Registrant Actions - 2001
[Federal Register: April 6, 2001 (Volume 66, Number 67)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 99-30]
Barry H. Brooks, M.D.; Continuation of Registration
On April 8, 1999, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to Barry H. Brooks, M.D. (Respondent), of Cleveland, Ohio, proposing to revoke his DEA Certificate of Registration BB2048127, pursuant to 21 U.S.C. 824(a)(1), (2), and (4), and to deny any pending applications for such registration pursuant to 21 U.S.C. 823(f).
Respondent timely requested a hearing on the issues raised by the Order to Show Cause, and following pre-hearing procedures, a hearing was held in Cleveland, Ohio, on December 7, 1999, before Administrative Law Judge Mary Ellen Bittner. At the hearing, both parties called witnesses and introduced documentary evidence. After the hearing, the
Government submitted proposed findings of fact, conclusions of law, and argument; and Respondent submitted a "Post Hearing Brief." On May 24, 2000, Judge Bittner issued her Opinion and Recommended Decision, recommending that the Respondent's registration be continued, and that any pending applications for renewal be granted. On July 18, 2000, Judge Bittner transmitted the record of these proceedings to the Administrator for his final order.
The Administrator has considered the record in its entirety, and pursuant to 21 CFR 1316.67, hereby issues his final order adopting the Opinion and Recommended Decision of the Administrative Law Judge. His adoption is in no matter diminished by any recitation of facts, issues, and conclusions herein, or by any failure to mention a matter of fact or law.
The Administrator finds that the Respondent graduated from Harvard Medical School in 1967 and thereafter completed training in psychiatry and internal medicine. Since 1979, he has been a member of the faculty at Case Western Reserve University School of Medicine, and he is currently on the staff at five hospitals, while maintaining a private practice in Cleveland, Ohio. Respondent is a recovering alcoholic who is actively involved in Alcoholics Anonymous and is a speaker at its meetings. He has been involved in Alcoholics Anonymous for over fifteen years.
The Administrator further finds that on or about March 7, 1985, Respondent
was convicted in the Cuyahoga County Court of Common Pleas of thirteen felony counts of attempted illegal processing of drug documents as a result of prescribing Dilaudid to patients for the treatment of heroin addiction. Respondent received a sentence of one year imprisonment, but the sentence was suspended and he was placed on one year probation and fined a thousand dollars plus court costs.
In a letter dated November 7, 1985, the State of Ohio Medical Board (Medical Board) notified Respondent of its intent to determine whether it should continue to permit him to practice medicine and surgery in the State of Ohio. The letter cited Respondent's conviction as the reason for the Medical Board's inquiry and advised Respondent of his right to a hearing. Respondent requested a hearing, and on February 11, 1986, he appeared before a hearing examiner for the Medical Board.
Following the hearing, the hearing examiner issued a Report and Recommendation to the Medical Board. The hearing examiner found that both Respondent's prescribing Dilaudid to drug addicted individuals to facilitate their detoxification and the 1985 conviction that resulted from this conduct were bases for revoking his license. The report stated that "Dr. Brooks' practice of prescribing Dilaudid to facilitate detoxification was not only illegal, but also blatant: the prescriptions themselves declared that the medication was being used for an explicitly illegal purposes." Consequently, the hearing examiner recommended that the Medical Board revoke Respondent's Ohio Medical license. In addition, the hearing examiner recommended that the Medical Board require Respondent immediately to surrender his DEA Certificate of Registration.
On July 24, 1986, the Medical Board issued an Entry of Order revoking Respondent's license to practice medicine in Ohio, staying the revocation, and placing Respondent on probation for a period of at least five years but no more than eight years. The Medical Board imposed various conditions, including requirements that Respondent (1) not prescribe, administer, dispense, order, or possess controlled substances, except those listed in Schedules IV and V, for a minimum of two years; (2) undergo psychiatric treatment at least twice a month and ensure that quarterly psychiatric reports were forwarded to the Medical Board; (3) submit daily specimens for random urine screening and ensure that weekly screening reports were forwarded to the Medical Board; (4) undertake and maintain participation in an alcohol rehabilitation program at least two times per week and submit reports that documented his continual compliance with the program; (5) abstain completely from the use of or possession of drugs, other than those that are available over-the-counter or those that were prescribed, administered, or dispensed to him by a person authorized by law; and (6) abstain completely from the used of alcohol.
On April 24, 1987, as a result of the Medical Board's action, Respondent surrendered his DEA Certificate of Registration AB7408619 in Schedules II and III. Respondent maintained his privileges to handle controlled substances in Schedules IV and V, however.
