Bartlett v. Mutual Pharm. Co.

2010 DNH 123

• Court: District Court, D. New Hampshire
• Decided: July 22, 2010
• Docket: CV-08-358-JL
• Status: Published

Opinion

Bartlett v. Mutual Pharm. Co. CV-08-358-JL 07/22/10 P UNITED STATES DISTRICT COURT DISTRICT OF NEW HAMPSHIRE

Karen L. Bartlett

v. Civil No. 08-cv-358-JL Opinion No. 2010 DNH 123 Mutual Pharmaceutical Company, Inc.

MEMORANDUM ORDER

This products liability case presents numerous disputes over

the admissibility of expert testimony. Plaintiff Karen Bartlett,

who took the generic drug Sulindac and suffered severe side

effects, brought suit against the drug's manufacturer. Mutual

Pharmaceutical Company, asserting state-law claims of strict

products liability and negligence based on defective design. She

alleges, in particular, that Sulindac's safety risks outweigh its

medical benefits, making it an unreasonably dangerous product.

This court has subject-matter jurisdiction under 28 U.S.C. §

1332(a)(1) (diversity), because Bartlett is a New Hampshire

citizen and Mutual is located in Pennsylvania.

Earlier in the case, this court denied Mutual's motion for

judgment on the pleadings, see Fed. R. Civ. P. 12(c), rejecting

the argument that Bartlett's claims were pre-empted by federal

law. Bartlett v. M u t . Pharm. Co., 659 F. Supp. 2d 279 (D.N.H.

2009). After discovery, both parties moved for summary judgment.

See Fed. R. Civ. P. 56. This court recently granted each of

1 their motions in part, eliminating several claims and defenses,

but allowing Bartlett to proceed to trial on her defective design

claims. Bartlett v. Mut. Pharm. Co., 2010 DNH 112.

Both parties have now moved to exclude or limit the

testimony of each other's expert witnesses at the upcoming trial.

See Fed. R. Evid. 702. After reviewing their submissions, this

court grants the motions in part and denies them in part. The

parties' experts have sufficient qualifications and a sufficient

foundation to support most of their proffered opinions. But they

may not offer legal opinions that impinge upon the roles of the

judge and jury, nor may they speculate about what the Food & Drug

Administration ("FDA") would have done in hypothetical

circumstances.

I. Applicable legal standard

"The touchstone for the admission of expert testimony in

federal court litigation is Federal Rule of Evidence 702." Crowe

v. Marchand, 506 F.3d 13, 17 (1st Cir. 2007). Rule 702 provides:

If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.

2 Fed. R. Evid. 702. As the structure of this rule suggests,

before the jury can consider expert testimony over the adverse

party's objection, the trial judge, serving as "gatekeeper," must

determine whether the testimony has a proper foundation. See,

e.g., Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 597

(1993). The party introducing the testimony bears the burden of

proving its admissibility. I d . at 592. "Rule 702 has been

interpreted liberally in favor of the admission of expert

testimony." Levin v. Dalva Bros., Inc., 459 F.3d 68, 78 (1st

C i r . 2006) .

While presented as Rule 702 challenges, many of the parties'

requests would be more accurately described as motions in limine,

since they seek to exclude testimony for lack of relevance rather

than lack of foundation. Like all evidence, expert testimony

must be relevant to the issues in the case. See, e.g.. United

States v. Pena, 586 F.3d 105, 110 (1st Cir. 2009). Evidence is

relevant if it has "any tendency to make the existence of any

fact that is of consequence to the determination of the action

more probable or less probable than it would be without the

evidence." Fed. R. Evid. 401. The relevance standard is also

interpreted liberally. See, e.g., Mitchell v. United States, 141

F.3d 8, 14 (1st Cir. 1998).

3 II. Background

The factual and procedural background of this case is set

forth in the recent summary judgment ruling, Bartlett, 2010 DNH

112, at 3-8, and need not be repeated here.

Ill. Analysis

A. Bartlett's motion

Bartlett has made 37 requests to exclude or limit testimony

by Mutual's experts. Some of her requests will be analyzed

together, since they involve closely related issues.

i. Generic drug labeling (Requests 1-8, 22, 29-30)

The first issue raised by Bartlett's motion is whether

Mutual's experts may testify about federal law, FDA policy and

procedure, or industry practice with regard to generic drug

labeling.1 This court has already ruled that federal law allows

generic drug manufacturers to strengthen a generic drug's safety

warning unilaterally. See Bartlett, 659 F. Supp. 2d at 302. But

■'■Although this court recently granted summary judgment to Mutual on Bartlett's failure-to-warn claims, Sulindac's label is still relevant to this case in at least one respect, which is that Mutual's "comment k" defense depends on the adequacy of the product's warning, among other things. See Bartlett, 2010 DNH 122, at 26 (discussing Restatement (Second) of Torts § 402A, c m t . k (1965)). This court will therefore resolve all of the expert challenges relating to Sulindac's label, without prejudice to any trial objections challenging the relevance of such evidence in light of this court's summary judgment ruling.

4 Mutual's experts intend to testify that such changes would be

inconsistent with the "real-life" FDA policy and industry

practice, which is for only the manufacturer of the brand-name or

"reference listed" drug to make such changes. Bartlett argues

that this testimony must be excluded from trial because it would

be contrary to this court's legal ruling and thus confusing to

the jury.

Since "it is the judge's role, not a witness's, to instruct

the jury on the law," this court "has broad discretion to exclude

expert opinion evidence about the law that would impinge on the

roles of the judge and the jury" or would cause "jury confusion."

Pelletier v. Main St. Textiles, L P , 470 F.3d 48, 54-55 (1st Cir.

