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United States v. Greene

United States District Court, N.D. Georgia, Gainesville Division

November 15, 2019

UNITED STATES OF AMERICA, Plaintiff,
v.
Dr. WILLIAM GREENE, Defendant.

          ORDER

          RICHARD W. STORY UNITED STATES DISTRICT JUDGE

         This case is before the Court on Plaintiff the United States' Motion for Summary Judgment [56] on the issue of Defendant Dr. William Greene's liability for recordkeeping violations under the Controlled Substances Act, 21 U.S.C. § 842(a)(5). The Court has reviewed the record, and, for the reasons below, the Government's Motion is GRANTED in part and DENIED in part.

         Background

         1. Dr. Greene's Practice

         Defendant Dr. William Greene is a medical doctor whose entire practice involves performing a unique surgery to restore fertility to women who previously had their fallopian tubes tied. During surgery, a nurse anesthetist in Greene's office uses Fentanyl, a controlled substance, to place the patient under anesthesia and manage her pain. [Plaintiff's Statement of Material Facts, Dkt. 56-2, at ¶ 11]. After the surgery is over, Dr. Greene (or one of his staff) gives the patient a bottle of 10 pills of 7.5mg of Hydrocodone, also a controlled substance, to manage her pain at home. [Id. at ¶ 13]. His office dispenses the pills directly, rather than writing a prescription, because he offers the entire service-surgery plus medicine-as a fixed cost package. [Greene Deposition at 29:4-9]. During the two-year period relevant here, Dr. Greene performed approximately 300 of these surgeries. [Id. at 108:14-17].

         2. Reported Theft of Controlled Substances

         In late 2016, Dr. Greene filed a police report alleging that his longtime employee Sharon Stewart had diverted Hydrocodone pills by forging his signature on order forms and stealing the pills when they were delivered to the office.

         Dr. Greene's practice had a long-established process for ordering the controlled substances, much of which was delegated to Sharon Stewart. [Plaintiff's Facts, at ¶¶ 35, 37]. She mailed the completed order forms. She received the drugs and put them in the safe. And she reviewed the invoices from the suppliers before turning them over to Nicole Mixon, the bookkeeper for the practice. Sometimes, Stewart had altered the invoices-changing the 10mg to 7.5mg, claiming that it was a mistake. [Defendant's Statement of Material Facts, Dkt. 63-2, at ¶ 2].

         In 2016, however, Mixon began to be suspicious of Stewart. The first red flag was when Stewart purchased four new cars in a short stretch. [Mixon Deposition at 102-04]. The next was when Stewart, while Mixon was on vacation, changed how one of the drug suppliers was paid to direct deposit, so that invoices would not be sent and reviewed in the same way. [Id. at 104-05]. At one point, to investigate her suspicions, Mixon requested the statements directly from the supplier. [Id. at 156]. When she received them, the invoices showed orders for thousands of Hydrocodone pills. Mixon showed the invoices to Dr. Greene. He fired Stewart soon after the discovery and reported the theft to law enforcement.

         3. The DEA Investigation

         The local police notified the DEA. Upon receiving the complaint, the DEA, led by Investigator Jason Allen, opened its own investigation. It began by reviewing the ordering history associated with Dr. Greene's DEA registrant number. The history showed a significant increase in the quantity of Hydrocodone pills ordered beginning in 2014. [Allen Report of Investigation, Dkt. 56-3-1, at ¶ 2]. Consistent with Dr. Greene's complaint, there were orders for 10mg pills in addition to 7.5mg pills. [Id.] Still, the DEA had concerns about Dr. Greene because it doubted that the purported diversions, which stretched back three years, could have all taken place without his knowledge.

         So, the DEA continued to investigate Dr. Greene, even despite his complaint about Stewart's alleged theft. Two weeks after Dr. Greene filed the criminal report, the DEA conducted an unannounced inspection and accountability audit of his practice. The investigators sought to determine if his records could account for the number of pills shown in the ordering history.

         4. Dr. Greene's Alleged Recordkeeping Deficiencies

         The DEA concluded that Greene's records were deficient, in three ways: first, Dr. Greene was unable to produce a record of his inventory of drugs, which the Controlled Substances Act required him to maintain. See 21 U.S.C. § 827(b).

