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 liability (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., 2010 DNH 112, 731 F.Supp.2d 135 (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
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, 2010 WL 2765358, at *10. 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.
"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).
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.
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, 78 U.S.L.W. 3745 (U.S. Dec. 10, 2010) (No. 09-1501); Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009), cert. granted, 78 U.S.L.W. 3522 (U.S. Dec. 10, 2010) (No. 09-993).
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, 2010 WL 2765358, at *3-4. 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, 2010 WL 2765358, at *5-8.
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 and 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
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, 2010 WL 2765358, at *10; 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))
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, 187, 2010 WL 2889114, at *1 (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
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.
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 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
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.
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:
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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.
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.
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)
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."
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.
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).
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.
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.
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
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."
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,
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,
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 case.
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.
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,
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."
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.
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 sulindac 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 other issue raised by Mutual's Rule 50 motion, in addition to the sufficiency of the evidence, is federal pre-emption. "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 Transp. 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 "pre-emption 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 plaintiff's claims as a defense). Here, Mutual has made essentially four different pre-emption arguments. This court will address each of them in turn.
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."
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 analogous context. Cf. Wimbush v. Wyeth, 619 F.3d 632, 645 (6th Cir.2010) (concluding that Wyeth's "rationale extends beyond the realm of failure-to-warn claims to apply to all pre-approval state law claims," including, in that case, a claim of negligence in bringing an FDA-approved drug to the market). Mutual has not cited any cases, before or since Wyeth, that interpreted federal law as prohibiting juries from deeming an FDA-approved drug to be more risky than beneficial. See Tobin v. Astra Pharm. Prods., Inc., 993 F.2d 528, 537 (6th Cir.), cert. denied, 510 U.S. 914, 114 S.Ct. 304, 126 L.Ed.2d 252 (1993) ("reject[ing] the argument that FDA approval pre-empts state product liability claims based on design defect," and noting that the "great majority" of courts had done the same
Relatedly, Mutual argues in its Rule 59 motion that this court violated due process by allowing Bartlett to "attack"
Second, Mutual argues that federal law (again, the FDCA and related FDA regulations) prohibited manufacturers from unilaterally changing the design of a generic drug, thus making "compliance with both state and federal law ... impossible." Good, 501 F.3d at 47 (describing the doctrine of impossibility pre-emption). As already explained, however, Mutual was not held liable for failing to change sulindac's design; it was held liable for selling an unreasonably dangerous product, with greater risks than benefits. Federal law did not require Mutual to sell sulindac. Nor, for that matter, did state law require Mutual to stop selling it, or to redesign it. See Bartlett, 2010 WL 3092649, at *8, 2010 U.S. Dist. LEXIS 111259, at *24 ("what strict products liability requires is that manufacturers compensate consumers for the damage caused by unreasonably dangerous products, not necessarily that they remove such products from the market" or "retrofit" them) (citing 5 Frumer & Friedman, supra, § 57.01[4], at 57-9). So it was not "impossible" for Mutual to comply with both federal and state law. Cf. Barnett Bank of Marion County, N.A. v. Nelson, 517 U.S. 25, 31, 116 S.Ct. 1103, 134 L.Ed.2d 237 (1996) (explaining that impossibility pre-emption arises "if the federal law said, `you must sell insurance,' while the state law said, `you may not'").
Third, Mutual attempts in its reply brief on its Rule 50 motion to raise the pre-emption argument that it advanced unsuccessfully earlier in this case: that federal law (again, the FDCA and related FDA regulations) prohibited manufacturers from unilaterally changing the warning for a generic drug, thus making it impossible for Mutual to comply with both federal and state law. See Bartlett, 659 F.Supp.2d at 279 (concluding that federal law allowed such changes and therefore did not pre-empt Bartlett's claims); accord Demahy, 593 F.3d at 428; Mensing, 588 F.3d at 603. Mutual failed, however, to raise that warning-related pre-emption argument in its opening brief in support of either of its post-trial motions. The argument is therefore waived. See, e.g., Doe v. Friendfinder Network, Inc., 540 F.Supp.2d 288, 303 n. 16 (D.N.H.2008); L.R. 7.1(e)(1) (reply is "restricted to rebuttal of factual and legal arguments raised in the objection").
