Judge James C. Chalfant, Case Number: 22STCP00574, Date: 2024-01-11 Tentative Ruling

Petitioner David James Smith, M.D. (“Smith”) seeks mandamus directing Respondent Medical Board of California (“Board”) to set aside its disciplinary action against his license.

The court has read and considered the moving papers, opposition, and reply, and renders the following tentative decision.

Petitioner Smith commenced this proceeding on February 17, 2022. The operative pleading is the verified First Amended Petition (“FAP”), filed on March 23, 2022, and alleging four causes of action for administrative mandamus. The FAP alleges in pertinent part as follows.

On August 25, 2020, the Board issued a decision to discipline Smith’s license (“2020 Decision”), placing Smith on probation and prohibiting him from performing any patient care or treatment involving intrathecal therapy until he completed a Clinical Competence Assessment Program. Smith complied with the terms of this probation, and the Board again permitted him to provide the intrathecal therapy modality.

On November 12, 2020, Smith filed a petition challenging the 2020 Decision in Smith v. Board of California, (“Smith I”), Case No. 20STCP03757.

On December 22, 2020, the Board filed another accusation against Smith (“2020 Accusation”). The 2020 Accusation concerned allegations virtually identical to those in the 2020 Decision.

On December 22, 2021, the Board issued a decision (“2021 Decision”) incorporating the 2020 Decision and adding to its discipline. The 2021 Decision was based on the same issues and period of medical care as the 2020 Decision. The 2021 Decision again placed Smith on probation, prohibited him from performing any patient care or treatment involving intrathecal pumps, and from advising any medical provider on such treatment, for the duration of his probation.

On January 24, 2022, the court in Smith I set aside the 2020 Decision because the Board had improperly excluded testimony from Smith’s expert on the standard of care.

Smith alleges that the 2021 Decision is void as a matter of law because Smith I set aside the underlying 2020 Decision. It also was not based on clear and convincing evidence to a reasonable medical certainty. Further, the discipline imposed constitutes administrative double jeopardy; Smith fully complied with the terms of his probation under the 2020 Decision and there was no cause for further discipline. The prohibition on advising other professionals on intrathecal therapy treatment also infringed Smith’s constitutional right to free speech.

Additionally, the 2021 Decision purports to resolve a dispute on the standard of care for pain medicine which arose after Smith’s treatment of patients in this case. The 2021 Decision also imposes opioid prescription guidelines that are inapplicable to pain management specialists treating patients suffering from chronic, intractable pain, and the Board engaged in underground rulemaking when it adopted those guidelines as the standard of care.

Smith seeks (1) a writ of mandate vacating the 2021 Decision; (2) a writ of mandate prohibiting the Board from imposing prior restraint of professional speech on physicians when it does not satisfy a compelling government interest by the least restrictive means; (3) a temporary restraining order, preliminary injunction, and permanent injunction enjoining the Board from imposing dosing guidelines, either directly or by disciplinary orders related to intrathecal therapy; (4) a declaration that imposition of such guidelines violates state law and regulations; (5) a stay of the 2021 Decision pending the outcome of these proceedings; and (6) attorney’s fees and costs.

On February 22, 2022, Smith served the Board with the Petition and Summons by substitute service, effective March 4, 2022.

On March 23, 2022, Smith filed the FAP. He subsequently served the Board on March 25, 2022.

CCP section 1094.5 is the administrative mandamus provision which structures the procedure for judicial review of adjudicatory decisions rendered by administrative agencies. Topanga Ass’n for a Scenic Community v. County of Los Angeles, (“Topanga”) (1974) 11 Cal.3d 506, 514-15.

CCP section 1094.5 does not in its face specify which cases are subject to independent review, leaving that issue to the courts. Fukuda v. City of Angels, (“Fukuda”) (1999) 20 Cal.4th 805, 811. In cases reviewing decisions which affect a vested, fundamental right the trial court exercises independent judgment on the evidence. Bixby v. Pierno, (“Bixby”) (1971) 4 Cal.3d 130, 143; see CCP §1094.5(c). An administrative decision imposing discipline on a professional licensee is decided under the independent judgment standard. Griffiths v. Superior Court, (2002) 96 Cal.App.4th 757, 767.

Under the independent judgment test, “the trial court not only examines the administrative record for errors of law but also exercises its independent judgment upon the evidence disclosed in a limited trial de novo.” Bixby, supra, 4 Cal.3d at 143. The court must draw its own reasonable inferences from the evidence and make its own credibility determinations. Morrison v. Housing Authority of the City of Los Angeles Board of Commissioners, (2003) 107 Cal.App.4th 860, 868. In short, the court substitutes its judgment for the agency’s regarding the basic facts of what happened, when, why, and the credibility of witnesses. Guymon v. Board of Accountancy, (1976) 55 Cal.App.3d 1010, 1013-16.

“In exercising its independent judgment, a trial court must afford a strong presumption of correctness concerning the administrative findings, and the party challenging the administrative decision bears the burden of convincing the court that the administrative findings are contrary to the weight of the evidence.” Fukuda, supra, 20 Cal.4th at 817. Unless it can be demonstrated by petitioner that the agency’s actions are not grounded upon any reasonable basis in law or any substantial basis in fact, the courts should not interfere with the agency’s discretion or substitute their wisdom for that of the agency. Bixby, supra, 4 Cal.3d 130, 150-51; Bank of America v. State Water Resources Control Board, (1974) 42 Cal.App.3d 198, 208.

The agency’s decision must be based on the evidence presented at the hearing. Board of Medical Quality Assurance v. Superior Court, (1977) 73 Cal.App.3d 860, 862. The hearing officer is only required to issue findings that give enough explanation so that parties may determine whether, and upon what basis, to review the decision. Topanga, supra, 11 Cal.3d 506, 514-15. Implicit in section 1094.5 is a requirement that the agency set forth findings to bridge the analytic gap between the raw evidence and ultimate decision or order. Id. at 115.

An agency is presumed to have regularly performed its official duties (Evid. Code §664), and the petitioner therefore has the burden of proof. Steele v. Los Angeles County Civil Service Commission, (1958) 166 Cal.App.2d 129, 137. “[T]he burden of proof falls upon the party attacking the administrative decision to demonstrate wherein the proceedings were unfair, in excess of jurisdiction or showed prejudicial abuse of discretion. Afford v. Pierno, (1972) 27 Cal.App.3d 682, 691.

The standard of proof in administrative proceeding is relevant on mandamus review. Li v. Superior Court (Sacramento County), (2021) 69 Cal.App.5^th 836, 844. Where the administrative burden of proof is clear and convincing evidence, the trial court must account for that standard of proof when exercising its independent judgment on the sufficiency of the evidence. Id. at 865. The trial court must apply the principles of deference and presumptive correctness in the context of whether the findings are supported by clear and convincing evidence rather than a mere preponderance of the evidence. Id.

Protection of the public shall be the highest priority for the Board, Division of Medical Quality,[2] Board of Podiatric Medicine, and administrative law judges of the Medical Quality Hearing Panel in exercising their disciplinary authority. Business & Professions Code (“B&P Code”) §§ 2001.1, 2229(a). In exercising such authority, an ALJ or the Division of Medical Quality shall, wherever possible, take action that is calculated to aid in the rehabilitation of the licensee, or where, due to a lack of continuing education or other reasons, restriction on scope of practice is indicated, to order restrictions as are indicated by the evidence. B&P Code §2229(b).

The legislative intent is for the Division of Medical Quality, Board of Podiatric Medicine, and enforcement program to seek out licensees who have demonstrated deficiencies in competency and take action. B&P Code §2229(c). Priority shall be given to the measures that will remove those deficiencies, including further education, restrictions from practice, and other means. Id. Where rehabilitation and protection are inconsistent, protection shall be paramount. Id.

The Board shall take action against any licensee who is charged with unprofessional conduct. Unprofessional conduct includes, but is not limited to, (b) gross negligence; (c) repeated negligent acts, defined as two or more negligent acts or omissions. An initial negligent act or omission followed by a separate and distinct departure from the applicable standard of care shall constitute repeated negligent acts; (d) incompetence; and (f) any action or conduct that would have warranted the denial of a certificate. This subdivision shall only apply to a certificate holder who is the subject of an investigation by the Board. B&P Code §2234.

The object of Board discipline is not to punish the physician, but to protect the life, health, and welfare of the people at large and set up a plan whereby those who practice medicine will have the qualifications which will prevent, as far as possible, the evils which could result. Pirouzian v. Superior Court, (2016) 1 Cal. App. 5th 438, 446. In other words, the purpose of discipline is to make the physician a better physician. Id.

On April 27, 2018, the Board’s Executive Director (“Complainant”) filed an Accusation against Smith. AR 8467. The Complainant filed a First Amended Accusation on February 13, 2019. AR 3144. (The Accusation and First Amended Accusation are collectively referred to herein as the “2019 Accusation”.)

The 2019 Accusation alleged Smith had initiated excessive doses of pain medication via both intrathecal pump and high dose systemic oral opioid drug therapy for five patients. AR 3148. The 2019 Accusation alleged in part that, on October 9, 2012, Smith initiated an excessive dose of fentanyl for Patient A. AR 3151. He failed to initiate intrathecal therapy in an inpatient or outpatient setting to observe whether Patient A had a safe response to the medication. AR 3151-52. Smith also failed to properly program medication information into Patient A's intrathecal pump, including the starting and final concentration of medication and other reported values of concentration and doses. AR 3152. The 2019 Accusation made allegations of excessive pain medicant for Patients B-E, none of which involved intrathecal therapy. AR 3153-162.

On June 25, 2020, ALJ Vallera Johnson issued a 100-page proposed decision after an administrative hearing on the 2019 Accusation. AR 3302-401. The ALJ’s proposed decision discussed Patient A’s care from May 2011 to 2017 (AR 3316), Patient B’s care from May 2011 to November 2013 (AR 3338), Patient C’s care from May 2011 to June 2012 (AR 3363), Patient D’s care from December 2011 to July 2021 (AR 3369), and Patient E’s care from April to October 2013 (AR 3375).

