same thing that a peer-

reviewed medical journal. Mutual's own expert, and the FDA have

all done.    See, e.g., Crowe, 

 ("Rule 703 was

enacted in part 'to bring the judicial practice into line with

the practice of the experts themselves when not in court.'")

(guoting Fed. R. Evid. 703, advisory committee notes    (1972));

Ramirez v. Debs-Elias, 

 (1st Cir. 2005)

("scholarly literature is information reasonably relied upon by

medical experts").




     19A s this guotation makes clear, there is no basis for
Mutual's assertion that "the [unpublished] Pharmacia report's
conclusion about sulindac's reporting rate was, essentially,
abandoned by Dr. Stern and his co-authors in [their] subseguent,
peer-reviewed article." The article expressly mentioned that
sulindac had one of the five highest reporting rates among
NSAIDs.

                                  26
     It is important to note, moreover, that Mutual extensively

cross-examined Bartlett's experts about the limitations of

adverse event data, and this court also took a number of steps to

prevent them from overstating its significance as a measure of a

drug's risk.   The experts were reguired, for example, to use the

phrase "reporting rate" in describing adverse event data, rather

than "incidence rate," "occurrence rate," "rate" alone, or

"relative risk."20   This court also gave a strong cautionary

instruction to the jury, both during the expert testimony and

again in the final jury charge:

     You have heard testimony about the alleged number of
     adverse event reports of SJS/TEN associated with
     sulindac and other drugs, and about their alleged
     "reporting rates." In the context of this trial, a
     "reporting rate" means the number of adverse event
     reports for a drug divided by the number of
     prescriptions for a drug. You should not confuse
     "reporting rate" with the rate at which SJS/TEN
     actually occurs with a drug.  Those are two different
     concepts.  You have not heard any testimony about the
     actual occurrence rate of SJS/TEN with sulindac
     individually, as compared with other individual drugs,
     except for those drugs that allegedly do not have any
     risk of SJS/TEN.


     20This court orally vacated a pre-trial ruling to the extent
that it would have allowed Bartlett's experts to testify about
"relative risk" based on adverse event reports.   See Bartlett,

, at *14, 

.
Mutual complains that this court nevertheless allowed Bartlett's
experts to compare sulindac's "risk-benefit profile" to that of
Bextra based, in part, on such reports. As this court explained
in front of the jury, however, "risk/benefit profile" means the
available information on "all risks and all benefits," not the
incidence rate of SJS/TEN in particular.   To the extent that
there may have been any confusion on that point, this court cured
it with the cautionary instruction set forth infra.

                                  27
Document no. 378, at 18.

     Mutual argues that, without any evidence of sulindac's

actual incidence rate of SJS/TEN, the jury had no reasonable

basis to "quantify" the risk.    But that assumes that the only way

to quantify risk is through a controlled study of the individual

drug (Bartlett's experts did testify about a controlled study of

acetic acid NSAIDs as a group, which found a higher risk of

SJS/TEN), and hence that a plaintiff cannot prevail without such

a study.   It is easy to understand why Mutual would prefer such a

requirement, since controlled studies can be hard for plaintiffs

to come by, especially for side effects as rare as SJS/TEN.     But

this court is not persuaded that the New Hampshire Supreme Court

would set the bar so high.    C f . Vautour, 

(allowing jury to make risk/benefit determination despite

limitations in expert testimony).

     Bartlett's experts quantified sulindac's risk of SJS/TEN in

other ways.   They testified, for example, that the FDA received

133 reports of SJS/TEN attributed to sulindac over the past 25

years, 39 of which resulted in death, and that more than 90

percent of cases go unreported, according to FDA estimates.     From

that testimony, the jury reasonably could have inferred that

sulindac probably caused more than a thousand cases of SJS/TEN,

and hundreds of deaths, over the past 25 years    (roughly 50 cases

and 15 deaths per year).     That is enough quantification to enable


                                  28
a risk/benefit analysis, even if the jury inferred a very high

number of prescriptions for sulindac.21   While the jury certainly

could have drawn other inferences from the data, or rejected some

of the data for the reasons argued by Mutual, that was not the

only rational approach permitted by the evidence.

     Next, Mutual argues that sulindac's risk of SJS/TEN is

simply too remote to result in liability for defective design.

As support for that argument. Mutual invokes dicta from an old

New Hampshire Supreme Court case that "in the absence of adeguate

warning a one-in-a-million risk of adverse reaction" to a drug is

not "a sufficient basis on which to impose strict liability."

Thibault, 

 (citing Davis v. Wyeth Labs., Inc., 

 (9th Cir. 1968), a failure-to-warn case).   As that guote

suggests, however, Thibault actually made that comment in

reference to failure-to-warn claims, not defective design claims.

See also Price, 

 (citing Thibault's comment in a

defective design case, but with a "cf." signal, meaning that the

case supported a different but analogous proposition),22    The



     21Dr. Tackett testified that, at one time (1987), sulindac
had been the 44th-most prescribed drug in the country, but that
it had been prescribed less in other years.

     22Indeed, the "one-in-a-million" comment has been
incorporated into New Hampshire's standard jury instruction for
failure-to-warn claims.   See Walter L. Murphy & Daniel C. Pope,
New Hampshire Civil Jury Instructions, § 23.4, at 23-5 (2007)
("This does not mean that a manufacturer must warn a
user/consumer of a one-in-a-million chance of injury."). Mutual
argues, in its Rule 59 motion, that this court erred by refusing

                               29
fact that a manufacturer need not have warned of a particular

risk does not necessarily mean that the risk did not render its

product unreasonably dangerous.

     But even accepting arguendo Mutual's premise that a "one-in-

a-million risk of adverse reaction" to a drug is never actionable

under a defective design theory, and its further      premise that the

jury had no   basis for concluding that sulindac's SJS/TEN risk was

any greater than the background rate for all drugs. Mutual's

conclusion still does not follow:      per the FDA, even the

background rate of SJS/TEN is greater than one-in-a-million, and

the top end of the range is six-in-a-million, or one in less than

175,000.   (Mutual appears to be ignoring the SJS rate and looking

solely at the rate for the more serious TEN, which is lower, but

still exceeds one-in-a-million at the top end.)      So even if the

risk-benefit analysis were strictly a guantitative mathematical

calculation, without any gualitative component involving the

severity of   the side effect. Mutual would not be entitled to

judgment as a matter of law on that basis.




to give that instruction.   But there was no failure-to-warn claim
left in the case, and this court specifically instructed the jury
(at Mutual's reguest) that Mutual's conduct in responding to
sulindac's risks was "not at issue" in the case.   Document no.
378, at 22. Giving the jury part of the failure-to-warn
instruction, and thereby suggesting that "a manufacturer must
warn a user/consumer of" certain risks, would have been
inconsistent and confusing.

                                  30
     Of course, the risk/benefit analysis is not just a

mathematical calculation.     Even with perfect information about

all of sulindac's risks and benefits, no mathematical formula

could determine to a legal certainty how many cases of SJS/TEN,

how many deaths, how many losses of sight, or how many severe

skin burns is a reasonable price to pay for the relief of

shoulder pain, arthritis, and other conditions that sulindac

provides.   It is, at bottom, a judgment call on which reasonable

people could disagree.    As the New Hampshire Supreme Court has

explained, making those sorts of difficult risk/benefit judgments

"is the very essence of the jury's function."     Vautour, 

; see also 2 Frumer & Friedman, supra, § 11.03 [4] [d] , at

11-101   ("The determination of a product's risks and benefits as a

matter of law ... will rarely be granted in design defect cases

if any of the elements is disputed.").

     Again, under New Hampshire law, courts may override the

jury's risk/benefit judgment in only two circumstances:       where

"the risk of harm is so remote as to be negligible," or where the

"the utility of the product completely outweighs the risk."

Price, 

.     Neither circumstance is present here.

While certainly remote, sulindac's risk of SJS/TEN cannot be

considered "negligible," particularly given the severity of the

disease and the estimated number of cases and deaths.     See

Webster's Third New International Dictionary 1514    (2002)


                                  31
(defining negligible to mean "of so little conseguence as to

reguire or deserve little or no attention:   trifling").   And

while reasonable people could certainly conclude that sulindac's

benefits outweigh its risks, the comparison is not so

"completely" one-sided that no one could reasonably conclude

otherwise.23

     In sum. Mutual has not met the "stringent" standard for

relief under Rule 50.   Malone, 610 F.3d at 20.   Viewing the

evidence in the light most favorable to the verdict, this court

concludes that Bartlett presented sufficient evidence for a

reasonable jury to find that sulindac's risks outweighed its

benefits, making it an unreasonably dangerous product.     Mutual

has not shown any errors or defects in the admission of that

evidence that would entitle it to relief under Rule 59 either.

The evidence supporting the jury's verdict was sufficiently

reliable to be admitted into evidence, see, e.g., notes 8, 12,




     23Mutual argues that Bartlett's experts conceded that
sulindac's benefits outweighed its risks by testifying that, if
not removed from the market, sulindac should at least be reserved
for patients who fail to respond to alternative treatments,
rather than being used as a "first-line therapy." At most,
however, that means that sulindac's benefits might outweigh its
risks for a certain subset of patients.   Under New Hampshire law,
a product's design must "meet risk-utility balancing standards as
seen from the point of view of the public as a whole," not just a
subset of it. Price, 

 (emphasis added) .
Moreover, the jury was free to disregard what was essentially the
experts' "backup" position.   See document no. 378, at 6
(instructing the jury, without objection, that "[y]ou may accept
all, part, or none of the testimony of an expert").

                                32
16, and 19, supra, and was properly disclosed to Mutual before

trial where required, see, e.g., notes 9 and 11, supra.     Mutual

has not suffered anything "tantamount to a miscarriage of

justice."    Crowe, 

.



     ii.    Safer alternative design

     The next issue raised by Mutual's Rule 50 motion is whether,

in addition to proving that sulindac's risks outweighed its

benefits, Bartlett needed to prove that sulindac had some other

"defect" in design.    Mutual argues that proof of some other

"defect" is required by Buckingham, 

, and that

Bartlett could not satisfy that requirement because sulindac is

incapable of being designed any other way.24   This court has

already analyzed that argument at length in two prior orders.

