Bartlett v. Mutual Pharmaceutical

2010 DNH 112

• Court: District Court, D. New Hampshire
• Decided: July 12, 2010
• Docket: CV-08-358-JL
• Status: Published

Opinion

Bartlett v. Mutual Pharmaceutical CV-08-358-JL 7/12/10 UNITED STATES DISTRICT COURT DISTRICT OF NEW HAMPSHIRE

Karen L. Bartlett

v. Civil No. 08-cv-358-JL Opinion No. 2010 DNH 112 Mutual Pharmaceutical Company, Inc.

OPINION & ORDER

The question in this case is whether a manufacturer may be

held liable for injuries caused by a prescription drug.

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, negligence, and fraud. She

alleges, in particular, that Sulindac is an unreasonably

dangerous product and that Mutual should have strengthened the

drug's safety warning in light of information reported in the

medical literature. This court has 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. See Bartlett

v. Mut. Pharm. Co., 659 F. Supp. 2d 279 (D.N.H. 2009). Both parties have now moved for summary judgment. See Fed.

R. Civ. P. 56. After hearing oral argument, this court grants

each motion in part. To the extent that Bartlett's claims are

based on Mutual's alleged failure to warn of safety risks. Mutual

is entitled to summary judgment because Bartlett cannot prove

that conduct caused her injuries. Her doctor, who is the person

Mutual had a duty to warn, prescribed Sulindac without reading or

relying upon its warning label. Thus, no matter what the label

said, it would not have affected the doctor's decision to

prescribe the drug or otherwise prevented Bartlett's injuries.

But to the extent that her claims are based not on the alleged

failure to warn, but on the theory that Sulindac is an

unreasonably dangerous product, they present a genuine dispute of

material fact that must be resolved at trial. Finally, Bartlett

is entitled to summary judgment on some of Mutual's affirmative

defenses.

I. Applicable legal standard

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

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

Mulvihill v. Top-Flite Golf Co., 335 F.3d 15, 19 (1st Cir. 2003) .

In making this 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." Id. On cross-motions for summary judgment, this

standard is applied to each party's motion separately. See,

e.g.. Am. Home Assurance Co. v. AGM Marine Contractors, Inc., 467

F .3d 810, 812 (1st Cir. 2006).

II. Background1

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.

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. Within weeks, she went to a

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

irritation, and other symptoms. She was soon diagnosed with

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

1This summary is based on undisputed facts in the record. To the extent that the summary judgment motions implicate disputed facts, this court will discuss them in the appropriate part of the analysis, drawing the reguired inferences in favor of the non-moving party.

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

characterized by necrosis of the skin and mucous membranes. See

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

She spent about three 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 these events, an international

medical journal published a study of the link between NSAIDs and

SJS/TEN. The study revealed that, from 1980 to 1997, Sulindac

had 89 reported cases of SJS/TEN in the Food and Drug

Administration's ("FDA") adverse event reporting system, more

than any other NSAID on the market and all but four drugs of any

kind. See Maja Mockenhaupt et al.. The Risk of SJS and TEN

Associated with NSAIDs: A Multinational Perspective, 30 Journal

of Rheumatology 2234-2240 (Oct. 2003). Mutual was not aware of

that study, however, because it had not been monitoring the

medical literature for information about Sulindac's safety risks.

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

version of the drug, was responsible for such monitoring.

At the time of Bartlett's prescription. Mutual's generic

version of Sulindac had the same FDA-approved package insert, or

warning label, as Clinoril. The label expressly listed SJS/TEN

as potential adverse reactions in its "Adverse Reactions"

4 section. In its "Warnings" section, however, the label did not

mention SJS/TEN by name. Rather, it stated as follows:

Hypersensitivity

Rarely, fever and other evidence of hypersensitivity (see ADVERSE REACTIONS) including abnormalities in one or more liver function tests and severe skin reactions have occurred during therapy with sulindac. Fatalities have occurred in these patients. Hepatitis, jaundice, or both, with or without fever, may occur within the first one to three months of therapy. Determination of liver function should be considered whenever a patient on therapy with sulindac develops unexplained fever, rash or other dermatologic reactions or constitutional symptoms. If unexplained fever or other evidence of hypersensitivity occurs, therapy with sulindac should be discontinued.[2]

Dr. Ergin admitted at his deposition that he never reviewed

Mutual's Sulindac label before treating Bartlett and that

"nothing about it influenced [his] prescribing of the drug" or

what he told Bartlett about it. When asked if he reviewed the

identical Clinoril label before treating Bartlett, Dr. Ergin

responded "not in detail, no." He then admitted that he never

read the part of the Clinoril label that listed SJS/TEN as

potential adverse reactions, nor the part that warned of

"hypersensitivity" and "severe skin reactions" that have caused

fatalities.

2A s discussed in Part III, infra, the parties disagree over whether this paragraph, together with the cross-referenced list of adverse reactions, amounted to an adeguate warning of SJS/TEN.

5 Even without reading the warning label. Dr. Ergin knew from

his medical background that Sulindac and other NSAIDs carried

some risk of causing SJS/TEN. But it was not his usual practice

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

Bartlett. If, however, there had been "strong warnings in place"

about "what may well be [a] higher risk of severe reactions like

SJS and TEN with Sulindac," Dr. Ergin claims that he likely would

have prescribed a different drug for Bartlett that carried less

risk of SJS/TEN. He admitted, however, that he still prescribes

Sulindac on rare occasions, even after learning of Bartlett's

ordeal.

Bartlett brought this suit against Mutual in New Hampshire

superior court in January 2008, asserting state-law claims of

strict products liability based on failure to warn of safety

risks (Count 1), strict products liability based on defective

design (Count 2), fraud (Count 3), and negligence based on both

failure to warn and defective design (Count 6).3 She alleges, in

particular, that Sulindac's safety risks outweigh its medical

benefits, making it an unreasonably dangerous product. She also

3Bartlett also asserted a gross negligence claim (Count 7). But "New Hampshire law does not distinguish causes of action based on ordinary and gross negligence," Barnes v. N.H. Karting Ass'n , 128 N.H. 102, 108 (1986), so this court will not separately discuss the gross negligence claim. Bartlett voluntarily dismissed her other claims, for breach of warranty (Counts 4 and 5).

6 alleges that Mutual should have strengthened Sulindac's safety

warning in light of the study mentioned above and other reports

in the medical literature about the connection between Sulindac

and SJS/TEN.

