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Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 11-73]

Jeffery J. Becker, D.D.S., and Jeffery J. Becker, D.D.S., Affordable Care Decision and Order

On December 22, 2011, Chief Administrative Law Judge John J. Mulrooney, II, (hereinafter, ALJ), issued the attached Recommended Decision.1 Respondent filed Exceptions to the ALJ's Decision, and the Government filed a Response to Respondent's Exceptions.

Having reviewed the record in its entirety, including Respondent's Exceptions, I have decided to adopt the ALJ's recommended rulings, factual findings, legal conclusions and decision except as discussed below. A discussion of Respondent's Exceptions follows.

Respondent's Exceptions

In his Exceptions, Respondent raises five main contentions. Having considered his Exceptions, and finding one of them to be of merit, I nonetheless conclude that the record supports the ALJ's recommended order of revocation.

Exception 1--Respondent's Violation of the Separate Registration Requirement Does Not Support the Revocation of His Registration

The evidence shows that Respondent maintains a dental practice at two offices, which are located in Norwalk and Avon, Ohio, each of which is open two days a week. However, Respondent holds a registration only for the Norwalk office, even though the evidence shows that he routinely performs procedures, which require that he administer controlled substances to his patients, at both offices.

Under 21 U.S.C. 822(e), "[a] separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances or list I chemicals."See also21 CFR 1301.12(a). While, by regulation, DEA has exempted several categories of locations from the registration requirement, with respect to practitioners, the exemption is limited to "[a]n office used by a practitioner * * * where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office,andwhere no supplies of controlled substances are maintained." 21 CFR 1301.12(b)(3) (emphasis added).

Respondent does not dispute that "he dispensed controlled substances at his unregistered Avon office," Resp. Exc. at 11, and he admitted in his testimony that he had continued to do so up until the date of the hearing. Tr. 764-65. Respondent maintains, however, that upon being informed during the December 2009 DEA inspection that he could not store controlled substances at the Avon office, he discontinued storing controlled substances there. Resp. Exc. at 11. As for why he did not cease administering controlled substances at his Avon office, Respondent contends that he "believed that the critical issue was where the controlled substances were 'stored' as opposed to 'administered.' "Id.(quoting Tr. 764-65).

To buttress the latter contention, Respondent cites the testimony of the Government's Expert witness, a D.D.S., whose practice is limited to providing intravenous (IV) sedation services for the patients of other dentists "throughout the Dayton-Cincinnati area," as well as at a local hospital. GX 14; Tr. 23-24. In particular, Respondent notes that the Government's Expert testified that he has only one registration, and that he does not obtain registrations for the numerous offices of other dentists at which he provides anesthesia to patients. Tr. 103. Citing the Government's Expert testimony that he is an expert on the state and federal regulations pertaining to controlled substances, as well as that he also teaches IV sedation and the standards of the dental profession to other dental practitioners in Ohio, Respondent asserts that revoking his registration cannot be reconciled with the Expert's testimony that a registration is only necessary "where you order your drugs, store your drugs and keep the records of disposal and usage." Tr. 103; Resp. Exc. at 13.

While Respondent now concedes that both his belief and that of the Expert were mistaken, he contends that the Expert's testimony "support[s] the reasonableness of [his] mistake in fact relating to the regulatory requirements."2 Resp. Exc. at 13. According to Respondent, his violations of the CSA were the "result of his confusion and apparent misunderstanding of the law."Id.However, Respondent then contends that "it is difficult to comprehend a situation that would be more confusing to a respondent than to sit in a courtroom and hear testimony of the Government's expert advocating the very position for which [his] registration is in jeopardy."Id.at 13-14. Thus, Respondent argues that the ALJ's findings that he "flagrantly" violated the law and that he has failed to acknowledge wrongdoing and establish his future compliance are unsupported by the record and that the recommended sanction of revocation is unwarranted.Id.at 14.

The argument is not persuasive because the determination of the meaning of the CSA and Agency regulations is not within the proper role of expert witnesses. Rather, it is a function vested in the Agency and the Federal Courts.See Chevronv.NRDC,467 U.S. 837 (1984). Most importantly, Respondent cannot credibly claim to have been confused as to the requirement that he obtain a separate registration for his Avon practice as both the Act itself and its implementing regulations provide clear notice as to what is required.See United Statesv.Clinical Leasing Serv., Inc.,925 F.2d 120, 123 (5th Cir. 1991) ("A physician of ordinary means and intelligence would understand that the federal registration provisions apply toeachimportant or consequential place of business where the physician distribute controlled substances. It is sufficiently clear that the application of the provisions is not limited toa singleimportant or consequential place of business where controlled substances are distributed.").

As set forth above, the CSA's registration provision states in relevant part that "[a] separate registration shall be requiredat each principal placeof business or professional practice where the applicant manufactures, distributes, ordispensescontrolled substances." 21 U.S.C. 822(e) (emphasis added). Likewise, the CSA defines the term dispense to "mean[] to deliver a controlled substances to an ultimate user * * * by * * * a practitioner, including the * * * administering of a controlled substance."Id.SS 802(10). Thus, the statute provides clear notice that it is the activity ofdispensing,which includes the administration of controlled substances, itself, which triggers the requirement, in the case of a practitioner, of obtaining a separate registration for a principal place of professional practice.See21 U.S.C. 822(e). And to similar effect, the text of 21 CFR 1301.12(b)(3), which uses the conjunction "and," makes clear that the exemption from registration for a practitioner's office obtains only whentwo conditions are met: (1) That the practitioner only engages in the prescribing of controlled substances and "neither administer[s] nor otherwise dispense[s]" at the office, and (2) that the practitioner does not maintain any supplies of controlled substances at the office.

To the extent Respondent suggests that the Expert's testimony establishes that there is widespread confusion among practitioners as to the scope of the registration requirements, the argument is unavailing. The clarity of the Act and the Agency's regulations is not determined by whether there are even a substantial number of members of the dental profession in Ohio who are confused as to the scope of the registration requirements. Rather, it is determined by assessing whether the text of the Act and regulations provide fair notice such that a person of ordinary intelligence can understand when a separate registration is required.See FCCv.Fox Television Stations, Inc.,132 S.Ct. 2307, 2310 (2012) (quotingUnited Statesv.Williams,553 U.S. 285, 304 (2008)). The Act and regulations pass this test with flying colors.

