Bartlett v. Mutual Pharmaceutical

Bartlett v. Mutual Pharmaceutical              CV-08-358-JL    9/14/10
                           UNITED STATES DISTRICT COURT
                             DISTRICT OF NEW HAMPSHIRE


Karen L. Bartlett

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

Mutual Pharmaceutical
Company, Inc.

                             MEMORANDUM ORDER

      This products liability case arises out of severe injuries

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, negligence, and fraud under New Hampshire

common law.     Her principal theories were that sulindac is a

defective product unreasonably dangerous to consumers and that

Mutual failed to warn of the drug's safety risks.             This court,

which has jurisdiction under 

(a)(1)            (diversity),

granted summary judgment to Mutual on Bartlett's strict liability

and negligence claims to the extent they were based on failure to

warn, and also on her fraud claim, because she could not prove

that sulindac's allegedly inadeguate warning caused her injuries.

See Bartlett v. Mut. Pharm. Co., 

.            Bartlett

proceeded to trial and prevailed on her strict liability claim of

defective design.
     After the summary judgment ruling, but in advance of trial,

this court ordered the parties to brief whether Bartlett had

sufficient evidence to support her negligence claim (under some

theory other than failure to warn) and, if not, whether she could

still pursue enhanced compensatory damages in connection with her

strict liability claim.   Bartlett responded by submitting her

evidence in support of three negligence theories:   that Mutual

failed to (1) seek Food & Drug Administration   ("FDA") approval of

a patient medication guide for sulindac;   (2) survey the medical

literature for information about sulindac's safety risks and

report such information to the FDA; and (3) file a citizen's

petition with the FDA regarding sulindac's safety risks.    She

further argued that, even if this court rejected those negligence

theories, the jury could award enhanced compensatory damages on

her strict liability claim.

     Having reviewed Bartlett's submission and Mutual's

corresponding brief, this court concludes that Bartlett's

negligence claim is mostly a self-described attempt to

"resurrect" her failure-to-warn theories, in contravention of

this court's summary judgment ruling.   See Bartlett, 

.   To the extent that the negligence claim is based

on conduct other than Mutual's alleged failure to warn, Bartlett

has not presented sufficient evidence to prove that conduct

caused her injuries.   And since her claim for enhanced

                                 2
compensatory damages is based on that same conduct, it also fails

for lack of causation, regardless of whether a strict liability

claim can theoretically sustain such damages.    Mutual is

therefore granted judgment as a matter of law on Bartlett's

claims for negligence and enhanced compensatory damages.       See

Fed. R. Civ. P. 56.

      The court initially announced this ruling in a summary order

issued before trial.    See document no. 329.   This order sets

forth the court's reasoning in greater detail.



I.   Applicable legal standard

      "It is without guestion that district courts, in appropriate

circumstances, are entitled to enter summary judgment sua

sponte."   P.R. Elec. Power Auth. v. Action Refund, 

 (1st Cir. 2008).    To guard against any unfairness to the

parties, our court of appeals has "reguired two conditions prior

to the district court's exercise of such a right:"       (1) "the

discovery process must be sufficiently advanced that the parties

have enjoyed a reasonable opportunity to glean the material

facts," and (2) "the district court must provide the targeted

party appropriate notice and a chance to present its evidence on

the essential elements of the claim."    

.

Both of those conditions have been met here:     the discovery


                                  3
process is over, and this court gave Bartlett notice and an

opportunity to present evidence on her claims for negligence and

enhanced compensatory damages.1    This court will therefore

evaluate those claims as it would in the context of a summary

judgment motion filed by Mutual.

     Summary judgment is appropriate where "the pleadings, the

discovery and disclosure materials on file, and any affidavits

show that there is no genuine issue as to any material fact and

that the movant is entitled to judgment as a matter of law."

Fed. R. Civ. P. 56(c)(2).    An issue is "genuine" if it could

reasonably be resolved in either party's favor at trial, and

"material" if it could sway the outcome under applicable law.

Mulvihill v. Top-Flite Golf Co., 

 (1st Cir. 2003) .

In making that determination, the "court must scrutinize the

record in the light most flattering to the party opposing the

motion, indulging all reasonable inferences in that party's

favor."   

    The following factual summary is consistent with

that approach.




     1See documents no. 281 (order), 305 to 318 (Bartlett's brief
and supporting exhibits), and 303 (Mutual's brief). In addition
to the briefing, this court discussed its concerns about
Bartlett's negligence claim with the parties during the final
pre-trial conference.   See document no. 301.

                                   4
II.     Background

        In December 2004, Bartlett sought medical treatment for pain

in her right shoulder.     Her doctor, Tahsin Ergin, prescribed a

non-steroidal anti-inflammatory drug ("NSAID") called Clinoril,

which the FDA has approved as a treatment for acute shoulder

pain.     Dr. Ergin did not read the potential adverse reactions and

safety warnings listed in the drug's label (or "package insert"),

but he knew from his medical background that sulindac and other

NSAIDs carried some risk of causing potentially fatal skin

conditions called Stevens-Johnson Syndrome        ("SJS") and toxic

epidermal necrolysis    ("TEN").   See Dorland's Illustrated Medical

Dictionary 1872 (31st ed. 2007).         It was not his usual practice

to discuss that risk with patients, and he did not do so with

Bartlett.

