The opinion
UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF LOUISIANA
M EDICAL PHARMACY, INC. CIVIL ACTION
VERSUS
UNITED STATES DRUG NO.: 19-00868-BAJ-RLB
ENFORCEMENT ADMINISTRATION,
ET AL.
RULING AND ORDER
Before the Court is Plaintiff’s Motion to Dissolve Immediate Suspension
Order Pursuant To 21 USC 824(d) and Request For Expedited Hearing, or
Alternatively Motion for Temporary Restraining Order by Medical
Pharmacy, Inc. (Doc. 2). Defendants filed an objection. (Doc. 5). For the reasons
stated herein, Plaintiff’s Motion is DENIED.
I. BACKGROUND
This action seeks to dissolve an order issued by the U.S. Drug Enforcement
Administration (DEA). Plaintiff is a pharmacy located in Zachary, Louisiana. It is
licensed by the Louisiana Board of Pharmacy and has been in operation for more than
fifty years. During this period, Plaintiff has operated under a DEA regulation which
has permitted it to dispense controlled drugs.
Plaintiff alleges that on March 28, 2019, Defendants began requesting
information regarding the prescriptions it filled for certain patients. Plaintiff alleges
that five administrative subpoenas were issued to it from March 2019 to September
2019 for this information. Plaintiff further alleges that in addition to patient
prescription information, Defendants also requested all of Plaintiff’s records for the
list of patients in the subpoenas. Plaintiff contends that it complied with all of
Defendants’ requests.
On November 20, 2019, Defendants served Plaintiff with an Immediate
Suspension Order (“ISO”). The ISO was based on Defendants’ administrative findings
that Plaintiff (1) routinely filled prescriptions for dangerous combinations of opioids,
benzodiazepines, and muscle relaxants or stimulants,1 (2) filled prescriptions for
large quantities and high doses of these drugs; (3) filled “pattern” prescriptions for
controlled substances2; (4) use of multiple payment methods by Plaintiff’s customers;
and (5) filled prescriptions for persons who traveled long distances to Plaintiff’s store
to fill these prescriptions. (Doc. 15 at p. 5- 6). As a result, Defendants determined that
there was an imminent danger to the public health or safety. See Id. The ISO
suspended Plaintiff’s DEA registration and ability to distribute controlled
substances.
On December 17, 2019, Plaintiff filed a Complaint (Doc. 1), alleging that
Defendants issued the ISO with no notice and no opportunity to be heard, in violation
of the right to due process under the Fourteenth Amendment. Plaintiff also sought a
temporary restraining order. A hearing was conducted on January 6, 2020. The Court
issued an Order denying Plaintiff’s request for injunctive relief. (Doc. 14). Plaintiff
1 The DEA has identified this combination of controlled substances as dangerous because the primary
side effects include difficulty breathing and death. The DEA recommends that health care
professionals limit the dosages and quantities of these drugs when prescribed together. (Doc. 24-12 at
p. 137). These combinations of drugs are also addictive and commonly abused. (Id.).
2 “Pattern” refers to prescriptions for the same drugs and the same quantities coming from the same
doctor. (See Doc. 24-15 at p. 137).
filed the instant motion, seeking to dissolve the ISO. Plaintiff asserts that the
decision to issue the ISO was arbitrary and capricious. Defendants filed an objection
to the motion, arguing that the ISO is supported by evidence that Plaintiff’s conduct
presents an imminent danger to public health or safety that justified the issuance of
the ISO without notice or opportunity to be heard.
The Court issued an Order for Defendants to produce the relevant portions of
the administrative record relied on by Defendants in making its decision to suspend
Plaintiff’s registration. (Doc. 23). Defendants complied with the Order. Plaintiff filed
a supplemental memorandum to address the administrative record (Doc. 38) and
Defendants filed a response to the memorandum. (Doc. 40). Plaintiff later filed a
reply memorandum in response. (Doc. 42).
II. LEGAL STANDARD
The denial, revocation, or suspension of a registration to manufacture,
distribute, or dispense a controlled substance is governed by 21 U.S.C. § 824 et seq.
Under subsection (d)(1), the Attorney General may suspend any registration
simultaneously with the filing of proceedings under this section in cases where the
agency finds that there is an imminent danger to the public health or safety.
Imminent danger to the public health or safety means that due to the actions of the
registrant, there is a substantial likelihood of an immediate threat that death, serious
bodily harm, or abuse of a controlled substance will occur in the absence of an
immediate suspension of the registration. 21 U.S.C. § 824(d)(2). In the absence of a
finding of imminent danger to the public health or safety, there can be no suspension
without notice and an opportunity to be heard. See Norman Bridge Drug Co. v.
Banner, 529 F. 2d 822, 828 (5th Cir. 1976). “A suspension under this subsection shall
continue in effect until the conclusion of such proceedings, including judicial review
thereof, unless sooner withdrawn by the Attorney General or dissolved by a court of
competent jurisdiction.”
