The Reed Smith blogging team has just returned from this year’s annual ACI Drug & Medical Device Litigation conference. In addition to excessive amounts of eating, drinking, and socializing (now called “networking”), we kept our eyes open for new and interesting topics to blog about. We were not disappointed. We learned a lot more regarding preemption of claims involving non-prescription, over-the-counter (“OTC”) drugs, particularly those governed by parts of the FDA’s monograph system that we haven’t considered much before.
We knew, of course, that OTC drug preemption is governed by 21 U.S.C. §379r, which contains not only an express preemption clause, but also a savings clause. Under the preemption clause, tort claims demanding warnings or other information that is “different from,” “addition[al] to,” or “otherwise not identical with” federal labeling requirements are preempted. However – and it’s a great big however – the savings clause exempts “product liability” claims from preemption. Id. §379r(e). That doesn’t mean that preemption covers nothing of interest to us. We’ve discussed at some length how many courts have considered non-personal injury claims to be outside the scope of the “product liability” saving language, and therefore precluded by express preemption. Most recently, we described a 2014 New Jersey case involving mouthwash that refused to apply a presumption against preemption to the express preemption clause, finding the presumption precedent “confused” and inapplicable. Bowling v. Johnson & Johnson, 65 F. Supp. 3d 371, 374 & n.17 (S.D.N.Y. 2014).
But what about implied preemption by reason of conflict – specifically the impossibility preemption rationale adopted in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2468, (2013)? What we heard at the ACI conference sounded good enough to us that we thought we’d investigate it pass along what we found.