After removing the case to this court. Mutual moved for

judgment on the pleadings, arguing that all of Bartlett's claims

were pre-empted by the Hatch-Waxman Amendments to the Federal

Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301 et seg.,

and regulations issued thereunder. Specifically, Mutual argued

that federal law prohibits a manufacturer from unilaterally

strengthening the safety warning for a generic drug approved by

the FDA, because the warning must remain identical to that of the

brand-name drug. This court denied the motion, concluding that

federal law allows such changes and thus does not pre-empt

Bartlett's claims. See Bartlett, 659 F. Supp. 2d at 279; accord

Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010); Mensing v.

Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009), petition for cert,

filed, 78 U.S.L.W. 3522 (U.S. Feb. 19, 2010) (No. 09-993).

As the case proceeded, the parties engaged in a series of

discovery disputes. See, e.g., Bartlett v. Mut. Pharm. Co., 2009

DNH 166 (imposing sanctions against Mutual for the late

production of certain FDA filings). With discovery now complete

and trial scheduled for August 2010, Mutual has moved for summary

judgment on all claims. See Fed. R. Civ. P. 56(b). Bartlett, in

7 turn, has moved for partial summary judgment on various issues,

some of which overlap with those raised by Mutual. See Fed. R.

Civ. P. 56(a). This court will address each issue in turn,

beginning with the key issues on which both parties seek summary

judgment (i.e., the adeguacy of Sulindac's safety warning and

whether its alleged inadeguacy caused Bartlett's injuries) and

then turning to the other issues that they have raised

separately.

Ill. Adecruacy of the safety warning

The first issue, on which both parties seek summary

judgment, is whether Mutual's Sulindac label adeguately warned

doctors of the risk of SJS/TEN. Bartlett has the burden of

proving its inadeguacy as an essential element of her claims for

strict liability (Count 1) and negligence (Count 6) based on

failure to warn. See, e.g., Brochu v. Ortho Pharm. Corp., 642

F.2d 652 (1st Cir. 1981) (applying New Hampshire law); see also

Nelson v. Daikon Shield Claimants Trust, No. 84-276-SD, 1994 WL

255392 (D.N.H. June 8, 1994). "An adeguate warning is one

reasonable under the circumstances" to notify the doctor of the

drug's safety risks. Brochu, 642 F.2d at 657. The adeguacy of a

given warning must be judged in the light of the facts known at

the time, without the benefit of hindsight. Id. "A warning may be inadequate in factual content, in expression of the facts, or

in the method by which it is conveyed." Id.

Bartlett argues that the Sulindac label was inadequate as a

matter of law because it failed to mention SJS/TEN in its

"Warnings" section, failed to list the severe complications that

SJS/TEN can cause (e.g., blindness, coma), and failed to identify

the steps that should be taken if they occur, as required by FDA

regulations. See 21 C.F.R. § 201.57(e) (2004). 4 Mutual, in

contrast, argues that the label was adequate as a matter of law

because it expressly listed SJS/TEN in its "Adverse Reactions"

section and then cross-referenced them in its "Warnings" section,

where it discussed the risk of "hypersensitivity" and "severe

skin reactions" that have caused fatalities, as well as the steps

that should be taken if "evidence of hypersensitivity occurs."

Both parties have proffered expert testimony in support of their

respective positions.

While neither party is entitled to summary judgment on this

genuinely disputed issue. Mutual is much closer to meeting the

summary judgment standard than Bartlett. In Guevara v. Dorsey

4Mutual argues that this FDA regulation applies only to manufacturers of brand-name drugs, not generic versions. But this court already rejected that argument in its earlier pre­ emption ruling. See Bartlett, 659 F. Supp. 2d at 289 n.13, 298 n.25. In any event, the regulation is not dispositive of the label's adequacy. See Part VIII, infra (explaining that violation of FDA safety regulations is evidence of negligence, but not negligence per se) . Labs., 845 F.2d 364 (1st Cir. 1988), the court of appeals

reversed a jury's finding that a drug label was inadeguate where

the label warned of "hypersensitivity" but "did not specifically

warn of the kind of [skin] reaction" the plaintiff suffered,

which caused blisters and scarring. Id. at 366. The court

reasoned that "the warning, read as a whole, clearly tells

doctors" of the risk of such a reaction because, according to the

plaintiff's own expert, "a doctor warned about hypersensitivity

should know that it could be manifested as a skin rash." Id. at

366-68. The court therefore ruled as a matter of law that a more

"detailed admonition" was not reguired. Id. at 366.

Of course, SJS/TEN is far more serious than a skin rash. It

has an estimated mortality rate of 30 to 60 percent and, for

those who survive, can cause a range of severe and lifelong

health problems, as it has for Bartlett. Nevertheless, some

courts have applied reasoning similar to Guevara's in SJS/TEN

cases, deeming a drug's safety warning, phrased similarly to the

one in this case, adeguate as a matter of law. See Arnes v .

Apothecon, Inc., 431 F. Supp. 2d 566, 573 (D. Md. 2006) ("One

might prefer to have SJS/TEN listed in the Warnings section, but

the present structure cannot be said to be unreasonable merely

because it reguires the reader to make a cross-reference."); see

also Hall v. Merck, Sharp & Dohme, 774 F. Supp. 604, 606-08 (D.

Kan. 1991); Williams v. Ciba-Geigy Corp., 686 F. Supp. 573, 578-

10 80 (W.D. La. 1988); Serna v. Roche Labs., 684 P.2d 1187, 1188-

1190 (N.M.C t . App. 1984).

This court is not persuaded, however, that summary judgment

is appropriate on the current record. Even assuming arguendo

that a reasonable doctor would have understood Sulindac's warning

of "hypersensitivity" and "severe skin reactions" as a cross-

reference to SJS/TEN, the guestion remains whether the warning

should have been clearer, more prominent, and more detailed.

Given the severity of SJS/TEN and the study indicating that

Sulindac had more reported cases than any other NSAID and all but

four other drugs, that guestion cannot be taken away from the

jury. See Brochu, 642 F.2d at at 658-59 (affirming jury's

finding that drug label was inadeguate where it did not refer to

key study indicating higher risk of a severe reaction); see also

Marchant v. Dayton Tire & Rubber Co., 836 F.2d 695, 701 (1st Cir.

1988) ("guestions regarding the adeguacy of warnings are almost

always an issue to be resolved by a jury") (guotation omitted).

