OUELLETTE et al v. MILLS et al
Filing
61
ORDER ON PARTIES' COMPETING MOTIONS ON FACIAL PREEMPTION re: 46 Motion for Summary Judgment; 58 Motion for Judgment on the Pleadings By JUDGE NANCY TORRESEN. (mjlt)
UNITED STATES DISTRICT COURT
DISTRICT OF MAINE
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 Maine,1
Defendants.
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ORDER ON PARTIES’ COMPETING MOTIONS ON FACIAL PREEMPTION
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
Pursuant to Federal Rule of Civil Procedure 25(d), Richard Rosen is substituted as a defendant
in this matter.
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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. See 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
The Plaintiffs themselves have not labeled their challenge to the Maine legislation as a “facial”
one. However, upon further examination of the relief requested in the Plaintiffs’ Complaint, it is clear
that they have only brought a facial challenge to the Maine legislation. As the First Circuit recently
explained, a party brings a facial challenge where the relief sought reaches beyond “ ‘the particular
circumstances’ ” of that plaintiff. Showtime Entm’t, LLC v. Town of Mendon, 769 F.3d 61, 70 (1st Cir.
2014) (quoting John Doe No. 1 v. Reed, 561 U.S. 186, 194 (2010)). Here, because the Plaintiffs seek to
strike down the Maine legislation in its entirety, not just as it applies to the particular plaintiffs in
this case, their challenge is facial.
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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
The Court’s instruction that Rule 12(c) was the proper procedural vehicle for the Plaintiff’s
motion was an error. Because the Plaintiffs had not labeled their challenge to the Maine legislation as
“facial” in any of their written submissions, the State understandably resisted responding to a motion
for summary judgment before the discovery process had begun. However, now that the Court has
identified the Plaintiffs’ challenge as facial, summary judgment via Rule 56 is indeed the appropriate
mechanism for adjudicating their preemption claim. See Showtime Entm’t, LLC, 769 F.3d at 69, 71
(resolving a facial statutory challenge through summary judgment); URI Student Senate v. Town of
Narragansett, 631 F.3d 1, 8, 15 (1st Cir. 2011) (same); McGuire v. Reilly, 386 F.3d 45, 59 (1st Cir. 2004)
(same); Abdullah v. Comm’r of Ins. of Mass., 84 F.3d 18, 20 (1st Cir. 1996) (same); N.H. Motor Transp.
Ass’n v. Rowe, 301 F.Supp.2d 38, 40-41 (D. Me. 2004) (same).
3
The Plaintiffs have cited a variety of agency materials in their filings, including letters from
the FDA to state and local officials between 2003 and 2008 opining on the legality of efforts by other
states and municipalities to create pharmaceutical importation programs. See, e.g., Compl. ¶ 20 (citing
Letter from Randall D. Lutter to Gov. Kenny Guinn (May 20, 2005), available at http://www.fda.gov/
Drugs/DrugSafety/ucm179414.htm (last visited Feb. 9, 2015)). The Plaintiffs offer no materials from
the FDA specifically dealing with the Maine legislation at issue.
The Supreme Court has instructed that the weight given to an “agency’s explanation of state
law’s impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness.”
Wyeth v. Levine, 555 U.S. 555, 576 (2009) (internal citations omitted). Even if the Plaintiffs had pointed
to an opinion from the FDA on the legality of the Maine legislation or its potential impact on the
enforcement of the FDCA, this Court would “not defer[ ] to an agency’s conclusion that the state law
is pre-empted.” Id. Ultimately, the determination as to preemption belongs to the Court. Id.
Accordingly, for purposes of the motions at hand, the Court sets these materials aside.
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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
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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
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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 Medicaid 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
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certification, and thus no regulations permitting such importation have issued. See
21 C.F.R. §§ 200-369.
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 (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
The State also asserts that where the Plaintiffs have no private right of action under the
FDCA, the Supremacy Clause does not create one. Defs.’ Mem. in Opp’n to Pls.’ Mot. for J. on the
Pleadings & Cross-Mot. for J. on the Pleadings 2-3. This Court has already resolved that issue in favor
of the Plaintiffs in light of Pharmaceutical Research and Manufacturers of America v. Concannon, 249
F.3d 66, 73-74 (1st Cir. 2001). See Order on Mot. to Dismiss 14. However, the Supreme Court has
granted certiorari on a similar, potentially dispositive question. See Armstrong v. Exceptional Child
Ctr., Inc., 567 Fed. Appx. 496 (9th Cir. 2014), cert. granted, 83 U.S.L.W. 3077 (U.S. Oct. 2, 2014) (No.
