District Court Rules that Maine Drug Importation Law is Unconstitutional and Preempted by the FDC Act

By Kurt R. Karst –      

In a 19-page decision handed down earlier this week by Judge Nancy Torresen of the U.S. District Court for the District of Maine, the court ruled that Maine’s 2013 law, titled “An Act To Facilitate the Personal Importation of Prescription Drugs from International Mail Order Prescription Pharmacies,”  2013 Me. Legis. Serv. Ch. 373 (S.P. 60) (L.D. 171) (West) (the “Maine Pharmacy Act Amendments” or “MPA Amendments”) permitting (as its title suggests) importation of drug products into the U.S. from licensed retail pharmacies located in certain foreign countries (i.e., Canada, Australia, New Zealand, and the United Kingdom), is unconstitutional under the theory of field preemption.  In doing so, Judge Torresen granted a Motion for Judgment on the Pleadings filed by two Maine pharmacists and three Maine trade associations (the Maine Pharmacy Association, Maine Society of Health-System Pharmacists, and Retail Association of Maine), and denied a Motion for Judgment on the Pleadings filed by Maine’s Attorney General (Janet T. Mills) and Commissioner of Administrative & Financial Services (formerly H. Sawin Millett, Jr., and now Richard Rosen). 

The February 23rd decision stems from a September 2013 Complaint filed by the Plaintiffs, as well as then-Plaintiff the Pharmaceutical Research and Manufacturers of America (“PhRMA”), challenging the MPA under several theories (see our previous posts here and here).  PhRMA was tossed out of the lawsuit last May after the district court ruled that the trade organization lacked Article III standing (see our previous post here). 

The State Defendants argue that the MPA Amendments “simply reduce the reach of the MPA,” “that it is within [the State’s] authority as a sovereign to choose not to regulate certain conduct,” and that to hold otherwise “would violate the Tenth Amendment principle that states may not be compelled to administer federal regulatory programs.”  On the other side, the Maine pharmacist and trade association Plaintiffs argue that the FDC Act “creates a comprehensive and ‘closed’ regulatory scheme, which strictly limits the introduction of prescription drugs into interstate commerce,” and that preempts the MPA Amendments under three theories of preemption: (1) field preemption (i.e., when  “[t]he intent to displace state law altogether can be inferred from a framework of regulation ‘so pervasive . . . that Congress left no room for the States to supplement it’ or where there is a ‘federal interest . . . so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject.’” Arizona v. United States, 132 S. Ct. 2492, 2501 (2012) (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947)); (2) direct conflict preemption (i.e., a form of implied preemption that occurs when there is an inescapable contradiction between state and federal law); and (3) obstacle preemption (i.e., when “the challenged state law ‘stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.’” Arizona, 132 S. Ct. at 2501 (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)).

Focusing on the Plaintiffs’ contention that the MPA Amendments violate the Supremacy Clause, U.S. Const. art. VI, cl. 2, and 42 U.S.C. § 1983, under the theory of field preemption, Judge Torresen first defined the “field” at issue:

The FDCA does not regulate the licensure of pharmacists; it instead leaves that area to individual states.  If the MPA Amendments were truly limited to the regulation of pharmacy licensure, then evidence of “a congressional decision to foreclose any state regulation in the area” would be lacking.

But by its plain language, the MPA Amendments extend beyond the regulation and licensure of pharmacies and pharmacists within Maine.  The MPA Amendments do not, as the State asserts, simply repeal state licensure regulations; the MPA Amendments select five countries whose licensed retail pharmacies “may export” prescription drugs to Maine residents. . . .  [T]he MPA Amendments extend beyond the traditionally local arena of public health and safety and into the traditionally federal spheres of foreign commerce and affairs.  [(Internal citations omitted)]

As such, the properly defined “field” for preemption purposes in the case, said Judge Torresen, is “the importation of foreign pharmaceuticals.”  From there, it was all downhill for the State Defendants, because the relevant question for the court to address was then whether the FDC Act forecloses Maine’s encroachment into the realm of pharmaceutical importation.

Citing the complex new drug approval process Congress created as part of the FDC Act, as well as provisions included as part of the 2003 Medicare Modernization Act concerning the importation of drugs from Canada, Judge Torresen was compelled to conclude that there’s a clear “Congressional intent to tightly control prescription drug importation,” and that the FDC Act “occupies the field of importation of pharmaceuticals from foreign countries” rather than state law.

No matter how they are applied, the MPA Amendments regulate within the field of pharmaceutical importation.  The State has not suggested any limiting construction which would allow a portion of the law to stand, and the parties have not briefed the issue of severability.  It is apparent that removing the portion of the statute that touches on foreign commerce would defeat the purpose of the law. Because they are contrary to clear Congressional intent to occupy the field of pharmaceutical importation, the MPA Amendments violate the Supremacy Clause and are therefore preempted.

It is unclear at this time whether or not an appeal will be made to the U.S. Court of Appeals for the First Circuit.  According to press reports (here), the sponsor of the bill that was enacted as the MPS Amendments, State Senator Troy Jackson, thinks an appeal is in order. 

Moving down the Eastern Seaboard to Capitol Hill, earlier this year Senators John McCain (R-AZ) and Amy Klobuchar (D-MN) introduced S. 122, the Safe and Affordable Drugs from Canada Act of 2015, which would amend the FDC Act to require the Department of Health and Human Services to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy under certain specified conditions.