See Bartlett, 

, 

;

Bartlett, 

, 

.     As

explained there, while Buckingham arguably supports Mutual's

position, two more recent cases from the New Hampshire Supreme

Court make clear that "a product is defective as designed if the


      24Mutual also objects to this court's use of the phrase
"defective condition," rather than "defect," throughout the final
jury charge. But the New Hampshire Supreme Court commonly uses
the phrase "defective condition" when setting forth the elements
of a defective design claim, see, e.g., Vautour, 

,
and so do New Hampshire's model jury instructions, see Murphy &
Pope, supra, §§ 23.1 and 23.2.    Indeed, even Mutual's proposed
instructions repeatedly used that phrase.    See document no. 254,
at 4 .

                                 33
magnitude of the danger outweighs the utility of the product,"

Vautour, 

, and that "the plaintiff is not reguired

to present evidence of a safer alternative design," Kelleher, 

.

     As a federal court exercising diversity jurisdiction over a

state-law action, this court "must apply the most recent

statement of state law by the state's highest court."     Vithus v.

Beatrice C o ., 

, 941-42   (10th Cir. 1997); see also,

e.g., Brunner v. Hampson, 

 (6th Cir. 2006);

Lamargue v. Mass. Indem. & Life Ins. Co., 

 (5th

Cir. 1986); Middle Atl. Utils. Co. v. S.M.W. Dev. Corp., 

 (2d Cir. 1968); cf. Smith v. F.W. Morse & Co., 

 (1st Cir. 1996)    (following the more "recently decided"

New Hampshire Supreme Court case that "speaks directly to the

guestion," rather than an older opinion).     Thus, even assuming

arguendo that the earlier Buckingham decision conflicts with

Vautour and Kelleher, this court must follow the express language

of the more recent cases.

     Mutual, taking its rhetoric to new heights     (or perhaps new

lows), describes this court's reading of Vautour and Kelleher as

"bizarre" and "tortured."    But Mutual still has not been able to

explain how, under its reading of those cases, a plaintiff could

prove a "defect" without having to prove some safer alternative

design.   Mutual's position appears to be that, as stated at the


                                  34
final pre-trial conference, "there has to be an alternative

[design]; you just don't have to prove up the alternative."

Document no. 302, at 46.   Proof, though, is all that counts in

determining a plaintiff's prima facie burden.     And Vautour

expressly states that "[t]he plaintiffs' burden was to present

evidence regarding the risk-utility factors; they did not have a

burden of proving a safer, alternative design."25    

; see also 

 ("plaintiffs presented sufficient

evidence that the [product] was unreasonably dangerous pursuant

to the risk-utility balancing test") .   As discussed in Part

III.A.i, supra, Bartlett satisfied that burden.

     Mutual also describes this court's reading of Vautour and

Kelleher as an act of "social engineering" and predicts that, if

plaintiffs can recover for defective design even where a product

is unavoidably unsafe and has an adeguate warning, no "prudent

manufacturer would sell any product in New Hampshire."26    Mutual

     25In its post-trial motions. Mutual resorts to dicta from
the Superior Court decision in Vautour in an unpersuasive attempt
to demonstrate that the New Hampshire Supreme Court meant
something other than what it expressly said.   If anything, that
approach strikes this court as the more unusual one, particularly
where the Supreme Court reversed the Superior Court decision.

     26A s this court previously observed. Mutual's position is
itself a call for social policymaking, in that it "would have the
practical effect of immunizing nearly all drug manufacturers from
[defective design] liability, no matter how dangerous the drug,
no matter how minimal its benefits, ... and even if other,
similar drugs offer the same benefits with less risk." Bartlett,

, at *1, 

, at *4-5
(noting that the only exception would be drugs whose dosage or
design could be altered to avoid the unreasonable danger).

                                35
seems to have forgotten, however, that this court ruled that

Mutual would "avoid liability for defective design if it can

prove, as an affirmative defense, that sulindac is unavoidably

unsafe and had an adeguate safety warning."    Bartlett, 

, 

.     That is

the very limitation for which Mutual has been advocating (albeit

in the form of a defense, not a prima facie burden).     It was

Mutual, not this court, that "engineered" a broader scope of

liability by voluntarily withdrawing that defense on the eve of

trial.   See document no. 332.   Presumably, not every "prudent

manufacturer" will choose to follow the same strategy.

     Recognizing, apparently, that its withdrawal of the "comment

k" defense undermines its position. Mutual argues in its Rule 59

motion that it withdrew the defense only because this court

allegedly "confirmed" that doing so would render inadmissible any

evidence regarding sulindac's warning, and that this court went

back on that promise at trial, in violation of Mutual's due

process rights.   But that is not what happened.   This court

expressly reserved judgment on that evidentiary issue, both in

its limine rulings, see Bartlett, 

, at *5 n.5,

, at *14-15, and at the final pre­

trial conference, during which Mutual first suggested that it

might withdraw the defense   (and another defense, known as "state

of the art," see N.H. Rev. Stat. § 507:8-g), and Bartlett


                                 36
responded that warning-related evidence could be presented at

trial anyway.   See document no. 301, at 98-99; document no. 302,

at 30-32, 52-54.

     After the final pre-trial conference, this court expressly

ordered that "[i]f Mutual withdraws the [state of the art]

defense, then [its] procedures   [for monitoring sulindac's risks]

will no longer be relevant and thus will not be presented to the

jury."   Bartlett v. Mut. Pharm. Co., 

, at *2 n.5,

, at *5 (document no. 329).     This

court never made any such statement with regard to the "comment

k" defense and warning-related evidence.   A few days before

trial. Mutual informed the court during a conference call that it

would decide "by the end of the day with regard to both [its]

state of the art and unavoidably unsafe [defenses] whether we're

withdrawing those defenses so that what is left is only no label

issues and only the issue about unreasonably dangerous."

Document no. 353, at 37.   This court replied with a one-word

"understood," 

 and moved on to other pressing topics.

     Mutual announced its withdrawal of both defenses later that

day, see document no. 332, and Bartlett responded by immediately

seeking a pre-trial ruling on the admissibility of warning-

related evidence, see document no. 339.    Mutual guickly filed two

briefs arguing against the admission of such evidence, see

documents no. 341, 342, and this court held another conference


                                 37
call with the parties devoted specifically to that issue.      Not

once did Mutual suggest, either in its briefs or during the

conference call, that it believed this court (apparently by

saying the word "understood" on the earlier conference call) had

already promised to exclude warning-related evidence if Mutual

withdrew its "comment k" defense.     That fact alone belies

Mutual's argument that it withdrew its "comment k" defense based

on this court's ruling that doing so would eliminate any warning-

related evidence from trial.

     On the day before trial, this court ruled that warning-

related evidence would be admissible, to a limited extent, with

regard to the issue of whether sulindac was unreasonably

dangerous.   See Bartlett, 

, 

.   Thus, while Mutual was indeed left with "only the issue

about unreasonably dangerous"   (to use its phrase from the earlier

conference call), the warning still had some potential relevance

to that issue.   The first footnote of that same order explained

that "Mutual recently withdrew its 'comment k' defense," and that

"[u]ntil that defense was withdrawn, there was no dispute that

evidence of the warning's adeguacy could be presented at trial,

which is why this issue has not been resolved until now."      

, at *1 n.l, 

, at *3-4

(citing Bartlett, 

, at *5 n.5, 

, at *14-15).


                                 38
        Mutual never moved for reconsideration of that ruling, never

disputed the order's account of the procedural history (until its

Rule 59 motion), and even more importantly, never sought to

reinstate its "comment k" defense on the ground that the

withdrawal had been contingent on the exclusion of warning-

related evidence    (even throughout the trial, as Bartlett

introduced the very evidence that Mutual now says it thought was

inadmissible).     Indeed, Mutual did not even ask this court to

instruct the jury on the "comment k" defense.     By failing to

raise the issue in a timely manner, when this court easily could

have afforded relief. Mutual waived its due process argument.

See, e.g.. United States v. Carpenter, 

 (1st Cir.

2007)    ("the raise-or-waive rule ... precludes a party from making

a tactical decision to refrain from objecting, and subseguently,

should the case turn sour, assigning error," without having

"afford[ed the trial court] an opportunity to correct the

problem").

        Even if Mutual's argument not been waived, it would be

difficult for this court to view the argument as anything more

than an unfounded, post hoc attempt to shirk responsibility for a

voluntary strategic decision.     Mutual has not shown any

unfairness whatsoever relating to its withdrawal of the "comment

k" defense, and certainly is not entitled to a new trial on that

basis.     Nor, in light of that withdrawal, is Mutual entitled to


                                  39
judgment as a matter of law on the ground that sulindac is

unavoidably unsafe, which (together with the adeguacy of

sulindac's warning) is an issue that Mutual itself chose to

remove from the case.



     iii.    Safer alternative product

     The next issue raised by Mutual's Rule 50 motion is whether

Bartlett needed to present evidence of a safer alternative

product   (as opposed to a safer alternative design).   Mutual

argues that such proof is also reguired under New Hampshire law

and that Bartlett failed to provide it.     But Mutual has not

cited, nor can this court find, any authority for such a

reguirement.    C f . Heath v. Sears, Roebuck & Co., 

 (1983)   (noting that "mere compliance with current industry

practice" is not "a defense to [to defective design] liability"

under New Hampshire law).    Moreover, Mutual's argument is

undermined by the fact that it objected--successfully--to this

court's proposed instruction that the jury, in weighing

sulindac's risks and benefits, could "consider whether there were

alternative products on the market that provided the same

benefits as sulindac, but with less risk."

     Mutual argued, at the time, that the proposed instruction

was inconsistent with a later instruction, included in the final

jury charge, that "a manufacturer is not obliged to design the


                                  40
safest possible product,   ... or one as safe as others make, so

long as the design it has adopted is not unreasonably dangerous."