Under the Administrative Procedure Act, a court may review the actions by an
administrative agency such as Defendants. “Agency action made reviewable by
statute and final agency action for which there is no other adequate remedy in a court
are subject to judicial review.” 5 U.S.C. § 704. Although it is not a final agency action,
Defendants’ decision to issue the ISO is made reviewable by a court of competent
jurisdiction under 21 U.S.C. § 824(d)(1). If necessary, the reviewing court shall set
aside agency action, including findings and conclusions found to be arbitrary and
capricious. See 5 U.S.C. § 706(2)(A). In making the determination of whether agency
action is arbitrary and capricious, a court shall review the whole record, or those parts
of it cited by a party. 5 U.S.C. § 706(2)(F).
“Arbitrary and capricious review focuses on whether an agency articulated a
rational connection between the facts found and the decision made.” ExxonMobil
Pipeline Co. v. U.S. Dep’t of Transp., 867 F.3d 564, 571 (5th Cir. 2017). A court must
“disregard any post hoc rationalizations of the agency’s action and evaluate it solely
on the basis of the agency’s stated rationale at the time of its decision.” Id. (citing
Luminant Generation Co., L.L.C. v. E.P.A, 675 F.3d 917, 925 (5th Cir. 2012). This
review “is narrow and a court is not to substitute its judgment for that of the agency.”
Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Auto. Ins. Co., 463 U.S. 29,43
(1983). “The administrative record, however, need only ‘indicate the determinative
reason for the final action taken.’” Pension Ben. Guar. Corp. v. Wilson N. Jones
Memorial Hosp., 374 F.3d 362, 367 (5th Cir. 2004) (citing Camp v. Pitts, 411 U.S. 138,
143 (1973)). The Court may “uphold a decision of less than ideal clarity if the agency’s
path may reasonably be discerned.” Id. (citing Bowman Transp., Inc. v. Arkansas-
Best Freight Sys., Inc., 419 U.S. 281, 286 (1974)). The party challenging the agency’s
action bears the burden of establishing that the agency’s determination was arbitrary
and capricious. La. Pub. Serv. Comm’n v. FERC, 761 F. 3d 540, 558 (5th Cir. 2014).
III. DISCUSSION
A. Plaintiff’s Arguments in Response to the Administrative
Record
Plaintiff filed a supplemental memorandum to address information in the
administrative record. In addition to arguing that the record does not support a
finding of imminent danger to the public health or safety, Plaintiff argues that
(1) Defendants incorrectly concluded that Plaintiff’s filling of allegedly suspicious
prescriptions was improper and Defendants did not check Plaintiff’s records to
determine if Plaintiff addressed the suspicions before filling the prescriptions;
(2) Defendants relied entirely upon its expert’s opinions to issue the ISO; and
(3) Defendants cannot reasonably rely on the opinions of its unqualified expert,
(Doc. 38 at pp. 5—23). Plaintiff further argues in its second supplemental
memorandum that the red flags identified by Defendants in the records, such as
filling prescriptions for out-of-state customers and filling combination prescriptions,
should not be considered red flags. (Doc. 42).
The Court declines to engage in an analysis of all of the arguments offered
because doing so would fall outside of the scope of judicial review under the arbitrary
and capricious standard. The Court reiterates that this type of review is narrow, and
that the Court must ensure that it does not substitute its judgment for that of
Defendants. See Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Auto. Ins. Co.,
463 U.S. 29,43 (1983). A full consideration of these arguments may result in the
substitution of the Court’s judgment for that of the Defendants. For example, if the
Court were to consider whether certain actions of the Plaintiff were correctly
identified as red flags, the Court would certainly be substituting the judgment of
Defendants with its own. Under arbitrary and capricious review, the Court is limited
to considering whether Defendants articulated a “rational connection between the
facts found and the decision made.” ExxonMobil Pipeline Co. v. U.S. Dep’t of Transp.,
867 F.3d 564, 571 (5th Cir. 2017). The Court is limited to evaluating the decision
solely on the basis of the agency’s stated rationale at the time of its decision. See Id.
B. Whether a Factual Basis Existed for the Issuance of the ISO.
Plaintiff argues that the letter issuing the ISO did not contain any facts on
which imminent danger to the public health and safety is founded. (Doc. 19 at pp. 23).
Plaintiff further argues that there are no facts in the administrative record that
support a finding of imminent danger resulting from Plaintiff’s operations and facts
that support the improper dispensing of controlled substances. (Doc. 35). Defendants
assert that the decision to immediately suspend Plaintiff’s registration is based on
facts gathered after an investigation, spanning several months, into Plaintiff’s
records. Defendants further assert that the evidence led to the “rational conclusion
that Plaintiff was filling prescriptions issued outside the usual course of professional
practice and without a legitimate medical purpose, thereby contributing to ongoing
abuse of controlled substances.” (Doc. 15 at pp. 6-7).
