Full opinion text
OPINION & ORDER JOSEPH N. LAPLANTE, District Judge. This products liability case arises out of severe and permanent injuries, including blindness, that plaintiff Karen Bartlett suffered after ingesting sulindac, a prescription drug manufactured by the defendant, Mutual Pharmaceutical Company. Bartlett brought claims against Mutual for strict liability (defective design), strict Lability (failure to warn), fraud, and negligence under New Hampshire law. This court granted summary judgment to Mutual on nearly all of the claims. See Bartlett v. Mut. Pharm. Co., 731 F.Supp.2d 135 (D.N.H.2010) (failure to warn, fraud, and part of negligence claim); Bartlett v. Mut. Pharm. Co., 2010 DNH 164, 2010 WL 3659789, 2010 U.S. Dist. LEXIS 96711 (remainder of negligence claim). Bartlett proceeded to trial and prevailed on her sole remaining claim, for defective design. The jury found in her favor and awarded her $21.06 million in compensatory damages. Mutual has now renewed its motion for judgment as a matter of law, see Fed. R.Civ.P. 50(b), arguing that Bartlett presented insufficient evidence to support her claim and that the claim is pre-empted by federal law. Mutual has also moved, in the alternative, for a new trial, see Fed. R.Civ.P. 59, arguing that numerous errors at trial tainted the jury verdict and that the damages award was excessive. Both motions are denied. Bartlett presented sufficient evidence for a reasonable jury to conclude that sulindac’s risks outweighed its benefits, making it a defective product unreasonably dangerous to consumers. Federal law does not prohibit states from imposing liability on that basis. In light of the severe injuries that Bartlett suffered, the damages award (though substantial) was within the acceptable range. And while no three-week trial is perfect, Mutual has not identified any errors that would warrant setting aside the jury verdict or retrying the case. To a large extent, Mutual’s post-trial motions attempt to escape the consequences of its own tactical decisions. For example, Mutual accuses this court of expanding the scope of manufacturer liability for injuries caused by products that cannot be made safer. But Mutual voluntarily withdrew an affirmative defense, recognized by this court in its summary judgment ruling, that would have relieved Mutual of liability if it proved that sulindac was unavoidably unsafe and had an adequate warning. See Bartlett, 731 F.Supp.2d at 151. Mutual also accuses Bartlett of giving the jury an unbalanced view of sulindac’s risks and benefits. But Mutual chose not to call any of its own witnesses at trial, foregoing the opportunity to rebut Bartlett’s evidence and put sulindac in a better light. Of course, Mutual was entitled to employ any trial strategy it wished. But, having made those tactical decisions, it must live with the consequences. It is not entitled to another trial where it can try a different strategy. I. Applicable legal standard “The standard for granting a Rule 50 motion [for judgment as a matter of law] is stringent.” Malone v. Lockheed Martin Corp., 610 F.3d 16, 20 (1st Cir. 2010). Courts may set aside a jury’s verdict and award judgment as a matter of law “only when the evidence points so strongly and overwhelmingly in favor of the moving party that no reasonable jury could have returned a verdict adverse to that party.” Id. In making that determination, the court must “view the evidence in the light most favorable to the verdict, making no determination[ ] of [its] own as to the credibility of witnesses or the weight of the evidence.” Rodriguez-Garcia v. Miranda-Marin, 610 F.3d 756, 765 (1st Cir.2010). It is the moving party’s burden to “specify ... the law and facts that entitle [it] to the judgment.” Coons v. Indus. Knife Co., 620 F.3d 38, 44 (1st Cir.2010) (quoting Fed.R.Civ.P. 50(a)(2)). The standard for granting a motion for new trial under Rule 59 is more flexible. “The district court has the power and duty to order a new trial whenever, in its judgment, the action is required to prevent injustice.” Rodriguez-Garcia, 610 F.3d at 765. In making that determination, the court “is free to independently weigh the evidence,” including “the credibility of the witnesses.” Jennings v. Jones, 587 F.3d 430, 436 (1st Cir.2009). But the court “cannot displace a jury’s verdict merely because [it] disagrees” with the outcome. Id. A new trial may be granted “only if the verdict is against the law, against the weight of the credible evidence, or tantamount to a miscarriage of justice.” Crowe v. Marchand, 506 F.3d 13, 19 (1st Cir.2007). It is the moving party’s burden to show that any “errors and defects” at trial affected its “substantial rights.” Fed.R.Civ.P. 61; see also Cabral v. U.S. Dep’t of Justice, 587 F.3d 13, 22 (1st Cir.2009). II. Background In December 2004, Bartlett sought medical treatment for pain in her right shoulder. Her doctor prescribed a non-steroidal anti-inflammatory drug (“NSAID”) called Clinoril. A nearby pharmacy filled the prescription with sulindac, a generic version of the drug manufactured by Mutual. Within weeks, Bartlett went to the emergency room complaining of skin blisters, 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). Her doctors concluded that the SJS/TEN was caused by sulindac. She spent about three months in the hospital recovering— two of them in a medically induced coma— and emerged with permanent injuries, including blindness. Bartlett brought suit against Mutual in New Hampshire Superior Court in January 2008, asserting claims for strict liability (defective design), strict liability (failure to warn), fraud, and negligence under New Hampshire law. She had three principal theories of liability: (1) that Mutual failed to warn adequately about sulindac’s risk of SJS/TEN; (2) that Mutual failed to survey the medical literature for information about sulindac’s risks and to report that information to the Food & Drug Administration (“FDA”); and (3) that sulindac’s risks outweighed its benefits, making it a defective product unreasonably dangerous to consumers. Mutual removed the case to this court, see 28 U.S.C. § 1441, which has subject-matter jurisdiction based on diversity of citizenship, see 28 U.S.C. § 1332(a)(1). At first, the litigation focused primarily on Bartlett’s failure-to-warn theory. Mutual moved for judgment on the pleadings, see Fed.R.Civ.P. 12(c), arguing that the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq., and related FDA regulations barred a manufacturer from unilaterally changing the warning for a generic drug, which must remain identical to that of the brand-name drug, and therefore pre-empted Bartlett’s claims. This court denied the motion, concluding that federal law allowed such changes and did not pre-empt Bartlett’s claims. See Bartlett v. Mut. Pharm. Co., 659 F.Supp.2d 279 (D.N.H.2009); accord Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir.2010), cert. granted, — U.S. -, 131 S.Ct. 817, 178 L.Ed.2d 550 (2010); Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009), cert. granted, — U.S. -, 131 S.Ct. 817, 178 L.Ed.2d 550 (2010). Mutual then moved for summary judgment, see Fed.R.Civ.P. 56, arguing that sulindac’s warning was adequate as a matter of law and that, in any event, Bartlett could not prove that any defect in the warning caused her injuries because her doctor admittedly never read the warning before prescribing