Based on his misconduct with these five patients, the ALJ’s proposed decision revoked Smith’s license, stayed the revocation, and placed Smith on a seven-year probation subject to certain terms and conditions. AR 3388-401. The conditions included enrollment in a Clinical Competence Assessment Program approved in advance by the Board or its designee. AR 3909. Smith was required to complete the program within six months of enrollment unless the Board or its designee agreed to an extension. AR 3909. Until Smith provided the Board with proof of completion of the program, he could not order, prescribe, dispense, administer, furnish, or possess Schedule II-IV drugs. AR 3910. He also could not perform any care or treatment with patients involving the use, management, or any surgical procedures related to intrathecal pumps. AR 3910.

On August 25, 2020, the Board adopted the proposed decision as the 2020 Decision, effective September 24, 2020. AR 3818.

On November 19, 2020, Smith filed a petition for a writ of mandate to compel the Board to set aside the 2020 Decision. Rifat Decl., ¶6, Ex. C. On January 24, 2022, Judge Beckloff issued a final decision granting the petition in Smith I on fair trial grounds with respect to three patients. Rifat Decl., ¶7, Ex. D, pp. 5-19. The court set aside the 2020 Decision but noted that nothing in its decision would limit or control the discretion legally vested in the Board. Rifat Decl., ¶7, Ex. D.

On February 28, 2022, Judge Beckloff entered judgment in Smith I. Rifat Decl., ¶5, Ex. B. The Board’s proposed judgment would have set aside the 2020 Decision without prejudice and remanded the matter to the Board for reconsideration pursuant to CCP section 1094.5(f). Rifat Decl., ¶5, Ex. B. The court struck language from the proposed judgment including “without prejudice” and the reference to remand and reconsideration by the Board, with the note “Objections considered.” Rifat Decl., ¶5, Ex. B. On April 18, 2022, the clerk issued a writ of mandate compelling the Board to set aside the 2020 Decision. Rifat Decl., ¶6, Ex. C.

On June 9, 2022, the Board filed and served a return to the writ in Smith I. Rifat Decl., ¶7, Ex. D. The return included a Board order issued earlier that day which vacated and set aside the 2020 Decision. Rifat Decl., ¶7, Ex. D, p. 4. The order stated that the Board would reconsider Smith’s case on July 22, 2022 in a manner consistent with the Smith I decision. Rifat Decl., ¶7, Ex. D, p. 4.

On August 11, 2022, the Board issued the 2022 Decision, retroactively effective from September 24, 2020. Rifat Decl., ¶4, Ex. A, pp. 2-98. The 2022 Decision is entitled “Decision after Superior Court Remand.” Rifat Decl., ¶4, Ex. A, p. 2. The Board reviewed the record and the court’s decision in Smith I before issuing the 2022 Decision. Rifat Decl., ¶4, Ex. A, p. 4. The 2022 Decision revoked Smith’s license, stayed the revocation, and placed him on probation for five years retroactive to September 24, 2020. Rifat Decl., ¶4, Ex. A, p. 86. The probation was subject to the same terms and conditions as the 2020 Decision. Rifat Decl., ¶4, Ex. A, pp. 86-98. Smith would receive full credit for the period of probation already served and for any term of probation satisfied before Smith I was remanded to the Board. Rifat Decl., ¶4, Ex. A, p. 86. The 2022 Decision attached the 2020 Decision. Rifat Decl., ¶4, Ex. A, pp. 101-201.

On August 26, 2022, Smith filed a petition for a writ of mandate to compel the Board to set aside the 2022 Decision. Rifat Supp. Decl., ¶3, Ex. E. On December 12, 2023, this court denied the petition in Smith II. Rifat Supp. Decl., ¶3, Ex. E. The court concluded in part that the Board’s June 2022 order to consider the appropriate penalty was a non-adoption of the ALJ’s proposed penalty for the 2020 Decision. Rifat Supp. Decl., ¶3, Ex. E, p. 15. It was not a reconsideration of the penalty, but an initial consideration of the penalty after such non-adoption. Rifat Supp. Decl., ¶3, Ex. E, p. 15.

On December 22, 2020, the Complainant filed the 2020 Accusation against Smith’s license. AR 12, 39. The 2020 Accusation alleged gross negligence as to Patient A based on treatment in 2016, Patient B based on treatment in 2015, and C based on treatment in 2018. AR 19, 27, 34.

ALJ Abraham Levy heard the matter in October 2021. Pertinent testimony is as follows.

Mark Wallace, M.D. (“Wallace”) testified as a Board expert. He has reviewed ten cases for the Board in the past 20 years. AR 10034. The standard of care is how a reasonable and prudent physician would provide care, based on their knowledge and skill in the time period in question. AR 10034-35.

Failure to program a pump to correctly reflect the concentration of the drug, in milligrams per milliliter (“mg/ml”), can overdose the patient. AR 10049. When these patients end up in other institutions, like emergency rooms, the staff may determine the drug needs to be refilled to avoid withdrawal and consult the drug’s concentration. AR 10049. If the concentration is listed as ten mg/ml when it is actually only 1 mg/ml, the institution will overdose the patient when they refill the drug with a concentration of 10 mg/ml. AR 10049.

Nothing in Patient A’s progress notes explains why Smith increased the rate of fentanyl pumped. AR 10083. Smith increased Patient A’s fentanyl dosage even when her pain score was low and she was improving in her activities of daily living (“ADL”). AR 10886-87. If Smith sought to reduce the pain score to zero, that was unrealistic and is never the goal in pain management. AR 10887-88. The goal is to balance pain level with an improvement in patient function. AR 10888. Trying to lower the pain level to zero increases the risk to the patient through the excessive use of medication. AR 10888. The physician should try to keep the dose of the drug to a minimum. AR 10888.

At one point, Smith lowered Patient A’s daily fentanyl dose from 13.7 mg per day to 6.87 mg per day. AR 10103. He recognized his mistake in the entry of the fentanyl concentration. AR 10103. By the end of 2017, however, he had increased the rates again. AR 10103. Wallace could not explain why there was such a huge increase. AR 10103.

These fentanyl dosages were excessive and beyond what Wallace had ever seen in an intrathecal pump before. AR 10096. Fentanyl is 100 times more powerful than morphine and 7.5 mg is enough to put somebody down for cardiac anesthesia. AR 10096. The Polyanalgesic Consensus Conference’s (“PACC”) guidelines have never recognized a fentanyl concentration of more than 5 mg/ml as within the standard of care. AR 10302-03. Patients should also start at the lowest concentration possible and work their way up. AR 10303. In contrast, the patients in this case started with concentrations of 25 or 17 mg/ml. AR 10303.

The excessively high dosages for both Patients A and B reflected an extreme departure from the standard of care. AR 10103-04, 10149. As of the end of 2017, Smith’s programming of Patient A’s pump was also an extreme departure from the standard of care because the listed drug concentrations did not reflect what actually was in the pump. AR 10104. The 2015-2016 records for Patient B show that Smith incorrectly programmed drug concentrations for her pump, and this was also an extreme departure from the standard of care. AR 10149.

Smith used ketamine in one of the intrathecal pumps. AR 10077. This was below the standard of care because animal studies have confirmed that ketamine is toxic. AR 10077-78. It results in vacuolization, or punched-out lesions, in the spinal cord. AR 10078. The case reports rarely reflect that ketamine is even used, so there are no long-term studies on it. AR 10079.

Wallace has reviewed the articles that Smith’s expert witness, Jack M. Berger, M.D. (“Berger”), cited in disagreeing with Wallace on the effects of ketamine on the spine. AR 10911-12. Berger concluded that the prescription of ketamine was part of the treatment, and that the amount did not pose a hazard of neurosis or as a neurotoxin. AR 10912. None of the articles cited by Berger support this conclusion, and one actually supported Wallace’s opinion. AR 10913.

Physicians that provide intrathecal therapy generally agree that psychological evaluation is necessary before either a pump trial or permanent implantation. AR 10076-77. Smith should have patients undergo psychological evaluation before a pump trial. AR 10075. Intrathecal therapy is a highly invasive and expensive therapy, and it requires a lot of healthcare reliance by the patient. AR 10066. The physician “marries” the patient. AR 10066. If a physician wants to begin such an invasive and expensive therapy, he should first ensure the patient has psychosocial stability based on controlled depression and anxiety. AR 10066, 10075-76.

The purpose of psychological evaluation is to provide the implanter with the details of the patient’s psychological status. AR 10870. Detail is required because the psychiatrist is not the practitioner who will manage the patient’s intrathecal therapy. AR 10871. The physician who will manage it needs to know all the psychological issues the patient has. AR 10871. The physician should also ask whether the patient has any other psychiatric illnesses and make sure the patient has realistic expectations and the social support system to get to the visits. AR 10066. Smith’s failure to do so constituted an extreme departure from the standard of care. AR 10077.

It also is a departure from the standard of care to use a patient’s unwillingness to manage oral medications as a reason to move forward with intrathecal therapy. AR 10194.

Between hearing days, Wallace learned about a scribbled note with psychological clearance for Patient B. AR 10869. This note was inadequate to satisfy the standard of care. AR 10870. Patient B needed a psychological evaluation, not a clearance. AR 10869-70. An evaluation is not just a “yes” or “no” as to whether the patient can obtain an intrathecal pump. AR 10870.

Nothing in Patient C’s medical record suggests that Smith even considered a patient psychological evaluation. AR 10179. Although Patient C never had a pump installed, it was still a departure from the standard of care to consider intrathecal therapy without slowing down for a psychological evaluation. AR 10179.

Patient C also wrote in a letter that she has a lot of stress which Wallace opined was psychologically driven. AR 10180. Patient C needed a biopsychosocial approach to her pain instead of focusing on intrathecal therapy, which is invasive and expensive. AR 10180. Pushing her into intrathecal therapy was an extreme departure from the standard of care. AR 10180.

