JOSEPH N. LAPLANTE, District Judge.
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.
Summary judgment is appropriate where "the pleadings, the discovery
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 necrolysis ("TEN"), a serious and potentially fatal condition characterized by necrosis of the skin and mucous membranes. See Dorland'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" section. In its "Warnings" section, however, the label did not mention SJS/TEN by name. Rather, it stated as follows:
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.
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).
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 seq., 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).
The first issue, on which both parties seek summary judgment, is whether Mutual's Sulindac label adequately warned doctors of the risk of SJS/TEN. Bartlett has the burden of proving its inadequacy 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. Dalkon Shield Claimants Trust, No. 84-276-SD, 1994 WL 255392 (D.N.H. June 8, 1994). "An adequate warning is one reasonable under the circumstances" to notify the doctor of the drug's safety risks. Brochu, 642 F.2d at 657. The adequacy 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).
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 Labs., 845 F.2d 364 (1st Cir.1988), the court of appeals reversed a jury's finding that a drug label was inadequate 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
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, adequate as a matter of law. See Ames 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 requires 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, 578-80 (W.D.La.1988); Serna v. Roche Labs., 101 N.M. 522, 684 P.2d 1187, 1188-1190 (N.M.Ct.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 question 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 question cannot be taken away from the jury. See Brochu, 642 F.2d at at 658-59 (affirming jury's finding that drug label was inadequate 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) ("questions regarding the adequacy of warnings are almost always an issue to be resolved by a jury") (quotation omitted). Accordingly, this court denies the parties' cross-motions for summary judgment on this issue.
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 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, 604 A.2d 570 (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, 858 A.2d 536 (2004). "Cause-in-fact requires the plaintiff to show that the injury would not have occurred but for the negligent conduct." Id. Legal cause, in turn, "requires 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 doctor
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 question, 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.
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 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.
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.
Bartlett attempts to fill the evidentiary gap by pointing to Mutual's legal position, which is that FDA regulations require 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 require 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 require 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 required to present evidence of causation because there is "a rebuttable presumption in favor of the plaintiff that a physician would have heeded an 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.
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 adequate 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 (quoting 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 is conclusive where, as here, it is not controverted by other evidence.
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, 304 n. 19 (D.N.H.2008).
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 "requires 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.
• Bartlett also suggested at oral argument that Mutual should have filed a citizen's petition with the FDA requesting 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 question 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 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 inadequate 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.
After oral argument, this court ordered supplemental briefing to help determine whether this causation problem is 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 inadequate 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.
Trull v. Volkswagen of Am., Inc., 145 N.H. 259, 264, 761 A.2d 477 (2000) (citations omitted). Such a claim is independent of any inadequacy in the product's safety warning and can be brought as an alternative ground for recovery under New Hampshire law. See 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 v. Sears, Roebuck & Co., 118 N.H. 802, 808, 395 A.2d 843 (1978) (citing two cases that involved prescription drugs). This principle is explained more fully in the Restatement (Second) of Torts:
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. Squibb & 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, 395 A.2d 843, 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 design case. Vautour v. Body Masters Sports Indus., Inc., 147 N.H. 150, 156, 784 A.2d 1178 (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 adequate safety warning. As explained above, however, the adequacy 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 qualify 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.
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," and which actually induces justifiable reliance. Snierson v. Scruton, 145 N.H. 73, 77, 761 A.2d 1046 (2000). This showing must be made by clear and convincing evidence. See, e.g., Burroughs v. Wynn, 117 N.H. 123, 124, 370 A.2d 642 (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.
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, 907 A.2d 931 (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)
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 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, 907 A.2d 931 (citing Aubert v. Aubert, 129 N.H. 422, 431, 529 A.2d 909 (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, 907 A.2d 931 (noting that the enhanced compensatory damage award in Aubert, 129 N.H. at 431, 529 A.2d 909, "was not excessive in light of the defendant's oppression and ill-will and the plaintiff's `severe and traumatic' injuries").
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 adverse events associated with Sulindac.
This court already made clear in its earlier pre-emption ruling that 21 C.F.R. § 314.80(b), which requires brand-name drug manufacturers to "develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA," applies equally to generic drug manufacturers by virtue of 21 C.F.R. § 314.98(a), which provides that they too "shall comply with the requirements 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 requires that generics `develop written procedures for the surveillance. . . of postmarketing adverse drug experiences to FDA.'") (quoting § 314.80(b)).
Mutual argues that § 314.98(a) makes generic manufacturers subject only to the specific subsections of § 314.80 entitled "Reporting requirements" and "Recordkeeping," see 21 C.F.R. § 314.80(c), (i), and not to the surveillance requirement in § 314.80(b), entitled "Review of adverse drug experiences." But the regulations make clear that "[a]ny person subject to the reporting requirements under paragraph (c)" of § 314.80 is also subject to the surveillance requirement. Id. § 314.80(b) (emphasis added). That language confirms this court's earlier conclusion that the surveillance requirement applies to generic manufacturers.
At oral argument, Mutual suggested that § 314.80(b) only requires 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 "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.
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, 291 A.2d 616 (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. Cf. Mailhot v. C & R Constr. Co., 128 N.H. 323, 514 A.2d 1255 (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, 807 A.2d 1266 (2002); Marquay v. Eno, 139 N.H. 708, 716, 662 A.2d 272 (1995). 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, 121 S.Ct. 1012, 148 L.Ed.2d 854 (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 & Co., 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).
There is no clear answer to this question under New Hampshire law. In such cases, federal courts must make "an 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,
Next, Bartlett seeks summary judgment on two of Mutual's affirmative defenses: (1) set-off and (2) spoliation.
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 Liquidation of Home Ins. Co., 158 N.H. 677, 680, 972 A.2d 1019 (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.") (quotation 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.
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
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, 969 A.2d 351 (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.
Finally, Mutual asks this court to revisit its earlier preemption ruling in light of the deposition testimony of three 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 preemption issue and, indeed, plays a minimal role in Mutual's arguments in support of its motion. Cf. 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 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
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 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.
Mutual's motion for summary judgment
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.
