Only a short post today, because Bexis is so blasted busy right now. When we were preparing our program for our recent Reed Smith side teleseminar about Recent Trends in Drug and Device Litigation, we looked at a lot of different preemption cases involving a lot of different products. One aspect that landed on the cutting room floor was preemption involving OTC drugs, since the express preemption clause for drugs sold over the counter is so limited. Specifically, 21 U.S.C. §379r(e) expressly preempts state law on one hand, but another section, §379s(d) excludes precisely the claims that interest us the most − product liability, by providing “[n]othing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.”
That’s bad if you’re representing OTC drug manufacturers, as we sometimes do. While there is still preemption of non-personal injury actions (such as for fraud or consumer fraud, as we’ve discussed here), that’s it. Indeed, §379s(d) is also a bad thing when a court takes the unfortunate position, as happened in Wyeth v. Levine, 555 U.S. 555 (2009), that if Congress wants express preemption it can say so, therefore to heck with implied preemption. See id. at 574 (“[i]f Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision”). Indeed, Levine footnoted §379s(d) later in the same paragraph. Id. at 575 n.8.
Our thought that prompted this post is that the converse proposition should also be true. Section 379s(d) demonstrates that, if Congress intended to exclude product liability cases specifically from broad express preemption clauses, it knows how to do that, too. That would have been nice fodder, had we needed it, with respect to medical device preemption as recognized in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). That section might also have been useful ammunition contrary to the result in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) – except that it wasn’t enacted until 1997.
But the existence, or not, of medical device preemption is now firmly established, so the import of our idea – that express preemption clauses should be taken at face value, since §379s(d) demonstrates that Congress knows how to exclude “product liability” if it wants to – is of greatest practical value outside of our sandbox. Preemption clauses are included in statutes covering everything from cigarettes to oil tankers (please keep separate, the combination could be explosive). Some of these clauses are quite broad. Plaintiffs have argued for years, with varying degrees of success, that preemptive terms such as “requirements” can’t be taken literally. But they should. Congress knows how to exclude specific topics such as “product liability” from preemption clauses if that is its intent, and §379s(d) proves it. We don’t need unmanageable, now-you-see-it-now-you-don’t “presumptions” limiting express preemption because as pointed out ironically in Levine, Congress knows how to make such exclusions explicit when it wants to.
Drug and device product liability defense is often quite specialized. Sometimes that, too, is unfortunate because there are obscure things in our bailiwick, such as §379s(d), that can be very useful to our colleagues defending other types of litigation. That may be the most important thought of all.