sulindac. This court rejected the first argument, finding that the adequacy of sulindac’s warning was for the jury to decide (sulindac’s label expressly mentioned SJS/TEN in its list of potential adverse reactions, but not in its warnings section). See Bartlett, 731 F.Supp.2d at 143-45. But this court agreed with the second argument, as to the lack of causation, and therefore granted summary judgment to Mutual on Bartlett’s claims for strict liability (failure to warn) and fraud, as well as her negligence claim to the extent it was based on a failure-to-warn theory. Id. at 145-49. After that ruling, this court sua sponte ordered the parties to brief whether Bartlett had a trialworthy claim for negligence based on her second theory: that Mutual failed to survey the medical literature for information about sulindac’s risks arid to report that information to the FDA. Bartlett’s brief made clear that the theory depended on speculation that the FDA, if advised of that information, would have withdrawn its approval of sulindac in whole or in part, contrary to what had actually happened (sulindac remains on the market to this day, with FDA approval). Accordingly, this court granted summary judgment to Mutual on the remainder of Bartlett’s negligence claim. See Bartlett, 2010 WL 3659789, at *4-12, 2010 U.S. Dist. LEXIS 96711, at *12-36. As a result, Bartlett also lost any ability to recover enhanced compensatory damages, since her claim for those damages was based on her failure-to-warn and failure-to-survey theories. Id., 2010 WL 3659789, at *12-13, 2010 U.S. Dist. LEXIS 96711, at *36-40. Those rulings left Bartlett with only one theory for trial: that sulindac’s risk outweighed its benefits, making it a defective product unreasonably dangerous to consumers. Mutual challenged that theory as well (albeit not until a motion for reconsideration of this court’s summary judgment ruling), arguing that New Hampshire law requires a plaintiff to prove, in addition to the product’s risks outweighing its benefits, some other “defect” in design. See Buckingham v. R.J. Reynolds Tobacco Co., 142 N.H. 822, 713 A.2d 381 (1998). But this court disagreed, explaining that under more recent New Hampshire Supreme Court cases “a product is defective as designed if the magnitude of the danger outweighs the utility of the product,” Bartlett v. Mut. Pharm. Co., 2010 DNH 130, 2010 WL 3239247, at *3, 2010 U.S. Dist. LEXIS 77902, at *7 (quoting Vautour v. Body Masters Sports Indus., Inc., 147 N.H. 150, 154, 784 A.2d 1178 (2001)), and “the plaintiff is not required to present evidence of a safer alternative design,” Bartlett v. Mut. Pharm. Co., 2010 WL 3303634, at *1, 2010 U.S. Dist. LEXIS 84924, at *3 (document no. 336) (quoting Kelleher v. Marvin Lumber & Cedar Co., 152 N.H. 813, 831, 891 A.2d 477 (2005)). Nevertheless, this court agreed with Mutual that if a drug cannot be redesigned to make it safer, the manufacturer’s liability must be limited. Following the view set forth in the Restatement (Second) of Torts § 402A, cmt. k (1965), this court ruled that Mutual could “avoid liability for defective design if it can prove, as an affirmative defense, that sulindac is unavoidably unsafe and had an adequate safety warning.” Bartlett, 731 F.Supp.2d at 151; see also 1 Louis R. Frumer & Melvin I. Friedman, Products Liability § 8.07[5], at 8-296 (2010) (noting that because comment k “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”). Mutual, however, voluntarily withdrew that “comment k” defense on the eve of trial, without explanation. See document no. 332. With Bartlett’s failure-to-warn theory and Mutual’s “comment k” defense out of the case, the adequacy of sulindac’s warning (meaning whether it reasonably informed doctors of the drug’s risks, see Brochu v. Ortho Pharm. Corp., 642 F.2d 652, 657 (1st Cir.1981)) was no longer an issue for trial. Mutual argued that this court should therefore exclude all warning-related evidence and instruct the jury to analyze sulindac’s risks and benefits “without regard to the warning.” But since a warning can affect a drug’s risks and benefits (e.g., by explaining how to use the drug safely, or by identifying certain patients who should not take it), this court concluded that the proposed instruction would provide no real guidance to the jury; either the drug’s risks and benefits must be weighed as if it had no warning at all, or they must be weighed in light of the warning that actually accompanied it. See Bartlett v. Mut. Pharm. Co., 2010 WL 3303864, at *3, 2010 U.S. Dist. LEXIS 102603, at *10 (document no. 345). Following a line of New Hampshire Supreme Court cases, which expressly stated that the jury in a defective design case may consider “the presence and efficacy of a warning to avoid an unreasonable risk of harm,” Vautour, 147 N.H. at 154, 784 A.2d 1178, this court ruled that warning-related evidence could be admitted at trial for a limited purpose: if the jury found that sulindac’s risks outweighed its benefits, then it could consider whether the warning—regardless of its adequacy—reduced those risks or increased those benefits to such an extent that it eliminated the unreasonable danger. In other words, the warning could operate only to Mutual’s benefit. Bartlett needed to prove that sulindac’s risks outweighed its benefits “despite its warning, not because of it.” Bartlett, 2010 WL 3303864, at *1, 2010 U.S. Dist. LEXIS 102603, at *4. This court also ruled on many other evidentiary and procedural issues in advance of trial, including nearly 50 challenges to expert witnesses and testimony, see Bartlett v. Mutual Pharm. Co., 2010 DNH 123, 742 F.Supp.2d 182, 186-87, 2010 WL 2889114, at *1, 2010 U.S. Dist. LEXIS 111959, at *3 (ruling that “[t]he parties’ experts have sufficient qualifications and a sufficient foundation to support most of their proffered opinions”), and nearly 50 motions in limine, see Bartlett v. Mut. Pharm. Co., 2010 DNH 125, 2010 WL 3156555 (document no. 278) (ruling on Bartlett’s limine motions); Bartlett v. Mut. Pharm. Co., 2010 DNH 131, 2010 WL 3092649, 2010 U.S. Dist. LEXIS 111259 (ruling on Mutual’s limine motions), as well as Mutual’s motion to bifurcate the trial into separate liability and damage phases, see Bartlett v. Mut. Pharm. Co., 2010 WL 3210724 (document no. 320) (denying the motion because bifurcation would result in duplication of evidence and other inefficiencies). Trial began in August 2010 and lasted nearly three weeks. Bartlett presented testimony from herself, her sister (Barbara Mourikas), two friends who were with her on the day she fell ill (Lynda Mailhot and Rebecca Padulo), eight doctors who treated her for various different injuries resulting from SJS/TEN (primary care physician Leo Lane, burn surgeons Nam Kim, Colleen Ryan, and John Schulz, eye surgeons Claes Dohlman and James Chodosh, pulmonologist Bijan Sadrnoori, and gynecologist Steven Pliskow), two Mutual employees (Robert Dettery and Andria Werynski), two retained expert witnesses who opined about sulindac’s risks and benefits (pharmacologist Randall Tackett and burn surgeon Roger Salisbury), and two retained experts who opined about Bartlett’s economic damages (economist Thomas Barocci and life care planner Carol Hyland). Mutual cross-examined Bartlett’s witnesses, but chose not to present any witnesses of its own (aside from designating additional testimony by certain unavailable