January 18, 2011
A recent decision by the U.S. District Court for the District of New Hampshire addressed a number of issues regarding defective design of an anti-inflammatory drug, in upholding a jury verdict of over $21 million in favor of the plaintiff. See Bartlett v. Mut. Pharm. Co., Civ. No. 08‑cv‑358‑JL, 2011 DNH 004 (D.N.H. Jan. 5, 2011). The plaintiff alleged that her use of the defendant's drug "sulindac" had caused her to suffer severe and permanent injuries, including blindness. Specifically, the plaintiff had contracted Stevens-Johnson Syndrome ("SJS"), progressing to toxic epidermal necrolysis ("TEN"), as a result of her use of sulindac. The plaintiff asserted claims of strict liability for defective design, strict liability for failure to warn, fraud, and negligence under state law. The district court granted the manufacturer's motion for summary judgment on all but the plaintiff's defective design claim, which was the sole cause of action proceeding to trial. The jury found in the plaintiff's favor and awarded her $21.06 million in compensatory damages, including $16.5 million for pain and suffering. Following the verdict, the defendant manufacturer renewed its motion for judgment as a matter of law under Federal Rule of Civil Procedure 50(b), arguing that there was insufficient evidence to support the plaintiff's claim.
The court rejected the defendant's argument that a controlled study is the only basis upon which risk may be quantified in a defective design case involving a drug. In so concluding, the court noted that in many cases involving unusual side effects, no controlled study is available. The manufacturer argued that without any evidence of the actual incidence rate of the plaintiff's injuries caused by sulindac, the jury had no reasonable manner in which to quantify the risk, for purposes of New Hampshire's risk/benefit test for defective product design. Under New Hampshire law, a product is defective in design if the magnitude of the danger outweighs the utility of the product. The court noted that under the New Hampshire risk/benefit test, a plaintiff is not required to present evidence of a safer alternative design. Rather, a product is defective in design if it does not meet the risk/utility balancing standards viewed from the perspective of the public as a whole, not just a particular subset of the public. The court held that the jury's determination that sulindac's risks outweighed its benefits was supported by sufficient evidence, including testimony by the plaintiff's expert witnesses that the drug had been confirmed to cause SJS/TEN and that the Food and Drug Administration had received 133 reports of such harm attributed to the drug in 25 years, 39 of which had resulted in death. The court also stated that under New Hampshire law, the plaintiff was not required, as part of her defective design case, to prove that the drug had any defect in design other than the fact that its risks outweighed its benefits.
As to the quantum of damages awarded by the jury, the court noted that various witnesses had testified as to the horrors of the progression of SJS to TEN caused by the defendant's drug. The court rejected the defendant's argument that such evidence should have been excluded on grounds of unfair prejudice—even though some witnesses had gone into graphic detail and some photographs shown to the jury had been unpleasant—in light of the fact that each witness had had something different to add, that the plaintiff's SJS/TEN had caused many different injuries and required treatment by many physicians, and that the plaintiff's experience, including a medically induced coma, was beyond the ken of the average juror. The court concluded that the jury's award, including $16.5 million for pain and suffering, was supported by the evidence and was not excessive. Observing that the award for pain and suffering was less than four times the plaintiff's special damages, the court noted that the plaintiff had suffered burns and lost skin over nearly two-thirds of her body, she had been in a medically induced coma for months, she had gone blind, she had lost the ability to have sexual intercourse, and she suffered from posttraumatic stress disorder.
Bartlett is noteworthy not only for the size of the award of damages, but for the fact that the court concluded that an award of such magnitude was sustainable simply on the basis of the application of the risk/benefit test from the perspective of the general public, without the necessity of proof of any other design defect in the drug and without evidence of a controlled study. This principle clearly may prove useful to plaintiffs' products liability practitioners in drug injury cases.