         Second, Greene was mostly unable to produce purchase order forms, called DEA Forms 222, which he was also required to maintain. See 21 U.S.C. § 827(a)(3); 21 C.F.R. §§ 1305.03, 1305.13. For the forms he did have that covered the relevant timeframe, Dr. Greene told the DEA that all but one were forged by Stewart.[1] [Plaintiff's Facts at ¶ 56]. And the one he acknowledged having signed was incomplete, lacking a notation required to show the drugs had been received.

         Third, the DEA found that he did not have appropriate records documenting his dispensing of the drugs, which he again was required to maintain. See 21 U.S.C. § 827(a)(3); 21 C.F.R. § 1304.22. There were of course no dispensing records of the 10mg pills, because the practice never used them. There were dispensing records of the 7.5mg pills and the fentanyl, but the DEA found these to be deficient, for different reasons: for the 7.5mg pills, the dispensing records- again, perhaps consistent with the allegations of diversion-could not account for a substantial portion of the pills ordered. And for the fentanyl, the DEA found the records to be inadequate because the logbook entries were handwritten and illegible, such that Investigator Allen could not complete his audit. [Id. at ¶ 80].

         5. The Current Case

         In light of the purported deficiencies, the Government initiated this civil suit. It alleged that Dr. Greene negligently failed to “make, keep, or furnish” records required under the CSA. See 21 U.S.C. § 842(a)(5). The parties have concluded discovery, and the Government now moves for summary judgment on the issue of Dr. Greene's liability for all three categories of records.

         Discussion

         I. Legal Standard: Motion for Summary Judgment

         Federal Rule of Civil Procedure 56 requires that summary judgment be granted “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.” “The moving party bears ‘the initial responsibility of informing the . . . court of the basis for its motion, and identifying those portions of the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, which it believes demonstrate the absence of a genuine issue of material fact.'” Hickson Corp. v. N. Crossarm Co., 357 F.3d 1256, 1259 (11th Cir. 2004) (quoting Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986)). Where the moving party makes such a showing, the burden shifts to the non-movant, who must go beyond the pleadings and present affirmative evidence to show that a genuine issue of material fact does exist. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 257 (1986).

         An issue is genuine when the evidence is such that a reasonable jury could return a verdict for the non-moving party. Id. at 249-50. A fact is material if a dispute over that fact would affect the outcome of the suit under the governing law. Id. at 248. The applicable substantive law identifies which facts are material. Id.

         In resolving a motion for summary judgment, the court must view all evidence and draw all reasonable inferences in the light most favorable to the non-moving party. Patton v. Triad Guar. Ins. Corp., 277 F.3d 1294, 1296 (11th Cir. 2002). But the court is bound only to draw those inferences that are reasonable. “Where the record taken as a whole could not lead a rational trier of fact to find for the non-moving party, there is no genuine issue for trial.” Allen v. Tyson Foods, Inc., 121 F.3d 642, 646 (11th Cir. 1997) (quoting Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986)). “If the evidence is merely colorable, or is not significantly probative, summary judgment may be granted.” Anderson, 477 U.S. at 249-50 (internal citations omitted); see also Matsushita, 475 U.S. at 586 (once the moving party has met its burden under Rule 56(a), the nonmoving party “must do more than simply show there is some metaphysical doubt as to the material facts”).

         II. CSA Recordkeeping Statutory Framework

         Here, the governing substantive law centers on the recordkeeping requirements under the Controlled Substances Act. See 21 § U.S.C. 801 et seq.

         A. Section 827: Specific Recordkeeping Requirements

         Dispensers of controlled substances must track the drugs they dispense. In particular, under 21 U.S.C. § 827, any registrant who dispenses controlled substances must maintain “a complete and accurate record” of:

• “all stocks . . . on hand, ” as measured every two years. § 827(a)(1);
• “each substance . . . received.” § 827(a)(3); and
• “each substance . . . sold, delivered, or otherwise disposed of.” Id.

         The purpose, of course, is to allow for the DEA to be able to review the records and track all the substances. The biennial inventory under § 827(a)(1) provides a baseline, and the ongoing records under § 827(a)(3) show substances moving in and out. All of these records must be maintained separately from other records, must be “readily retrievable, ” and must be kept for two ...


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