Bartlett v. Mut. Pharm. Co. Inc.

• Decision Date: 05 January 2011
• Docket Number: Civil No. 08–cv–358–JL.
• Citation: 760 F.Supp.2d 220
• Parties: Karen L. BARTLETTv.MUTUAL PHARMACEUTICAL COMPANY, INC.
• Court: U.S. District Court — District of New Hampshire

760 F.Supp.2d 220

Karen L. BARTLETT
v.
MUTUAL PHARMACEUTICAL COMPANY, INC.

Civil No. 08–cv–358–JL.

United States District Court, D. New Hampshire.

Jan. 5, 2011.

[760 F.Supp.2d 227]

Bryan Ballew, Keith M. Jensen, Patrick J. O'Neal, Eric Roberson, Jensen Belew & Gonzalez PLLC, Fort Worth, TX, Christine M. Craig, Timothy P. Beaupre, Shaheen & Gordon, Dover, NH, for Karen L. Bartlett.Jeffrey D. Geoppinger, Joseph P. Thomas, Linda E. Maichl, Paul J. Cosgrove, Ulmer & Berne LLP, Cincinnati, OH, Stephen J. Judge, Pierre A. Chabot, Wadleigh Starr & Peters PLLC, Manchester, NH, for Mutual Pharmaceutical Company, Inc.

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 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., 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

[760 F.Supp.2d 228]

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

[760 F.Supp.2d 229]

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 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 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 *36–40.¹

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