2006). Indeed, "[e]xpert testimony proffered solely to establish

the meaning of a law is presumptively improper." United States

v. Mikutowicz, 365 F.3d 65, 73 (1st Cir. 2004); see also Nieves-

Villanueva v. Soto-Rivera, 133 F.3d 92, 99 (1st Cir. 1997). And

even if such testimony has independent factual significance,

i.e., aside from the content of the law, it still may be excluded

"if its probative value is substantially outweighed by the danger

of unfair prejudice, confusion of the issues, or misleading the

jury." Fed. R. Evid. 403; see also United States v. Ahrendt, 560

F.3d 69, 76 (1st Cir. 2009).

As an initial matter. Mutual concedes that its experts

cannot and will not "provide testimony that interprets any

5 statutes or regulations." This concession is well taken. Again,

such testimony would be presumptively improper. See Mikutowicz,

365 F.3d at 73. It would also be unfairly prejudicial to

Bartlett and confusing to the jury, because it would conflict

with this court's legal rulings and, presumably, its jury

instructions. Since Mutual has not opposed that part of

Bartlett's request, it is granted. No defense experts may

testify about the meaning or applicability of the law. See Fed.

R. Evid. 403; Pelletier, 470 F.3d at 54-55 (affirming exclusion

of expert testimony regarding applicability of federal workplace

safety regulations).

Mutual argues that, so long as its experts steer clear of

the actual statutes and regulations, they should be allowed to

testify about FDA policy and procedure. But such testimony

raises many of the same concerns, because it is based largely on

FDA documents that analyze or parrot the language of the relevant

statutes and regulations. Indeed, they are some of the very same

documents that this court interpreted in its earlier ruling.

See, e.g., Bartlett, 659 F. Supp. 2d at 293 n.19 (rejecting

Mutual's interpretation of 2004 industry guidance); i d . at 294

n.21 (rejecting Mutual's interpretation of "the FDA's remarks in

proposing and promulgating these regulations"). The testimony is

thus a roundabout way of challenging this court's ruling. As

such, it creates the same danger of undue prejudice and confusion

6 as testimony about the statutes and regulations themselves. See

Fed. R. Evid. 403.

Moreover, Mutual's experts have not pointed to any evidence

of the supposed policy in action, so their testimony about it

amounts to little more than "speculation as to what FDA might

have done in hypothetical circumstances." In re Rezulin Prods.

Liab. Litiq., 309 F. Supp. 2d 531, 550 (S.D.N.Y. 2004) (excluding

such speculation). Both parties seem to agree that there is no

historical evidence, at least in this record, that the FDA has

either accepted or rejected previous attempts by generic drug

manufacturers to unilaterally strengthen a drug warning. So the

policy is not based on what the FDA has actually done; rather, it

is based on what the FDA purportedly believed or would have done,

according to former FDA officials. Such testimony is not

sufficiently reliable to satisfy Rule 702(2) .

If Mutual had "simply no other practical means to prove the

point," then this court might be more inclined to admit the

testimony about FDA policy and procedure, despite its problems.

United States v. Fields, 871 F.2d 188, 198 (1st Cir. 1989); see

also United States v. Scott, 270 F.3d 30, 51 (1st Cir. 2001)

(noting that the "availability of other means of proof" is an

"appropriate factor" to consider in determining whether evidence

should be excluded). But that is not the case. Mutual can make

its point effectively through testimony about industry practice.

7 without needing to try to cast it as a matter of FDA policy and

procedure. Specifically, Mutual's experts can testify that the

longstanding industry practice is for the manufacturer of the

brand-name or "referenced listed" drug to make changes to the

drug's label, and for generic manufacturers simply to parrot any

such changes.

Bartlett argues that testimony about industry practice is

also unduly prejudicial and confusing to the jury. But this

court disagrees. "[I]n general, the customs and practices of an

industry are proper subjects for expert testimony." Pelletier,

470 F.3d at 55. The jury is fully capable of understanding that

there may be a gap between what the law requires and what

industry members actually do. Indeed, conformity with industry

practice is not an absolute defense to liability under New

Hampshire law, because "entire industries may lag behind" the

standard of care. Heath v. Sears, Roebuck & Co., 123 N.H. 512,

530 (1983). But it is nonetheless a factor that the jury may

consider in evaluating strict liability claims, see, e.g.,

Thibault v. Sears, Roebuck & Co., 118 N.H. 802, 814 (1978), and

negligence claims, see, e.g., 8 Richard B. McNamara, New

Hampshire Practice § 4.74, at 4-107 (3d ed. 2003) .

In sum, this court concludes that Mutual's experts may not

testify about federal law (whether directly or under the guise of

FDA policy and procedure) on the issue of whether a generic manufacturer has the ability or responsibility to strengthen a

generic drug's safety warning. The probative value of such

testimony is substantially outweighed by the danger of unfair

prejudice and jury confusion. See Fed. R. Evid. 403. Witnesses

may, however, testify about industry practice in that regard.

ii. Late production of prior transcript (Request 9)

The next issue is whether Dr. Stewart Ehrreich, designated

by Mutual as a pharmacological expert, should be precluded from

testifying altogether because Mutual failed to produce (until the

day of his deposition) a transcript from a deposition he gave in

another case, where he testified that the label for ibuprofen was

inadequate because it did not mention the possibility of death.

According to Bartlett, the parties had agreed that any such

transcripts would be produced at least seven days before Dr.

Ehrreich's deposition. Mutual, however, denies that any such

agreement existed (or that Bartlett complied with it for her own

experts, see Part III.B.i, infra) . According to Mutual, Dr.

Ehrreich "simply forgot" about that prior deposition, and

Bartlett suffered no prejudice because Dr. Ehrreich testified

about it anyway.

Whether an agreement actually existed between the parties is

unclear from the record. Mutual proposed a schedule in which

transcripts of Dr. Ehrreich's prior depositions would be produced

9 seven days in advance of his deposition in this case, but the

record contains no written acceptance of this proposal by

Bartlett, and Mutual denies reaching agreement. In any event,

even if an agreement existed, Bartlett has not suffered any

prejudice from the late production. At his deposition in this

case. Dr. Ehrreich testified in detail about the earlier case and

the specific opinions that he gave there. Bartlett's counsel

thus had an adequate opportunity to explore that issue. Under

the circumstances, it would be inappropriate to exclude Dr.