14-15) (“Does the Supremacy Clause give Medicaid providers a private right of action to enforce
§ 1396a(a)(30)(A) against a state where Congress chose not to create enforceable rights under that
statute?”). The grant of certiorari in Armstrong does not affect this Court’s prior ruling, but does
present the possibility that this case will ultimately be dismissable on justiciability grounds, should it
be pending on appeal when Armstrong is decided.
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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 Amendments pursuant to the Supremacy Clause. The Plaintiffs offer three
distinct theories of preemption—field preemption, direct conflict, and obstacle
preemption.
III.
The Governing Law
A. Facial Challenges
As plead, the Plaintiffs are only bringing a facial challenge to the MPA
Amendments. The Supreme Court has instructed that “[a] facial challenge to a
legislative Act is, of course, the most difficult challenge to mount successfully, since
the challenger must establish that no set of circumstances exists under which the Act
would be valid.” United States v. Salerno, 481 U.S. 739, 745 (1987); see also Thayer v.
City of Worcester, 755 F.3d 60, 71 n.3 (1st Cir. 2014) (citing Salerno as the applicable
standard for non-speech-related facial challenges). “The existence of a hypothetical
or potential conflict is insufficient to warrant the pre-emption of the state statute.”
Rice v. Norman Williams Co., 458 U.S. 654, 659 (1982). In addition, the Court must
avoid declaring the MPA Amendments unconstitutional where a constitutionally
permissible construction is available. See Vaquería Tres Monjitas, Inc. v. Pagan, 748
F.3d 21, 26 (1st Cir. 2014).
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B.
Preemption
1.
General Framework
To understand the theory behind preemption, it is helpful to step back, as the
Supreme Court recently did, and review the basics of federalism:
Federalism, central to the constitutional design, adopts the principle
that both the National and State Governments have elements of
sovereignty the other is bound to respect. From the existence of two
sovereigns follows the possibility that laws can be in conflict or at crosspurposes. The Supremacy Clause provides a clear rule that federal law
“shall be the supreme Law of the Land; and the Judges in every State
shall be bound thereby, any Thing in the Constitution or Laws of any
State to the Contrary notwithstanding.” U.S. Const. art. VI, cl. 2. Under
this principle, Congress has the power to preempt state law.
Arizona v. United States, 132 S. Ct. 2492, 2500 (2012) (citations omitted).
There are a number of ways in which federal law may preempt state law. First,
Congress can expressly state that it is preempting state law. Gade v. Nat’l Solid
Wastes Mgmt. Assoc., 505 U.S. 88, 98 (1992). Second, the courts may find that
although Congress did not expressly preempt state law, preemption can be inferred.
See In re Celexa & Lexapro Mktg. & Sales Practices Litig., No. 14-1290, slip op. at 2
(1st Cir. Feb 20, 2015). There are, it appears, two variants of implied preemption,
which have come to be known as “field” and “conflict” preemption. Id. Field
preemption occurs 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, 132 S. Ct. at 2501 (quoting Rice v. Santa Fe Elevator Corp., 331
U.S. 218, 230 (1947)). Conflict preemption is sometimes further broken down into
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“impossibility” preemption and “obstacle” preemption. Impossibility preemption
occurs “where ‘compliance with both federal and state regulations is a physical
impossibility . . . .’ ” Id. (quoting Fla. Lime & Avocado Growers, Inc. v. Paul, 373 U.S.
132, 142-43 (1963)). Obstacle preemption occurs where “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)). However, the Supreme Court has acknowledged that these
“pre-emption categories are not ‘rigidly distinct.’ ” Gade, 505 U.S. at 104 n.2 (quoting
English v. Gen. Elec. Co., 496 U.S. 72, 79 n.5 (1990)).
2.
Competing Presumptions
The Court must consider two competing presumptions regarding preemption.
On the one hand, the Court must begin with the “presumption that the state statute
is valid,” Pharm. Research & Mfrs. of Am. v. Walsh, 538 U.S. 644, 661 (2003),
particularly if it regulates matters of public health, see Hillsborough Cnty., Fla. v.