Accordingly, this court denies the parties' cross-motions for

summary judgment on this issue.

IV. Causation

The second issue on which both parties seek summary judgment

is whether Mutual's alleged failure to issue a stronger warning

caused Bartlett's injuries. Bartlett has the burden of proving

11 causation as an essential element of her claims for strict

liability (Count 1) and negligence (Count 6) based on failure to

warn. See, e.g., LeFavor v. Ford, 135 N.H. 311, 313 (1992);

Brochu, 642 F.2d at 659; Nelson, 1994 WL 255392, at *8.

Causation has two components under New Hampshire law: cause-in-

fact and legal cause. Carignan v. N.H. Int'l Speedway, Inc., 151

N.H. 409, 414 (2004). "Cause-in-fact reguires the plaintiff to

show that the injury would not have occurred but for the

negligent conduct." Id. Legal cause, in turn, "reguires the

plaintiff to establish that the negligent conduct was a

substantial factor in bringing about the harm." Id. In this

context, that means Bartlett "must prove that had the learned

intermediary [i.e., her doctor5] been warned adeguately, the drug

would not have been used, or would have been used differently."

5 Louis R. Frumer & Melvin I. Friedman, Products Liability §

50.05[4] , at 50-84 (2010) .

5It is well established that a manufacturer's duty to warn of a drug's safety risks "reguires that the physician, not the patient, be warned." Brochu, 642 F.2d at 661. This is sometimes called 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, 1994 WL 255392, at *4 (guoting Garside v. Osco Drug, Inc., 976 F.2d 77, 80 (1st Cir. 1992)).

12 In moving for summary judgment on this issue, Bartlett

argues that the deposition testimony of her treating physician.

Dr. Ergin, proves that he would have prescribed a different drug

with a lower risk of SJS/TEN if he had been given a stronger

warning by Mutual of "what may well be [a] higher risk of severe

reactions like SJS and TEN with Sulindac." Even if true,

however, that addresses only the last link in the causal chain.

The logically prior guestion, which Mutual raises in its own

summary judgment motion, is whether a stronger warning by Mutual

would have reached Dr. Ergin's attention in the first place,

enabling it to affect his decision in that manner. As explained

below, Bartlett has presented no evidence to establish that link

in the causal chain. Indeed, the evidence in the record is to

the contrary. Mutual is therefore entitled to summary judgment

on this issue.

A. Bartlett's doctor never reviewed the warning label

At his deposition. Dr. Ergin made clear that he never

reviewed Mutual's Sulindac label before treating Bartlett and

that nothing about it influenced his decision to prescribe the

drug or what he told her about it. Instead, he relied on his

background knowledge of the drug's safety risks, including his

knowledge that it could cause SJS/TEN. Thus, even assuming

arguendo that Mutual had a duty to strengthen the SJS/TEN warning

13 on its Sulindac label, that stronger warning would not have

affected Dr. Ergin's decision or prevented Bartlett's injuries.

See, e.g., Motus v. Pfizer Inc., 358 F.3d 659, 661 (9th Cir.

2004) (affirming summary judgment based on lack of causation

where plaintiff's "doctor testified that he did not read the

warning label"); Porterfield v. Ethicon, Inc., 183 F.3d 464, 468

(5th Cir. 1999) (same); 5 Frumer & Friedman, supra, § 50.05 [4],

at 50-88 (noting that "most courts will find an absence of

causation as a matter of law" where "the physician testifies that

he or she never read the warnings given").

Bartlett argues that the jury could nevertheless find

causation based on Dr. Ergin's review of the identical label for

the brand-name drug, Clinoril. But Dr. Ergin testified at his

deposition that he never reviewed the Clinoril label either ("no,

not in detail" was his precise response). Even if one infers

from that response that Dr. Ergin may have given the label a

cursory review, he proceeded to acknowledge that he never read

the part of the label that listed SJS/TEN as potential adverse

reactions (in the "Adverse Reactions" section), nor the part that

warned of "hypersensitivity" and "severe skin reactions" that

have caused fatalities (in the "Warnings" section). Thus, even

if those warnings had been stronger, as Bartlett alleges they

should have been, they would not have reached Dr. Ergin's

attention or prevented Bartlett's injuries.

14 Moreover, Bartlett has presented no evidence that if Mutual

had strengthened its Sulindac label, the FDA would have required

corresponding changes to the Clinoril label.6 So far as the

record indicates, that sequence of events (i.e., unilateral

changes to a generic drug label, followed by FDA-mandated changes

to the brand-name drug label) would have been highly unusual, if

not unprecedented. Indeed, Bartlett herself points to this lack

of precedent in arguing that it would be speculative for Mutual's

experts to opine that the FDA would not have taken such action.7

But she, too, has offered nothing but speculation. Since it is a

6Even now, more than five years after Bartlett's prescription, the FDA has not mandated the sort of label changes that Dr. Ergin said would have influenced his prescription decision. In response to a citizen's petition filed by a group of doctors in 2005, the FDA required that all NSAID labels (including Sulindac's) use the following language in their "Warnings" section:

NSAIDs, including [sulindac], can cause serious skin adverse events such as exfoliative dermatitis, Stevens- Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Nothing in that warning suggests "what well may be [a] higher risk of severe reactions like SJS and TEN with Sulindac" (to use Dr. Ergin's phrase). If anything it implies that all NSAIDs have a similar risk of SJS/TEN. Thus, even if the label change is admissible (which the parties dispute, see Fed. R. Evid. 407), it hurts rather than helps Bartlett on the issue of causation.

7Document no. 151 at 6.

15 plaintiff's burden to prove causation, that evidentiary gap is

fatal to any causation theory based on the Clinoril label. See

Lockridge v. Univ. of Me. Sys., 597 F.3d 464, 471 n.6 (1st Cir.

2010) ("unsupported speculation . . . is insufficient to

forestall summary judgment").

Bartlett attempts to fill the evidentiary gap by pointing to

Mutual's legal position, which is that FDA regulations reguire a

generic drug's label to remain the same as that of the brand-name

drug. She seems to be arguing that Mutual is therefore estopped

from contesting whether changes to the Sulindac label would have

resulted in corresponding changes to the Clinoril label. But

Mutual's position is that FDA regulations prohibit unilateral

changes to generic drug labels, not that they reguire the brand-

name drug label to copy such changes. In any event, Bartlett

argued against Mutual's position in her objection to the earlier

motion for judgment on the pleadings, and this court agreed with

her. See Bartlett, 659 F. Supp. 2d at 304 (ruling that federal

regulations "did not in fact reguire the generic drug's labeling

to remain the same as [brand-name] drug's post-approval"). She

cannot use her opponent's unsuccessful legal theory as a

substitute for evidence of causation.