Document no. 378, at 15-16 (guoting Thibault, 

).

But there was no inconsistency:     a jury can consider a factor

without it being dispositive.27   That is clearly the role that a

safer alternative design plays under New Hampshire case law, see

Vautour, 

 ("proof of an alternative design is ...

neither a controlling factor nor an essential element"), and

there is no reason to believe that a safer alternative product

would be treated any differently.

     While not reguired to do so, Bartlett presented considerable

evidence for the jury to consider with regard to safer

alternative products.   See Part III.A.i, supra.    For example, her

experts testified that sulindac is part of two NSAID groups--

acetic acid NSAIDs and longer half-life NSAIDs--believed to have

a greater risk of SJS/TEN than other NSAIDs, with no greater

benefits   (aside from the "longer benefit" associated with having

a longer half-life).    In addition, they testified that aspirin

and Tylenol, while perhaps not perfect alternatives to sulindac,

have no risk of SJS/TEN, are egually effective in treating

conditions like shoulder pain (for which Bartlett took sulindac) ,



     270ut of an abundance of caution, this court nevertheless
granted Mutual's reguest to exclude the proposed instruction,
allowing Bartlett to argue the point in her closing, but not
instructing on it.

                                  41
have additional benefits that sulindac does not have, and are

safer alternative products overall.

     Mutual argues that, to be considered a safer alternative, a

product must be equally effective and less dangerous in all

respects, not just overall.      But in Vautour, where the

plaintiffs' expert testified that "under similar circumstances

[to those encountered by the plaintiff], machines with [an

alternative] design would be, overall, less dangerous," the New

Hampshire Supreme Court concluded that it "was up to the jury to

assess the weight to be given this testimony."      

(emphases added).      Again, there is no reason to believe that

safer alternative products would be treated any differently from

safer alternative designs.      So it was up to the jury, in

assessing sulindac's risks and benefits, to determine how much

weight   (if any) to give Bartlett's evidence regarding safer

alternative products.



     iv.   Causation

     The next issue raised by Mutual's Rule 50 motion is whether

Bartlett presented sufficient evidence of causation.         See, e.g.,

Vautour, 

 (requiring proof that the product's

defective "condition caused injury to the user").      Mutual argues

that Bartlett failed to do so, because she presented "no evidence

whatsoever that any alternative design would have avoided [her]


                                   42
injury."28   As already explained, however, the New Hampshire

Supreme Court has expressly ruled that "the plaintiff is not

required to present evidence of a safer alternative design."

Kelleher, 

.    By the same token, a plaintiff is not

required to prove that the alternative design would have avoided

her injuries.     See Vautour, 

 (ruling that

plaintiffs presented trialworthy claim even though their "expert

failed to offer any testimony regarding ... how his proposed

alternative design would prevent the type of injuries suffered").

     Mutual also argues that, since this court allowed the jury

to consider whether sulindac's warning avoided an otherwise

unreasonable danger, see Bartlett, 

, at *4, 

, at *11        (citing Vautour, 

), there was no causation because Bartlett's doctor never read

that warning.29    But Mutual never "distinctly articulated" that

     28Mutual also argues that this court's use of a general
verdict form made it "impossible to determine if [the jury]
concluded that plaintiff satisfied each element of a design
defect claim," including causation. But the final jury charge
made clear that "to recover on her claim for strict products
liability, Mrs. Bartlett must prove each of the ... elements by a
preponderance of the elements." Document no. 37 8, at 14. Given
that instruction, there is no reason to doubt that the jury found
Bartlett had proven each element.   See, e.g.. United States v.
Gentles, 

 (1st Cir. 2010) ("It is a well
established tenet of our judicial system that juries are presumed
to follow [the court's] instructions."); Goulet v. New Penn Motor
Express, Inc., 

, 43 n.6 (1st Cir. 2008) (finding no
fault with the use of general verdict form where "the jury was
amply instructed" on the requirements for liability).

     29As discussed supra, that was why this court granted
summary judgment to Mutual on Bartlett's failure-to-warn theory.

                                  43
argument in its close-of-evidence motion for a directed verdict

under Rule 5 0 (a), so it cannot be raised now.    Parker v. Gerrish,

 (1st Cir. 2008)   (explaining that a Rule 50(b)

motion "is bounded by the movant's earlier Rule 50(a) motion").

Indeed, this court cannot find any warning-related arguments that

Mutual "distinctly articulated" in its Rule 5 0 (a) motion and then

renewed in its Rule 50(b) motion.30    So for Rule 50 purposes, at

least, sulindac's warning is no longer at issue.

     Moreover, even if properly raised. Mutual's warning-related

causation argument would fail on the merits.      The warning was not

sulindac's defective condition; the unreasonable danger was.        See

document no. 378, at 16 (instructing the jury that it could

consider the warning only if it determined, first, that sulindac

was unreasonably dangerous, and even then, only to determine

whether the warning avoided the unreasonable danger); Bartlett,

, 

.      The fact that

Bartlett's doctor never read a warning that, in the jury's view,

did not eliminate sulindac's unreasonable danger, was of no

conseguence.   The chain of causation on a defective design claim

does not run through the warning.     See, e.g., Vautour, 147 N.H.




See Bartlett, 

, 

.

     30See Part III.B.iii, infra (discussing Mutual's warning-related pre-emption argument, which was raised in the Rule 5 0 (a)
motion but not again until the Rule 50 (b) reply) .

                                 44
at 154 (requiring only proof that the defective "condition caused

injury to the user").

     Mutual argues, finally, that "unreasonable danger does not

cause an injury."   Again, however. Mutual never "distinctly

articulated" that argument in its Rule 5 0 (a) motion, so it cannot

be raised now under Rule 50(b).    Parker, 

.

Moreover, even if properly raised, the argument would fail on the

merits.    What made sulindac unreasonably dangerous, according to

Bartlett, was "its inherent propensity to cause SJS/TEN."      That

was the (sole) theory that Bartlett presented to the jury, both

in her opening statement and her closing argument    (using the

quoted language both times) .31   The evidence was overwhelming,

and essentially uncontested, that Bartlett suffered SJS/TEN as a

side effect of sulindac.    So there was sufficient evidence for

the jury to find causation.



B.   Federal pre-emption

      The other issue raised by Mutual's Rule 50 motion, in

addition to the sufficiency of the evidence, is federal pre­

emption.    "A fundamental tenet of our federalist system is that

constitutionally enacted federal law is supreme to state law.


     31Mutual protests that this court never instructed the jury
on that theory. But Bartlett sought such an instruction in the
final jury charge, and Mutual successfully opposed it, persuading
this court that it might be misconstrued as implicitly endorsing
the theory.

                                  45
See U.S. Const, art. VI cl. 2.   As a result, federal law

sometimes pre-empts state law either expressly or by

implication."   N.H. Motor Transp. Ass'n v. Rowe, 

(1st Cir. 2006), aff'd , 

 (2008).    Federal "pre­

emption is an affirmative defense upon which [the] defendant

bears the burden of proof."   Cambridge Literary Props., Ltd. v.

W. Goebel Porzellanfabrik G.m.b.H. & Co., 

 (1st

Cir. 2007); see also Wyeth, 129 S. C t . at 1193 (characterizing a

manufacturer's argument that federal drug law pre-empted the

plaintiff's claims as a defense).     Here, Mutual has made

essentially four different pre-emption arguments.     This court

will address each of them in turn.



     i.   "Second-guessing" the FDA

     First, Mutual argues that federal law (specifically, the

FDCA and related FDA regulations) impliedly pre-empts any state-

law tort claim that requires the jury to "second-guess" the FDA's

risk/benefit analysis of a drug, because such claims "stand[] as

an obstacle to the accomplishment and execution of the full

purposes and objectives of Congress."32    Good v. Altria Group,

Inc., 

 (1st Cir. 2007), aff'd , 

 (2008)



     32It is worth noting that Mutual did not raise this pre­
emption argument in its earlier motions for judgment on the
pleadings or for summary judgment, which raised the other pre­
emption arguments discussed infra.

                                 46
(describing the doctrine of obstacle pre-emption).       As support

for that argument. Mutual relies on Geier v. American Honda Motor

C o ., 

 (2000), where the Supreme Court held that a

federal regulation that called for a gradual phase-in of airbags

in cars pre-empted state-law tort claims based on a

manufacturer's failure to install airbags earlier, because such

claims presented an obstacle to achieving Congress's objectives,

which included winning consumer acceptance of airbags and

spurring further technological innovation during the phase-in

period.

     This case, however, has very little     (if anything) in common

with Geier.   It has much more in common with Wyeth, 12 9 S. C t . at

1187, a more recent case where a drug manufacturer argued--much

like Mutual does here--that "because the FDCA reguires the FDA to

determine that a drug is safe and effective under the conditions

set forth in its labeling, the agency must be presumed to have

performed a precise balancing of risks and benefits and to have

established a specific labeling standard that leaves no room for

different state-law judgments."     Id. at 1200.   The Supreme Court

rejected that argument, concluding that the regulatory framework

applicable to prescription drugs is "guite different" from the

one in Geier and that "the FDA long maintained that state law

offers an additional, and important, layer of consumer protection

that complements FDA regulation."      Id. at 1202-03.


                                  47
     Wyeth is arguably not directly controlling here, because it

involved a failure-to-warn claim, not a defective design claim.

But this court cannot see, nor has Mutual articulated, any reason

why Wyeth's logic would not extend to this closely analogous

context.   C f . Wimbush v. Wyeth, 

 (6th Cir. 2010)

(concluding that Wyeth's "rationale extends beyond the realm of

failure-to-warn claims to apply to all pre-approval state law

claims," including, in that case, a claim of negligence in

bringing an FDA-approved drug to the market).    Mutual has not

cited any cases, before or since Wyeth, that interpreted federal

law as prohibiting juries from deeming an FDA-approved drug to be

more risky than beneficial.   See Tobin v. Astra Pharm. Prods.,

Inc., 

   (6th Cir.), cert, denied, 

(1993)   ("reject[ing] the argument that FDA approval pre-empts

state product liability claims based on design defect," and




                                 48
noting that the "great majority" of courts had done the same33) .

