Bartlett v. Mutual Pharmaceutical

Bartlett v . Mutual Pharmaceutical     CV-08-358-JL   8/12/10   P
                   UNITED STATES DISTRICT COURT
                     DISTRICT OF NEW HAMPSHIRE


Karen L . Bartlett

     v.                            Civil N o . 08-cv-00358-JL
                                   Opinion N o . 

Mutual Pharmaceutical
Company, Inc.

                         MEMORANDUM ORDER

     This products liability case, which arises from injuries

allegedly caused by the prescription drug Sulindac, is scheduled

to begin trial next week.   In advance of trial, this court

ordered the parties to brief whether the defendant Mutual

Pharmaceutical Company has sufficient evidence to support its

affirmative defenses based on (1) plaintiff Karen Bartlett’s

failure to stop taking the drug Sulindac and/or to seek medical

care as soon as she began feeling sick; and (2) her doctor Tahsin

Ergin’s failure to read Sulindac’s warning label and/or to warn

Bartlett of the drug’s safety risks. After reviewing the

parties’ submissions, this court concludes that Mutual (which has

not designated an expert to explain how any of those failures

caused or contributed to Bartlett’s injuries) does not have

sufficient evidence to support those defenses and accordingly

strikes them from the case.1


     1
      The court initially announced this ruling during a
conference call with the parties on August 1 1 , 2010, and in a
summary order later that day, see document n o . 329. This order
sets forth the court’s reasoning in greater detail.
I.   Applicable legal standard

      “It is without question that district courts, in appropriate

circumstances, are entitled to enter summary judgment sua

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

 7 ,

64 (1st Cir. 2008).   To guard against any unfairness to the

parties, our court of appeals has “required 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 or defense.”    

.

Both of those conditions have been met here: the discovery

process is over, and this court gave Mutual notice and an

opportunity to present evidence on its defenses.2    This court

will therefore evaluate those defenses as it would in the context

of a summary judgment motion filed by Bartlett.3


      2
      See documents n o . 296 (order), 322 (Mutual’s brief), and
326 (Bartlett’s brief). In addition to the briefing, this court
discussed its concerns about the defenses with the parties during
the final pre-trial conference. See document n o . 3 0 1 , at 29-42.
      3
      Of course, this court would also have the authority at
trial to refuse to instruct the jury on defenses for which Mutual
has not presented sufficient evidence. See Fed. R. Civ. P.
50(a)(1). Mutual would not fare any better then, because (as
explained infra) it lacks sufficient expert testimony to support

                                  2
      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., 

 5 , 19 (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.



II.   Background4

      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.

Dr. Ergin did not read the drug’s label before prescribing i t .



its defenses, and the expert disclosure rules prevent it from
remedying that defect by introducing new expert opinions at
trial. See Fed. R. Civ. P. 26(a)(2)(B).
      4
      For a more detailed summary of the case’s factual and
procedural background, see this court’s recent summary judgment
ruling. Bartlett v . Mut. Pharm. Co., 

 1 2 , 3-8.

                                  3
Even without reading the label, D r . Ergin knew from his medical

background that the drug could cause a serious and potentially

fatal skin disease known as Stevens-Johnson syndrome (“SJS”) or

toxic epidermal necrolysis (“TEN”).   But it was not his usual

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

with Bartlett. Instead, D r . Ergin told Bartlett that if she

developed any adverse symptoms or abnormal reactions, she should

stop taking the drug and contact his office.

     Bartlett took the prescription to a nearby pharmacy, 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” if certain possible side effects,

including diarrhea, “continue or are bothersome,” to “check with

your doctor as soon as possible if you experience rash or other

skin conditions,” and to “contact your doctor immediately if you

experience swelling of hands, face, lips, eyes, throat, or

tongue” or certain other symptoms.

     Within weeks of the prescription, Bartlett began to feel

sick.   Her symptoms started on a Saturday as a bout with

diarrhea, which continued into Sunday.   She then went to work on

Monday, but did not feel well enough to work a full day.    That

was the first day she contacted D r . Ergin or her primary care

physician.   She went to an emergency room the following day

                                4
(Tuesday), at which point she was complaining of a skin rash,

fever, and eye irritation.     She continued taking Sulindac until

that point (and possibly a little longer, since there is a

discrepancy between the number of pills she recalls taking and

the number of pills left, see Bartlett, 

 1 2 , at 37-38).

Soon thereafter, she was diagnosed with SJS/TEN.     She spent about

three months in the hospital recovering, two of them in a

medically induced coma, and emerged with permanent injuries.



