Source: https://www.federalregister.gov/documents/2014/06/16/2014-14006/roy-s-schwartz-decision-and-order
Timestamp: 2018-08-18 01:23:32
Document Index: 65491001

Matched Legal Cases: ['§\u2009824', '§\u2009824', '§\u2009841', '§\u2009823', '§\u2009822', '§\u2009844', '§\u2009823', '§\u2009802', '§\u2009802', '§\u2009802', '§\u2009841', '§\u2009827', '§\u2009827', '§\u2009827', '§\u2009824', '§\u2009823', '§\u2009885']

Federal Register :: Roy S. Schwartz; Decision and Order
A Notice by the Drug Enforcement Administration on 06/16/2014
34360-34364 (5 pages)
https://www.federalregister.gov/d/2014-14006 https://www.federalregister.gov/d/2014-14006
On October 7, 2013, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to Roy S. Schwartz, D.D.S. (hereinafter, Registrant), of Tacoma, Washington. The Show Cause Order proposed the revocation of Registrant's DEA Certificate of Registration, which authorizes him to dispense controlled substances as a practitioner, and the denial of any pending applications to renew or modify his registration, on the ground that his “continued registration is inconsistent with the public interest.” GX 1, at 1.
More specifically, the Show Cause Order alleged Registrant had procured controlled substances for one Dr. Raymond Wilkinson, who had previously held a DEA registration but which he had surrendered for cause, and that Registrant distributed controlled substances to Dr. Wilkinson who used them to sedate a patient at Registrant's registered address. Id. at 1-2. The Show Cause Order also alleged Dr. Wilkinson removed the controlled substances from Registrant's registered address and administered them “to individuals with whom [Registrant] did not establish a doctor patient relationship.” Id. at 2 (citations omitted).
Next, the Show Cause Order alleged that Registrant had made “material false and misleading statements to investigators during the initial phase of the investigation, including denying [that he knew] where Dr. Wilkinson obtained the controlled substances, denying ordering controlled substances, and stating that [he was] unfamiliar with DEA Forms-222.” Id. The Order then set forth various statements Registrant allegedly made including that on November 2, 2012, he told Washington Department of Health Investigators that he “did not know where Dr. Wilkinson obtained controlled substances and that [he] never ordered controlled substances.” Id. Based on various statements Registrant made to both Washington State and DEA Investigators, the Government also alleged that Registrant had “turned a willful blind eye to the diversion of controlled substances you obtained using your own DEA Certificate of Registration.” Id. at 3.
The Show Cause Order further alleged that during an on-site inspection of his registered location, DEA Investigators found that Registrant: (1) Did not have an initial or biennial inventory of controlled substances; (2) failed to properly document the receipt of controlled substances on DEA Form 222s; (3) failed to maintain all invoices of schedule II through V controlled substances and/or “failed to maintain . . . records in readily retrievable form”; and 4) failed to maintain effective controls against diversion by “allowing Dr. Wilkinson to maintain controlled substances in a locked suitcase in an unlocked cabinet at an unregistered location.” Id. at 3-4 (citations omitted). Finally, the Show Cause Order alleged DEA Investigators conducted an audit, which found that Registrant had overages of two ampules of 2 ml. fentanyl 50mcg/ml., ten ampules of 5 ml fentanyl 50mcg/ml., and 131 vials of 2 ml. midazolam 1mg/ml. Id. at 4.
On October 8, 2013, a DEA Diversion Investigator (DI) personally served the Show Cause Order on Registrant. GX 4. While the Show Cause Order explained that Registrant had the right to request a hearing on the allegations, the procedure for requesting a hearing (by sending his request to the Hearing Clerk, DEA Office of Administrative Law Judges, at a Springfield, Va., mailing address) and that if he failed to do so within 30 days of receipt of the Order, he would “be deemed to have waived [his] right to a hearing,” GX 1, at 4; Registrant did nothing until November 20, 2013, when he wrote the DI (who was located in Seattle, Washington) requesting a continuance of the time for him to respond to the Order. GX 5, at 3. On December 4, 2013, after the letter to the DI was returned undelivered, Registrant wrote the Hearing Clerk requesting a continuance; this letter was received on December 9, 2013, and the matter was assigned to an Administrative Law Judge (ALJ).
