Case Notes

In Bartlett v. Mutual Pharmaceutical Company, Inc., 678 F.3d 30 (1st Cir. May 2, 2012), the plaintiff suffered toxic epidermal necrolysis (TEN) after taking sulindac, a generic version of the non-steroidal anti-inflammatory drug Clinoril'. The plaintiff sued the drug's manufacturer in New Hampshire state court for breach of warranty, negligence and fraud, based on the drug's allegedly defective manufacture and design and the manufacturer's alleged failure to warn of the drug's dangers. After the defendant removed the case to the United States District Court for the District of New Hampshire, the federal district court dismissed all but the design defect claim, which proceeded to trial. At trial, the plaintiff argued that sulindac's risks outweighed its benefits, thus making it unreasonably dangerous to consumers, notwithstanding the U.S. Food and Drug Administration (FDA)'s having approved the brand-name drug to which sulindac was identical as “safe and effective” and never having withdrawn that approval. The jury found for the plaintiff, awarding over $21 million, and the district court denied the defendant's motion for judgment as a matter of law.

On appeal to the United States Court of Appeals for the First Circuit, the defendant contended that the plaintiff's claim failed as a matter of law because the plaintiff was required to prove a specific “defect” in addition to the drug's unreasonable dangerousness, and no proof of any identifiable defect in sulindac was shown. The defendant also argued the claim was preempted by the federal Food, Drug, and Cosmetic Act (FDCA) because sulindac's design was required by the act to be the “same” as the branded drug's, and that the testimony of the plaintiff's experts based on “adverse event reports” (AERs) to the FDA should have been excluded under Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), which requires the proponent of expert testimony to demonstrate that it is reliable based on such factors as objective testing, peer-reviewed publication and the like.