There is likewise no merit to Respondent's contention that the Government's position is "irreconcilable" with the Expert's acknowledgement that he does not hold registrations at each of the numerous offices where he administers controlled substances. Resp. Exc. at 12-13. The CSA's registration requirement applies only to "eachprincipalplace of * * * professional practice * * * where controlled substances are * * * dispensed by a person." 21 CFR 1301.12(a) (emphasis added). While the record establishes that the Government's Expert travels to numerous offices of other dentists to provide anesthesia services for their patients, he does so on an apparently as-needed and random basis, and there is no evidence that he maintains a place of professional practice, let alone a principal one, at any of these locations. Nor is there any evidence as to whether the dentists who call on him to provide anesthesia to their patients themselves have DEA registrations.See21 CFR 1301.22(b).

By contrast, the evidence shows that Respondent maintains two offices, at which he regularly both sees and administers controlled substances in the course of treating patients. Notwithstanding that the word "principal" ordinarily means the "most important, consequential, or influential,"Webster's Third New International Dictionary1802 (1993), or the "main, prominent" or "leading,"see Hertz Corp.v.Friend,130 S.Ct. 1181, 1192 (2010) (quoting 12 Oxford English Dictionary 495 (2d ed. 1989)), by inserting the word "each" into the statutory text, Congress clearly was aware that practitioners frequently maintain multiple places of professional practice and manifested its intent that such an office be registered if the practitioner administers controlled substances at the location. Any other interpretation would undermine Congress' purpose of requiring registration to ensure that those locations at which controlled substance activities take place have adequate security and procedures in place to prevent the diversion of drugs from their legitimate use.

Nor is there any merit to Respondent's contention that the ALJ erred in finding that he "flagrantly" violated the registration provision. Resp. Exc. at 14. Even if at the time of the December 2009 inspection, the Agency's Investigator told him only that he could not store controlled substances at his Avon office and did not mention that he was also prohibited from administering drugs at this location because it was not registered, subsequently, the Show Cause Order specifically cited 21 CFR 1301.12, the provision which makes plain that he was required to hold a registration at this Office. ALJ Ex. 1, at 2. Moreover, in its Pre-Hearing Statement, the Government provided notice that it intended to establish that Respondent's Avon office "is not registered with DEA to handle controlled substances[,]" and that "DEA learned that Respondent administered controlled substances to patients from his Avon dental practice." ALJ Ex. 5, at 7. Yet even after being provided with notice that the Government was alleging that he was in violation of the registration provision, Respondent acknowledged that he had administered controlled substances at his Avon office as recently as the week before the hearing. Tr. 764-65. This is more than enough to establish that Respondent flagrantly violated the statute, and in the absence of mitigating evidence, it is sufficiently egregious to support the revocation of his registration.

Exception 2--Respondent's Violation of 21 CFR 1301.75(b) Does Not Support the Revocation of His Registration

Respondent also argues that the evidence pertaining to the storage of controlled substances at his Avon location in violation of 21 CFR 1301.75 does not "reflect an intentional disregard for security," and that the ALJ ignored evidence of steps he took to comply when the adequacy of security was questioned by a State Board Inspector. Resp. Exc. at 17. However, while the ALJ found that Respondent violated 21 CFR 1301.75(b) by leaving controlled substances (unattended) in open storage bins in the sterilization room at the Avon office (rather than keeping them in a securely-locked and substantially-constructed cabinet), there is also credible evidence that Respondent had changed his storage practices at the time of the December 2009 DEA inspection and that he was then in compliance with the above regulation.SeeTr. 595. The ALJ did not, however, discuss this evidence in his decision. Had Respondent's violations of 21 CFR 1301.75 been the only allegations sustained on the record, they would not support the sanction recommended by the ALJ. However, as explained above, they are not the only violations proved.

Exception 3--The Provisions of 21 CFR 1307.21(a) Are Not Mandatory, Are Void for Vagueness, and Are Inapplicable in Light of State Regulation

As noted above, the record shows that Respondent administered controlled substances intravenously to patients and that he disposed of the excess drug by squirting it down the sink. Respondent did not, however, notify the Agency of this practice and did not complete DEA Form 41 for these disposals.3 The Government thus alleges that Respondent violated 21 CFR 1307.21(a), because he "did not provide prior notification to DEA of such disposal as required by" this regulation. ALJ Ex. 1, at 2.

While Respondent admits that he disposed of controlled substances in this manner, he argues that the regulation does not set forth mandatory procedures for disposing of controlled substances. Resp. Exc. at 18-19. Alternatively, he argues that the regulation "is void for vagueness,"id.at 19, and that the regulation, when coupled with the instructions provided on DEA Form 41, create "an alarming morass of confusion" as to what it requires.Id.at 21. As support for his contention, Respondent points to the testimony of the Government's Expert that, he too, disposes of a drug, in excess of what he administered to a patient, by squirting it down the sink, and does so without obtaining permission from the Agency.Id.at 22-23. Respondent further points to the testimony of an Agency Investigator that "a large portion" of the practices he has inspected dispose of excess drugs by squirting them into either the sink or toilet.4 Id.at 24 (quoting Tr. 631).

Responding to Respondent's contention that the regulation does not provide fair notice, the Government argues that the various cases he relies on "are applicable to criminal or civil proceeding[s], but inapplicable to regulated persons subject to the licensing requirement set forth by an administrative agency or provision of the Administrative Procedures [sic] Act." Gov. Resp. to Exceptions, at 6-7. However, contrary to the Government's understanding, just last term the Supreme Court invalidated an FCC order finding various broadcasters liable for violating that Agency's indecency policy, because the FCC failed to provide fair notice that their conduct would be deemed a violation.FCCv.Fox Television Stations, Inc.,132 S.Ct. 2307 (2012). InFCCv.Fox,the Court reiterated that the "requirement of clarity in regulation is essential to the protections provided by the Due Process Clause," and that a "punishment fails to comply with due process if the statute or regulation under which it is obtained `fails to provide a person of ordinary intelligence fair notice of what is prohibited, or is so standardless that it authorizes or encourages seriously discriminatory enforcement.' "Id.(quotingUnited Statesv.Williams,553 U.S. 285, 304 (2008)).