        Bartlett took the prescription to a pharmacy in Plaistow,

New Hampshire, which filled it with sulindac, a generic version

of the drug, manufactured by Mutual.         The pharmacy gave Bartlett

a "prescription advisor," which she read, that advised her to

"check with your doctor as soon as possible if you experience

rash or other skin conditions."     Within weeks, Bartlett went to a

local emergency room complaining of skin blisters, a fever, eye

irritation, and other symptoms.         She was soon diagnosed with a

severe case of SJS/TEN.     The consensus among her doctors was that

her SJS/TEN was a side effect of sulindac.         She spent about three

                                    5
months in the hospital recovering, two of them in a medically

induced coma, and emerged with permanent injuries, including

blindness.

     More than a year before Bartlett's prescription, an

international medical journal published a study of the link

between NSAIDs and SJS/TEN.   See Maja Mockenhaupt et al., The

Risk of SJS and TEN Associated with NSAIDs: A Multinational

Perspective, 30 Journal of Rheumatology 2234-2240   (Oct. 2003) .

The article revealed that, from 1980 to 1997, the FDA's adverse

event reporting system 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.   The article

also noted that sulindac was one of four NSAIDs whose rate of

reported SJS/TEN cases, per one million prescriptions, was not

significantly lower than that of piroxicam, which the authors

chose as the "comparator drug" because of its "high risk" in a

controlled study.2




     2Unpublished drafts of the article, prepared privately for
the drug manufacturer Pharmacia by Dr. Robert Stern (who was
later retained as an expert witness by Mutual) in 2001 and 2002,
listed the precise reporting rates of SJS/TEN for various NSAIDs
Sulindac's rate was higher than that of any other NSAID listed.
See documents no. 307-1 and 308-1.

                                 6
     Mutual was not aware of that Journal of Rheumatology article

or adverse event reporting data, because   (by its own admission)

it had not been monitoring the medical literature for information

about sulindac's safety risks.   See document no. 149, at 15.

Mutual believed that the manufacturer of Clinoril, the brand-name

version of the drug, was responsible for such monitoring and for

reporting pertinent safety information to the FDA.    

; but see Bartlett, 

   (concluding that

generic drug manufacturers are also responsible for safety

surveillance and reporting under 

(b)).

     While Bartlett was in the hospital battling SJS/TEN, a group

of doctors   (including two whom Bartlett later retained as expert

witnesses) filed a citizen's petition with the FDA advocating a

stronger SJS/TEN warning in the label for another NSAID,

ibuprofen.   Soon thereafter, the FDA reguired not just ibuprofen,

but all NSAIDs, including sulindac, to insert a stronger SJS/TEN

warning in their labels.   See Bartlett, 

, at 15 n.6

(setting forth the language of that new warning).    The FDA also

reguired that all NSAIDs be accompanied by a patient medication

guide, see 

, with an express warning of "life-

threatening skin reactions" and an instruction that patients

should stop taking the drug if they experienced "skin rash or

blisters with fever."



                                 7
     In a written response to the citizen's petition, the FDA

explained that it had "engaged in a comprehensive review of the

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

approved NSAID products," and that it had specifically reviewed

the Journal of Rheumatology article and the adverse event

reporting data referenced above.   Based on that review, the FDA

concluded that one NSAID, Bextra, should be withdrawn from the

market due to its SJS/TEN and cardiovascular ("CV") risks.     The

FDA explained:

     We have concluded . . . that Bextra has been
     demonstrated to be associated with an increased risk of
     serious adverse CV events . . . .  The increased risk
     of serious adverse CV events alone, however, would not
     be sufficient to warrant withdrawal of Bextra since we
     have no data showing that Bextra is worse than other
     NSAIDs with regard to CV risk. Our recommendation for
     withdrawal is based on the fact that, in addition to
     this CV risk, [Bextra] already carries a boxed warning
     in the package insert for serious, and potentially
     life-threatening, skin reactions (e.g., TEN, SJS,
     erythema multiforme) and FDA has received 7 spontaneous
     reports of deaths from these reactions.  The reporting
     rate for these serious skin reactions appears to be
     greater for Bextra than other [NSAIDs called] COX-2
     selective agents . . . .  To date, there have been no
     studies that demonstrate an advantage of [Bextra] over
     other NSAIDs that might offset the concern about these
     serious skin risks.

Bextra was the fourth drug to be removed from the market due, in

part, to its SJS/TEN risk as demonstrated by adverse event

reports.3


     3The others were benaxaprofen, zomepirac acid, and isoxicam
Since then, the FDA has also refused to approve the drug Provigi
for pediatric use because of its SJS/TEN risk.
       Although sulindac had more reported cases of SJS/TEN than

any other NSAID and more reported deaths   (39) than Bextra, the

FDA did not recommend that sulindac be removed from the market

after its "comprehensive review" of all NSAIDs in 2005.    In fact

sulindac remains on the market to this day.    Mutual has never

filed a citizen's petition with the FDA regarding the safety of

sulindac or seeking its removal from the market.    The company

has, however, filed nine citizen's petitions for other reasons

between 2001 and 2009, including one petition regarding the

dosage form of sulindac and various petitions regarding safety

information in the labels of other drugs   (some manufactured by

Mutual's competitors).    The FDA has generally responded to those

petitions in less than a year.



