Bartlett v. Mut. Pharm. Co.

• Decision Date: 02 May 2012
• Docket Number: No. 10–2277.,10–2277.
• Parties: Karen L. BARTLETT, Plaintiff, Appellee, Gregory S. Bartlett, Plaintiff, v. MUTUAL PHARMACEUTICAL COMPANY, INC., Defendant, Appellant, United Research Laboratories, Inc., n/k/a URL Pharma, Inc.; Brooks Pharmacy, Defendants.
• Court: U.S. Court of Appeals — First Circuit

678 F.3d 30

Karen L. BARTLETT, Plaintiff, Appellee,

Gregory S. Bartlett, Plaintiff,

v.MUTUAL PHARMACEUTICAL COMPANY, INC., Defendant, Appellant,United Research Laboratories, Inc., n/k/a URL Pharma, Inc.; Brooks Pharmacy, Defendants.

No. 10–2277.

United States Court of Appeals,First Circuit.

Heard Dec. 7, 2011.

Decided May 2, 2012.

Joseph P. Thomas with whom Linda E. Maichl, Paul J. Cosgrove, Ulmer & Berne LLP, Stephen J. Judge, Pierre A. Chabot and Wadleigh, Starr & Peters PLLC were on brief for appellant.

Joseph P. Lucia, David R. Geiger, Nabeel Ahmad, Foley Hoag LLP and Hugh F. Young, Jr., Product Liability Advisory Council, Inc., on brief for the Product Liability Advisory Council, Inc., Amicus Curiae.

Keith M. Jensen with whom Eric N. Roberson, Jensen & Associates, PLLC, Steven M. Gordon, Christine M. Craig and Shaheen & Gordon were on brief for appellee.

Louis M. Bograd, Center for Constitutional Litigation, P.C., Andru H. Volinsky, Chair, New Hampshire Association for Justice Amicus Committee, and Bernstein Shur, P.C. on brief for the American Association for Justice and the New Hampshire Association for Justice, Amici Curiae.

Before BOUDIN, STAHL and THOMPSON, Circuit Judges.

BOUDIN, Circuit Judge.

This products liability case arises out of severe and permanent injuries sustained by plaintiff Karen Bartlett after taking sulindac, a generic non-steroidal anti-inflammatory drug (“NSAID”) manufactured by (among others) defendant Mutual Pharmaceutical Company (“Mutual”). Sulindac is known to cause, in rare instances, a hypersensitivity reaction called Stevens–Johnson Syndrome and its more generous cousin toxic epidermal necrolysis (“SJS/TEN”). In December 2004, Bartlett's doctor prescribed (for her shoulder pain) sulindac under the brand-name Clinoril made by the original provider, and her pharmacist dispensed generic sulindac.

The consequences were disastrous. Bartlett developed SJS/TEN early in 2005. TEN is diagnosed when 30 percent or more of the outer skin layer on a patient's total body surface area has deteriorated, been burned off or turned into an open wound. In Bartlett's case, the percentage rose to 60–65 percent of her body; she spent 70 days at Massachusetts General Hospital—including over 50 in its burn unit. Both her suffering and permanent injury, including permanent near-blindness, are described below in connection with the award of damages.

Bartlett brought a bevy of claims against Mutual in New Hampshire state court, including claims for breach of warranty, fraud, and negligence, as well as the perennial trio of products liability claims: design defect, failure to warn, and manufacturing defect. After Mutual removed the case to federal court on diversity grounds, all but the design defect claim were dismissed by the district court on summary judgment or voluntarily by Bartlett. Bartlett v. Mutual Pharm. Co., No. 08–cv–358, 2010 WL 3659789 (D.N.H. Sept. 14, 2010); Bartlett v. Mutual Pharm. Co., 731 F.Supp.2d 135 (D.N.H.2010).

Bartlett originally planned her evidence across a range of possible claims, including an attack on the adequacy of the warning label and information that accompanied Mutual's sulindac drug. It was not until after the trial was completed that further legal developments (discussed below) foreclosed a direct attack on the adequacy of the label; but the district court dismissed Bartlett's warning claim because her prescribing doctor admitted that he had not read the box label or insert. Bartlett, 731 F.Supp.2d at 146–49.

Although Bartlett's experts had prepared their initial reports to cover multiple theories advanced in the complaint, by trial the core remaining theory of design defect was narrowed to this: that sulindac's risks outweighed its benefits making it unreasonably dangerous to consumers, despite the federal Food and Drug Administration (“FDA”) having never withdrawn its statutory “safe and effective” designation that the original manufacturer had secured and on which Mutual was entitled to piggyback. See21 U.S.C. § 355(b)(1), (d) (2006); id. § 355(j)(2)(A).

A 14–day trial occurred in late August and early September 2009, during which Bartlett called witnesses to her suffering and her treatment, including two important experts: a burn surgeon and—more critical to design defect—a pharmacologist/toxicologist. The latter expert in particular sought to show from incident reports made to the FDA and other information that sulindac had a worse record of causing SJS/TEN than other available drugs, and a safety profile similar to other drugs deemed dangerous enough to have been withdrawn from the market—such as valdecoxib, another NSAID sold under the brand name Bextra, which was withdrawn in 2005.