WhileFCCv.Foxinvolved the imposition of a monetary penalty, it hardly broke new ground.See General Electric Co.v.EPA,53 F.3d 1324, 1328-29 (D.C. Cir. 1995);Diamond Roofing Co.v.OSHRC,528 F.2d 645, 649 (5th Cir. 1976)Nor is there any no doubt that the Government's obligation to provide "fair notice" of what conduct is prohibited applies to licensing proceedings as well. Indeed, this has been the law for more than forty years.See Trinity Broadcasting of Florida, Inc.,v.FCC,211 F.3d 618, 628 (D.C. Cir. 2000);Radio Athens, Inc.,v.FCC,401 F.2d 398, 404 (D.C. Cir. 1968). Thus, inTrinity Broadcasting,the D.C. Circuit recognized that the denial of an application to renew a license is "a severe penalty," and "held that `in the absence of notice--for example, where the regulation is not sufficiently clear to warn a party about what is expected of it--an agency may not deprive a party of property by imposing civil or criminal liability.' "Id.(quotingG.E.v.EPA,53 F.3d at 1328-29). Accordingly, if the regulation (or other pronouncements interpreting it) do not provide "fair notice" of what is required, Respondent cannot be deemed to have violated it.

The starting point for resolving these contentions is, of course, the language of the regulation. The regulation, which was one of the original regulations promulgated by DEA's predecessor, the Bureau of Narcotics and Dangerous Drugs,see36 FR 7802 (1971) (then codified at 21 CFR 307.21), provides, in relevant part, that:

21 CFR 1307.21(a) (emphasis added).5

The ALJ rejected Respondent's contention that the regulation does not impose a mandatory requirement of notification, reasoning that its language "[n]ecessarily * * * implies that a person who does not request assistance to dispose of a controlled substance does not have authority to dispose of such substance. This is a classic example of permissive language which `plainly carr[ies] a restrictive meaning.' " Order Regarding Respondent's Multiple Motions For Appropriate Relief (ALJ Ex. 25), at 10 (quotingForest Grove School Dist.v.T.A.,557 U.S. 230, 254 n.1 (2009) (Souter, J., dissenting)). The ALJ further reasoned that "[u]nder a plain reading of the regulation, a registrant is not required to dispose of controlled substances, but once he or she elects to do so, such disposal may not be made without authorization from the specified DEA official."Id.at 11.

I conclude, however, that the regulation's text does not provide sufficient clarity to conclude that it provides a mandatory procedure which must be followed in all instances in which a person seeks to dispose of a controlled substance rather than simply a mechanism by which a person who requires assistance to dispose of a controlled substance can obtain such assistance. Moreover, while the ALJ's interpretation might be permissible, it rests on the unsupported premise that authority must always be obtained to lawfully dispose of a controlled substance. However, neither the Government, nor the ALJ, undertook to analyze the CSA and explain why this conclusion is required.

Significantly, unlike most (if not all) other DEA regulations which are indisputably mandatory, the relevant text uses the word "may" rather than "shall" to modify the words "request assistance." As the Supreme Court has explained, "[t]he word `may' customarily connotes discretion," and this is particularly true where, as here, an enactment also uses the word "shall."Jamav.ICE,543 U.S. 335, 346 (2005). Likewise, the phrase's use of the words "request assistance" rather than "request authority," notwithstanding that obtaining authority may well be the ultimate purpose of the procedure provided in the regulation (at least insome cases), is hardly the language of a mandatory requirement or command.

Thus, while on its face, section 1307.21(a) is broad in scope as it applies to all persons (and not only registrants) as well as all means of disposal, it is far from clear why a person, like Respondent, who disposes of a controlled substance by squirting or flushing it down the drain, would necessarily need any assistance to do so. Nor, even assuming that there are circumstances in which a person is required to obtain authority from DEA to dispose of a controlled substance (i.e.,because the person lacks authority to distribute the drug to another), is it clear why a person, who disposes of a controlled substance in the manner Respondent did, requires authority from DEA to do so. Thus, while it is clearly reasonable to construe the regulation as providing a mandatory procedure for disposing of controlled substances where a person must distribute the controlled substances to another person--because other provisions of the CSA make clear that a person cannot lawfully distribute a controlled substance without the required registration--that does not mean that the regulation provides fair notice that it is mandatory when applied to other circumstances.

Indeed, the regulation's use of the word "may" rather than "shall" itself suggests that there are circumstances in which authority from DEA is not required to dispose of a controlled substance.6 So too, that the regulation "shall not be construed as affecting or altering in any way the disposal of controlled substances through procedures provided in laws and regulations adopted by any State," 21 CFR 1307.21(d), raises the question of whether its procedures are still mandatory if one disposes of controlled substance in compliance with state law (and thus has authority) without engaging in a distribution.

In its pleadings, the Government acknowledges that "the administrative case law is relatively silent on the requirements of a registrant under 21 CFR 1307.21." Gov. Resp. to Respondent's Motion to Exclude Paragraph 7 of the Order to Show Cause (ALJ Ex. 17), at 2. Indeed, while this regulation has been in existence for more than forty years, the Government points to no case in which a person, whether a practitioner or ultimate user, has been either criminally or administratively prosecuted for destroying a controlled substance, without notifying the Agency, which he/she lawfully possessed and retained possession of during the destruction process.7 Nor does the Government cite to either an interpretive rule or guidance document it has issued explaining that this regulation requires all persons, including practitioners, to first obtain authority from the Agency before they destroy a controlled substance of which they retain possession.8 Finally, even in this litigation, the Government does not explain why a person, who destroys controlled substances which they lawfully possess and which they do not distribute to another, nonetheless requires either "assistance" or "authority" to do so.

Notably, the CSA itself contains no provision explicitly prohibiting or regulating (other than through recordkeeping) the destruction of controlled substances. Moreover, in enacting the Secure and Responsible Drug Disposal Act of 2010, which amended the CSA, Congress found that "take-back programs often cannot dispose of the * * * controlled substance medications * * * because Federal law does not permit take-back programs to accept controlled substances unless they get specific permission from [DEA] and arrange for full-time law enforcement officers to receive the controlled substances directly from the member of the public who seeks to dispose of them." Secure and Responsible Drug Disposal Act of 2010, Public Law 111-273, SS 2(4)(B), 124 Stat. 2858, 2859 (2010). Yet Congress further found that:

Id.SS 2(4)(C). Of significance, while Congress noted the lack of legal authority for take-back programs to accept controlled substances without Agency permission, it made no similar observation that those individuals who dispose of their controlled substances by discarding or flushing them also lack legal authority to do so.9

To be sure, because of their role in the closed system of distribution, the CSA imposes requirements on registrants which are not imposed on ultimate users, and the Act generally limits the authorized activities of practitioners to the dispensing of controlled substances and prohibits them from distributing a controlled substance. Yet the Government offers no argument that squirting the small amount of excess medication, which has been drawn into a syringe but not administered to a patient, into a sink or toilet and flushing it, constitutes a distribution within themeaning of the CSA, or is otherwise prohibited by the Act.10 Indeed, disposing of the excess amount of a controlled substance, pursuant to the administration of the drug to a patient in the course of professional practice and in this manner, would seem to be a necessary incident of administering the drug and within the scope of a practitioner's authorized activities.

