United States District Court, N.D. Georgia, Gainesville Division
RICHARD W. STORY UNITED STATES DISTRICT JUDGE
case is before the Court on Plaintiff the United States'
Motion for Summary Judgment  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
Dr. Greene's Practice
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.
Reported Theft of Controlled Substances
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.
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].
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
The DEA Investigation
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
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
Dr. Greene's Alleged Recordkeeping
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. §
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. [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.
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].
The Current Case
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.
Legal Standard: Motion for Summary Judgment
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
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.
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”).
CSA Recordkeeping Statutory Framework
the governing substantive law centers on the recordkeeping
requirements under the Controlled Substances Act. See 21
§ U.S.C. 801 et seq.
Section 827: Specific Recordkeeping Requirements
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.” §
• “each substance . . . sold, delivered, or
otherwise disposed of.” Id.
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 ...