Bartlett also argues that she is not reguired to present

evidence of causation because there is "a rebuttable presumption

in favor of the plaintiff that a physician would have heeded an

16 adequate warning" if the drug's manufacturer had given one.

Garside, 976 F.2d at 80 (citing Restatement (Second) Torts, §

402A, comment j ) . Whether that so-called "heeding presumption"

applies under New Hampshire law is questionable. See Wilson v.

Bradlees of New Eng., Inc., 250 F.3d 10, 16 (1st Cir. 2001)

(declining to apply heeding presumption because the New Hampshire

Supreme Court had not yet done so). But even assuming arguendo

that it applies, the presumption has been rebutted by Dr. Ergin's

deposition testimony, which makes clear that he did not review

Mutual's Sulindac warning label before prescribing the drug to

Bartlett and thus would not have heeded any changes that Mutual

made to it.8

Finally, Bartlett argues that summary judgment is

inappropriate because the jury could reject Dr. Ergin's testimony

on credibility grounds. But that is always true of any witness's

sworn statements submitted in support of summary judgment. A

party's "bare assertion that the opposing party's uncontroverted

8Nor is Bartlett saved by the principle "that a physician's carelessness . . . should not relieve a drug manufacturer of liability if the manufacturer's failure to warn adequately may have contributed to that carelessness." Brochu, 642 F.2d at 660 (quoting McCue v. Norwich Pharmacal Co., 453 F.2d 1033, 1035 (1st Cir. 1972)). Nothing in the record suggests that Mutual's alleged failure to warn of SJS/TEN contributed to Dr. Ergin's decision not to read Sulindac's warning label or, for that matter, that he was careless in not doing so. As discussed above. Dr. Ergin already knew from his medical background that Sulindac could cause SJS/TEN.

17 evidence might be disbelieved is insufficient to resist judgment

as a matter of law on an issue as to which the party resisting

judgment bears the burden of proof." Favorito v. Pannell, 27

F.3d 716, 721 (1st Cir. 1994); see also Levesgue v. Doocy, 560

F.3d 82, 87 (1st Cir. 2009) ("[A] mere challenge to the

credibility of a movant's witness without any supporting evidence

does not raise a trialworthy issue of fact.").

Bartlett points to "a line of cases holding that a

physician's statement about what s/he would have done in the face

of an adeguate warning raises a credibility issue which must be

decided by a jury," because that sort of "hindsight opinion is

not conclusive." Garside, 976 F.2d at 83 n.9 (guoting Doe v .

Miles Lab., Inc., 927 F.2d 187, 195 n.32 (4th Cir. 1991)). But

Bartlett is the one who moved for summary judgment based on Dr.

Ergin's opinion testimony about what he hypothetically would have

done in response to a stronger warning. (She apparently sees

credibility as no barrier to summary judgment in her favor on

this issue.) Mutual, in contrast, moved for summary judgment

based on Dr. Ergin's factual testimony about what he actually did

before prescribing the drug. Such testimony i_s conclusive where,

as here, it is not controverted by other evidence.

18 B. Non-label theories

At oral argument, this court also explored whether a

stronger warning by Mutual could have reached Dr. Ergin's

attention through some other means (apart from the label).

Although Bartlett had not asserted any "non-label" theories of

causation in her summary judgment objection, she seized the

opportunity to do so when the court raised the theories at oral

argument, arguing that she or Dr. Ergin would have seen the

warning if Mutual had created a medication guide for Sulindac

users, sent a "Dear Doctor" letter directly to healthcare

providers, filed a citizen's petition with the FDA, or launched

an educational campaign. Ordinarily, this court will not

consider theories raised for the first time at oral argument, out

of fairness to the adverse party. See, e.g., Johnson v. Gen.

Dynamics Info. Tech., Inc., 675 F. Supp. 2d 236, 241 n.3 (D.N.H.

2009); Doe v. Friendfinder Network, Inc., 540 F. Supp. 2d 288,

309 n.19 (D.N.H. 2008).9

9Even after oral argument, both parties continued to present new theories on various summary judgment issues, inserting them (somewhat incongruously) into their briefs on the pending motions in limine. Bartlett, for example, argued that a stronger warning could have reached Dr. Ergin's attention through an FDA press release or health advisory. Since those arguments are untimely and improperly raised, this court will not consider them.

19 Even if considered on the merits, however, Bartlett's "non­

label" theories would not prevent summary judgment on the issue

of causation:

• Starting with the patient medication guide, it is well

established that a manufacturer's duty to warn of a drug's

safety risks "reguires that the physician, not the patient,

be warned." Brochu, 642 F.2d at 661; see also Nelson, 1994

WL 255392, at *4. Since Mutual had no duty to warn Bartlett

directly, its failure to issue such a warning (in the form

of a medication guide or otherwise) cannot serve as the

basis for a finding of causation.

• Turning to the "Dear Doctor" letter, Bartlett admitted at

oral argument that there is no evidence about whether Dr.

Ergin has a practice of reading such letters. Moreover,

there is little, if any, evidence about the process for

distributing such letters. See, e.g., Demahy, 593 F.3d at

444-45 & n. 108 (suggesting that "generic manufacturers

cannot send 'Dear Doctor' letters without prior FDA

approval"). With the record in this undeveloped state, any

causation theory based on a "Dear Doctor" letter is purely

speculative.

20 • Bartlett also suggested at oral argument that Mutual should

have filed a citizen's petition with the FDA reguesting

changes to the Sulindac and Clinoril labels, such as a

"black box" warning of SJS/TEN. As she acknowledged,

however, that theory puts her back in the same predicament

discussed above, because Dr. Ergin never would have seen

those label changes (even assuming arguendo that the FDA

would have approved them).

• Finally, Bartlett suggested that Mutual should have launched

an educational campaign to promote early monitoring of

Sulindac's side effects. She emphasized at oral argument

that the manufacturer of Bextra, another NSAID linked to

SJS/TEN, advocated such a campaign to Canadian regulators.