fact witnesses whose testimony Bartlett presented by deposition). At the close of evidence, Mutual moved for judgment as a matter of law, see Fed.R.Civ.P. 50(a)(2), which this court orally denied. On the fourth day of deliberations, the jury returned a verdict in Bartlett’s favor, finding that she had proven her claim for strict liability (defective design) by a preponderance of the evidence and awarding her $21.06 million in damages, consisting of $1.25 million for past medical expenses (to which the parties had stipulated), $2,377 million for future medical expenses, $933,000 for lost wages, and $16.5 million for pain, suffering, and loss of enjoyment of life. See document no. 381. This court entered judgment in accordance with the verdict and the earlier summary judgment rulings. See document no. 389. Mutual then renewed its motion for judgment as a matter of law, see Fed. R.Civ.P. 50(b), arguing that Bartlett presented insufficient evidence to support her claim and that the claim is pre-empted by federal law. Mutual also moved, in the alternative, for a new trial, see Fed. R.Civ.P. 59, arguing that numerous errors at trial tainted the jury verdict and that the amount of damages was excessive. The execution of judgment has been stayed pending the resolution of those post-trial motions and any subsequent appeal. See Bartlett v. Mut. Pharm. Co., 2010 WL 4174591, 2010 U.S. Dist. LEXIS 114978 (document no. 406) (applying Fed. R.Civ.P. 62). This court will now analyze each of Mutual’s arguments in turn. III. Analysis A. Sufficiency of the evidence i. Risks outweighing benefits The first issue raised by Mutual’s Rule 50 motion is whether Bartlett presented sufficient evidence for a reasonable jury to find that sulindac’s risks outweighed its benefits. The New Hampshire Supreme Court has stated that, “barring a determination that the utility of the product completely outweighs the risk associated with its use or that the risk of harm is so remote as to be negligible,” the weighing of risks and benefits is a “question[ ] of fact to be decided by the jury.” Price v. BIC Corp., 142 N.H. 386, 390, 702 A.2d 330 (1997) (citing Thibault v. Sears, Roebuck & Co., 118 N.H. 802, 809, 395 A.2d 843 (1978)). As explained below, this court cannot make either of those risk-benefit determinations as a matter of law in light of the evidence that Bartlett presented. Mutual’s challenge to the sufficiency of that evidence is therefore rejected. As an initial matter, Mutual argues that Bartlett’s experts (Drs. Tackett and Salisbury) were not qualified to testify at all about sulindac’s risks and benefits, because neither works directly with sulindac and other NSAIDs. “It is not required,” however, “that experts be ‘blue-ribbon practitioners’ with optimal qualifications,” United States v. Vargas, 471 F.3d 255, 262 (1st Cir.2006), or that they have “an intimate level of familiarity with every component of a [product] as a prerequisite to offering expert testimony,” Crowe, 506 F.3d at 18. They need only be “qualified as an expert by knowledge, skill, experience, training, or education.” Fed.R.Evid. 702; see also Levin v. Dalva Bros., Inc., 459 F.3d 68, 78 (1st Cir.2006) (“Rule 702 has been interpreted liberally in favor of the admission of expert testimony.”). Both of Bartlett’s experts easily met that standard. Dr. Tackett has been a pharmacologist for more than 30 years and is a pharmacology professor at the University of Georgia. Dr. Salisbury has been a burn surgeon for more than 35 years and has treated more than 400 patients with SJS/TEN. Both have demonstrated familiarity with the medical literature on sulindac’s risks and benefits, as well as NSAIDs and SJS/TEN more generally. They were qualified to testify on those topics. See Bartlett, 742 F.Supp.2d at 198-99, 2010 WL 2889114, at *13, 2010 U.S. Dist. LEXIS 111959, at *36-38 (deeming Drs. Tackett and Salisbury qualified before trial); Lofton v. McNeil Consumer & Specialty Pharms., No. 05-cv1531, 2008 WL 4878066, at *9-10, 2008 U.S. Dist. LEXIS 94391, at *28-30 (N.D.Tex. July 25, 2008) (allowing them to testify in a similar case involving an NSAID that allegedly caused SJS/TEN, citing their “extensive experience”). Mutual also argues that Bartlett’s experts should have been prohibited from testifying about sulindac’s risks and benefits because their expert reports—like much of the early litigation—focused primarily on Bartlett’s failure-to-warn theory, not her defective design theory. See Fed. R.Civ.P. 26(a)(2)(B)(I) (requiring pre-trial disclosure of “all opinions that the witness will express”). But the reports were filled with opinions about sulindac’s risks and benefits, which were clearly relevant to the defective design theory as well. “The purpose of expert reports is to ... convey the substance of the expert’s opinion ... so that the opponent will be ready to rebut [and] cross examine.” Metavante Corp. v. Emigrant Sav. Bank, 619 F.3d 748, 762 (7th Cir.2010). Bartlett’s expert reports accomplished that purpose, as evidenced by Mutual’s “able cross-examination” of the experts at trial. Id. Mutual notes that Bartlett’s experts never opined that sulindac was “unreasonably dangerous,” which is the ultimate issue in a defective design case. That is true; this court prohibited them from using that particular phrase at trial because they had not used it in their expert reports. But they did expressly state in their reports, and testify at trial, that sulindac’s risks outweighed its benefits, which is what the phrase “unreasonably dangerous” means in this context. See Vautour, 147 N.H. at 154, 784 A.2d 1178. There is no requirement that experts utter the magic words “unreasonable danger” for a plaintiff to recover for defective design. Cf. Kelleher, 152 N.H. at 832, 891 A.2d 477 (rejecting “the defendant’s assertion that the plaintiff was required to use the exact phrase, ‘unreasonably dangerous,’ to adequately plead” a defective design claim). As for the opinion that sulindac’s risks outweighed its benefits, Mutual argues that it was merely a “passing reference, without support.” But Bartlett’s experts supported the opinion with a litany of specific facts, most of them drawn directly from the medical literature or published FDA analyses. They testified, for example, to the following: • Causation of SJS/TEN. Sulindac is one of many drugs, including nearly every NSAID and nearly every antibiotic, that can cause SJS/TEN. This causal link has been confirmed by positive re-challenges, i.e., cases where patients who had previously developed SJS/TEN after taking sulindac developed it again after re-administration of the drug. See, e.g., Glen D. Park et al., Serious adverse reactions associated with sulindac, 142 Archives of Internal Medicine 1292-94 (1982). • Background rate of SJS/TEN. The background rate of SJS associated with drug therapy is 1.2 to 6 per million prescriptions, and the background rate of TEN (the more serious form of the disease) is 0.4 to 1.2 per million prescriptions, according to FDA estimates. See Letter from Steven K. Galson, Director, FDA Center for Drug Evaluation & Research, to Dr. Salisbury, at 5 (June 22, 2006) (document no. 310-1) (citing medical literature). • Group risk of SJS/TEN. While no controlled study has measured its individual risk of SJS/TEN, sulindac is part of a group of NSAIDs, known as acetic acid NSAIDs, that has been shown to have a greater risk of SJS/TEN than another group, known as propionic acid NSAIDs, in a controlled study. See Maja Mockenhaupt et al., SJS and TEN: assessment of medication risks with emphasis on recently marketed dmgs; the EuroS-CAR-study, 128 Journal of Investigative Dermatology 35, 41 (2008). In addition, sulindac is one of the NSAIDs with longer half-lives, which are suspected of having a greater risk of SJS/TEN because they stay in the body longer. See, e.g., Pierre E. Wolkenstein et al., Drug-induced TEN, 16 Climes in Dermatology 399, 403 (1998). • Adverse event reports of SJS/TEN. From 1980 to 1997, the FDA’s adverse event reporting database—which collects spontaneous reports of drug side effects from doctors, manufacturers, patients, etc.