
NATIONAL
PHARMACIES, INC., Plaintiff,
v.
Carmen
Feliciano DE MELECIO, Secretary Of Health, et al., Defendants.
No. Civ.
95-1342(HL).
United
States District Court,
D. Puerto
Rico.
March 31,
1999.
OPINION
AND ORDER
LAFFITTE,
Chief Judge.
Before
the Court is Plaintiff National Pharmacies, Inc.'s
("National") request for declaratory and injunctive relief.
National, a New Jersey corporation engaged in the business of filling
medical prescriptions through the mail, challenges the constitutionality
of certain Puerto Rico statutes which govern the pharmacy industry.
National claims that these laws and their attempted enforcement by
Defendants violate National's rights under the Dormant Commerce Clause
and the First Amendment. Defendants are Carmen Feliciano, the Puerto
Rico Secretary of Health; the Colegio de Farmaceuticos ("Colegio"),
a quasi-public corporation charged with governing the conduct and
defending the rights of pharmacists practicing in Puerto Rico; and the
Asociacion de Duenos de Farmacias de Puerto Rico ("Asociacion"),
a non-profit organization comprised of owners of retail pharmacies in
Puerto Rico. The Puerto Rico Secretary of Justice has intervened as a
defendant in this case. [FN1] Also, the American Managed Care Pharmacy
Association and Retired Persons Services, Inc. have filed amicus curae
briefs in support of National's position. The parties have submitted
extensive briefs, as well as a set of stipulated facts. [FN2]
FN1.
See 28 U.S.C.A. § 2403(b) (West 1994) (In a suit where the
constitutionality of a state law is challenged, the attorney general of
the state shall be allowed to intervene).
FN2.
Defendants had objected to stipulated facts numbered 14 and 16. They
objected not because they believed them to be untrue, but merely because
they felt they were not relevant. These stipulated facts detail the
nature of National's operations. The Court holds that these facts are
relevant. The objection is denied.
In its
complaint and motion for injunctive relief, National challenges sections
385, 396, 401, and 402 of the Pharmacy Act of Puerto Rico [FN3] and
section 433 of the chapter which creates the Colegio de Farmaceuticos.
[FN4] Section 385 requires that every practicing pharmacist be
registered with the Board of Pharmacy [FN5] and be a member of the
Colegio. P.R.Laws Ann. tit. 20, § 385. Section 396 reads in pertinent
part
FN3.
P.R.Laws Ann. tit. 20, §§ 381 - 406 (1988).
FN4.
P.R.Laws Ann. tit. 20, §§ 431 - 441 (1988).
FN5.
The Board of Pharmacy is composed of five Puerto Rico pharmacists who
are appointed by the Governor. In addition to registering pharmacists,
the Board oversees regulations governing the practice of pharmacy and
the licensing examination for pharmacists. P.R.Laws Ann. tit. 20, §§
383 & 384.
Every
establishment devoted, or which may hereafter be devoted, to the sale of
medicines, chemical or pharmaceutical products, patent medicines, drugs
wholesale or retail, or manufacture of medicines shall have to apply to
the Secretary of Health for a license and the Secretary of Health shall
have power to issue same after inspection of the establishment, provided
the establishment, in the discretion of the Secretary of Health, meets
the purposes and requirements of this chapter.
Id.
§ 396. Section 401 reads as follows: "In all cases where a
pharmacist is practicing his profession he shall be a member of the
College of Pharmacists of Puerto Rico, of age, shall manage in person
the establishment under his supervision, and shall reside in the town in
which he is practicing." Id. § 401. Section 402 requires
that every pharmacy be managed by a pharmacist authorized to practice in
Puerto Rico. The section further requires that the pharmacist may only
be absent from the pharmacy for a limited number of hours per week. Id.
§ 402. Section 433 states All pharmacists admitted to practice the
profession by the Board of Pharmacists of Puerto Rico and those
pharmacists to whom the Board of Pharmacists has issued special
authorization to practice at a Commonwealth or municipal government
health facility pursuant to the provisions of section 71 et seq. of this
title shall be members of the College.
No person
who is not a member thereof may practice the profession of pharmacists
in the Commonwealth of Puerto Rico. Id. § 433. The Secretary of
Health is charged with inspecting pharmacies in Puerto Rico and with
enforcing these laws. Id. § 383. National's general claim is
that this statutory framework prevents it from doing business in Puerto
Rico and that therefore the statutes unconstitutionally restrict
interstate commerce.
The
parties have stipulated to the following facts: Plaintiff National owns
and operates a mail-order pharmacy in New Jersey. National is properly
registered under the appropriate New Jersey laws and is registered with
the Drug Enforcement Administration of the United States Department of
Justice. National employs a number of pharmacists who are properly
licensed and registered under the relevant laws of New Jersey. National
is also registered in twenty-two states as a nonresident pharmacy.
National is subject to inspection and audits by authorities from New
Jersey, the DEA, and those states where it is registered as a
nonresident pharmacy. National's customer base consists of patients
throughout the United States. These customers mail their prescriptions
to National. The company's pharmacists in New Jersey then fill the
prescriptions and mail them out to the customers. There is thus no face-
to-face contract between pharmacist and patient. National does not own
or operate a pharmacy in Puerto Rico. None of its pharmacists reside in
Puerto Rico, are licensed to practice here, or are members of the
Colegio. In January 1994 National entered into a contract with Blue
Cross of Puerto Rico, a health insurance provider. Pursuant to this
agreement, National would fill the prescriptions of Blue Cross' clients
by mail. [FN6]
FN6.
Docket no. 55.
In
addition to the above-mentioned stipulated facts, the record indicates
the following: In 1992, the Colegio filed an administrative complaint
with the Department of Health against Blue Cross of Puerto Rico. The
administrative claim alleged that Blue Cross was beginning a marketing
campaign to offer a mail-order pharmacy service to its customers and
that such a service violated the pharmacy laws of Puerto Rico. [FN7] In
September 1994, the Colegio moved to dismiss this administrative claim
and filed a claim against Blue Cross for declaratory and injunctive
relief in Puerto Rico Superior Court. In its Superior Court complaint,
the Colegio alleged that Blue Cross' program to provide prescription
medicines through the mail meant that prescriptions would be filled by a
pharmacist not licensed to practice in Puerto Rico and working at a
pharmacy not authorized to do business in Puerto Rico. [FN8] Therefore,
the Colegio claimed, Blue Cross' practice violated the pharmacy laws of
Puerto Rico.
FN7.
Docket no. 44, exhibit D.
FN8.
Civil no. KPE 94-0563(907), San Juan Part. Docket no. 37, exhibit E.
