We posted last month about a Baycol ruling and noted that the one of us who wrote that post had not previously briefed the admissibility of foreign regulatory activites in American product
It’s a left-brain/right-brain kind of thing. The other one of us pulled out a brief from a couple of years ago.
The argument against allowing foreign regulatory actions to be admitted in American courts looked like this a couple of years ago. Today, it would presumably look something like this again, with the research updated and a cite to the new Baycol case thrown in:
This is a U.S. product liability case involving events that occurred only in this country. Under U.S. statutes and regulations, the FDA approved the U.S. label for this drug, and only that U.S. label is involved in this case. As the court held in Harrison v. Wyeth Labs., 510 F. Supp. 1, 4-5 (E.D. Pa. 1980), aff’d, 676 F.2d 685 (3d Cir. 1982), a pharmaceutical manufacturer’s liability must be judged only by the company’s actions in the country where the alleged injury occurred:
“Each country has its own legitimate concerns and its own unique needs which must be factored into its process of weighing the drug’s merits, and which will tip the balance for it one way or the other. . . . [F]airness to the defendant [manufacturer] mandates that defendant’s conduct be judged by the standards of the community affected by its actions.”
Any conduct relating to this drug that took place in another country is both irrelevant and, if relevant, more prejudicial than probative. This is particularly true because foreign regulatory agencies impose very different requirements than the FDA does, and plaintiff has neither identified as an exhibit any foreign regulations governing pharmaceutical labeling nor designated an expert competent to testify about foreign regulatory requirements. Plaintiff cannot establish any foundation for the relevance or admissibility of foreign labeling.
Because of the differences between U.S. and foreign regulatory environments, courts routinely exclude evidence of foreign regulatory standards in U.S. actions. See, e.g., Hurt v. Coyne Cylinder Co., 956 F.2d 1319, 1327 (6th Cir. 1992) (“foreign legal standards have been found excludable by the 11th Circuit . . . and we will follow that holding”); Deviner v. Electrolux Motor, AB, 844 F.2d 769, 771 n.2, 773 (11th Cir. 1988) (affirming exclusion of evidence that Swedish law required chain brakes on chain saws, because “Swedish standards are not relevant in a U.S. product liability case involving a saw sold in the U.S.”); Tews v. Husqvarna, Inc., 390 N.W.2d 363, 366 (Minn. Ct. App. 1986) (affirming trial court’s exclusion of evidence because “legal standards in other countries are irrelvant”).
Depending on how plaintiff sought to introduce the foreign regulatory standards, other arguments might also be available for the defense. For example, in In re Rezulin Prods. Liab. Litig., 309 F. Supp. 531 (S.D.N.Y. 2004), the court excluded testimony about foreign regulatory requirements because plaintiff’s experts “are not the appropriate vehicles for its introduction.” Id. at 553. Knowledge of foreign regulatory activities involves a lay subject matter that plaintiff would improperly “use as [a] springboard for arguments about [the defendant’s] conduct in the United States.” Id. Frankly, we suspect there’s more to be said on this subject than we found in that old brief. But that’s a start, and we’re happy to share it with you.