Ehrreich from testifying. See Fed. R. Civ. P. 37( c ) (1)

(providing for exclusion of expert witness due to untimely

disclosures "unless the failure was substantially justified or

harmless").

iii. References to "bad luck" (Request 10)

Bartlett argues that no defense expert should be allowed to

characterize her injuries as "bad luck," "luck of the draw," or

any similar description, which in her view is an "advanced"

expert opinion that lacks a proper foundation. It is true that

the word "luck" could have a more advanced connotation in this

context, with more specific implications (i.e., that Bartlett's

injuries were entirely random side effects of Sulindac, unrelated

to her physical traits or any other nonrandom factors). But

Mutual's experts seem to be using it in a less advanced way, as a

10 shorthand for saying that only a very small percentage of the

people who have taken Sulindac have suffered SJS/TEN as a side

effect. That is a probative fact for which, on the record before

the court, it appears that a proper foundation has been laid

under Rule 7 02.

Nevertheless, there is some risk that the jury, upon hearing

an expert describe Bartlett's injuries as "bad luck" or "luck of

the draw," might be misled into thinking that the expert intends

the more advanced, implicative meaning, for which a proper

foundation appears not to have been laid under Rule 702. While

that risk is not very high, the probative value of the word

"luck" is even lower. Mutual's experts can make the same point

using other words that avoid any risk of unfair prejudice.

Bartlett's request to exclude defense experts from using the word

"luck" in reference to her injuries is therefore granted.2 See

iv. Filling of prescription (Requests 11-13)

Next, Bartlett challenges three of Dr. Ehrreich's opinions

2This ruling is limited to expert testimony. Depending on the context, such language may be permissible in closing argument, where counsel is generally given "some leeway to comment on the evidence." Gomes v. Bradv, 564 F.3d 532, 538 (1st Cir. 2009); see also Lewis v. City of Chicago Police Dep't, 590 F.3d 427, 444 (7th Cir. 2009). Coming from an attorney rather than an expert, the word "luck" does not carry the same risk of unfair prejudice.

11 about the filling of her Sulindac prescription: (1) that the

pharmacy could have filled the prescription with another

manufacturer's version of the drug; (2) that the pharmacy

"likely" filled the prescription with Mutual's version because it

was the cheapest; and (3) that Bartlett would have suffered the

same injuries if she took one of theother versions, since they

all had the same active ingredients. Bartlett argues that all of

these opinions are speculative. She is right as to the second

one; Dr. Ehrreich admitted in his expert report that the

pharmacy's reason for choosing Mutual's version "is not known."

Bartlett's request to exclude that opinion is therefore granted.

See Fed. R. Evid. 702(1).

But the other two opinions have a sufficient foundation.

Indeed, the first one is consistent with the testimony of

Bartlett's doctor, who wrote the prescription. And the third one

is based on the fact that the FDA requires all versions of a drug

to have the same active ingredients. Bartlett notes that it is

theoretically possible that her injuries were caused by

Sulindac's inactive ingredients, which need not be identical.

But Dr. Ehrreich made clear that his opinion was based on the

assumption that the active ingredients caused Bartlett's

injuries, which he understood to be one of her allegations.

Bartlett has not disclaimed that understanding of her claims or

identified any evidence to the contrary. See Levin, 459 F.3d at

12 79 ("an expert may offer opinions based on assumptions that are

not contrary to the evidence at trial") . Bartlett's request to

exclude those opinions is therefore denied.3

v. Number of NSAID users (Request 14)

Bartlett requests that another defense expert, dermatologist

Robert Stern, be precluded from testifying about the number of

people in the United States who have used NSAIDs. She argues

that such testimony, which Dr. Stern derived from FDA materials,

is hearsay and is not relevant. But "expert opinions based on

otherwise inadmissible hearsay" may be admitted if the underlying

"facts or data are 'of a type reasonably relied upon by experts

in the particular field in forming opinions or inferences upon

the subject.'" Daubert, 509 U.S. at 595 (quoting Fed. R. Evid.

703); see also United States v. Corev, 207 F.3d 84, 89 (1st Cir.

2000) . The underlying "facts or data need not be admissible in

order for the opinion or inference to be admitted." Fed. R.

Evid. 703.

Experts in the field of medicine reasonably and routinely

rely on FDA materials in forming their opinions on prescription

drugs and their use in the United States. Thus, Dr. Stern's

3Bartlett's challenge to the relevance of such evidence will be considered in connection with her first motion in limine (document no. 185). The court expresses no opinion on that issue he r e .

13 opinion may be admitted even if it is based on hearsay.

Furthermore, the number of NSAID users is relevant contextual

evidence for evaluating whether Sulindac is unreasonably

dangerous. See, e.g.. First Marblehead Corp. v. House, 541 F.3d

36, 42 (1st Cir. 2008) ("Testimony that provides a necessary

context and framework ... can be appropriate for expert

testimony."); see also Fed. R. Evid. 401, 402. Bartlett's

request to exclude such testimony is denied.

vi. FDA awareness of SJS/TEN risks (Request 15)

Bartlett argues that Dr. Ehrreich should be precluded from

testifying about the FDA's awareness of the SJS/TEN risks posed

by NSAIDs because he left the agency many years ago, rendering

any such opinion speculative. Actually, Dr. Ehrreich worked for

the FDA from 1979 to 1986, and his opinion is that the FDA has

been aware of the risks since the early 1980s, so his time at the

agency overlaps with the period on which he is opining. But that

is ultimately immaterial, because his testimony is based on

express statements in FDA documents from the time period in

question, not on mere extrapolation from his personal experience

in an earlier era. On this record, his opinion appears to have a

sufficient foundation under Rule 702(1) . Bartlett's request to

exclude the testimony is denied.