Mutual's pre-emption argument is therefore rejected.

     Relatedly, Mutual argues in its Rule 59 motion that this

court violated due process by allowing Bartlett to "attack" the

FDA's decision to approve sulindac, thereby "putting the FDA on

trial" even though it was not a party to the case and even though

"plaintiff's claims were not related to FDA or its actions

related to sulindac."   But even assuming, dubitante, that Mutual

has standing to raise the due process rights of a non-party, that

argument clearly has no merit.   The FDA's "actions related to

sulindac" were guite relevant to Bartlett's claim.     See Fed. R.

Evid. 401   (evidence is relevant if it has "any tendency to make

the existence of any fact that is of conseguence ... more or less

probable").   Indeed, Mutual repeatedly emphasized the FDA's

approval of sulindac throughout the trial.    If anything, it would

have violated Bartlett's due process rights to allow Mutual to


     33Tobin, incidentally, belies Mutual's repeated refrain that
this case is unprecedented in holding a drug manufacture liable
for defective design under a risk/benefit analysis.   In that
case, which involved injuries caused by the drug ritodrine, the
Sixth Circuit agreed with the manufacturer that (as here) the
plaintiff could not recover on her failure-to-warn theory due to
a lack of causation, id. at 536, but nevertheless upheld a jury
verdict of liability on a defective design theory, where (as
here) "evidence of the risks and benefits associated with
ritodrine were a main focus" at trial, id., and the plaintiff's
theory was that the drug posed a risk of "disturbing" side
effects, id. at 539, with only "some benefit," id. at 537 n.8.
The Sixth Circuit ruled that there was sufficient evidence for
the jury to disagree with the FDA's risk/benefit analysis.    Id.
at 538.

                                 49
use the FDA's approval as a shield to liability, without allowing

Bartlett to challenge it.



       ii.   Design pre-emption for generic drugs

       Second, Mutual argues that federal law (again, the FDCA and

related FDA regulations) prohibited manufacturers from

unilaterally changing the design of a generic drug, thus making

"compliance with both state and federal law ... impossible."

Good, 

 (describing the doctrine of impossibility

pre-emption).    As already explained, however. Mutual was not held

liable for failing to change sulindac's design; it was held

liable for selling an unreasonably dangerous product, with

greater risks than benefits.     Federal law did not reguire Mutual

to sell sulindac.     Nor, for that matter, did state law reguire

Mutual to stop selling it, or to redesign it.       See Bartlett, 

, at *8, 

, at *24 ("what

strict products liability reguires is that manufacturers

compensate consumers for the damage caused by unreasonably

dangerous products, not necessarily that they remove such

products from the market" or "retrofit" them)       (citing 5 Frumer &

Friedman, supra, § 57.01[4], at 57-9).     So it was not

"impossible" for Mutual to comply with both federal and state

law.   C f . Barnett Bank of Marion County, N.A. v. Nelson, 

 (1996)    (explaining that impossibility pre-emption arises


                                  50
"if the federal law said,    'youmust sell   insurance,'while    the

state law said,    'you may not'").



     iii.    Warning pre-emption   for generic drugs

     Third, Mutual attempts in     its reply brief on its    Rule 50

motion to raise the pre-emption argument that it advanced

unsuccessfully earlier in this case:       that federal law (again,

the FDCA and related FDA regulations) prohibited manufacturers

from unilaterally changing the warning for a generic drug, thus

making it impossible for Mutual to comply with both federal and

state law.     See Bartlett, 

 (concluding that

federal law allowed such changes and therefore did not pre-empt

Bartlett's claims); accord Demahy, 

; Mensing, 

.    Mutual failed, however, to raise that warning-

related pre-emption argument in its opening brief in support of

either of its post-trial motions.       The argument is therefore

waived.   See, e.g.. Doe v. Friendfinder Network, Inc., 

, 303 n.16 (D.N.H. 2008); L.R. 7.1(e)(1)        (reply is

"restricted to rebuttal of factual and legal arguments raised in

the objection").34


     341he same is true of Mutual's argument that this court
erred by failing to instruct the jury that Mutual could not
change its warning, which also appeared for the first time in the
reply brief. Moreover, such an instruction would have been
inconsistent with the instruction set forth in the next
paragraph, infra, which is presumably why Mutual did not object
to the final jury charge on that basis.

                                   51
     The argument is also moot, since this court granted summary

judgment to Mutual on Bartlett's failure-to-warn theory, see

Bartlett, 

, 

, and Mutual withdrew its "comment k" defense, see

document no. 332, thereby eliminating from the case the issue of

whether Mutual could have or should have strengthened sulindac's

warning.   Indeed, this court expressly instructed the jury (at

Mutual's reguest) that Mutual's "conduct in ... responding" to

sulindac's safety risks, which included any failure to change its

warning, was "not relevant to this case, and you should put [it]

out of your mind."   See document no. 378, at 22 .35   Mutual

protests that the warning was still a part of the case, which is

true, but not in the sense that Mutual could have been held

liable for failing to change it.      See Bartlett, 

,

at *1, 

, at *4 ("Bartlett "must prove

that sulindac was unreasonably dangerous despite its warning, not

because of it.").

     Moreover, even if it were neither waived nor moot, this

court would reject Mutual's argument on the merits, for the

     35A s this court explained in a previous ruling, strict
liability "claims focus on the product itself rather than the
defendant's conduct." Bartlett, 

, at *12, 

, at *38 (citing 2 Frumer & Friedman,
supra, § 14.03[1][b], at 14-35, and Racer v. Utterman, 

 (Mo. A p p . C t . 1981), which noted that "most ... courts
have treated strict liability in tort as a doctrine which looks
to the product not to the conduct of the manufacturer" and that
"liability arises because of the condition of the product
regardless of the care exercised by the manufacturer").

                                 52
reasons explained at length in its earlier opinion.        See

Bartlett, 

.       Mutual argues that a recent

amicus brief filed by the United States Solicitor General in

Mensing calls this court's reasoning into guestion.        See Brief of

the United States as Amicus Curiae, 

, at *13,

Pliva, Inc. v. Mensing, No. 09-993       (U.S. Nov. 2, 2010)   (stating,

albeit with limited discussion, that the manufacturer of a

generic drug "may not unilaterally change its approved

labeling").    But the Solicitor General's view is not dispositive.

See Wyeth, 129 S. C t . at 1201-04     (disagreeing with Solicitor

General's view on a similar issue).       This court still finds the

reasoning in its earlier opinion--and later adopted in Demahy,

--to be more persuasive.



     iv.    Buckman pre-emption

     Finally, in what amounts to a fourth pre-emption argument.

Mutual argues in its Rule 59 motion that this court erred by

allowing the jury, in determining whether sulindac's warning

avoided an otherwise unreasonable danger, to consider whether the

warning complied with FDA labeling reguirements, because only the

federal government has authority to enforce those reguirements.

See 

(a)   ("all such proceedings for the enforcement

[of the FDCA] "shall be by and in the name of the United

States").   As support for that proposition. Mutual relies on


                                  53
Buckman v. Plaintiffs' Legal Committee, 

 (2001),

where the Supreme Court held that state-law claims for fraud-on-

the-FDA were impliedly pre-empted by the FDCA, in part because

they would interfere with the FDA's statutory power to enforce

its own disclosure requirements.        

.

     Buckman pre-emption, however, applies where a state-law

claim arises "solely from the violation of FDCA requirements."

.   That is not even close to the situation here.

This court instructed the jury that "compliance or non-compliance

with FDA labelinq requirements is not necessarily conclusive or

controllinq" on the issue of whether sulindac's warninq avoided

an otherwise unreasonable danqer, and could be qiven "as much or

as little weiqht as you think it deserves, in liqht of all the

evidence."   Document no. 37 8, at 19.      Moreover, this court

instructed the jury that it could not even consider sulindac's

warninq and the FDA requirements unless it determined, first,

that sulindac was unreasonably danqerous.        Id. at 16, 19.     So

Bartlett's claim did not arise from a violation of FDA

requirements at all (much less "solely"); it arose from

sulindac's unreasonable danqer.

     Mutual has not cited any authority for extendinq Buckman

pre-emption to this very different context.           Indeed, there is a

split of authority reqardinq whether Buckman pre-emption even

extends to neqliqence claims where FDA requlations establish a


                                   54
per se standard of care.    See Bartlett, 

, at *13-

14, 

 (citing cases on both

sides of that issue).   This case is far removed even from that.

Moreover, even assuming dubitante that this court erred by

instructing the jury on the FDA's labeling reguirements. Mutual

has not shown that doing so was "tantamount to a miscarriage of

justice."   Crowe, 

.     Mutual made the FDA's approval

of sulindac's warning a point of emphasis throughout the trial.

It was not unjust for the jury to be told what the FDA's

standards for approval were and to be able to consider them in

evaluating the warning.36



C.   Judicial conduct

      Having determined that Bartlett presented sufficient

evidence to support her claim and that the claim is not pre­

empted by federal law, this court will now turn to the remaining

issues raised by Mutual's Rule 59 motion.      The first such issue

relates to this court's conduct.      Mutual argues that a new trial

is necessary because "the proceedings were not being conducted in

an impartial fashion," but rather in such a way as to favor

Bartlett and disfavor Mutual.   As support for that argument.

Mutual points to a handful of comments and actions by this court


     36Mutual has not made any Rule 50 argument for Buckman pre­
emption, either at the close of evidence or post-trial, so to
that extent the argument is waived.   See Parker, 

.

                                 55
that, in its view, suggest judicial bias.     As explained below,

however. Mutual has taken those comments and actions out of

context, or otherwise misconstrued them.     This court sincerely

meant what it said in the final jury charge:     that it "is neutral

and impartial in this matter and does not take sides."      Document

n o . 37 8, at 32.