For purposes of causation, however, the key guestion is not

whether Mutual should have advocated such a campaign, but

what would have happened if it did. Because there is no

evidence on that point, it is pure speculation to say that

such a campaign would have prevented Bartlett's injuries.

All of these "non-label" theories, moreover, rest upon a

dubious proposition: that even if Mutual had strengthened the

SJS/TEN warning on its Sulindac label (i.e., disclosing

prominently in the "Warnings" section that Sulindac had more

21 reported cases of SJS/TEN than any other NSAID and all but four

other drugs, and listing all the potential complications of

SJS/TEN), that still would have been a legally inadeguate warning

unless Mutual took additional steps beyond the label to

disseminate such information. Bartlett has not identified any

authority or evidence for that proposition. Indeed, as already

discussed, it is debatable whether Mutual even had a duty to

include such detailed information in the label itself. See Part

III, supra.

In sum, Bartlett has not met her burden of coming forward

with "specific facts, in suitable evidentiary form, to establish

the presence of a trialworthy issue" as to whether Mutual's

alleged failure to warn caused her injuries. Clifford v.

Barnhart, 449 F.3d 276, 280 (1st Cir. 2006); see also Fed. R.

Civ. P. 56(e)(2). Her causation theories "rest[] merely upon

conclusory allegations, improbable inferences, and unsupported

speculation." Meuser v. Fed. Express Corp., 564 F.3d 507, 515

(1st Cir. 2009). Mutual is accordingly entitled to summary

judgment on Bartlett's claims of strict products liability (Count

1) and negligence (Count 6) based on failure to warn.

C. Defective design claims

After oral argument, this court ordered supplemental

briefing to help determine whether this causation problem is

22 fatal to Bartlett's other claims of strict products liability

(Count 2) and negligence (Count 6) based on defective design.

Mutual argues those claims, too, are really failure-to-warn

claims because the only "defect" that Bartlett alleges is an

inadeguate safety warning. But that is not accurate. Bartlett

also alleges that Sulindac is defective because its safety risks

outweigh its medical benefits, making it an unreasonably

dangerous product.10 As the New Hampshire Supreme Court has

explained:

A design defect exists when the product is manufactured in conformity with the intended design but the design itself poses unreasonable dangers to consumers. A strict liability action based upon a theory of defective design may be joined with an action grounded in negligence. To maintain a products liability claim based on defective design, a plaintiff must prove: (1) that the design of the product created a defective condition unreasonably dangerous to the user; (2) that the condition existed when the product was sold . . .; (3) that the use of the product was reasonably foreseeable by the manufacturer; and (4) that the condition caused injury to the user or the user's property.

Trull v. Volkswagen of Am., Inc., 145 N.H. 259, 264 (2000)

(citations omitted). Such a claim is independent of any

inadeguacy in the product's safety warning and can be brought as

an alternative ground for recovery under New Hampshire law. See

10Bartlett further alleges that Mutual should have removed Sulindac from the market in light of its unreasonable dangerousness. This court need not consider that issue here, though, because both parties agree that defective design claims do not reguire such a finding.

23 Brochu, 642 F.2d at 657 (explaining that it is "neither illogical

nor inconsistent" to bring both claims in a case involving

prescription drugs).

This is not to say, however, that Mutual cannot use

Sulindac's safety warning as part of its defense against

Bartlett's defective design claims. The New Hampshire Supreme

Court has said that "[s]ome products are so important that a

manufacturer may avoid liability [for defective design] as a

matter of law if he has given proper warnings." Thibault, 118

N.H. at 808 (citing two cases that involved prescription drugs).

This principle is explained more fully in the Restatement

(Second) of Torts:

Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are guite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging conseguences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies

24 the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the gualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate conseguences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

Restatement (Second) of Torts § 402A, cmt. k (1965); see also

Bellotte v. Zayre Corp., 116 N.H. 52, 55 (1976) (citing cmt. k);

Brochu, 642 F.2d at 656 (same).

Because this comment "is traditionally viewed as an

exception and a defense to strict liability, courts generally

place the initial burden of proving the various . . . factors on

the defendant," meaning that "plaintiff's burden of proof on his

or her prima facie case remains the same as in any products

liability case." 1 Frumer & Friedman, supra, § 8.07 [5], at 8-

296; see also, e.g., Castrignano v. E.R. Sguibb & Sons, Inc., 900

F.2d 455, 457 (1st Cir. 1990) (applying Rhode Island law). This

court predicts that the New Hampshire Supreme Court would follow

that majority approach, particularly since it has referred to the

exception as a way "that a manufacturer may avoid liability,"

Thibault, 118 N.H. at 808, and has said that "proof of an

alternative design" (i.e., avoidability) is not an essential

element that must be proved by the plaintiff in a defective

25 design case. Vautour v. Body Masters Sports Indus., Inc., 147

N.H. 150, 156 (2001) .

Applying these principles to the current record, this court

concludes that Bartlett has presented enough evidence (primarily

in the form of expert testimony) to create a trialworthy issue as

to whether Sulindac is unreasonably dangerous and whether that

defective condition caused her injuries. Assuming arguendo that

the jury finds for her on those points. Mutual might nonetheless

be able to avoid liability for defective design if it can prove,

as an affirmative defense, that Sulindac is unavoidably unsafe

and had an adeguate safety warning. As explained above, however,

the adeguacy of Sulindac's safety warning is a matter of genuine

dispute on this record. See Part III, supra. Because "a product

without a proper warning, even if otherwise unavoidably unsafe,

does not gualify for the strict liability exemption," 1 Frumer &

Friedman, supra, § 8.07[5], at 8-276, summary judgment is

inappropriate on Bartlett's defective design claims.

V. Fraud claim

Mutual also seeks summary judgment on Bartlett's fraud claim

(Count 3). "To establish fraud" under New Hampshire law, "a

plaintiff must prove that the defendant made a representation

with knowledge of its falsity or with conscious indifference to

its truth with the intention to cause another to rely upon it,"

26 and which actually induces justifiable reliance. Snierson v.

Scruton, 145 N.H. 73, 77 (2000). This showing must be made by

clear and convincing evidence. See, e.g.. Burroughs v. Wynn, 117

N.H. 123, 124 (1977). On this record, Bartlett has not presented

any evidence--much less clear and convincing evidence--of actual

reliance on Mutual's allegedly fraudulent misrepresentations. To

the contrary, the record shows that neither Bartlett nor her

doctor read or relied upon Sulindac's warning label. See Part

IV, supra. Summary judgment is therefore granted to Mutual on

Bartlett's fraud claim.