According to the affidavit of an Investigator with the Washington Department of Health (hereinafter, DOH), the DOH received complaints that one Dr. Raymond Wilkinson had used expired fentanyl and ketamine to perform conscious sedation on patients at the University of Washington's Periodontics Clinic. GX 10, at 1. However, the drugs (which are schedule II and schedule III controlled substances Start Printed Page 34361respectively [1] ) were not stocked at the clinic. Id. Moreover, years ago, Dr. Wilkinson had surrendered his DEA registration for cause. GX 18, at 6.
Registrant agreed to an interview, during which he stated that neither he nor Wilkinson provided conscious sedations at Registrant's office. Id. Registrant admitted, however, that he knew that Wilkinson was providing conscious sedation at other offices. Id. Moreover, Registrant stated that he had no idea as to how Wilkinson had obtained the drugs he used to sedate patients and “that he did not order or use sedation drugs in his practice.” Id. However, Registrant then admitted knowing that Wilkinson kept controlled substance in a briefcase at Registrant's office and that Wilkinson took the drugs offsite to perform conscious sedation. Id. He also stated that he was unfamiliar with the DEA Form which is used to order schedule II controlled substances (Form-222).
Dr. Wilkinson then showed the DOH Investigators his “sedation kit,” which according to the DOH Investigator, “he kept in a locked file-box within an unlocked cabinet.” Id. Upon opening the kit, the Investigator found the following items: (1) A cash receipt for a prescription for Registrant for 50 midazolam 2mg/ml injectable; (2) an un-opened box of 25 midazolam 2mg/ml vials; (3) an opened box which contained 11 midazolam 2mg/ml vials; (4) a blister pack of 10 ampules of fentanyl citrate 250mcg; and (5) a blister pack with one ampule remaining of fentanyl citrate 100mcg; and (6) a hand-written drug log. Id.
On November 9, 2012, DEA Investigators went to Registrant's practice. GX 2, at 3. Registrant admitted that “he did not make, maintain, or review any of the controlled substance records.” Id. Registrant acknowledged that he knew that Wilkinson did not have a DEA registration and yet was providing sedation to patients at other offices; he also asserted that Wilkinson “did not provide sedation for his . . . patients.” Id. at 4. Registrant also admitted that he used his DEA registration to obtain the controlled substances that Wilkinson needed to perform sedation and acknowledged having signed several Form 222s. Id. at 4. Registrant further stated that the controlled substances belonged to Wilkinson and that he was “doing a favor for a friend.” Id.
Dr. Wilkinson stated that Registrant “never had access to the controlled substances or records” and stated that all of the drugs were ordered from a local pharmacy. Id. at 5. Wilkinson also stated that 90 percent of the sedations he did were done at the practices of other dentists. Id.
The DIs further determined that Registrant did not have either an initial or biennial inventory of the controlled substances. Id. According to a DI, while Dr. Wilkinson produced a dispensing log, which contained twenty-six records, “[a]ll of the entries failed to record” the “patient address, finished form and initials of [t]he dispenser.” Id. Moreover, only three of the entries “noted the volume of the finished form” which was dispensed. Id. The DI further asserted that “the dispensing log did not contain at least two years' worth of records.” Id.
The DI, who had previously obtained copies of the Form-222s from the pharmacy where Registrant purchased the drugs, determined that Registrant was missing at least one such form. Id. at 6. Moreover, Registrant had failed to record the actual number of containers received and the dates of receipt. Id. The DI further asserted that Registrant was unable to identify who had prepared several of the forms. Id. In addition, the DI found that Registrant “failed to maintain . . . any Schedule III-V acquisitions invoices” and that while the controlled substances were kept “in a locking briefcase,” they were kept in an unlocked cabinet in Wilkinson's office. Id.
Subsequently, the DI conducted an audit “utilizing the closing inventory assembled during the on-site inspection, [the] dispensing log entries, and the Form-222s.” Id. The DI did not, however, “record the acquisition of any [s]chedule III-V controlled substances due to the lack of invoices.” Id. The DI further stated that he “used an initial inventory date of January 1, 2012, beginning of business, and noted that the initial inventory was `zero' due to lack of an initial or biennial inventory.” Id.