14 vii. Other NSAID safety warnings (Request 16)

The next issue is whether defense experts may testify about

the safety warnings for NSAIDs other than Sulindac. Bartlett

argues that such testimony should be allowed only if it relates

to NSAIDs that were specifically evaluated by the FDA or removed

from the market, because otherwise it is not relevant. Mutual

argues, in response, that such testimony is relevant to whether

Sulindac had an adequate warning. This court agrees with Mutual.

While conformity with industry practice is not an absolute

defense to liability under New Hampshire law, it is a relevant

consideration in evaluating both products liability and

negligence claims. See Thibault, 118 N.H. at 814; 8 McNamara,

supra, § 4.74, at 4-107; see also Fed. R. Evid. 401, 402.

Bartlett's request to confine such evidence to that which favors

her position is denied.

viii. Undisclosed opinions (Request 17)

Bartlett requests a blanket ruling that no defense expert

may testify at trial to any opinion not already set forth in his

or her expert report. It is true that an expert's report "must

contain ... a complete statement of all opinions the witness will

express and the basis and reasons for them." Fed. R. Civ. P.

15 2 6( a ) (2)(B)(I). And where "a party fails to provide information

... as required by Rule 26(a)," that party "is not allowed to use

that information or witness to supply evidence ... at a trial,

unless the failure was substantially justified or is harmless."

Fed. R. Civ. P. 37(c)(1). But whether an untimely disclosure is

substantially justified or harmless cannot be determined in the

abstract; it depends on the particular circumstances.4 This

court therefore declines to issue a blanket ruling, but rather

will resolve any such issues as they arise at trial in the

context of their specific facts.

ix. Hypersensitivity warning (Requests 18-21)

The next issue is whether D r s . Stern and Ehrreich may

testify that the hypersensitivity warning in the Sulindac label

(quoted in Bartlett, 2010 DNH 112, at 5) served as an adequate

warning of SJS/TEN. Bartlett argues that such testimony is

beyond the scope of their expert reports and their expertise.

Mutual appears to accept that Dr. Ehrreich cannot testify to that

particular opinion, which he never properly disclosed, so

Bartlett's request to exclude his testimony on this subject is

4There is also Rule 703's corollary--pertaining to the informational basis of expert opinion testimony--that such testimony may under some circumstances be based on facts "perceived by or make known to the expert at or before the hearing." Fed. R. Evid. 703 (emphasis added).

16 granted. But Mutual argues that Dr. Stern, as one of the world's

leading experts on SJS/TEN, is well qualified to testify about

the meaning and adequacy of the hypersensitivity warning and that

he properly disclosed his opinion in his expert report.

Contrary to what Bartlett suggests. Dr. Stern's expert

report made clear that, in his opinion, the Sulindac label's

hypersensitivity warning and its reference to "severe skin

reactions," coupled with its cross-reference to a list of adverse

reactions that included SJS/TEN, served as an adequate warning

that SJS/TEN were among the risks of taking Sulindac. Indeed,

one of the headings in his report is: "The warning in the 2004

sulindac labeling was clear and consistent with the knowledge

concerning the risk of severe skin reactions including Stevens-

Johnson Syndrome and Toxic Epidermal Necrolysis." Bartlett's

argument that he failed to disclose that opinion in his report is

unpersuasive.

Equally unpersuasive is Bartlett's argument that Dr. Stern

lacks sufficient expertise to offer that opinion. Dr. Stern

founded an international study of SJS/TEN, wrote some of the

leading articles on their connection to NSAIDs (including one in

the New England Journal of Medicine entitled "Severe adverse

cutaneous reactions to drugs"), is the chief of dermatology at

Beth Israel Deaconess Hospital in Boston, is a full-time

professor of dermatology at Harvard Medical School, and has

17 chaired multiple FDA advisory committees on the safety and

efficacy of drugs. See, e.g., Forrestal v. Maqendantz, 848 F.2d

303, 308 (1st Cir. 1988) (affirming admission of doctor's expert

testimony "based on his own knowledge and experience").

Bartlett argues that Dr. Stern should not be allowed to

offer any opinions on Sulindac's label (including the

hypersensitivity warning) because he stated at his deposition

that "I'm not an expert on labeling." But Dr. Stern actually

amended that statement in an errata sheet, adding the word "regs

at the end to clarify that he is not an expert on the FDA

regulations applicable to drug labels. See Fed. R. Civ. P.

30(e)(1)(B) (allowing deponent to make "changes in form or

substance" to his deposition transcript). That is a plausible

interpretation of what he meant. While calling the correction a

"sham," Bartlett has not moved to strike it. She is, of course,

free to explore it on cross-examination. See, e.g., Daroczi v.

V t . Ctr. for the Deaf & Hard of Hearing, Inc., 2 0 04 DNH 02 7

(Muirhead, M.J.) (citing 7 Moore's Federal Practice § 30.63[3]

(3d. ed. 2003)).

In any event, it is Dr. Stern's qualifications, not his

extemporaneous disclaimer, that determine the permissible scope

of his testimony. C f . Pineda v. Ford Motor Co., 520 F.3d 237,

245 (3d Cir. 2008) (allowing expert to testify about certain

aspects of product's safety warning even though he denied being "warnings" expert, because he was an expert on the product in

question). Dr. Stern is sufficiently "qualified to render an

opinion regarding the completeness or accuracy of the [Sulindac]

label based on his knowledge of the risks of [Sulindac] and his

own clinical experience." In re Bavcol Prods. Litiq., 532 F.

Supp. 2d 1029, 1064 (D. Minn. 2007); see also In re Rezulin, 309

F. Supp. 2d at 556; In re Diet Drugs Prods. Liab. Litiq., No. MDL

1203, 2000 WL 876900, at *11-12 (E.D. Pa. June 20, 2000) .

