International Trade Commission, Meet Buckman

Bexis vividly remembers how he first learned of 21 U.S.C. §337(a). It was early 1995, and he had just joined the Danek Medical legal team in the early going of the Orthopedic Bone Screw MDL. The plaintiffs' complaints went on and on about "negligence per se" and purported violations of the FDCA. Bexis figured that he better learn all he could about negligence per se as fast as he could. He had already (since 1987) been churning out internal monthly memos to the firm product liability group about new developments in Pennsylvania personal injury law, and some of those cases involved negligence per se. So he searched for the term. That produced a couple of intriguing (and then relatively recent) OSHA cases, Ries v. National Railroad. Passenger Corp., 960 F.2d 1156 (3d Cir. 1992), and Rolick v. Collins Pine Co., 975 F.2d 1009 (3d Cir. 1992) - and Third Circuit law governed where the just-being-established Orthopedic Bone Screw MDL was situated.

OSHA has a provision, 29 U.S.C. §653(b)(4), that provided, in relevant part "Nothing in this chapter shall be construed . . . to enlarge or diminish or affect in any other manner the common law. . . ." Both Rolick and Ries had held that that provision meant that "a violation of an OSHA regulation could not constitute negligence per se." Rolick, 975 F.2d 1015 (quoting Ries, 960 F.2d at 1165. That seemed pretty good, so Bexis pulled out the maroon colored statute book that contained the FDCA and read it from beginning to end, looking for anything analogous that he could argue did the same for tort claims based on the FDCA. He found §337(a), which provides: "all such proceedings for the enforcement, or to restrain violations, of this chapter [the FDCA] shall be by and in the name of the United States."

That seemed pretty good, even better than the OSHA language in some respects. There wasn't much law, and nothing in the product liability field, but it was "run whatcha brung." With plaintiffs trying to create new causes of action, it was up to our side to create new defenses. So Bexis ran (some would say amok) with §337(a) throughout the Bone Screw MDL litigation - eventually all the way to the Supreme Court where, in a Bone Screw appeal, the Supreme Court agreed. "The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions." Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 349 n.4 (2001) (quoting §337(a)).

That, in a nutshell, is how Buckman came to be.

And Buckman (and §337(a)) is the gift that keeps on giving, most recently in Amarin Pharma, Inc. v. International Trade Comm'n, 923 F.3d 959 (Fed. Cir. 2019). Yes, that's the same Amarin. Amarin v. ITC, involved completely different claims concerning the same drug, Vascepa, that several years ago produced the...