Automated Med. Lab., Inc., 471 U.S. 707, 718 (1985). There is a presumption against
preemption “in any field in which there is a history of state law regulation, even if
there is also a history of federal regulation.” In re Pharm. Indus. Average Wholesale
Price Litig., 582 F.3d 156, 178 (1st Cir. 2009) (citing Wyeth, 555 U.S. at 565 n.3). If a
state law regulates in an area of traditional local concern, Congress must make its
intent to preempt that state law clear. Nat’l Foreign Trade Council v. Natsios, 181
F.3d 38, 73 (1st Cir. 1999) (citing Rice, 331 U.S. at 230). For example, in Hillsborough
County, the Supreme Court held that local ordinances regulating blood plasma
donation were not preempted by federal standards also governing blood plasma
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donation under a theory of field preemption. 471 U.S. at 723. There, the
comprehensiveness of the FDA’s regulations was not enough to overcome the
presumption against preemption for “state or local regulation of matters related to
health and safety.” Id. at 715.
The Plaintiffs, on the other hand, argue that a competing presumption in favor
of preemption should apply because the MPA Amendments touch on foreign affairs
and thus the state is acting in an area traditionally reserved to the federal
government. Natsios, 181 F.3d at 73, 77 (finding preemption where state legislation
affected foreign affairs), aff’d on other grounds sub nom. Crosby v. Nat’l Foreign Trade
Council, 530 U.S. 363 (2000).6 This presumption in favor of preemption where a state
legislates in the traditional federal area of foreign affairs is based in part on a need
for federal uniformity regarding foreign commerce, which is “pre-eminently a matter
of national concern.” Japan Line, Ltd. v. Los Angeles Cnty., 441 U.S. 434, 448 (1979);
see also Hines, 312 U.S. at 63 (“Our system of government is such that the interest of
the cities, counties and states, no less than the interest of the people of the whole
nation, imperatively requires that federal power in the field affecting foreign
relations be left entirely free from local interference.”). If Congress has spoken with
respect to foreign commerce, any state law that compromises the uniformity of that
federal directive must be carefully scrutinized.
The Supreme Court affirmed Natsios on the basis of obstacle preemption rather than field
preemption, but noted that “field pre-emption may be understood as a species of conflict pre-emption.”
Crosby, 530 U.S. at 374 n.8 (2000).
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When undertaking preemption analysis, courts may evaluate whether the aim
of the state law is to affect an area of federal regulation or interest. For instance, in
Natsios, the First Circuit was unmoved by Massachusetts’ claim that its law
restricting trade with Burma was an exercise of its state procurement authority, a
traditional area of state power, when the state law was “aimed primarily at effecting
change in and expressing disapproval of the current regime in Burma.” 181 F.3d at
74; see also N.H. Motor Transport Ass’n, 301 F.Supp.2d at 44 (evaluating whether a
Maine tobacco delivery law was a “disguised attempt to impose state regulations on
interstate trucking.”).
IV.
Application of the Governing Law
The Plaintiffs have not argued that the FDCA expressly preempts state law,
but focus instead on whether the MPA Amendments are preempted under field
preemption and conflict preemption principles. The Court begins with the Plaintiffs’
contention that the MPA Amendments violate the Supremacy Clause under the
theory of field preemption.
A.
Defining the Field
In order to decide whether Congress intended to occupy the field, it is
important, first, to define the field.7 The Plaintiffs assert that the relevant field is the
The First Circuit’s decision in In re Pharmaceutical Industry Average Wholesale Price
Litigation, 582 F.3d 156 (2009), demonstrates the importance of properly defining the field in
preemption analysis. There, the district court found that a pharmaceutical company violated a
Massachusetts consumer protection statute by publishing false “average wholesale prices,” and
therefore injuring those who paid inflated drug prices. In re Pharm. Indus. Average Wholesale Price
Litig., 582 F.3d at 160. The company appealed and argued that Congress’s complex Medicare scheme
preempted the Massachusetts law with respect to the computation and reimbursement of claims. Id.
at 172. Because the consumers’ claims did not challenge the government’s calculation of
reimbursements under Medicare, but instead challenged the pharmaceutical company’s publication of
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importation of prescription drugs into the United States. The State counters that the
relevant field is limited to the regulation and licensure of pharmacies and
pharmacists, an area traditionally reserved for the states.
Pharmacist licensure does indeed implicate the traditionally local sphere of
public health and safety. Maine, like other states, has a Board of Pharmacy
responsible for regulating the licensure of pharmacies and pharmacists. See 32
M.R.S. § 13711. The FDCA does not regulate the licensure of pharmacists; it instead
leaves that area to individual states. See, e.g., 21 U.S.C. § 360(g) (referencing
“pharmacies which maintain establishments in conformance with any applicable
local laws regulating the practice of pharmacy.”); 21 U.S.C. § 384(a)(2) (defining
“pharmacist” as “a person licensed by a State to practice pharmacy.”). 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. Arizona, 132 S. Ct. at 2502.