Moreover, even if it were neither waived nor moot, this court would reject Mutual's argument on the merits, for the reasons explained at length in its earlier opinion. See Bartlett, 659 F.Supp.2d at 279. Mutual argues that a recent amicus brief filed by the United States Solicitor General in Mensing calls this court's reasoning into question. See Brief of the United States as Amicus Curiae, 2010 WL 4339894, at *13, Pliva, Inc. v. Mensing, No. 09-993 (U.S. Nov. 2, 2010) (stating, albeit with limited discussion, that the manufacturer of a generic drug "may not unilaterally change its approved labeling"). But the Solicitor General's view is not dispositive. See Wyeth, 129 S.Ct. at 1201-04 (disagreeing with Solicitor General's view on a similar issue). This court still finds the reasoning in its earlier opinion— and later adopted in Demahy, 593 F.3d at 440—to be more persuasive.
Finally, in what amounts to a fourth pre-emption argument, Mutual argues in its Rule 59 motion that this court erred by allowing the jury, in determining whether sulindac's warning avoided an otherwise unreasonable danger, to consider whether the warning complied with FDA labeling requirements, because only the federal government has authority to enforce those requirements. See 21 U.S.C. § 337(a) ("all such proceedings for the enforcement" [of the FDCA] "shall be by and in the name of the United States"). As support for that proposition, Mutual relies on Buckman v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), where the Supreme Court held that state-law claims for fraud-on-the-FDA were impliedly pre-empted by the FDCA, in part because they would interfere with the FDA's statutory power to enforce its own disclosure requirements. Id. at 349, 121 S.Ct. 1012.
Buckman pre-emption, however, applies where a state-law claim arises "solely from the violation of FDCA requirements." Id.
Mutual has not cited any authority for extending Buckman pre-emption to this very different context. Indeed, there is a split of authority regarding whether Buckman pre-emption even extends to negligence claims where FDA regulations establish a per se standard of care. See Bartlett, 2010 WL 2765358, at * 13-14, 2010 U.S. Dist. LEXIS 69825, at *42 (citing cases on both sides of that issue). This case is far removed even from that. Moreover, even assuming dubitante that this court erred by instructing the jury on the FDA's labeling requirements, Mutual has not shown that doing so was "tantamount to a miscarriage of justice." Crowe, 506 F.3d at 19. Mutual made the FDA's approval of sulindac's warning a point of emphasis throughout the trial. It was not unjust for the jury to be told what the FDA's standards for approval were and to be able to consider them in evaluating the warning.
Having determined that Bartlett presented sufficient evidence to support her claim and that the claim is not pre-empted by federal law, this court will now turn to the remaining issues raised by Mutual's Rule 59 motion. The first such issue relates to this court's conduct. Mutual argues that a new trial is necessary because "the proceedings were not being conducted in an impartial fashion," but rather in such a way as to favor Bartlett and disfavor Mutual. As support for that argument, Mutual points to a handful of comments and actions by this court that, in its view, suggest judicial bias. As explained below, however, Mutual has taken those comments and actions out of context, or otherwise misconstrued them. This court sincerely meant what it said in the final jury charge: that it "is neutral and impartial in this matter and does not take sides." Document no. 378, at 32.
It is important, in considering Mutual's specific allegations of bias, to keep in mind the bigger picture. See, e.g., United States v. DeCologero, 530 F.3d 36, 56 (1st Cir.2008) ("Charges of partiality should be judged not on an isolated comment or two, but on the record as a whole."). This is a case where the court granted summary judgment to Mutual on nearly all of Bartlett's claims, one of them sua sponte. See Bartlett, 731 F.Supp.2d 135, 2010 WL 2765358, 2010 U.S. Dist. LEXIS 69825; Bartlett, 2010 WL 3659789, 2010 U.S. Dist. LEXIS 96711. Moreover, this court kept a tight rein on Bartlett's counsel throughout the trial, as described in Part D, infra. It is understandable, then, that Bartlett's counsel regard Mutual's judicial bias argument as "totally contrary to the plaintiff's experience during the entirety of this case
Moreover, it should be noted that Mutual's purported examples of judicial bias— culled from a nearly three-year litigation requiring hundreds of pre-trial rulings, and culminating in a three-week trial— come nowhere near the kind of conduct that our court of appeals has deemed insufficient to demonstrate judicial bias or require a new trial. See United States v. Rodriguez-Rivera, 473 F.3d 21, 28 (1st Cir.2007) (collecting cases where "stern[ ] rebukes of counsel or litigants [were] insufficient to demonstrate judicial bias," including trial judges' calling plaintiff "an absolute and incorrigible liar," referring to defense counsel's cross-examination as "very devious," and warning counsel he was being reported for violating the rules of professional conduct).