I therefore conclude that the use of the phrase "may request assistance" in the relevant language of the regulation creates an ambiguity as to whether it is permissive or mandatory in all instances in which a person disposes of a controlled substance. Because the Government points to no provision of the CSA which prohibits this method of disposal or otherwise requires that a practitioner obtain authority to dispose of controlled substances in all circumstances, and because notwithstanding that the regulation has been in existence for more than forty years, the Government has not published any administrative interpretation holding that disposal in this manner violates the Act or requires authority from the Agency, I hold that the Government has not provided fair notice that Respondent's conduct was prohibited.11 Accordingly, this conduct cannot be used as a basis for finding a violation of the CSA.12

Exception 4--The ALJ's Recommended Decision Is Arbitrary and Capricious and Unsupported By Law

Respondent also takes exception to the ALJ's factual findings, legal conclusions, and recommended sanction, contending that they are "arbitrary, capricious and unsupported by law." Resp. Exc. at 27. However, with the exception of the ALJ's legal conclusions pertaining to the alleged violations of 21 CFR 1307.21, I find that the ALJ's findings of fact and legal conclusions are supported by substantial evidence. Based on the ALJ's findings that: (1) Respondent violated the separate registration requirement by failing to register his Avon practice, notwithstanding that he regularly administered controlled substances at this office,seeALJ at 37; (2) even after he was on notice that he was in violation of this provision, he continued to violate the Act and was still doing so the week before the hearing,see id.(citing Tr. 660 & 764); (3) Respondent failed to maintain proper records in that he was missing purchase records as well as order forms (DEA 222) for the schedule II controlled substances he purchased,see id.at 39-40; and (4) Respondent failed to properly secure the controlled substance he took to his Avon office,see id.at 38-39; I conclude that the ALJ's finding that Respondent has committed acts which render his registration inconsistent with the public interest is supported by substantial evidence and that the Government has satisfied itsprima facieburden.See id.

While I acknowledge that Respondent produced evidence that he has changed his storage practices at his Avon office, he has offered no evidence that he has applied for a registration for the Avon office, nor provided any evidence to support a finding that he has addressed the serious recordkeeping violations proven on this record. Moreover, even to this day, Respondent does not accept responsibility for his violations of the registration requirement; instead, he argues--notwithstanding that the Agency's regulation is clear on its face--that because others violate the same regulation, his violations should be excused. Exacerbating this violation, Respondent continued to administer controlled substance at his Avon office in violation of the registration requirement even after being told by the DI that he was in violation and even after being served with the Show Cause Order. Accordingly, I agree with the ALJ's conclusion that Respondent has not rebutted the Government'sprima faciecase and will order that Respondent's registration be revoked and that any pending applications be denied.13

Order

Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificates of Registration Numbers FB2238865 and BB0569775, issued to Jeffery J. Becker, D.D.S., be, and they hereby are, revoked. I further order that any pending application of Jeffery J. Becker, D.D.S., to renew or modify any of the above registrations, be, and it hereby is, denied. This Order is effective January 4, 2013.

Robert Walker, Esq.,for the Government Frank Recker, Esq.,&Todd Newkirk, Esq.,for the RespondentRecommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge

Chief Administrative Law Judge John J. Mulrooney, II. On July 28, 2011, the Deputy Assistant Administrator of the Drug Enforcement Administration (DEA or Government), issued an Order to Show Cause (OSC) seeking the revocation of DEA Certificates ofRegistration (COR), Number BB0569775,1 and Number FB2238865,2 of Jeffrey J. Becker, D.D.S. (Respondent), as a practitioner, pursuant to 21 U.S.C. 824(a) (2006 & Supp. III 2010), and denial of a pending application for renewal of Respondent's DEA COR, Number BB0569775, pursuant to 21 U.S.C. 823(f) (2006). The OSC alleges that the Respondent's continued enjoyment of the privileges vested in his COR registrations is inconsistent with the public interest, as that term is used in 21 U.S.C. 823(f). On August 25, 2011, the Respondent, through counsel, timely requested a hearing, which was conducted in Arlington, Virginia on November 8-9, 2011.

The issue ultimately to be adjudicated by the Administrator, with the assistance of this recommended decision, is whether the record as a whole establishes, by substantial evidence, that the Respondent's CORs should be revoked3 as inconsistent with the public interest, as that term is used in 21 U.S.C. 823(f) and 824(a).

After carefully considering the testimony elicited at the hearing, the admitted exhibits, the arguments of counsel, and the record as a whole, I have set forth my recommended findings of fact and conclusions of law below.

The Allegations

The OSC issued by the Government contends that revocation of the Respondent's CORs is appropriate because: (1) The Respondent has practiced dentistry from a location in Avon, Ohio without obtaining a DEA COR to handle controlled substances at that location;4 (2) the Respondent "maintained * * * controlled substances at an unregistered [location] in violation [of] 21 U.S.C. 822(e);" (3) the Respondent "maintained controlled substances in an unsecured area in violation of 21 CFR SS 1301.75(b);" (4) "sometime in 2009 [the Respondent] distributed controlled substances * * * to an unregistered location in violation of 21 CFR SS 1307.11;" (5) an accountability audit of the Respondent's "handling of fentanyl, diazepam and midazolam * * * revealed shortages of fentanyl and midazolam and an overage of diazepam;" and (6) the Respondent disposed of controlled substances but "did not provide prior notification to DEA of such disposal as required by 21 CFR SS 1307.21(a)." ALJ Ex. 1 at 1-2.

The Stipulations of Fact

The Government and the Respondent, through counsel, have entered into stipulations regarding the following matters:

(1) The Respondent is registered with DEA as a practitioner in Schedules II-V under DEA registration number BB0569775 at 282 Benedict Avenue, Suite C, Box 22, Norwalk, Ohio 44857. While this registration reflects an expiration date of July 31, 2011, the Respondent timely submitted an application for renewal of registration on June 3, 2011.

(2) The Respondent is also registered with DEA as a practitioner in Schedules II-V under DEA registration number FB2238865 at Affordable Care, 6015 West Forest Home Avenue, Milwaukee, Wisconsin 53220. This registration expires by its terms on July 31, 2013.5

(3) Fentanyl is a Schedule II controlled substance pursuant to 21 CFR 1308.12(c)(9) (2011).

(4) Diazepam is a Schedule IV controlled substance pursuant to 21 CFR 1308.14(c)(14) (2011).