Ill.   Analysis

       As explained above, this court ordered the parties before

trial to brief (A) whether Bartlett had sufficient evidence to

support her negligence claim, and (B) if not, whether she could

still pursue enhanced compensatory damages in connection with he

strict liability claim.    As explained below, the answer to both

guestions is no.    Mutual is therefore granted judgment as a

matter of law on Bartlett's claims for negligence and enhanced

compensatory damages.
A.   Negligence claim

      Bartlett has submitted evidence in support of three

negligence theories:    that Mutual   (1) failed to seek FDA approval

of a medication guide for sulindac;     (2) failed to survey the

medical literature for information about sulindac's safety risks

and to report such information to the FDA; and (3) failed to file

a citizen's petition with the FDA seeking either sulindac's

removal from the market or the removal of its approved indication

for acute shoulder pain.    Bartlett claims that "the duty that was

breached [by Mutual] in each of these areas is the failure to

communicate with the FDA as a reasonable manufacturer would

have."4

      To prevail on any of those theories, Bartlett must prove

that Mutual's negligent conduct caused her injuries.       See

Carignan v. N.H. Int'l Speedway, Inc., 

 (2004) .

Causation has two components:    the plaintiff must show, first,

"that the injury would not have occurred but for the negligent

conduct," and second, "that the negligent conduct was a

substantial factor in bringing about the harm."      

   Here,

Bartlett claims that if Mutual had taken any of steps listed


     4Bartlett expressly withdrew her claim for negligent design,
see document no. 301, at 15, and implicitly withdrew or waived
any other negligence theories by not raising them in her
submission, see document no. 305.

                                 10
above, the FDA would have   (1) required a patient medication guide

for sulindac before her prescription, rather than after it,     (2)

removed sulindac's approved indication for acute shoulder pain,

and/or (3) removed sulindac from the market, any of which would

have prevented her from taking the drug and thus prevented her

inj uries.

     This court will address each of Bartlett's negligence

theories in turn.   As explained below, most of them are really

failure-to-warn theories and are therefore barred by this court's

summary judgment ruling, which granted summary judgment to Mutual

on all such theories.   See Bartlett, 

.     The

only one that is not a failure-to-warn theory is Bartlett's claim

that the FDA would have removed Sulindac from the market if

Mutual had advocated that removal in a citizen's petition or had

submitted the latest safety information from the medical

literature.   But that claim fails because its causal chain

depends on improbable inferences and speculation.    See Enica v.

Princip, 

 (1st Cir. 2008)   ("summary judgment

cannot be defeated by relying on improbable inferences,

conclusory allegations, or rank speculation").




                                 11
     i.     Patient medication guide

     Bartlett's first negligence theory is that Mutual should

have sought FDA approval of a patient medication guide for

sulindac.     The FDA may reguire that a drug be accompanied by a

medication guide if it determines that "patient labeling could

help prevent serious adverse effects," that safety information

"could affect patients' decision to use, or to continue to use"

the drug in the face of "serious risk(s)," or that "patient

adherence to directions for use is crucial to the drug's

effectiveness."     

.   As discussed above, the FDA

reguired a medication guide for sulindac and all other NSAIDs not

long after Bartlett's prescription.      Bartlett argues that the FDA

would have reguired a medication guide before her prescription if

Mutual had sought it, and that she never would have ingested

sulindac if she had read the guide.

     This court expressly rejected Bartlett's medication guide

theory (among other failure-to-warn theories) in its summary

judgment ruling, both because Bartlett failed to raise it in her

summary judgment objection and because, on the merits,

     it is well established [under New Hampshire law] that a
     manufacturer's duty to warn of a drug's safety risks
     "reguires that the physician, not the patient, be
     warned." Brochu v. Ortho Pharm. Corp., 

 (1st Cir. 1981); see also Nelson v. Daikon Shield
     Claimants Trust, No. 84-276-SD, 

, at *4
     (D.N.H. June 8, 1994).  Since Mutual had no duty to
     warn Bartlett directly, its failure to issue such a
     warning (in the form of a medication guide or

                                  12
     otherwise) cannot serve as the basis for a finding of
     causation.

Bartlett, 

.    The principle articulated in that

passage is known as the "learned intermediary" rule, because its

underlying rationale "is that the prescribing physician, as the

'learned intermediary' standing between the manufacturer and the

consumer/patient, is generally in the best position to evaluate

the [drug's] potential risks and benefits . . . and to advise the

patient accordingly."   Nelson, 

, at *4 (guoting

Garside v. Osco Drug, Inc., 

 (1st Cir. 1992)).

     Bartlett's self-described attempt to "resurrect" her

medication guide theory in the face of that express summary

judgment ruling is really a motion for reconsideration.      See

Rodriguez-Antuna v. Chase   Manhattan Bank Corp.,

(1st Cir. 1989)   ("a motion which asks the court   to modify its

earlier disposition . . . solely because of an ostensibly

erroneous legal result" is a motion for reconsideration).         This

court will analyze it as such.    A motion for reconsideration must

"demonstrate that the order was based on a manifest error of fact

or law" and must be filed within 14    days of the order, unless the

party shows cause for not filing it   within that time.    L.R.