According to the DI's affidavit, the audit found overages of two ampules of 2ml fentanyl 50mcg/ml; ten ampules of 5ml fentanyl 50mcg/ml; and 131 vials of 2 ml midazolam 1mg/ml. Id. at 7. However, the record also includes a computation chart which lists various data that were obtained from Dr. Wilkinson's records as well as the pharmacy which supplied the drugs. See GX 12, at 2. Notably, this data includes figures (other than 0) in the “initial inventory” column and which are listed in entries that are labeled “Wilkinson Records,” as well as data for the midazolam purchases based on both the pharmacy records and Wilkinson's records. Id. Moreover, using Wilkinson's figures, the audit found, with respect to both the fentanyl and midazolam, that all of the drugs which were purchased were accounted for. Id.
The DI further declared that he had been informed by a DOH Investigator that one of Registrant's patients (J.F.) had received conscious sedation from Dr. Wilkinson at the latter's office. GX 2, at 8. As found above, in November 2012, Registrant had stated to both DOH and DEA Investigators that Wilkinson had not provided conscious sedation at his office. According to the DI, he subpoenaed J.F.'s medical records and determined “that in July 2012, Dr. Wilkinson utilized controlled substances to provide conscious sedation to” J.F. at Registrant's practice. Id.; see also GX 17 & 20.
As part of the record, the Government included several letters from Registrant to both DOH and the DI. In a letter to DOH, Registrant asserted “that under the sense of friendship[,] collegiality and economy, I made the decision to let another doctor share my DEA license” and “[i]t did not occur to me that sharing the license with a dentist operating in my office and building would be illegal” as he was told by the Start Printed Page 34362DI.[2] GX 15, at 7. Registrant further stated that he had known that “Dr. Wilkinson had taught [iv] [s]edation at the University of Washington Dental School for years,” and that he “had complete confidence that he would be well versed in the proper procedures for ordering and using the drugs for [iv] [s]edation.” Id. Registrant then stated that Wilkinson told him “that he would use the drugs in `neighboring practices' where dental sedation was required in the treatment of patients” and that it was his “understanding” that this meant only “dental practices in our immediate locality.” Id.
Registrant then explained that Dr. Wilkinson arranged with his secretary “to order the drugs he needed” and that he “would sign off on the order.” Id. Registrant further stated that he “never saw, received or handled the drugs that were ordered by Dr. Wilkinson,” and that the “drugs were given directly to Dr. Wilkinson for his use and maintenance” on patients that were unknown to Registrant. Id.; see also id. at 9. Registrant further stated that “Dr. Wilkinson was responsible for maintaining the required paperwork for using these drugs including receipts, dispensing, and inventory of what amount of the drugs remained in his possession.” Id. at 7.
Registrant further wrote that he was unaware that Dr. Wilkinson's state dental license had been suspended and that he had surrendered his DEA registration for cause, as Wilkinson had not informed him of this when they “discussed the sharing of my DEA license.” Id. at 8. Registrant further noted that he had prescribed controlled substances “for over fifty years without any incidents.” Id.
Registrant further stated that he always gives his patients a prescription, and that “[i]n his over fifty years of practice, [he] has never stored any controlled substances in his office.” Id. at 10. He also denied making false and misleading statements to either DOH or DEA Investigators. Id. Finally, he stated that he did not employ Dr. Wilkinson. Id.
Section 304(a) of the Controlled Substances Act (CSA) provides that a registration to “dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section.” 21 U.S.C. § 824(a)(4) (emphasis added). With respect to a practitioner, the Act requires the consideration of the following factors in making the public interest determination:
“These factors are . . . considered in the disjunctive.” Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I “may rely on any one or a combination of factors[,] and may give each factor the weight [I] deem[] appropriate in determining whether a registration should be revoked. Id.; see also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I am required to consider each of the factors, I “need not make explicit findings as to each one.” MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).[3]
Even where a Registrant fails to request a hearing or to submit a written statement in lieu of a hearing, the Government has the burden of proving, by a preponderance of the evidence, that the requirements for revocation or suspension pursuant to 21 U.S.C. § 824(a) are met. 21 CFR 1301.44(e). In this matter I have considered all of the statutory factors and deem it unnecessary to make findings with respect to factors one, two, three, and five. However, having considered all of the evidence in this matter, including the statements Registrant made to Investigators, I conclude that evidence with respect to factor four is sufficient to establish that Registrant has committed such acts as to render his registration inconsistent with the public interest.