The PACC guidelines are not standards of care. AR 11207. Physicians can use their own experience and judgment to go outside those guidelines if appropriate because they are familiar with what they are doing. AR 11207. No one can really judge their decision as long as they document the appropriateness of the decision in their thought process. AR 11207.

A patient uses an intrathecal pump to alleviate the necessity to take pain medications. AR 11228. That medication could contribute to the patient’s emotional discord or impair the patient’s cognitive ability. AR 11228. Because of this, there is no standard of care requirement for a psychiatric or psychological evaluation before a pump trial. AR 11228, 11245.

The standard of care does not require a psychological evaluation before permanent implantation of a pump unless the physician suspects the patient is incapable of understanding the procedure or consenting to it. AR 11245, 11385. If Smith had suspected that based on his initial screening of the patient, the standard of care would have required him to reach out to a psychiatrist for evaluation. AR 11386-87.

The ketamine in Patient A’s pump was present for over a year without any adverse effect. AR 11336. The absence of harm to some extent supports the conclusion that it was safe to use for that specific patient if it was adding a benefit. AR 11336. Patient A had complex regional pain syndrome, and ketamine is useful when treating it. AR 11342. It was appropriate to use ketamine at least on a trial basis to see if it would provide additional benefit. AR 11342. Berger would only reduce the ketamine if he saw some level of harm associated with its use rather than the other drugs in the pump. AR 11337. The use of ketamine ultimately was a non-issue because it did not cause injury to Patient A. AR 11341.

Fentanyl is very soluble, and you can have very high concentrations in the pump such as 25 mg/ml without a problem of precipitation. AR 11369. Patients A and B did not suffer harm from the dose levels of fentanyl administered through the intrathecal pump, aside from one incident with Patient A. AR 11369. This suggests that Smith’s treatment of both patients was within the standard of care. AR 11369.

Berger had Smith’s help in preparing his expert reports for this case. AR 11409. Berger generally tries to find notes to dispute accusations made by the Board’s expert. AR 11409. When there are a lot of records, he needs help finding those notes. AR 11409-410. There was a lot of discussion and a lot to prepare in this case. AR 11410. Smith found the notes that helped Berger prepare his report. AR 11410. Although Berger typed the report himself, he may have cited language from Smith’s notes. AR 11410. Nevertheless, Berger would not have submitted the report if he did not agree with everything it said. AR 11410.

Medtronic, the company from whom Smith buys intrathecal pumps, said that he is probably the largest private implanter in San Diego. AR 10793-94.

Intrathecally delivered drugs have a greater effect at smaller doses than intravenously delivered drugs. AR 10779. When asked if toxic drugs have a different effect on the spine when introduced intrathecally instead of intravenously, Smith replied that was beyond his level of knowledge. AR 10779.

Smith rejected Wallace’s assertion that his dosing levels of intrathecal fentanyl were excessive and below the standard of care. AR 10990-91. If the Board permits him to work on intrathecal pumps in the future, he will not decrease the dosage. AR 10991. He also rejected Wallace’s opinion as to the use of intrathecal ketamine in pumps. AR 10991. If the Board permits him to work with intrathecal pumps, he will continue to use ketamine in those pumps. AR 10991.

Smith contested Wallace’s assertion that his failure to obtain a psychological evaluation for Patients A-C fell below the standard of care. AR 10991-92. Smith did get psychological clearance for Patients A and B. AR 10992. Psychological evaluations are not required, but he has gotten them for every patient in the last 4-5 years if the trial pump was successful. AR 10992.

He has been restricted from using intrathecal pumps for a little bit more than a year. AR 11041. The Board has communicated directly with Smith to tell him he can probably return to treating patients with intrathecal pumps within the next couple of weeks. AR 11041.

Smith’s counsel argued against discipline prohibiting him from advising on the use of intrathecal pumps. AR 11495. For example, if Smith wanted to teach, such discipline could keep him from teaching about the use of intrathecal pain pumps. AR 11495. This raises serious First Amendment issues relative to the desired probation term. AR 11495.

On November 9, 2021, ALJ Levy issued a proposed decision for the 2020 Accusation. AR 9773-860. The proposed decision concluded Smith had departed from standards of care through his (1) use of ketamine and excessive use of fentanyl in intrathecal therapy, (2) failure to obtain psychological evaluations for Patients A-B before proceeding with pump implantation or for Patient C before scheduling her for a trial pump, and (3) failure to correctly program the pumps for two of the patients. AR 9774. He also failed to maintain adequate records and engaged in unprofessional conduct. AR 9774. To protect the public, the proposed decision prohibited Smith from performing intrathecal therapy or advising other medical providers regarding intrathecal therapy. AR 9774. This prohibition would run concurrently with the probation imposed under the 2020 Decision. AR 9774.

The proposed decision referred to the 2020 Decision and identified the performance of intrathecal therapy procedures as an issue in both the 2020 Decision and the instant matter. AR 9775-76.

Patient A had suffered from depression since she was an adolescent. AR 9779. Patient A’s signed intake documents from December 2016 included a patient authorization form permitting Smith to obtain psychotherapy notes from Patient A’s clinical psychologist. AR 9779. Smith never obtained those notes. AR 9779.

A May 2, 2017 operative procedure report documented that Patient A had undergone psychological testing and was cleared to proceed with the pump trial. AR 9780. This report did not identify who conducted the testing or when. AR 9781. Smith testified that he talked to Patient A’s psychiatrist after the pump trial, not before. AR 9781. The ALJ concluded that the operative procedure report was inaccurate. AR 9781.

Smith surgically implanted the intrathecal tube on June 13, 2017. AR 9782. Between that date and August 2017, the pump’s programmed drug concentration was higher than the actual concentration. AR 9782. Wallace testified that if a third-party doctor had interrogated the pump during this time, he could have prescribed a drug that would have caused Patient A to overdose. AR 9783. On August 30, 2017, Smith corrected the initial concentration and current pump rate programmed into the pump, but he did not note the corrections in Patient A’s records. AR 9783, 9787.

Although Patient A’s pain levels often decreased from June to August 2017, Smith often increased the fentanyl dosage without explanation. AR 9783-86. By the end of 2017, Smith had increased the fentanyl dosage 14 times despite improvement in her reported pain levels. AR 9790. The rate of intrathecal ketamine remained constant throughout. AR 9790.

On March 2, 2018, Patient A experienced excruciating pain when she put her full weight on her right leg. AR 9791. At the University of California San Diego Medical Center (“UCSD”), several doctors noted she was on a on a very high-dosage intrathecal therapy opioid regimen and was opioid tolerant. AR 9791-92. They fine-tuned pain management during her hospital stay with the administration of opioids and ketamine. AR 9792.

Less than an hour after her March 30, 2018 refill at Smith’s office, Patient A suffered from acute drug overdose. AR 9792. Her husband called 911, and EMTs administered Narcan to revive her. AR 9793. She was admitted to UCSD for observation, where one physician determined that a small amount of fentanyl had been subcutaneously deposited during the refill. AR 9793. Because her intrathecal therapy dosages were incredibly high, a risk of overdose and death was present with every refill. AR 9793. The hospital pain management physician told Patient A that she had enough fentanyl in her pump to kill everyone in the emergency room. AR 9793-94.

Wallace identified four ways in which Smith departed from applicable standards of care in his treatment of Patient A. AR 9799. Smith incorrectly programmed Patient A’s initial drug concentrations, failed to have her undergo psychological evaluation to see if she was an appropriate candidate for intrathecal therapy, administered excessively high dosages of fentanyl, and administered ketamine in the pump. AR 9799.

As to the programming error, inaccurate concentrations can lead to an overdose or underdose if another institution must refill the pump. AR 9799. Because the error would have led to overdose and harm in Patient A’s case, this was an extreme departure from the standard of care. AR 9799.

The standard of care requires psychological evaluation of any patients identified for intrathecal therapy. AR 9799. This evaluation identifies any psychosocial barriers that might prevent a successful outcome. AR 9799-800. The PACC guidelines recommend this, and other intrathecal therapy specialists widely accept it as necessary. AR 9800. Intrathecal therapy is a highly invasive and expensive therapy, and it requires a lot of healthcare reliance by the patient. AR 9800. The physician “marries” the patient. AR 9800. He therefore should first ensure the patient will be reliable, be psychosocially stable, and have realistic expectations as to the outcome. AR 9800.

Nothing in Patient A’s records suggested she underwent psychological testing. AR 9800. Wallace dismissed Smith’s statement in the May 2, 2017 operative procedure report that she had psychological testing. AR 9800. Patient A’s depression by itself was not a contraindication for intrathecal therapy. AR 9800. However, Patient A’s reported depression, her management thereof through medication, and her mother’s mental health history made it important that Patient A undergo psychological evaluation before even the pump trial. AR 9800-01. The failure to conduct this evaluation was an extreme departure from the standard of care. AR 9800.

For intrathecal dosages, the standard of care requires use of small dosages in intrathecal therapy because the drug is targeted for delivery in the spinal cord. AR 9801. Fentanyl is also 100 times more potent than morphine, and a small amount outside the pump can pose a risk to the patient. AR 9801. The dosages of fentanyl used for Patient A reflect an extreme departure from the standard of care. AR 9801. Wallace has never seen anyone administer the dosages at issue here via intrathecal pump, and treatment should not start with fentanyl as the driver drug. AR 9801. This excessive dosage caused harm on March 30, 2018, when a small amount administered outside the pump pocket caused Patient A to overdose. AR 9801-03.

Although there is no known upper limit to intrathecal use, there is still a limit based on clinical judgment. AR 9802. Smith’s decision to start Patient A on a high amount of fentanyl and titrate her further up without explanation raises doubts as to his clinical judgment. AR 9802-03. Patient A never had the chance to see if a lower dosage would have improved her pain level and allowed her to better function. AR 9802-9803.