7.2(e).   Here, Bartlett sought reconsideration about a month




                                 13
after the court's ruling, well after the 14-day deadline.5      She

has not shown good cause for that delay.     Her reguest is

therefore denied as untimely.

     Even if it were timely, however, Bartlett's reguest for

reconsideration would still be denied, because she has not

identified a "manifest error of fact or law" in this court's

ruling.     She makes three arguments in that regard:

     First, Bartlett argues that this court should not have

considered her medication guide theory at all because it was "not

raised" by Mutual's summary judgment motion, which in her view

"missed the boat" by focusing solely on the drug's label.      But

this argument sinks.     Mutual moved for summary judgment on all of

Bartlett's claims, including her negligence claim, arguing that

"failure to warn is the common thread in each alleged liability

theory."    Thus, Bartlett had the burden to come forward with

evidence to support all of her failure-to-warn claims, including

her medication guide theory and any other "non-label" theories.

See Evans Cabinet Corp. v. Kitchen Int'l, Inc., 

(1st Cir. 2010).     Instead, she focused on her label-based

theories.    A motion for reconsideration "does not provide a




     5By that point. Mutual had filed not only a motion for
reconsideration of the summary judgment ruling, see document no.
263, but a motion for reconsideration of the court's denial of
its first motion for reconsideration, see document no. 293.

                                  14
vehicle for a party to undo its own procedural failures."

Iverson v. City of Boston, 

 (1st Cir. 2006).6

     Second, Bartlett argues that this court should create a

special exception to the learned intermediary rule for medication

guides, since they are a "new development" in the law, see 

, having been introduced by the FDA in 1998, four

years after the most recent case that applied the learned

intermediary rule under New Hampshire law.     See Nelson, 

, at *4.   In her summary judgment objection, though,

Bartlett called it "an uncontested claim [that] the learned

intermediary doctrine means the drug company need only adeguately

warn the physician."     She did not argue for a special exception

for medication guides.    A motion for reconsideration "does not

. . . allow a party to advance arguments that could and should

have been presented" earlier.     Iverson, 

.

     Moreover, even if Bartlett's argument had been properly

presented, this court is not persuaded that medication guides

constitute so significant a change to prescription drug labeling

as to warrant what would amount to a significant change to (and



     6During oral argument on the summary judgment motion, this
court asked Bartlett about her "non-label" theories in an
abundance of caution, i.e., to determine if they might somehow
salvage her failure-to-warn claims, not (as Bartlett seems to
believe) in an attempt to expand its summary judgment ruling
beyond the scope of Mutual's motion.   Those theories would be
barred now even if this court had never mentioned them.

                                  15
expansion of) state tort law.    Indeed, the FDA expressed

precisely the opposite view when it promulgated the medication

guide regulation, stating that "FDA does not believe that this

rule would adversely affect civil tort liability" because it

"does not alter the duty, or set the standard of care for

manufacturers," and because "courts have not recognized an

exception to the 'learned intermediary' defense in [other]

situations where FDA has reguired patient labeling."     

, 66383-66384   (Dec. 1, 1998).

     Bartlett has not identified, nor has this court found, any

case that supports her view that medication guides warrant a

special exception to the learned intermediary rule, which remains

"nearly universal."    5 Louis R. Frumer & Melvin I. Friedman,

Products Liability § 50.04[2], at 50-58.1   (2010).   "A federal

court sitting in diversity cannot be expected to create new

doctrines expanding state law," Noonan v. Staples, Inc., 

   (1st Cir. 2009), and this court declines Bartlett's

invitation to do so here.

     Third, Bartlett argues that a medication guide, because it

is "reprinted at the end of the [drug's] labeling" or package

insert, 21 C.F.R. 201.57(f)(2), can be considered a warning to

doctors   (not just patients) and thus is not barred by the learned

intermediary rule.    As explained in this court's summary judgment

ruling, however, Bartlett's doctor did not read or rely upon

                                 16
sulindac's label before prescribing the drug to her.   So the

medication guide, even if reprinted there, would not have

affected the doctor's decision or prevented Bartlett's injuries.

Thus, Mutual's failure to seek a medication guide cannot be

considered the cause of Bartlett's injuries.   See Carignan, 

.7



     ii.   Removal of indication for shoulder pain

     Bartlett's second negligence theory is that, if Mutual had

filed a citizen's petition with the FDA or otherwise submitted


     7While on the topic of medication guides, it is worth taking
a moment to explain the evidentiary rulings on that topic.    This
court initially granted Mutual's motion in limine seeking to
exclude from trial any evidence regarding medication guides,
"because they would imply a duty to warn the patient, would be
confusing to the jury and unfairly prejudicial to Mutual."
Bartlett v. Mut. Pharm. Co., 

 (citing Fed. R.
Evid. 403). At trial, however, this court orally modified that
ruling, allowing evidence of the medication guide to be admitted
with a cautionary instruction designed to avoid juror confusion
and unfair prejudice.   The cautionary instruction was given
several times during the trial, including in the final jury
charge.   See document no. 378, at 21-22.
     The reasons for that modification were twofold.   First,
since the jury was allowed to consider the changes that the FDA
made to sulindac's labeling in 2005, see Bartlett, 

, and the medication guide was part of those changes, it
was necessary to give the jury a complete and accurate
understanding of what the FDA did.   Second, this court determined
that the jury could consider the medication guide in evaluating
"the presence and efficacy of a warning to avoid an unreasonable
risk of harm," which is an analytically distinct guestion from
whether Mutual had a duty to warn via a medication guide.
Bartlett v. Mut. Pharm. Co., No. 08-cv-358, 

, at
*1 (D.N.H. Aug. 16, 2010) (document no. 345) (guoting Vautour v.
Body Masters Sports Indus., Inc., 

 (2001)).