(5) Lorazepam is a Schedule IV controlled substance pursuant to 21 CFR 1308.14(c)(28) (2011).

(6) Versed is a brand name for a product containing midazolam, a Schedule IV controlled substance pursuant to 21 CFR 1308.14(c)(35) (2011).

The Evidence

The Government presented the testimony of Diversion Investigator (DI) Scott Brinks. Tr 428. DI Brinks testified that he has been employed as a DI in the Cleveland, Ohio, field office for just over ten years, Tr. 429, and that, during this time, he has been a part of at least a hundred investigations relating to practitioners. Tr. 431.

DI Brinks testified that, sometime prior to December of 2009, he was contacted by Investigator Flugge of the Ohio Dental Board (Board), who informed DI Brinks that "he had some drug related problems with [Respondent]." Tr. 433. After the conversation with Investigator Flugge, DI Brinks ran a query on the Respondent in the ARCOS6 and RICS7 databases. Tr. 433-436. Although Brinks ascertained from the Internet that the Respondent maintained a practice in Avon, Ohio, the RICS database query did not indicate that the Respondent had a COR for the Avon location. Tr. 435-36.

On the morning of December 21, 2009, DI Brinks met Investigator Flugge at a McDonalds across the street from the Respondent's practice in Norwalk, Ohio. Tr. 432. At this meeting, Investigator Flugge gave DI Brinks the Board's investigative file on the Respondent, including "an anonymous complaint [and] a complaint by Rebecca Crockett." Tr. 433. Investigator Flugge also "gave * * * a brief overview of the [the Board's] investigation and why he was referring [the matter]." Tr. 433. However, "Investigator Flugge said he did not want to come along because of [the Respondent's] relationship with the [B]oard." Tr. 438. When asked to clarify this remark, DI Brinks explained Investigator Flugge's reluctance to join the investigation "had to do with some hearing that [the] Respondent had went to." Tr. 438-40.8

After meeting with Investigator Flugge, DI Brinks and a second DI drove across the street to the Respondent's office. Tr. 438. Upon entering the office, the DIs identified themselves, and presented the Respondent with a DEA Form 82, Notice of Inspection of Controlled Premises, which theRespondent reviewed and signed.9 Tr. 438; Gov't Ex. 7. DI Brinks also requested that the Respondent provide "all DEA Form 222s for the purchases of Schedule II controlled Substances, his purchase records for Schedule III-V [controlled substances, and] his dispensing records for Schedules II-V [controlled substances.]" Tr. 442. DI Brinks also requested "any DEA form 41s * * * Destruction of Controlled Substances, and any DEA Form 106, the Theft and Losses of Controlled Substances, and then [Respondent's biennial] inventory." Tr. 443. DI Brinks testified that, during their conversations,10 he found the Respondent to be "very nervous and his hands were shaking."11 Tr. 442, 624.

The Respondent was able to produce only three controlled substance order forms (DEA Form 222) that related to a two-year period of practice, but even that modest number had one that did not contain all the information required. Tr. 444, 446-48, 639-40. When he realized he was unable to supply more than three Form 222s, the Respondent contacted his controlled substance supplier and had company purchase records faxed to his office for Brinks to review. Tr. 444, 638. The Respondent did provide his dispensing logs, Tr. 563, but no controlled substance destruction forms (DEA Form 41) or controlled substance theft/loss reports (DEA Form 106).12 Tr. 443, 448-49.

After using the forms provided to conduct an audit that Brinks characterized as "extremely short on * * * midazolam and * * * fentanyl," the DIs asked the Respondent if he had a way of justifying the shortages. Tr. 451. The Respondent responded that he had records and controlled substances at an office in Avon. Tr. 451. After completing their inspection of the Norwalk Office, the DIs traveled to the Respondent's (unregistered) office at Avon, where they found additional files and three-fourths of a bottle of fentanyl.13 Tr. 452.

During the inspection of the Respondent's dispensing logs, DI Brinks "observed * * * that [Respondent] had provided large quantities of midazolam." Tr. 455.14 DI Brinks testified that he became concerned "as soon as I started seeing 70 and * * * 100 [miligrams administered]."15 Tr. 457. DI Brinks asked Peg Herner, a dental assistant at Respondent's office, about doses of the medication that the DI divined were excessive, and was told that "I just write down what [the Respondent] tells me to write down." Tr. 456. After consulting with Ms. Herner, DI Brinks asked the Respondent about the midazolam prescribing, and the Respondent told him that the patients "build up a tolerance." Tr. 457-58. At some point during this conversation, DI Brinks questioned the Respondent about whether he was abusing controlled substances, and the Respondent twice volunteered to show the DIs his arms. Tr. 460, 621. When the Respondent pulled up the sleeves of his lab coat, DI Brinks observed three or four small "poke marks" on the left arm, but no bruising or scarring. Tr. 460-62. Respondent said that the marks were caused by dental students he allowed to practice IV techniques in a sedation class he taught at Case Western Reserve School of Dentistry on Fridays. Tr. 462. The following day, the DIs went to Case Western Reserve. Tr. 596. During their visit the DIs encountered the Respondent and, at the request of officials at the university,16 he invoked his right to an attorney. Tr. 596.

As a result of his visit to the Respondent's practice, DI Brinks concluded that Respondent violated the DEA's regulations by failing to have a registration for his Avon Office. Tr. 640. DI Brinks also concluded that Respondent had violated DEA regulations by failing to maintain purchase records, and by failing to maintain accurate dispensing records. Tr. 639-40. It was Brinks' recollection that he informed the Respondent of "some of the record keeping issues [and] the storing controlled substances at an unregistered location." Tr. 597-598. Brinks characterized the Respondent as "cooperative" during the investigation. Tr. 603, 637.

Brinks also discovered evidence that unused controlled substances that were left over in hypodermic needles at the conclusion of dental procedures conducted at the Respondent's practice were being disposed of by squirting them down the sink. Brinks explained that practitioners are not routinely provided with written guidance by the local DEA office on the issue of waste procedures authorized by the regulations,17 and although there are options for compliance (utilization of DEA-registered reverse distributors, Ohio Pharmacy Board assistance, and providing medications directly to DEA),18 "a large portion" of the practitioners he has inspected over the course of his career dispose of residual controlled substance medication from hypodermic needles by squirting it "either down the sink or the toilet." Tr. 631.