During
this same time period, the Colegio and the Asociacion were attacking the
mail-order business on another front. The presidents of both
organizations wrote to the Secretary of Health to complain about the
mail-order pharmacy business and to inquire as to the Department of
Health's position on this practice. [FN9] The Secretary of Health asked
her general counsel for an opinion on the legality of this business. In
her counsel's response he opined that the Pharmacy Act provides that
only a pharmacy registered in Puerto Rico which employs a pharmacist who
is a member of the Colegio can fill a prescription in Puerto Rico.
Moreover, the Act requires that the pharmacist be present at the place
where the pharmacy operates in Puerto Rico and that the pharmacist
reside in the town where he is practicing. The Secretary's counsel
concluded that therefore the practice of filling prescriptions outside
of Puerto Rico and delivering them by mail to the customers violated the
Pharmacy Act. [FN10] Based on this opinion, the Secretary of Health
wrote back to the Colegio and the Asociacion on November 29, 1994. In
her letters she stated that the mail-order pharmacy business violated
Puerto Rico law and that any member of either organization who was aware
of this practice should file an administrative complaint with the
Department of Health. [FN11] In January 1995, the Asociacion brought an
administrative complaint before the Department of Health against Blue
Cross, National, other mail-order pharmacies, and other organizations
that sponsored health plans which offered this service. The complaint
alleged that mail-order pharmacy violated Puerto Rico law. [FN12] The
administrative claim has since been stayed, and the Superior Court case
has been dismissed. [FN13] The administrative claim was stayed pending
the resolution of the case before this Court. The Superior Court case
was dismissed without prejudice, by agreement of the parties. It appears
that the Superior Court case dismissal--like the stay in the
administrative case--was entered in deference to the resolution of the
controversy presently before this Court. [FN14]
FN9.
Docket no. 44, exhibits F & J.
FN10.
Docket no. 44, exhibit N.
FN11.
Docket no. 44, exhibits G & K.
FN12.
Docket no. 37, exhibit I.
FN13.
Civil no. KPE94-0563 (803), Puerto Rico Superior Court, San Juan Part;
Complaint no. Q-95-1-01, Puerto Rico Department of Health Administrative
hearing. The Court takes judicial notice of the proceedings in these
cases. See Lamar v. Micou, 114 U.S. 218, 223, 5 S.Ct. 857,
859, 29 L.Ed. 94 (1885) ("The law of any State of the Union,
whether depending upon statutes or upon judicial opinions, is a matter
of which the courts of the United States are bound to take judicial
notice, without plea or proof."); Retired Chicago Police Ass'n
v. City of Chicago, 7 F.3d 584, 609 n. 30 (7th Cir.1993) ("This
court can take judicial notice of the decisions of federal and state
courts."); Parente v. Town of West Warwick, 868 F.2d 522,
523 (1st Cir.1989) (taking judicial notice of a state court's opinion);
see generally Fed.R.Evid. 201.
In order
to make the record as complete as possible, the Court orders the Clerk
to enter and translate the following documents from the Superior Court
case: a motion to stay dated October 5, 1995, an order setting a status
conference to discuss the motion, the minutes to the status conference,
and the judgment dismissing the case. The Court further orders that the
notification of stay in the administrative claim be filed and
translated.
FN14.
In the Superior Court case, the parties agreed to a dismissal of the
case at a status conference held on October 25, 1995. The minutes to the
conference do not specify the parties' reasons for this agreement. The
conference was held to discuss a motion by Defendant Blue Cross. In that
motion Blue Cross requested that the case be stayed pending the
resolution of the federal court case and stated that the parties were in
agreement on this matter. See Motion of Blue Cross filed October
5, 1995 & Notification of status conference dated October 16, 1995.
Accordingly, the Court assumes that the Superior Court case was
dismissed for the reasons set forth in the motion to stay, that is, to
allow this Court to resolve the present controversy.
Faced
with this hostility to its modus operandi, National brought the present
action. It alleges that the above-cited statutes constitute
protectionist measures which prevent it from conducting business in
Puerto Rico. Therefore, National argues, these statutes
unconstitutionally limit interstate commerce in violation of the Dormant
Commerce Clause. National also argues that the Puerto Rico statutes are
preempted by the federal Comprehensive Drug Abuse Prevention and Control
Act of 1970. [FN15] National seeks declaratory and injunctive relief.
Defendants have opposed this request, arguing that National does not
have standing to bring this claim; that the practice of pharmacy is a
profession and not a part of interstate commerce; and that the subject
laws constitute a legitimate exercise of Puerto Rico's police powers
over the health and welfare of its citizens.
FN15.
Pub.L. No. 91-513, 84 Stat. 1236 (codified in scattered sections of 18,
19, 21, 26, 31, 40, 42, and 46 U.S.C.).
DISCUSSION
1. National's
standing
The
Secretary of Justice argues that National lacks standing to bring this
caim. [FN16] He argues that National's claims are hypothetical and that
it has not suffered any concrete injuries. Standing, one of the most
complex areas in the field of federal jurisdiction, is a threshold issue
which goes to a federal court's power to hear a claim. Berner v.
Delahanty, II, 129 F.3d 20, 23 (1st Cir.1997). Before a court may
consider the merits of a case, it must first determine whether there is
standing to bring the cause of action. Id. If the plaintiff lacks
standing, the court lacks jurisdiction to entertain the case. New
Hampshire Right to Life Political Action Comm. v. Gardner, 99 F.3d
8, 12 (1st Cir.1996). In order to have standing, the plaintiff must
establish the following elements: (1) an "injury in
face"--that the plaintiff has suffered an actual or threatened
injury which is particularized and concrete, and not merely hypothetical
or conjectural; (2) causation--that the injury is fairly traceable to
complained-of conduct of the defendant; and (3) redressability--that it
is likely that the alleged injury will be redressed by the requested
relief. Legal Aid Soc'y of Hawaii v. Legal Services Corp., 145
F.3d 1017, 1030 (9th Cir.1998) (White, J.(Ret.), sitting by
designation); Gardner, 99 F.3d at 13; Caribbean Int'l News Corp. v.
Fuentes Agostini, 12 F.Supp.2d 206, 211-12 (D.P.R.1998).
FN16.
In addition to claiming that National lacks standing, the Secretary of
Justice argues that this controversy is not ripe for adjudication.
Whether a plaintiff has suffered an injury is an integral issue under
both the standing and ripeness doctrines. Oftentimes the two concepts
overlap. In such cases, whether the injury analysis is done as a
question of standing or of ripeness is of no moment. See generally
Erwin Chemerinsky, Federal Jurisdiction § 2.4.1, at 114-15 (2d
ed.1994); Hallandale Professional Fire Fighters Local 2238 v. City of
Hallandale, 922 F.2d 756, 760 n. 3 (11th Cir.1991). So it is here.
In the interest of conciseness, the Court will treat the ripeness and
standing arguments as one and the same.