About January of 1989, after Respondent had satisfied the two year minimum restriction on handling Schedule II and III controlled substances, the Medical Board reinstated Respondent's state privileges to handle Schedule II and III controlled substances.
On February 6, 1989, Respondent submitted an application to DEA as a practitioner to handle controlled substances in Schedules II through V. Question 4(b) of this DEA application asks: "Has the applicant ever been convicted of a felony in connection with controlled substances under State and Federal law, or over surrendered or had a CSA registration revoked, suspended, or denied?" Respondent answered "no."
In June 1992, Respondent submitted an application to the Medical Board for renewal of his medical license. This application included the following questions: "Have you been found guilty of, or pled guilty or no contest to: (A.) A felony or misdemeanor. (B.) A federal or state law regulating the possession, distribution or use of any drug?" In response to each of these questions, Respondent checked "yes."
On or about November 21, 1995, Respondent signed an Application for Privileges to the Health Care Network/Facility/Organization and/or Hospital. Page nine of this form contains the following questions:
- Have there ever been any actions against your professional license, including but not limited to, restrictions, limitations, denial, revocation, suspension, voluntary or involuntary surrender or cancellation in any state?
- Has your DEA license ever been restricted, reduced, denied, suspended, canceled or been voluntarily or involuntarily relinquished?
- Have you ever been convicted of a felony?
The responses marked on the form indicate a "yes" answer to each of these three questions. Respondent testified that he signed the form, but he was unsure whether he signed it before or after it was filled out. He further testified that although he signed this form, he did not read it, and it was completed by an administrator.
On June 16, 1992, and again or June 19, 1995, Respondent submitted DEA Registration renewal applications. Question 2(b) on each of these applications asks the following:
Has the applicant ever been convicted of a crime in connection with controlled substances under State or Federal law, or ever surrendered or had a Federal controlled substance registration revoked, suspended, restricted or denied, or ever had a State professional license or controlled substance registration revoked, suspended, denied, restricted or place on probation?
In response to this question, Respondent checked "no" on both the 1992 and 1995 applications.
A Staff Coordinator in the DEA Office of Diversion Control, Chemical Investigation Unit, testified that the DEA applications for registration contain three liability questions that are intended to elicit information from applicants to determine if further investigation is needed. The first liability question asks whether the state or the jurisdiction in which the applicant is practicing has granted the applicant the authority to handle controlled substances. The second and third liability questions asks whether an applicant has ever been convicted of a felony in connection with controlled substances under state or federal law, or ever surrendered or had a controlled substances registration revoked, suspended, or denied. The Staff Coordinator testified that the answers to these questions determine whether further investigation is required. If further investigation is required, the application is sent from DEA Headquarters to the appropriate DEA field office to determine the extent of the applicant's criminal history and the status of his controlled substance registrations, and a "hold" is placed on that application until the field office returns an approval to DEA Headquarters.
In April 1996, the DEA Cleveland Resident Office received a change-of-address request from the Respondent. A DEA Diversion Investigator (DI) testified that he was working in the Cleveland office at the time and reviewed Respondent's request. The DI noted that there seemed to be some discrepancies
in the Respondent's submissions that warranted further investigation, and consequently, he reviewed Respondent's drug-related criminal history in a DEA computer database and discovered Respondent's 1985 felony conviction.
The DI testified that he and another DEA Diversion Investigator met with Respondent on November 19, 1996. At that meeting, Respondent admitted that he was familiar with the 1989 DEA application, and that he had checked "no" in response to question 4(b). The DI further testified that during this meeting, Respondent indicated that he was familiar with the 1992 and 1995 renewal applications, and that he signed each of them. The DI testified that Respondent stated that he believed he was again eligible for Medical Board privileges after the passage of five years following his conviction, that Respondent also stated that he believed he could obtain his DEA privileges as soon as he was eligible for Medical Board privileges, and for these reasons, he answered "no" to the liability questions on the various DEA applications. The DI further testified that later in the meeting, however, Respondent admitted that "he had screwed up" in answering the liability questions. Similarly, the Respondent testified before Judge Bittner in these proceedings regarding his responses to the DEA liability questions that he "definitely had made a mistake and realized that."