—received 89 reports of SJS/TEN attributed to sulindac, more than the number of reports for any other NSAID on the market and all but four drugs of any kind. See Maja Mockenhaupt et al., The risk of SJS and TEN associated with NSAIDs: a multinational perspective, 30 Journal of Rheumatology 2234 (2003) (document no. 230-4). Through 2004, the number of SJS/TEN reports attributed to sulindac had increased to 134. In 39 of those cases, the patient died. According to FDA estimates, more than 90 percent of adverse events go unreported. • Reporting rate of SJS/TEN. Sulindac’s rate of SJS/TEN reports from 1980 to 1997, per million prescriptions, was the highest of any NSAID, according to an unpublished manuscript (document no. 230-2) prepared for the drug company Pharmacia by the authors of the Journal of Rheumatology article just mentioned (one of whom was Mutual’s own expert, dermatologist Robert Stern). • Risks other than SJS/TEN. According to a recent FDA analysis, there is no evidence that any one NSAID—including sulindac—is more or less risky than other NSAIDs with regard to various other known side effects, including gastrointestinal bleeding, renal toxicity, hepatic enzyme elevation, bronchospasm, fluid retention, and edema. See John K. Jenkins, Director, FDA Office of New Drugs, Analysis and recommendations for Agency action regarding NSAIDs and cardiovascular risk 12 (Apr. 6, 2005) (document no. 309-1). • Benefits. Sulindac has been approved by the FDA for treatment of acute painful shoulder and various arthritic conditions (acute gouty arthritis, rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis). It is the only NSAID approved to treat the first two conditions. Nevertheless, according to a recent FDA analysis, there is no evidence that any one NSAID—including sulindac—provides greater relief of pain and inflammation than other NSAIDs. See Jenkins, supra, at 2. • Risk/benefit profile. The FDA has recommended that five NSAIDs be removed from the market due, in part, to their risk of SJS/TEN as demonstrated by adverse event reports (sometimes fewer than 15). While sulindac has not been removed from the market, it has a similar “risk/benefit profile” to valdecoxib (known by the brand name Bextra), one of the removed NSAIDs, in that neither drug has a demonstrated advantage over other NSAIDs with regard to their benefits or various known risks other than SJS/TEN, see id. at 2, 12, both drugs had a higher reporting rate of SJS/TEN than other NSAIDs, see id. at 17, and sulindac had more reported deaths from SJS/TEN (39) than did Bextra (7), see id. • Safer alternative products. Two alternatives to sulindac, aspirin and acetaminophen (known by the brand name Tylenol), carry no risk of SJS/TEN, at least in adults, and are equally effective as sulindac, at least in treating conditions like shoulder pain (for which Bartlett took sulindac). While they carry some additional risks that sulindac does not (e.g., aspirin can cause Reye’s syndrome) and may not be equally effective in treating every condition that sulindac treats, they also provide additional benefits that sulindac does not. Overall, they are safer alternative products. Mutual faults Bartlett’s experts for focusing primarily on sulindac’s risk of SJS/ TEN and failing to consider all of its other risks and its benefits. As just mentioned, however, Bartlett’s experts (while acknowledging sulindac’s approved uses) testified broadly that there is no evidence that sulindac has any greater benefit than other NSAIDs, or any lesser risk of various known side effects other than SJS/TEN. They based that testimony on a recent FDA analysis, see Jenkins, supra, at 2, 12, which resulted from what the FDA called “a comprehensive review of the risks and benefits, including the risks of SJS and TEN, of all approved NSAID products,” Galson, supra, at 2, and which was admitted into evidence as a full exhibit. So their risk/benefit analysis was sufficiently comprehensive. Mutual argues that this court should have prohibited Bartlett’s experts from relying on the FDA’s analysis, in light of their testimony that the FDA has insufficient resources to monitor the safety of all drugs, which is how Bartlett’s experts attempted to downplay the FDA’s approval of sulindac. See Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 1202, 173 L.Ed.2d 51 (2009) (noting that “FDA has limited resources to monitor the 11,000 drugs on the market” and that, as discussed in Part III.B.i, infra, FDA approval does not preclude state tort liability). That was indeed a theoretical tension in Bartlett’s case, and one that Mutual highlighted for the jury during closing argument. But it went to the weight, not the admissibility, of the experts’ opinions. A reasonable jury could have agreed with Bartlett’s experts that the FDA was right about some things, but wrong about others. If Mutual had evidence to refute the FDA’s analysis, such as evidence that sulindac is more beneficial than other NSAIDs or that it has less risk of certain side effects other than SJS/TEN, then Mutual could have presented that evidence at trial in its own case (or, at the very least, confronted Bartlett’s experts with it). A plaintiff bringing a claim for defective design cannot be expected to sing the praises of the allegedly defective product, or to put the product in the best possible light. So far as this court can tell, Mutual chose not to present its own experts because it feared that they would actually strengthen, not weaken, Bartlett’s case. Next, Mutual argues that Bartlett presented insufficient evidence for the jury to evaluate sulindac’s risk of SJS/TEN. As just mentioned, however, Bartlett’s experts testified at length on that issue, opining that sulindac has been confirmed to cause SJS/TEN; that the background rate of SJS/TEN is as many as six cases per million prescriptions; that sulindac is part of two groups of NSAIDs (acetic acid NSAIDs and longer half-life NSAIDs) believed to have a higher risk of SJS/TEN; that the FDA received 133 reports of SJS/ TEN attributed to sulindac over the last 25 years; that 39 of those reported cases resulted in death; that sulindac had both a higher number, and a higher rate, of reported cases than any other NSAID from 1980 to 1997 (and the fifth-most of any drug); and that some alternatives to sulindac carry no risk of SJS/TEN. Mutual argues that this court should have prohibited Bartlett’s experts from relying on adverse event reports, since such reports are anecdotal, sometimes unverified or incomplete, and can be influenced by non-random factors. “To be sure, [both parties] agree that adverse event reports—whether