The
"injury in fact" element requires that the plaintiff have
suffered "an invasion of a legally protected interest which is (a)
concrete and particularized, and (b) actual or imminent, not conjectural
or hypothetical." Lujan v. Defenders of Wildlife, 504 U.S.
555, 560, 112 S.Ct. 2130, 2136, 119 L.Ed.2d 351 (1992) (citations and
internal quotations omitted). The concept of imminence is intended to
ensure that the plaintiff's alleged injury is not overly speculative. Sea
Shore Corp. v. Sullivan, 158 F.3d 51, 56 (1st Cir.1998). In the
present case it is uncontested that National operates a mail-order
pharmacy and that it has contracted with Blue Cross of Puerto Rico to
provide such services to Puerto Rico residents. It is also uncontested
that the Secretary of Health believes such practice to be illegal under
Puerto Rico law and that she has encouraged the members of the Colegio
and the Asociacion to bring lawsuits against mail-order pharmacy
companies. [FN17] The Asociacion has done exactly that with its
administrative complaint before the Department of Health against Blue
Cross, National, and other mail-order pharmacies. This administrative
complaint alleged that mail-order pharmacy violated Puerto Rico law.
[FN18] The conduct of Defendants as a whole constitutes a concrete, non-
speculative threat to National's business operations. Thus, there is
present in the case a viable injury in fact for purposes of standing.
FN17.
Docket no. 44, exhibits G & K.
FN18.
Docket no. 37, exhibit I.
With
regard to the other two elements of standing, any injury suffered by
National would be properly redressed by an action seeking to have the
Puerto Rico laws regulating pharmacy declared unconstitutional and
naming as a defendant the Secretary of Health in her official capacity,
the government official charged with enforcing these laws. [FN19]
Gardner, 99 F.3d at 13; Caribbean Int'l News, 12 F.Supp.2d at 212.
Furthermore, National's alleged injury is traceable to these laws and
their attempted enforcement to stop National from filling the
prescriptions of Puerto Rico residents by mail. Thus, the three prongs
of the standing requirement are met.
FN19.
In its complaint, National seeks declaratory and injunctive relief, but
no monetary relief. Thus, this claim is properly brought against the
Secretary of Health in her official capacity only. See Will v.
Michigan Dep't of State Police, 491 U.S. 58, 71 n. 10, 109 S.Ct.
2304, 2312 n. 10, 105 L.Ed.2d 45 (1989).
The
standing doctrine also embodies prudential concerns regarding the proper
exercise of federal jurisdiction. Dubois v. United States Dep't of
Agric., 102 F.3d 1273, 1281 (1st Cir.1996); United States v. AVX
Corp., 962 F.2d 108, 114 (1st Cir.1992). To meet these additional
concerns, a suit must satisfy certain criteria. First, the complaint
must "fall within the zone of interests protected by the law
invoked." Gardner, 99 F.3d at 15 (quoting Allen v. Wright,
468 U.S. 737, 751, 104 S.Ct. 3315, 3324, 82 L.Ed.2d 556 (1984) (internal
quotations omitted)); Caribbean Int'l, 12 F.Supp.2d at 213. Second, the
plaintiff generally should assert only his own rights and should not
base his claim on the rights and interests of a third party. Gardner, 99
F.3d at 15 (quoting Warth v. Seldin, 422 U.S. 490, 499, 95 S.Ct.
2197, 2205, 45 L.Ed.2d 343 (1975)). Third, the case must contain more
than "abstract questions of wide public significance which amount
to generalized grievances, pervasively shared and most appropriately
addressed in the representative branches." Gardner, 99 F.3d at 15
(quoting Valley Forge Christian College v. Americans United for
Separation of Church and State, 454 U.S. 464, 475, 102 S.Ct. 752,
760, 70 L.Ed.2d 700 (1982) (internal quotations omitted)).
In the
present case, National's claims implicate its rights to operate in
interstate commerce free from unconstitutional burdens; therefore, it
falls within the zone of protected constitutional rights. Second,
National is bringing its claim solely on its own behalf. Third, its
claims that the challenged laws prevent it from doing business in Puerto
Rico are sufficiently specified grievances. Therefore, the Court finds
that these additional criteria are also satisfied. Based on all of the
above, the Court finds that National has established the existence of an
actual or threatened injury which is traceable to the challenged
statutes and which would be redressed by the relief requested. Also,
there are prudential concerns which justify the exercise of federal
jurisdiction. Accordingly, the Court finds that National has standing to
bring this claim.
2. Abstention
The
Secretary of Health argues that this Court should refrain from hearing
this controversy under the abstention doctrines of either Younger v.
Harris, 401 U.S. 37, 91 S.Ct. 746, 27 L.Ed.2d 669 (1971) or Colorado
River Water Conservation District v. United States, 424 U.S. 800, 96
S.Ct. 1236, 47 L.Ed.2d 483 (1976). Abstention is an "extraordinary
and narrow exception" to a federal court's duty to hear a case
properly before it. Colorado River, 424 U.S. at 813, 96 S.Ct. at 1244
(quoting County of Allegheny v. Frank Mashuda Co., 360 U.S. 185,
188-89, 79 S.Ct. 1060, 1063, 3 L.Ed.2d 1163 (1959) (internal quotations
omitted)); Harris County Comm'rs Court v. Moore, 420 U.S. 77, 83,
95 S.Ct. 870, 875, 43 L.Ed.2d 32 (1975). A federal court has a
"virtually unflagging obligation" to exercise its
jurisdiction. Colorado River, 424 U.S. at 817, 96 S.Ct. at 1246; Pustell
v. Lynn Public Schools, 18 F.3d 50, 53 (1st Cir.1994). Generally,
federal courts should almost always assert their jurisdiction. Delgado
v. Plaza Las Americas, Inc., 139 F.3d 1, 3 (1st Cir.1998). This
jurisdiction should not be lightly relinquished, even when the court is
confronted with difficult state law issues or parallel state litigation.
Lundborg v. Phoenix Leasing, Inc., 91 F.3d 265, 272 (1st
Cir.1996). A federal court ordinarily may abstain out of deference to an
ongoing local court proceeding which was initiated prior to the federal
action.
Chaulk
Serv., Inc. v. Massachusetts Comm'n Against Discrimination,
70 F.3d 1361, 1368 (1st Cir.1995); see also Harris County, 420
U.S. at 84, 95 S.Ct. at 875 ("Where there is an action pending in
state court that will likely resolve the state-law questions underlying
the federal claim, we have regularly ordered abstention.").