Bartlett also argues that Dr. Stern's testimony about the

hypersensitivity warning is unreliable because in 2006, after the

events at issue in this case, the FDA adopted a new label for

Sulindac that included both a hypersensitivity warning and a new

SJS/TEN warning in its "Warnings" section. See Bartlett, 2010

DNH 112, at 15 n.6. She reasons that the FDA would not have

approved "side-by-side redundant and duplicative warnings" and

therefore must believe that -- contrary to Dr. Stern's opinion --

the hypersensitivity language in the earlier label did not

adequately warn of SJS/TEN. But Bartlett has not presented any

authority or evidence to support that proposition (which is just

as speculative as Mutual's excluded testimony about FDA beliefs,

see Part III.A.i, supra) . There is nothing inherently illogical

about repeating a safety warning, especially when one wants to

emphasize a point.

And in any event, an expert's opinion need only be "based

19 upon sufficient facts or data," Fed. R. Evid. 702(1), not

perfectly consistent with every piece of available evidence.

Emphasizing inconsistencies between an expert's opinions and the

evidence, of course, is one of the principal purposes of expert

cross-examination. Bartlett's request to exclude Dr. Stern's

testimony about the warning is denied.

x. Other NSAID side effects (Request 23)

other NSAID side effects that Bartlett never suffered, such as

gastrointestinal problems. Bartlett argues that such testimony

is not relevant. But it is highly relevant to determining

whether Sulindac's safety risks outweigh its medical benefits,

making it an unreasonably dangerous product. See, e.g.. Price v.

BIG Corp., 142 N.H. 386, 389 (1997) (noting that whether a

product is unreasonably dangerous "is determined by the jury

using a risk-utility balancing test"); see also Fed. R. Evid.

401, 402. The jury is not limited to considering only the side

effects that Bartlett suffered. Bartlett's request to exclude

such testimony is denied.

xi. Impact on FDA and industry (Requests 24-25)

Bartlett seeks to preclude Dr. Ehrreich from testifying that

20 if generic drug manufacturers were each responsible for

monitoring the safety of their drugs or strengthening their

warnings, they would either have to raise prices or go out of

business, and that the FDA would be over-burdened. This court

has already ruled, as a matter of federal law, that generic

manufacturers are indeed responsible for such safety

surveillance, see Bartlett, 2010 DNH 112, at 29-31 (citing 21

C.F.R. § 314.80(b)), and for the content of their drugs'

warnings, see i d . at 9 n.4 (citing 21 C.F.R. § 201.57(e) ) .

Mutual's experts may not suggest otherwise, either expressly or

implicitly. To that extent, Bartlett's request is granted. See

xii. Rebuttal of Bartlett's experts (Requests 2 6-2 8)

Bartlett argues that Dr. Ehrreich should not be allowed to

criticize Bartlett's experts without first identifying the

specific opinions with which he is disagreeing. She notes, for

example, that Dr. Ehrreich's report launched a number of

broadsides against her expert Dr. Randall Tackett's report,

calling it "disturbing" and claiming to be "shocked and dismayed"

by the amount of "misinformation." While Dr. Ehrreich's specific

disagreements with Bartlett's experts and the basis of those

disagreements are relevant and admissible evidence (assuming they

have a proper foundation), the extent to which he is "disturbed"

21 or "shocked and dismayed" by Bartlett's expert opinions and his

pejorative characterizations of them are not. See, e.g.. United

States v. Gonzalez-Maldonado, 115 F.3d 9, 16 (1st Cir. 1997)

(expert opinion on another witness's credibility "is ordinarily

inadmissible pursuant to Rule 702"); see also Ramirez v. Debs-

Elias, 407 F.3d 444, 447-49 (1st Cir. 2005). Bartlett's request

to exclude such comments is granted.

Bartlett also argues that Dr. Ehrreich should be precluded

from expressing two particular opinions that purport to rebut

arguments that Bartlett's expert Dr. Tackett never made: one

relating to so-called "black box" warnings, and the other

relating to "due diligence." In both instances. Dr. Ehrreich's

characterization of Dr. Tackett's opinion is not quite accurate.

Dr. Tackett opined that Mutual should have advocated to the FDA

for a "black-box" warning, not (as Dr. Ehrreich says) that Mutual

should have implemented one unilaterally. And Dr. Tackett opined

that Mutual should have conducted "due diligence" before filing

its initial application to manufacture Sulindac, not afterward

(as Dr. Ehrreich says). Accordingly, this court grants

Bartlett's request to exclude the inaccurate comments.

xiii. Industry standards of care (Request 31)

The next issue is whether Dr. Ehrreich may testify about

22 standards of care within the pharmaceutical industry. Bartlett

argues that such testimony should be prohibited unless her own

experts may also testify about those standards, because Dr.

Ehrreich is no more qualified than they are and because he

provided no foundation for his opinions. But one party's failure

to disclose an expert opinion on a given issue has little or no

bearing on the admissibility of an adverse party's properly

disclosed expert opinion evidence on that issue. C f . Adams v . J .

Myers Builders, 2009 DNH 181, 18 n.7. Whether Dr. Ehrreich's

testimony may be admitted depends on his own qualifications, not

on whether Bartlett's experts would be qualified to opine on the

same issues.

As a pharmacologist who has held high-ranking jobs with the

FDA and three major drug companies. Dr. Ehrreich is sufficiently

qualified to testify about the standards of care within that

industry. The foundation for that testimony is his own

experience. See, e.g., Forrestal, 848 F.2d at 308 (affirming

admission of doctor's expert testimony "based on his own

knowledge and experience"); Fed. R. Evid. 702, advisory committee

notes (2000) (noting that "the text of Rule 702 expressly

contemplates that an expert may be qualified on the basis of

experience," which may be "the predominant, if not sole, basis

for a great deal of reliable expert testimony"). Bartlett's

request to exclude the testimony is denied.

23 xiv. Knowledge in medical community (Requests 32-35)

Bartlett argues that Dr. Stern should be precluded from

testifying about what doctors generally know about SJS/TEN and

their link to NSAIDs, because such testimony is speculative.