published in safety databases or the medical literature—have significant limitations.” In re Neurontin Mktg., Sales Practices & Prods. Liab. Litig., 612 F.Supp.2d 116, 153 (D.Mass.2009) (Saris, J.). For precisely the reasons that Mutual cites, they “do not provide as much information as controlled epidemiological studies do.” Id. (quoting McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1254-54 (11th Cir.2005), and also citing In re Baycol Prods. Litig., 532 F.Supp.2d 1029, 1040 (D.Minn.2007), both of which excluded expert testimony based on adverse event reports). As in many cases involving rare side effects, however, no controlled study of sulindac’s SJS/TEN risk is currently available. Under such circumstances, “[c]ourts may, and often do, rely on ... adverse event data” to inform the analysis of a drug’s risks. Id. at 153 (citing In re PPA Prods. Liab. Litig., 289 F.Supp.2d 1230, 1242 (W.D.Wash.2003)); see also, e.g., In re Fosamax Prods. Liab. Litig., 645 F.Supp.2d 164, 200 (S.D.N.Y.2009) (noting that the admissibility of such data “may depend on case-specific circumstances,” and stressing the “rarity” of the disease and the “relatively high number” of reports as reasons for admitting it). Despite its limitations, such data has significant probative value and is “reasonably relied upon by experts in the [pharmacological] field in forming opinions and inferences.” Fed.R.Evid. 703. Indeed, Mutual’s own designated expert Dr. Stern (and his co-authors) expressly relied on adverse event data in their peer-reviewed Journal of Rheumatology article on “The risk of SJS/TEN associated with NSAIDs,” which served as the basis for much of Bartlett’s expert testimony on this issue. See, e.g., Mockenhaupt 2003, supra, at 2238 (“To identify NSAID[s] widely used in the U.S. ... that have risks of SJS and TEN comparable to those of piroxicam [which had a “high risk” in a controlled study], we compared spontaneous reporting rates for all NSAID[s],” per million prescriptions, and “identified four NSAID[s] ... with spontaneous reporting rates comparable to those of piroxicam: diflunisal, sulindac, oxaprozin, and etodolac.”) (emphasis added). The FDA also expressly relied on adverse event data in its recent risk/benefit analysis of NSAIDs. See, e.g., Jenkins, supra, at 17 (noting that the “reporting rate of [SJS/TEN] appears to be greater for Bextra than other” NSAIDs). This court is not prepared to deem it unreasonable, as a matter of law, for Bartlett’s experts to have done the same thing that a peer-reviewed medical journal, Mutual’s own expert, and the FDA have all done. See, e.g., Crowe, 506 F.3d at 18 (“Rule 703 was enacted in part ‘to bring the judicial practice into line with the practice of the experts themselves when not in court.’ ”) (quoting Fed.R.Evid. 703, advisory committee notes (1972)); Ramirez v. Debs-Elias, 407 F.3d 444, 449 (1st Cir.2005) (“scholarly literature is information reasonably relied upon by medical experts”). It is important to note, moreover, that Mutual extensively cross-examined Bartlett’s experts about the limitations of adverse event data, and this court also took a number of steps to prevent them from overstating its significance as a measure of a drug’s risk. The experts were required, for example, to use the phrase “reporting rate” in describing adverse event data, rather than “incidence rate,” “occurrence rate,” “rate” alone, or “relative risk.” This court also gave a strong cautionary instruction to the jury, both during the expert testimony and again in the final jury charge: You have heard testimony about the alleged number of adverse event reports of SJS/TEN associated with sulindac and other drugs, and about their alleged “reporting rates.” In the context of this trial, a “reporting rate” means the number of adverse event reports for a drug divided by the number of prescriptions for a drug. You should not confuse “reporting rate” with the rate at which SJS/TEN actually occurs with a drug. Those are two different concepts. You have not heard any testimony about the actual occurrence rate of SJS/TEN with sulindac individually, as compared with other individual drugs, except for those drugs that allegedly do not have any risk of SJS/TEN. Document no. 378, at 18. Mutual argues that, without any evidence of sulindac’s actual incidence rate of SJS/TEN, the jury had no reasonable basis to “quantify” the risk. But that assumes that the only way to quantify risk is through a controlled study of the individual drug (Bartlett’s experts did testify about a controlled study of acetic acid NSAIDs as a group, which found a higher risk of SJS/TEN), and hence that a plaintiff cannot prevail without such a study. It is easy to understand why Mutual would prefer such a requirement, since controlled studies can be hard for plaintiffs to come by, especially for side effects as rare as SJS/TEN. But this court is not persuaded that the New Hampshire Supreme Court would set the bar so high. Cf. Vautour, 147 N.H. at 157, 784 A.2d 1178 (allowing jury to make risk/benefit determination despite limitations in expert testimony). Bartlett’s experts quantified sulindac’s risk of SJS/TEN in other ways. They testified, for example, that the FDA received 133 reports of SJS/TEN attributed to sulindac over the past 25 years, 39 of which resulted in death, and that more than 90 percent of cases go unreported, according to FDA estimates. From that testimony, the jury reasonably could have inferred that sulindac probably caused more than a thousand cases of SJS/TEN, and hundreds of deaths, over the past 25 years (roughly 50 cases and 15 deaths per year). That is enough quantification to enable a risk/benefit analysis, even if the jury inferred a very high number of prescriptions for sulindac. While the jury certainly could have drawn other inferences from the data, or rejected some of the data for the reasons argued by Mutual, that was not the only rational approach permitted by the evidence. Next, Mutual argues that sulindac’s risk of SJS/TEN is simply too remote to result in liability for defective design. As support for that argument, Mutual invokes dicta from an old New Hampshire Supreme Court case that “in the absence of adequate warning a one-in-a-million risk of adverse reaction” to a drug is not “a sufficient basis on which to impose strict liability.” Thibault, 118 N.H. at 808, 395 A.2d 843 (citing Davis v. Wyeth Labs., Inc., 399 F.2d 121 (9th Cir.1968), a failure-to-warn case). As that quote suggests, however, Thibault actually made that comment in reference to failure-to-warn claims, not defective design claims. See also Price, 142 N.H. at 390, 702 A.2d 330 (citing Thibault’s comment in a defective design case, but with a “cf.” signal, meaning that the case supported a different but analogous proposition). The fact that a manufacturer need not have warned of a particular risk does not necessarily mean that the risk did not render its product unreasonably dangerous. But even accepting arguendo Mutual’s premise that a “one-in-a-million risk of adverse reaction” to a drug is never actionable under a defective design theory, and its further premise that the jury had no basis for concluding that sulindac’s SJS/ TEN risk was any greater than the background rate for all drugs, Mutual’s conclusion still does not follow: per the FDA, even the background rate of SJS/TEN is greater than one-in-a-million, and