Ouellette v. Mills

91 F.Supp.3d 1

Charles OUELLETTE, Amelia Arnold, Maine Pharmacy Association, Maine Society of Health–System Pharmacists, and Retail Association of Maine, Plaintiffs

v.Janet MILLS, in her official capacity as Attorney General of the State of Maine, and Richard Rosen, in his official capacity as Commissioner of Administrative & Financial Services for the State of Maine¹ Defendants.

No. 1:13–cv–00347–NT.

United States District Court, D. Maine.

Signed Feb. 23, 2015.

David B. McConnell, Joseph G. Talbot, Perkins Thompson, PA, Portland, ME, John M. Gore, Michael A. Carvin, Jones Day, Washington, DC, for Plaintiffs.

Paul Stern, Thomas A. Knowlton, Office of the Attorney General, Augusta, ME, for Defendants.

ORDER ON PARTIES' COMPETING MOTIONS ON FACIAL PREEMPTION

NANCY TORRESEN, Chief Judge.

Before the Court are the parties' competing motions for judgment on the pleadings pursuant to Federal Rule of Civil Procedure 12(c) (ECF Nos. 46, 57). For the reasons stated below, the Plaintiffs' motion is GRANTED and the Defendants' motion is DENIED.

PROCEDURAL HISTORY

Two licensed Maine pharmacists and three trade organizations representing the interests of Maine pharmacists (the “Plaintiffs ”) bring suit against Janet Mills and Richard Rosen, in their official capacities (the “Defendants ” or the “State ”), pursuant to the Supremacy Clause, U.S. Const. art. VI, cl. 2, and 42 U.S.C. § 1983. The Plaintiffs claim that the federal Food, Drug, and Cosmetics Act (the “FDCA ”), 21 U.S.C. §§ 301 –399f, preempts certain amendments to the Maine Pharmacy Act (the “MPA ”), 32 M.R.S. §§ 13701 –13847.

This Court issued an order on the Defendants' motion to dismiss pursuant to Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6), disposing of the Plaintiffs' Foreign Commerce Clause claim and dismissing the Pharmaceutical Research and Manufacturers of America from this suit. 'ISee Order on Mot. to Dismiss (ECF No. 39). Shortly thereafter, the Plaintiffs moved for summary judgment (ECF No. 46), and the Defendants responded by asking this Court either to deny the motion or continue the matter so they could conduct limited discovery (ECF No. 50). The Plaintiffs countered by asserting that no discovery was necessary to resolve their “purely legal” challenge to the Maine legislation. Pls.' Summ. J. Reply & Fed.R.Civ.P. 56(d) Opp'n 1, 14 (ECF No. 51).

The Court called a conference of counsel and determined that it could resolve whether the Plaintiffs are entitled to declaratory relief on their facial preemption challenge without discovery. Report of Conf. of Counsel & Order 2 (ECF No. 56).² The Court also determined that it would treat the Plaintiffs' motion for summary judgment as a motion for judgment on the pleadings pursuant to Federal Rule of Civil Procedure 12(c) and disregard any facts that would be properly considered at summary judgment, after the benefit of discovery. Report of Conf. of Counsel & Order 2.³ The Defendants thereafter filed their own cross-motion for judgment on the pleadings. Defs.' Mem. in Opp'n to Pls.' Mot. for J. on the Pleadings & Cross–Mot. for J. on the Pleadings (ECF No. 57).

The Court now resolves the parties' competing motions on the facial preemption question.⁴

LEGAL STANDARD

“The court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a). This standard applies with equal force where parties file cross-motions for summary judgment, in which case the court's role is to “ ‘determine whether either of the parties deserves judgment as a matter of law on [the] facts that are not disputed.’ ” Showtime Entm't, LLC, 769 F.3d at 69 (quoting Wightman v. Springfield Terminal Ry. Co., 100 F.3d 228, 230 (1st Cir.1996) ). Because this is a facial challenge to the Maine legislation, and no discovery has taken place, the Court decides this matter by the terms of the relevant statutes, without any information about the effects of the Maine legislation or how it is being enforced. See N.H. Motor Transp. Ass'n, 301 F.Supp.2d at 41.