During his testimony, DI Brinks attempted to explain the results of his drug audit. Apart from individual doses of medications reflected in the medication logs which, based on his experience, he concluded were high, Brinks' testimony regarding his audit was confusing, inconsistent, and unreliable. Brinks was unable to explain the data that he had collected and compiled. Brinks had processed his findings into a multicolor chart which he designed to compare the Respondent's levels of midazolam dispensing at his private practices with levels he dispensed at Case Western University School of Dentistry and the U.S. Food and Drug Administration (FDA) recommended maximum dosages. Tr. 464-77. When the numbers on his proposed chart could not be reconciled with the raw data he claimed to have based it on, the witness acknowledged that he really had no idea what the chart (he created) signified.19 Tr. 475. The data in Brink's audit computation chart suffered from like blunders and was similarly excluded. Gov't Ex. 8 (ID); Tr. 478-90. An overnight break in the proceedings afforded the DI the opportunity to make revisions on his initial, ill-fated computation chart,20 but there were issues with the revised version as well. Gov't Ex. 16; Tr. 583-89, 610, 612-17. The DI's initial computation chart was ultimately received into evidence at the behest of the Respondent. Resp't Ex. M. Given the confusing nature of the Government's presentation and the surprise nature of its revised audit results (generated during the proceedings) the revised document, Gov't Ex. 16, was not considered to establish its purported results in these proceedings.

DI Brinks presented testimony that was detailed, plausible, and generally credible. Ironically, the candor with which this witness addressed some profound preparation errors actually enhanced his credibility, even to the extent that it compromised his testimony's effectiveness. The errata that marred the Government's evidence regarding the audit of the Respondent's practice, although certainly the product of self-inflicted wounds, did not bear the indicia of any form of intentional malice toward the Respondent. Interestingly however, they were clearly also not the result of a rush to justice. DI Brinks testified that, after completing his investigation sometime in March 2010, the investigation (and the collected data) lay dormant for sixteen (16) months until approximately July of 2011, when this matter was initiated.21 Tr. 599. During this time of investigative inaction, the Respondent applied for, and on September 14, 2010 received, the COR for his dental office in Milwaukee, Wisconsin. Tr. 601; Gov't Exs. 2,3. That registration is also the subject of these proceedings. ALJ Ex. 1.

The Government also presented the testimony of Lili C. Reitz, the Executive Director of the Ohio State Dental Board, the agency who referred this matter to DEA. Ms. Reitz holds a law degree from the Cleveland Marshall College of Law and formerly worked as an Assistant Attorney General with the Ohio Attorney General's Office.22 During her testimony, Ms. Reitz explained the permitting requirements for conscious sedation versus general anesthesia for dentists in Ohio, and testified that a records check she conducted informed that the Respondent possesses the former permit, but not the latter. Tr. 374-83, 421.

Ms. Reitz also provided some background regarding the manner in which the Ohio Dental Board executes its mandate to investigate complaints of wrongdoing related to its licensed dentists. Tr. 384-85, 388. Ms. Reitz testified that she supervises a 15-person office that investigates 500 to 1,000 complaints per year against the state's 7,000 dentists.Id.Furthermore, Reitz discussed her agency's practice of sharing information with other law enforcement and regulatory authorities, including DEA. Tr. 390-91.

Regarding the Respondent, Ms. Reitz testified to the results of the Ohio Dental Board's investigation into Respondent's practice that commenced upon the receipt of an anonymous complaint alleging that the Respondent was using controlled substances from his practice at home.23 Tr. 397-399. As a result of the complaint, the Ohio Dental Board sent two of its investigators to the Respondent's practice to conduct an infection control evaluation.24 Tr. 400. The Respondent was not at the Norwalk office, so the Board investigators met him at his Avon location. Tr. 401. The report of the Board's investigators (which Reitz read from with no apparent knowledge beyond the four corners of the document) indicated,inter alia,that they found an unsecured plastic bin in the Respondent's office containing medications, including fentanyl and Valium. Tr. 401-03. According to Ms. Reitz, a complaint was subsequently filed by Ms. Crockett that strongly resembled the anonymous complaint previously received regarding the Respondent's alleged drug use. Tr. 405-06. Based on the information they had at the time, the investigators interviewed Ms. Crockett, and the matter remains under investigation. Tr. 408-12.

Ms. Reitz's testimony was sufficiently detailed, consistent, and plausible to be afforded credibility,25 but the weight of her testimony regarding the Board's investigation of the Respondent is diminished by the reality that she was doing no more than relating the results of a report prepared by her subordinates, and admitted that she knew nothing more than (and could provide no insight beyond) the words on the page of her investigators' report. Tr. 401-03. Thus, it would be unreasonable to afford her testimony in this regard greater weight than if the report upon which she so heavily depended (and which was her constant companion on the stand) was admitted and considered without her appearance.26

The Government also presented affidavits and testimony from three individuals who were employed at the Respondent's dental practice during the events that form the basis of its current revocation actions. The first of these former employees was Rebecca Crockett.27 Ms. Crockett testified that at the outset of her employment at the Respondent's practice she was charged with the responsibility of maintaining drug logs completed on patients during procedures, and with alerting the Respondent when sedation medication stocks were dwindling to a level where more needed to be ordered. Tr. 154, 182, 196;see alsoGov't Ex. 12 at 2. Crockett recalled no occasion during her tenure as the drug-log custodian when controlled substances were missing or unaccounted for,28 but did recall that Rebecca Tetzloff, an employee who subsequently assumed responsibility for the drug log, approached her with concerns about missing medication.Id.Crockett testified that the Respondent maintained two Ohio offices; one at Norwalk and another at Avon, and that she worked at both locations (which were each open two days per week) and observed the Respondent transport controlled substances to and from both practice locations. Tr. 154-58. The controlled substances (lorazepam, diazepam, and fentanyl) were transported on a cart that was loaded at the Norwalk office and driven to the Avon office. Tr. 157, 186-88, 197. According to Crockett, controlled substances were routinely stored in both the Norwalk and the Avon offices. Tr. 156-57, 186-88, 197-98. Crockett stated that because the daily preparations in the Avon office were frequently done in a hurry, controlled substances were routinely left unsecured on top of a sterilization room counter. Tr. 158. The sterilization room at the Avon office although not locked, was located in an inner, treatment area of the practice, to the rear of front reception desk, and was separated from the patient waiting roomby some form of controlled-access door.29 Tr. 158-60, 210.