        It is important, in considering Mutual's specific

allegations of bias, to keep in mind the bigger picture.        See,

e.g.. United States v. DeCologero, 

 (1st Cir.

2008)    ("Charges of partiality should be judged not on an isolated

comment or two, but on the record as a whole.").     This is a case

where the court granted summary judgment to Mutual on nearly all

of Bartlett's claims, one of them sua sponte.     See Bartlett, 

, 

; Bartlett, 

, 

.     Moreover, this court kept

a tight rein on Bartlett's counsel throughout the trial, as

described in Part D, infra.     It is understandable, then, that

Bartlett's counsel regard Mutual's judicial bias argument as

"totally contrary to the plaintiff's experience during the

entirety of this case including every minute of trial."        Document

n o . 409-1, at 4.

        Moreover, it should be noted that Mutual's purported

examples of judicial bias--culled from a nearly three-year

litigation reguiring hundreds of pre-trial rulings, and


                                  56
culminating in a three-week trial--come nowhere near the kind of

conduct that our court of appeals has deemed insufficient to

demonstrate judicial bias or require a new trial.    See United

States v. Rodriquez-Rivera, 

 (1st Cir. 2001)

(collecting cases where "stern [] rebukes of counsel or litigants

[were] insufficient to demonstrate judicial bias," including

trial judges' calling plaintiff "an absolute and incorrigible

liar," referring to defense counsel's cross-examination as "very

devious," and warning counsel he was being reported for violating

the rules of professional conduct).



     i.   Ruling on motion before sur-reply

     First, Mutual points to a ruling that this court made on a

motion to strike filed by Bartlett, before Mutual had filed its

sur-reply.37   The motion sought to strike Mutual's expert Dr.

Stern for failing to produce the Pharmacia report   (discussed in

Part III.A.i, supra) .   After reviewing Bartlett's motion.

Mutual's objection, and Bartlett's reply, this court granted the

motion in part.   See document no. 251.   While not striking Dr.

Stern altogether, this court agreed with Bartlett that the report

should have been disclosed earlier and, given its potential

significance, ordered that Dr. Stern (and one other defense


     37To the extent that Mutual refers to other unidentified
"motions," its argument is conclusory and insufficiently
developed.

                                 57
expert) be made available for supplemental depositions regarding

the report.     At that point, only one month remained until trial,

so time was of the essence.

        Shortly after this court's order. Mutual sought leave to

file a sur-reply.      While not reguired to accept a sur-reply on a

non-dispositive motion, see L.R. 7.1(e) (3)       ("leave to file a

surreply will only be granted under extraordinary

circumstances"), this court nevertheless granted Mutual's reguest

and then issued another order--longer than the first--analyzing

and rejecting the arguments raised in Mutual's sur-reply.         See

Bartlett v. Mut. Pharm. Co., 

        (document no. 272).

This court gave the sur-reply full consideration, and did so with

an open mind.     Mutual may have disliked the result, but neither

the result nor the process leading up to it reflects judicial

bias.     See also, e.g., Bartlett, 

, 

     (giving full consideration to Mutual's motion to

reconsider the denial of an earlier motion to reconsider) .



        ii.   Comments during discovery hearing

        Next, Mutual points to this court's statement, made during a

discovery-related hearing in October 2009, that Mutual is a

"giant corporation" represented by "experienced counsel" from a

"huge law firm."      It is important to put those statements in

their proper context.      The issue before the court during that


                                   58
hearing was whether to sanction Mutual under Fed. R. Civ. P.

37(c)(1) for failing to timely produce certain FDA filings that

Bartlett had specifically reguested in discovery.    See Bartlett

v. Mut. Pharm. Co., 

, 

, 

   (imposing some, but not all, of the sanctions

Bartlett sought); but see document no. 125 (disallowing the

monetary part of the sanctions after Bartlett failed to timely

submit an itemized bill).

     Mutual, as part of its argument against sanctions, alleged

that Bartlett, too, had failed to produce certain documents kept

in her home, but explained that Mutual had declined to seek

sanctions on that basis, considering it unprofessional.    This

court responded that "your point is well taken, " but noted that

the analysis of whether a discovery error is substantially

justified under Rule 37(c)(1) might be "a little bit different"

for "Mutual with its ... experienced counsel with 20 years

experience in this type of litigation" than for "a plaintiff who

is disabled and has probably never been ... in a litigation

before."   This court went on to clarify:

     I'm not going to hold [Bartlett] to a different
     standard than you. That's not what I mean to say. You
     probably get sick of hearing that you're the giant
     corporation with the huge law firm, but you deal with
     this every day, and to me there's a difference between
     dropping the ball on this discovery reguest and a
     plaintiff who left some [documents in her house]."

Document no. 99, at 46-47.


                                 59
     As that context makes clear, this court was not denigrating

Mutual as a "giant corporation with [a] huge law firm;" to the

contrary, it was acknowledging that such characterizations can be

tiresome.   Nevertheless, this court was expressing skepticism

about Mutual's suggested analogy between its failure to produce

its FDA filings, which "are standard fare for discovery in

pharmaceutical litigation of this sort," Bartlett, 

, at *4, 

, at *12, and

Bartlett's failure, as a blind plaintiff, to locate certain

documents in her home and produce them.    Whatever one may think

of that analogy and this court's response to it, neither had any

bearing on the sanctions ruling (which was based on Mutual's

discovery error, not how it compared with Bartlett's alleged

error) or any other ruling in this case.



     iii.   Comments during trial conference

     Next, Mutual points to this court's comment, made during a

trial conference conducted outside the presence of the jury, that

"I want you to prove your case if you can."     Mutual interprets

that statement to mean that this court wanted Bartlett to prevail

on the merits.   But that is not at all what the court was saying,

as the context again makes clear.     The court was in the process

of explaining to Bartlett that one of the opinions given by her

expert Dr. Tackett   (regarding sulindac's risk of liver toxicity)


                                 60
had not been properly disclosed in his expert report and that the

court would be instructing the jury to disregard that testimony.

In other words, the court was in the process of granting relief

reguested by Mutual.

     Before granting that relief, this court asked Bartlett if

she could identify "anything remotely representing [a disclosure

of Dr. Tackett's opinion] to try to give you the benefit of the

doubt because you are the plaintiff and I want you to prove your

case if you can--I want you to be able to prove your case without

barriers from me."     This court did not mean, by that statement,

that it wanted Bartlett to prevail over Mutual in the end.

Rather, this court meant only that it wanted Bartlett to be able

to present her case without any artificial barriers from the

court--provided she stayed within the confines of the Federal

Rules of Evidence and Civil Procedure.     Perhaps, in retrospect,

the point could have been better worded, but it was not

reflective of judicial bias.



     iv.   "Smoking gun"

     Next, Mutual complains that this court, outside the presence

of the jury, referred to the Pharmacia report as a "smoking gun."

That was how Bartlett referred to the report in her filings.        See

document no. 230-1, at 6 ("This document, guite literally, is the

smoking gun of smoking guns.").     This court did not agree with


                                  61
that over-the-top characterization; to the contrary, it told the

parties early in the trial that "I am much less inclined to think

that [the report] has anything approaching the smoking gun."

Nevertheless, this court used the phrase "smoking gun," or "so-

called smoking gun," as a shorthand that the parties would

instantly recognize.   The jury never heard that phrase, so it

obviously had no affect on the trial or the verdict.     Nor did its

use reflect judicial bias.



     v.   Rephrasing questions

     Next, Mutual points to a few occasions during trial when

this court rephrased questions by Bartlett's counsel that were

leading or lacking in foundation.     But this court did not

intervene on those occasions out of favor for Bartlett; it did so

to fulfill its responsibility to "exercise reasonable control

over the mode ... of interrogating witnesses and presenting

evidence so as to (1) make the interrogation and presentation

effective for the ascertainment of the truth," and "(2) avoid

needless consumption of time."   Fed. R. Evid. 611(a); see also

Nat'l R.R. Passenger Corp. v. Certain Temporary Easements, 

 (1st Cir. 2004)   ("Decisions regarding the mode ... of

witness questioning lie within the district court's broad

discretion") .




                                 62
     Contrary to what Mutual suggests, this court's involvement

in guestioning was guite minimal; it did not "advantage or

disadvantage a party unfairly," or indeed at all.         United States

v. Angulo-Hernandez, 

, 10 (1st Cir. 2009)        (concluding

that even a "court's rather freguent guestioning and commentary"

did not cross the line, where the court's intent was "to clarify

testimony, respond to defense counsels' objections,        ... and

expedite the trial, all legitimate purposes"); cf. also

Rodriguez-Rivera, 

        (similar); Raviart v. Yates,

No. 03-0164, 

, *14, 

,

at *38 (E.D. Cal. Aug. 31, 2007)        (concluding that "the trial

judge's involvement in the guestioning of witnesses did not

bespeak a bias in favor of the prosecution or otherwise render

petitioner's trial fundamentally unfair").



     vi.     Blowing nose and wiping eyes

     Finally, Mutual argues that this court gave at least an

appearance of partiality by blowing its nose and wiping its eyes

during some emotional testimony by Bartlett's sister.         But this

court specifically addressed that issue with the jury (after

Mutual raised concerns the next morning), explaining that "as a

matter of fact I did not have an emotional reaction to that

testimony.     I was merely blowing my nose and dealing with a

little allergic, itchy eye."     Many of the jurors nodded in


                                   63
understanding.   This court further instructed the jury that even

if someone observing the trial were to have an emotional reaction

to the evidence presented, it would not have "any bearing upon

this case" and "wouldn't be something you should consider one way

or the other."   Those frank instructions cured any possible

prejudice to Mutual.     See, e.g., Rodriguez-Rivera, 

 ("such a charge usually mitigates any perceived partiality

from the bench").