In the
case before the Court, there are no ongoing local proceedings to which
this Court may defer. Of the two proceedings that were begun prior to
the initiation of the present case, one was dismissed by mutual
agreement of the parties and the other was stayed. The administrative
court complaint was stayed precisely to allow this Court to rule first,
and it appears that the dismissal of the Superior Court case was done
for the same reason. Thus, the local proceedings have deferred to the
federal court. An abstention now would unduly delay the final resolution
of this controversy and would run counter to the justification for the
staying of the local proceedings. Because the local fora have deferred
to this one, because any abstention would further delay this case, and
because this Court should be hesitant to abstain from hearing a case
properly before it, the Court holds that abstention is not appropriate
in this case. See also Cuesnongle v. Ramos, 835 F.2d 1486,
1499-1500 (1st Cir.1987) (Abstention not appropriate where it would
cause delay and where highest local court has declined to hear matter).
3. National's
argument that Puerto Rico's pharmacy lawsare preempted by federal
statutes
In
addition to claiming that the Puerto Rico statutes unconstitutionally
limit interstate commerce and the First Amendment, National also asserts
that the statutes are preempted by the Comprehensive Drug Abuse
Prevention and Control Act. A court should first attempt to resolve a
case on statutory grounds before addressing any constitutional ones. New
York City Transit Auth. v. Beazer, 440 U.S. 568, 582, 99 S.Ct. 1355,
1364, 59 L.Ed.2d 587 (1979); Cuesnongle, 835 F.2d at 1493-94; Aggarwal
v. Ponce School of Medicine, 745 F.2d 723, 726 (1st Cir.1984). Thus,
the Court first must address National's preemption argument.
The
Constitution provides that federal statutes "shall be the supreme
Law of the Land," notwithstanding any contrary state laws. U.S.
Const. art. VI., § 2. Therefore, when a state statute conflicts with a
federal one, the latter preempts the former; the state statute thus is
without effect. Maryland v. Louisiana, 451 U.S. 725, 746, 101
S.Ct. 2114, 2128-29, 68 L.Ed.2d 576 (1981); Rini v. United Van Lines,
104 F.3d 502, 504 (1st Cir.1997). If Congress has not made an express
statement that a federal law should supplant a state one, preemption may
be established in one of two ways. First, if Congress intends that a
federal statute "occupy a given field," state law on that area
is preempted. California v. ARC America Corp., 490 U.S. 93, 100,
109 S.Ct. 1661, 1665, 104 L.Ed.2d 86 (1989). Second, state law is
preempted when it "actually conflicts" with federal law so
that it is impossible to comply with both a federal and state statute or
when the state law becomes an obstacle to the accomplishment of
Congressional intent. Id. at 100-01, 109 S.Ct. at 1665.
In the
determination of whether a federal law preempts a state law, Congress'
purpose is the "ultimate touchstone." Medtronic, Inc. v.
Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240, 2250, 135 L.Ed.2d 700
(1996) (quoting Retail Clerks Int'l Ass'n v. Schermerhorn, 375
U.S. 96, 103, 84 S.Ct. 219, 223, 11 L.Ed.2d 179 (1963) (internal
quotations omitted)). When making its analysis, a court should begin
with the assumption that a state's historic powers should not be
superseded by a federal statute unless it was Congress' clear and
manifest intent to do so. ARC, 490 U.S. at 101, 109 S.Ct. at 1665; Rice
v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152,
91 L.Ed. 1447 (1947); Massachusetts v. F.D.I.C., 102 F.3d 615,
622 (1st Cir.1996). A court should not quickly infer a congressional
attempt to preempt traditional police powers of the states. Smith v.
America West Airlines, Inc., 44 F.3d 344, 346 (5th Cir.1995). These
historic police powers include those of a state to legislate to protect
the safety and health of its citizens. Medtronic, 518 U.S. at 475, 116
S.Ct. at 2245.
Where
Congress has included an express clause on preemption, a court should
begin its analysis with that clause's language. Grenier v. Vermont
Log Bldgs., Inc., 96 F.3d 559, 562-63 (1st Cir.1996); Wilson v.
Bradlees of New England, Inc., 96 F.3d 552, 554 (1st Cir.1996). The
federal statute relevant to this case contains the following provision:
Application
of State Law
No
provision of this subchapter shall be construed as indicating an intent
on the part of the 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
consistently stand together.
21 U.S.C.A. § 903 (West 1981). This express statement by Congress that the
federal drug law does not generally preempt state law gives the usual
assumption against preemption additional force. United States v.
Moffitt, Zwerling & Kemler, P.C., 83 F.3d 660, 668 (4th
Cir.1996). In the present case, the Puerto Rico laws which National is
challenging regulate the registration and licensing of pharmacists in
Puerto Rico. The federal statutes which National claims to preempt the
local laws deal with the manufacture, distribution, and dispensing of
controlled substances. "Controlled substances" are defined by
the federal statute as those drugs or medications which have the
potential for abuse and which can cause dependency. See 21
U.S.C.A. §§ 802(6) & 812 (West 1981 & Supp.1998). The Puerto
Rico statutes, by contrast, govern pharmacies and pharmacists in their
work with both controlled substances and other classes of medications.
National does not indicate how it would be impossible to comply with
both the federal and Puerto Rico laws nor how the Puerto Rico laws
regulating pharmacists create an obstacle to the fulfillment of the
goals of the Comprehensive Drug Abuse Prevention and Control Act.
Moreover, National does not indicate that this federal law was intended
to occupy the entire field of regulation of pharmacists. National does
argue that the requirements of the Puerto Rico laws unduly burden
interstate commerce and that National's own compliance with the federal
statutes and New Jersey's pharmacy laws should satisfy any concerns
Puerto Rico might have regarding the control and regulation of
pharmacists. This claim goes to the question of whether the Puerto Rico
laws constitute an unconstitutional restriction on interstate commerce,
and the Court addresses that issue below. It is a claim which does not,
however, demonstrate that there is an actual conflict between the
federal and local statutory regimes. Therefore, the Court denies
National's argument that the challenged Puerto Rico laws are preempted
by the Comprehensive Drug Abuse Prevention and Control Act.
4. Defendants'
argument that pharmacy is a profession and not subject to interstate
commerce analysis
Defendants
claim that the practice of pharmacy is a profession, not a part of
commerce, and Puerto Rico's regulation of pharmacists is therefore not
subject to the strictures of the dormant commerce clause. It is clear
that the states have broad powers to regulate and license the practice
of the professions. Goldfarb v. Virginia State Bar, 421 U.S. 773,
792, 95 S.Ct. 2004, 2015-16, 44 L.Ed.2d 572 (1975); Goldfarb v.