VI. Enhanced compensatory damages

Mutual also seeks summary judgment on Bartlett's claim for

enhanced compensatory damages. Under New Hampshire law, punitive

damages are prohibited by statute, see N.H. Rev. Stat. § 507:16,

but an award of compensatory damages may nevertheless be enhanced

in "exceptional cases" where the defendant's tortious "act is

wanton, malicious, or oppressive." Stewart v. Bader, 154 N.H.

75, 87 (2006). An act is "wanton" if the defendant recklessly

creates a risk of great harm. See Minion, Inc. v. Burdin, 929 F.

Supp. 521, 525 (D.N.H. 1996) (McAuliffe, D.J.) (citing Thompson

v. Forest, 136 N.H. 215, 220 (1992)). An act is "malicious" if

the defendant has "ill will, hatred, hostility, or evil motive."

27 Stewart, 154 N.H. at 87. 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." Fiqlioli v. R.J.

Moreau Cos., 151 N.H. 618, 622 (2005).

Bartlett has presented enough evidence, particularly as to

wantonness, to avoid summary judgment on this issue. The court

cannot say, at least on the current record, that no reasonable

jury could conclude that Mutual recklessly created a risk of

great harm to consumers like Bartlett. For example, a finding of

such recklessness could be based on Mutual's admitted (though

explained) failure to survey the medical literature for

information about Sulindac's safety risks and its continual

manufacture and sale of Sulindac in the face of those risks, even

though other drugs were withdrawn from the market based on a

similar link to SJS/TEN. Mutual's request for summary judgment

on this issue is therefore denied. The scope of Bartlett's claim

for enhanced compensatory damages and this court's corresponding

jury instruction will be determined based on the evidence at

trial.

Mutual further argues that any award of enhanced

compensatory damages must be based solely on its own conduct, not

on the severity of Bartlett's injuries. It is true that

28 compensatory damages may be enhanced only if Mutual acted

wantonly, maliciously, or oppressively (regardless of what

injuries Bartlett suffered). But in analyzing Mutual's conduct,

the jury may consider the nature of the risk that Mutual created.

See Stewart, 154 N.H. at 87 (citing Aubert v. Aubert, 129 N.H.

422, 431 (1987), and Kowalski v. Gagne, 914 F.2d 299, 303 (1st

Cir. 1990)). It is undisputed, for example, that Mutual knew

Sulindac posed risks on the order of those Bartlett suffered.

Moreover, Bartlett's actual injuries are a relevant factor in

determining the amount of any enhancement. See id. at 88 (noting

that the enhanced compensatory damage award in Aubert, 12 9 N.H.

at 431, "was not excessive in light of the defendant's oppression

and ill-will and the plaintiff's 'severe and traumatic'

injuries") .11

VII. Surveillance of medical literature

Next, Bartlett seeks summary judgment on the part of her

negligence claim (Count 6) which alleges that Mutual breached its

duty of care by failing to survey the medical literature for

11In its reply. Mutual also argues for the first time that an award of enhanced compensatory damages would violate its due process rights under the Fourteenth Amendment to the United States Constitution. This court generally "does not consider theories advanced for the first time in reply" and sees no reason to make an exception here. Friendfinder, 540 F. Supp. 2d at 303 (citing L.R. 7.1(e)(1), which restricts reply "to rebuttal of factual and legal arguments raised in the objection").

29 adverse events associated with Sulindac.12 There is no factual

dispute on this issue: Mutual concedes that it did not conduct

such surveillance. But the parties disagree over the law.

Bartlett argues that FDA regulations reguired generic

manufacturers to survey the medical literature for adverse drug

events and that those regulations establish the minimum standard

of care under New Hampshire law. Mutual, in contrast, argues

that FDA regulations imposed no surveillance reguirement on

generic manufacturers and, even if they did, only the federal

government would have the power to enforce them.

This court already made clear in its earlier pre-emption

ruling that 21 C.F.R. § 314.80(b), which reguires brand-name drug

manufacturers to "develop written procedures for the

surveillance, receipt, evaluation, and reporting of postmarketing

adverse drug experiences to FDA," applies egually to generic drug

manufacturers by virtue of 21 C.F.R. § 314.98(a), which provides

that they too "shall comply with the reguirements of § 314.80

regarding the reporting and recordkeeping of adverse drug

experiences." See Bartlett, 659 F. Supp. 2d at 289, 307; accord

Demahy, 593 F.3d at 448 ("The FDA also reguires that generics

12Although this allegation played a more prominent role in Bartlett's failure-to-warn claims (and, to that extent, is moot), it is also relevant to her defective design claims, in that it bears on Mutual's degree of fault, if any, in selling an unreasonably dangerous product. See Part VI, supra.

30 'develop written procedures for the surveillance . . . of

postmarketing adverse drug experiences to FDA.'") (guoting §

314.80 (b)) .

Mutual argues that § 314.98(a) makes generic manufacturers

subject only to the specific subsections of § 314.80 entitled

"Reporting reguirements" and "Recordkeeping," see 21 C.F.R.

§§ 314.80(c), (i), and not to the surveillance reguirement in

§ 314.80(b), entitled "Review of adverse drug experiences." But

the regulations make clear that " [a]ny person subject to the

reporting reguirements under paragraph (c)" of § 314.80 is also

subject to the surveillance reguirement. Id. § 314.80(b)

(emphasis added). That language confirms this court's earlier

conclusion that the surveillance reguirement applies to generic

manufacturers.

At oral argument. Mutual suggested that § 314.80(b) only

reguires manufacturers to develop procedures for collecting

reports of specific adverse experiences associated with their own

drugs, not for surveying the medical literature for broader

safety studies (such as the international study of NSAIDs and

SJS/TEN referenced in Part II, supra) . But the regulation states

that manufacturers "shall promptly review all adverse drug

experience information obtained or otherwise received by the

applicant from any source, foreign or domestic," including

specifically "reports in the scientific literature" and

31 "postmarketing epidemiological/surveillance studies." 21 C.F.R.