D.   Counsel's conduct

      The next issue raised by Mutual's Rule 59 motion relates to

the conduct of Bartlett's counsel.      Mutual argues that a new

trial is necessary because, from voir dire to closing argument,

Bartlett's counsel "engaged in conduct designed to improperly

inflame and influence the jury."       In determining whether

allegedly improper conduct by counsel warrants a new trial, "the

court must examine the totality of the circumstances, including

(1) the nature of the comments;    (2) their freguency;   (3) their

possible relevance to the real issues before the jury;      (4) the

manner in which the parties and the court treated the comments,"

including any curative instructions; "(5) the strength of the

case; and (6) the verdict itself."      Granfield v. CSX Transp.,

Inc., 

    (1st Cir. 2010).




                                  64
     As explained below, there is no question that Bartlett's

counsel made this court's job at trial more difficult than it

needed to be, repeatedly testing the limits of this court's

rulings    (not to mention its patience).   Anticipating just such an

approach, however, this court kept a tight rein on Bartlett's

counsel throughout the trial, imposing various restrictions to

prevent misconduct, stopping counsel whenever they pushed too far

(sometimes in response to Mutual's objections, but often sua

sponte), giving curative instructions or other relief where

appropriate    (again, often sua sponte), and even reprimanding

counsel in front of the jury a few times.      As a result, whether

or not counsel's conduct was "designed to improperly inflame and

influence the jury," this court is confident that it did not have

that effect.



     i.    Voir dire

     First, Mutual argues that Bartlett's counsel improperly

asked prospective jurors, during attorney-conducted voir dire,

whether they would be unable to award damages greater than $20

million.    But this court sustained Mutual's objection to that

question and prohibited Bartlett's counsel from using specific

dollar figures from that point forward.      Bartlett had expressly

disclosed before trial that she intended to ask such questions

and, indeed, argued that she was entitled to do so.      See document


                                  65
no. 259, at 3 (citing Geehan v. Monahan, 

 (7th

Cir. 1967)).    So if Mutual wanted to prevent the questions from

being asked at all, it should have filed a specific objection

before trial, rather than merely objecting in general to

Bartlett's request for attorney-conducted voir dire, and then

waiting to object to specific questions after they had already

been asked.

     In any event, this court is not persuaded that the limited

questioning about a specific damage figure caused any prejudice

to Mutual, especially in light of this court's immediate

intercession.38   This court expressly instructed the jury, in the

final charge, that any amount mentioned by Bartlett's counsel was

"not evidence in this case" and that any damage award needed to

be "based solely on the evidence presented during the course of

the trial."    Document no. 378 at 28 .39   As explained in Part

      38Indeed, there is a split of authority on whether such
questioning is even improper in the first place.    See Richard L.
Ruth, Propriety of inquiry on voir dire as to juror's attitude
toward amount of damage awards, 

, §§ 2 [a] and
3 [a] (1998) (noting that "several courts have established as a
general rule that a party may inquire on voir dire as to
prospective jurors' attitudes toward specific damage figures,"
though some courts have disagreed, as this court did by
sustaining Mutual's objection).

     39During an in-chambers conference before the final jury
charge, Bartlett's counsel disclosed that they also planned to
request a specific amount in closing (which turned out to be
"between $20 and $30 million"). The parties agreed to the
instruction set forth above as a means of addressing that
request. Mutual did not object to the request then, or when it
happened, and has not raised it as an issue in its Rule 59
motion.   In light of that, it is nearly impossible to imagine

                                  66
III.F, supra, this court has no reason to believe that the jury

ignored that instruction.



     ii.    Demonstrative aids

     Next, Mutual argues that Bartlett's counsel misused two

demonstrative aids:    a visual presenter known as an "Elmo," on

which Bartlett's counsel allegedly left exhibits for longer than

necessary, and an easel, on which Bartlett allegedly summarized

evidence in a misleading fashion.       But this court, after noticing

some initial misuse of those aids, severely restricted Bartlett's

counsel in the use of both (in addition to correcting, by way of

a contemporaneous instruction, the misleading information on the

easel).    Specifically, this court restricted Bartlett's counsel

to publishing exhibits on the Elmo only while asking the witness

a guestion to which the exhibit related.      And this court

prohibited Bartlett's counsel from referring back to the easel

during closing argument.    Those restrictions prevented any

possible prejudice to Mutual.



     iii.    Staging dramatic moments

     Next, Mutual argues that Bartlett's counsel improperly

staged two dramatic moments designed to elicit sympathy from the



that Mutual could have been prejudiced by counsel's mentioning
the $20 million figure during jury selection.

                                 67
jury:     (1) having Bartlett return late to the courtroom after one

break in testimony, with the hope that the jury would see her

walk, with assistance, to counsel's table; and (2) having

Bartlett's husband Greg sob in view of the jury while Bartlett's

sister was testifying, and then leave the gallery.     But the first

moment never happened.     Mutual brought Bartlett's absence to this

court's attention, the jury was briefly excused (without being

told why), and Bartlett returned to the courtroom before the jury

did, so that the jury never saw her walking (except when she

walked to and from the witness stand).     So that incident had no

effect on the jury whatsoever.

        As for the sobbing by Bartlett's husband, this court cannot

recall it (or any objection by Mutual, which would have made a

record of it), but takes Mutual at its word that it did.     Indeed,

one can hardly be surprised that a husband would cry at some

point during a three-week trial relating to severe injuries

suffered by his wife.     Most courts have concluded, however, that

a brief emotional reaction of that sort does not warrant a new

trial, "at least if the judge admonished the jury to disregard

such manifestation in reaching their verdict."     L.S. Tellier,

Manifestation of emotion by party during civil trial as ground

for new trial, 

, § 2 (1960); see also, e.g.,

Malandris v. Merrill Lynch, 

 (10th Cir. 1981) .

This court gave precisely such an instruction on the day
following Bartlett's sister's testimony, as discussed in Part

Ill.C.vi, supra.40



     iv.     Net sales figure

     Next, Mutual argues that Bartlett's counsel improperly

allowed the jury to see Mutual's annual net sales figure during

videotaped testimony by Mutual employee Robert Dettery.41      This

court ruled before trial that Bartlett could not present any

evidence of Mutual's financial condition, see Bartlett, 

, at *8, 

, at *25-27

(explaining that such evidence was not relevant), and

specifically ruled that Bartlett could not show the jury the

following guestion-and-answer from Dettery's videotaped

testimony:     "Q.   And '07 sales were greater than $480 million?

A.   I'm not sure."     Document no. 352, at 5.   Bartlett's counsel

modified the video presentation so that those words were not

audible, but the guestion (without the answer) nevertheless

appeared briefly in the subtitles, before the video and subtitles

jumped ahead to the next admissible guestion-and-answer.

      40Mutual also complains that Bartlett's husband violated
this court's witness seguestration order by observing part of his
sister-in-law's testimony.    See Bartlett, 

, at *9,

, at *28-29 (citing Fed. R. Evid.
615) . But Bartlett's husband never testified at trial, so
seguestration was not necessary.

     41Mutual moved for a mistrial on that basis shortly after
Dettery's testimony.   See document no. 358. This court heard
argument on the motion and then denied it orally.

                                   69
     The parties disagree about whether that error was

intentional.     At trial, Bartlett's counsel told this court that

it was a computer glitch, resulting from the way that their

software program synched up the video/audio file and the separate

text file shown in the subtitles.      They attempted to replicate

the glitch for this court a number of times, but were unable to

do so.   Mutual, with the support of an affidavit from the

managing director of the software company that made the program,

claims that a glitch of that sort is impossible and therefore

must have been a deliberate act (if not a criminal one).

Bartlett's counsel, in turn, claim that they have now replicated

the glitch, having figured out through discussions with the

software company that it resulted from the difference in screen-

size ratios between their laptop computer and the court's

televisions.

     This court need not resolve that debate, however, because--

even if intentional--the brief, silent display of a guestion

containing Mutual's net sales figure still would not warrant a

new trial.     The jury already knew, from Mutual's own statement

during voir dire, that Mutual had 500 employees     (which itself

elicited a note of caution from this court, since Mutual's

statement came close to implying to the jurors that employee jobs

might be at stake, making it potentially prejudicial to

Bartlett).     And the jury knew, from Dettery's admissible


                                  70
testimony, that Mutual had a portfolio of about 250 generic

drugs, as well as a few brand-name drugs.    So with or without

seeing the net sales figure, the jury surely assumed that Mutual

had substantial annual sales.   See, e.g., Simek v. J.P. King

Auction C o ., 

 (10th Cir. 2005)

(unpublished)   (finding no prejudice from guestion about net worth

where the "evidence already tended to show [the party's]

wealth").

     Moreover, this court expressly instructed the jury that

"[g]uestions ... by lawyers are not evidence, unless the witness

adopts the facts set forth in the guestion," and that

"[t]estimony that has been excluded ... is not evidence and must

not be considered."   Document no. 378, at 9-10.    To the extent

that the jurors even noticed the net sales figure    (which is

unknown), they surely also noticed that it was contained in a

guestion that was neither spoken aloud nor answered by the

witness, indicating that, pursuant to this court's instructions,

it was not evidence and could not be considered.    Under the

totality of the circumstances, this court does not believe that

Mutual suffered any significant prejudice from the brief, silent

display of the annual sales guestion.42

     42This case is nothing like the one on which Mutual relies.
City of Cleveland v. Peter Kiewit Sons' Co., 

 (6th
Cir. 1980), where counsel "almost continuously sought to plant
the seed in the minds of the jurors that [defendant] was a very
large corporation with international operations" and "to inject
into the trial the idea that [defendant] had insurance which

                                 71
      v.   Expert's "script" or "notes"

      Next, Mutual argues that Bartlett's counsel improperly

prepared a document   (Mutual calls it a "script," Bartlett calls

it "notes") for one of Bartlett's experts. Dr. Tackett, to use

during his testimony.    See document no. 394-1.    The document

contained hundreds of typed guestions, some with handwritten

answers next to them and/or citations to expert reliance

materials.    The document also contained about a dozen points for

Dr. Tackett to make during cross-examination.      Dr. Tackett

testified at trial that Bartlett's counsel typed up the document

based on their telephone conversations before trial and gave it

to him the day before his testimony.      Mutual noticed the document

during Dr. Tackett's direct examination and used it to challenge

his credibility on cross-examination, asking detailed guestions

about how the document was prepared and how Dr. Tackett had used

it.   Indeed, that was Mutual's opening salvo on both days of Dr.