III.       Analysis

A.   Defenses based on Bartlett’s conduct

       Mutual has asserted four affirmative defenses based on

Bartlett’s failure to stop taking the drug Sulindac and/or to

seek medical care as soon as she began feeling sick.     The first

defense is comparative negligence. See N.H. Rev. Stat. § 507:7-

d.   The second is plaintiff’s misconduct, which is the strict

liability equivalent of comparative negligence.5     See Thibault v .

Sears, Roebuck & Co., 

 0 2 , 813 (1978).   The third is

apportionment of liability.     See N.H. Rev. Stat. § 507:7-e;

DeBenedetto v . CLD Consulting Eng’rs, Inc., 

(2006).      The fourth is superseding or intervening cause.   See




       5
      Mutual sometimes refers to this defense as “failure to
follow instructions.”

                                   5
Marcotte v . Timberlane/Hampstead Sch. Dist., 

 3 1 , 347-48

(1999).

     All of those defenses have at least one element in common:

causation.   Mutual must prove by a preponderance of the evidence

that Bartlett’s conduct caused or contributed to her injuries.

See N.H. Rev. Stat. § 507:7-d (comparative negligence--defendant

has “burden of proof as to the existence or amount of fault

attributable” to the plaintiff); Thibault, 

(plaintiff’s misconduct--defense not available “if plaintiff’s

misconduct did not cause the loss or injury”); Tiberghein v . B.R.

Jones Roofing, Co., 

 1 0 , 115 (2007) (apportionment–-

defense involves “fault allocation . . . between parties who have

causally contributed to an accident”); Bruzga v . PMR Architects,

P.C., 

 (1997) (superseding cause–-defendant

must show that superseding event “breaks the causal connection”

between its conduct and plaintiff’s injuries).

     Although Mutual has not conceded the underlying premise that

Sulindac caused Bartlett’s SJS/TEN, see document n o . 3 2 0 , at 3

(noting that Mutual has no intent to challenge that point but

will require Bartlett to prove i t ) , its causation theory for

these defenses seems to be that Bartlett’s injuries would have

been less severe if she had stopped taking Sulindac and gone to

the emergency room immediately after she started to feel sick

with diarrhea, rather than waiting a few days until she had

                                  6
developed more serious symptoms. Mutual has not, however,

designated any experts to testify in support of that theory.

Instead, Mutual relies on the deposition testimony of various

treating physicians (as well as one of Bartlett’s experts), all

of whom testified that immediate cessation of the offending drug

is the first and most important aspect of treating a drug

reaction.

     None of those witnesses, however, explained how or to what

extent (if any) Bartlett’s conduct affected her actual injuries.

To the contrary, some of the treating physicians suggested that

medical knowledge of SJS/TEN has not advanced to the point where

that question can be reliably answered.        D r . John Schulz, for

example, testified that “the horse is out of the barn” after the

initial “medication exposure” and that “once the syndrome is

initiated, God knows where it will plateau.”           Similarly, D r .

Colleen Ryan acknowledged that while it “makes sense” to stop

taking the drug immediately, “it’s unclear the relationship of

dose to the process.”   Mutual’s counsel echoed those sentiments

during oral argument on the summary judgment motions,

representing to the court that a person could take only one

Sulindac pill and “be struck to the same degree as M s . Bartlett

was in this case.”   Document n o . 2 2 0 , at 5 3 .

     The only witness who ventured an opinion on this causation

theory is Mutual’s expert D r . Robert Stern, who testified at his

                                    7
deposition that “there is a possibility that since Sulindac may

have been the cause of [Bartlett’s] reaction, . . . she may have

had a somewhat less severe outcome” if she had stopped taking the

drug earlier. He then repeated:        “That’s a possibility.”     But

Mutual needs to prove more than a mere possibility; it needs to

prove a probability.    Thus, D r . Stern’s conclusory opinion is not

enough to sustain Mutual’s defenses. The court also notes that

Dr. Stern’s opinion was expressed for the first time at his

deposition, not in his expert report, and thus was not properly

disclosed under Fed. R. Civ. P. 26(a)(2)(B)(i).

     Without expert testimony, the jury has no reliable way of

determining whether, or to what extent, Bartlett’s conduct caused

or contributed to her injuries, which were far beyond the

experience of average jurors. See Lemay v . Burtnett, 

 (1995) (“Expert testimony is required whenever the

matter to be determined is so distinctly related to some science,

profession, business or occupation as to be beyond the ken of the

average layman.”); Thorpe v . New Hampshire, 

(1990) (explaining that expert testimony is necessary if “any

inference of the requisite causal link must depend on observation

and analysis outside the common experience of jurors”).          Any

finding of causation would be purely speculative on this record.