In compliance with the Court’s Order, Defendants provided voluminous
records detailing the Plaintiff’s prescription history. (Doc. 24). Defendants also
provided three reports by Defendants’ expert, Dr. Diane Ginsburg, Ph.D., and data
from a prescription monitoring program conducted from October 2016 to July 2019.
(Id).3 Dr. Ginsburg reviewed the prescription monitoring program data, which
provides details regarding the drugs dispensed, customer names, customer addresses,
the prescribing doctors, and payment methods. (Docs. 24-14 and 24-15). Dr. Ginsburg
reviewed these records to determine whether there are any red flags to suggest that
a pharmacy is operating as a pill mill.4
3 Dr. Ginsburg is the former Interim Head of the Pharmacy Practice Division at the University of
Texas at Austin College of Pharmacy. She is currently a clinical professor at the University of Texas,
having served in this role since 1984. She is the author of numerous journal publications and has
served on several pharmacy-related boards and committees. (Doc. 24-4 at pp. 5-64).
4 According to Ginsburg’s reports, red flags identified by the DEA include patterns of prescribing and
dispensing combinations of frequently abused controlled substances, geographic anomalies, quantity
and the strength of controlled substances, evidence of a high percentage of customers paying cash, and
prescriptions written by doctors for illnesses not consistent with their area of specialty. (Doc. 24-15 at
p. 155). “Pill mill” is a term used to describe a clinic or pharmacy that prescribes or dispenses controlled
prescription drugs inappropriately. See 2014 National Drug Threat Assessment, www.dea.gov.
In her first report, Dr. Ginsburg identified prescription trends, an excessive
dosage and quantity of Schedule II and Schedule III controlled substances dispensed,
and many instances where a combination of opioids, benzodiazepines, and muscle
relaxants or stimulants were dispensed on the same prescription. (Doc. 24-15 at
p. 137-138.) Dr. Ginsburg also identified a significant number of prescriptions that
were paid for with multiple payment methods or by cash only. Dr. Ginsburg further
concluded that many customers traveled a significant distance to Plaintiff’s location.
Dr. Ginsburg concluded that these findings are suggestive of a pill mill operation. Id.
The Court finds that the records reviewed by Dr. Ginsburg support her
conclusions and the Defendants’ basis for issuing the ISO. The prescription records
reveal a disturbing pattern of prescriptions being issued by just a few doctors, and
that the physicians prescribed drugs such as opioids, benzodiazepines, and muscle
relaxants or stimulants often in the same prescription.5 The highest possible strength
and quantities of these medications were frequently dispensed by Plaintiff in
quantities as high as 120 pills. Some prescriptions were filled for 150 to 180 pills. The
records also reflect that several customers traveled from Mississippi on a monthly
basis, despite the presence of several other pharmacies located closer to the
customers’ homes, and some customers traveled from as far away as Texas and
Oklahoma. The Mississippi customers each traveled at least 40 miles or more to
Plaintiff’s location.
5 Hydrocodone (opioid), Oxycodone (opioid), Alprazolam (benzodiazepine), Diazepam (benzodiazepine),
and Carisoprodol (muscle relaxant) appear frequently in the prescription records.
The records further reflect that several of these prescriptions were paid for
with multiple payment methods, such as insurance and cash, or cash only. These
transactions are identified as “other” and are located in the column titled “payment”
in the prescription monitoring program data. (See Doc. 26-11 at pp. 1-883; Doc. 26-12
at pp. 1-128; Doc. 26-13 at pp. 1-135). Defendants’ allegations of imminent danger to
public health and safety are completely supported by the administrative record. The
Court finds that Defendants have established, through the administrative record, a
rational basis for the issuance of the ISO. Thus, Defendants’ decision was not
arbitrary and capricious.
C. Whether Plaintiff’s Due Process Rights Were Violated by the
Issuance of the ISO.
As previously noted, 21 U.S.C. § 824(d)(1) authorizes the suspension of a
registration upon a finding of imminent danger to the public health and safety. See
Norman Bridge Drug Co. v. Banner, 529 F. 2d 822, 828 (5th Cir. 1976). Following a
review of the administrative record, the Court has determined that Defendants have
provided sufficient evidence to establish a rational connection between the facts found
during its administrative investigation and its decision to issue the ISO. Defendants
found that Plaintiff filled several prescriptions in a manner that contributes to the
ongoing abuse of controlled substances; thus, a finding of an imminent danger to
public health and safety justifies and supports the suspension of the registration
without notice and an opportunity to be heard at the time of the suspension. Thus,
Plaintiff’s due process rights were not violated.
IV. CONCLUSION
Accordingly,
IT IS ORDERED that Plaintiff’s Motion (Doc. 2) is DENIED.
The Immediate Suspension Order will not be disturbed.
IT IS FURTHER ORDERED that the Defendants’ Joint Motion for Entry of
a Consolidated Briefing Schedule (Doc. 27) is DENIED AS MOOT.
Baton Rouge, Louisiana, this 3rd day of July, 2020
______________________________________
JUDGE BRIAN A. JACKSON
UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF LOUISIANA