First, Mutual points to a ruling that this court made on a motion to strike filed by Bartlett, before Mutual had filed its sur-reply.
Shortly after this court's order, Mutual sought leave to file a sur-reply. While not required to accept a sur-reply on a non-dispositive motion, see L.R. 7.1(e)(3) ("leave to file a surreply will only be granted under extraordinary circumstances"), this court nevertheless granted Mutual's request and then issued another order— longer than the first—analyzing and rejecting the arguments raised in Mutual's sur-reply. See Bartlett v. Mut. Pharm. Co., 2010 WL 2990824 (document no. 272). This court gave the sur-reply full consideration, and did so with an open mind. Mutual may have disliked the result, but neither the result nor the process leading up to it reflects judicial bias. See also, e.g., Bartlett, 2010 WL 3303634, 2010 U.S. Dist. LEXIS 84924 (giving full consideration to Mutual's motion to reconsider the denial of an earlier motion to reconsider).
Next, Mutual points to this court's statement, made during a discovery-related hearing in October 2009, that Mutual is a "giant corporation" represented by "experienced counsel" from a "huge law firm." It is important to put those statements in their proper context. The issue before the court during that hearing was whether to sanction Mutual under Fed.R.Civ.P. 37(c)(1) for failing to timely produce certain FDA filings that Bartlett had specifically requested in discovery. See Bartlett v. Mut. Pharm. Co., 2009 DNH 166, 2009 WL 3614987, 2009 U.S. Dist. LEXIS 102494 (imposing some, but not all, of the sanctions Bartlett sought); but see document no. 125 (disallowing the monetary part of the sanctions after Bartlett failed to timely submit an itemized bill).
Document no. 99, at 46-47.
As that context makes clear, this court was not denigrating Mutual as a "giant corporation with [a] huge law firm;" to the contrary, it was acknowledging that such characterizations can be tiresome. Nevertheless, this court was expressing skepticism about Mutual's suggested analogy between its failure to produce its FDA filings, which "are standard fare for discovery in pharmaceutical litigation of this sort," Bartlett, 2009 WL 3614987, at *4, 2009 U.S. Dist. LEXIS 102494, at *12, and Bartlett's failure, as a blind plaintiff, to locate certain documents in her home and produce them. Whatever one may think of that analogy and this court's response to it, neither had any bearing on the sanctions ruling (which was based on Mutual's discovery error, not how it compared with Bartlett's alleged error) or any other ruling in this case.
Next, Mutual points to this court's comment, made during a trial conference conducted outside the presence of the jury, that "I want you to prove your case if you can." Mutual interprets that statement to mean that this court wanted Bartlett to prevail on the merits. But that is not at all what the court was saying, as the context again makes clear. The court was in the process of explaining to Bartlett that one of the opinions given by her expert Dr. Tackett (regarding sulindac's risk of liver toxicity) had not been properly disclosed in his expert report and that the court would be instructing the jury to disregard that testimony. In other words, the court was in the process of granting relief requested by Mutual.
Before granting that relief, this court asked Bartlett if she could identify "anything remotely representing [a disclosure of Dr. Tackett's opinion] to try to give you the benefit of the doubt because you are the plaintiff and I want you to prove your case if you can—I want you to be able to prove your case without barriers from me." This court did not mean, by that statement, that it wanted Bartlett to prevail over Mutual in the end. Rather, this court meant only that it wanted Bartlett to be able to present her case without any artificial barriers from the court—provided she stayed within the confines of the Federal Rules of Evidence and Civil Procedure. Perhaps, in retrospect, the point could have been better worded, but it was not reflective of judicial bias.
Next, Mutual complains that this court, outside the presence of the jury, referred
Next, Mutual points to a few occasions during trial when this court rephrased questions by Bartlett's counsel that were leading or lacking in foundation. But this court did not intervene on those occasions out of favor for Bartlett; it did so to fulfill its responsibility to "exercise reasonable control over the mode ... of interrogating witnesses and presenting evidence so as to (1) make the interrogation and presentation effective for the ascertainment of the truth," and "(2) avoid needless consumption of time." Fed.R.Evid. 611(a); see also Nat'l R.R. Passenger Corp. v. Certain Temporary Easements, 357 F.3d 36, 42 (1st Cir.2004) ("Decisions regarding the mode ... of witness questioning lie within the district court's broad discretion").