Supreme Court of Virginia, 766 F.2d 859, 862 (4th Cir.1985). It is
similarly clear that the states' police powers include the authority to
legislate to protect the health and safety of their citizens. See
Medtronic, 518 U.S. at 475, 116 S.Ct. at 2245; Maine v. Taylor,
477 U.S. 131, 151-52, 106 S.Ct. 2440, 2454, 91 L.Ed.2d 110 (1986); Ferndale
Laboratories v. Cavendish, 79 F.3d 488, 495 (6th Cir.1996). In the
present case, Puerto Rico has a legitimate interest in regulating the
pharmacy industry within its borders. See Ferndale, 79
F.3d at 495. When a state legislates in an area of legitimate local
concern, however, it continues to be limited by the Commerce Clause. Minnesota
v. Clover Leaf Creamery Co., 449 U.S. 456, 471, 101 S.Ct. 715, 727,
66 L.Ed.2d 659 (1981). This limitation applies even for state
regulations regarding the health of its citizens. See Taylor,
477 U.S. at 137-152, 106 S.Ct. at 2446- 54; Dean Milk Co. v. City of
Madison, Wis., 340 U.S. 349, 353-57, 71 S.Ct. 295, 297-99, 95 L.Ed.
329 (1951).
Courts
have considered whether state laws that regulate a profession
unconstitutionally limited interstate commerce. See Head v.
New Mexico Bd. of Exam'r in Optometry, 374 U.S. 424, 428-29, 83 S.Ct.
1759, 1762-63, 10 L.Ed.2d 983 (1963) (law prohibiting optometrists from
mentioning specific prices in their advertising); Tolchin v. Supreme
Court of New Jersey, 111 F.3d 1099, 1106-11 (3rd Cir.1997)
(requirements for the practice of law in state); Kirkpatrick v. Shaw,
70 F.3d 100, 103 (11th Cir.1995) (rules for lawyers' admission to state
bar); Tetra Technologies, Inc. v. Harter, 823 F.Supp. 1116,
1121-24 (S.D.N.Y.1993) (law on licensing engineers); see also Ferndale,
79 F.3d at 492-96 (regulation of wholesale distributors of
pharmaceuticals); K-S Pharmacies v. American Home Products, 962
F.2d 728, 730-32 (7th Cir.1992) (statute forbidding price discrimination
in wholesale transactions of prescription drugs) (Easterbrook, J.). In
the Sherman Act antitrust context, the professions are considered a part
of interstate commerce. [FN20] See Summit Health, Ltd. v.
Pinhas, 500 U.S. 322, 329-33, 111 S.Ct. 1842, 1847-49, 114 L.Ed.2d
366 (1991) (Allegation that hospitals conspired to exclude a single
physician from the market for ophthalmological services in Los Angeles
was sufficient to establish a nexus to interstate commerce for purposes
of antitrust jurisdiction); Goldfarb, 421 U.S. at 786-88, 95 S.Ct. at
2012-14 (In case involving a minimum legal fee schedule established by
bar association, Court rejected argument that the learned professions
were not a part of trade or interstate commerce); Boddicker v.
Arizona State Dental Ass'n, 549 F.2d 626, 629-32 (9th Cir.1977)
(Dental associations' membership requirements on individual dentists
affected interstate commerce and these practices were not entitled to a
"learned profession" exemption). These antitrust cases have
included the practice of pharmacy. See Northern California
Pharm. Ass'n v. United States, 306 F.2d 379, 386-88 (9th Cir.1962); Fed.
Prescription Serv., Inc. v. Am. Pharm. Ass'n, 484 F.Supp. 1195,
1206-07 (D.D.C.1980) (Mail order pharmacy company challenged defendants'
practices which had affected interstate commerce), rev'd in part on
other grounds, 663 F.2d 253 (D.C.Cir.1981); Am. Pharm. Ass'n v.
United States Dep't of Justice, 344 F.Supp. 9, 12 (E.D.Mich.1971)
(Rejecting an argument that the professional practice of pharmacy is
exempt from the antitrust laws), aff'd 467 F.2d 1290 (6th Cir.1972); United
States v. Utah Pharm. Ass'n, 201 F.Supp. 29, 32-33 (D.Utah 1962)
(Alleged conspiracy by pharmacists to fix and control prices of
prescriptions affected interstate commerce).
FN20.
The scope of the Sherman Act is coterminous with Congress' powers to
regulate interstate commerce. Gulf Oil Corp. v. Copp Paving Co.,
419 U.S. 186, 194, 95 S.Ct. 392, 398, 42 L.Ed.2d 378 (1974); Western
Waste Serv. Systems v. Universal Waste Control, 616 F.2d 1094, 1096
(9th Cir.1980); J.P. Mascaro & Sons, Inc. v. William J. O'Hara,
Inc., 565 F.2d 264, 267 (3rd Cir.1977). Thus, the Court shall look
to antitrust cases for guidance on the issue of whether the pharmacy
profession is part of interstate commerce.
In the
present case, Defendants cite to no case which holds that the practice
of pharmacy, as a profession, is exempt from the jurisprudence on the
dormant commerce clause. The case law cited above indicates that in fact
the contrary proposition is true. This point bears clarification. The
subject laws on the practice of pharmacy within Puerto Rico's territory
constitute a legitimate exercise of its police powers to regulate a
profession whose practice affects the health of Puerto Rico's citizens.
These laws, however, must comply with--and are not exempt from--the
limitations of the Commerce Clause. See Taylor, 477 U.S.
at 150-51, 106 S.Ct. at 2454; Clover Leaf Creamery, 449 U.S. at
471, 101 S.Ct. at 727; Head, 374 U.S. at 427-29, 83 S.Ct. at
1761-63. The Court therefore rejects Defendants' argument that pharmacy
is a profession and not part of interstate commerce.
5. National's
argument that the Puerto Rico pharmacy laws unconstitutionally limit
interstate commerce
National's
primary argument is that the Puerto Rico laws which regulate the
practice of pharmacy constitute an unconstitutional burden on interstate
commerce. The Commerce Clause of the Constitution expressly provides
Congress with the power to regulate interstate commerce. U.S. Const.
art. I, § 8, cl. 3. As a complement to this explicit grant of authority
to Congress, the courts have developed the doctrine of the Dormant
Commerce Clause. Under this doctrine, states are limited in their
authority to enact laws which impose an undue burden on interstate
commerce. [FN21] Lewis v. BT Inv. Managers, Inc., 447 U.S. 27,
35-36, 100 S.Ct. 2009, 2015, 64 L.Ed.2d 702 (1980); United Egg
Producers v. Dep't of Agric., 77 F.3d 567, 570 (1st Cir.1996). The
Dormant Commerce Clause prohibits states from regulating in a manner
that would discriminate against or unduly burden interstate commerce and
would thereby impede free trade in the national marketplace. General
Motors Corp. v. Tracy, 519 U.S. 278, 287, 117 S.Ct. 811, 818, 136
L.Ed.2d 761 (1997). States may not create barriers discriminating
against interstate trade. Lewis, 447 U.S. at 35, 100 S.Ct. at 2015. In
this context, "discrimination" refers to a state's different
treatment for in-state economic interests as compared to out-of-state
interests, with the treatment benefitting the former and burdening the
latter. Oregon Waste Sys., Inc. v. Dep't of Envtl. Quality, 511
U.S. 93, 99, 114 S.Ct. 1345, 1350, 128 L.Ed.2d 13 (1994). A court should
view with suspicion a state statute which requires that business
operations be done in the home state when they could be done more
efficiently out of state. Even though the state may be pursuing a
legitimate local interest with such a regulation, the burden it imposes
on commerce will generally cause the regulation to be declared per se
illegal. Pike v. Bruce Church, Inc., 397 U.S. 137, 145, 90 S.Ct.