§ 314.80(b). The most logical interpretation is that those are

the same types of sources that manufacturers must develop

procedures for surveying.13

The guestion, then, is whether Mutual's admitted failure to

develop safety surveillance procedures as reguired by federal law

constitutes a per se violation of its duty of care under New

Hampshire law. Unlike most states. New Hampshire generally

regards "a causal violation of a statute [as] not merely evidence

of fault but [as] legal fault," provided that the plaintiff is a

member of the class protected by the statute and the harm is the

type against which the statute is designed to protect. 8 Richard

13Mutual also argues that, under the doctrine of "primary jurisdiction," this court should defer to the FDA for a determination of which regulations apply to generic manufacturers and whether they have been violated. That doctrine "comes into play whenever enforcement of [a] claim reguires the resolution of issues which, under a regulatory scheme, have been placed within the special competence of an administrative body; in such a case the judicial process is suspended pending referral of such issues to the administrative body for its views." United States v. W. Pac. R.R. C o ., 352 U.S. 59, 64 (1956). But it was Mutual that initially asked this court to interpret the FDA regulations by moving for judgment on the pleadings based on its pre-emption defense, suggesting, at least, that it regarded the court as competent to resolve these issues. In any event, the interpretation of those regulations is not something for which the judiciary needs the FDA's special competence, as the growing and (so far) uniform body of case law interpreting and applying those regulations indicates. See, e.g., Alpharma, Inc. v. Pennfield Oil Co., 411 F.3d 934, 939 (8th Cir. 2005) ("primary jurisdiction should seldom be invoked unless a factual guestion reguires both expert consideration and uniformity of resolution") (guotation omitted).

32 B. McNamara, New Hampshire Practice, § 4.70, at 4-103 (citing

cases). Both of those prerequisites seem to be satisfied here:

the FDA's surveillance requirement is designed to protect

patients like Bartlett against safety risks like SJS/TEN by

ensuring that the drug's warning label reflects up-to-date

information.

But the FDA's surveillance requirement is not a statute; it

is a safety regulation. The New Hampshire Supreme Court has

suggested that safety codes generally "are not to be accepted as

absolute standards" of care "unless they have been incorporated

into statutes or ordinances by either State or local legislative

bodies." Lemery v. O'Shea Dennis, Inc., 112 N.H. 199, 200

(1972). That cautionary language casts serious doubt on whether

New Hampshire would treat the violation of a safety regulation as

negligence per se, particularly a federal regulation which, so

far as the record indicates, has not been incorporated into any

such statutes or ordinances. C f . Mailhot v. C&R Constr. Co., 128

N.H. 323 (1986) (leaving this issue open in a case involving

federal workplace safety regulations).

Another factor that New Hampshire courts consider in

determining whether to recognize a negligence per se theory is

whether doing so would be consistent with the legislative intent

as expressed in the relevant law. See, e.g., Wong v. Ekberg, 148

N.H. 369, 375 (2002); Marguay v. Eno, 139 N.H. 708, 716 (1995).

33 Here, the FDCA expressly provides that "all such proceedings for

[its] enforcement . . . shall be by and in the name of the United

States." 21 U.S.C. § 337(a). The Supreme Court has said that

this provision "leaves no doubt that it is the Federal Government

rather than private litigants who are authorized to file suit for

noncompliance." Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S.

341, 349 n .4 (2001) .

"Because the FDCA does not provide for a private cause of

action, many courts have held plaintiffs cannot seek to enforce

it through negligence per se tort actions." Hackett v. G.D.

Searle & C o ., 246 F. Supp. 2d 591, 594 (W.D. Tex. 2002) (citing

Talley v. Danek Med., Inc., 179 F.3d 154, 161 (4th Cir. 1999) and

other cases); see also Kemp v. Medtronic, Inc., 231 F.3d 216, 236

(6th Cir. 2000); Rimbert v. Eli Lilly and Co., 577 F. Supp. 2d

1174, 1239-40 (D.N.M. 2008). 14 Other courts, though, have

allowed such suits, reasoning that they do not assert private

rights of action under the FDCA, but rather a negligence theory

long recognized at common law. See, e.g.. In re Orthopedic Bone

Screw Prods. Liab. Litig., 193 F.3d 781, 788-89 (3d Cir. 1999)

(citing cases) .

There is no clear answer to this guestion under New

Hampshire law. In such cases, federal courts must make "an

14Indeed, Mutual even argues that doing so would raise federal pre-emption concerns, citing Buckman, 531 U.S. at 353.

34 informed prophecy of what the [state's highest court] would do in

the same situation, seeking guidance in analogous state court

decisions, persuasive adjudications by courts of sister states,

learned treatises, and public policy considerations." Walton v.

Nalco Chem. Co., 272 F.3d 13, 20 (1st Cir. 2001). Based on the

sources and considerations discussed above, this court's view is

that the New Hampshire Supreme Court would not treat Mutual's

violation of 21 C.F.R. § 314.80(b) as establishing a per se

breach of its duty of care, but rather would allow the jury to

consider that violation as evidence of such a breach. See, e.g.,

Lemery, 112 N.H. at 201 (noting that "standards embodied in

safety codes might be of aid to the trial court or the jury on an

issue of due care"); 8 McNamara, supra, § 4.13, at 4-26 n.5.15

Bartlett's reguest for summary judgment on this issue is

therefore denied.

15In light of this ruling, the court need not decide whether premising a negligence per se claim on a violation of FDA regulations amounts to an impermissible private right of action under the FDCA. This court's ruling also avoids the pre-emption concerns raised by Mutual. See Buckman, 531 U.S. at 352-53 (allowing state-law claims to "parallel federal safety reguirements" where they arise "from the manufacturer's alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA reguirements").

35 VIII. Mutual's affirmative defenses

Next, Bartlett seeks summary judgment on two of Mutual's

affirmative defenses: (1) set-off and (2) spoliation.16 Both

defenses were originally stricken by this court in its discovery

order following the preliminary pre-trial conference in October

2008, "without prejudice to being reinstated on reguest if

warranted by the evidence."17 Mutual, without making any

evidentiary showing, reinstated both defenses in the answer to

Bartlett's amended complaint that it filed in February 2010.

Bartlett argues that neither Mutual's answer nor its summary

judgment objection amounts to a formal reguest for reinstatement.

But even construing them as such, this court sees no basis for

reinstating either defense.