                                17
information from the medical literature regarding sulindac's risk

of SJS/TEN, the FDA would have removed sulindac's approved

indication for acute shoulder pain, "advising doctors of this

through effective means" and thereby preventing Bartlett's doctor

from prescribing the drug to her for that purpose.     As Bartlett's

reference to "advising doctors" betrays, however, this too is

really a failure-to-warn theory, which Bartlett could have and

should have raised in her summary judgment objection.     Since she

failed to do so, the theory has been waived.     See Iverson, 

 (a motion for reconsideration "does not . . . allow a

party to advance arguments that could and should have been

presented" earlier).

     Moreover, even if Bartlett's removal-of-indication theory

had been properly presented, this court would have rejected it on

the merits.    A prescription drug's approved indications, like its

potential adverse reactions and warnings, are set forth in its

label.   See 

(c).    As explained in this court's

summary judgment ruling, Bartlett's doctor did not read or rely

upon sulindac's label before prescribing the drug to her.     So the

deletion from that label of the indication for acute shoulder

pain would not have affected the doctor's decision or prevented

Bartlett's injuries.     Thus, Mutual's failure to seek a removal of

the indication cannot be considered the cause of Bartlett's

injuries.     See Carignan, 

.

                                  18
     Seemingly unfazed by the rules of summary judgment, Bartlett

also argues that her doctor might have learned of the removal-of-

indication (or other label changes) from an FDA press release,

public health advisory, or mass mailing to physicians.        This

court expressly rejected that argument in its summary judgment

order, explaining that it had been "untimely and improperly

raised" in Bartlett's separate limine briefing, not in her

summary judgment objection (or even at oral argument on the

summary judgment motion), and was therefore waived.     See

Bartlett, 

, at 19 n.9.    The argument has not become

any more timely or proper in the intervening period.8



     iii.   Removal from the market

     Bartlett's third negligence theory is that if Mutual had

filed a citizen's petition with the FDA or otherwise submitted

information from the medical literature regarding sulindac's risk

of SJS/TEN (including the Journal of Rheumatology article, which

revealed that sulindac had more reported cases of SJS/TEN in the

FDA's adverse event database than any other NSAID), the FDA would

have removed sulindac from the market entirely, thus preventing


     8Moreover, Bartlett still has not presented any evidence
that her doctor would have read any such materials--only his
deposition testimony (unmentioned in her summary judgment and
limine briefing) that "as physicians we'll often receive them."
Of course, receiving a mass mailing is not the same as reading
it.

                                19
Bartlett's doctor from prescribing it and thereby preventing her

injuries.     This is Bartlett's only negligence theory that is not

based on failure to warn and hence is not barred by this court's

summary judgment ruling.     Nevertheless, the theory suffers from a

number of other fatal flaws.

        The theory's most obvious flaw, which this court discussed

briefly in a previous order, is that it is "contrary to what has

actually happened."     Bartlett, 

.   The FDA said

that it "engaged in a comprehensive review of the risk and

benefits, including the risks of SJS/TEN, of all approved NSAID

products" in 2005, after receiving a citizen's petition from a

group of doctors    (two of whom later became Bartlett's experts).

As part of that review, the FDA specifically considered the

Journal of Rheumatology article and the adverse event reporting

data.    While deciding to strengthen the SJS/TEN warning on all

NSAID labels, the FDA concluded that only one NSAID should be

removed from the market due in part to its SJS/TEN risk:     Bextra.

"Sulindac remains on the market today . . . even though the FDA

has long been aware of the adverse event data and medical

literature upon which Bartlett relies."     Id. at 11-12.

        Bartlett argues that sulindac's risk-benefit profile was

actually even worse than Bextra's.     Regardless of how the two

drugs compare, however, the bottom line is that the FDA concluded

that Bextra should be removed from the market, but that sulindac

                                  20
could stay on the market with a stronger SJS/TEN warning.

Bartlett's theory that the FDA would have removed sulindac from

the market if Mutual had submitted the Journal of Rheumatology

article and other available information from the medical

literature is counterfactual.     C f . Buckman Co. v. Pis.' Legal

Comm., 

 (2001)    (Stevens, J., concurring in the

judgment, joined by Thomas, J.)    ("The fact that the FDA has done

nothing to remove the devices from the market, even though it is

aware of the basis for the [plaintiff's] fraud allegations,

convinces me that [causation] cannot be proved.").