For the use of ketamine, the standard of care requires that the physician uses safe drugs for intrathecal therapy. AR 9803. The safety of ketamine is not a “gray area” because it is toxic to the spinal cord. AR 9803-04. One study expressed concern for the long-term effects of its use in intrathecal therapy. AR 9804. It cited a postmortem of a cancer patient who underwent ketamine intrathecal therapy and had holes in his spinal cord. AR 9804. Its toxicity to dogs and sheep prompted the Food and Drug Administration to suspend clinical trials in humans. AR 9804. Wallace was aware of only two case reports where ketamine was used in intrathecal therapy, and both were cancer patients where more aggressive pain management treatments may be warranted. AR 9805. A study cited in Berger’s report supports the conclusion that there are long-term safety concerns with ketamine use in intrathecal therapy. AR 9805. None of the other articles Berger cites mention ketamine. AR 9806.

The Centers for Medicare & Medicaid Services (“CMS”) has authorized ketamine’s use in intrathecal therapy via local coverage determination (“LCD”). AR 9805. However, the LCD does not establish the standard of care. AR 9805. The use of ketamine in intrathecal therapy represents an extreme departure from the standard of care. AR 9804.

Berger has performed medical-legal evaluations and has served as a consultant for the Board. AR 9806. He has coauthored many published papers and abstracts on pain management through 2021. AR 9807. He has served as a consultant for the Board. AR 9806. He was one of the earliest implanters of intrathecal pumps in the 1980s and has implanted 40-50 pumps, three or four of them with ketamine. AR 9807.

Berger asserted that Smith’s programming error was a simple departure from the standard of care, not an extreme one. AR 9808. His report states the dosage discrepancies were small and would not have caused harm to Patient A. AR 9812.

Berger asserted that Smith did not deviate from the standard of care as to the other three issues. AR 9808. There is disagreement in the pain management community as to whether a psychological evaluation is necessary before intrathecal therapy. AR 9808. Smith did not need one for Patient A before the trial pump. AR 9808. Berger conceded the standard of care may require a psychological evaluation based on a patient’s presentation. AR 9808. If so, the physician still decides what to do with this information. AR 9808. He does not need it to “clear” the patient for intrathecal therapy. AR 9808.

Berger’s report noted that Patient A was under the care of a psychiatrist and a therapist. AR 9808. This suggests that Berger believed that any need for a psychological evaluation was obviated. AR 9808. No documentation supports that Patient A had such care and Berger admitted that his understanding that Patient A was under the care of a psychiatrist and a psychologist from his conversation with Smith. AR 9808-09.

For fentanyl dosages, PACC’s 2017 guidelines state that the patient’s physician and good clinical judgment should guide individual patient care. AR 9809. As long as the physician documents his reasoning for the dosage, his judgment cannot be questioned. AR 9809. Physicians can go beyond consensus guidelines because it is appropriate, and they are familiar with what they are doing. AR 9809.

Physicians use clinical judgment when they find the appropriate dosage level based on the patient’s response to the current dose. AR 9810. They start with one or two drugs and slowly increase the dosage or number of drugs as they monitor the patient. AR 9810. If the patient does not respond to one drug, the physician may replace the drug or add a second one. AR 9810.

Smith correctly treated Patient A through a pump trial of fentanyl. AR 9810. Based on her response, he then decided to implant the intrathecal pump with a similar concentration. AR 9810. Smith slowly increased the dosage to find the best possible relief without side effects. AR 9811. He knew the concentrations were high, but he monitored Patient A carefully. AR 9811. He saw her regularly and adjusted her dosage based on her description of her condition and her consent to the increase. AR 9811. The dosage gave significant pain relief and allowed Patient A to return to ADLs. AR 9811.

Finding the appropriate fentanyl dosage is not an exact science and there is no maximum dose of fentanyl for intrathecal therapy. AR 9810. The maximum dosage in intrathecal therapy is the dose that provides relief without side effects. AR 9810. Intrathecal therapy delivers the medication into the intrathecal sac so that it contacts the spinal cord. AR 9810. This reduces the impact on the body’s system compared to delivery of the drug systematically. AR 9810.

For ketamine, Berger opined that its use in intrathecal therapy should not be strictly prohibited. AR 9811. Studies disagree on whether it is neurotoxic in low dosages, and Berger does not believe it is. AR 9812. Ketamine enhanced fentanyl’s effect for Patient A without requiring a higher dosage of fentanyl. AR 9811-12. This combined therapy provided the best relief with minimal side effects. AR 9812.

Berger recognized that there is debate regarding ketamine’s neurotoxicity at low doses. AR 9812. His report was not as certain as his testimony about whether the use of ketamine is within the standard of care. AR 9812. He wrote that Smith’s use of ketamine at low dosages “does not appear” to have departed from the standard of care. AR 9812. This contrasts sharply with the certainty he expressed in his testimony. AR 9812.

When Smith first saw Patient B, she had been under the care of a psychiatrist for many years. AR 9813. Her medical history included schizophrenia, a history of opioid abuse, anxiety, depression, spinal injury, and traumatic brain injury secondary to domestic abuse. AR 9813. Smith knew Patient B likely engaged in opioid abuse and overdosed based on her response to Narcan. AR 9814. Despite this, he did not discuss with Patient B whether she should undergo psychological evaluation before considering her for a pump trial. AR 9814.

Smith implanted an intrathecal pump in Patient B on December 17, 2015. AR 9817. Smith submitted a barely legible handwritten note as evidence. AR 9817. He asserted that this note was written by Laurence Saben, M.D. (“Saben”) and that it cleared Patient B for the procedure. AR 9817. This note was not in Saben’s records for Patient B. AR 9817. Nor is it among the records for Patient B initially submitted by Smith as Patient B’s complete records. AR 9818.

Smith increased Patient B’s fentanyl dosage across multiple visits in 2016. AR 9819-20. During a March 2017 refill, Smith added ketamine to the medication formula without explanation. AR 9823. Smith concedes that he programmed the pump incorrectly on that date. AR 9823.

On August 10, 2017, Smith signed a letter discharging Patient B from this care, effective the same day. AR 9824.

Wallace identified the same departures from the standard of care as with Patient A. AR 9824. The programming error was an extreme departure from the standard of care. AR 9824. It likely would have led to drug overdose if someone had used the drug concentrations programmed into the pump. AR 9824.

The standard of care required Patient B to undergo psychological evaluation before Smith selected her for intrathecal therapy. AR 9824-25. Her mental health history and her history of drug use made this especially important. AR 9825. She had previously overdosed and had a history of opioid abuse. AR 9825. She had traumatic brain injury with cognitive impairment, severe mental health disturbances, schizophrenia, and major depression. AR 9825. She complained during her pump trial of swelling, paralysis, and worsening of her schizoaffective symptoms. AR 9825.

Intrathecal therapy only succeeds if the patient has such mental health conditions under control. AR 9825. Based on Patient B’s history, Smith needed hand-to-hand participation of a therapist to even consider intrathecal therapy. AR 9826. He also should have determined whether Patient B was even psychologically able to have a pump. AR 9826.

Nothing in the record suggested that Saben evaluated Patient B before the trial or pump implantation. AR 9826. Assuming Saben wrote the note, a psychological evaluation is required, not just a clearance to proceed with the intrathecal therapy. AR 9825-26. The evaluation should provide information about the physical and mental aspects of the patient’s pain. AR 9825. The note does not provide the information Smith needed to assess Patient B’s psychosocial state and decide whether to proceed with her intrathecal therapy. AR 9825-26. The failure to subject Patient B to psychological evaluation was an extreme departure from the standard of care. AR 9825.

For the fentanyl dosage, Wallace reiterated the doses exceeded those for cardiac anesthesia and were extreme for intrathecal therapy. AR 9827. The starting daily rate of 1.997 mg was very high and unjustified, and the rate increase to 7 mg per day was also high. AR 9827. As for ketamine, Wallace again asserted that its use in intrathecal therapy is an extreme departure from the standard of care. AR 9827.

Berger again asserted that Smith’s programming error was only a standard departure from the standard of care. AR 9829. The difference in concentration was not so extreme as to make a huge difference in the pump output. AR 9829. As with Patient A, Berger asserted the other three issues do not reflect a departure from the standard of care. AR 9827-28.

Because Patient B’s medical records twice note she had both a psychiatrist and a therapist, Smith did not need a psychological evaluation before the pump trial. AR 9828. Active mental illness is not a contraindication for intrathecal therapy. AR 9828. The pain management doctor himself judges whether a patient is an appropriate candidate based on their interactions and the patient’s answers to questions the doctor chooses. AR 9828.

Berger recognized the importance of psychological evaluation for some patients before intrathecal therapy. AR 9828. Paradoxically, he also minimized the importance of psychological evaluation for any patient. AR 9828.

Smith exercised sound clinical judgment in fentanyl dosing. AR 9828. He closely monitored and followed Patient B. AR 9828. Her pain levels improved, she was able to do her ADLs, and she even transitioned to an independent living facility. AR 9828.

For the use of ketamine in intrathecal therapy, Berger reiterated the same arguments that it does not breach the standard of care as for Patient A. AR 9829.

On March 20, 2018, Patient C asked to discuss a treatment plan for her back and knee pain. AR 9830. The medication regimen she used to address her back and knee pain was completely ineffective. AR 9830. Smith changed her prescription to an opioid. AR 9830. As Smith left the exam room, Patient C said that the new medication would not be effective. AR 9830. She said her only options were to overtake medications or commit suicide. AR 9830. Whether Smith ever learned about these comments was unclear. AR 9831.

Smith recommended an intrathecal pump trial for April 24, 2018. AR 9831. Smith did not document discussing with Patient C her threat of suicide, or the need to obtain a psychological evaluation before the trial. AR 9831.

On April 6, Patient C returned and asked for a refill of her medication. AR 9831. She said that she overused the medication because it was ineffective. AR 9831. This was 13 days before her medication should have run out, and the second time she had run out early. AR 9831. Smith informed Patient C that her option was to undergo the intrathecal pump trial on April 9, 2018. AR 9831. Patient C agreed. AR 9831.