See Lockridge v . Univ. of M e . Sys., 

 6 4 , 471 n.6 (1st



                                   8
Cir. 2010) (“unsupported speculation . . . is insufficient to

forestall summary judgment”).

      Since Mutual has not presented sufficient evidence to

establish a trialworthy defense of comparative fault, plaintiff’s

misconduct, apportionment, or superseding cause based on

Bartlett’s conduct, Bartlett is granted judgment as a matter of

law on those defenses.



B.   Defenses based on Dr. Ergin’s conduct

      Mutual has also asserted two defenses based on D r . Ergin’s

conduct, including specifically his failure to read Sulindac’s

warning label before prescribing the drug and/or his failure to

warn Bartlett that the drug could cause SJS/TEN.    The first

defense is third-party negligence and apportionment of liability.

See N.H. Rev. Stat. § 507:7-e; DeBenedetto, 

. The

other is superseding or intervening cause. See Marcotte, 

.   This court will address each defense in turn.



      i.   Apportionment

      Under New Hampshire law, “[w]here the defendant seeks to

reduce or eliminate the plaintiff’s recovery by apportioning

professional liability” to a doctor who is not a party to the

litigation, the defendant must “carry the plaintiff’s burden of

proof outlined in . . . N.H. Rev. Stat. § 507-E:2,” which is the

                                 9
statute applicable to medical malpractice cases. Goudreault v .

Kleeman, 

 (2009).    That statute requires

“‘affirmative evidence which must include expert testimony of a

competent witness’ of the standard of reasonable care, breach

thereof and proximate causation of damages.”    

 (quoting N.H.

Rev. Stat. § 507-E:2) (emphasis added).

    Mutual has not designated any expert witnesses to opine on

those three elements. Instead, Mutual relies on deposition

testimony by two of Bartlett’s experts, Drs. Randall Tackett and

Roger Salisbury.   This court does not see how Mutual could elicit

such testimony at trial consistent with the Federal Rules of

Evidence and the Federal Rules of Civil Procedure. The testimony

would be beyond the permissible scope of cross-examination

(accepting Bartlett’s representation at the final pre-trial

conference that she will not ask about such matters on direct

examination).   See Fed. R. Evid. 611(b).   And to the extent that

Mutual intends to call Drs. Tackett and Salisbury in its own

case, it failed to make the timely expert disclosures required by

Fed. R. Civ. P. 26(a)(2)(A).

    This court recognizes that, under some circumstances, “a

trial court has discretion to decide whether to require a witness

to testify for an opposing party” at trial, including an expert

witness.   Jasty v . Wright Med. Tech., Inc., 

 8 , 39 (1st

Cir. 2008).   But there is no requirement that the court do s o ,

                                 10
especially “[i]n the absence of any showing of a need for [the

opposing party] to call the witness.”    

 (affirming trial

court’s decision not to allow one party to call the other party’s

damages expert).   This court is not inclined to exercise its

discretion to allow such testimony here. Any “need” that Mutual

may have to call Bartlett’s witnesses is entirely of its own

making, in that it failed to designate its own expert to testify

about the standard of care (despite long ago disclosing an

apportionment defense based on D r . Ergin’s conduct, see

documents n o . 11 and 322-1).   Allowing Mutual to bypass the

strictures of Rule 26 by simply posing out-of-scope questions to

Bartlett’s experts at their depositions would put Bartlett at an

unfair disadvantage, since her expert proof on this issue was

confined by Rule 2 6 .

     In any event, even if Mutual could use the testimony of

Bartlett’s experts, that testimony would still be insufficient to

sustain Mutual’s apportionment defense. One of Bartlett’s

experts, D r . Tackett, is a pharmacologist, not a treating

physician.   Thus, he is not qualified to express an expert

opinion on the standard of care that D r . Ergin, an orthopedic

surgeon, should have followed in prescribing a drug like

Sulindac. See Fed. R. Evid. 702. Moreover, even if he were

qualified, D r . Tackett did not testify that the standard of care

required D r . Ergin to read Sulindac’s label or to warn Bartlett

                                  11
that the drug could cause SJS/TEN.    At most, his testimony

suggests that D r . Ergin should have “provided [Bartlett] with a

sufficient warning about if she had side effects to contact him.”

That is precisely the warning that D r . Ergin gave, so D r .

Tackett’s testimony is of no help to Mutual in proving these

defenses.

