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On May 8, 2000, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Robert A. Leslie, M.D. (Respondent), proposing to deny his application for a DEA Certification of Registration pursuant to 21 U.S.C. 823(f) for reason that such registration would be inconsistent with the public interest. Specifically, the Order to Show Cause alleged the following:
(1) On August 17, 1990, Respondent's DEA Certificate of Registration, ALOO33186, was revoked based in part on findings that: (a) On or about October 3, 1986, Respondent was convicted in the Superior Court for the County of Los Angeles, California of eight counts of unlawfully prescribing, administering, furnishing, or dispensing controlled substances; and (b) effective March 23, 1990, the California Board of Medical Quality Assurance suspended Respondent's license to practice medicine for ninety days and placed his medical license on probation for five years.
(2) During February 1992, Respondent submitted a new application for registration. Following a hearing, the then-Administrator of DEA denied Respondent's application, effective March 15, 1995, noting, inter alia, that Respondent was either unable or unwilling to discharge the responsibilities inherent in a DEA registration. Respondent's petition for review of this decision was denied by the United States Court of Appeals for the Ninth Circuit on August 5, 1996.
(3) On or about December 13, 1996, Respondent submitted a new application for a DEA registration. The then-Deputy Administrator concluded that the previous administrative proceeding was res judicata for the purposes of the then-current proceeding. Effective June 14, 1999, the Deputy Administrator again denied Respondent's application, concluding that other than the passage of time, the circumstances existing at the time of the prior proceeding had not sufficiently changed to warrant issuance of a DEA registration.
Respondent, acting pro se, filed a timely request for a hearing on the issues raised in the Order to Show Cause. Following prehearing procedures, a hearing was held on September 21, 2000, and February 8, 2001, in Los Angeles, California before Administrative Law Judge Mary Ellen Bittner (Judge Bittner). At the hearing, the Government called two witnesses to testify and the Respondent testified on his own behalf. Both parties also introduced documentary evidence. After the hearing, both parties submitted proposed findings of fact, conclusions of law, and argument.
On August 2, 2001, Judge Bittner issued her Opinion and Recommended Ruling, Findings of Fact, Conclusions of Law and Decision recommending that the Respondent's application be denied. On or around August 17, 2001, the Respondent timely filed exceptions to Judge Bittner's recommended ruling. Thereafter, Judge Bittner transmitted the record of these proceedings to the Administrator of the Drug Enforcement Administration.
On March 4, 2002, the Respondent filed Judge Bittner, a letter (the March 2002 letter) in which he represented, among other things, that a provision under California law allows physician assistants to prescribe certain drugs “with or without preprinted prescriptions from the supervising physician.” The Respondent further requested that Judge Bittner transmit the additional document to the Deputy Administrator for consideration. It appears from a review of the record before the Deputy Administrator that matters involving the role of physician assistants and the prescribing of controlled substances were litigated. It is unclear however why the Respondent did not introduce the March 2002 at the hearing or reference its contents in his post-hearing submissions. Therefore, in rendering his decision in this matter, the Deputy Administrator has not considered the Respondent's untimely Start Printed Page 15228submission, as it seeks to introduce evidence not submitted at the hearing in this matter. See Richard S. Wagner, M.D. 63 FR 6771 (1998).
On August 20, 2002, the Deputy Administrator received from Government counsel a letter, with attachments, informing that due to an administrative oversight, DEA Certificate of Registration, BL6652312, was erroneously issued to the Respondent on February 9, 2000. In light of the Respondent's current registration status, the question for resolution now before the Deputy Administrator is whether or not the Respondent's continued registration with DEA is inconsistent with the public interest.
The Deputy Administrator finds that the Respondent previously possessed DEA Certificate of Registration AL0033186. On June 21, 1989, an Order to Show Cause was issued proposing to revoke that Certificate of Registration. Robert A. Leslie, M.D. 64 FR 25908 (1999). The Respondent initially requested a hearing, but later requested the opportunity ot submit a written statement in lieu of a hearing. Based on the Government's investigative file and Respondent's written statement, the then-Acting Administrator revoked Respondent's registration effective August 17, 1990. See 55 FR 29,278 (July 18, 1990).