DISCUSSION

I. The Statutory Background

A. The MPA Amendments

In 2013, the Maine legislature passed, without the Governor's signature, “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) (effective Oct. 9, 2013) (the “MPA Amendments ”). The Maine Pharmacy Act generally requires those who “engage in the practice of pharmacy” to be licensed. 32 M.R.S. § 13731(1). The MPA Amendments, which exempt certain entities from the licensing requirement, provide:

B. A licensed retail pharmacy that is located in Canada, the United Kingdom of Great Britain and Northern Ireland, the Commonwealth of Australia or New Zealand that meets its country's statutory and regulatory requirements may export prescription drugs by mail or carrier to a resident of this State for that resident's personal use. A licensed retail pharmacy described in this paragraph is exempt from licensure under this Act; and

C. An entity that contracts to provide or facilitate the exportation of prescription drugs from a licensed retail pharmacy described in paragraph B may provide or facilitate the provision of prescription drugs from that pharmacy by mail or carrier to a resident of this State for that resident's personal use. An entity that provides or facilitates the provision of prescription drugs pursuant to this paragraph is exempt from licensure under this Act.

Id.

The MPA Amendments also include a “Consumer Choice Preserved” provision, which states:

Nothing in this chapter may be construed to prohibit:

1. Ordering or receiving prescription drugs. An individual who is a resident of the State from ordering or receiving prescription drugs for that individual's personal use from outside the United States by mail or carrier from a licensed retail pharmacy described in section 13731, subsection 1, paragraph B or an entity described in section 13731, subsection 1, paragraph C; or

2. Dispensing or providing prescription drugs. A licensed retail pharmacy described in section 13731, subsection 1, paragraph B or an entity described in section 13731, subsection 1, paragraph C from dispensing, providing or facilitating the provision of prescription drugs from outside the United States by mail or carrier to a resident of the State for that resident's personal use.

32 M.R.S. § 13799.

The sponsor of the MPA Amendments explained that because “frequently prescriptions from Canada are far less expensive than those from the United States,” the purpose of the Act was to “expand[ ] the definition of a ‘mail order prescription pharmacy’ under the Maine Pharmacy Act to include an entity located outside of the United States that dispenses prescription medications by mail or carrier from a facility not located in this State to a pharmacy or to a patient who resides in this State.” Testimony from Senator Troy Jackson in Support of L.D. 171, An Act to Facilitate the Licensing of International Mail Order Prescription Pharmacies by the Maine Board of Pharmacy: Hearing on L.D. 171 Before the J. Standing Comm. on Labor, Commerce, Research and Econ. Dev., 126th Legis., 1st Sess. (Me.2013).

B. The FDCA

The FDCA creates a regulatory scheme that sets limits on the importation of prescription drugs from other countries. Specifically, the FDCA prohibits the importation or introduction into interstate commerce of any “new drug” that has not received FDA approval, 21 U.S.C. § 355, of any prescription drug not labeled as required by federal law, 21 U.S.C. § 352, 353, and of any prescription drug dispensed without a valid prescription issued by a licensed practitioner, 21 U.S.C. § 353(b). The FDCA also restricts the importation of “American goods returned,” by prohibiting any person other than the original manufacturer from importing a prescription drug that was originally manufactured in the United States and sent abroad. 21 U.S.C. § 381(d)(1).

In 2003, Congress enacted the Medicare Prescription Drug, Improvement, and Modernization Act (the “MMA ”), which contemplated the promulgation of “regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States.” Pub. L. No. 108–173, § 1121, 117 Stat. 2066, 2464 (codified at 21 U.S.C. § 384(b) ). This portion of the MMA only takes effect when the Secretary of Health and Human Services certifies that such importation will be safe and cost-effective. 21 U.S.C. § 384(l ). No Secretary has supplied that certification, and thus no regulations permitting such importation have issued. See 21 U.S.C. §§ 301 –369.

II. The Parties' Positions

A. The State's Position

The State contends that the MPA Amendments simply reduce the reach of the MPA and that it is within its authority as a sovereign to choose not to regulate certain conduct. To hold otherwise, the State asserts, would violate the Tenth Amendment principle that states may not be compelled to administer federal regulatory programs. Printz v. United States, 521 U.S. 898, 935, 117 S.Ct. 2365, 138 L.Ed.2d 914 (1997). In other words, “Maine is leaving to the federal government the enforcement of any federal laws that regulate the sale of prescription drugs to Mainers by pharmacies located in certain foreign countries.” Defs.' Reply Mem. in Supp. of their Cross–Mot. for J. on the Pleadings 2 (ECF No. 60).⁵

B. The Plaintiffs' Position

The Plaintiffs contend that the FDCA creates a comprehensive and “closed” regulatory scheme, which strictly limits the introduction of prescription drugs into interstate commerce. The Plaintiffs also point out that Congress contemplated the potential importation of prescription drugs from Canada in the MMA, but that this section has not taken effect because the Secretary has not granted the necessary certification. See 21 U.S.C. § 384(l ). The Plaintiffs assert that the FDCA preempts the MPA A...