Daily Rules, Proposed Rules, and Notices of the Federal Government
On December 22, 2011, Chief Administrative Law Judge John J. Mulrooney, II, (hereinafter, ALJ), issued the attached Recommended Decision.
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.
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.
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."
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.' "
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."
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.
As set forth above, the CSA's registration provision states in relevant part that "[a] separate registration shall be required
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.
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 "each
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,"
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.
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.
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.
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,"
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.
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,
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 (quoting
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."
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 (
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.
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.
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:
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 the
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.
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,
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's
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.
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 of
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 revoked
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 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;
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.
(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 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 ARCOS
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.
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 the
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).
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.
During the inspection of the Respondent's dispensing logs, DI Brinks "observed * * * that [Respondent] had provided large quantities of midazolam." Tr. 455.
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,
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.
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.
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.
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.
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.
Ms. Reitz's testimony was sufficiently detailed, consistent, and plausible to be afforded credibility,
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.
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.
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,
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 affidavit
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 letter
Tetzloff also related her recollection of marks on the Respondent's upper extremities which she felt were suspiciously reminiscent of track marks,
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.
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;
Toth's affidavit also described a post-DEA inspection restaurant interaction wherein the Respondent purportedly confessed to Toth that he was taking Valium
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,
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.
The Government also presented the testimony and written report,
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 "deep
At the Government's request, Dr. Becker reviewed forty-three records of IV sedation
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.