Indeed, most courts have prohibited experts from testifying

"about what all doctors generally consider in making prescription

decisions" or about "what doctors generally think," unless the

testimony is based on something more reliable than simply the

expert's own experience as a doctor. In re Diet Drugs, 2000 WL

876900, at *11-12; see also, e.g.. In re Bavcol, 532 F. Supp. 2d

at 1064; Pfizer Inc. v. Teva Pharms. USA, Inc., 461 F. Supp. 2d

271, 277 (D.N.J. 2006); In re Rezulin, 309 F. Supp. 2d at 556.

Since Dr. Stern has not identified a more reliable basis,

Bartlett's request to exclude his testimony about what doctors

generally know is granted. See Fed. R. Civ. P. 2 6 ( a ) (2)(B); Fed.

R . Ev i d . 7 02.

Dr. Stern may, however, testify about what a reasonable

doctor should know about the link between NSAIDs and SJS/TEN and

how a reasonable doctor would interpret Sulindac's safety

warning. Such testimony is properly based on his experience as a

professor of dermatology at Harvard Medical School, the chief of

dermatology at a major Boston hospital, and the author of

frequently cited articles on SJS/TEN and its link to NSAIDs. See

Fed. R. Evid. 702; First Marblehead, 541 F.3d at 42 (upholding

24 admission of a financial expert's testimony on how a reasonable

investor would have analyzed stock options).

xv. Dr. Valuck (Request 36)

Bartlett seeks to exclude the testimony of another defense

expert, pharmacology professor Dr. Robert Valuck, on the grounds

that he was allegedly unprepared for his deposition. In

particular, Bartlett emphasizes that Dr. Valuck erroneously

stated that there were no Sulindac cases in a particular SJS/TEN

study on which he opined, when in fact there was one such case.

But this error (assuming it was one) resulted from a discrepancy

between the print and online versions of the study. Dr. Valuck

relied on the print version, which listed no Sulindac cases,

whereas the online version listed one case. At his deposition.

Dr. Valuck made clear that regardless of which version of the

study is correct, it would not change his opinions.

Moreover, Bartlett has the ability to explore Dr. Valuck's

error (if any) and its impact (if any) through cross-examination.

"It is not the job of the court to insure that [expert testimony]

is error-free" -- only that it has a sufficiently reliable

foundation to satisfy Rule 702. Southwire Co. v. J.P. Morgan

Chase & C o ., 528 F. Supp. 2d 908, 928 (W.D. Wis. 2007). Because

Dr. Valuck's testimony about the SJS/TEN study appears, on this

25 record, to have a proper foundation, Bartlett's request to

exclude his testimony is denied.

xvi. Dr. Duffy (Request 37)

Finally, Bartlett argues that the testimony of Mutual's

economic expert. Dr. Martin Duffy, should be excluded because he

used the wrong figure for the cost of Bartlett's eye surgeries,

thus rendering all of his computations unreliable. Mutual

concedes that Dr. Duffy accidentally imported the wrong figure

from the report of another defense expert. Dr. Jane Mattson, but

argues that Dr. Duffy's economic methodology is nonetheless

reliable and that he should be allowed to testify using the

corrected figures.

The general rule is that an expert's minor computational

errors go to the weight of his testimony, rather than to its

admissibility. See, e.g.. In re Scrap Metal Antitrust Litiq.,

527 F.3d 517, 530 (6th Cir. 2008); see also In re Pharm. Indus.

Avq. Wholesale Price Litiq., 582 F.3d 156, 198 (1st Cir. 2009)

(affirming admission of expert's testimony, even if he made

"small" errors, because they did not affect "the reliability of

his damages calculation"). Indeed, in a case involving this same

expert, our court of appeals ruled that "whatever shortcomings

existed in Duffy's calculations went to the weight, not the

26 admissibility, of the testimony." Cummings v. Std. Register Co.,

265 F.3d 56, 65 (1st Cir. 2001). The same reasoning applies

here. Dr. Duffy's error is unrelated to his methodology and easy

for him to correct in his trial testimony (or to expose on cross-

examination if he does no t ) . Bartlett's request to exclude him

from testifying is denied.

B. Mutual's motion

For its part. Mutual seeks to exclude or limit the testimony

of Bartlett's expert witnesses on various grounds and also to

exclude any expert testimony by Bartlett's treating physicians.

This court will address each request in turn (identifying them by

the section of Mutual's motion in which they were raised).

i. Failure to produce prior transcripts (Request A)

The first issue raised by Mutual's motion is whether three

of Bartlett's experts should be precluded from testifying because

Bartlett failed to produce their prior deposition transcripts

from other cases. This is essentially the mirror image of

Bartlett's request to exclude one of Mutual's experts. Dr.

Ehrreich, from testifying due to the late production of such a

transcript. See Part III.A.ii, supra. This court denied

Bartlett's request and, for similar reasons, denies Mutual's

27 request as well. It is not clear from the record that Bartlett

violated any disclosure obligations, and even if she did,

exclusion would be an inappropriate sanction under the

circumstances. See Fed. R. Civ. P. 37( c ) (1) (providing for

exclusion of expert witness for failure to disclose, "unless the

failure was substantially justified or harmless").

ii. Similarity of experts' reports (Request A)

Mutual also argues that two of Bartlett's experts,

pharmacologist Dr. Randall Tackett and burn surgeon Dr. Roger

Salisbury, should be precluded from testifying because their

reports contain such similar language that both reports must have

been prepared by Bartlett's counsel, not by the experts

themselves. Mutual argues that this is a violation of Fed. R.

Civ. P. 26( a ) (2)(B), which requires each party's expert

disclosures to "be accompanied by a written report ... prepared

and signed by the witness." Bartlett argues, in response, that

the reports are "99 percent textually distinct" and contain

similar language in only a few areas where the two experts have

shared experiences and expertise.

It is well established that "Rule 26(a) (2) (B) does not

preclude counsel from providing assistance to experts in

preparing reports, and indeed," in some complex cases, "this

28 assistance may be needed." Fed. R. Civ. P. 26(a) (2) (B) , advisory

committee notes (1993). The report, however, must be based on

the expert's prior substantive input, must reflect the testimony

to be given by the witness, and must be signed by the witness.

