In Parker v. Stryker Corp., 2008 WL 4457864 (D. Colo. Oct. 1, 2008), the District of Colorado addressed Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), and the applicability of the express preemption clause of the Medical Device Amendments in a case where the manufacturer sought a discovery stay pending resolution of its motion to dismiss product liability claims regarding its PMA device, a hip implant. Although the motion to dismiss has not yet been resolved, the court exercised its discretion to decline the stay to allow discovery into plaintiffs' claims which supposedly parallel federal requirements. The case is not reported, and its lack of detail means it has limited value (if any) to future courts. So does Parker's failure to address authorities that shape and define what this so-called "parallel requirements" exception really takes. Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996) (state duty must be "identical" to the corresponding existing federal requirements for a plaintiff to survive preemption); see also McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005) (even a permitted act that is turned into a state requirement will not constitute a "parallel" requirement).
Preemption issues reach many products in the life sciences industry, and for preemption geeks, one category of over-the-counter (OTC) drugs is frequently featured in preemption jurisprudence: head lice treatments. Mills v. Warner-Lambert Co., --- F.Supp.2d ----, 2008 WL 4488308 (E.D.Tex. Sept. 30, 2008) is the latest. In Mills, the Eastern District of Texas interpreted and applied the express preemption provision for nonprescription drugs, Section 379r of the Federal Food, Drug and Cosmetic Act. Plaintiffs asserted that the lice treatment medications manufactured and sold by the defendants were ineffective, and asserted claims of breach of implied warranty of merchantability and violation of the Texas Deceptive Trade Practices Act. Defendants argued that Section 379r preempted these claims because they constituted a requirement on the marketing and sale of the products that differed from that provided under the FDCA. The district court agreed, holding that (1) while the medication was not approved through the NDA process but through the "monograph system for over-the-counter drugs," the FDA's oversight and review over the medication constituted a federal requirement within the meaning of Section 379r; (2) the plaintiffs' lawsuit would create a state requirement related to the medications, which followed that same holding in Riegel; (3) this state requirement would be different from, and in addition to, the federal requirement that allowed these manufacturers to sell the lice medication labeled as they were; and (4) the savings clause of Section 379r(e), which saved product liability claims from preemption, would not operate the same as for claims that were based on a contractual ground.
Of certain significance to the larger preemption context was the court's understanding of what constituted a federal requirement. As held by the U.S. Supreme Court in Riegel, the premarket approval for Class III medical device has been concluded to create federal requirements, and the court here agreed with the dissenting Justice Ginsberg's comment in Riegel that the premarket approval process paralleled the approval process for drugs, called the New Drug Application process. Id. at *20-*21. Therefore, this court surmised that the "NDA process establishe[d] a requirement with respect to drug labeling under the FDCA." Id. at *21. While the medication at issue here was not approved through the NDA process, but rather through the monograph system governing over-the-counter drugs, the court closely examined the rigor of the labeling regulations for the monograph system and concluded that they, too, created federal requirements with preemptive effect, similar to that found for Class II medical devices. See Papike v. Tambrands, 107 F.3d 737 (9th Cir. 1997) (regulations governing Class II medical devices--tampons--created a federal requirement with respect to the substantive content on labeling); Mills, 2008 WL 4488308, at *22-*23. This specific holding, as well as the court's dicta, goes to the heart of what a "federal requirement" for purposes of preemption means. Rather than clinging to the specific process at issue--i.e., is this premarket approved or not?--the operative question shifted to the rigor of the FDA's review process before it approved drugs and devices for the market.