On March 28, 1997, an Assistant United States Attorney for the Northern District of Ohio wrote to Respondent's attorney at that time, advising that the United States Attorney's Office had decided to pursue a criminal prosecution of Respondent pursuant to 21 U.S.C. 843(a)(4)(A). On April 8, 1997, Respondent wrote to DEA's Registration Unit advising that his 1989, 1992, and 1995 DEA registration applications were in error with respect to the liability questions, and requesting that the "no" answers to liability questions on his pending 1995 renewal application be changed to "yes" answers. Respondent was indicted on two counts of violating 21 U.S.C. 843(a)(4)(A) (in 1992 and 1995, respectively) and was acquitted after a two day trial in August 1997.
Respondent gave testimony in these proceedings with regard to why he answered the liability questions on the DEA applications as he did. Specifically, he stated he did not believe he had to refer to his conviction after the passage of five years, and he further stated he though his conviction had been expunged. Respondent further testified that he thought the surrender of his registration in Schedules II and III was tied to his conviction, and therefore, he believed that the surrender was also expunged. He also testified that he believed DEA knew about his conviction prior to his submission of the 1989, 1992, and 1995 DEA applications because in accordance with the Medical Board's order he had submitted his surrender of schedule II and III privileges to a DEA Diversion Investigator in 1987.
Respondent testified that at the time he executed the 1992 and 1995 DEA applications he believed he was not required to report his conviction. Respondent testified that he believed the Medical Board was the "gold standard;" that is, if the Medical Board did not require him to report a conviction after five years, he was not required to report it on any other application.
With regard to his negative answers to the liability questions on his 1989 DEA application, Respondent testified that although this application was completed less than five years after his felony conviction, he believed his conviction had been expunged. Similarly, Respondent testified that he provided a negative response on his 1989 DEA application to the question of whether he had ever surrendered a controlled substances registration because he believed that the surrender was tied to his conviction.
In support of these contentions, Respondents testified that in the late 1980's he sponsored an attorney in Alcoholics Anonymous, and at some point told the attorney about his 1985 felony conviction. Respondent testified that the attorney recommended to him that the conviction be expunged, and that he told the attorney "go ahead and do it." Respondent testified that although he never paid the attorney anything, he later received a letter from the attorney that the expungement "had been accomplished." Respondent testified he did not have a copy of the letter because it was subsequently destroyed in a fire. Respondent testified that he was informed by the court (presumably the same court that convicted him) there was no record of the expungement sometime during the 1997 DEA investigation leading to these proceedings.
Pursuant to 21 U.S.C. 824(a)(1), the Administrator may revoke a DEA Certificate of Registration and deny any pending applications for such a certificate upon a finding that the registrant has materially falsified any DEA application for registration. Pursuant to 21 U.S.C. 824(a)(2), the Administrator may revoke a DEA Certificate of Registration and deny any pending applications for such a certificate upon a finding that the registrant has been convicted of a felony related to controlled substances under state or federal law.
In addition, the Administrator may revoke a DEA Certificate of Registration and deny any pending applications for such a certificate if he determines that the issuance of such registration would be inconsistent with the public interest as determined pursuant to 21 U.S.C. 824(a)(4) and 823(f). Section 823(f) requires that the following factors be considered:
- The recommendation of the appropriate state licensing board or professional disciplinary authority.
- The applicant's experience in dispensing, or conducting research with respect to controlled substances.
- The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
- Compliance with applicable State, Federal, or local laws relating to controlled substances.
- Such other conduct which may threaten the public health and safety.
As a threshold matter, it should be noted that the factors specified in section 823(f) are to be considered in the disjunctive: The Administrator may properly rely on any one or a combination of the factors, and give each factor the weight he deems appropriate, in determining whether a registration should be revoked or an application for a registration denied. Henry J. Schwarz, Jr., M.D., 54 FR 16,422 (DEA 1989).
Pursuant to 21 U.S.C. 824(a)(1), falsification of a DEA application constitutes independent grounds to revoke a registration. Past cases have established that the appropriate test for determining whether an applicant materially falsified any application is whether the applicant "knew or should have known" that the submitted application was false. Terrance E. Murphy, M.D., 61 FR 2,841, 2,844 (DEA 1996); Bobby Watts, M.D., 58 FR 46,995 (DEA 1993).
It is undisputed that after his 1985 conviction, on his 1989 application for DEA registration Respondent provided a "no" response to the question of whether he had ever been convicted of a felony in connection with controlled substances under state or federal law or ever surrendered a federal controlled substances registration. Similarly, on his 1992 and 1995 DEA applications, Respondent answered in the negative to the question of whether he had ever been convicted of a crime in connection
with controlled substances under state or federal law or ever surrendered a federal controlled substances registration. In addition, after the Medical Board restricted Respondent's controlled substances privileges in 1986, Respondent provided "no" responses on his 1992 and 1995 DEA applications when asked whether he had ever a state professional license or controlled substances registration revoked, denied, restricted or placed on probation.