844, 849, 25 L.Ed.2d 174 (1970).
FN21.
Puerto Rico is treated as a state for purposes of the Dormant Commerce
Clause. Used Tire Int'l, Inc. v. Diaz-Saldana, 155 F.3d 1, 4 n. 2
(1st Cir.1998); Trailer Marine Transp. Corp. v. Rivera Vazquez,
977 F.2d 1, 7 (1st Cir.1992).
Additionally,
the Commerce Clause prevents a state statute from being applied to
commerce which occurs wholly outside the state's borders, even though
the commerce may have effects within the state. Healy v. Beer
Institute, Inc., 491 U.S. 324, 336, 109 S.Ct. 2491, 2499, 105
L.Ed.2d 275 (1989); Brown-Forman Distillers v. N.Y. State Liquor Auth.,
476 U.S. 573, 582-85, 106 S.Ct. 2080, 2086-87, 90 L.Ed.2d 552 (1986); Edgar
v. MITE Corp., 457 U.S. 624, 641-43, 102 S.Ct. 2629, 2640-41, 73
L.Ed.2d 269 (1982). The critical question is whether the practical
effect of the state law is to control commerce beyond the state's
borders. Healy, 491 U.S. at 336, 109 S.Ct. at 2499. Any state regulation
which attempts to directly assert jurisdiction over persons or property
outside the state's territory exceeds the limits of that state's power.
Edgar, 457 U.S. at 643, 102 S.Ct. at 2641.
a. The
requirements of membership in the Colegio of sections 385, 401, and 433
One of
National's challenges is to the provisions of sections 385, 401, and 433
which require that in order to practice pharmacy in Puerto Rico, a
pharmacist must be a member of the Colegio. P.R.Laws Ann. tit. 20, §§
385, 401, & 433. National claims that it is impossible for
out-of-state pharmacists to become members of the Colegio and that this
membership requirement places an insurmountable burden on interstate
commerce. National fails, however, to explain these assertions. Nowhere
does National establish what are the requirements for membership in the
Colegio, which specific requirement prevents an out-of-state pharmacist
from joining, or how this requirement burdens interstate commerce. The
extent of National's argument on this point is the repeated allegation
that the Colegio is "guild-like." It belabors the pellucidly
obvious to state that, without a greater development of this issue, the
Court is unable to hold that a Puerto Rico statute is unconstitutional
merely because it imposes a requirement that pharmacists belong to an
organization which is "guild-like." [FN22] Therefore, the
Court rejects this argument. [FN23]
FN22.
Generally, guilds are organizations dedicated to protect and further
a common
interest of its members. In medieval Europe, guilds were professional
organizations made up of members from a particular trade or craft and
were dedicated to promoting the welfare of that craft and its members.
Merchant guilds were powerful associations in the 12th and 13th
centuries. Guilds were not limited to professional or economic goals,
however. Some were religious confraternities with purely spiritual
objectives. Others had social functions. IV The New Encyclopaedia
Britannica Micropaedia at 786 (15th ed.1984).
FN23.
Section 385 also requires that a pharmacist must be registered with the
Board of Pharmacy. National claims that it is impossible for it to
register with the Board and that this requirement constitutes an
insurmountable burden on interstate commerce. This challenge must be
rejected for the same reason that the challenge to the Colegio
membership requirement was rejected. That is, there is no developed
argument to explain why National cannot register with the Board.
National does not specify what rule, regulation or requisite prevents it
from registering. Thus, the Court rejects the challenge to this part of
section 385 as well.
b. The
extraterritorial effects of sections 396, 401, and 402
National
also challenges three other sections on the grounds that they regulate
commerce occurring outside the borders of Puerto Rico. Specifically,
National argues that sections 396, 401, and 402 unconstitutionally
burden interstate commerce by requiring that a prescription for a Puerto
Rico consumer may only be filled by a pharmacist residing in the town
where his pharmacy is located; that a pharmacy serving Puerto Rico must
be managed by a pharmacist who must be present at the pharmacy for a
specified number of hours per week; and that any pharmacy serving Puerto
Rico consumers be licensed by the Secretary of Health and be subject to
inspections by the Secretary. National claims that it is unable to
comply with these requirements and that therefore these laws constitute
an undue burden on interstate commerce. Section 396 reads in part as
follows:
Every
establishment devoted, or which may hereafter be devoted, to the sale of
medicines, chemical or pharmaceutical products, patent medicines, drugs
wholesale or retail, or manufacture of medicines shall have to apply to
the Secretary of Health for a license and the Secretary of Health shall
have power to issue same after inspection of the establishment, provided
the establishment, in the discretion of the Secretary of Health, meets
the purposes and requirements of this chapter.
P.R.Laws
Ann. tit. 20, § 396. Section 401 reads
Qualification
for practice
In all
cases where a pharmacist is practicing his profession he shall be a
member of the College of Pharmacists of Puerto Rico, of age, shall
manage in person the establishment under his supervision, and shall
reside in the town in which he is practicing.
Id.
§ 401. Section 402 reads in pertinent part
Management
of establishments by pharmacist required; responsibility
Every
establishment engaged in the preparation, sale or distribution of
medicines, chemical or pharmaceutical products and drugs wholesale or
retail, such as pharmacies ... shall be managed personally by a duly
registered pharmacist authorized to practice his profession in the
Commonwealth of Puerto Rico....
The
pharmacist shall at no time be absent from the pharmacy ... under his
care or supervision except for temporary absences not exceeding six (6)
hours during a working day nor more than thirty (30) hours in each
calendar week, during which absence he shall be substituted by a duly
authorize pharmacy assistant....
Id.
§ 402.
Where, as
in the present case, a federal court is asked to rule on the
constitutionality of a state or local statute, serious federalism
concerns come into play. A federal court faced with a challenge to the
constitutionality of a federal law should attempt to construe the
statute in a way that will maintain the law within constitutional
limits. Arizonans for Official English v. Arizona, 520 U.S. 43,
78, 117 S.Ct. 1055, 1074, 137 L.Ed.2d 170 (1997); Edward J. DeBartolo
Corp. v. Fla. Gulf Coast Bldg. & Constr. Trades Council, 485
U.S. 568, 575, 108 S.Ct. 1392, 1397, 99 L.Ed.2d 645 (1988); Cuesnongle,
835 F.2d at 1495. A federal court does not have this same authority to
narrowly construe, however, when a state law is at issue. Grayned v.