A. Set-off

16Bartlett initially challenged a large number of defenses, but Mutual conceded that some of them should be stricken (i.e., standing, unclean hands, laches, waiver, estoppel, statute of limitations, and excessive delay), and Bartlett withdrew some of her other challenges in her reply brief. She also withdrew one at oral argument (failure to mitigate). Another defense that she challenged (product modification) is moot in light of this court's ruling that Mutual is entitled to summary judgment on Bartlett's failure-to-warn claims, see Part IV, supra, since the defense was based on the pharmacy's decision to give Bartlett a pharmacy-created "prescription adviser" instead of Mutual's safety warning.

17Document no. 24.

36 According to Mutual, its "set-off" defense is based on its

argument that fault should be apportioned to a third party. Dr.

Ergin, or to Bartlett herself under New Hampshire's apportionment

statute, N.H. Rev. Stat. § 507:7-e. But "set-off" is not the

correct label for that defense. See, e.g.. In re Liguidation of

Home Ins. C o ., 158 N.H. 677, 680 (2009) ("Setoff allows entities

that owe each other money to apply their mutual debts against

each other, thereby avoiding the absurdity of making A pay B when

B owes A.") (guotation omitted). Moreover, Mutual has already

asserted a specific apportionment defense, which Bartlett has not

challenged, seeking reduction of its liability based on the

conduct of third parties. In light of that defense, there is no

need to reinstate Mutual's mislabeled set-off defense.

B. Spoliation

The spoliation defense is based on the fact that Mutual has

never been allowed to inspect Bartlett's original Sulindac

container and unused pills. But the transcript from Bartlett's

deposition in May 2009 shows that the parties arranged for

Mutual's counsel to contact Bartlett's counsel afterward to

arrange such an inspection. That appears never to have happened.

Bartlett recently sent Mutual pictures of the container and pills

and confirmed her willingness to arrange an inspection in advance

of trial. If Mutual still wishes to conduct the inspection, it

37 may do so by accepting one of the reasonable options offered by

Bartlett's counsel.

Based on the pictures that Bartlett provided. Mutual also

argues that the number of unused Sulindac pills (15 out of the

original 60) is inconsistent with Bartlett's testimony about how

many pills she took (40), thus indicating either that she took

too many pills or that some pills were destroyed. But that

discrepancy alone is not enough to warrant reinstatement of

Mutual's spoliation defense, at least on the current record.

Spoliation occurs where a party culpably destroys relevant

evidence in her possession while under a duty to preserve it.

See N.H. Ball Bearings, Inc. v. Jackson, 158 N.H. 421, 434

(2009). Mutual has not identified any evidence that Bartlett,

who was in a coma for months after developing SJS/TEN, culpably

destroyed pills while anticipating litigation.18

IX. Pre-emption redux

Finally, Mutual asks this court to revisit its earlier pre­

emption ruling in light of the deposition testimony of three

180f course, this is a pretrial ruling based on a summary judgment record. Nothing prevents Mutual from using the number of pills remaining to challenge Bartlett's testimony about the number of pills she took. If her testimony suggests culpable destruction, then Mutual may reguest that this court reconsider whether to give a spoliation instruction. See, e.g.. Testa v. Wal-Mart Stores, Inc., 144 F.3d 173, 177 (1st Cir. 1998).

38 former FDA officials, each of whom testified that the FDA's

policy is to prohibit manufacturers from unilaterally

strengthening a generic drug's label. See Bartlett, 659 F. Supp.

2d at 279 (ruling that federal law allows such changes). But as

Mutual concedes, those officials "were not deposed to offer

opinions or interpretations of federal statutes or regulations."

Their testimony thus has little, if any, relevance to the pre­

emption issue and, indeed, plays a minimal role in Mutual's

arguments in support of its motion. C f . Rose v. Chase Bank USA,

N .A . , 513 F.3d 1032, 1038 n.4 (9th Cir. 2008) (noting that "no

amount of discovery" would change the court's pre-emption ruling,

which was based on congressional intent).

Although presented in the guise of a summary judgment

motion. Mutual's argument is really one for reconsideration of

the court's earlier ruling. See Rodriguez-Antuna v. Chase

Manhattan Bank Corp., 871 F.2d 1, 2 (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 therefore analyze

it as such. A motion for reconsideration must "demonstrate that

the order [being challenged] 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, Mutual filed its motion about six months

39 after this court's earlier ruling, long after the 14-day

deadline.

Mutual seems to be suggesting that the depositions of former

FDA officials constitute "newly available material evidence,"

which can be cause for a late filing under Local Rule 7.2(e) .

But as explained above, such evidence is not material or even

relevant to the pre-emption issue. Nor is it truly "new."

Mutual admitted at oral argument that at least two of the

officials had testified many times in other cases and that it

anticipated what they would say when deposed here. And even if

the evidence were new and material. Mutual unreasonably delayed

in filing its motion. One of the depositions took place less

than a month after this court's earlier ruling, and even the most

recent one occurred more than two months before Mutual's motion.

This court therefore denies Mutual's motion for reconsideration

as untimely.

Even if it were timely. Mutual's motion for reconsideration

would still be denied because Mutual has not identified "a

manifest error of fact or law" in this court's earlier ruling,

which analyzed the relevant statutes and regulations in

painstaking detail. Since that ruling, two federal circuit

courts have reached the same conclusion that this court reached,

based on substantially the same reasoning. See Demahy, 593 F.3d

at 428; Mensing, 588 F.3d at 603. While generic drug

40 manufacturers (including Mutual) continue to refine and adapt

their arguments in response to those unsuccessful outcomes, this

court is not persuaded that those refinements change the

fundamental analysis or the outcome.19

X. Conclusion

Mutual's motion for summary judgment20 is GRANTED as to

Bartlett's claims of strict products liability (Count 1) and

negligence (Count 6) based on failure to warn, as well as her

claim of fraud (Count 3), but is DENIED as to her claims of

strict products liability (Count 2) and negligence (Count 6)

based on defective design, as well as her reguest for enhanced

compensatory damages. Mutual's separate motion for summary

judgment based on federal pre-emption,21 which is actually a

motion for reconsideration of this court's earlier pre-emption

ruling, is also DENIED. Bartlett's motion for partial summary

judgment22 is GRANTED as to Mutual's set-off and spoliation

defenses, but is otherwise DENIED.

19Since this court's pre-emption ruling remains in effect, Bartlett's competing reguest for summary judgment on issues relating to pre-emption is moot.

20Document no. 146.

21Document no. 145.

22Document no. 131.

41 SO ORDERED.

seph N . Ifaplante nited States District Judge

Dated: July 12, 2010

cc: Keith M. Jensen, Esq. 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.