Contrary to what Mutual suggests, this court's involvement in questioning was quite minimal; it did not "advantage or disadvantage a party unfairly," or indeed at all. United States v. Angulo-Hernandez, 565 F.3d 2, 10 (1st Cir.2009) (concluding that even a "court's rather frequent questioning and commentary" did not cross the line, where the court's intent was "to clarify testimony, respond to defense counsels' objections, ... and expedite the trial, all legitimate purposes"); cf. also Rodriguez-Rivera, 473 F.3d at 27-28 (similar); Raviart v. Yates, No. 03-0164, 2007 WL 2505575, *14, 2007 U.S. Dist. LEXIS 64712, at *38 (E.D.Cal. Aug. 31, 2007) (concluding that "the trial judge's involvement in the questioning of witnesses did not bespeak a bias in favor of the prosecution or otherwise render petitioner's trial fundamentally unfair").
Finally, Mutual argues that this court gave at least an appearance of partiality by blowing its nose and wiping its eyes during some emotional testimony by Bartlett's sister. But this court specifically addressed that issue with the jury (after Mutual raised concerns the next morning), explaining that "as a matter of fact I did not have an emotional reaction to that testimony. I was merely blowing my nose and dealing with a little allergic, itchy eye." Many of the jurors nodded in understanding. This court further instructed the jury that even if someone observing the trial were to have an emotional reaction to the evidence presented, it would not have "any bearing upon this case" and "wouldn't be something you should consider one way or the other." Those frank instructions cured any possible prejudice to Mutual. See, e.g., Rodriguez-Rivera, 473 F.3d at 28-29 ("such a charge usually mitigates any perceived partiality from the bench").
The next issue raised by Mutual's Rule 59 motion relates to the conduct of Bartlett's counsel. Mutual argues that a new trial is necessary because, from voir dire to closing argument, Bartlett's counsel "engaged in conduct designed to improperly
As explained below, there is no question that Bartlett's counsel made this court's job at trial more difficult than it needed to be, repeatedly testing the limits of this court's rulings (not to mention its patience). Anticipating just such an approach, however, this court kept a tight rein on Bartlett's counsel throughout the trial, imposing various restrictions to prevent misconduct, stopping counsel whenever they pushed too far (sometimes in response to Mutual's objections, but often sua sponte), giving curative instructions or other relief where appropriate (again, often sua sponte), and even reprimanding counsel in front of the jury a few times. As a result, whether or not counsel's conduct was "designed to improperly inflame and influence the jury," this court is confident that it did not have that effect.
First, Mutual argues that Bartlett's counsel improperly asked prospective jurors, during attorney-conducted voir dire, whether they would be unable to award damages greater than $20 million. But this court sustained Mutual's objection to that question and prohibited Bartlett's counsel from using specific dollar figures from that point forward. Bartlett had expressly disclosed before trial that she intended to ask such questions and, indeed, argued that she was entitled to do so. See document no. 259, at 3 (citing Geehan v. Monahan, 382 F.2d 111, 115 (7th Cir. 1967)). So if Mutual wanted to prevent the questions from being asked at all, it should have filed a specific objection before trial, rather than merely objecting in general to Bartlett's request for attorney-conducted voir dire, and then waiting to object to specific questions after they had already been asked.
In any event, this court is not persuaded that the limited questioning about a specific damage figure caused any prejudice to Mutual, especially in light of this court's immediate intercession.
Next, Mutual argues that Bartlett's counsel misused two demonstrative aids: a visual presenter known as an "Elmo," on which Bartlett's counsel allegedly left exhibits for longer than necessary, and an easel, on which Bartlett allegedly summarized evidence in a misleading fashion. But this court, after noticing some initial misuse of those aids, severely restricted Bartlett's counsel in the use of both (in addition to correcting, by way of a contemporaneous instruction, the misleading information on the easel). Specifically, this court restricted Bartlett's counsel to publishing exhibits on the Elmo only while asking the witness a question to which the exhibit related. And this court prohibited Bartlett's counsel from referring back to the easel during closing argument. Those restrictions prevented any possible prejudice to Mutual.
Next, Mutual argues that Bartlett's counsel improperly staged two dramatic moments designed to elicit sympathy from the jury: (1) having Bartlett return late to the courtroom after one break in testimony, with the hope that the jury would see her walk, with assistance, to counsel's table; and (2) having Bartlett's husband Greg sob in view of the jury while Bartlett's sister was testifying, and then leave the gallery. But the first moment never happened. Mutual brought Bartlett's absence to this court's attention, the jury was briefly excused (without being told why), and Bartlett returned to the courtroom before the jury did, so that the jury never saw her walking (except when she walked to and from the witness stand). So that incident had no effect on the jury whatsoever.