City of Rockford, 408 U.S. 104, 110, 92 S.Ct. 2294, 2300, 33 L.Ed.2d
222 (1972); Gooding v. Wilson, 405 U.S. 518, 520, 92 S.Ct. 1103,
1105, 31 L.Ed.2d 408 (1972); United States v. Thirty-Seven
Photographs, 402 U.S. 363, 369, 91 S.Ct. 1400, 1405, 28 L.Ed.2d 822
(1971); K-S Pharmacies, 962 F.2d at 730.
That is
not to say that a federal court called upon to rule on a state law's
compliance with the United States Constitution should hide behind the
mantle of federalism and shirk all duties of statutory interpretation.
Whenever a federal court is confronted with a state statute's
constitutionality, it must of course interpret the statute. Broadrick
v. Oklahoma, 413 U.S. 601, 617 n. 16, 93 S.Ct. 2908, 2919 n. 16, 37
L.Ed.2d 830 (1973); Sherman v. Community Consol. Sch. Dist. 21,
980 F.2d 437, 442 (7th Cir.1992); Caribbean Int'l News, 12 F.Supp.2d at
215. In so doing, the federal court should consider the same principals
that the state court would. Village of Hoffman Estates v. Flipside,
Hoffman Estates, Inc., 455 U.S. 489, 494 n. 5, 102 S.Ct. 1186, 1191
n. 5, 71 L.Ed.2d 362 (1982); K-S Pharmacies, 962 F.2d at 730; Whiting
v. Town of Westerly, 942 F.2d 18, 21 n. 3 (1st Cir.1991).
The Court
finds guidance in Judge Easterbrook's reasoning in K-S Pharmacies. In
that case, three Wisconsin pharmacies and a trade association alleged
that American Home Products ("AHP") violated a state law which
required all sellers of medicines to offer to all its purchasers the
same price that it offered to its "most favored purchaser."
962 F.2d at 729-30. AHP, a seller of medicines, responded that the law
was an unconstitutional burden on interstate commerce. The statute did
not specify whether the phrase "most favored purchaser"
included purchasers outside Wisconsin or only purchasers within the
state. The Seventh Circuit recognized that states do not have the power
to legislate beyond their own borders and that the Supreme Court of
Wisconsin had itself acknowledged this limitation in rulings it had made
on state tax legislation. Id. at 730. Furthermore, a state
statute which requires a seller to charge the same price within its
borders as it does outside them is unconstitutional under the Dormant
Commerce Clause. Id. The Seventh Circuit concluded that therefore
the Wisconsin Supreme Court would interpret the phrase "most
favored purchaser" to mean "most favored purchaser in
Wisconsin." Id. at 730-31 (emphasis added).
The
Seventh Circuit's reading of the state statute is not a remarkable or
controversial decision. To read the statute literally so that it applied
to most favored purchasers anywhere in the country would have given the
statute an interpretation which would have contravened the Wisconsin
Supreme Court's practice on statutory construction, would have read the
law to be in obvious violation of the Dormant Commerce Clause, and would
have transgressed the universally accepted premise that a state may not
legislate beyond its own borders. An analogous analysis is appropriate
in the present action. Section 396 provides that the Secretary of Health
shall issue a license to a pharmacy after inspecting it. The section
does not specify where the pharmacies are that she may inspect.
Similarly, sections 401 and 402 of the Pharmacy Act place limitations on
pharmacies, but they do not specify which pharmacies. A reading of these
statutes to hold that the Puerto Rico Secretary of Health may inspect
out-of-state pharmacies or that a pharmacist in another state must
reside in the town where he is practicing or that an out-of-state
pharmacist may only be absent from his pharmacy during the times set
forth in section 402 would read these sections to be an unconstitutional
attempt to regulate commerce outside the borders of Puerto Rico. See
Healy, 491 U.S. at 336, 109 S.Ct. at 2499; Brown-Forman Distillers,
476 U.S. at 582-85, 106 S.Ct. at 2086-87; Edgar, 457 U.S. at 641-43, 102
S.Ct. at 2640-41; K-S Pharmacies, 962 F.2d at 730-31. The Puerto Rico
Supreme Court has recognized that a state may exercise jurisdiction only
over persons and things located within its territory. Pueblo v.
Contreras, 95 J.T.S. 161, 402 n. 1 (1995); Toro Ruiz v. Junta de
Libertad Bajo Palabra, 93 J.T.S. 120, 11033 n. 2 (1993); Medina
v. Tribunal Superior, 104 P.R.Dec. 346, 348, 4 Official Translations
483, 486 (1975). Therefore, this Court concludes that the Puerto Rico
Supreme Court would read the provision in section 396 on inspections by
the Secretary of Health, in section 401 on the pharmacist's town of
residence, and in section 402 on hours when the pharmacist must be
present at the pharmacy to refer only to "establishments" or
"pharmacies" in Puerto Rico. Accordingly, the Court holds that
these provisions are not applicable to the management and operation of
National's business in New Jersey. These provisions cannot be used to
prevent National from servicing customers in Puerto Rico. Because the
Court holds that these provisions, as construed in this opinion, do not
apply to National, the Court need not address at this time National's
argument that the provisions constitute an undue burden on interstate
commerce. Accordingly, this argument is denied without prejudice.
The
conclusion that these laws should only apply to pharmacies in Puerto
Rico and not to National's operations is supported by a second reason.
The Pharmacy Act was enacted in 1945; the statutes which created the
Colegio took effect in 1938. See 1945 Laws of Puerto Rico No.
282, at 998-1034, May 15, 1945; 1938 Laws of Puerto Rico No. 243, at
458-63, May 15, 1938. Although the laws have been amended over the
years, they have not been substantially changed, at least not in any way
relevant to the present controversy. It is evident from the language of
the statutes that they were not enacted with mail-order pharmacies in
mind: nowhere is there any mention of them. This is not surprising,
given the fact that mail-order pharmacies a la National's operations did
not exist at the time these statutes were originally enacted. [FN24]
Based on a reading of the laws as a whole and on their historical
context, it is apparent that Puerto Rico's pharmacy laws were drafted
with the intention of regulating and licensing only those pharmacies
that were operated and located in Puerto Rico.
FN24.