On April 18, Patient C told Smith she did not want to go through with the pump trial because the possible complications outweighed the benefits. AR 9831. Smith refused to prescribe more oral medication because she was non-compliant with the treatment plan. AR 9832.

Wallace testified that Smith’s failure to obtain a psychological evaluation was an extreme departure from the standard of care. AR 9832. Patient C exhibited several red flags. AR 9832. She was on high doses of opioids with little pain control, and she was non-compliant with the prescribed opioid use. AR 9832. Smith was pushing her into intrathecal therapy. AR 9832.

Berger reiterated that the standard of care does not require a psychological evaluation. AR 9833. Smith also did not pressure Patient C into having the pump. AR 9833. She had time to consider whether it was appropriate for her. AR 9833.

Smith testified that Patients A-C all tried many pain therapy modalities before intrathecal therapy. AR 9834. He does not rush his patients to intrathecal therapy and the trial pump is simple and minimally invasive. AR 9834. It allows him to adjust the dosages whereas a permanent pump is better for fine tuning drugs. AR 9834.

Smith agreed that implanting a pump is akin to marrying the patient and raises the patient’s dependency on the physician. AR 9834. The process is a collaboration. AR 9834. He talks to his patients to see if he should increase the rate. AR 9834. He does if the patient is improving without any red flags. AR 9834.

Patient A’s overdose happened because a drop of fentanyl entered her system subcutaneously during the refill, which is rare. AR 9835. The extra drop caused a change or decrease in Patient A’s consciousness, but she did not lose consciousness. AR 9835. (Hospital records confirm that Patient A did lose consciousness. AR 9835.) Patient A wanted to continue intrathecal therapy even after this incident. AR 9835. She remains Smith’s patient to this day. AR 9835.

Smith disagreed with Wallace’s assertion that trial pump therapy caused Patient A’s opioid dependence and withdrawal. AR 9836. Her dependency was caused by her fentanyl patches and oral medication. AR 9836.

Smith felt that Patient B was an excellent candidate for a pump because it allowed for the delivery of pain medication without taking oral medications with possible abuse. AR 9839. He recognized that Patient B presented a challenge, and he obtained a psychological clearance from Saban. AR 936-37.

For the use of ketamine, his own research did not reveal its spinal cord toxicity in 2015 and 2016. AR 9838.

Smith has complied with the terms of his probation. AR 9839. He completed the Clinical Competence Assessment Program required by the probation terms of the 2020 Decision. AR 9840. He can now perform surgical procedures related to intrathecal pumps. AR 9840.

Complainant’s counsel argued that Wallace is a leading expert in intrathecal therapy and has published extensively in the field, while Berger’s intrathecal therapy experience is limited. AR 9841. Berger has never published on the subject. AR 9841. Berger’s testimony also raised doubt as to his credibility because actual harm is not required to demonstrate an extreme departure from the standard of care. AR 9841. Complainant requested the Board to prohibit Smith from practicing intrathecal therapy during the remainder of his probation imposed by the 2020 Decision. 9841.

Smith’s counsel responded that there is no consensus as to fentanyl dosages and the evidence is not clear as to the standard of care. AR 9841. He monitored Patients A and B and adjusted their doses based on their responses to current doses. AR 9841. He talked to Patient A’s psychiatrist and simply failed to document it. AR 9842. There is no evidence that Patient B is schizophrenic. AR 9842. CMS permits the use of ketamine in intrathecal therapy. AR 9842. The programming error was a simple departure from the standard of care, not an extreme one. AR 9842. Smith also argued that no purpose would be served by imposing discipline as he is already on probation and revocation of his license would not serve any purpose either. AR 9842.

Complainant replied that, while there is no known upper limit for fentanyl dosing in intrathecal therapy, Wallace did not rely only on the consensus guidelines for his opinion on the fentanyl dosages. AR 9842-43. Smith also did not want to accept responsibility for the programming errors, which were an extreme departure from the standard of care because they could have led to incorrect dosing of the patients. AR 9843. This action was not a do-over of the discipline under the 2020 Decision; the only shared issue between the cases was the programming error. AR 9843.

The 2020 Accusation’s first and second causes allege gross and simple negligence for Patients A-B and gross negligence for Patient C. AR 9844-45. To the extent that Smith committed acts of gross negligence for Patients A-B, he also committed repeated negligent acts. AR 3692, 9844.

The 2020 Accusation alleges gross negligence based on Smith’s failure to obtain psychological evaluations before implantation of intrathecal pumps in Patients A-B and before scheduling Patient C for a pump trial. AR 9844. Wallace’s assertion that this was an extreme departure from the standard of care is persuasive. AR 9844. He testified the standard of care requires such evaluation before implantation of a pump or use of a trial pump. AR 9844. This allows the doctor to ensure the patient has both the psychosocial stability to follow up with care and realistic expectations of the goals of pain management. AR 9844.

All three patients had mental health issues that required an evaluation before any intrathecal therapy. AR 9844. Patient A suffered from, and was undergoing treatment for, depression. AR 9844. Patient B had a history of serious mental illness and had overdosed on methadone. AR 9844. Patient C had history of anxiety and sleep problems, had overused opioid pain medications, was opioid dependent, and threatened to kill herself if Smith did not refill her medication. AR 9844-45. Smith did not obtain psychological evaluations for any of these patients. AR 9845.

No evidence substantiates the assertion that Saben wrote the scribbled note about Patient B. AR 9845. Even if he did, the note was worthless because it does not contain information to identify Patient B’s psychosocial state. AR 9845. Smith asserted that Patient C did not need psychological evaluation before intrathecal therapy because she did not proceed with the trial. AR 9846. This ignores the standard of care, which Wallace stated requires a psychological evaluation before proceeding with intrathecal therapy. AR 9846.

Wallace’s testimony was more persuasive than Berger’s testimony that the dosages of fentanyl for Patients A and B were excessive. AR 9846. Wallace had more extensive experience as an intrathecal therapy practitioner, and he was familiar with the current state of relevant research. AR 9846. Nothing in Berger’s CV suggested that he performs or has published on intrathecal therapy and his experience in the practice is limited. AR 9847.

Wallace testified that the standard of care requires small dosages because the drugs are delivered directly into the spinal cord. AR 9847. A small amount outside the pump can be dangerous, and Patient A’s overdose proves that. AR 9847. Wallace has never seen the levels of fentanyl administered to Patients A and B used in any other intrathecal pump. AR 9847. The doses were akin to those in cardiac anesthesia. AR 9847.

Wallace also testified that Smith’s clinical judgment was lacking. AR 9847. Smith never explained why he started Patients A-B on those dosages and increased them even when the patients showed good improvement. AR 9847. Berger testified that no one can question a pain management doctor’s decision if he documents the appropriateness of the dosage level in his thought process, but Smith never did so. AR 9847-48.

As for ketamine, Wallace’s testimony that its use was an extreme departure from the standard of care was persuasive. AR 9848. He based this opinion on his extensive and up to date knowledge of studies and case reports in this area. AR 9848. Even a study Berger cited supports this conclusion. AR 9848.

Wallace’s testimony was again more persuasive on whether the failure to correctly program the pumps constitutes a normal or extreme departure from the standard of care. AR 9848. This failure could have caused another physician to either overdose or underdose the patient based on the inaccurate concentration levels. AR 9848. Contrary to Berger’s testimony, actual patient harm is not a prerequisite to finding a departure is extreme. AR 9849.

The third cause for discipline alleged committed repeated acts of clearly excessive prescribing drugs or treatment to Patients A-B. AR 9849. Wallace’s testimony that Smith excessively prescribed fentanyl was more persuasive than Berger’s testimony that he did not. AR 9849. Smith’s failure to document the reason for the dosages supports this conclusion. AR 9849.

The fourth cause for discipline alleged a failure to maintain adequate and accurate records for Patients A-B. AR 9849. Smith failed to document the reasons for the selected dosages of fentanyl and ketamine. AR 9849. He did not document why he reduced Patient B’s fentanyl dose rate by half. AR 9849-50. His documented programming of both pumps was also inaccurate. AR 9850.

The fifth cause for discipline alleged unprofessional conduct. AR 9850. The findings for the other causes support a conclusion that Smith committed unprofessional conduct. AR 9850.

License revocation is not necessary to ensure public protection. AR 9858. A probationary period to run concurrently with Smith’s existing probation, with the added prohibition on intrathecal therapy practice, would ensure public protection. AR 9858.

Smith’s misconduct was serious and exposed Patients A-B to actual harm, particularly when Patient A overdosed during her refill. AR 9858. He excessively administered fentanyl to both patients and increased the dosage even when they reported improvements in pain levels and function. AR 9858. He also administered ketamine, which may be neurotoxic, and did so without documenting the reason. AR 9858. He never obtained psychological evaluations for his three patients despite evidence that all three suffered from problems that raised concerns as to psychological stability. AR 9858. His programming errors regarding drug concentration in the pumps alone also would warrant serious discipline. AR 9859.

Several mitigation factors existed. AR 9859. Smith complied fully with the terms of his probation, including monitoring and his completion of a Clinical Competence Assessment Program. AR 9859. He credibly asserted that he is committed to improved recordkeeping and has made changes to his practice to prevent future programming errors. AR 9859. Smith also was attentive and closely followed Patients A-C during their treatment. AR 9859.

The ALJ’s proposed decision revoked Smith’s license, stayed the revocation, and placed him on probation for the same duration as under the 2020 Decision. AR 9859. In addition to the existing probation terms, Smith was prohibited from performing any patient treatment involving the use, management, or surgical procedure related to intrathecal pumps. AR 9859-60. He also was prohibited from advising any medical provider on the care or treatment of patients involving the use, management or any surgical procedure related to intrathecal pumps. AR 9860.

The Board adopted the ALJ’s proposed decision as the 2021 Decision on December 22, 2021, with an effective date of January 21, 2022. AR 9772.