As for the sobbing by Bartlett's husband, this court cannot recall it (or any objection by Mutual, which would have made a record of it), but takes Mutual at its word that it did. Indeed, one can hardly be surprised that a husband would cry at some point during a three-week trial relating to severe injuries suffered by his wife. Most courts have concluded, however, that a brief emotional reaction of that sort does not warrant a new trial, "at least if the judge admonished the jury to disregard such manifestation in reaching their verdict." L.S. Tellier, Manifestation of emotion by party during civil trial as ground for new trial, 69 A.L.R.2d 954, § 2 (1960); see also, e.g., Malandris v. Merrill Lynch, 703 F.2d 1152, 1179 (10th Cir.1981). This court gave precisely such an instruction on the day following Bartlett's sister's testimony, as discussed in Part III.C.vi, supra.
Next, Mutual argues that Bartlett's counsel improperly allowed the jury to see Mutual's annual net sales figure during videotaped testimony by Mutual employee Robert Dettery.
The parties disagree about whether that error was intentional. At trial, Bartlett's counsel told this court that it was a computer glitch, resulting from the way that their software program synched up the video/audio file and the separate text file shown in the subtitles. They attempted to replicate the glitch for this court a number of times, but were unable to do so. Mutual, with the support of an affidavit from the managing director of the software company that made the program, claims that a glitch of that sort is impossible and therefore must have been a deliberate act (if not a criminal one). Bartlett's counsel, in turn, claim that they have now replicated the glitch, having figured out through discussions with the software company that it resulted from the difference in screen-size ratios between their laptop computer and the court's televisions.
This court need not resolve that debate, however, because—even if intentional—the brief, silent display of a question containing Mutual's net sales figure still would not warrant a new trial. The jury already knew, from Mutual's own statement during voir dire, that Mutual had 500 employees (which itself elicited a note of caution from this court, since Mutual's statement came close to implying to the jurors that employee jobs might be at stake, making it potentially prejudicial to Bartlett). And the jury knew, from Dettery's admissible testimony, that Mutual had a portfolio of about 250 generic drugs, as well as a few brand-name drugs. So with or without seeing the net sales figure, the jury surely assumed that Mutual had substantial annual sales. See, e.g., Simek v. J.P. King Auction Co., 160 Fed.Appx. 675, 685 (10th Cir.2005) (unpublished) (finding no prejudice from question about net worth where the "evidence already tended to show [the party's] wealth").
Moreover, this court expressly instructed the jury that "[q]uestions ... by lawyers are not evidence, unless the witness adopts the facts set forth in the question," and that "[t]estimony that has been excluded... is not evidence and must not be considered." Document no. 378, at 9-10. To the extent that the jurors even noticed the net sales figure (which is unknown), they surely also noticed that it was contained in a question that was neither spoken aloud nor answered by the witness, indicating that, pursuant to this court's instructions, it was not evidence and could not be considered. Under the totality of the circumstances, this court does not believe that Mutual suffered any significant prejudice from the brief, silent display of the annual sales question.
Next, Mutual argues that Bartlett's counsel improperly prepared a document (Mutual calls it a "script," Bartlett calls it "notes") for one of Bartlett's experts, Dr. Tackett, to use during his testimony. See document no. 394-1. The document contained hundreds of typed questions, some with handwritten answers next to them and/or citations to expert reliance materials. The document also contained about a dozen points for Dr. Tackett to make during cross-examination. Dr. Tackett testified at trial that Bartlett's counsel typed up the document based on their telephone conversations before trial and gave it to him the day before his testimony. Mutual noticed the document during Dr. Tackett's direct examination and used it to challenge his credibility on cross-examination, asking detailed questions about how the document was prepared and how Dr. Tackett had used it. Indeed, that was Mutual's opening salvo on both days of Dr. Tackett's cross-examination.
While Bartlett claims that it is "common witness preparation" to discuss questions and answers with expert witnesses before their testimony, and sometimes even to write them out in a "script," LeCroy v. Sec'y, Fla. Dep't of Corr., 421 F.3d 1237, 1267 (11th Cir.2005), it is a strange practice, if not an improper one, for the witness to carry such a document with him to the stand and refer to it while testifying. Indeed, it is rather like walking into a punch, given how bad it looks to the jury on cross-examination. This court is not persuaded, however, that the document resulted in Dr. Tackett's giving opinions that were not his own, or that were not reliably based on his knowledge and expertise.