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. See 32 M.R.S. § 13731(1)(B). Unlike the local
blood plasma donation law in Hillsborough County, the MPA Amendments extend
inflated prices, the First Circuit held that the field, correctly described, was consumer protection. Id.
at 177-78.
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beyond the traditionally local arena of public health and safety and into the
traditionally federal spheres of foreign commerce and affairs. See id. The existence of
a state interest does not preclude a finding that the field is within the traditional
federal sphere of foreign commerce. See Natsios, 181 F.3d at 74.
The legislative history of the MPA Amendments indicates that their purpose
was to allow the importation of pharmaceuticals from pharmacies abroad. The Act’s
title—“An Act To Facilitate the Personal Importation of Prescription Drugs from
International
Mail
Order
Prescription
Pharmacies”—further
supports
this
interpretation of the State’s aim. The MPA Amendments did not merely repeal
pharmacy licensure laws. Instead, they were the State’s attempt to enable
importation of certain cheaper foreign pharmaceuticals.
The Court agrees with the Plaintiffs that, properly defined, the field at issue
here is the importation of foreign pharmaceuticals. The question, then, is whether
the FDCA forecloses the State’s foray into the realm of pharmaceutical importation.
“[W]hether the regulation of an entire field has been reserved by the Federal
Government is, essentially, a question of ascertaining the intent underlying the
federal scheme.” Hillsborough Cnty., Fla., 471 U.S. at 714.
B.
Purpose and Structure of the FDCA
As the Supreme Court has observed, “Congress enacted the FDCA to bolster
consumer protection against harmful products.” Wyeth, 555 U.S. at 574. In
furtherance of this purpose, Congress has created a complex regulatory scheme
covering the importation of pharmaceuticals into the United States. The FDCA
prohibits the importation or introduction into interstate commerce of any “new drug”
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that has not received FDA approval. See 21 U.S.C. § 355. “New drug applications”
require a variety of information, including information on the drug manufacturer, the
drug’s packaging, and how the drug will be labeled. See 21 U.S.C. § 355(b)(1). As such,
even if a foreign drug is chemically identical to its domestic counterpart, it is still
“unapproved”—and thus cannot be imported legally—unless it is manufactured,
packaged, and labeled according to the specifications in its new drug application. See
United States v. 1500 90-Tablet Bottles, 384 F.Supp.2d 1205, 1218 (N.D. Ill. 2005).
Congress has also legislated explicitly with respect to the importation of drugs
from Canada. As discussed above, even though the relevant section has not taken
effect, the MMA does provide a path to legally permissible importation. See 21 U.S.C.
§ 384. As the Eighth Circuit has reasoned:
That Congress created a special procedure for authorizing importation
of prescription drugs from Canada supports our conclusion that the preexisting system established by the [FDCA] does not permit such
importation. While it is true that no federal statute by its express terms
bans importation of prescription drugs from Canada, such an explicit
country-by-country prohibition is unnecessary to accomplish the task.
By creating the comprehensive regulatory system described above,
Congress has effectively precluded importation of these drugs absent the
sort of special authorization contemplated by 21 U.S.C. § 384.8
In re Canadian Import Antitrust Litig., 470 F.3d 785, 790 (8th Cir. 2006). The
importation contemplated, but not yet allowed, under the MMA, together with the
complex regulatory system established by the FDCA’s drug approval, labeling, and
packaging provisions, demonstrate a clear Congressional intent to tightly control
21 U.S.C. § 384 contains the MMA’s certification provision. It instructs that “[t]his section
shall become effective only if the Secretary certifies to the Congress that the implementation of this
section will (A) pose no additional risk to the public’s health and safety; and (B) result in a significant
reduction in the cost of covered products to the American consumer.” 21 U.S.C. § 384(l)(1).
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prescription drug importation.9 Based on the foregoing, the Court concludes that the
FDCA occupies the field of importation of pharmaceuticals from foreign countries.
The MPA Amendments’ singling out of certain countries from which
pharmaceuticals may be imported compromises the tightly regulated structure set up
by the FDCA and the federal government’s ability to “speak with one voice” when it
regulates foreign commerce. Japan Line, 441 U.S. at 449.
