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Complaint — United States v. Konstantinos Zarkadas (E.D.N.Y., Dkt. 1, September 15, 2020)

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Complaint filed September 15, 2020 (Document 1) by the United States of America against Konstantinos Zarkadas, Civil Action No. 2:20-cv-04310-GRB-SIL, in the United States District Court for the Eastern District of New York. The complaint seeks penalties and injunctive relief under the Controlled Substances Act and alleges that the defendant, licensed to practice medicine in New York, distributed approximately 20,100 dosage units of Phentermine on approximately 292 occasions between in or about December 2012 and April 2016 without keeping records. It also alleges incorrect record dates on 71 occasions and failures to keep receipt records and inventories. The First Claim for Relief asks for a civil penalty of not more than $10,000.00 for violations on or before November 2, 2015 and not more than $15,040 for later ones.

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“Complaint — United States v. Konstantinos Zarkadas (E.D.N.Y., Dkt. 1, September 15, 2020).” Original at archive.org. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/court-filing-no-2-20-cv-04310-dkt-1-e-d-n-y-6bea661e8b/, SHA-256 1a0d577db5c5a4c240da33394b2b44fa6443d497e38ec687840eda4021681813.

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 Case 2:20-cv-04310-GRB-SIL Document 1 Filed 09/15/20 Page 1 of 4 PageID #: 9




UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK
-------------------------------------------------X

UNITED STATES OF AMERICA,                                COMPLAINT

                          Plaintiff,                     Civil Action
                                                         No.
                 - against –

KONSTANTINOS ZARKADAS,

                          Defendant.

------------------------------------------------X

        Plaintiff UNITED STATES OF AMERICA, by its attorney, SETH D. DuCHARME, Acting

United States Attorney for the Eastern District of New York, Diane C. Leonardo, Assistant United

States Attorney, of counsel, hereby alleges for its complaint upon information and belief:

        1.       This is a civil action seeking penalties and injunctive relief under the Controlled

Substances Act, as amended, 21 U.S.C. § 801 et seq.


                                   JURISDICTION AND VENUE

        2.       This Court has jurisdiction over this action pursuant to 21 U.S.C. § 843(f)(1) and 28

U.S.C.§§ 1345, 1355.

        3.       Venue is proper in the Eastern District of New York pursuant to 21 U.S.C.

§ 843(f)(2) and 28 U.S.C. § 1395(a).

                          STATUTORY AND REGULATORY BACKGROUND

        4.       The Comprehensive Drug Abuse Prevention and Control Act of 1970, otherwise known

as the Controlled Substances Act, 21 U.S.C. § 801, et seq., ( “CSA”) and its implementing regulations

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Case 2:20-cv-04310-GRB-SIL Document 1 Filed 09/15/20 Page 2 of 4 PageID #: 10




set forth a comprehensive federal regulatory regime for the manufacture, distribution, dispensing, and

possession of controlled substances. In order to prevent the diversion of controlled substances from

legitimate to illegitimate uses, the CSA establishes a closed regulatory system under which it is unlawful

to manufacture, distribute, dispense or possess any controlled substance except in a manner authorized

by the CSA. See 21 U.S.C. § 841(a).

        5.      At all times relevant to this action, Phentermine has been a Schedule IV controlled

substance pursuant to 21 U.S.C. § 812 and 21 C.F.R. §1308.12(c).

        6.      The CSA requires persons and entities engaged in the manufacture, distribution, and/or

dispensing of controlled substances to register with the Drug Enforcement Administration (“DEA”),21

U.S.C. § 823, and to maintain records, 21 U.S.C. § 827(a).

        7.      A person engaged in the dispensing of controlled substances is required, inter alia, to

maintain records that accurately set forth information concerning of the controlled substances he has

dispensed, 21 U.S.C. § 827(a)(3) and 21 C.F.R. §§ 1304.21(a) and 1304.22(c); to maintain records that

accurately set forth information concerning the controlled substances that he has received, 21 U.S.C. §

827(a)(3) and 21 C.F.R. § 1304.21(a); to maintain an initial inventory of controlled substances on hand,

21 U.S.C. § 827(a)(1) and 21 C.F.R. § 1304.11(a); and to maintain a biennial inventory of controlled

substances on hand, 21 U.S.C. § 827(a)(1) and 21 C.F.R. § 1304.11(c).

        8.      Pursuant to 21 U.S.C. § 842(a)(5), it is unlawful for any person to refuse or negligently

fail to keep a record required to be kept under the CSA.

                                          THE DEFENDANT

        9.      Defendant Konstantinos Zarkadas (“Zarkadas” or “the defendant”) is licensed to

practice medicine in the State of New York and practices medicine in Nassau County and New York
                                                2
Case 2:20-cv-04310-GRB-SIL Document 1 Filed 09/15/20 Page 3 of 4 PageID #: 11




County, New York. At all times relevant to this action, the defendant was registered with the United

States Drug Enforcement Administration (“DEA”) under DEA registration number BZ9788716.

                                        FACTUAL BACKGROUND

      10.       Plaintiff repeats and realleges paragraphs 1 through 9 as if fully set forth herein.

      11.       On approximately 292 occasions between in or about December 2012 and April 2016 in

Nassau County, New York and New York County, New York, the defendant distributed approximately

20,100 dosage units of Phentermine, without maintaining and keeping records in violation of 21 U.S.C. §

827(a)(3) and 21 C.F.R. §§ 1304.21(a) and 1304.22(c).

       12.      On 71 occasions between April 2014 and February 2015, the defendant incorrectly

recorded and entered dates in his records for distribution of Phentermine in violation of 21 U.S.C. §

827(a)(3) and 21 C.F.R. §§ 1304.21(a) and 1304.22(c).

       13.      The defendant failed to maintain records of his receipt of controlled substances for the

time period of August 2012 through February 2015 in violation of 21 U.S.C. § 827(a)(3) and 21 C.F.R.

§ 1304.21(c).

       14.      The defendant failed to maintain an initial inventory of controlled substances on

hand, in violation of 21 U.S.C. § 827(a)(1) and 21 C.F.R. § 1304.11(a).

       15. The defendant failed to maintain biennial inventory of controlled substances on hand, in

violation of 21 U.S.C. § 827(a)(1) and 21 C.F.R. § 1304.11(c).

                                FIRST CLAIM FOR RELIEF

       16.      Plaintiff repeats and realleges paragraphs 1 through 15 as if fully set forth herein.

       17.      As a result of the foregoing, the defendant is liable to the United States of America for:
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Case 2:20-cv-04310-GRB-SIL Document 1 Filed 09/15/20 Page 4 of 4 PageID #: 12




a) a civil penalty in the amount of not more than ten thousand dollars ($10,000.00) for violations that

occurred on or before November 2, 2015; and b) a civil penalty in an amount of not more than fifteen

thousand and forty dollars ($15,040) for violations that occurred after November 2, 2015 pursuant to 21

U.S.C. §§ 842(a)(5) and 842 (c)(1)(B)(i) and 28 C.F.R. § 85.5.

               WHEREFORE, plaintiff United States of America respectfully requests that:

        1. Judgment be entered against defendant in an amount to be determined on the First Claim

for Relief.

        2. Plaintiff be awarded its reasonable costs and disbursements in this action; and

        3. The Court grant such other and further relief as the Court may deem just and proper.

Dated: Central Islip, New York
       September 15, 2020                      SETH D. DuCHARME
                                               Acting United States Attorney
                                               Eastern District of New York
                                               Attorney for Plaintiff

                                       By:     /s/Diane C. Leonardo
                                               Diane C. Leonardo
                                               Assistant U.S. Attorney




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