In drug and device cases, plaintiffs often rely on foreign labels including different warnings from the FDA-approved label as proof of defendant’s knowledge of a risk or failure to warn. In the first “bellwether” trial in an MDL proceeding involving claims of liver damage from the use of Tylenol, Defendants’ moved in limine to exclude such evidence, arguing that foreign regulatory processes for labeling are so different from the FDA’s processes that information about foreign labels and regulatory actions was irrelevant, unduly prejudicial, and confusing to the jury.
A federal court in the Eastern District of Pennsylvania denied the motion. See In re: Tylenol Marketing, Sales Practices and Products Liability Litigation, 2:13-md-02436, 2016 WL 1569719 (E.D. Pa. Apr. 19, 2016). The court accepted plaintiffs’ argument that the foreign labels were evidence of defendants’ knowledge of potential risks related to their products.
In reaching this ruling, the In re: Tylenol court observed, “I recognize that the admission of foreign labels may require context of a foreign country’s regulatory system in order to present them accurately, leading to a trial within a trial and undue delay. However, I believe it’s possible for the plaintiff to offer evidence that foreign regulatory agencies raised concerns about acetaminophen dosing years before the decedent’s death, to show notice and/or knowledge.” The court also recognized that a jury instruction could be given, “to ensure that jurors understand the limited nature of this evidence.” In re: Tylenol, 2016 WL1569719, *19.
The Court also limited plaintiffs’ ability to use the evidence as proof of causation, finding, “[i]t would be unfair to allow evidence of foreign labeling in countries requiring different regulatory and/or statutory duties to show that the defendants breached their duties under United States laws.” In re: Tylenol, 2016 WL1569719, *20.
The ruling regarding evidence of foreign labeling and regulatory actions was just one of eighteen motions in limine decided in In Re: Tylenol. Other issues decided included the use of adverse event reports at trial, the admissibility of expert testimony of corporate state of mind, and the admissibility of communications with the FDA and marketing and promotional materials. The full In Re: Tylenol opinion can be found here.