On January 12, 2022, Smith file a petition for reconsideration of the 2021 Decision. AR 3709. The Board denied the petition for reconsideration by operation of law. AR 9866.

Petitioner Smith argues that (1) the Board’s 2021 Decision amends the 2020 Decision that was set aside and is void, (2) the Board abused its discretion where it imposed an unconstitutional gag order and imposed an illogical practice restriction, and (3) these restrictions were not supported by the weight of the evidence.

Smith argues that the 2021 Decision based its conclusions on his fitness to practice medicine and terms of discipline on the 2020 Decision which Judge Beckloff set aside. The 2021 Decision expressly made its duration and effectiveness concurrent with the 2020 Decision. When the 2020 Decision was set aside, all discipline under that Decision necessarily ended as a matter of law, including the discipline grafted onto it by the 2021 Decision. Therefore, the 2021 Decision is void as a matter of law and must be vacated. Smith’s counsel warned the Board about the potential for such a result at the hearing on the 2020 Accusation, particularly since the 2020 Decision was before this court for review at the time. Pet. Op. Br. at 6; Reply at 3-4.

Smith acknowledges that there is an apparent absence of authority on the question of what happens to a disciplinary decision that appends itself to a prior decision. He analogizes the Board’s decisions to the legal framework for civil judgments. If the Board’s 2020 Decision is treated as a judgment and the 2021 Decision is treated as an amendment of that judgment, the Board’s error becomes legally apparent. Vacating a judgment leaves “the case ‘at large’ for further proceedings as if it had never been tried, and as if no judgment had ever been rendered.” 9 Witkin, California Procedure, (5th ed. 2008), §869; see Weisenburg v. Cragholm, (1971) 5 Cal. 3d 892, 896.

By analogy, when Judge Beckloff set aside the 2020 Decision, it was as if that Decision had never been made. Therefore, the 2021 Decision, which relied upon and was appended to the 2020 Decision, likewise had never been made. Pet. Op. Br. at 6-7. While this court in Smith II viewed (without conclusively finding) the 2022 Decision as effectively a decision after non-adoption of the 2020 Decision, the 2022 Decision did not mention or revive the 2021 Decision. Consequently, the 2021 Decision must be set aside. Reply at 5.

Smith’s analogy is defective. First, the 2020 Decision was not a civil judgment; it was an administrative decision not governed by the law of procedure for civil actions. There is no reason to believe that the law concerning judgments has any bearing on the analysis of the 2020, 2021, and 2022 Decisions.

Second, and more important, the 2021 Decision never purported to be an amendment to the 2020 Decision. The 2021 Decision was made after a hearing on the 2020 Accusation and its allegations concerning Smith’s treatment of three patients, whereas the 2020 Decision was made after a hearing on the 2019 Accusation its allegations concerning the treatment of five different patients.[3] The 2020 Decision specifically concerned Smith’s overprescription of pain medication to his chronic pain patients. In contrast, the Board’s 2021 Decision describes the nature of Smith’s misconduct concerning his intrathecal therapy for the three patients at issue.

While Smith is correct that the 2021 Decision ordered that the probation imposed would run concurrently with the probation imposed in the 2020 Decision, and that the 2020 Decision was set aside in Smith I, the Board imposed probation and a prohibition of intrathecal therapy in the 2021 Decision because Smith’s conduct represented a danger to patients based upon the evidence in this case. In ordering the practice restriction, the ALJ emphasized that Patient A had suffered actual harm where she lost consciousness after her intrathecal therapy pump was filled with a high dosage of fentanyl at Smith’s clinic and had to be revived by paramedics with Narcan and taken by ambulance to UCSD’s Emergency Department.[4] Opp. at 13.

The 2021 Decision summarized Smith’s prior discipline from the 2020 Decision as a seven-year probation effective August 25, 2020, with terms including a prohibition from performing intrathecal pain procedures until Smith had completed a clinical competence course. AR 9775. The 2021 Decision noted that Smith testified at hearing that he “completed the clinical competence assessment course and can now perform surgical procedures related to intrathecal pumps.” AR 9840. Nothing in these references made the 2021 Decision an amendment of the 2020 Decision. Opp. at 14.

Nor did the 2021 Decision tie Smith’s probation term to the 2020 Decision. Rather, the 2021 Decision tied the probation to Smith’s Administrative Case No. 800-2015-013651, which at the time was a seven-year probation. AR 9859. The 2020 Decision was set aside in Smith I, but the 2022 Decision placed Smith on probation for Case No. 800-2015-013651 for five years retroactive to September 24, 2020. Rifat Decl., ¶4, Ex. A, p. 86-98. The 2022 Decision and its five-year probation was upheld in Smith II. Thus, Smith’s probation in Case No. 800-2015-013651 is five years and the concurrent probation from the 2021 Decision (Case No. 800-2018-042234) is for the same period, ending on September 24, 2025. See Ex. A, pp. 86-98; AR 9859.

In sum, the 2021 Decision – which concerned different patients and different misconduct than the 2020 Decision -- merely cited the prior discipline in the 2020 Decision and incorporated the probation in Case No. 800-2015-013651, which started as seven years but was reduced to five years. This is an incorporation by reference, not a “symbiotic appendage” that died when the 2020 Decision was set aside. See Reply at 3. The 2021 Decision stands alone, and its period of probation and disciplinary order are legally enforceable. See Opp. at 14.

2. The 2021 Decision Does Not Impose an Unconstitutional Gag Order and Was a Legitimate Exercise of the Board’s Authority

Smith notes that the 2021 Decision added a probationary term that prohibits him from performing intrathecal therapy, including a restriction on advising medical providers:

“[Smith] is prohibited from . . . advising any medical provider on the care or treatment of patients involving the use, management, or any surgical procedure related to intrathecal pumps for the duration of his probation [resulting from the 2020 Decision].” AR 9859-60.

Smith argues that this gag order is plainly unconstitutional and requires that the 2021 Decision be set aside. Smith’s counsel warned the Board about making such an order: “I think there’s some serious constitutional, particularly First Amendment issues, relative to that desired probation term.” AR 11495.

Smith relies on the Ninth Circuit case of Conant v. Walters, (“Conant”) (9th Cir. 2002) 309 F.3d 629. Pet. Op. Br. at 7. In Conant, California and Arizona had passed medical marijuana initiative authorizing the use of marijuana for seriously ill patients and protecting physicians who recommended it. Id. at 632. In response, the federal government adopted a policy that a doctor’s recommendation of the use of “medical marijuana” was not in the public interest as reflected by the federal Controlled Substances Act and any doctor who made such a recommendation could have his or her registration to prescribe controlled substances revoked. Id. The Department of Justice and Department of Health & Humas Services later sent a letter to national, state, and local physician associations cautioning that physicians who “intentionally provide their patients with oral or written statements in order to enable them to obtain controlled substances in violation of federal law . . . risk revocation of their DEA prescription authority.” Id. at 633. The trial court issued an injunction against the federal government either investigating or revoking a physician’s registration to issue controlled substances where the government’s action is based solely the physician’s recommendation of the use of medical marijuana. Id. at 632.

In upholding the district court’s injunction, the Ninth Circuit stated that the government policy struck at the core First Amendment interests of doctors and patients, whom have an imperative need for confidence and trust. Id. at 636. An integral component of the practice of medicine is the communication between a doctor and a patient, and physicians must be able to speak frankly and openly to patients as reflected by the common law doctor-patient privilege. Id. Being a member of a regulated profession does not result in a surrender of First Amendment rights. To the contrary, professional speech may be entitled to “the strongest protection our Constitution has to offer.” Id. at 637 (citations omitted).

The government policy sought to punish doctors based on the content of their communications with patients. Id. at 637. It did not merely prohibit the discussion of marijuana; it condemned a particular viewpoint about marijuana, and the condemnation of particular views is especially troubling in the First Amendment context. Id. “When the government targets not subject matter but particular views taken by speakers on a subject, the violation of the First Amendment is all the more blatant.’….Indeed, even content-based restrictions on speech are ‘presumptively invalid.’” Id. (citations omitted).

To survive First Amendment scrutiny, the government’s policy must have narrow specificity, but the government was unable to articulate exactly what speech was proscribed. Id. at 639. Whether a doctor patient discussion of medical marijuana constitutes a “recommendation” depends on how the patient interprets the doctor’s words, which is not permissible under the First Amendment. Id. (citations omitted). The court stated that its decision is consistent with principles of federalism that leave states as the primary regulators of professional conduct. Id. (citations omitted).

Relying on Conant, Smith concludes that, if restrictions on physician-patient communications are an unconstitutional infringement on speech, certainly the 2021 Decision’s restriction on his ability to advise medical providers on the intrathecal therapy modality is unconstitutional. The 2021 Decision does not merely restrict Smith from providing treatment recommendations to patients as in Conant and lacks narrow specificity because it prohibits him from “advising any medical provider” about the modality. The 2021 Decision’s discipline was not based on evidence of incompetent advice to other medical providers. The scope of this gag order is breathtaking because it not only precludes Smith from providing treatment recommendation to patients but also from referring his intrathecal therapy patients to other physicians to ensure the continuity of their care. It further prohibits Smith from advising those referral physicians about the history of a patient’s intrathecal therapy treatment and its rationale. It also prohibits Smith from teaching about a modality that he has used for more than three decades and from publishing any case studies or other research concerning the modality. Pet. Op. Br. at 8-9.[5]

Smith adds that the Supreme Court more recently issued an instructive decision in National Institute of Family and Life Advocates v. Becerra, (“NIFLA”) (2018) 585 U.S. ___, 138 S. Ct. 2361. In NIFLA, the Supreme Court, considered a First Amendment challenge to the California Reproductive Freedom, Accountability, Comprehensive Care, and Transparency Act (“FACT Act”), which regulated pro-life centers that offer pregnancy-related services. Id. at 2365. Licensed clinics were required notify women that California provides free or low-cost services, including abortions, and give them a phone number. Unlicensed clinics were required to notify women that California had not licensed the clinics to provide medical services. Id. The Ninth Circuit affirmed the denial of a preliminary injunction against enforcement of the FACT Act, concluding that the licensed notice survived a lower level of scrutiny applicable to the regulation of “professional speech” and that the unlicensed notice survived any level of scrutiny. Id.