Next, Mutual complains that Bartlett's counsel repeatedly asked leading questions on direct examination. See Fed. R.Evid. 611 ("Leading questions should not be used on the direct examination of a witness except as may be necessary to develop the witness' testimony."). That is true, but the other half of the story is that Bartlett's counsel met with repeated rebukes from this court when they did so, sometimes in response to Mutual's objections (which were mostly sustained) and sometimes sua sponte (since Mutual often did not object). Some of those rebukes came in the presence of the jury. It is well established that trial courts have "extensive discretion over the phrasing of questions." United States v. Hansen, 434 F.3d 92, 105 (1st Cir.2006). This court exercised that discretion throughout trial to prevent Bartlett from using leading questions to gain an unfair advantage over Mutual.
Mutual also argues that Bartlett's counsel repeatedly attempted to elicit undisclosed expert opinions. See Fed. R.Civ.P. 26(a)(2)(B)(i) (requiring pre-trial disclosure of "all opinions that the [expert] witness will express"). Again, however, this court went to great lengths to prevent Bartlett's experts from giving such opinions. For example, this court required an advance, written proffer of all opinions that Bartlett's counsel intended to elicit from Dr. Tackett, and went through those opinions one-by-one with the parties to rule out any that had not been properly disclosed before trial (then cautioning Dr. Tackett, before his testimony and outside the presence of the jury, about the opinions deemed off-limits). This court also required Bartlett's counsel to obtain prior approval before eliciting opinions to which they believed Mutual's cross-examination had "opened the door."
Where Bartlett's counsel strayed from the pre-approved opinions, this court did not hesitate to stop them (again, sometimes sua sponte) and to strike the testimony or grant other appropriate relief. To the extent that any undisclosed opinions may nonetheless have squeaked past, it happened without objection from Mutual and thus is not a basis for post-trial relief. See, e.g., Fonten Corp. v. Ocean Spray Cranberries, Inc., 469 F.3d 18, 21 (1st Cir.2006) ("Failure to timely object to an attorney's misconduct will frequently result in the denial of a motion for new trial."). Moreover, Mutual has not shown that any of the key opinions regarding sulindac's risks and benefits were undisclosed, see Part III.A.i, supra, so it did not suffer any prejudice.
Mutual also argues that Bartlett's counsel improperly attempted to admit other inadmissible evidence, including testimony that Mutual failed to survey the medical literature for information about sulindac's safety risks, as well as copies of the medical literature and the unpublished Pharmacia report. Again, however, this court rebuffed those attempts, so Mutual suffered no prejudice. Moreover, this court expressly instructed the jury (at Mutual's request) that Mutual's "conduct in seeking . . . knowledge" of sulindac's risks was "not relevant to this case." Document no. 378, at 22.
Next, Mutual argues that Bartlett's counsel violated one of this court's orders by making a "missing witness" argument, i.e., commenting during closing argument on Mutual's failure to call any witnesses. See Bartlett, 2010 WL 3156555, at *7 (document no. 278) (stating that parties "may not comment on ... uncalled witnesses unless and until [they] lay[ ] a proper foundation and obtain[ ] this court's
This court is not persuaded that Bartlett's counsel exceeded the scope of that permission, or otherwise strayed into improper argument. Even if they did, however, this court reminded the jury (sua sponte) immediately after the closing that "while it is accurate to say Mutual did not call witnesses after the plaintiff rested her case, Mutual's counsel did put on a defense in this case, through cross-examination of the plaintiff's witnesses and through its presentation of its own portions of the videotape deposition testimony or read testimony from a transcript that immediately followed the plaintiff's presentation, with respect to witnesses like [Mutual's employee] Dettery." In light of that instruction, Mutual suffered no prejudice.
Finally, Mutual argues that Bartlett's counsel made a number of other improper comments during trial:
• During opening statement, Bartlett's counsel mentioned their own experience in the United States military, which obviously was not relevant. See Fed.R.Evid. 401, 402. But this court sustained Mutual's immediate objection to that comment, cutting off Bartlett's counsel before they had finished the point, and instructed Bartlett's counsel, in the presence of the jury, to "talk about the evidence," not to "describe [their] experience, background." Document no. 430, at 89-90. So Mutual suffered no prejudice.