In contrast to the DEA applications, on separate occasions Respondent submitted applications to organizations other than DEA and provided accurate information in response to liability questions. On an application to the Medical Board dated June 1992, Respondent provided "yes" responses when asked whether he had been convicted of a felony or misdemeanor or whether he had been found guilty of a federal or state law regulating the handling of any drugs. Respondent signed and dated this application approximately three days after submitting a DEA application on which he provided a "no" response to similar liability questions. Also, in November of 1995, Respondent signed an "Application For Privileges To The Health Care Network/Facility/ Organization And/Or Hospital" on which he provided "yes" responses when asked whether he had ever been convicted of a felony and whether his DEA registration had ever been "restricted, reduced, denied, suspended, canceled or been voluntarily or involuntarily relinquished."
In sum, Respondent testified he believed that (1) he was not required to report the conviction on applications for licensure filed more than five years after his convictions; (2) an attorney with whom he was acquainted had expunged the conviction for him; (3) his surrender of Schedule II and III privileges in 1987 was tied to his conviction; and (4) the DEA knew of his conviction because the agency was involved in an investigation that eventually led to it.
An examination of Respondent's contentions reveals the following. On February 6, 1989, Respondent provided a "no" response when asked on a DEA application whether he had ever been convicted of a felony related to controlled substances. Respondent signed and dated this application approximately four years following his 1985 conviction, controverting his assertion that five years was the cutoff point. Respondent testified that his explanation for answering "no" in this instance was that he believed his conviction had been expunged. Respondent also testified that on the same application he answered "no" when asked whether he had ever surrendered a federal controlled substances registration because he believed that the surrender was related to the conviction, and therefore expunged. Respondent offered the same explanation with regard to the negative answers he provided a similar questions on his 1992 and 1995 DEA applications He also offered these explanations when testifying as to why he responded "no" on his 1992 and 1995 DEA applications when asked whether he had ever had a state professional license or controlled substances registration revoked, suspended, denied, restricted or placed on probation.
Judge Bittner noted, and the Administrator concurs, that the liability questions on the DEA applications ask whether the applicant has "ever been convicted" of a crime in connection with controlled substances or "ever surrendered" a federal controlled substances registration. (Emphasis added). Similarly, the application that Respondent signed in 1992 and 1995 ask whether the applicant "ever had a State professional license or controlled substance registration revoked, suspended, denied, restricted or placed on probation." (Emphasis added). Nothing on the application forms suggests that the mere passage of time relieves the applicant of the obligation of providing accurate answers. Judge Bittner also observed that with regard to Respondent's expungement allegation, Respondent provided no documentary evidence to support his belief that the 1985 conviction had ever been expunged, and he offered no clear explanation for his belief that the surrender of his federal or state controlled substances registrations were related to his conviction. Judge Bittner therefore found, and the Administrator concurs, that Respondent's beliefs were not reasonable, that Respondent knew his answers to the liability questions were false, and therefore were not valid defenses.
Judge Bittner found, and the Administrator concurs, that Respondent's attempt to argue that DEA was aware of Respondent's 1985 conviction, and therefore, that any omission of the conviction on the DEA applications was immaterial, is also without merit. As the DEA Staff Coordinator testified, the liability questions on the DEA applications for registrations are intended to extract information from applicants to determine whether further investigation is needed. "Answers to the liability question[s] are always material because DEA relies on the answers to these questions to determine whether it is necessary to conduct an investigation prior to granting an application." Theodore Neujahr, D.V.M., 64 Fed. Reg. 72,362, 72,364 (DEA 1999) (citing Bobby Watts, M.D., 58 FR 46,995 (DEA 1993); Ezzat E. Majd Pour, M.D., 55 FR 47,547 (DEA 1990).
Prior DEA cases have established that " '[s]ince [it] must rely on the truthfulness of information supplied by applicants in registering them to handle controlled substances, falsification cannot be tolerated.' " Terrance E. Murphy, M.D., 61 FR 2,841, 2,845 (DEA 1996) (quoting Bobby Watts, M.D., 58 FR 46,995 (DEA 1993). Judge Bittner found, and the Administrator concurs, that Respondent's contentions concerning the reasons for his untruthful answers on his DEA applications are meritless, and therefore constitute grounds for revoking Respondent's registration pursuant to section 824(a)(1). In addition, pursuant to 21 U.S.C. 824(a)(2), conviction of a felony related to controlled substances constitutes independent grounds to revoke a DEA registration. Judge Bittner further noted, however, that in prior DEA cases the Deputy Administrator has held that the totality of the circumstances is to be considered in determining whether a registration should be revoked because of a registrant's material falsification of an application. See Martha Hernandez, M.D., 62 FR 61,145, 61,147-48 (DEA 1997).