The State’s arguments do not convince the Court otherwise. The State argues
that it has no obligation to regulate in order to further the policies underlying the
FDCA, because it is inconsistent with the Tenth Amendment for the federal
government to “compel the States to enact or administer a federal regulatory
program.” New York v. United States, 505 U.S. 144, 188 (1992); see also Printz, 521
U.S. at 933. However, this Tenth Amendment principle cannot save a state law that
obstructs federal law. Printz, 521 U.S. at 913. To use the Plaintiffs’ example, if the
federal government bans coffee for health reasons, the federal government cannot
insist that the states follow suit by also banning coffee. But, states may not authorize
the purchase of foreign coffee if the federal government institutes an embargo
prohibiting its importation. See Pls.’ Combined Reply in Supp. of Mot. for J. on the
In the past, the State seemed to acknowledge that it owed deference to federal law in the area
of prescription drug importation. For example, in 2005 the Maine legislature enacted “An Act to
Establish a Program for the Purchase of Prescription Drugs from out of the Country for the Elderly
and Disabled.” 2005 Me. Legis. Serv. Ch. 165 (H.P. 369) (L.D. 494) (West), codified at 22 M.R.S. § 254C. Any program pursuant to § 245-C would only be established “when permitted by federal law or by
the granting of a waiver by the United States Secretary of Health and Human Services.” 22 M.R.S.
§ 254-C. The “when permitted” language suggests that the Maine legislature did not believe a
Canadian importation program was consistent with then-existing federal law. Section 254-C does,
however, reflect an optimism that the relevant section of the MMA would someday take effect.
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Pleadings & Opp’n to Defs.’ Cross-Mot. for J. on the Pleadings 3 (ECF No. 59). Federal
law may preempt state law even where the federal government may not compel a
state government to enact or administer a federal legislative or regulatory scheme.
See Printz, 521 U.S. at 913. The Tenth Amendment does not save the MPA
Amendments from preemption.
The marijuana cases cited by the State are distinguishable as well. See Defs.’
Mem. in Opp’n to Pls.’ Mot. for J. on the Pleadings & Cross-Mot. for J. on the
Pleadings 13, 17, 20, 21 (citing Ter Beek v. City of Wyoming, 495 Mich. 1 (2014);
Qualified Patients Ass’n v. City of Anaheim, 187 Cal. App. 4th 734 (Cal. App. 2010);
Cnty. of San Diego v. San Diego NORML, 165 Cal. App. 4th 798 (Cal. App. 2008);
People v. Crouse, No. 12CA2298, 2013 WL 6673708 (Colo. App. Dec. 19, 2013)). None
of the marijuana cases involved field preemption because Congress included a
“savings clause” in the Controlled Substances Act that expressly provides that
Congress did not intend to occupy the field. See 21 U.S.C. § 903 (“No provision of this
subchapter shall be construed as indicating an intent on the part of Congress to
occupy the field in which that provision operates, including criminal penalties, to the
exclusion of any State law on the same subject matter which would otherwise be
within the authority of the State, unless there is a positive conflict between that
provision of this subchapter and that State law so that the two cannot stand
together.”).10 Accordingly, these cases are not on point.
Congress included a savings clause in the 1962 amendments to the FDCA, which instructs
that “[n]othing in the amendments made by this Act . . . shall be construed as invalidating any
provision of State law which would be valid in the absence of such amendments unless there is a direct
and positive conflict between such amendments and such provision of State law.” Pub. L. No. 87-781,
10
17
The Plaintiffs have established that “no set of circumstances exists under
which the Act would be valid.” Salerno, 481 U.S. at 745 (1987). 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.11
CONCLUSION
For the reasons stated above, the Court GRANTS the Plaintiffs’ motion (ECF
No. 46) with respect to Count I and declares that the FDCA preempts the MPA
Amendments pursuant to the Supremacy Clause of the United States Constitution.
The Court therefore DENIES the Defendants’ motion (ECF No. 57). The Clerk’s
Office will schedule a conference of counsel to discuss what remains of this case in
light of this Order.
SO ORDERED.
76 Stat. 793. The State mentions this savings clause in its briefing, see Defs.’ Mem. in Opp’n to Pls.’
Mot. for J. on the Pleadings & Cross-Mot. for J. on the Pleadings 10, but does not develop how it should
affect the Court’s preemption analysis. In any event, the Court does not view the FDCA’s savings
clause as affecting field preemption analysis in this case.
The Court does not reach the Plaintiffs’ additional theories of preemption because the MPA
Amendments are unconstitutional under the theory of field preemption.
11
18
/s/ Nancy Torresen
United States Chief District Judge
Dated this 23rd day of February, 2015.
19
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