• During opening statement, Bartlett's counsel also noted that Mutual had never apologized to Bartlett. Id. at 128. Again, that was not relevant. See Fed. R.Evid. 401, 402. But Mutual did not object to that comment, either as it happened or during the sidebar after the opening (when Mutual raised other objections to Bartlett's opening statement). Moreover, this court expressly instructed the jury that Mutual's conduct was "not at issue" and should not be considered. Document no. 378, at 22. Mutual again suffered no prejudice.
• During both opening and closing, Bartlett's counsel commented that sulindac "stole" Bartlett's freedom, see document no. 430, at 89, 91, which Mutual considers an improper reference to its conduct. But, on its face, the comments referred to the drug's effect, not Mutual's conduct. And again, Mutual did not object to the comments. In any event, Mutual suffered no prejudice in light of the instruction just described (regarding Mutual's conduct not being at issue).
• On a number of occasions, Bartlett's counsel referred to the Pharmacia report as the work of Mutual's expert Dr. Stern, who never testified at trial, and as a "draft" of the Journal of Rheumatology article. Mutual argues that those comments were unfair and misleading, but this court disagrees. Dr. Stern was, in fact, the report's author and one of Mutual's designated experts. Until the end of trial, when Mutual rested without calling any witnesses, it was unclear whether Mutual would call Dr. Stern. And Dr. Stern acknowledged at his deposition that the published article was based on data from the Pharmacia report, such that he even sought Pharmacia's permission to publish the article.
• During closing argument, Bartlett's counsel incorrectly stated that the FDA
• Bartlett's counsel also argued, during closing argument, that sulindac's warning violated FDA labeling regulations. Again, however, this court granted Mutual's request for a cautionary instruction on that point, telling the jury (consistent with the final jury charge) that "compliance or noncompliance with FDA labeling ... is not necessarily controlling" on the issue of whether sulindac's warning avoided an unreasonable danger, and that "you may give such evidence as much or little weight as you think it deserves." Subject to that instruction (and probably even without it), the argument was permissible. See Part III.B.iv, supra.
• Bartlett's counsel also stated, during closing argument, that questions by attorneys are not evidence.
The next issue raised by Mutual's Rule 59 motion is whether this court allowed Bartlett to present too much evidence of her severe injuries. Mutual argues, first, that this court should have bifurcated the trial into separate liability and damages phases to prevent such evidence from improperly influencing the liability determination. See Fed.R.Civ.P. 42(b) ("For convenience, to avoid prejudice, or to expedite or economize, the court may order a separate trial of one or more separate issues"). This court has already addressed that argument at length in a pre-trial order. See Bartlett, 2010 WL 3210724 (document no. 320). As explained there, the party seeking bifurcation bears the burden of proving that it will satisfy the rule's objectives, see, e.g., 8 Moore's Federal Practice, § 42.20[8], at 42-55 (3d ed. 2007), and the court has broad discretion in determining whether bifurcation is appropriate, see, e.g., Lisa v. Fournier Marine Corp., 866 F.2d 530, 531 (1st Cir. 1989).
Mutual failed to show that bifurcation was appropriate in this case. Even if the trial had been bifurcated, evidence of SJS/TEN's severity still would have been admissible at the liability phase, to inform the jury's risk/benefit analysis. See Fed. R.Evid. 402; Price, 142 N.H. at 389, 702 A.2d 330 (jury may consider "the risk of danger posed by [the product's] use)." Moreover, since Mutual put Bartlett to her proof on causation (even though, as already mentioned, that point was essentially
Short of bifurcation, Mutual argues that "evidence of plaintiff's injuries... only needed to be presented one time," and that this court erred by allowing "witness after witness to testify, often in graphic detail, about plaintiff's injuries and medical treatment." See Fed.R.Evid. 403 (allowing exclusion of relevant evidence "if its probative value is substantially outweighed by the danger of unfair prejudice... or needless presentation of cumulative evidence"). Each witness, though, had something different to add. Bartlett's ordeal with SJS/TEN caused many different injuries, requiring the involvement of many doctors (with various specialties), and impacting many aspects of her life. No single witness, even Bartlett herself, could have given the jury a full picture of what happened.