The Supreme Court noted that First Amendment precedent distinguishes between content-based and content-neutral regulations of speech. Id. at 2371. As a general matter, content-based laws “are presumptively unconstitutional” and may be justified only if narrowly tailored to serve compelling state interests. Id. (citation omitted). The licensed notice was a content-based regulation, requiring a particular message. Id. Although the licensed notice was content-based, the Ninth Circuit did not apply strict scrutiny because it concluded that the notice regulates “professional speech.” Id. at 2371. The high court has not recognized professional speech as a separate category of speech. Speech is not unprotected merely because it is uttered by professionals. Id. at 2371-72. The Court’s precedents have afforded less protection to professional speech only in two categories: (a) laws that require professionals to disclose factual, non-controversial information in their commercial speech and (b) the regulation of professional conduct even though that conduct incidentally involves speech. Id at 2372. The required notice was not limited to “purely factual and uncontroversial information about" services. Nor was it a regulation of professional conduct that incidentally burdens speech; it applied to all interactions between a covered facility and its patients, regardless of whether a medical procedure is ever sought. Id. The unlicensed notice also unduly burdened protected speech. Id. at 2377. Constraints on physician speech can extend “no broader than reasonably necessary.” Id. (citations omitted).

Smith argues that the probation term restraining him from advising any medical provider on the care or treatment of patients related to intrathecal pumps is constitutionally infirm and of such overbreadth as to be dangerous for his patients who cannot even be told about the intrathecal therapy modality’s availability in connection with a referral to another pain management provider. The Board had the ability to thoughtfully craft its discipline of Smith. If it had wanted to, the Board could simply have prohibited him from providing intrathecal therapy, at least temporarily until assured of his competence in the modality as it had done in the 2020 Decision. Given the binary outcome options given to the court by CPP section 1094.5(f) -- i.e., either to set aside the 2021 Decision or deny the writ -- the Board’s overstep is fatal to its discipline. CCP section 1094.5(f) offers no alternative but to set aside the 2021 Decision. Pet. Op. Br. at 10.

The Board relies (Opp. at 15) on Pickup v. Brown, (“Pickup”) (9^th Cir. 2014) 740 F.3d 1208, 1221, which held that a state law banning mental health providers from engaging in sexual orientation change efforts with patients under 18 did not violate free speech rights of doctors or patients. The law regulated professional speech for which First Amendment protections are somewhat diminished and the law did not require heightened scrutiny. Id. at 1227-28. At one end of a continuum, the First Amendment protection of a professional is greatest where he or she advocates a treatment that the medical establishment considers outside the mainstream, or even dangerous. Id. at 1227. At the midpoint of the continuum, within the confines of the professional relationship, the First Amendment tolerates a substantial amount of speech regulation within the professional-client relationship that it would not tolerate outside of it. Id. at 1228. The law in question was at the other end of the continuum, regulation of professional conduct, where the state’s power is greatest even though such regulation may have an incidental effect on speech. Id. at 1229. The law at issue regulated conduct, did nothing to prevent licensed therapists from discussing the pros and cons of sexual orientation change with patients and simply prevented mental health providers from engaging in it with minors. Id. This limited reach was lawful even though the treatment is performed through speech alone. Id. at 1230.

Based on Pickup, the Board argues that its 2021 Decision’s restriction regulates “professional conduct”, and any burden it imposes on Smith’s speech is incidental. The restriction is rationally related to a legitimate Board interest in fulfilling its duty under B&P Code section 2229, which provides that “[t]he Board has legal authority to place restrictions on a licensee’s scope of practice”, “order restrictions as are indicated by the evidence”, and “seek out those licensees who have demonstrated deficiencies in competency and then take those actions as are indicated…including further education, restrictions from practice…that will remove those deficiencies.” (emphasis added). Opp. at 15.

The Board argues that it is restricting a doctor on probation for negligent medical practice from advising medical providers (including nurses and physician assistants) on the care or treatment of patients for a specific area of medical practice where serious deficiencies in his knowledge have been established, and the practice restriction has been narrowly tailored to the evidence. Two physicians, Dr. Thompson and Dr. Rouff, testified for Smith. Both stated they managed intrathecal therapy pumps under Smith’s direct supervision at his clinic. AR 11119-24,11158-60. Both stated that they followed Smith’s treatment plan for intrathecal therapy pumps, and that he advised them on drug formulas, concentrations, calculations, and dosage levels of intrathecal fentanyl. Id. Dr. Thompson also testified that nurses frequently received instruction from Smith on the maintenance and filling of intrathecal therapy pumps at his clinic. AR 11125-29. This testimony shows that the Board’s restriction against advising other medical providers is rationally related to fulfilling its mandated duty of public protection. Opp. at 15-16.

Smith’s provision of intrathecal therapy is contrary to applicable standards of care. This was established by Wallace’s testimony, and he is a leading expert in this specialized area of medicine. Smith doubled down on his sub-standard practice when he testified that he would not change his dosage levels of intrathecal therapy fentanyl or his use of ketamine in intrathecal therapy pumps if permitted by the Board to continue the practice of intrathecal therapy. Because of its statutory duty of public protection, the Board has no choice but to prohibit him from advising other medical providers on intrathecal therapy. The Board cannot ignore the risk that will imperil the safety of patients if Smith continues to perform intrathecal therapy indirectly through nurses, physician assistants, or other doctors employed at his clinic. Opp. at 16.

The court agrees with the Board that it may impose subject matter restrictions on Smith’s professional speech. NIFLA noted that First Amendment precedent distinguishes between content-based and content-neutral regulations of speech and that content-based laws are presumptively unconstitutional and may be justified only if narrowly tailored to serve compelling state interests. 138 S. Ct. at 2371. (citation omitted). The high court added that speech is not unprotected merely because it is uttered by professionals (id. at 2371-72), but the Court’s precedents have afforded less protection to professional speech in two categories: (a) laws that require professionals to disclose factual, non-controversial information in their commercial speech and (b) the regulation of professional conduct even though that conduct incidentally involves speech. Id at 2372.

The Board is authorized to impose restrictions on Smith’s practice under B&P Code section 2229. The probation term restricting Smith from advising another medical provider about intrathecal therapy is a subject matter-based restriction and is based on Smith’s lack of competence with respect to intrathecal therapy. The restriction is part of the regulation of professional conduct where the state’s power is greatest, even though such regulation may have an incidental effect on speech. See Pickup, supra, 740 F.3d at 1229.

However, constraints on physician speech can extend “no broader than reasonably necessary.” NIFLA, supra, 138 S. Ct. at 2377 (citations omitted). Conant stated that the violation of the First Amendment is blatant when the government regulates particular views taken by speakers on a subject. 309 F.3d at 637 (citations omitted). To survive First Amendment scrutiny, the government’s policy must have narrow specificity. Id. at 639. The First Amendment protection of a professional is greatest where he or she advocates a treatment that the medical establishment considers outside the mainstream, or even dangerous. Pickup, supra, 740 F.3d at 1227.

When properly interpreted, the probation restriction on Smith’s professional speech is narrowly tailored. The restriction prohibits Smith from advising any medical provider on the care or treatment of patients involving the use, management or any surgical procedure related to intrathecal pumps. AR 9860.[6] The 2021 Decision concluded that “[p]ublic protection would be served if during the duration of his probation under Case No. 800-2015-013651 [Smith] is prohibited from performing intrathecal therapy or consulting with other providers regarding intrathecal therapy.” The term “consult” in the medical world has a common meaning of a consultation between medical providers about a particular patient’s ongoing or future care.

The court interprets the probation restriction against “advising” medical providers to mean that Smith cannot consult with other medical providers about ongoing or future intrathecal therapy for a particular patient. This interpretation fits well within the continuum referred to by Pickup and addresses the Board’s concern that Smith not continue to perform intrathecal therapy indirectly through nurses, physician assistants, or other doctors employed at his clinic. Smith is not proscribed, however, from referring a patient to another provider for intrathecal therapy. Contrary to Smith’s belief, the restriction also does prevent him from informing referral physicians about the history of a patient’s intrathecal therapy treatment. Nor does it prohibit Smith from teaching about intrathecal therapy or publishing case studies or other research concerning the modality.

To the extent that the prohibition could be interpreted more broadly, the court should interpret its scope to be narrowly tailored consistent with Smith’s First Amendment rights as articulated in NIFLA, Conant, and Pickup. As interpreted, the restriction does not violate the First Amendment.

3. The 2021 Disciplinary Decision Is Supported by the Weight of the Evidence

It is well settled that the purpose of license discipline is to protect the public, not to punish the licensee. See B&P Code §2229(a)-(c); Camacho v. Youde, (1979) 95 Cal.App.3d 161, 164. The propriety of a penalty imposed by an administrative agency is a matter in the discretion of the agency, and its decision may not be disturbed unless there has been a manifest abuse of discretion. Lake v. Civil Service Commission, (1975) 47 Cal.App.3d 224, 228; Borden v. Division of Medical Quality, (1994) 30 Cal.App.4th 874, 884. The policy consideration underlying this allocation of authority is the expertise of the administrative agency. Cadilla v. Board of Medical Examiners, (1972) 26 Cal.App.3d 961. “‘[T]he object of the Board’s discipline ‘is not to punish’ the physician, but ‘rather, ‘to protect the life, health and welfare of the people at large and to set up a plan whereby those who practice medicine will have the qualifications which will prevent, as far as possible, the evils which could result…In short, the purpose of discipline is to make the [physician] a better physician.’” Pirouzian v. Superior Court, (2016) 1 Cal. App. 5th 438, 446 (citations omitted);

“Although the Department's discretion with respect to the penalty is broad, it does not have absolute and unlimited power. It is bound to exercise legal discretion.…The discretion intended, however, is not a capricious or arbitrary discretion, but an impartial discretion, guided and controlled in its exercise by fixed legal principles. Harris v. Alcoholic Bev. Etc. Appeals Bd., (1965) 62 Cal. 2d 589, 594-95 (acts over eight-day period of serving beer to minors, serving wine to investigators, and serving beer to intoxicated person, although imputed to the licensee, were not of nature requiring license revocation). See also Magit v. Board of Medical Examiners, (1961) 57 Cal. 2d 74, 88 (in determining whether agency abused its discretion, trial court must consider all the circumstances, including that revocation of medical license would prevent medical doctor from being gainfully occupied in his profession).