In February 1992, Respondent applied for a new DEA registration. An Order to Show Cause was issued on May 13, 1993, proposing to deny the application. Following a hearing before Judge Bittner, the then-Deputy Administrator adopted Judge Bittner's recommended ruling and denied the Respondent's application for registration, effective March 15, 1995. See 60 FR 14,004 (1995).
During the 1993 proceeding before Judge Bittner, the record established that on October 9, 1986, after a jury trial, Respondent was found guilty in the Municipal Court of Long Beach, California, of eight misdemeanor counts of unlawfully prescribing, administering, furnishing, or dispensing controlled substances between July 1985 and January 1986. The convictions were affirmed on appeal by the Appellate Department of the Superior Court, State of California, on May 18, 1988. As a result of these convictions, the California Board of Medical Quality Assurance (Board), on a date not specified in the record, revoked the Respondent's medical license. However, the Board stayed the revocation for five years, suspended Respondent from the practice of medicine for ninety days, and placed him on probation subject to various conditions. In response to the Board's decision, the Respondent sued the Board, but was unsuccessful. The court in which Respondent brought the action ultimately fined him $10,000 and found that his appeal was frivolous. In addition, the court found that the Respondent must “accept responsibility for his actions.”
As outlined in a prior final order, the then-Deputy Administrator found at the 1993 hearing, the Respondent attacked his criminal convictions. See 64 FR 25908 (May 13, 1999). However, Judge Bittner and the then-Deputy Administrator found that the conviction was res judicata and that Respondent was therefore prohibited from relitigating the matter. The agency also found that although he was free to offer evidence that he would never again engage in the sort of conduct that resulted in his conviction, Respondent did not avail himself of that opportunity and offered no evidence of remorse for his misconduct, efforts at rehabilitation, or recognition of the severity of his conduct. Judge Bittner and the then-Deputy Administrator therefore concluded that Respondent was either unwilling or unable to discharge the responsibilities of a DEA registrant and recommended that his application be denied. Respondent filed a petition for review of the 1995 final order in the United States Court of Appeals for the Ninth Circuit. The court denied that petition on August 5, 1996.
On December 13, 1996, Respondent again applied for a DEA registration, and an Order to Show Cause was issued on December 23, 1997, proposing to deny the application. Following a hearing, Administrative Law Judge Gail A. Randall recommended that the application be granted, subject to certain conditions. Judge Randall found that Respondent had been forthcoming on his registration application about his convictions and prior DEA proceedings, there were no new allegations that Respondent had handled controlled substances improperly after his 1986 conviction, and there had been no complaints or adverse actions against his medical license since the 1988 Board proceeding. Judge Randall further found that Respondent had continued to make valuable contributions to the medical profession; participated in continuing medical education; there were no restrictions on his medical license in California; and Respondent had become more conservative in his approach to prescribing controlled substances.
In the May 13, 1999, Final Order, the then-Deputy Administrator found that the final order published on March 15, 1995, was res judicata for purposes of the proceeding before him, and adopted that final order in its entirety. 64 FR 25908, supra. While the then-Deputy Administrator adopted the findings of fact and conclusions of law as set forth, he did not adopt the recommended ruling of the Administrative Law Judge. Instead, the Deputy Administrator found that in addition to his criminal conviction and the suspension of his medical license, the Respondent was unrepentant, and continued to blame everyone but himself for his unlawful actions. Therefore, the then-Deputy Administrator concluded that Respondent's registration would not be consistent with the public interest and denied the application.
On June 29, 1999, Respondent again applied for a DEA registration to handle controlled substances. That application and the disposition of the Certificate of Registration that was mistakenly issued to the Respondent, are the subjects of the instant proceedings.