Id.; see also United States v. Kalvmon, 541 F.3d 624, 637-38 (6th

Cir. 2008); Jenkins v. Bartlett, 487 F.3d 482, 488 (7th Cir.

2 0 07); Crowley v. Chait, 322 F. Supp. 2d 530, 543 (D.N.J. 2004).

Here, both experts' reports satisfy those requirements. Mutual's

request to exclude their testimony under Rule 2 6 ( a ) (2)(B) is

denied.

iii. FDA regulations (Requests B.l-2)

The next issue raised by Mutual's motion is whether

Bartlett's experts may testify about the meaning or applicability

of FDA regulations and whether Mutual violated them. Such

opinions appear frequently in Dr. Tackett's report and, to a

lesser extent, in Dr. Salisbury's report. As discussed in Part

III.A.i, supra, this court has "broad discretion to exclude

expert opinion evidence about the law that would impinge on the

roles of the judge and the jury." Pelletier, 470 F.3d 48, 54-55.

Indeed, "[e]xpert testimony proffered solely to establish the

meaning of a law is presumptively improper." Mikutowicz, 365

F .3d at 73.

29 Bartlett seems to believe that these principles apply only

when the expert is wrong about the law, but that is not so. They

apply even when the expert is right. See, e.g., Nieves-

Villanueva, 133 F.3d at 100 ("the judge's expert knowledge of the

law makes any such assistance at best cumulative, and at worst

prejudicial") (emphasis added). Mutual's request to exclude such

testimony is therefore granted. See Fed. R. Evid. 403. If

Bartlett wants the jury to know what relevant FDA regulations

require, she can propose appropriate jury instructions. And if

she wants to show the jury that Mutual violated them, she may do

so by introducing evidence of Mutual's acts or failures to act,

rather than conclusory opinions from her experts.

iv. Calling Mutual "negligent" (Request B.3)

A related issue is whether Bartlett's experts may describe

Mutual's conduct as "negligent," which they repeatedly do in

their expert reports. The general rule is that "testimony in the

form of an opinion or inference otherwise admissible is not

objectionable because it embraces an ultimate issue to be decided

by the trier of fact." Fed. R. Evid. 704(a). But that rule

"does not vitiate the rule against expert opinion on questions of

law." Nieves-Villaneuva, 133 F.3d at 100. Nor is it "a carte

blanche for experts to substitute their views for matters well

within the ken of the jury." Dinco v. Dvlex Ltd., Ill F.3d 964,

30 973 (1st Cir. 1997) .

Courts have generally prohibited experts from using the term

"negligent" to describe the defendant's conduct in a negligence

case where the opposing party objects to it. See 4 Weinstein's

Federal Evidence § 704.04[1], at 704-10 (2d ed. 1997) (citing

Andrews v. Metro N. Commuter R.R., 882 F.2d 705, 708 (2d Cir.

1989), and Owen v. Kerr-McGee Corp., 698 F.2d 236, 240 (5th Cir.

1983) ) ; see also Persinqer v. Norfolk & W. Rv. Co., 920 F.2d

1185, 1189 (4th Cir. 1990); Shahid v. City of Detroit, 889 F.2d

1543, 1547 (6th Cir. 1989). In light of Mutual's objection,

Bartlett's experts may not use that term at trial to describe

Mutual's conduct.

v. Qualifications (Request C)

Mutual also argues that D r s . Tackett and Salisbury lack

sufficient expertise to testify about drug labeling and FDA

regulatory procedures, because neither has ever worked for the

FDA or a drug manufacturer, and both misused FDA terminology at

their depositions. "It is not required," however, "that experts

be 'blue-ribbon practitioners' with optimal qualifications."

United States v. Vargas, 471 F.3d 255, 262 (1st Cir. 2006)

(affirming admission of fingerprint expert's testimony even

though he could not answer certain questions about fingerprint

31 characteristics). They need only be sufficiently "qualified ...

by knowledge, skill, training, or education" to offer a reliable

opinion. Fed. R. Evid. 702.

Dr. Tackett easily meets that standard. He has been a

pharmacologist for more than 30 years, is a professor of

pharmacology at the University of Georgia (where he has offered

classes on FDA regulations and even conducted workshops for FDA

employees), and has worked as a research investigator for various

drug manufacturers. He also recently received a grant from a

group of state Attorneys General to educate health care

professionals about how to evaluate drug information. As another

federal court recently concluded in allowing Dr. Tackett to

testify, this "extensive experience" is enough to qualify him as

an expert in this area. Lofton v. McNeil Consumer & Specialty

Pharms., 05-cv-1531, 2008 WL 4878066, at *9 (N.D. Tex. July 25,

2008).

Dr. Salisbury's qualifications make for a closer call. He

is certainly well qualified to testify about SJS/TEN by virtue of

his 36 years as a burn surgeon and his treatment of more than 400

patients with the disease. But his experience with drug labeling

and the FDA is less extensive. His most significant credential

is that he served as the lead author of a citizen's petition

filed with the FDA in 2005, after Bartlett's injuries, that

resulted in the addition of a more explicit SJS/TEN warning to

32 NSAID labels. See Bartlett, 2010 DNH 112, at 15 n.6. In his

capacity as a professor of plastic surgery, he also "instructs

his students [on] how to review [drug] labels ... so that they

can appropriately communicate warnings to their patients."

Lofton, 2008 WL 4878066, at *9.