the top end of the range is six-in-a-million, or one in less than 175,000. (Mutual appears to be ignoring the SJS rate and looking solely at the rate for the more serious TEN, which is lower, but still exceeds one-in-a-million at the top end.) So even if the risk-benefit analysis were strictly a quantitative mathematical calculation, without any qualitative component involving the severity of the side effect, Mutual would not be entitled to judgment as a matter of law on that basis. Of course, the risk/benefit analysis is not just a mathematical calculation. Even with perfect information about all of sulindac’s risks and benefits, no mathematical formula could determine to a legal certainty how many cases of SJS/TEN, how many deaths, how many losses of sight, or how many severe skin burns is a reasonable price to pay for the relief of shoulder pain, arthritis, and other conditions that sulindac provides. It is, at bottom, a judgment call on which reasonable people could disagree. As the New Hampshire Supreme Court has explained, making those sorts of difficult risk/benefit judgments “is the very essence of the jury’s function.” Vautour, 147 N.H. at 157, 784 A.2d 1178; see also 2 Frumer & Friedman, supra, § 11.03[4][d], at 11-101 (“The determination of a product’s risks and benefits as a matter of law ... will rarely be granted in design defect cases if any of the elements is disputed.”). Again, under New Hampshire law, courts may override the jury’s risk/benefit judgment in only two circumstances: where “the risk of harm is so remote as to be negligible,” or where the “the utility of the product completely outweighs the risk.” Price, 142 N.H. at 390, 702 A.2d 330. Neither circumstance is present here. While certainly remote, sulindac’s risk of SJS/TEN cannot be considered “negligible,” particularly given the severity of the disease and the estimated number of cases and deaths. See Webster’s Third New International Dictionary 1514 (2002) (defining negligible to mean “of so little consequence as to require or deserve little or no attention: trifling”). And while reasonable people could certainly conclude that sulindac’s benefits outweigh its risks, the comparison is not so “completely” one-sided that no one could reasonably conclude otherwise. In sum, Mutual has not met the “stringent” standard for relief under Rule 50. Malone, 610 F.3d at 20. Viewing the evidence in the light most favorable to the verdict, this court concludes that Bartlett presented sufficient evidence for a reasonable jury to find that sulindac’s risks outweighed its benefits, making it an unreasonably dangerous product. Mutual has not shown any errors or defects in the admission of that evidence that would entitle it to relief under Rule 59 either. The evidence supporting the jury’s verdict was sufficiently reliable to be admitted into evidence, see, e.g., notes 8, 12, 16, and 19, supra, and was properly disclosed to Mutual before trial where required, see, e.g., notes 9 and 11, supra. Mutual has not suffered anything “tantamount to a miscarriage of justice.” Crowe, 506 F.3d at 19. ii. Safer alternative design The next issue raised by Mutual’s Rule 50 motion is whether, in addition to proving that sulindac’s risks outweighed its benefits, Bartlett needed to prove that sulindac had some other “defect” in design. Mutual argues that proof of some other “defect” is required by Buckingham, 142 N.H. at 822, 713 A.2d 381, and that Bartlett could not satisfy that requirement because sulindac is incapable of being designed any other way. This court has already analyzed that argument at length in two prior orders. See Bartlett, 2010 WL 3239247, 2010 U.S. Dist. LEXIS 77902; Bartlett, 2010 WL 3303634, 2010 U.S. Dist. LEXIS 84924. As explained there, while Buckingham arguably supports Mutual’s position, two more recent cases from the New Hampshire Supreme Court make clear that “a product is defective as designed if the magnitude of the danger outweighs the utility of the product,” Vautour, 147 N.H. at 154, 784 A.2d 1178, and that “the plaintiff is not required to present evidence of a safer alternative design,” Kelleher, 152 N.H. at 831, 891 A.2d 477. As a federal court exercising diversity jurisdiction over a state-law action, this court “must apply the most recent statement of state law by the state’s highest court.” Vitkus v. Beatrice Co., 127 F.3d 936, 941-42 (10th Cir.1997); see also, e.g., Brunner v. Hampson, 441 F.3d 457, 465 (6th Cir.2006); Lamarque v. Mass. Indem. & Life Ins. Co., 794 F.2d 194, 196 (5th Cir.1986); Middle Atl. Utils. Co. v. S.M.W. Dev. Corp., 392 F.2d 380, 384 (2d Cir.1968); cf. Smith v. F.W. Morse & Co., 76 F.3d 413, 429 (1st Cir.1996) (following the more “recently decided” New Hampshire Supreme Court case that “speaks directly to the question,” rather than an older opinion). Thus, even assuming arguendo that the earlier Buckingham decision conflicts with Vautour and Kelleher, this court must follow the express language of the more recent cases. Mutual, taking its rhetoric to new heights (or perhaps new lows), describes this court’s reading of Vautour and Kelleher as “bizarre” and “tortured.” But Mutual still has not been able to explain how, under its reading of those cases, a plaintiff could prove a “defect” without having to prove some safer alternative design. Mutual’s position appears to be that, as stated at the final pre-trial conference, “there has to be an alternative [design]; you just don’t have to prove up the alternative.” Document no. 302, at 46. Proof, though, is all that counts in determining a plaintiffs prima facie burden. And Vautour expressly states that “[t]he plaintiffs’ burden was to present evidence regarding the risk-utility factors; they did not have a burden of proving a safer, alternative design.” 147 N.H. at 154, 784 A.2d 1178; see also id. at 157, 784 A.2d 1178 (“plaintiffs presented sufficient evidence that the [product] was unreasonably dangerous pursuant to the risk-utility balancing test”). As discussed in Part III.A.i, supra, Bartlett satisfied that burden. Mutual also describes this court’s reading of Vautour and Kelleher as an act of “social engineering” and predicts that, if plaintiffs can recover for defective design even where a product is unavoidably unsafe and has an adequate warning, no “prudent manufacturer would sell any product in New Hampshire.” Mutual seems to have forgotten, however, that this court ruled that Mutual would “avoid liability for defective design if it can prove, as an affirmative defense, that sulindac is unavoidably unsafe and had an adequate safety warning.” Bartlett, 731 F.Supp.2d at 151. That is the very limitation for which Mutual has been advocating (albeit in the form of a defense, not a prima facie burden). It was Mutual, not this court, that “engineered” a broader scope of liability by voluntarily withdrawing that defense on the eve of trial. See document no. 332. Presumably, not every “prudent manufacturer” will choose to follow the same strategy. Recognizing, apparently, that its withdrawal of the “comment k” defense undermines its position, Mutual argues in its Rule 59 motion that it withdrew the defense only because this court allegedly “confirmed” that doing so would render inadmissible any evidence regarding sulindac’s warning, and that this court went back on that promise at trial, in violation of Mutual’s due process rights. But that