ORDER ON DEFENDANT DAVID M. WASANYI'S MOTION TO DISMISS AND MOTION TO STRIKE EXPERT TESTIMONY AND GRANTING IN PART AND DENYING IN PART GOVERNMENT'S MOTION FOR SUMMARY JUDGMENT
JOHN PRESTON BAILEY, District Judge.
This matter now comes before the Court for consideration of defendant David M. Wasanyi's ("Wasanyi") Motion to Dismiss [Doc. 58], filed on September 22, 2016. The Government filed a Response in Opposition to Wasanyi's Motion to Dismiss on September 29, 2016 [Doc. 60]. The Government then filed a Motion for Summary Judgment [Doc. 68] on December 29, 2016. As to defendant Amy Wasanyi (now "Amy Louise"
On February 29, 2016, the Government filed a complaint against the above-named defendants, alleging violations of the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. §§ 801-971 ("the CSA"), and seeking civil penalties for the same [Doc. 1]. Specifically, the United States alleges violations of 21 U.S.C. § 842(a)(1), 21 U.S.C. § 829, 21 C.F.R. § 1306.04, 21 C.F.R. § 1306.05 and 21 C.F.R. § 1306.11 [Id.]. The Government claims that the individual defendants utilized City Pharmacy, LLC ("CP"), and City Pharmacy of Charles Town, Inc. ("CPCT"), to fill illegitimate prescriptions for controlled substances, including those which were: (1) written by medical providers located in distant states; (2) presented by individuals who traveled from distant locations; (3) paid for using cash; (4) altered by scratching out the medical provider's fill date, increasing the number of units being prescribed or changing the strength, nature or type of controlled substance; and (5) lacking the full name or address of the patient for whom the prescription was written [Id.].
Defendant CP is a West Virginia limited liability company, with its principal place of business located in Martinsburg, West Virginia [Doc. 1 at ¶ 2]. Defendant CPCT is a West Virginia corporation, with its principal place of business in Charles Town, West Virginia [Id. at ¶ 3]. CP and CPCT were both registered by the U.S. Drug Enforcement Administration ("DEA"), and both companies were engaged in the business of operating a retail pharmacy [Id. at ¶¶ 4-7]. During the time of the events alleged in the Complaint, Amy and David Wasanyi were married although, again, the former Amy Wasanyi has since divorced David Wasanyi and changed her name to Amy Louise [Doc. 85 at 1]. Roger Lewis is the father of Amy Louise and former father-in-law of Wasanyi [Doc. 1 at ¶ 16]. Finally, Wasanyi was a pharmacist, licensed by the West Virginia Board of Pharmacy, and was the primary pharmacist at both CP and CPCT [Id. at ¶¶ 9-11].
In this action, the Government alleges that from 2010 into 2015, CP and CPCT filled 1,181 invalid prescriptions for Schedule II and Schedule III controlled substances, written by 45 physicians located in Florida, Georgia, Tennessee and Virginia for patients in Alabama, Florida, Georgia, Kentucky, Maryland, Ohio, Tennessee and Virginia [Doc. 71-1
As to defendant Wasanyi, the Government alleges that in his capacity as a pharmacist, Wasanyi filled the majority of the aforementioned 1,181 illegitimate prescriptions until his arrest in April of 2014 [Doc. 71-1 at ¶ 11]. At that time, Wasanyi was arrested and indicted by the State of West Virginia for improper delivery of controlled substances, and ultimately he faced charges in two separate Berkeley County cases and one Jefferson County case [Id. at ¶ 12]. In April of 2016, Wasanyi was convicted in the Circuit Court of Berkeley County (Case No. 15-F-17) of two counts of improper delivery of diazepam and one count of improper delivery of buprenorphine [Id. at ¶ 13]. Then, in October of 2016, Wasanyi was convicted in the Circuit Court of Berkeley County (Case No. 16-F-54) on 13 counts of improper delivery of a controlled substance [Id. at ¶ 14]. The charges in Case No. 16-F-54 involved 13 prescriptions presented by two women from Kentucky and written by a Georgia provider and are, in turn, allegedly similar to the 1,181 prescriptions at issue in this Federal civil action [Id.]. Finally, in February of 2016, Wasanyi was indicted in Jefferson County Circuit Court (Case No. 16-F-123) for his alleged role in a conspiracy to obtain controlled substances by fraud; these charges are pending [Id. at ¶ 15]. This action followed those related state-court matters.
II. Standard of Review
Fed. R. Civ. P. 56 provides that summary judgment is appropriate "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." The party seeking summary judgment bears the initial burden of showing the absence of any genuine issues of material fact. See
However, as the United States Supreme Court noted in
In assessing the instant Motion for Summary Judgment, this Court is satisfied that the questions before it are not factual, but rather legal, in nature. As such, this Court will decide whether the Government has asserted and proven a cognizable claim for a civil penalty as to defendant Wasanyi. See
A. Defendant David Wasanyi is liable for violations of 21 U.S.C. § 842(a)(1).
In deciding the disposition of Wasanyi's Motion to Dismiss [Doc. 58] and the Government's Motion for Summary Judgment [Doc. 68] as to Wasanyi, this Court is cognizant of the applicable federal regulations that applied to Wasanyi's conduct as a pharmacist during the time that he worked in that capacity at CP and CPCT. 21 U.S.C. § 842(a)(1) makes it unlawful for any person to "distribute or dispense a controlled substance in violation of [21 U.S.C. §] 829." In turn, 21 U.S.C. § 829 sets forth the rules and regulations regarding the issuance and filling of prescription drugs, while the related Code of Federal Regulations provisions, 21 C.F.R. §§ 1306.01 — 1306.27, provide the scope of 21 U.S.C. § 829.