Under the CSA, it is “unlawful for any person [to] knowingly or intentionally . . . distribute . . . a controlled substance,” “[e]xcept as authorized by this subchapter.” 21 U.S.C. § 841(a)(1). The CSA specifically recognizes various categories of registration to include, inter alia, manufacturers, distributors and practitioners, see id. § 823; and provides that a registrant may possess and engage in controlled substance activities “to the extent authorized by their registration and in conformity with the other provisions of this subchapter.” Id. § 822(b); see also 21 CFR 1301.13(e) (“Any person who is required to be registered and who is not so registered, shall make application for registration for one of the following groups of activities, which are deemed to be independent of each other.”). So too, the CSA limits the circumstances in which a person may lawfully possess a controlled substance to where the substance “was obtained directly, pursuant to a valid prescription or order, from a practitioner, while acting in the course of his professional practice, or except as otherwise authorized by” the CSA. 21 U.S.C. § 844(a).
Under the CSA, a practitioner's registration authorizes its holder to dispense controlled substances, 21 U.S.C. § 823(f); i.e., “to deliver a controlled substance to an ultimate user . . . by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance.” Id. § 802(10). Thus, except for in limited circumstances, a practitioner is not authorized to distribute controlled substances.[4]
Here, the evidence shows that while Registrant did not physically possess the controlled substances, he nonetheless unlawfully distributed them to Dr. Wilkinson. Under the CSA, Wilkinson could not have lawfully obtained the controlled substances because he was not registered. Indeed, the whole purpose of the agreement between Wilkinson and Registrant was—in Registrant's own words—to “share” his DEA registration, so that Wilkinson could obtain possession of controlled substances. With Registrant's knowledge and consent, the controlled substances were ordered under Registrant's registration and were then delivered to Wilkinson. This constitutes a distribution under the CSA. See 21 U.S.C. § 802(11) (“The term `distribute' means to deliver (other than by administering or dispensing) a controlled substance . . .”); id. § 802(8) (“The terms `deliver' or `deliver' mean the actual, constructive, or attempted transfer of a controlled substances . . . whether or not there exists an agency relationship.”).
While Registrant asserted that he was unaware that Wilkinson had surrendered his DEA registration years earlier, he obviously knew that Wilkinson was unregistered as there would have been no reason for Registrant to “share” his DEA license if Wilkinson was registered. Moreover, he also knew that Wilkinson was taking the controlled substances from his practice, which was his registered location, to other dental offices. Accordingly, I find that Registrant violated the CSA when he distributed the controlled substances to Wilkinson. See 21 U.S.C. § 841(a)(1). However, while this is technically diversion because Dr. Wilkinson was unregistered and thus outside the closed system of distribution established by the CSA, there is no evidence that any of the drugs were administered to patients other than in the course of providing legitimate dental treatment.
The evidence also shows that Registrant failed to comply with various recordkeeping requirements. Under 21 U.S.C. § 827(a)(1), “every registrant . . . shall . . . as soon . . . as such registrant first engaged in the manufacture, distribution, or dispensing of controlled substances, and every second year thereafter, make a complete and accurate record of all stocks thereof on hand.” Even if Registrant or his Secretary (who apparently prepared the order forms) never physically possessed the drugs, upon the use of his registration for the purpose of enabling Wilkinson to obtain controlled substances, he engaged in the distribution of controlled substances and under DEA regulations, he was still required to prepare an initial inventory. See 21 CFR 1304.11(b) (“In the event a person commences business with no controlled substances on hand, he/she shall record this fact as the initial inventory.”). The evidence showed, however, that Registrant had no inventories.
Also, pursuant to 21 U.S.C. § 827(a)(3), “every registrant . . . manufacturing, distributing, or dispensing a controlled substance or substances shall maintain, on a current basis, a complete and accurate record of each such substances manufactured, received, sold, delivered, or otherwise disposed of by him.” See also 21 CFR 1304.21(a). Thus, Registrant was required to keep records of the purchases he authorized and his subsequent distributions to Wilkinson.
While Registrant had some DEA Form-222s for the fentanyl purchases, the forms were not completed to show the actual quantities received and the dates of receipt. See 21 CFR 1305.13(e). Nor could he produce any invoices or other records documenting the purchases for the other controlled substances that were ordered. Likewise, he had no records documenting the subsequent distributions of the controlled substances to Wilkinson. Registrant thus violated the CSA by failing to maintain required records.[5] 21 U.S.C. §§ 827(a)(3) & 842(a)(5); 21 CFR 1304.21(a); 21 CFR 1304.22(b).