Tackett's cross-examination.

      While Bartlett claims that it is "common witness

preparation" to discuss guestions and answers with expert

witnesses before their testimony, and sometimes even to write

them out in a "script," LeCroy v. Sec'y, Fla. Dep't of Corr., 421


would cover any damages." 

. Bartlett's counsel did
not invoke Mutual's financial condition at all, much less
"continuously," after the silent display of the sales figure.

                                 

, 1267 (11th Cir. 2005), it is a strange practice, if

not an improper one, for the witness to carry such a document

with him to the stand and refer to it while testifying.       Indeed,

it is rather like walking into a punch, given how bad it looks to

the jury on cross-examination.     This court is not persuaded,

however, that the document resulted in Dr. Tackett's giving

opinions that were not his own, or that were not reliably based

on his knowledge and expertise.43      Nor is this court persuaded

that the document's use caused any prejudice to Mutual,

especially in light of Mutual's effective cross-examination of

Dr. Tackett, based on the "script" itself.



     vi.   Leading questions

     Next, Mutual complains that Bartlett's counsel repeatedly

asked leading questions on direct examination.      See Fed. R. Evid.

611 ("Leading questions should not be used on the direct

examination of a witness except as may be necessary to develop

the witness' testimony.").     That is true, but the other half of



     43This case is nothing like the one on which Mutual relies.
In re Scrap Metal Antitrust Litig., No. 02-cv-0844, 

, 

 (N.D. Ohio Sept. 30, 2006),
where counsel used a script "to educate [a fact witness] about
facts which, whether he ever knew them or not, he did not
presently recall, and then put him on the stand to testify ...
that he did presently recall all of the topics covered in the
outline," which the court deemed "tantamount to suborning
perjury." 

, at *7, 

, at *31.

                                  73
the story is that Bartlett's counsel met with repeated rebukes

from this court when they did so, sometimes in response to

Mutual's objections   (which were mostly sustained) and sometimes

sua sponte (since Mutual often did not object).    Some of those

rebukes came in the presence of the jury.    It is well established

that trial courts have "extensive discretion over the phrasing of

questions."   United States v. Hansen, 

 (1st Cir.

2006).   This court exercised that discretion throughout trial to

prevent Bartlett from using leading questions to gain an unfair

advantage over Mutual.44

     If anything, this court may have been too hard on Bartlett's

counsel, since some of their leading questions appear, in

hindsight, to have been designed to elicit disclosed opinions

from Bartlett's experts, while keeping the experts away from

related topics that this court had deemed off-limits.    In such

instances. Mutual still had the opportunity to test the experts'

opinions through cross-examination.   See 

 (noting that

"thorough cross-examination" may eliminate any prejudice from

leading questions).




     44"There is, of course, a degree of tolerance for leading
questions under certain circumstances." Hansen, 

.
One such circumstance, which arose a few times during this trial,
is where an unavailable witness's testimony is presented by
deposition, and the leading questions cannot simply be rephrased
as they would be during live testimony.

                                 74
     vii.   Undisclosed expert opinions

     Mutual also argues that Bartlett's counsel repeatedly

attempted to elicit undisclosed expert opinions.     See Fed. R.

Civ. P. 26(a)(2)(B)(I)    (requiring pre-trial disclosure of "all

opinions that the [expert] witness will express").     Again,

however, this court went to great lengths to prevent Bartlett's

experts from giving such opinions.     For example, this court

required an advance, written proffer of all opinions that

Bartlett's counsel intended to elicit from Dr. Tackett, and went

through those opinions one-by-one with the parties to rule out

any that had not been properly disclosed before trial (then

cautioning Dr. Tackett, before his testimony and outside the

presence of the jury, about the opinions deemed off-limits).

This court also required Bartlett's counsel to obtain prior

approval before eliciting opinions to which they believed

Mutual's cross-examination had "opened the door."

     Where Bartlett's counsel strayed from the pre-approved

opinions, this court did not hesitate to stop them (again,

sometimes sua sponte) and to strike the testimony or grant other

appropriate relief.    To the extent that any undisclosed opinions

may nonetheless have squeaked past, it happened without objection

from Mutual and thus is not a basis for post-trial relief.       See,

e.g., Fonten Corp. v. Ocean Spray Cranberries, Inc., 

 (1st Cir. 2006)    ("Failure to timely object to an attorney's


                                  75
misconduct will frequently result in the denial of a motion for

new trial.").    Moreover, Mutual has not shown that any of the key

opinions regarding sulindac's risks and benefits were

undisclosed, see Part III.A.i, supra, so it did not suffer any

prej udice.



     viii.    Other attempts to present inadmissible evidence

     Mutual also argues that Bartlett's counsel improperly

attempted to admit other inadmissible evidence, including

testimony that Mutual failed to survey the medical literature for

information about sulindac's safety risks, as well as copies of

the medical literature and the unpublished Pharmacia report.

Again, however, this court rebuffed those attempts, so Mutual

suffered no prejudice.    Moreover, this court expressly instructed

the jury (at Mutual's request) that Mutual's "conduct in seeking

... knowledge" of sulindac's risks was "not relevant to this

case." Document no. 378, at 22.



     ix.   "Missing witness" argument

     Next, Mutual argues that Bartlett's counsel violated one of

this court's orders by making a "missing witness" argument, i.e.,

commenting during closing argument on Mutual's failure to call

any witnesses.    See Bartlett, 

, at *7 (document

no. 278)   (stating that parties "may not comment on ... uncalled


                                  76
witnesses unless and until [they] lay[] a proper foundation and

obtain[] this court's permission to do so").     But Bartlett's

counsel raised that issue with this court before the closing and

obtained permission to make limited comments in that regard.        In

fact. Mutual conceded that Bartlett's counsel "can comment on the

fact that [Mutual] didn't call any witnesses," provided "that's

as far as they can go."     Document no. 439, at 14.

     This court is not persuaded that Bartlett's counsel exceeded

the scope of that permission, or otherwise strayed into improper

argument.     Even if they did, however, this court reminded the

jury (sua sponte) immediately after the closing that "while it is

accurate to say Mutual did not call witnesses after the plaintiff

rested her case. Mutual's counsel did put on a defense in this

case, through cross-examination of the plaintiff's witnesses and

through its presentation of its own portions of the videotape

deposition testimony or read testimony from a transcript that

immediately followed the plaintiff's presentation, with respect

to witnesses like [Mutual's employee] Dettery."        In light of that

instruction. Mutual suffered no prejudice.



     x.     Other improper comments

     Finally, Mutual argues that Bartlett's counsel made a number

of other improper comments during trial:

•    During opening statement, Bartlett's counsel mentioned their
     own experience in the United States military, which

                                  77
obviously was not relevant.  See Fed. R. Evid. 401, 402.
But this court sustained Mutual's immediate objection to
that comment, cutting off Bartlett's counsel before they had
finished the point, and instructed Bartlett's counsel, in
the presence of the jury, to "talk about the evidence," not
to "describe [their] experience, background." Document no.
430, at 89-90.  So Mutual suffered no prejudice.

During opening statement, Bartlett's counsel also noted that
Mutual had never apologized to Bartlett.  Id. at 128.
Again, that was not relevant.  See Fed. R. Evid. 401, 402.
But Mutual did not object to that comment, either as it
happened or during the sidebar after the opening (when
Mutual raised other objections to Bartlett's opening
statement). Moreover, this court expressly instructed the
jury that Mutual's conduct was "not at issue" and should not
be considered.  Document no. 378, at 22. Mutual again
suffered no prejudice.

During both opening and closing, Bartlett's counsel
commented that sulindac "stole" Bartlett's freedom, see
document no. 430, at 89, 91, which Mutual considers an
improper reference to its conduct. But, on its face, the
comments referred to the drug's effect, not Mutual's
conduct. And again. Mutual did not object to the comments.
In any event. Mutual suffered no prejudice in light of the
instruction just described (regarding Mutual's conduct not
being at issue).

On a number of occasions, Bartlett's counsel referred to the
Pharmacia report as the work of Mutual's expert Dr. Stern,
who never testified at trial, and as a "draft" of the
Journal of Rheumatology article. Mutual argues that those
comments were unfair and misleading, but this court
disagrees.  Dr. Stern was, in fact, the report's author and
one of Mutual's designated experts. Until the end of trial,
when Mutual rested without calling any witnesses, it was
unclear whether Mutual would call Dr. Stern. And Dr. Stern
acknowledged at his deposition that the published article
was based on data from the Pharmacia report, such that he
even sought Pharmacia's permission to publish the article.

During closing argument, Bartlett's counsel incorrectly
stated that the FDA "didn't have" the Pharmacia report
 (whereas the evidence was only that Dr. Stern had not
personally provided the report to the FDA). But this court
granted Mutual's reguest for a curative instruction on that
point, explaining to the jury that Bartlett's counsel had

                          78
     mischaracterized the record.  In light of that instruction.
     Mutual suffered no prejudice.

     Bartlett's counsel also argued, during closing argument,
     that sulindac's warning violated FDA labeling regulations.
     Again, however, this court granted Mutual's reguest for a
     cautionary instruction on that point, telling the jury
      (consistent with the final jury charge) that "compliance or
     noncompliance with FDA labeling ... is not necessarily
     controlling" on the issue of whether sulindac's warning
     avoided an unreasonable danger, and that "you may give such
     evidence as much or little weight as you think it deserves."
     Subject to that instruction (and probably even without it),
     the argument was permissible.   See Part III.B.iv, supra.

     Bartlett's counsel also stated, during closing argument,
     that guestions by attorneys are not evidence.45 But that
     comment tracked this court's jury instructions, see document
     no. 378, at 8-9 ("Questions ... by lawyers are not evidence,
     unless the witness adopts the facts set forth in the
     guestion."), which in turn tracked controlling case law, see
     United States v. Cudlitz, 

 (1st Cir.
     1996) ("guestions of counsel are not evidence"). To the
     extent that it differed at all, this court instructed the
     jury to "take the law from the court." Document no. 378, at
     9. So, again. Mutual suffered no prejudice.