     Bartlett attempts to overcome this problem by pointing to

earlier, unpublished drafts of the Journal of Rheumatology

article   (prepared by defense expert Dr. Stern for the drug

manufacturer Pharmacia in 2001 and 2002), which contain

additional information about sulindac's SJS/TEN risk that did not

appear in the final article.    Specifically, the drafts reveal

that sulindac's rate of reported SJS/TEN cases per million

prescriptions   (not just its absolute number of reports) was the

highest of any NSAID listed.    Bartlett argues that Mutual should

have obtained those unpublished drafts and submitted them to the

FDA, which (she claims) has never considered that reporting rate

data and would have responded by recommending sulindac's removal

from the market.



                                  21
     There is insufficient evidence, though, to support any of

the links in that causal chain.    Even assuming, dubitante, that a

reasonable manufacturer would have asked the authors of a

published, peer-reviewed article for their unpublished drafts         (a

proposition for which Bartlett has not offered any expert

testimony or other evidence), there is no evidence from which a

jury could reasonably conclude that such a reguest would have

been granted.   Dr. Stern testified that, because of his contract

with Pharmacia, he had to seek Pharmacia's permission even to use

the unpublished data in developing the Journal of Rheumatology

article.   Pharmacia granted his reguest, but the current record

provides no basis for reliably evaluating whether it would have

allowed the unpublished drafts to be shared directly with a

competitor like Mutual, leaving this link in the causal chain to

speculation.

     There is likewise no evidence from which a jury could

reasonably conclude that Pharmacia did not itself share those

unpublished drafts with the FDA.       While Dr. Stern did not send

the drafts to the FDA himself and has no "direct knowledge" of

whether Pharmacia did so, he considers it a "high likelihood that

Pharmacia would have filed a report of this type" with the FDA.

Of course. Dr. Stern's speculation is not dispositive.       But

without any evidence of what Pharmacia actually did, it would be

egually speculative to conclude that the FDA never received the

                                  22
drafts.      See Enica, 

 ("summary judgment cannot be

defeated by relying on improbable inferences, conclusory

allegations, or rank speculation").

         Moreover, even if Pharmacia never shared Dr. Stern's

reporting rate calculations with the FDA, those calculations were

based entirely on publicly available information from the federal

government.      Dr. Stern used, as his numerator, the number of

SJS/TEN reports for each drug in the FDA's own adverse event

reporting database.      And he used, as his denominator, the

estimated number of prescriptions for each drug in the National

Ambulatory Medical Care Survey ("NAMCS"), compiled by the federal

Centers for Disease Control and Prevention ("CDC").      The FDA's

analyses of Bextra in 2005 and Provigil in 2007 both indicate

that, either through those government sources or other means, the

FDA has the ability to calculate and has calculated the SJS/TEN

reporting rates for NSAIDs.9

         Finally, even assuming, dubitante, that the FDA was unaware

of the precise SJS/TEN reporting rates for sulindac and other


     9See document no. 309-1, at 12 ("While other COX-2 selective
and non-selective NSAIDs also have a risk for these rare, serious
skin reactions, the reported rate for these serious side effects
appears to be greater for Bextra than for other COX-2 agents.");
id. at 17 ("The reporting rate for these serious skin reactions
appears to be greater for Bextra than other COX-2 selective
agents."); document no. 309-3, at 19 ("the calculated reporting
rate for [Provigil] associated SJS/TEN in all ages in the U.S. is
5.7 per 1,000,000 patients as compared to the background rate of
1- 2 " ) .

                                   23
NSAIDs, the final article published in the Journal of

Rheumatology (which the FDA definitely did review) expressly

listed sulindac as one of only four NSAIDs with a reporting rate

comparable to that of piroxicam, which the authors chose as the

"comparator drug" because of its "high risk" in a controlled

study.    The clear implication was that sulindac had one of the

highest SJS/TEN reporting rates among NSAIDs    (albeit without

reference to the precise numbers).     Despite that information, the

FDA did not conclude that sulindac should be removed from the

market.   Bartlett's claim that more specific data would have

changed the FDA's mind is, again, pure speculation.     See Enica,

.

     This court recognizes that it is not possible to prove with

absolute certainty what the FDA would have done in response to

hypothetical communications that never occurred.     To the extent,

if any, that failure to communicate with the FDA can serve as a

basis for a state negligence claim, see infra (discussing federal

pre-emption concerns raised by such claims under Buckman, 

), the plaintiff must be given some inferential leeway

in establishing causation.    See, e.g., Stanton v. Astra Pharm.

Prods., Inc., 

   (3d Cir. 1983)   (holding, albeit

before Buckman, that a reasonable jury could find causation based

on "evidence tending to show that the information withheld from

the FDA was of great importance . . . and that the FDA would have

                                  24
taken action had it been aware of [the drug's] propensity to

cause adverse reactions").   But the inferences still must be

reasonable, not improbable or based "upon speculation as to the

FDA's behavior in a counterfactual situation," which is the case

with Bartlett's negligence theory.     Buckman, 

(Stevens, J., concurring in the judgment).

     Bartlett also seems to be suggesting the FDA would have

taken a harder look at sulindac and ultimately reached a

different decision if Mutual, one of the drug's own

manufacturers, had filed a citizen's petition reguesting its

removal from the market.   But that too is speculative, at least

on the record before the court.    There is no evidence to suggest

that the FDA makes its decisions that way.     The FDA claimed to

have conducted a "comprehensive review" of all NSAIDs, including

sulindac, and their SJS/TEN risk in 2005, after receiving a

citizen's petition from Bartlett's experts.     Whether or not that

review was truly comprehensive, it is pure speculation to assume

that the FDA would have conducted a more thorough review in

response to a citizen's petition from Mutual.