Accordingly, I find that Registrant “has committed such acts as would render his registration . . . inconsistent with the public interest.” 21 U.S.C. § 824(a)(4).[6] While I have carefully considered Registrant's statements in his letters, I find that Registrant has not acknowledged that he violated federal law by both: (1) Distributing controlled substances to an unregistered person, and (2) failing to maintain CSA-required records.[7] Moreover, Respondent clearly knew that his activities were illegal as there would be no reason to “share” his DEA license if Wilkinson was himself registered; indeed, he even knew that Wilkinson had given up “his DEA license because of the `haggle' over it at [Wilkinson's] Puyallup practice.” GX 5, at 4. Registrant also knew that Wilkinson intended to take the controlled substance to other dental offices.
On the other hand, Registrant's statements suggest that he does not accept responsibility for his misconduct. Moreover, the Agency has Start Printed Page 34364a strong interest in deterring similar acts on the part of other registrants. Accordingly, while I reject the Government's contention that Registrant's registration should be revoked, I will order that his registration be suspended outright for a period of one year.[8]
Pursuant to the authority vested in me by 21 U.S.C. §§ 823(f) and 824(a)(4), as well as 28 CFR 0.100(b) and 0.104, I order that the DEA Certificate of Registration issued to Roy S. Schwartz, D.D.S., be, and it hereby is, suspended for a period of one year. The suspension of Dr. Schwartz's registration shall be effective July 16, 2014. I further order that Dr. Schwartz's registration shall be restricted as set forth above; said restrictions shall be, and hereby are, effective immediately.[9]
1. See 21 CFR 1308.12(c) (fentanyl) and 21 CFR 1308.13(c) (ketamine).
2. See also GX 5, at 4 (Registrant's letter of Nov. 20, 2013 to DI) (“He [Wilkinson] told me, at the time that we made the agreement, that he had decided to `give up' his DEA license because of the `haggle' over it at his Puyallup practice.”).
3. “In short, this is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant's misconduct.” Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has recognized, findings under a single factor can support the revocation of a registration. MacKay, 664 F.3d at 821.
4. One such exception is found at 21 CFR 1307.11(a). It provides that:
(a) A practitioner who is registered to dispense a controlled substance may (without being registered to distribute) a quantity of such substance to—
(1) Another practitioner for the purpose of general dispensing by the practitioner to patients provided that—
Respondent did not, however, raise this provision as an affirmative defense, see 21 U.S.C. § 885(a)(1), and because Wilkinson was not registered, could not have successfully raised it.
5. Notwithstanding that the Order to Show Cause alleged that DEA's audit found that Registrant had various overages, GX 1, at 4, in its discussion of the public interest factors, the Government made no reference to the audit results. Accordingly, I do not consider this evidence.
6. Because Registrant had already distributed the controlled substances to Wilkinson and there is no evidence that Wilkinson acted as Registrant's agent when he performed sedation (other than with the possible exception of when he sedated J.F.), I place no weight on the inadequacies identified by the DI regarding the dispensing log maintained by Dr. Wilkinson. So too, because the controlled substances had been distributed to Wilkinson, I place no weight on the evidence that they were not “stored in a securely locked, substantially constructed cabinet.” 21 CRF 1301.75
7. In his May 21, 2013 letter to the DOH Investigator, Respondent stated that “Dr Wilkinson was responsible for maintaining the required paperwork for using these drugs including receipts, dispensing, and an inventory of what amount of the drug remained in his possession.” GX 15, at 7. While this may have been his arrangement with Wilkinson, as explained above, because Registrant engaged in the acquisition and distribution of controlled substances he was also required to maintain records.
Moreover, on the issue of whether he allowed controlled substances to be taken from his registered location, Registrant wrote: “Dr. Wilkinson was given the drugs he ordered. What he did with them after that was done without my knowledge or consent.” GX 18, at 8. Registrant did, however, know that Wilkinson intended to and did take the controlled substances out of his office.
8. This Order does not preclude the Government from seeking revocation of Registrant's registration in the event the State of Washington suspends or revokes Registrant's dental license.
9. In the event Registrant is in possession of any controlled substances other than those which have been lawfully prescribed to him, he shall contact the DEA field office for instructions on how to dispose of them. Registrant shall have ten (10) business days to dispose of any such controlled substances.