Mutual had designated its own expert in the same field as well as other witnesses but ultimately chose to put on no affirmative case of its own, although it cross-examined Bartlett's experts vigorously and offered substantial legal arguments to the judge as to why it should not be found liable. After several days of deliberation, the jury found for Bartlett and awarded $21.06 million in compensatory damages. The district court denied Mutual's motion for judgment as a matter of law, Fed.R.Civ.P. 50(b), and motion for a new trial, Fed.R.Civ.P. 59. Bartlett v. Mutual Pharm. Co., 760 F.Supp.2d 220 (D.N.H.2011).

Mutual now appeals, arguing that the district court misunderstood New Hampshire law on design defect claims; that such claims as to generic drugs are preempted under federal law; that causation was not proved; that Bartlett's expert evidence was inadmissible on multiple grounds; that instructions as to label warnings were inaccurate; that misconduct by Bartlett's counsel required a new trial; and that damages were excessive and required a new trial. The standard of review depends upon the issue, the first two raising strictly issues of law that we review de novo. U.S. ex rel. Loughren v. Unum Grp., 613 F.3d 300, 307–08 (1st Cir.2010).

Design Defect. Although courts “traditionally have refused to review the reasonableness of the designs of prescription drugs,” Restatement (Third) of Torts: Products Liability § 6, cmt. f, at 156 (1998), this court reads New Hampshire law now to permit such review, Brochu v. Ortho Pharm. Corp., 642 F.2d 652, 655 (1st Cir.1981). Brochu is consistent with the New Hampshire Supreme Court's adoption of Restatement (Second) of Torts § 402A (1965), see Buttrick v. Lessard, 110 N.H. 36, 260 A.2d 111, 113 (1969), which “imposes liability for selling ‘any product in a defective condition unreasonably dangerous to the user or consumer’ when the product causes injury to the user or consumer.”

However, Mutual interprets Buckingham v. R.J. Reynolds Tobacco Co., 142 N.H. 822, 713 A.2d 381 (1998), to require not merely unreasonable dangerousness but also proof that there exists an alternative, safer design for the product (like a new guard on a motorized table saw), see id. at 384. The claim in Brochu could satisfy such a test, because the drug at issue there contained a mix of progestogen and estrogen, and its unreasonable dangerousness could be attributed to the design-flaw of an unnecessarily high proportion of estrogen.

By contrast, Mutual says that Bartlett failed to allege and prove that sulindac could be made in a different and safer form, and this almost certainly has to be true: sulindac is a one-molecule drug; and the variations in sulindac as sold consist of inactive ingredients that ordinarily do not have significant pharmacological effects. But Buckingham does not clearly say that a safer alternative is a necessary element of design defect over and above an unreasonably dangerous product, and a subsequent decision disavows any such requirement.

In Vautour v. Body Masters Sports Indus., Inc., 147 N.H. 150, 784 A.2d 1178, 1183 (2001), which followed after Buckingham, the New Hampshire Supreme Court held that proof of a safer alternative design “should be neither a controlling factor nor an essential element that must be proved in every [design defect] case.” Rather, it said that “a product is defective as designed ‘if the magnitude of the danger outweighs the utility of the product.’ ” Id. at 1182 (quoting Keeton et al., Prosser and Keeton on the Law of Torts § 99, at 699 (5th ed.1984)).

Buckingham involved a design defect claim against cigarette manufacturers, and the court dismissed the claim on the ground that cigarettes are inherently dangerous and commonly known to be so. 713 A.2d at 384;see also Restatement (Second) of Torts § 402A, cmt. i (danger “beyond that which would be contemplated by the ordinary consumer”). But an ordinary consumer would hardly know without further warning that sulindac or any other ordinary analgesic carries a risk of the kind of ill effects and suffering that Bartlett encountered.

Accordingly, the district court properly allowed Bartlett to show that sulindac was in a “defective condition” by showing that it was “unreasonably dangerous” due to its propensity to cause SJS/TEN—a harrowing hypersensitivity reaction characterized by necrosis of the skin and mucous membranes, and often causing blindness or death. Although Mutual could still have avoided liability by proving that sulindac was unavoidably unsafe but was highly useful and had an adequate safety warning, Bartlett, 731 F.Supp.2d at 150–51;Restatement (Second) Torts § 402A, cmt. k, Mutual abandoned that defense on the eve of trial.¹

Mutual restates its no-defect argument as an issue of causation; but given the overwhelming evidence that sulindac triggered Bartlett's reaction, “but for” cause is plainly established, Bartlett, 760 F.Supp.2d at 246. Mutual's position that “Bartlett could not present evidence that a non-existent defect in the sulindac proximately caused her injury,” merely restates the argument about New Hampshire law that we have just rejected.

Preemption. The most far-reaching of Mutual's objections is that Bartlett's design...