Fentanyl, a powerful prescription painkiller, is often delivered transdermally via time-release patches.  In Miller v. Mylan, the estate of a Michigan woman sued fentanyl patch manufacturer Mylan, alleging that her death was caused by a defective patch delivering too much of the narcotic too fast.  Mylan moved to dismiss, claiming statutory immunity under Mich. Comp. Laws § 600.2946(5), which immunizes manufacturers of FDA-approved “drugs”—with “drug” defined by the Federal Food, Drug, and Cosmetic Act—from suit.  The district court dismissed the suit, finding that the time-release mechanism of the patch was merely a “component” of the fentanyl, akin to the time-release capsules often used to administer drugs orally.

On appeal, a divided Sixth Circuit panel narrowed the scope of the Michigan statute, holding that it does not protect manufacturers of “combination products,” which the Act defines as combining both a “drug” and “device.”  The majority cited the general principle that “statutes in derogation of the common law should be narrowly construed,” but did not elaborate on whether this was a discrete principle or whether the narrowness of construction should correlate with the degree to which a statute derogates the common law.  The similar, but more modest, rebuttable-presumption statutes in other states derogate the common law of torts considerably less than the Michigan statute’s categorical immunity.  See, e.g. N.J. Stat. § 2A:58C-4 (providing a rebuttable presumption in favor of the adequacy of an FDA-approved warning for “a drug or device or food or food additive” as defined by the Federal Food, Drug, and Cosmetic Act).  The unique breadth of the Michigan immunity statute might have led the court to interpret it especially narrowly.  See Kyle D. Logue, Coordinating Sanctions In Tort, 31 Cardozo L. Rev. 2313, 2344 (2010) (explaining that “a number of states have . . . creat[ed] a sort of rebuttable regulatory compliance defense,” but “[n]o other state has gone [as] far” as Michigan, where the presumption is non-rebuttable).

The majority, Judges Merritt and Gibbons, acknowledged that the patch was regulated as a “drug,” but did not find this to be dispositive of whether the patch “is” a drug because the amendment creating the “combination product” definition did not create a corresponding new mode of regulation, but permitted combination products to be regulated as either drugs or devices.  The majority speculated that the patch’s “effect on the human body” might be “mechanical (rather than chemical),” and remanded to the district court to resolve the factual question of the proper definition of the patch: is it a “combination product” or simply a “drug”?  Judge Gibbons also wrote separately to chide the district court for straying beyond the complaint to consider documents submitted by Mylan in support of its defense.

Judge McKeague dissented on both procedural and substantive grounds.  First, he pointed out that Plaintiffs had not alleged the patch to be a “combination product” in their complaint or in their pleadings before the district court, and therefore it was inappropriate for the Sixth Circuit to consider the argument in the first instance.  Second, relying heavily on the documents submitted by Mylan (“the only evidence in the record shows that the FDA designated the fentanyl patch as a ‘drug’”), he concluded that the fentanyl patch was a drug, not a combination product, and therefore it was not necessary to reach the question of whether combination products were covered by the Michigan statute.