The CSA and applicable regulations place the responsibility for the proper dispensing of controlled substances on the pharmacist that fills the prescription. See 21 C.F.R. §§ 1306.04 — 1306.06; see also
21 C.F.R. § 1306.04 provides that in order for a prescription for a controlled substance to be effective it must be issued for a legitimate medical purpose by a practitioner acting in the usual course of his professional practice. The regulation also provides that, while "[t]he responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practicioner . . . a corresponding responsibility rests with the pharmacist who fills the prescription." 21 C.F.R. § 1306.04; see also 21 C.F.R. § 1306.06. Furthermore, an order that is not issued in the usual course of professional treatment is not a prescription, and the person knowingly filling such an order is subject to the penalties specified for violations of the CSA. Id. As discussed by the Government's expert witness Dr. Carmen Catizone, the Executive Director of the National Association of Boards of Pharmacy, in her Affidavit [Doc. 73-2], and the Drug Enforcement Administration ("DEA") in its "Pharmacist's Manual" outlining the CSA, a pharmacist has certain duties when faced with suspicious orders:
Drug Enforcement Administration,
As defined by Dr. Catizone, "a `red flag' is a circumstance arising during the presentation of a prescription which creates a reasonable suspicion that the prescription is not, on its face, legitimate. The existence of a `red flag' in relation to a prescription imposes on a pharamcist the obligation to conduct further and sufficient inquiry to determine whether the prescription is or is not legitimate." [Doc. 71-2 at 4]. See
In this matter, Dr. Catizone avers that obvious red flags were ignored repeatedly at CP and CPCT [Doc. 73-2 at 3-5]. For example, defendant Wasanyi, by and through CP and CPCT, repeatedly filled, "pattern prescriptions," or the same types of drugs in the same quantities from the same prescriber [Id. at 4]. The evidence also shows that Wasanyi, through CP and CPCT, filled prescriptions despite significant geographic abnormalities between the prescribing doctors and patients [Id. at 3-6]. Prescriptions were issued by doctors in far-flung states, including Florida, Georgia, Virginia, and Tennessee, to patients in states including Alabama, Florida, Georgia, Kentucky, Maryland, Ohio, Pennsylvania, Tennessee, and Virginia [Id.]. Dr. Catizone also represents that CP and CPCT filled nearly 1,181 illegitimate prescriptions written by 45 separate physicians located in Florida, Georgia, Tennessee, and Virginia [Doc. 73-1 at 2; 4-5].
The Government also offers the testimony of DEA Diversion Investigator Lindsey Malocu, who represents that, until he was indicted and arrested by the State of West Virginia in April of 2014, Wasanyi filled nearly all of the illegitimate prescriptions presented and filled at CP and CPCT [Doc. 71-1]. Furthermore, Amy Louise testified that Wasanyi was an organizer, owner and manager of CP and CPCT [Doc. 71-3 at 21-22]. Indeed, Wasanyi chose the pharmaceutical companies from which CP and CPCT would order narcotics, and would instruct her to call those companies to fulfill orders [Id. at 26-27]. Indeed, until he was arrested and charged with felonies in Berkeley County in April of 2014, David Wasanyi was the principal pharmacist at CP, where most of the illegitimate prescriptions were presented and filled [Doc. 71-1]. Accordingly, this Court finds that there is no genuine issue of material fact that Wasanyi was involved in the manufacture, distribution and dispensing of controlled substances within the meaning of 21 U.S.C. § 822, and is subject to the prohibitions in 21 U.S.C. § 842(a)(1). Because Wasanyi, as a licensed pharmacist in charge of CP and CPCT, repeatedly filled prescriptions for controlled substances that were not valid, Wasanyi is liable for violations of § 842(a)(1). See 21 C.F.R. § 1306.04;
B. This Court Will Conduct an Evidentiary Hearing on Damages to be Assessed Against David Wasanyi.
In cases, such as this instant matter, a defendant who has been found liable for violating 21 U.S.C. § 842(a)(1), "shall be subject to a civil penalty of not more than $25,000," for any such violation. 21 U.S.C. § 842(c)(1)(
C. Defendant Wasanyi's Motion to Strike and Motion for Hearing on the Motion to Strike Must be Denied. However, Defendant Wasanyi's Motion for Extension of Time is Granted.
On February 28, 2017, Wasanyi filed a Motion to Strike Dr. Catizone's Affidavit [Doc. 96], wherein he argues that Dr. Catizone's expert opinions set forth in an Affidavit [Doc. 69-2] should be struck. He argues that Dr. Catizone's testimony somehow violates the Clayton Act and West Virginia Code § 5A-3C-12 [Doc. 96 at 2-3]. However, Wasanyi's Motion is simply without merit, as the statutes he cites are completely inapplicable to this action. In general, the Clayton Act, 15 U.S.C.A. § 12 et seq., prohibits price discrimination, tying and exclusive dealing contracts, improper corporate mergers (e.g. acquisition of competing companies by one, and interlocking directorates. These practices are deemed illegal when they might substantially lessen competition or tend to create a monopoly in any line of commerce. See
In his Motion for Extension of Time to File Voir Dire, Jury Instructions, and Verdict Form [Doc. 111], Wasanyi avers that he is in custody in the Martinsburg Correctional Facility, and that, "his freedom to do this preparations [sic] is limited," and that his "handwritten forms . . . might not be legible." As such, Wasanyi requests additional time to file those documents. For good cause shown, this Court finds that defendant Wasanyi's Motion for Extension is hereby granted as to the issue of damages.
For the reasons stated more fully above, defendant Wasanyi's
However, defendant Wasanyi's
It is so
The Clerk is directed to transmit copies of this Order to all counsel of record herein and to the pro se defendant.