E.   Cumulative evidence

      The next issue raised by Mutual's Rule 59 motion is whether

this court allowed Bartlett to present too much evidence of her

severe injuries.   Mutual argues, first, that this court should

have bifurcated the trial into separate liability and damages

phases to prevent such evidence from improperly influencing the



     45Mutual seems to be concerned primarily with a set of
guestions about whether Bartlett's experts knew that sulindac was
listed as a preferred drug on various drug formularies.   But the
experts' "no" answers to those guestions were not evidence that
the formularies actually listed sulindac; they were merely
evidence that the experts did not know either way.

                                79
liability determination.     See Fed. R. Civ. P. 42(b)   ("For

convenience, to avoid prejudice, or to expedite or economize, the

court may order a separate trial of one of more separate

issues").     This court has already addressed that argument at

length in a pre-trial order.     See Bartlett, 

(document no. 320).    As explained there, the party seeking

bifurcation bears the burden of proving that it will satisfy the

rule's objectives, see, e.g., 8 Moore's Federal Practice, §

42.20[8], at 42-55    (3d ed. 2007), and the court has broad

discretion in determining whether bifurcation is appropriate,

see, e.g., Lisa v. Fournier Marine Corp., 

       (1st

Cir. 1989).

     Mutual failed to show that bifurcation was appropriate in

this case.     Even if the trial had been bifurcated, evidence of

SJS/TEN's severity still would have been admissible at the

liability phase, to inform the jury's risk/benefit analysis.        See

Fed. R. Evid. 402; Price, 

 (jury may consider "the

risk of danger posed by [the product's] use).     Moreover, since

Mutual put Bartlett to her proof on causation (even though, as

already mentioned, that point was essentially undisputed), some

evidence of her particular injuries also would have been

admissible on that issue, if not also to "paint[] the backdrop"

of the case.     Faigin v. Kelly, 

 (1st Cir. 1999) .




                                  80
As a result, bifurcation likely would have resulted in

"duplication of evidence" and would have "force[d] busy doctors

from Boston hospitals to make two trips to New Hampshire for this

trial," which would have been inefficient.    Bartlett, 

, at *2 (document no. 320); see also 8 Moore's, supra, §

42.20[4][a], at 42-46 (bifurcation is "not the normal course of

events, and a single trial will usually be more expedient and

efficient").

     Short of bifurcation. Mutual argues that "evidence of

plaintiff's injuries ... only needed to be presented one time,"

and that this court erred by allowing "witness after witness to

testify, often in graphic detail, about plaintiff's injuries and

medical treatment."    See Fed. R. Evid. 403 (allowing exclusion of

relevant evidence "if its probative value is substantially

outweighed by the danger of unfair prejudice ... or needless

presentation of cumulative evidence").    Each witness, though, had

something different to add.    Bartlett's ordeal with SJS/TEN

caused many different injuries, reguiring the involvement of many

doctors   (with various specialties) , and impacting many aspects of

her life.   No single witness, even Bartlett herself, could have

given the jury a full picture of what happened.46




     46Indeed, Bartlett spent months of her recovery in a
medically induced coma. Mutual contested whether Bartlett could
feel pain during that period, which obviously did not help to
reduce the amount of pain-related testimony.

                                 81
       It is true that some of the witnesses went into graphic

detail about Bartlett's injuries, and that some of the pictures

shown to the jury were unpleasant, but that is because Bartlett's

injuries were so horrific and, in many respects, far beyond the

experience of the average juror.        See Part III.F, infra.   There

was really no other way for Bartlett to convey to the jury the

full extent of her pain and suffering.       See United States v.

Morales-Aldahondo, 

 (1st Cir. 2008)       ("The trial

judge's job is to avoid unfair prejudice," not "to scrub the

trial clean of all evidence that may have an emotional impact.").

This court "balanced the competing concerns of Rule 403 by," for

example, reviewing proffered photographs in open court (outside

the presence of the jury) and "limiting the number of images

presented," as well as by excluding proffered video footage of

the type of eye surgery that Bartlett underwent, among other

things.    

   Mutual has not shown any miscarriage of justice in

that regard.



F.   Damages award

      The next issue raised by Mutual's Rule 59 motion is whether

the jury awarded Bartlett an excessive amount of compensatory

damages.   As mentioned earlier, the jury awarded a total of

$21.06 million, consisting of $4.56 in special damages that were

largely uncontested ($1.25 million for past medical expenses


                                   82
stipulated by the parties, $2,377 million for future medical

expenses, and $933,000 for lost wages) plus $16.5 million for

pain, suffering, and loss of enjoyment of life.       Mutual argues

that the amount, and particularly the pain and suffering

component, was so high as to be "undoubtedly punitive" and "based

purely on the jury's passion and prejudice."       This court

disagrees.     While substantial, the award was within the

acceptable range, in light of the horrific injuries that Bartlett

suffered.     Given this court's instruction on the issue in the

final jury charge, there is no reason to think that the pain and

suffering award was punitive.47

        "District courts   may grant amotion for new trial" based      on

the amount of damages      "only if the award exceeds any   rational

appraisal or estimate of the damages that could be based on the

evidence before the jury and is grossly excessive, inordinate,

shocking to the conscience of the court, or so high that it would

be a denial of justice to permit it to stand."       Franceschi v.

Hosp. Gen. San Carlos, Inc., 

 (1st Cir. 2005); see

also Bielunas v. F/V Misty Dawn, Inc., 

 (1st Cir.

2010)    ("only rarely and in extraordinary circumstances will


     47This court instructed the jury (at Mutual's reguest) that
it was "not permitted to award punitive damages or any other
money damages for the purpose of punishing Mutual or making an
example of it for the public good or for the purpose of
preventing Mutual and others from similar conduct."    Document no.
378, at 27; see also Gentles, 

 ("juries are
presumed to follow [the court's] instructions").

                                    83
[courts] veto the jury's decision").    That is a "weighty burden"

for Mutual to meet.    Bielunas, 

.   This court cannot

"jettison a damage award simply because" it is "generous in

comparison to other (hand-picked) cases," or in comparison to

what the court might have awarded.    

.

     No one who witnessed the trial in this case could deny the

horror of Bartlett's injuries.    To name just some of them:

Bartlett suffered burns and lost skin over nearly two-thirds of

her body; she was in a medically induced coma for months; she

lost her sight (despite 12 eye surgeries, to date, attempting to

save it, and likely many more to come); she lost the ability to

have sexual intercourse due to vaginal injuries; she lost the

ability to eat normally due to esophageal stricture    (reguiring

multiple surgeries to stretch the esophagus so that she can eat

safely at all); she lost the ability to engage in aerobic

activities   (in which she had previously been an avid participant)

due to lung injuries; she suffered scarring to her face, back,

anus, and vagina; and she suffers from post-traumatic stress

disorder.    Children, she said, are scared of her appearance.      And

at 50 years old, she is expected to live with her injuries for

more than 30 years.

     "There is," of course, "no mathematical formula for

determining the monetary eguivalent of non-economic injuries."

Bielunas, 

.    Nor is there any "one 'correct' sum.


                                 84
but, rather, a range of acceptable awards."        Blinzler v. Marriott

Int'1, Inc., 

       (1st Cir. 1996).   In many

cases, "the spread between the high and low ends of the range

will be great.     The choice within the range" is "largely within

the jury's ken."     

.   That is indeed the case here.

The jury's choice to award $16.5 million for Bartlett's pain and

suffering--less than four times her special damages--was a

rational response to the evidence.       While Mutual has cited cases

where juries awarded much less for similar injuries, Bartlett has

cited cases where juries awarded much more.        Her award fell

within the "wide universe of acceptable awards," 

 and was

neither shocking to the conscience nor unjust to Mutual.48



G.   Cumulative error

      The final issue raised by Mutual's Rule 59 motion is

cumulative error.    Mutual argues that the combined effect of the

errors discussed above warrants a new trial, even if none of the

errors individually would.     As already discussed, however, many



     480ur court of appeals ruled in Whitfield v. Melendez-Rivera, 

 (1st Cir. 2005), that $3 million was the most
a plaintiff could recover for pain and suffering after being shot
in the leg and thereafter dealing with a "weak knee" and "limited
range of motion" (albeit not enough to prevent him from
"pass[ing] the Navy's physical readiness test").   

.
Having witnessed Bartlett's testimony firsthand and considered
the other evidence presented at trial, this court has no doubt
that her pain and suffering surpasses that endured by the
Whitfield plaintiff by many orders of magnitude.

                                    85
of the errors that Mutual cites were not errors at all.       See,

e.g., Williams v. Drake, 

 (1st Cir. 1998)

("cumulative-error analysis is inappropriate when a party

complains of the cumulative effect of non-errors").      Moreover, to

the extent that errors occurred, they did not cause any

significant prejudice.      Mutual has not "come close to [showing]

the critical mass   [of errors] necessary to cast a shadow upon the

integrity of the verdict."      United States v. Sepulveda, 

 (1st Cir. 1993).



IV.   Conclusion

      For the reasons set forth above. Mutual's motion for

judgment as a matter of law49 and its motion for a new trial50 are

both DENIED.



      SO ORDERED.




                                  Jorseph N. Laplante
                                  l/nited States District Judge

Dated:   January 5, 2011

cc:   Keith M. Jensen, Esq.
      Bryan Ballew, Esq.
      Patrick J. O'Neal, Esq.


      49Document no. 395.

      "Document no. 3 94.

                                   86
Eric Roberson, Esq.
Christine M. Craig, Esq.
Timothy P. Beaupre, Esq.
Joseph P. Thomas, Esq.
Paul J. Cosgrove, Esq.
Jeffrey D. Geoppinger, Esq.
Linda E. Maichl, Esq.
Stephen J. Judge, Esq.
Pierre A. Chabot, Esq.




                              87