June 5, 2012
The U.S. Court of Appeals for the First Circuit recently affirmed a $21.06 million judgment, including $16.5 million for pain and suffering, in favor of a plaintiff who suffered severe injuries resulting from her use of "sulindac," the defendant's generic anti-inflammatory drug. See Bartlett v. Mut. Pharm. Co., No. 10-2277, 2012 WL 1522004 (1st Cir. 2012). Sulindac is known to cause a hypersensitivity reaction called Stevens-Johnson Syndrome and a related disease called toxic epidermal necrolysis ("SJS/TEN"). In December 2004, the plaintiff's physician prescribed sulindac under the brand name Clinoril for pain in the plaintiff's shoulder, and the plaintiff's pharmacist dispensed generic sulindac.
According to the court, the consequences for the plaintiff were "disastrous." The plaintiff developed SJS/TEN early in 2005. The court noted that TEN is diagnosed when 30% or more of the outer layer of skin on a patient's total body surface area has deteriorated, been burned off, or turned into an open wound. The plaintiff suffered TEN over 60% to 65% of her body. She was hospitalized for 70 days, including over 50 days in the burn unit. She suffered permanent injuries, including permanent near-blindness, esophageal burns, vaginal and lung injuries, and disfigurement. The plaintiff was unable to have sexual relations or to read, drive, or work. The plaintiff asserted multiple causes of action against the manufacturer in New Hampshire state court. The defendant removed the case to the federal district court. After removal, all claims but the plaintiff's defective-design cause of action were dismissed on summary judgment or voluntarily by the plaintiff.
Initially, the court of appeals noted that under the governing New Hampshire law, the plaintiff, who alleged that sulindac was defectively designed, was required to show that the drug was unreasonably dangerous due to its propensity to cause SJS/TEN. However, she was not required to establish that there existed an alternative, safer design for the drug. In reaching this conclusion, the court rejected the manufacturer's argument that a safer alternative is an essential element of a design-defect claim, over and above the existence of an unreasonably dangerous product. Hence, the district court had correctly permitted the plaintiff to establish that the sulindac was in a defective condition because it was unreasonably dangerous due to its propensity to cause SJS/TEN. Interestingly, on the eve of trial, the defendant abandoned a potential defense that the drug was unavoidably unsafe but was sold with an adequate warning.
The court next addressed the defendant's assertion that the plaintiff's state law claim was preempted by the Federal Food, Drug, and Cosmetic Act ("FDCA"). Citing the Supreme Court's conclusion in Wyeth v. Levine, 555 U.S. 555 (2009), that Congress did not intend Food and Drug Administration ("FDA") oversight to be the exclusive means of ensuring drug safety and effectiveness, the court of appeals extended the holding of Wyeth, which involved a failure-to-warn claim, to the design-defect claim at issue in the case under consideration. In so doing, the court noted that in a later decision, the Supreme Court had created an exception to Wyeth for failure-to-warn claims against generic drug manufacturers, on the theory that Congress wanted to reduce medical costs by spurring the manufacture and marketing of generic drugs and that requiring a generic drug manufacturer to pay damages under state law would suppress the development of such drugs, given that a generic drug manufacturer cannot alter the approved labeling of the brand-name drug. The Bartlett defendant argued that this exception should also apply to design-defect claims involving generic drugs because the manufacturer of such a drug similarly cannot alter the composition of the brand-name drug. The court observed, however, that while the defendant could not legally make sulindac with another composition, it could choose not to manufacture and sell the drug at all. According to the court, the FDCA might permit States to tell the defendant that it should not be manufacturing the drug if the applicable risk-benefit analysis weighs against making and selling the drug. Although it noted that such an analysis is second-guessing the FDA, the court returned to the fact that Wyeth resolved the conflict against general preemption. On balance, the court of appeals concluded that the Wyeth Court had adopted a general, no-preemption stance, and said that it is up to the Supreme Court to decide whether the exception to the absence of preemption is to be extended to design-defect claims involving generic drugs.
The court of appeals further concluded that the district court did not commit plain error in instructing the jury that it could consider the FDA's requirements for drug labels in determining whether the warning on the allegedly defective sulindac mitigated the drug's unreasonably dangerous condition. The court also held that the district court did not plainly err in failing to instruct the jury that the manufacturer could not legally change the drug's label. The court noted that the jury instructions made clear that the label was relevant to the design-defect claim since, although unalterable by the defendant, the label's arguable inadequacies put limits on the extent to which the drug's dangerousness was offset by adequate warnings.As to the issue of damages, which figured so prominently in the case, the court recounted the plaintiff's "truly horrific" injuries in affirming the largest damages award in New Hampshire history. The plaintiff's burn surgeon described her time in treatment as "hell on earth." 2012 WL 1522004, at *10. Moreover, the permanent damage she suffered was severe. In light of these facts, the court found that the outcome of the case was "not surprising" or, with respect to sulindac, "patently alarming." Id. The court noted that sulindac is a recognized and leading cause of SJS/TEN and that the drug carries other risks as well. In light of the evidence, the jury's award of $16.5 million for pain, suffering, and loss of enjoyment of life was not excessive.