The Deputy Administrator finds that the Respondent's June 1999 application was forwarded to DEA's Los Angeles office for investigation because Respondent had answered “yes” to questions on the form that ask whether the applicant has ever been convicted of a crime in connection with controlled substances, ever surrendered or had adverse action taken on a federal controlled substance registration, or has ever had action taken against a state professional license or controlled substance registration. A DEA Diversion Investigator testified that on November 24, 1999, she spoke with the Respondent and asked him why he believed his application should be granted. According to the investigator, the Respondent attacked the prior DEA and criminal proceedings in which he had been involved, but did not say anything that would suggest that he would act responsibly in the future if his application were granted, nor did he divulge any actions he had taken that would support his application.
Respondent then wrote a ten-page letter dated November 25, 1999, to the Diversion Investigator explaining his position with respect to the 1986 conviction and his efforts first to maintain and then to regain DEA registration. Specifically, the Respondent made various claims regarding the inadequacy of the 1986 criminal proceedings resulting in his conviction, as well as his legal representation during those proceedings. In support of the latter assertion, Respondent offered into evidence in the instant matter a letter from the State Bar of California dated Start Printed Page 15229August 3, 1999, indicating that his attorney “resigned from the practice of law with charges pending” in 1994.
Respondent also contended in the aforementioned letter that his applications for habeas corpus, coram nobis, and declarative relief were denied, asserting that he was “unable to submit an adequate habeas corpus petition because defense counsel refused to release [Respondent's] criminal file, although [sic] sued for its return in the legal malpractice suit, until given an ultimatum to do so by the state bar, when [Respondent] was no longer in custody.”
With respect to the various DEA proceedings described above, the Respondent asserted in his letter that his registration was initially revoked “without notice or hearing based on false, inadmissible hearsay evidence given to the agency by the medical board.” The Respondent recited numerous additional allegations with respect to DEA's action against his previous registration, as well as his applications for registration, which are summarized as follows: DEA took action against the Respondent's registration because he advised the agency of the criminal activities taking place at a clinic in Long Beach; an undercover operative gave false information that Respondent supplied Schedule II drugs for weight control when in fact he used Schedule IV drugs; the then-Administrator did not consider all the pleadings and evidence; no other physician has had a registration revoked based on a misdemeanor conviction for improperly prescribing Schedule III drugs; he had three years of training in pharmacology and was familiar with the drugs he handled; hearsay was improperly admitted; and the then-Administrator's decision conflicted with those of the trial judge, the state administrative law judge for the Board, as well as the Board itself.
The Respondent further contended in his letter that the denial of his 1992 application was based on his purported failure “to take unspecified ‘rehabilitative' steps.” With respect to the denial of his 1996 application, Respondent asserted, inter alia, that the then-Deputy Administrator's order conflicted with the opinion of the administrative law judge who heard the evidence, and was made on the “incorrect basis that in [Respondent's] administrative hearing he failed to offer any evidence that [he] has been rehabilitated and can handle restricted substances even on a restricted bas[i]s.”
The Government also presented the testimony of a second Diversion Investigator from the agency's Los Angeles office. The investigator testified that on July 13, 2000, DEA personnel seized approximately 13,000 prescriptions from Plaza Pharmacy in Hawthorne, California, in the course of an investigation unrelated to Respondent. Three of the seized prescriptions, which were admitted into evidence as Government exhibits appeared to be written by someone on a preprinted prescription pad with a caption that read, “Robert M.D. Clinic.” The prescriptions in question also bore the clinic's address as well as the Respondent's name. One of the prescriptions was issued to a patient hereinafter identified by his initials “FU” and dated January 12, 2000, for promethazine with codeine (a Schedule IV controlled substance); prescriptions were also issued to patient “GB” and dated January 19, 2000, for forty cephalexinll (a non-controlled drug) and eight ounces of Phenergan with codeine (a brand name for promethazine); and the third prescription was issued to a “JH” and dated December 27, 1999, for cephalexin and promethazine with codeine. Further review of the third prescription reveals the Respondent's previous DEA registration number, AL0033186, written in the lower left corner of the document. As noted above, the DEA registration number was revoked, effective August 17, 1990.