While Dr. Salisbury may not be the optimal witness for this

type of case, another federal court recently concluded that "his

extensive practical experience with SJS/TEN patients and the

efficacy of warning labels in the clinical setting" qualified him

to testify about the adequacy of an NSAID's label. Id. This

court agrees. Dr. Salisbury falls in the same camp as Mutual's

corresponding expert Dr. Stern: both of them clearly know more

about SJS/TEN than about drug labeling, but nevertheless have

enough knowledge and experience to testify about the adequacy of

Sulindac's safety warning as it relates to SJS/TEN. See Part

III.A.ix, supra. Mutual's request to exclude Drs. Tackett and

Salisbury from testifying due to a lack of qualifications is

therefore denied.

vi. Mutual's ethics and motives (Requests D.l.a, D.2)

Mutual argues that Drs. Tackett and Salisbury should be

precluded from testifying about the ethics or morality of

Mutual's decisions or about Mutual's motive or state of mind in

making them. Bartlett concedes, in response, that "other than

33 state of mind as might plainly appear on a document or from

deposition testimony," she will not "offer any opinions from Drs.

Tackett or Salisbury on ethical obligations, state of mind,

knowledge or intent." In light of that concession, which the

court interprets to cover motive as well. Mutual's request to

exclude such testimony is moot. Any remaining objections in this

area that Mutual may have can be made at trial.

vii. Generic drug labeling (Requests D.l.a, D.2)

Mutual also seeks to preclude Drs. Tackett and Salisbury

from testifying that if Mutual had attempted to strengthen

Sulindac's safety warning, the FDA would have approved those

changes based on the information in the medical literature. Such

testimony is indeed speculative on this record, for reasons that

this court explained in its recent summary judgment ruling, see

Bartlett, 2010 DNH 112, at 15, and in denying Bartlett's

analogous request to exclude Mutual's experts from speculating

that the FDA would not have allowed such changes. See Part

III.A.i, supra (citing In re Rezulin, 309 F. Supp. 2d at 550,

which excluded an expert's "speculation as to what FDA might have

done in hypothetical circumstances"). As such, it lacks a

sufficient foundation to satisfy Rule 702. Mutual's request to

exclude such testimony is granted.

34 viii. Sulindac's risk of SJS/TEN (Request D.l.b)

Next, Mutual argues that Bartlett's experts should not be

allowed to suggest that Sulindac carries a higher risk of SJS/TEN

than other NSAIDs or other drugs. Mutual argues that such

testimony is speculative, because the available evidence on that

point -- including, in particular, the adverse event data

reported by Maja Mockenhaupt et a l ., The Risk of SJS and TEN

Associated with NSAIDs: A Multinational Perspective, 30 Journal

of Rheumatology 2234-2240 (Oct. 2003)) -- is largely anecdotal

and not statistically significant. But Bartlett's experts

acknowledged the limits of the data at their depositions, so this

is really an issue for cross-examination, as opposed to outright

exclusion. Moreover, a recently discovered draft of the study

suggests that the data might be more extensive than is apparent

from the published article. See document no. 251 (ordering

supplemental depositions regarding that draft). Mutual's request

to exclude testimony on this topic is denied.

Mutual also argues that Dr. Tackett should be prohibited

from using information about Bactrim, another drug that Mutual

manufactures and that has been linked to SJS/TEN, to support his

opinion about what Mutual should have done with respect to

Sulindac. Mutual argues that whether Bactrim creates a risk of

SJS/TEN has no bearing on whether Sulindac creates such a risk

and that, even it did. Mutual acquired Bactrim only one month or

35 so before Bartlett filled her prescription. But those issues

also go to weight, not admissibility. Mutual's request to

exclude such testimony is denied.

ix. Treating physicians (Request E)

Finally, Mutual seeks to exclude Bartlett's treating

physicians from offering any expert testimony at trial, since

they did not prepare expert reports pursuant to Fed. R. Civ. P.

26(a) (2) (B) . Both parties agree, however, that "Rule 26(a) (2) (B)

reports are not required as a prerequisite to a treating

physician expressing opinions as to causation, diagnosis, [and]

prognosis ... where they are based on the [plaintiff's]

treatment," provided, as is the case with each doctor, that the

witness has been properly designated as an expert under Rule

26( a ) (2)(A). Sprague v. Liberty M u t . Ins. Co., 177 F.R.D. 78, 81

(D.N.H. 1998) (Muirhead, M.J.); see also Aumand v. Dartmouth

Hitchcock Med. Ctr., 611 F. Supp. 2d 78, 87-89 (D.N.H. 2009).

Bartlett has disavowed any intent to present testimony that goes

beyond that scope.

To the extent that the parties may disagree about where the

line should be drawn between "treatment" opinions and "non­

treatment" opinions (which is not entirely clear from their

briefing), those disagreements can be resolved at trial, in

accordance with the basic principle set forth above. As a

36 general matter, Bartlett's treating physicians may testify about

whether Sulindac caused Bartlett's injuries, provided that they

reached that conclusion in a reliable manner while examining and

treating Bartlett. See Sprague, 177 F.R.D. at 81. But they

should not be asked "hypothetical question[s]" about causation

that "include[] information not learned during the course of

treatment." Vosburqh v. Bourassa, 2008 DNH 133, at 7-8

(McAuliffe, C.J.). Such opinions would render them "witness[es]

... retained or specially employed to provide expert testimony in

the case," requiring expert reports under Fed. R. Civ. P.

26( a ) (2)(B), which were not produced.

IV. Conclusion

As set forth above, Bartlett's motion to exclude or limit

Mutual's expert testimony5 is GRANTED in part and DENIED in part.

Mutual's corresponding motion to exclude or limit Bartlett's

expert testimony6 is also GRANTED in part and DENIED in part.

SO ORDERED.

/s/Joseph N. Laplante_____ Joseph N. Laplante United States District Judge

Dated: July 22, 2010

cc: Keith M. Jensen, Esq.

5Document no. 12 8.

6Document no. 142.

37 Bryan Ballew, Esq. Patrick J. O'Neal, Esq. Christine M. Craig, Esq. Eric Roberson, Esq. Timothy P. Beaupre, Esq. Jeffrey D. Geoppinger, Esq. Joseph P. Thomas, Esq. Linda E. Maichl, Esq. Paul J. Cosgrove, Esq. Stephen J. Judge, Esq.