is not what happened. This court expressly reserved judgment on that evidentiary issue, both in its limine rulings, see Bartlett, 2010 WL 3092649, at *5 n. 5, 2010 U.S. Dist. LEXIS 111259, at *14-15, and at the final pretrial conference, during which Mutual first suggested that it might withdraw the defense (and another defense, known as “state of the art,” see N.H.Rev.Stat. § 507:8-g), and Bartlett responded that warning-related evidence could be presented at trial anyway. See document no. 301, at 98-99; document no. 302, at 30-32, 52-54. After the final pre-trial conference, this court expressly ordered that “[i]f Mutual withdraws the [state of the art] defense, then [its] procedures [for monitoring sulindac’s risks] will no longer be relevant and thus will not be presented to the jury.” Bartlett v. Mut. Pharm. Co., 2010 WL 3219357, at *2 n. 5, 2010 U.S. Dist. LEXIS 92403, at *5 (document no. 329). This court never made any such statement with regard to the “comment k” defense and warning-related evidence. A few days before trial, Mutual informed the court during a conference call that it would decide “by the end of the day with regard to both [its] state of the art and unavoidably unsafe [defenses] whether we’re withdrawing those defenses so that what is left is only no label issues and only the issue about unreasonably dangerous.” Document no. 353, at 37. This court replied with a one-word “understood,” id., and moved on to other pressing topics. Mutual announced its withdrawal of both defenses later that day, see document no. 332, and Bartlett responded by immediately seeking a pre-trial ruling on the admissibility of warning-related evidence, see document no. 339. Mutual quickly filed two briefs arguing against the admission of such evidence, see documents no. 341, 342, and this court held another conference call with the parties devoted specifically to that issue. Not once did Mutual suggest, either in its briefs or during the conference call, that it believed this court (apparently by saying the word “understood” on the earlier conference call) had already promised to exclude warning-related evidence if Mutual withdrew its “comment k” defense. That fact alone belies Mutual’s argument that it withdrew its “comment k” defense based on this court’s ruling that doing so would eliminate any warning-related evidence from trial. On the day before trial, this court ruled that warning-related evidence would be admissible, to a limited extent, with regard to the issue of whether sulindac was unreasonably dangerous. See Bartlett, 2010 WL 3303864, 2010 U.S. Dist. LEXIS 102603. Thus, while Mutual was indeed left with “only the issue about unreasonably dangerous” (to use its phrase from the earlier conference call), the warning still had some potential relevance to that issue. The first footnote of that same order explained that “Mutual recently withdrew its ‘comment k’ defense,” and that “[u]ntil that defense was withdrawn, there was no dispute that evidence of the warning’s adequacy could be presented at trial, which is why this issue has not been resolved until now.” Id., 2010 WL 3303864, at *1 n. 1, 2010 U.S. Dist. LEXIS 102603, at *3-4 (citing Bartlett, 2010 WL 3092649, at *5 n. 5, 2010 U.S. Dist. LEXIS 111259, at *14-15). Mutual never moved for reconsideration of that ruling, never disputed the order’s account of the procedural history (until its Rule 59 motion), and even more importantly, never sought to reinstate its “comment k” defense on the ground that the withdrawal had been contingent on the exclusion of warning-related evidence (even throughout the trial, as Bartlett introduced the very evidence that Mutual now says it thought was inadmissible). Indeed, Mutual did not even ask this court to instruct the jury on the “comment k” defense. By failing to raise the issue in a timely manner, when this court easily could have afforded relief, Mutual waived its due process argument. See, e.g., United States v. Carpenter, 494 F.3d 13, 30 (1st Cir.2007) (“the raise-or-waive rule ... precludes a party from making a tactical decision to refrain from objecting, and subsequently, should the case turn sour, assigning error,” without having “afford[ed the trial court] an opportunity to correct the problem”). Even if Mutual’s argument not been waived, it would be difficult for this court to view the argument as anything more than an unfounded, post hoc attempt to shirk responsibility for a voluntary strategic decision. Mutual has not shown any unfairness whatsoever relating to its withdrawal of the “comment k” defense, and certainly is not entitled to a new trial on that basis. Nor, in light of that withdrawal, is Mutual entitled to judgment as a matter of law on the ground that sulindac is unavoidably unsafe, which (together with the adequacy of sulindac’s warning) is an issue that Mutual itself chose to remove from the ease. iii. Safer alternative product The next issue raised by Mutual’s Rule 50 motion is whether Bartlett needed to present evidence of a safer alternative product (as opposed to a safer alternative design). Mutual argues that such proof is also required under New Hampshire law and that Bartlett failed to provide it. But Mutual has not cited, nor can this court find, any authority for such a requirement. Cf. Heath v. Sears, Roebuck & Co., 123 N.H. 512, 530, 464 A.2d 288 (1983) (noting that “mere compliance with current industry practice” is not “a defense to [to defective design] liability” under New Hampshire law). Moreover, Mutual’s argument is undermined by the fact that it objected—successfully—to this court’s proposed instruction that the jury, in weighing sulindac’s risks and benefits, could “consider whether there were alternative products on the market that provided the same benefits as sulindac, but with less risk.” Mutual argued, at the time, that the proposed instruction was inconsistent with a later instruction, included in the final jury charge, that “a manufacturer is not obliged to design the safest possible product, ... or one as safe as others make, so long as the design it has adopted is not unreasonably dangerous.” Document no. 378, at 15-16 (quoting Thibault, 118 N.H. at 808, 395 A.2d 843). But there was no inconsistency: a jury can consider a factor without it being dispositive. That is clearly the role that a safer alternative design plays under New Hampshire case law, see Vautour, 147 N.H. at 156, 784 A.2d 1178 (“proof of an alternative design is ... neither a controlling factor nor an essential element”), and there is no reason to believe that a safer alternative product would be treated any differently. While not required to do so, Bartlett presented considerable evidence for the jury to consider with regard to safer alternative products. See Part III.A.i, supra. For example, her experts testified that sulindac is part of two NSAID groups— acetic acid NSAIDs and longer half-life NSAIDs—believed to have a greater risk of SJS/TEN than other NSAIDs, with no greater benefits (aside from the “longer benefit” associated with having a longer half-life). In addition, they testified that aspirin and Tylenol, while perhaps not perfect alternatives to sulindac, have no risk of SJS/TEN, are equally effective in treating conditions like shoulder pain (for which Bartlett took sulindac), have additional benefits that sulindac does not have, and are safer alternative products overall. Mutual argues that, to be considered a safer alternative, a product must be equally effective and less dangerous in all respects, not just overall. But in Vautour, where the plaintiffs’ expert testified that “under similar circumstances [to those encountered by the plaintiff], machines with [an alternative] design would be, overall, less dangerous,” the New Hampshire Supreme Court concluded that it “was up to the jury to assess the weight to be given this testimony.” 