Crockett testified that she and other employees noticed marks on the Respondent's upper extremities that they feared may have indicated IV drug use on his part, and observed behavior on the part of the Respondent that they communally deemed to be overly erratic, moody, and emotional. Tr, 164-67. After discussing these observations amongst themselves, they met with him as a group (in what some of their number termed an "intervention") and received his assurance that he was "getting help" for what ailed him. Tr. 164-67, 181, 202-03; Gov't Ex. 12 at 2-3. The Respondent did not share with the group what help he was getting or what it was for.Id.Crockett related a 2009 incident where she believed that the Respondent appeared to be intoxicated and/or disoriented at the outset of a procedure30 and raised the issue with the office manager, Christina Painley. Tr. 172-73, 202.

Ms. Crockett testified that she voluntarily elected not to return to her position at the Respondent's practice at the conclusion of a period of maternity leave,31 due to her concerns regarding her safety brought about by the Respondent's animated, angry outbursts, as well as concerns she had for the Respondent's patients, based on her suspicion that the Respondent was abusing sedation controlled substances maintained in the office. Gov't Ex. 12 at 3; Tr. 167-69, 174, 190. Crockett related that subsequent to her departure from the Respondent's employment she filed for unemployment benefits and sent a letter to the Ohio Dental Board outlining her suspicions regarding the Respondent's drug abuse. Tr. 177, 206-07. Ms. Crockett testified that her letter to the Dental Board was motivated by her concern for the safety of both the Respondent and his patients. Tr. 177-79.

Ms. Crockett's testimony was sufficiently detailed, internally consistent, and plausible to be relied upon as credible in this recommended decision. No persuasive reason for her to fabricate evidence against the Respondent has been offered into, or is supported by, the current record.

The Government also presented the testimony and affidavit32 of former employee Rebecca Tetzloff, who worked on the Respondent's staff from March 2008 through October 2009. Gov't Ex. 10 at 1. Like Ms. Crockett, Ms. Tetzloff testified that she worked at both the Norwalk and Avon offices of the Respondent's practice, transported controlled substances to the Avon office, and that the Respondent routinely administered and stored controlled substances at the Avon office. Tr. 221, 223-27; Gov't Ex. 10 at 2. In fact, Ms. Tetzloff testified that she actually maintained a log recording controlled substances stored at Avon. Tr. 225-26. According to Tetzloff, before the Ohio Dental Board insisted on the installation of a safe, controlled substances were routinely kept at Avon in an intermittently-locked filing cabinet in an arrangement that frequently yielded ready access to the keys that could lock (or unlock) it. Tr. 227-32.

Consistent with Crockett's testimony, Tetzloff recollected that when controlled substances were unpacked at the Avon office, they were left unsecured in the "rush, rush, rush" of setting up equipment at the outset of the day. Tr. 233. According to Tetzloff, the controlled substances (midazolam, diazepam, and fentanyl) would be transported to Avon in a bin on a cart and left on a counter in the sterilization room. Tr. 233-36.

At some point during her employment at the Respondent's practice, Tetzloff was charged with the responsibility of accounting for the controlled substances used and on-hand in the practice. Gov't Ex. 10 at 2. In the discharge of these duties, Ms. Tetzloff became concerned about an apparent spike in the level at which office supplies were requiring replacement, and began having trouble reconciling the quantities of medications on hand. Tr. 237; Gov't Ex. 10 at 2. Ms. Tetzloff tacitly acknowledged that this was a rather unscientific process where, by the mere act of counting vials of medication, she would somehow divine whether too many vials had been used based on her expectation of how many vials should have been present, with no appreciable expertise to appraise how many vials were used on the procedures performed. Tr. 282-84, 291, 295, 307, 314-15. Tetzloff recalled that on one occasion when she called the Respondent while he was at his teaching position at Case Western Reserve University and asked him about a particular controlled substance deficit, he informed her that he had taken the medication with him. Tr. 237-38; Gov't Ex. 10 at 2-3. On another occasion, upon her arrival at the Norwalk office one morning, Tetzloff discovered a vial of diazepam sitting unsecured on top of the office safe. Tr. 241. When queried on the issue of why a controlled substance was left out in the open in that fashion, the Respondent's answer was merely to acknowledge what Tetzloff perceived with her own eyes, without any attempt at explanation. Tr. 241-42. When Tetzloff's suspicions grew, and she became increasingly concerned that medications were not being effectively locked up in the Norwalk office, she sought the advice of an attorney, who assisted her in drafting a letter raising her concerns to the Respondent and seeking discharge from her duties related to the accounting of office controlled subsances. Tr. 238, 243-47, 296-97. Tetzloff credibly testified that she presented the letter33 to the Respondent and a member of his staff. Tr. 247-48; Gov't Ex. 10 at 3-4.

Tetzloff also related her recollection of marks on the Respondent's upper extremities which she felt were suspiciously reminiscent of track marks,34 as well as bouts of animated anger bursts, "irritability,"35 and essentially eratic behavior36 during the work day on the Respondent's part,37 all of which culminated in a staff meeting on a Friday when no patient appointments were scheduled ("the intervention"), wherein the Respondentassured all present that he was seeking (unspecified) help that was related, Tetzloff thought, to a depression condition. Tr. 223, 249-32, 255-60, 263, 285, 298; Gov't Ex. 10 at 4. According to Tetzloff, the Respondent took a week-long vacation immediately after the meeting. Tr. 252.

On the issue of disposal, Tetzloff recalled routinely squirting controlled substances remaining in hypodermic needles at the conclusion of procedures into the sink. Tr. 305.

Ms. Tetzloff, like Ms. Crockett, testified that she cared about the Respondent, describing him as "a good surgeon" and "a very good boss." Tr. 278. Ms. Tetzloff's testimony was sufficiently detailed, internally consistent, and plausible to be relied upon as credible in this recommended decision. No persuasive reason for her to fabricate evidence against the Respondent has been offered into, or is supported by, the current record.

The final former employee presented by the Government in its case-in-chief was Dr. Brian Toth, D.D.S.38 Like the Respondent, Dr Toth, is a DEA registrant and a licensed Ohio dentist in good standing. Gov't Exs. 4, 13; Tr. 320-21, 337, 344. Although Dr. Toth's affidavit states that he "worked at [Respondent's] Norwalk and Avon dental offices from January 2009 through January 2010," Gov't Ex. 13, at P 2, during his testimony he agreed that the period of his employment could have been from April 2009 through February 2010. Tr. 336.

