United States v. Heim, CASE NO. 5:13CV210

Decision Date22 January 2014
Docket NumberCASE NO. 5:13CV210
PartiesUNITED STATES OF AMERICA, PLAINTIFF, v. BRIAN D. HEIM, M.D., DEFENDANT.
CourtU.S. District Court — Northern District of Ohio

JUDGE SARA LIOI

MEMORANDUM OPINIONAND ORDER

Before the Court is the motion for summary judgment on liability filed by plaintiff, United States of America. (Doc. No. 13.) Defendant has not filed any opposition. For the reasons set forth herein, the motion is granted.

I. PROCEDURAL BACKGROUND

On January 29, 2013, plaintiff filed this action against defendant to recover civil penalties for alleged violations of the Comprehensive Drug Abuse Prevention Control Act of 1970, 21 U.S.C. § 801, et seq., and regulations thereunder. In three counts, the complaint alleges, in relevant part:

2. The Defendant, Brian D. Heim, M.D., is registered under 21 U.S.C. §§ 822 and 823 as a practitioner authorized to dispense Schedule II, III, IV, and V controlled substances to the extent permitted by federal law, and has been assigned Registration Number BH7542283 by the Drug Enforcement Administration ("DEA"). Defendant is licensed under the laws of Ohio to practice medicine, and his registered location is 3562 Ridge Park Drive, Suite A, Akron, Ohio 44333.
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COUNT I: FAILURE TO MAINTAIN PURCHASE RECORDS
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14. Between August 17, 2011, and June 5, 2012, Defendant refused or negligently failed to make, keep, or furnish records of the controlled substance hydrocodone as required by 21 U.S.C. § 827(a)(3) and 21 C.F.R. § 1304.22(c) and prohibited by 21 U.S.C. § 842(a)(5).
15. This constitutes at least fourteen separate violations of 21 U.S.C. § 842(a)(5) . . . .
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COUNT II: FAILURE TO MAINTAIN DISPENSING RECORDS
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19. On an unknown number of occasions between August 17, 2011 and July 16, 2012, Defendant refused or negligently failed to make, keep, or furnish dispensing records of at least 11,500 hydrocodone tablets as required by 21 U.S.C. § 827(a)(3) and 21 C.F.R. § 1304.22(c), and prohibited by 21 U.S.C. § 842(a)(5).
20. This constitutes an unknown number of violations of 21 U.S.C. § 842(a)(5) . . . . The precise number of violations will be determined at the time of trial.
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COUNT III: FAILURE TO MAINTAIN BIENNIAL INVENTORY
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23. Between January 1, 2011, and January 1, 2012, Defendant refused or negligently failed to make, keep, or furnish a biennial inventory of his stock of controlled substances on hand as required by 21 U.S.C. § 827(a)(1) and 21 C.F.R. §1304.11(c), and prohibited by 21 U.S.C. § 842(a)(5).
24. This constitutes a violation of 21 U.S.C. § 842(a)(5) . . . .
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(Complaint, Doc. No. 1.)

On March 20, 2013, represented by counsel, defendant filed his answer, denying the allegations in ¶¶ 14, 15, 19, and 20 of the complaint, and admitting the allegations in ¶¶ 23 and 24. Although not entirely clear, the answer appears to deny the allegations in ¶ 2 of the complaint.1 (Answer, Doc. No. 6.)

The Case Management Conference ("CMC") was convened by the Court on May 10, 2013. Counsel for plaintiff was in attendance, along with Drug Enforcement Administration ("DEA") Diversion Investigator, Scott Brinks. Defendant and his attorney also attended. The Court issued the Case Management Plan and Trial Order, setting case management dates.

On September 4, 2013, the Court conducted a status conference, with both attorneys and clients or client representatives in attendance. During that conference, counsel advised the Court that the parties were considering a settlement and, therefore, plaintiff agreed to wait until the deadline to file any dispositive motion.

On November 4, 2013, plaintiff timely filed the instant motion for summary judgment on the question of liability, which has gone unopposed.

II. DISCUSSION
A. Legal Standard

Under Fed. R. Civ. P. 56(a), "[t]he court shall grant summary judgment if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." "If a party . . . fails to properly address another party's assertion of fact as required in Rule 56(c), the court may: . . . (2) consider the fact undisputed for purposes of the motion; [and] (3) grant summary judgment if the motion and supporting materials—including the facts considered undisputed—show that the movant is entitled to it[.]" Fed. R. Civ. P. 56(e).2

B. Undisputed Material Facts

In support of its motion for summary judgment, plaintiff has submitted evidentiary materials, including the declaration of Scott Brinks. (Doc. No. 13-2 ["Decl."].)

Brinks is "a duly appointed Diversion Investigator" of the DEA, who was "assigned to the Cleveland Resident Office for the last eleven years." (Decl. ¶ 2.) The material facts stated herein are supported by Brinks's declaration and are completely unrefuted by defendant.3

Defendant was registered under the Act as a medical practitioner and was authorized to handle controlled substances Schedules II, III, IV, and V. (Id. ¶ 4; see 21 U.S.C. §§ 822 and 823.) His registered location was 3562 Ridge Park Drive, Suite A, Akron, Ohio. (Id. ¶ 5.)