The second DEA Diversion Investigator further testified at the hearing that the handwriting on each of the Plaza Pharmacy prescriptions appeared to be different, and that the person who signed each prescription appeared to be someone other than the person who wrote the patient's name, the medication to be dispensed, and date. The investigator further testified that the DEA registration number written on these prescriptions did not appear to be in Respondent's handwriting.
Respondent testified that he was retained as a physician in the Robert M.D. Clinic in Hawthorne in December 1999 as a supervisor of physician assistants, that he did not personally see patients or write prescriptions, and that he only went to the clinic once or twice per week to sign charts. The Respondent further testified that he neither wrote the prescriptions at issue nor authorized anyone else to write them, and did not know any of the patients to whom the prescriptions were issued. Respondent also testified that he did not think he signed the prescriptions because he usually wrote out his whole name when signing prescriptions and some letters appeared to be missing from the prescriptions at issue. However, Respondent also acknowledged that “[i]t might be” his signature on the prescription for GB, and if so, he may have signed the prescription in blank, as he would not have issued the prescription as written. With respect to the prescription to JH, Respondent testified that the physician signature, instructions, and the patient's name and address were not in his handwriting.
DEA's investigation did not reveal whether the Respondent actually issued the above referenced prescriptions. The Deputy Administrator concurs with Judge Bittner's finding that the record is not sufficient to determine whether or not Respondent signed the three prescriptions in evidence. However, Respondent testified that his practice was to sign “a bunch of” blank prescriptions preprinted with his name and make them available to the clinic's physician assistants, with a “proviso that they did not prescribe any restricted substances.” Respondent further testified that he told the physician assistants not to issue prescriptions for controlled substances, and that a sign posted in the clinic advised patients that the clinic would not issue controlled substances prescriptions.
In addition, a part time physician assistant employed at the Robert M.D. Clinic for two or three months beginning in early August 2000, testified that she had seen blank pads with prescriptions similar in appearance to the prescriptions issued to GB and FU. The physician assistant added that the DEA and license numbers on the prescriptions were those that the owner of the clinic had told her she would need to provide to pharmacists in order to have prescriptions filled. The DEA and license numbers referenced by the physician assistant belonged to the Respondent. The physician assistant further testified that she was told by both the clinic owner and Respondent that she could use the Respondent's DEA number when calling a pharmacy to authorize prescriptions for medications to treat high blood pressure and diabetes.
Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy Administrator may revoke a DEA Certificate of Registration and deny any pending application for renewal for such registration, if he determines that the continued registration would be inconsistent with the public interest. Section 823(f) requires that the following factors be considered in determining the public interest:
(1) The recommendation of the appropriate state licensing board or professional disciplinary authority.Start Printed Page 15230
(2) The applicant's experience in dispensing or conducting research with respect to controlled substances.
(3) The applicant's conviction record under federal or state laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable state, federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health or safety.
These factors are to be considered in the disjunctive; the Deputy Administrator may rely on any one or a combination of factors and may give each factor the weight he deems appropriate in determining whether a registration should be revoked or an application for registration denied. See Henry J. Schwartz, Jr., M.D., 54 FR 16422 (1989).
Regarding factor one, in 1990, the Board revoked the Respondent's medical license, stayed the revocation, but suspended his license for 90 days and then placed it on probation for five years. There is no evidence before the Deputy Administrator demonstrating that Respondent's medical license is currently restricted in any form. Nevertheless, state license is a necessary, but not a sufficient condition for registration, and therefore, this factor is not dispositive. See e.g., Wesley G. Harline, M.D., 65 FR 5665 (2000); James C. LaJevice, D.M.D., 64 FR 55962 (1999).
Factors two and four, Respondent's experience is dispensing controlled substances and compliance with applicable controlled substance laws are relevant in determining whether Respondent's continued registration would be inconsistent with the public interest. Respondent improperly prescribed, administered, or otherwise dispensed controlled substances in 1985 and 1986. Although the Respondent has maintained that he has done nothing wrong, a jury convicted him of eight misdemeanor counts as a result of this conduct, and the judgment was affirmed on appeal.