     Moreover, Bartlett's argument that Mutual should have filed

a citizen's petition with the FDA highlights yet another flaw

with her negligence theory, which is that Mutual did not even

need the FDA's permission to stop selling sulindac.     It could

have done so unilaterally at any time.     The reason that Bartlett

                                  25
has inserted the FDA as a middleman is that "almost all of the

opinions which have addressed the issue have found that there is

no common law duty to recall" products from the market, even if

they are unreasonably dangerous.      5 Frumer & Friedman, supra, §

57.01[4], at 57-9.   As this court noted in a previous order,

"strict products liability requires . . . that manufacturers

compensate consumers for the damage caused by unreasonably

dangerous products, not necessarily that they remove such

products from the market."    Bartlett, 

.

     Bartlett has lengthened the chain of causation to include

the FDA in an attempt to overcome the lack of any duty on

Mutual's part to stop selling sulindac.     Nevertheless, the duty

problem persists.    Bartlett has not presented any expert

testimony or other evidence to suggest that a reasonable

manufacturer in Mutual's position would have filed a citizen's

petition advocating that its own drug be removed from the market,

when it simply could have stopped selling the drug on its own.

Bartlett argues that Mutual's conduct in filing nine citizen's

petitions over the past decade establishes a "standard of care to

file citizen's petitions."    It is true that a defendant's

internal practices can serve as evidence of a standard of care.

See, e.g.. Hood v. City of Nashua, 

 (1940) .    But none

of Mutual's citizen's petitions sought the removal of one of

Mutual's own drugs, so they do not establish any standard of care

                                 26
in that regard.   Indeed, so far as the record indicates, there

appears to be no precedent for such a petition.

     As if the many problems discussed above were not enough,

Bartlett's negligence theory also raises serious federal pre­

emption concerns under the Supreme Court's decision in Buckman,

, which held that "state-law fraud-on-the-FDA

claims conflict with, and are therefore impliedly pre-empted by"

the Federal Food, Drug, & Cosmetic Act, 

 et seg.

The claim in Buckman was that the defendant drug manufacturer

"made fraudulent misrepresentations" to the FDA in the course of

obtaining approval of a medical device, and "that such

representations were at least a 'but for' cause of injuries that

plaintiffs sustained.      . . . Had the representations not been

made, the FDA would not have approved the devices, and plaintiffs

would not have been injured."     Id. at 343.

     The Supreme Court reasoned that such claims "inevitably

conflict with the FDA's responsibility to police fraud

consistently with [its own] judgment and objectives," and by

raising the prospect of state tort liability for failure to

communicate with the FDA, would give drug manufacturers "an

incentive to submit a deluge of information that the [FDA]

neither wants nor needs, resulting in additional burdens on the

FDA's evaluation."   Id.    The Court concluded that "this sort of

litigation would exert an extraneous pull on the scheme

                                   27
established by Congress, and it is therefore pre-empted by that

scheme."    Id. at 353,

     While this case involves an allegedly negligent

nondisclosure to, rather than an intentional fraud on, the FDA,

it raises some of the same concerns identified in Buckman.       If

drug manufacturers could be held liable under state law for

negligent "failure to communicate with the FDA" (which is how

Bartlett describes all of her negligence theories), then there is

a very real possibility that the FDA would be "deluged" with

citizen's petitions and other correspondence from manufacturers

seeking to protect themselves against such state tort liability.

That could impede the FDA's efforts to fulfill its regulatory

mission in an efficient manner.

     Whether Buckman's logic extends to this type of negligent

nondisclosure claim is debatable.       Some courts have construed

Buckman narrowly as applying only to true "fraud-on-the-FDA"

claims.    See, e.g., Desiano v. Warner-Lambert & Co., 

 (2d Cir. 2006), aff'd without opinion by an egually divided

court, 

 (2008).    Other courts, however, have read

Buckman more broadly as encompassing other types of claims that

raise similar concerns.    See, e.g., Garcia v. Wyeth-Ayerst Labs.,

 (6th Cir. 2004); Hughes v. Boston Sci. Corp., 

   (S.D. Miss. 2009)    (stating that the "Buckman

holding did not turn on intentional versus negligent"

                                  28
misrepresentation and calling that "a distinction without a

difference").      This court need not choose a side in that debate,

given the many other problems with Bartlett's negligence theory,

as discussed above.      Suffice it to say, however, that Mutual's

argument for Buckman pre-emption is not a frivolous one.