In 1998, Heim entered guilty pleas to twenty-four (24) felony counts of theft of drugs and twenty-one (21) felony counts of illegal processing of drug documents.4 His medicallicense was suspended and he was given treatment in lieu of conviction. (Id. ¶ 6 and Att. 1 at 104.)

On June 6, 2012, Heim was arraigned in Summit County Court of Common Pleas on seven counts of aggravated trafficking in drugs and one count of tampering with evidence. (Id. ¶ 7 and Att. 2.) The drug charges were eventually dropped in return for defendant's guilty plea to one count of obstruction of justice. (Id. ¶ 8 and Att. 3.) He also agreed to surrender his medical license and his DEA registration as part of his plea. (Id. ¶¶ 9, 10.)5 As a result, defendant is no longer permitted to dispense or prescribe Schedule II - V drugs.

On July 5, 2012, Brinks checked the DEA Automation of Reports and Consolidated Orders System ("A.R.C.O.S."), which is a DEA database used to capture the activity of controlled substances from the point of manufacture and/or distribution to the point of sale to the retail level registrant. (Id. ¶ 11.) This check of A.R.C.O.S. revealed that defendant was purchasing extraordinarily large amounts of hydrocodone/APAP tablets (hydrocodone and acetaminophen) from the pharmaceutical wholesaler Henry Schein, Inc. (Id. ¶ 12.)

On July 11, 2012, plaintiff obtained an administrative warrant to inspect, copy, and verify the correctness of defendant's records, reports, and other documents. This warrant was served on defendant on July 16, 2012. (Id. ¶ 13; see 21 U.S.C. §§ 878(a)(2) and 880, 21 C.F.R. § 1316.) That inspection, and subsequent investigation, revealed that, on fourteen separate dates between January 17, 2011 and January 4, 2012, defendant purchased a total of 11,500hydrocodone tablets from Henry Schein, Inc. (Id. ¶ 14.)6 When defendant was asked during the inspection to produce copies of a biennial inventory for his controlled substances (required under 21 U.S.C. § 827(a)(1)), he admitted to not keeping such a record. (Id. ¶ 15.) When asked to produce copies of purchase records and dispensing records for the hydrocodone he received from Henry Schein, Inc. (required under 21 U.S.C. § 827(a)(3)), he failed to comply. (Id. ¶¶ 16, 17.) Defendant indicated that the records were at his home (although federal regulations require that such records be kept at the registered location). (Id. ¶¶ 18, 19; see 21 C.F.R. § 1304.11(a).) Defendant then went to his home to retrieve the records, but returned with only one invoice, dated March 27, 2012, for 500 tablets of hydrocodone 10/500 MG. He stated that he could not locate his dispensing log, and that he had no hydrocodone on hand. (Id. ¶¶ 20, 21.)

DEA's investigation revealed that defendant failed to keep any records for the hydrocodone he purchased from August 17, 2011 through June 5, 2012, and for the hydrocodone he dispensed from August 17, 2011 through July 16, 2012. (Id. ¶ 22.) As a result of defendant's failure to keep records, there is no record of what actually happened to the 11,500 tablets of hydrocodone from Henry Schein, Inc. (Id. ¶ 23.)

By letter dated September 24, 2012, DEA received a copy of what defendant claimed was his purchase log (styled "Meds In") and dispensing log (styled "Meds Out"). (Id. ¶ 24; Motion, Ex. C.7 ) Upon receiving these logs, Brinks interviewed six of the twelve patients listed on the "Meds Out" log, and discovered that most, if not all, of the hydrocodone dispensings never occurred. (Decl. ¶ 25.) Brinks further discovered that defendant had personallycontacted at least five of his patients and requested that they tell DEA he had dispensed tablets to them in the past, even if they did not remember receiving the tablets. (Id. ¶ 26.)

C. Analysis

Registrants under the Comprehensive Drug Abuse Prevention Control Act of 1970,8 21 U.S.C. § 801, et seq. ("the Act"), are required to maintain a biennial inventory "of all stocks . . . on hand,"9 as well as "a complete and accurate record of each [controlled] substance . . . received, sold, delivered, or otherwise disposed of by him[.]" 21 U.S.C. §§ 827(a)(1) and (3).10 The records must be maintained "separately from all other records of the registrant . . . and . . . shall be kept and be available, for at least two years, for inspection and copying by officers or employees of the United States authorized by the Attorney General." 21 U.S.C. § 827(b). Failure to comply with these record-keeping requirements is an unlawful act subject to penalties of up to $10,000 per violation. 21 U.S.C. §§ 842(a)(5) and (c)(1)(B).

Under the facts outlined above, it is undisputed that defendant has failed to comply with the record-keeping requirements of the Act. He has committed one (1) violation of the requirement to maintain a biennial inventory (Count III) and fourteen (14) violations of the requirement to maintain purchase records (Count I).

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