Also in his affidavit, Dr. Toth asserts that, "[f]rom my observations, I believe that [Respondent] has injected himself with fentanyl and Versed (midazolam). I base my belief on my training as well as my observations of [Respondent's] erratic and aggressive behavior, red eyes, mood swings, anger, frustration, and lack of care while treating patients." Gov't Ex. 13, at P 2. The affidavit also identifies the following as alleged indices of drug abuse: (1) Respondent's physical assault of Christina Painley; (2) track marks on Respondent's arms;39 (3) "meth bugs," described as "scratching, and sores about the wrists, arms, and head;"40 (4) an incident on a undated Friday41 morning where Dr. Toth observed Respondent enter the Norwalk dental office, appearing "[d]isheveled, out of sorts, [and] wobbly,"42 in "pajamas and flip flops," and walk in the general direction of the office drug safe stating that he needed antibiotics for a cold.43 Gov't Ex. 13, at PP 3-4; Tr. 327-28. Toth, like other witnesses, testified that the Respondent was prone to "drastic mood swings" and "erratic behavior." Tr. 332.

Toth's affidavit also described a post-DEA inspection restaurant interaction wherein the Respondent purportedly confessed to Toth that he was taking Valium44 as a sleep aid, and subsequently told him that adjustments were being made to office controlled substance records to shield the losses from DEA scrutiny. Gov't Ex. 13 at 3. When pressed on the issue, however, Dr. Toth was not at all clear on whether the incident happened before or after DEA's involvement in the case. Tr. 353-56.

Dr. Toth testified that he is a recovering alcoholic and cocaine addict, and that he has been "clean and sober" since 2006. Tr. 322-23. Notwithstanding the witness's unambiguous assurance of his uninterrupted recovery and sobriety, when confronted with documentation concerning his April 2011 convictions for disorderly conduct/intoxication and marijuana possession,45 Dr. Toth conceded that he had been arrested and pled guilty to those offenses. Tr. 337-44, 346.

The issue of Dr. Toth's success at his substance abuse recovery efforts (at least on the present record) is, without question, a collateral issue. However, when Dr. Toth volunteered, under oath, that he had been clean and sober since 2006, and then grudgingly acknowledged marijuana and alcohol-related convictions seven months prior to the commencement of the hearing, he deprived his own testimony of any measure of credibility in these proceedings.46 Simply stated, Dr. Toth is not a person who is willing to provide candid and truthful testimony under oath, and in those instances where his account conflicts with other credible evidence of record it cannot be believed. Thus, his testimony cannot be afforded weight in supporting a substantial-evidence finding by this recommended decision and ultimately, by the Agency. Furthermore, inasmuch as he was unable to supply virtually any temporal details of the factual events he described, and his purported observation of a "disheveled" and "wobbly" Respondent standing in his own office, on some unspecified date, headed in the general direction in his office where controlled substances were stored, would (even if deemed credible) shed no light on anything that must be decided in this case, the absence of his testimony here will be of no moment.

The Government also presented the testimony and written report,47 of Daniel Becker, D.D.S. Dr. Becker,48 currently serves as an Associate Director of Education in the General Dental Practice Department at Miami Valley Hospital, in Dayton, Ohio, is an Associate Editor of Anesthesia Progress for the American Dental Society of Anesthesiology, and also serves as an Adjunct Professor of Life and Health Sciences at Sinclair Community College in Dayton, Ohio. Gov't Ex. 14. Additionally, Dr. Becker is the Chairman of the Human Patient Simulation Training Subcommittee at the American Dental Society of Anesthesiology.Id.Dr. Becker also testified that he teaches intravenous sedation techniques to dental residents, and is actively engaged in the practice of IV sedation to patients at numerous dental practices in Ohio. Tr. 32. Dr. Becker was received without objection as an expert in the practice of general dentistry in regards to pharmacology, sedation, and anesthesia. Tr. 29-30.

In his testimony, Dr. Becker (like Ms. Reitz) explained that in Ohio there are two varieties of dental sedation that are sanctioned by state law, with separate practitioner permits specified for each type. A "conscious sedation permit," is required to sedate a patient to a depth where the patient is capable of being aroused, that is capable of responding to verbal commands. Tr. 41, 71. A "deepsedation/general anesthesia permit," in contrast, is required to sedate a patient to unconsciousness. Tr. 42. A conscious sedation permit may be obtained by a dentist after the completion of a course on the subject, while a deep sedation/general anesthesia permit requires the successful completion of a year-long residency. Tr. 41-42, 44-45. Becker testified that where general anesthesia is utilized,49 additional personnel and monitoring equipment normally will be required. Gov't Ex. 15 at 1; Tr. 62-64, 85-86.

At the Government's request, Dr. Becker reviewed forty-three records of IV sedation50 that had been administered by the Respondent and found all but one of the records were below "the standard of practice" because they did not reflect current vital signs or actual time at the time the medications were administered. Gov't Ex. 15 at 1. Dr. Becker's report further identified 17 patient charts which he found to be "egregious."Id.The report also sets forth Becker's expert opinion that the doses recorded in the charts he reviewed were sufficiently high that, at least in his view, monitoring, staff, equipment, and general anesthesia training beyond what was apparent in the reviewed documents would have been required.Id.Becker noted that despite what he characterized as "staggering doses," the records he evaluated reflected only four occasions where reversal drugs were administered, and that the records reflected none of the complications such as hypotension or respiratory arrest that he would have expected to encounter with doses at those levels.Id.At 2. In Becker's opinion, "[t]his raises a question as to whether these doses were actually administered [because] [f]ollowing these dosages, serious complications would most surely have been encountered."Id.

According to Dr. Becker, in most cases where midazolam is used for conscious sedation, the required level of sedation could be obtained by 10 mgs or less, but that more midazolam might be needed for a longer appointment.51 Tr. 58-60. Dr. Becker further testified that a patient's resistance to midazolam could alter the amount of drug necessary to achieve the desired sedation. For example, Dr. Becker opined that for a "fairly resistant" patient, twenty to thirty milligrams of midazolam might be necessary for a 3-4 hour procedure, and that there are some patients who are simply not sedatable with this medication.52 In Becker's opinion, however, those cases that require the higher doses and demonstrate resistance are rare. Tr. 60-61. Midazolam, according to Dr. Becker, is administered in one-to-two milligram increments to achieve the desired level of sedation. Tr. 62. A five-miligram increment would cause a patient to lose consciousness, which in turn risks th

Dated: November 16, 2012. Michele M. Leonhart, Administrator.
ACTION: 85In its Posthearing Brief the Government contends that "the agency has recently admitted and considered testimony with regard to community impact [of revocation]." Gov't Posth'g Brf. at 33. However, the Agency has recently once again re-affirmed its view that "community impact evidence is not relevant in determining whether to * * * revoke an existing registration under the various authorities provided in 21 U.S.C. 824(a)."Cheek, M.D.,76 FR at 66972. Accordingly, community impact has not played a role in this recommended decision.Id.