         In sum, Bartlett's claim that the FDA would have removed

sulindac from the market in response to a citizen's petition or

other submission from Mutual is largely counterfactual and

otherwise based on improbable inferences and speculation.      The

claim therefore fails for lack of causation.      The claim also runs

into problems on the element of duty, especially to the extent

that Bartlett is arguing that Mutual should have advocated that

its own drug be removed from the market.      Finally, while the

court need not decide this issue in light of the lack of

causation, the claim raises substantial federal pre-emption

concerns under the Supreme Court's holding in Buckman, since it

is premised on Mutual's alleged "failure to communicate with the

FDA. "



B.   Enhanced compensatory damages

         Since Bartlett has not presented sufficient evidence to

support any of her negligence theories, this court must proceed

to answer the other guestion briefed by the parties:      whether



                                   29
Bartlett can nevertheless recover enhanced compensatory damages

on her strict liability claim.      Under New Hampshire law, an award

of compensatory damages may be enhanced in "exceptional cases"

where the defendant's tortious "act is wanton, malicious, or

oppressive."     Stewart v. Bader, 

 (2006).    An act

is "wanton" if the defendant recklessly creates a risk of great

harm.     See Minion, Inc. v. Burdin, 

 (D.N.H.

1996)    (McAuliffe, D.J.)   (citing Thompson v. Forest, 

 (1992)).     An act is "malicious" if the defendant has "ill

will, hatred, hostility, or evil motive."       Stewart, 

.     An act is "oppressive" if it constitutes an abuse of power.

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

Instructions § 9.14, at 9-17 (1996) .     It is the plaintiff's

burden "to present evidence of wanton, malicious or oppressive

conduct."     Figlioli v. R.J. Moreau Cos., 

(2005) .

        In the summary judgment ruling, this court concluded that a

reasonable jury could award enhanced compensatory damages in this

case based on Mutual's "failure to survey the medical literature

for information about sulindac's safety risks," and any other

failures that followed from that one, such as a failure to report

such information to the FDA.      Bartlett, 

.   But

that was before Bartlett submitted her evidence in support of

that theory, and obviously before this court concluded that her

                                    30
evidence was insufficient to prove that Mutual's failure to

survey the medical literature caused her injuries.          See Part

III.A.ill, supra.      The question is whether that lack of

causation, which clearly defeats Bartlett's claim for regular

compensatory damages based on that conduct, defeats her claim for

enhanced compensatory damages as well.

     Analogizing to punitive damages cases from other states,

Bartlett argues that enhanced compensatory damages could

nevertheless be awarded on her strict liability claim, which

alleges that sulindac was a defective product unreasonably

dangerous to consumers.          It is true that, even though such claims

focus on the product itself rather than the defendant's conduct,

most courts allow punitive damages to be awarded where there is

"proof that a higher level of fault exists than that which

supports the actual damage award."          2 Frumer & Friedman, supra,

14.03[1] [b] , at 14-35    (quoting Racer v. Utterman, 

 (Mo. C t . A p p . 1981)).     In other words, most courts allow

punitive damages where the defendant has acted recklessly in

relation to the product, even if that reckless conduct was

"immaterial" or legally unnecessary to a finding of strict

liability.    

     But punitive damages are prohibited by statute in New

Hampshire, see N.H. Rev. Stat. § 507:16, and the New Hampshire

Supreme Court has made clear that enhanced compensatory damages

                                       31
are different from punitive damages.       They are, "as their name

indicates, compensatory and not punitive in nature."       State v.

Hynes, 

 (2009).       They cannot "be awarded as a

punishment to the defendant or as a warning and example to deter

him and others from committing like offenses in the future."

Stewart, 

.    Nor can they be treated as somehow

"separate from actual damages."     Nollet v. Palmer, 

 (DiClerico, J.)    (citing Vratsenes v. N.H. Auto. Inc., 

 (1972)).     Rather, they must "reflect the aggravating

circumstances of an injury caused to the plaintiff."       DCPB, Inc.

v. City of Lebanon, 

 (1st Cir. 1992)      (applying

New Hampshire law).     So Bartlett's analogy to punitive damages is

unpersuasive.

     Both parties agree that there is no precedent in New

Hampshire for awarding enhanced compensatory damages on a strict

liability claim.     This court need not decide whether such an

award is ever possible.    All that need be said is that such an

award is not possible on the particular facts of this case.       It

would be inconsistent with New Hampshire law for enhanced

compensatory damages to be awarded based on conduct by Mutual

that, due to a lack of causation, could not serve as the basis

for an award of regular compensatory damages      (which is true of

all of Mutual's conduct that arguably could be considered

"wanton, malicious, or oppressive").       That would make the

                                  32
enhanced compensatory damages "separate from actual damages" and

would make them impermissibly punitive in nature.    See Evans v.

Taco Bell Corp., 

   (DiClerico, J.)   ("Because

[the plaintiff] has not shown a genuine issue of material fact as

to whether [the defendant's] allegedly wrongful actions caused

her claimed damages, she cannot recover enhanced compensatory

damages .") .10



IV.   Conclusion

      For the reasons set forth above. Mutual is granted judgment

as a matter of law on Bartlett's claims for negligence and

enhanced compensatory damages.


      SO ORDERED.




Dated:   September 14, 2010

cc:   Keith M. Jensen, Esq.
      Bryan Ballew, Esq.
      Patrick J. O'Neal, Esq.


     10Even without the ability to seek enhanced compensatory
damages, Bartlett recovered $21.06 million in compensatory
damages at trial, which consisted of $1.25 million in past
medical expenses (stipulated by the parties), $2,377 million in
future medical expenses, $933,000 in lost wages, and $16.5
million in pain and suffering.

                                 33
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.




                          34