147 N.H. at 157, 784 A.2d 1178 (emphases added). Again, there is no reason to believe that safer alternative products would be treated any differently from safer alternative designs. So it was up to the jury, in assessing sulindae’s risks and benefits, to determine how much weight (if any) to give Bartlett’s evidence regarding safer alternative products. iv. Causation The next issue raised by Mutual’s Rule 50 motion is whether Bartlett presented sufficient evidence of causation. See, e.g., Vautour, 147 N.H. at 154, 784 A.2d 1178 (requiring proof that the product’s defective “condition caused injury to the user”). Mutual argues that Bartlett failed to do so, because she presented “no evidence whatsoever that any alternative design would have avoided [her] injury.” As already explained, however, the New Hampshire Supreme Court has expressly ruled that “the plaintiff is not required to present evidence of a safer alternative design.” Kelleher, 152 N.H. at 831, 891 A.2d 477. By the same token, a plaintiff is not required to prove that the alternative design would have avoided her injuries. See Vautour, 147 N.H. at 153, 784 A.2d 1178 (ruling that plaintiffs presented trialworthy claim even though their “expert failed to offer any testimony regarding ... how his proposed alternative design would prevent the type of injuries suffered”). Mutual also argues that, since this court allowed the jury to consider whether sulindac’s warning avoided an otherwise unreasonable danger, see Bartlett, 2010 WL 3303864, at *4, 2010 U.S. Dist. LEXIS 102603, at *11 (citing Vautour, 147 N.H. at 154, 784 A.2d 1178), there was no causation because Bartlett’s doctor never read that warning. But Mutual never “distinctly articulated” that argument in its close-of-evidence motion for a directed verdict under Rule 50(a), so it cannot be raised now. Parker v. Gerrish, 547 F.3d 1, 12 (1st Cir.2008) (explaining that a Rule 50(b) motion “is bounded by the movant’s earlier Rule 50(a) motion”). Indeed, this court cannot find any warning-related arguments that Mutual “distinctly articulated” in its Rule 50(a) motion and then renewed in its Rule 50(b) motion. So for Rule 50 purposes, at least, sulindac’s warning is no longer at issue. Moreover, even if properly raised, Mutual’s warning-related causation argument would fail on the merits. The warning was not sulindac’s defective condition; the unreasonable danger was. See document no. 378, at 16 (instructing the jury that it could consider the warning only if it determined, first, that sulindac was unreasonably dangerous, and even then, only to determine whether the warning avoided the unreasonable danger); Bartlett, 2010 WL 3303864, 2010 U.S. Dist. LEXIS 102603. The fact that Bartlett’s doctor never read a warning that, in the jury’s view, did not eliminate sulindac’s unreasonable danger, was of no consequence. The chain of causation on a defective design claim does not run through the warning. See, e.g., Vautour, 147 N.H. at 154, 784 A.2d 1178 (requiring only proof that the defective “condition caused injury to the user”). Mutual argues, finally, that “unreasonable danger does not cause an injury.” Again, however, Mutual never “distinctly articulated” that argument in its Rule 50(a) motion, so it cannot be raised now under Rule 50(b). Parker, 547 F.3d at 12. Moreover, even if properly raised, the argument would fail on the merits. What made sulindae unreasonably dangerous, according to Bartlett, was “its inherent propensity to cause SJS/TEN.” That was the (sole) theory that Bartlett presented to the jury, both in her opening statement and her closing argument (using the quoted language both times). The evidence was overwhelming, and essentially uncontested, that Bartlett suffered SJS/TEN as a side effect of sulindae. So there was sufficient evidence for the jury to find causation. B. Federal pre-emption The other issue raised by Mutual’s Rule 50 motion, in addition to the sufficiency of the evidence, is federal preemption. “A fundamental tenet of our federalist system is that constitutionally enacted federal law is supreme to state law. See U.S. Const. art. VI cl. 2. As a result, federal law sometimes pre-empts state law either expressly or by implication.” N.H. Motor Tramp. Ass’n v. Rowe, 448 F.3d 66, 74 (1st Cir.2006), aff'd, 552 U.S. 364, 128 S.Ct. 989, 169 L.Ed.2d 933 (2008). Federal “preemption is an affirmative defense upon which [the] defendant bears the burden of proof.” Cambridge Literary Props., Ltd. v. W. Goebel Porzellanfabrik G.m.b.H. & Co., 510 F.3d 77, 102 (1st Cir.2007); see also Wyeth, 129 S.Ct. at 1193 (characterizing a manufacturer’s argument that federal drug law pre-empted the plaintiffs claims as a defense). Here, Mutual has made essentially four different pre-emption arguments. This court will address each of them in turn. i. “Second-guessing” the FDA First, Mutual argues that federal law (specifically, the FDCA and related FDA regulations) impliedly pre-empts any state-law tort claim that requires the jury to “second-guess” the FDA’s risk/benefit analysis of a drug, because such claims “stand[ ] as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Good v. Altria Group, Inc., 501 F.3d 29, 47 (1st Cir.2007), aff'd, 555 U.S. 70, 129 S.Ct. 538, 172 L.Ed.2d 398 (2008) (describing the doctrine of obstacle pre-emption). As support for that argument, Mutual relies on Geier v. American Honda Motor Co., 529 U.S. 861, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000), where the Supreme Court held that a federal regulation that called for a gradual phase-in of airbags in cars pre-empted state-law tort claims based on a manufacturer’s failure to install airbags earlier, because such claims presented an obstacle to achieving Congress’s objectives, which included winning consumer acceptance of airbags and spurring further technological innovation during the phase-in period. This case, however, has very little (if anything) in common with Geier. It has much more in common with Wyeth, 129 S.Ct. at 1187, a more recent case where a drug manufacturer argued—much like Mutual does here—that “because the FDCA requires the FDA to determine that a drug is safe and effective under the conditions set forth in its labeling, the agency must be presumed to have performed a precise balancing of risks and benefits and to have established a specific labeling standard that leaves no room for different state-law judgments.” Id at 1200. The Supreme Court rejected that argument, concluding that the regulatory framework applicable to prescription drugs is “quite different” from the one in Geier and that “the FDA long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation.” Id at 1202-03. Wyeth is arguably not directly controlling here, because it involved a failure-to-warn claim, not a defective design claim. But this court cannot see, nor has Mutual articulated, any reason why Wyeth’s logic would not extend to this closely