In the most recent proceeding, the Respondent, by his own admission, signed blank prescriptions and made them available to physician assistants. While there was no evidence presented that Respondent issued or signed any of the three controlled substance prescriptions, his pre-signing prescription forms made it possible for “prescriptions” to be issued in violation of 21 U.S.C. 829, 841, and 843. Therefore, the Deputy Administrator finds that factors two and four weigh in favor of a finding that Respondent's continued registration would be inconsistent with the public interest.
With respect to factor five, the Deputy Administrator concurs with Judge Bittner that the Respondent continues to argue that his convictions were improper, continues to blame others for his misconduct, and refuses to accept responsibility for his actions. In addition, the Respondent made a practice of making pre-signed prescriptions available to physician assistants at the Robert, M.D. Clinic, who were then free to issue those prescriptions with no supervision from Respondent. The Deputy Administrator further concurs with Judge Bittner that Respondent knew or should have known that he would be liable for those prescriptions, but nonetheless appears to think that posting signs in the clinic and advising physician assistants not to issue prescriptions for controlled substances absolve him from liability.
After reviewing the record, Judge Bittner found that based on the Respondent's refusal to take responsibility for past misconduct and his irresponsible pre-signing of prescription pads, he continues to be unwilling or unable to accept the obligations that the Controlled Substances Act and its implementing regulations impose upon DEA registrants. Judge Bittner therefore concluded that a preponderance of the credible evidence in the record established that Respondent's continued registration would be inconsistent with the public interest, and recommended that his application be denied. In light of the subsequent issuance of a Certificate of Registration to the Respondent, the Deputy Administrator must now determine whether or not that registration should be continued.
The Respondent filed exceptions to Judge Bittner's recommended ruling. With respect to findings that he provided blank prescriptions bearing his signature in violation of 21 U.S.C. 829, 841, and 843, the Respondent argued that was simply complying with California law which, according to the Respondent, allows for the establishment of a prescription protocol between physician and physician assistant. With respect to pre-signed prescriptions, Respondent further argued that the protocol he established with his physician assistant did not allow for the prescribing of controlled substances; the physician assistant must account for all prescriptions before receiving more prescription blanks; the Respondent did not put his DEA number on blank prescriptions given to physician assistants; and that such a policy would be violative of the equal protection clause of the United States constitution. The Respondent further argued that “physician assistants are allowed to prescribe Schedule III and IV drugs whether or not the supervising physician has a narcotic registration.”
The Deputy Administrator finds that the Respondent's exceptions with respect to pre-signed prescriptions lack merit. First, the Respondent's assertion that he did not place his DEA registration number on blank prescriptions is of no moment. As noted above, testimony was offered at the hearing that the Respondent not only left pre-signed prescriptions with the staff of the Robert M.D. Clinic, but also authorized the use of his previous DEA number by a physician assistant. The unlawful practice of pre-signing prescriptions has been a contributing factor in DEA determinations that a registration is inconsistent with the public interest. See e.g., Christopher E. Castle, M.D., 67 FR 71196-97 (2002); James C. Womack, M.D., 67 FR 35137 (2002); Edward L.C. Broomes, M.D., 61 FR 3946-47 (1996); Jude R. Hayes, M.D., 59 FR 41785 (1994); Veera Sripinyo, M.D. 56 FR 64809 (1991).
Second, the establishment of a prescription protocol with a physician assistant does not absolve the Respondent from liability that arises out of improperly issued prescriptions for controlled substances. The Respondent's conduct in this regard created a situation that allowed unauthorized persons to issue prescriptions without supervision. The Deputy Administrator finds that the Respondent's counter argument regarding his compliance with the terms of a prescription protocol is yet another demonstration of his unwillingness to accept responsibility for his misconduct.