After World War II, the United States Department of Veterans Affairs was
confronted with the problem of having many of its VA hospitals being
responsible for providing services to all the veterans living in what
were often large territories. To accomplish this, the department began
to use mail-order delivery of prescription drugs. The American
Association of Retired Persons established a similar service in 1959 to
fill prescriptions for its members in remote rural areas. The success of
the AARP's program piqued the private sector's interest, which began to
form for-profit mail- order pharmacies in the 1970s and 1980s. See
docket no. 77, at 3-4; Suz Redfearn, Mail-order Pharmacies, The Greater
Baton Rouge Business Report, April 16, 1996.
National's
recourse, then, is to seek a license from the Secretary of Health and to
register with the Board of Pharmacy. The Court recognizes that the
Puerto Rico pharmacy laws do not specifically provide for mail-order
pharmacies. This is an oversight which can be readily corrected. The
statutes and regulations of a number of states offer a wide range of
examples on how to deal with this industry. In all, at least
thirty-eight states have enacted measures on mail-order pharmacies. See
Ala.Code § 34-23-31; Alaska Stat. § 08.80.158; Ark.Code Ann. §
17-92-401; Cal.Bus. & Prof.Code § 4112; Colo.Rev.Stat.Ann. §
12-22-130; Conn.Gen.Stat.Ann. §§ 20-627 to 20-630; Del.Code Ann. tit.
24, §§ 2538 - 2540; Fla.Stat. ch. 465.0156; Haw.Rev.Stat. § 461-15;
Idaho Code §§ 54-1743 to 54- 1748; 225 Ill.Comp.Stat. 85/16a; Ind.Code.
§ 25-26-13-17; Iowa Code § 155A.13A; Kan.Stat.Ann. § 65-1657;
Ky.Rev.Stat.Ann. § 315.0351; La.Rev.Stat.Ann. §§ 2702 - 2704;
Me.Rev.Stat.Ann. tit. 32, §§ 13721, 13751; Md.Code Ann., Health Occ.
§ 12-403; Mich.Comp.Laws § 333.17748; Minn.Stat. § 151.19;
Miss.Code.Ann. § 73-21-106; Mo.Ann.Stat. § 338.337; Mont.Code Ann. §
37-7-703; Neb.Rev.Stat. § 71-2407; Nev.Rev.Stat. § 639.2328;
N.M.Stat.Ann. § 61-11-14.1; N.C.Gen.Stat. § 90-85.21A; N.D.Cent.Code
§ 43-15-34.1; Or.Admin.R. 855-041-0300; S.C.Code Ann. § 40-43-83; S.D.
Codified Laws §§ 36-11-19.2 to 36-11-19.9; Tenn.Code Ann. §
63-10-410; Tex. Health Code Ann. 4542a-1; Utah Code §§ 58-17a-102
& 58-17a-303; Va.Code Ann. § 54.1-3434.1; Wash.Rev.Code §§
18.64.350 to 18.64.400; W.Va.Code § 30-5-6a; Wyo.Stat.Ann. §
33-24-152.
A
provision on mail-order pharmacy may be as simple as a single
administrative regulation. For example, Oregon's administrative rules
require simply that any mail-order pharmacy shall be registered with
Oregon's Board of Pharmacy, be registered in good standing in the state
where it is located, and designate one of its pharmacists to be
responsible for all prescriptions delivered to Oregon residents.
Or.Admin.R. 855-041-0300. Missouri has a statute which is similarly
concise. It requires only that any out-of-state pharmacy be licensed
with Missouri's board of pharmacy. Mo.Ann.Stat. § 338.337. Other states
have more complex requirements. Nevada mandates that any mail-order
pharmacy be licensed with the state board; that it also be licensed in
the state where it is located; that it comply with all federal laws and
regulations; and that it submit evidence that its facility and records
comply with the laws of the state where it is located. Nev.Rev.Stat. §
639.2328. California requires that every out-of-state mail-order
pharmacy register with the California board of pharmacy; provide the
names of its agent for service of process in California, its
pharmacists, and its corporate officers; comply with the pharmacy laws
of the state where it is located; keep records of all controlled
substances or potentially dangerous drugs dispensed to California
customers; and maintain a toll-free telephone service to allow for
communications between California patients and pharmacists at the
mail-order pharmacy. Cal.Bus. & Prof.Code § 4112. Delaware, Iowa,
and Kansas all have statutes with requirements comparable to those of
California's, including that for a toll-free telephone number for
customer questions. Del.Code Ann. tit. 24, §§ 2538-2540; Iowa Code §
155A.13A; Kan.Stat.Ann. § 65-1657.
The
Court, of course, makes no judgment as to which of the variety of state
statutes would best enable Puerto Rico to regulate mail-order pharmacy.
[FN25] The Court holds only that the challenged provisions in sections
396, 401, and 402--that a prescription for a Puerto Rico patient may
only be filled by a pharmacist residing in the town where his pharmacy
is located, that a pharmacist must be present at the pharmacy he manages
for a specified number of hours per week, and that any pharmacy be
subject to inspections by the Secretary of Health--do not apply to
pharmacies outside of Puerto Rico and, so construed, do not
unconstitutionally burden interstate commerce. Declaratory judgment
shall be entered to this effect. National's proper recourse is to seek
licensing and registration from the appropriate Puerto Rico authorities.
And because the above-mentioned provisions of sections 396, 401, and 402
do not apply to out-of-state pharmacies, National may not be denied a
license or registration on the grounds that it does not comply with
these provisions. [FN26]
FN25.
The Court notes that the Puerto Rico legislature has recently considered
a bill that would explicitly provide for mail-order pharmacies. See
H.R. Project 1021, 13th Leg. (P.R.1997); docket no. 104, exhibit A.
FN26.
National also claims that because the pharmacy laws prevent it from
doing business in Puerto Rico, its First Amendment rights to commercial
speech are being violated. In the discussion of National's Commerce
Clause claim, the Court holds in Section 5b. of this opinion that these
laws do not prevent National from doing business in Puerto Rico and
therefore they do not pose an undue burden on interstate commerce. The
same reasoning applies to the First Amendment claim. Because these laws
do not prevent National from doing business, the Court holds that the
First Amendment is similarly not implicated at this time.
WHEREFORE,
the Court denies without prejudice National's challenge to the
constitutionality of the above-discussed statutes regulating the
practicing of pharmacy in Puerto Rico. Declaratory judgment shall be
entered holding that the provision of 20 L.P.R.A. § 396 requiring that
a pharmacy be subject to inspections by the Secretary of Health, the
provision of 20 L.P.R.A. § 401 requiring that a pharmacist reside in
the town where his or her pharmacy is located, and the provision in 20
L.P.R.A. § 402 specifying the number of hours per week that a
pharmacist must be present at his or her pharmacy apply only to
pharmacies in Puerto Rico. Accordingly, National's out-of-state mail-
order pharmacy may not be denied a license or registration on the
grounds that it does not comply with these provisions.
IT IS SO ORDERED.
Summary
Analysis <Full-Text> Case
Index