     Bartlett’s other expert, D r . Salisbury, is a burn surgeon

who has some experience prescribing drugs that carry a risk of

SJS/TEN, so he arguably is qualified to opine about the

applicable standard of care. See 

     But his testimony also

fails to establish that D r . Ergin breached the standard of care

in a way that caused or contributed to Bartlett’s injuries. See

Goudreault, 

. D r . Salisbury opined in his expert

report that Sulindac’s label should have included the following

statement: “patients should be warned to discontinue NSAID

should they develop any rash, fever without an alternative

explanation, or mucosal symptoms.”    Again, however, D r . Ergin did

advise Bartlett to stop taking the medication and contact his

office if she developed any adverse symptoms or abnormal

reactions.   And in any event, there is no expert testimony

regarding how, or to what extent, earlier cessation of the drug

would have changed Bartlett’s injuries. See Part III.A, supra.

     Dr. Salisbury also testified at his deposition that

physicians “have the responsibility,” as a matter of “generally

                                 12
accepted practice in medicine,” to review the warning label or

Physician’s Desk Reference entry (which also contains the

warning) for drugs that they prescribe. He explained that the

“reason for that” is “not only to help them in understanding the

drug, but in order to counsel the patient what to look for and

what problems may occur with stopping the drug.”   But D r . Ergin

already knew, even without reading Sulindac’s warning label, that

the drug could cause SJS/TEN, which is essentially all that the

label said in that regard.6   There is no evidence to suggest that

his failure to read the label affected his decisionmaking process

and thus no evidence to suggest that it caused or contributed to

Bartlett’s injuries.

     This defense ultimately stands or falls on whether the

standard of care required D r . Ergin, knowing that Sulindac could

cause SJS/TEN, to warn Bartlett specifically of that remote but

serious risk and what it could entail. D r . Salisbury expressed

no opinion on that issue. His statement that the “reason” for

reading the drug’s label is to help the doctor “counsel the

patient what to look for [i.e., early symptoms] and what problems

may occur with stopping the drug [i.e., as opposed to taking it]”



     6
      Dr. Salisbury’s opinion that D r . Ergin was “underinformed
. . . about the known and scientifically knowable risks of
Sulindac” was relative to what Sulindac’s label should have said
(in his view), not what the label actually said. It is thus
irrelevant here.

                                 13
does not address which types of risks should be conveyed to the

patient, whether Sulindac’s risk of SJS/TEN falls in that

category, or how that risk should have been conveyed.

       This court has no doubt that Mutual’s evidence of D r .

Ergin’s negligence, if presented by a plaintiff in a medical

malpractice case, would be considered insufficient as a matter of

law.    Under Goudreault, that means it is also insufficient as a

matter of law to sustain Mutual’s apportionment defense.



       ii.   Superseding cause

       Mutual’s superseding cause defense fares no better.    In

order to establish that defense, Mutual must prove that the

superseding cause was not reasonably foreseeable. See, e.g.,

Marcotte, 

. Mutual has not even attempted to

argue, nor could any reasonable jury find, that D r . Ergin’s

failure to read the Sulindac label and/or his failure to warn

Bartlett of the drug’s risk of SJS/TEN were unforeseeable to

Mutual.      Indeed, as Mutual emphasized in arguing for summary

judgment on Bartlett’s failure-to-warn claims, and as this court

noted in its order granting summary judgment to Mutual, there are

many cases with very similar facts. See Bartlett, 

 1 2 ,

at 14 (citing examples).




                                   14
      Since Mutual has not presented sufficient evidence to

establish a trialworthy defense of apportionment or superseding

cause based on D r . Ergin’s conduct, Bartlett is granted judgment

as a matter of law on those defenses as well.



IV.   Conclusion

      For the reasons set forth above, Bartlett is granted

judgment as a matter of law on Mutual’s affirmative defenses of

comparative fault, apportionment, plaintiff’s misconduct, and

superseding cause.



         SO ORDERED.




                               Jos/ph ___ N. ______ nte ___________
                               Un e ted States District Judge

Dated:   August 1 2 , 2010

cc:   Keith M . Jensen, Esq.
      Bryan Ballew, Esq.
      Patrick J. O’Neal, Esq.
      Eric Roberson, Esq.
      Christine M . Craig, Esq.
      Timothy P. Beaupre, Esq.
      Joseph P. Thomas, Esq.
      Paul J. Cosgrove, Esq.
      Jeffrey D. Geoppinger, Esq.
      Linda E . Maichl, Esq.
      Stephen J. Judge, Esq.
      Pierre A . Chabot, Esq.




                                15