The Deputy Administrator similarly finds no merit in the Respondent's challenge of the applicability of the 21 U.S.C. 829, 841, and 843 as they relate to his providing blank, pre-signed prescriptions to his staff. The referenced statutory provisions address the proper manner in which prescriptions for controlled substances are to be issued (section 829) and/or prohibited acts with respect to the prescribing of controlled substances (sections 841 and 843). Specifically, section 843(a) states in pertinent part:
It shall be unlawful for any person knowingly or intentionally—(2) to use in the course of the * * * dispensing of a controlled substance * * * a registration number which is fictitious, revoked, suspended, expired, or issued to another person.
The Respondent's action in providing to the staff of the Robert M.D. Clinic, presigned prescriptions, his giving Start Printed Page 15231authorization to others to use a revoked DEA number, and the controlled substances ordered under that number, are clearly conduct and circumstance contemplated under sections 829, 841 and 843.
The Respondent's remaining argument regarding the hearsay nature of the presigned prescriptions at issue is similarly without merit. Despite the Respondent's objections to the admissibility of such evidence, it is well established that hearsay is admissible in these proceedings. See Nicholas A. Sychak, d/b/a/ Medicap Pharmacy, 65 FR 75959 (2000); Arthur Sklar, R.Ph., d/b/a King Pharmacy, 54 FR 34627 (1989). “Hearsay is both admissible, and may, standing by itself, constitute substantial evidence in support of an administrative decision.” Klinestiver v. DEA, 606 F.2d 1128 (D.C. Cir. 1979).
In the DEA Final Order of May 1999, the then-Deputy Administrator found that any determination regarding the Respondent's fitness to obtain a DEA Certificate of Registration was contingent, not merely upon the passage of time, but whether circumstances existing at the time of the prior proceeding had sufficiently changed to warrant issuance of such registration. With the additional passage of time, and the Respondent having obtained a DEA Certificate of Registration (albeit by way of an administrative error), obviously circumstances have changed with respect to the Respondent's handling of controlled substances. The Deputy Administrator also finds it noteworthy that there is no evidence that Respondent has mishandled controlled substances under his present registration. Nevertheless, the Deputy Administrator remains unconvinced that the Respondent possesses the fitness to maintain that registration.
The Deputy Administrator agrees with Judge Bittner that the Respondent refuses to take responsibility for his past misconduct. In addition, the Respondent demonstrated irresponsible conduct by pre-signing prescription pads and providing his revoked DEA registration number for the use of his staff.
The Deputy Administrator finds the Respondent's recalcitrance puzzling. In the face of DEA's repeated concerns regarding his lack of contrition, the Respondent remains steadfast in his insistence upon denying any previous wrongdoing. Despite previous findings that his criminal convictions were res judicata, the Respondent in his support of his most recent application for registration attempted yet again to re-litigate his criminal convictions and attack the quality of his previous legal representation.
In three previous final orders, DEA has essentially provided the Respondent with a roadmap to reacquiring his DEA registration by outlining concerns relating to Respondent's previous misconduct and pointing to his refusal to accept responsibility for such actions. If the Respondent were to satisfactorily address the agency's concerns, and conform his conduct accordingly, he would at the very least, improve his prospects for reacquiring and maintaining a DEA Certificate of Registration. In the absence of such reassurances, the Deputy Administrator is left with the conclusion that the Respondent remains unwilling or unable to accept the obligations that the Controlled Substances Act and its implementing regulations impose upon DEA registrants. Therefore, the Deputy Administrator concludes that the Respondent's continued registration would be inconsistent with the public interest.
Accordingly, the Deputy Administrator of the Drug Enforcement Administration, pursuant to the authority vested in him by 21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.014, hereby orders that DEA Certificate of Registration BL6652312, previously issued to Robert A. Leslie, M.D., be, and it hereby is, revoked. This order is effective April 28, 2003.Start Signature
Dated: March 6, 2003.
John B. Brown III,
[FR Doc. 03-7390 Filed 3-27-03; 8:45 am]
BILLING CODE 4410-09-M