With regard to the public interest factors found at 21 U.S.C. 823(f), it is undisputed that Respondent currently is authorized by the State of Ohio to handle controlled substances, and thus satisfies the first factor. Since state licensure is a necessary but insufficient condition for DEA registration, however, Judge Bittner found, and the Administrator concurs, that this factor is not determinative. James C. LaJevic, D.M.D., 64 FR 55,962, 55,964 (DEA 1999).
With regard to the second public interest factor, Respondent's experience in handling controlled substances, Judge Bittner found, and the Administrator concurs, that since Respondent's felony conviction approximately fifteen years ago for illegally prescribing a controlled substance, Dilaudid, to patients for the treatment of heroin addiction, there have been no further allegations that Respondent has abused his controlled substances privileges since regaining a DEA registration in 1989.
With regard to the third public interest factor, Respondent's conviction record relating to controlled substances,
it is undisputed that on or about March 7, 1985, in the Cuyahoga Court of Common Pleas, Cleveland, Ohio, Respondent was convicted of thirteen felony counts involving attempted illegal processing of drug documents.
With regard to the fourth public interest factor, Respondent's compliance with applicable State, Federal, or local laws relating to controlled substances, it is undisputed that Respondent was convicted of attempted illegal processing of drug documents, as noted above. In addition, the State Medical Board of Ohio found that the acts that led to Respondent's conviction constituted a violation of the Ohio Revised Code. Furthermore, pursuant to 21 CFR 1306.04(c) (1999), a practitioner-registrant is prohibited from issuing prescriptions for the dispensing of narcotic drugs listed in any schedule for detoxification treatment. Respondent violated this section by prescribing Dilaudid to known drug addicts for the purpose of facilitating detoxification. Since Respondent violated 21 CFR 1306.04(c), he also violated 21 CFR 1306.04(a) by issuing prescriptions illegally, not for a legitimate medical purpose and not in the usual course of professional practice. Judge Bittner found, and the Administrator concurs, that the findings pursuant to this factor weigh in favor of finding Respondent's continued registration inconsistent with the public interest.
With regard to the fifth public interest factor, such other conduct which may threaten the public health and safety, Judge Bittner noted, and the Administrator concurs, that Respondent's actions in providing inaccurate answers to the liability questions on the various applications are relevant to this factor. Since the issues regarding this conduct have already been discussed, they need not be reiterated here.
Judge Bittner concluded, and the Administrator concurs, that it is undisputed that Respondent was convicted of a drug related felony in 1985 and that he provided inaccurate responses to the liability questions on at least three DEA applications. The Administrator also concurs with Judge Bittner's finding that Respondent's purported justifications for his inaccurate responses are not credible. Thus, the Administrator concurs with Judge Bittner's finding that there are grounds to revoke Respondent's registration pursuant to both 21 U.S.C. 824(a)(1) and 824(a)(2).
The Administrator concurs with Judge Bittner's recommendation that Respondent's registration be continued, however. The totality of the circumstances in this case suggest that the public interest is best served by allowing Respondent to maintain his registration. Respondent has held a DEA registration since 1989, and there is no evidence nor allegation that Respondent has abused the registration since that time. The Administrator concludes that the evidence shows that throughout Respondent has readily admitted fault, has taken responsibility for his past misconduct, and has fully cooperated with and assisted in the investigations concerning his illicit activities. Furthermore, considering the support systems he has in place, including his long-term and active leadership in Alcoholics Anonymous, strong faith in God, a strong and close marriage, and full time employment in a professional medical community, the Administrator concludes that Respondent is unlikely to repeat his past mistakes and that his continued registration is consistent with the public interest.
Accordingly, the Administrator of the Drug Enforcement Administration, pursuant to the authority vested in him by 21 U.S.C. 823 and 824 and 28 C.F.R. 0.100(b) and 0.104, hereby orders that DEA Certificate of Registration BB2048127, issued to Barry H. Brooks, M.D., be continued, and any pending applications for renewal granted. This order is effective May 7, 2001.
Dated: March 27, 2001.
Donnie R. Marshall,
[FR Doc. 01-8477 Filed 4-5-01; 8:45 am]
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