It is true that some of the witnesses went into graphic detail about Bartlett's injuries, and that some of the pictures shown to the jury were unpleasant, but that is because Bartlett's injuries were so horrific and, in many respects, far beyond the experience of the average juror. See Part III.F, infra. There was really no other way for Bartlett to convey to the jury the full extent of her pain and suffering. See United States v. Morales-Aldahondo, 524 F.3d 115, 120 (1st Cir.2008) ("The trial judge's job is to avoid unfair prejudice," not "to scrub the trial clean of all evidence that may have an emotional impact."). This court "balanced the competing concerns of Rule 403 by," for example, reviewing proffered photographs in open court (outside the presence of the jury) and "limiting the number of images presented," as well as by excluding proffered video footage of the type of eye surgery that Bartlett underwent, among other things. Id. Mutual has not shown any miscarriage of justice in that regard.
The next issue raised by Mutual's Rule 59 motion is whether the jury awarded Bartlett an excessive amount of compensatory damages. As mentioned earlier, the jury awarded a total of $21.06 million, consisting of $4.56 in special damages that were largely uncontested ($1.25 million for past medical expenses stipulated by the parties, $2.377 million for future medical expenses, and $933,000 for lost wages) plus $16.5 million for pain, suffering, and loss of enjoyment of life. Mutual argues that the amount, and particularly the pain and suffering component, was so high as to be "undoubtedly punitive" and "based purely on the jury's passion and prejudice." This court disagrees. While substantial, the award was within the acceptable range, in light of the horrific injuries that Bartlett suffered. Given this court's instruction on the issue in the final jury charge, there is
"District courts may grant a motion for new trial" based on the amount of damages "only if the award exceeds any rational appraisal or estimate of the damages that could be based on the evidence before the jury and is grossly excessive, inordinate, shocking to the conscience of the court, or so high that it would be a denial of justice to permit it to stand." Franceschi v. Hosp. Gen. San Carlos, Inc., 420 F.3d 1, 5 (1st Cir.2005); see also Bielunas v. F/V Misty Dawn, Inc., 621 F.3d 72, 80 (1st Cir.2010) ("only rarely and in extraordinary circumstances will [courts] veto the jury's decision"). That is a "weighty burden" for Mutual to meet. Bielunas, 621 F.3d at 80. This court cannot "jettison a damage award simply because" it is "generous in comparison to other (hand-picked) cases," or in comparison to what the court might have awarded. Id. at 80-82.
No one who witnessed the trial in this case could deny the horror of Bartlett's injuries. To name just some of them: Bartlett suffered burns and lost skin over nearly two-thirds of her body; she was in a medically induced coma for months; she lost her sight (despite 12 eye surgeries, to date, attempting to save it, and likely many more to come); she lost the ability to have sexual intercourse due to vaginal injuries; she lost the ability to eat normally due to esophageal stricture (requiring multiple surgeries to stretch the esophagus so that she can eat safely at all); she lost the ability to engage in aerobic activities (in which she had previously been an avid participant) due to lung injuries; she suffered scarring to her face, back, anus, and vagina; and she suffers from post-traumatic stress disorder. Children, she said, are scared of her appearance. And at 50 years old, she is expected to live with her injuries for more than 30 years.
"There is," of course, "no mathematical formula for determining the monetary equivalent of non-economic injuries." Bielunas, 621 F.3d at 80. Nor is there any "one `correct' sum, but, rather, a range of acceptable awards." Blinzler v. Marriott Int'l, Inc., 81 F.3d 1148, 1161-62 (1st Cir.1996). In many cases, "the spread between the high and low ends of the range will be great. The choice within the range" is "largely within the jury's ken." Id. at 1162. That is indeed the case here. The jury's choice to award $16.5 million for Bartlett's pain and suffering—less than four times her special damages—was a rational response to the evidence. While Mutual has cited cases where juries awarded much less for similar injuries, Bartlett has cited cases where juries awarded much more. Her award fell within the "wide universe of acceptable awards," id., and was neither shocking to the conscience nor unjust to Mutual.
The final issue raised by Mutual's Rule 59 motion is cumulative error. Mutual argues that the combined effect of the errors discussed above warrants a new trial, even if none of the errors individually would. As already discussed, however, many of the errors that Mutual cites were not errors at all. See, e.g., Williams v. Drake, 146 F.3d 44, 49 (1st Cir.1998) ("cumulative-error analysis is inappropriate when a party complains of the cumulative effect of non-errors"). Moreover, to the extent that errors occurred, they did not cause any significant prejudice. Mutual has not "come close to [showing] the critical mass [of errors] necessary to cast a shadow upon the integrity of the verdict." United States v. Sepulveda, 15 F.3d 1161, 1196 (1st Cir.1993).
For the reasons set forth above, Mutual's motion for judgment as a matter of law