Where the administrative burden of proof is clear and convincing evidence, the trial court must account for that standard of proof when exercising its independent judgment on the sufficiency of the evidence. Li v. Superior Court (Sacramento County), supra, 69 Cal.App.5^th at 865. The trial court must apply the principles of deference and presumptive correctness in the context of whether the findings are supported by clear and convincing evidence rather than a mere preponderance of the evidence. Id.

The court may not substitute its judgment on the proper penalty in place of the discretion of the administrative agency. Nightingale v. State Personnel Board, (1972) 7 Cal.3d 507, 515; Deegan v. City of Mountain View, (1999) 72 Cal.App.4th 37, 45. “If reasonable minds may differ as to the propriety of the penalty imposed, there has been no abuse of discretion. It is only in the exceptional case, when it is shown that reasonable minds cannot differ on the propriety of the penalty, that an abuse of discretion is shown.” Id. at 46-47 (citations omitted).

Smith notes that the 2021 Decision was based on care provided to Patients A-C between 2015 and 2018. AR 9777-95 (Patient A); AR 9812-23 (Patient B); AR 9829-31 (Patient C). The 2020 Decision was likewise based on care provided to patients between 2015 and 2018, or well-before that period. AR 3316-21 (Patient A between 2011-2017); AR 3338-63 (Patient B between 2011-2013); AR 3363 (Patient C between 2008-2012), AR 3369 (Patient D between 2011-2012); AR 3375 (Patient E between April-October 2013). Both the 2021 and 2020 Decisions evaluated Smith’s competency and quality of care in treating patients with the intrathecal therapy modality, and the 2020 Decision discipline included a probation restriction prohibiting Smith from performing any care or treatment with patients involving intrathecal pumps until after successful completion of Clinical Competence Assessment Program had been provided to the Board. AR 3910.

Smith argues that he satisfied the 2020 Decision’s competence assessment requirement and was permitted to again provide the intrathecal therapy modality. Smith called his Board probation officer to testify at the hearing on the 2020 Accusation, and he confirmed Smith’s compliance with his probation. AR 11169-74. The Board acknowledged the restoration of Smith’s right to perform intrathecal therapy after a determination of competency in the 2021 Decision: Smith “has fully complied with the terms of his probation, he completed a clinical competency course, and has been subject to monitoring.” AR 9775-76, 9859 (emphasis added). Pet. Op. Br. at 10-11.

Despite this, the Board purported to restore its ban on Smith’s ability to provide patients with intrathecal therapy care in the 2021 Decision, imposed through a permanent restriction during probation. AR 9858-59. This ban was based on evidence from Smith’s practice before the Board restored his ability to treat patients with the intrathecal therapy modality. AR 9859. The chronology of the Board’s actions is: (a) in 2020, the Board took away Smith’s faculty to provide intrathecal therapy treatment until he had completed a clinical competency program as a term of his probation based on treatment provided to patients between 2011 and 2018; (b) Smith completed the clinical competency program; (c) the Board restored Smith’s ability to provide intrathecal therapy treatment; and (d) in the 2021 Decision, the Board again took away Smith’s faculty to provide intrathecal therapy treatment until the end of his probation based on treatment provided to patients between 2015 and 2018. Pet. Op. Br. at 12; Reply at 7.

Despite its findings of restored competency, despite evaluating Smith’s competency during the same period of care, and despite having already disciplined Smith based on his use of the intrathecal therapy modality for the same period, the Board again disciplined him in the 2021 Decision. This is capricious and dangerous. Any physician who treated his patients under a misapprehension or misapplication of professional standards could endure years of repeated accusations and discipline simply by the Board serially selecting one or a group of patients at a time to prosecute each accusation. This is not what the Medical Practice Act contemplates. As a result, the 2021 Decision’s intrathecal therapy ban is punishment, not discipline, and the 2021 Decision must be set aside as lacking clear and convincing evidence to a reasonable degree of certainty. Pet. Op. Br. at 11-12.

Smith’s argument of potential abuse is a fair one. The Complainant could piecemeal a physician’s treatment of a number of patients over a single period into a series of accusations, seeking greater and greater discipline in a circumstance that should be a single accusation. This potential for abuse is real, and multiple accusations should be subject to scrutiny.

But that is not what happened in Smith’s two cases. He is correct that the 2021 Decision concerned the treatment of three patients between the years 2015 and 2018. He is also correct that the 2020 Decision concerned the treatment of five patients between the years 2011 and 2017. It is also accurate to note the 2020 Decision imposed a temporary restriction on Smith’s ability to practice intrathecal therapy whereas the 2021 Decision imposed a restriction for the duration of his probation.

However, the 2019 Accusation underlying the 2020 Decision and the 2020 Accusation underlying the 2021 Decision did not involve the same intrathecal therapy issues during the same period of medical care. Comparing the two records shows that the intrathecal therapy deficiencies in front of the Board for the 2021 Decision were fundamentally different and significantly more serious than in the 2019 Accusation.

The 2019 Accusation and the 2020 Decision were predominantly based on violations of over-prescribing oral pain medication. AR 3144. The 2019 Accusation alleged intrathecal therapy violations for only one of the five patients, Patient A, and mostly centered around a single office visit in 2012 for which Smith failed to properly program medication information into Patient A’s pump. AR 3151-52. This was not a primary allegation, and the 2019 Accusation did not allege any violations concerning psychological evaluations, use of intrathecal ketamine, or routine use of excessively high doses of intrathecal fentanyl. Allegations in connection with intrathecal therapy were made for the first time in the 2020 Accusation and addressed by the Board in the 2021 Decision.[7]

The Board also argues that Smith’s chronology is misleading. He implies that his probation monitor’s testimony is proof that he again was permitted to provide the intrathecal therapy modality. Smith testified that he had received direct communication from the Board that he would be able to resume intrathecal therapy “in the next couple of weeks.” AR 11041. No other evidence was provided at the hearing to support this claim. The probation monitor testified only that she had received an email from Smith that he had completed the clinical competency program. AR 11170. The probation monitor did not know whether in fact he had completed the program because she had not yet received a final report from the program. Id. Opp. at 17-18.

The court assumes that Smith has completed the clinical competency program (see rejected RJN Ex. F), but that does not make him competent. Smith’s competency in intrathecal therapy is best evaluated by his testimony in which he rejected Wallace’s assertion that his dosing levels of intrathecal fentanyl were excessive and fell below the standard of care. AR 10990-91. He testified that, if the Board permits him to work on intrathecal pumps in the future, he will not decrease the dosage. AR 10991. He also rejected Wallace’s opinion as to the use of intrathecal ketamine in pumps. AR 10991. If the Board permits him to work with intrathecal pumps, he will continue to use ketamine in those pumps. AR 10991. The 2021 Decision was based in part on the fact that Smith’s testimony shows that he will continue a dangerous and harmful brand of intrathecal therapy in the absence of a practice restriction.

Smith fail to show the Board’s 2021 Decision to impose a practice restriction lacked clear and convincing evidence and was capricious. The 2021 Decision is based upon evidentiary findings of dangerous conduct which warrant a greater practice restriction than imposed in the 2020 Decision. Smith fails to show that the practice restriction is not justified by substantial evidence.

The Petition is denied. The Board’s counsel is ordered to prepare a proposed judgment, serve it on Smith’s counsel for approval as to form, wait ten days after service for any objections, meet and confer if there are objections, and then submit the proposed judgment along with a declaration stating the existence/non-existence of any unresolved objections. An OSC re: judgment is set for February 13, 2024 at 1:30 p.m.

[1] Smith seeks judicial notice of (1) the Board’s August 11, 2022 decision (“2022 Decision”) made after Smith I vacated the 2020 decision (Rifat Decl., ¶4, Ex. A); (2) Judge Beckloff’s final decision in Smith I, dated February 28, 2022 (Rifat Decl., ¶5, Ex. B); (3) the peremptory writ of mandate issued in Smith I on February 28, 2022 (Rifat Decl., ¶6, Ex. C); and (4) the Board’s return to the peremptory writ of mandamus in Smith I, dated June 9, 2022 (Rifat Decl., ¶7, Ex. D). In reply, Smith seeks judicial notice of (1) the proposed judgment in Smith v. Medical Board of California, (“Smith II”), Case No. 22STCP03155 (Rifat Supp. Decl., ¶3, Ex. E); and (2) a transcript of proceedings before the Board on July 22, 2022 that was part of the administrative record in Smith II (Rifat Supp. Decl., ¶4, Ex. F).

The requests to judicially notice Exhibits A-E are granted. Evid. Code §§ 452 (c)-(d). The request to judicially notice Exhibit F is denied. The hearing transcript from the administrative record in Smith II is not an official act of the legislative, executive, or judicial department of the state and is not part of the record for this action.

[2] As used in the Medical Practice Act, the Division of Medical Quality refers to the Board. B&P Code §2002.

[3] The 2022 Decision reduced to two the number of patients considered for the 2019 Accusation.

[4] Patient A testified that a UCSD pain medicine physician said that she had enough fentanyl in her intrathecal therapy pump to “kill all the people in the emergency room.” AR 11082.

[5] The Board’s opposition distinguishes Conant as a case concerning a federal enforcement policy under which a doctor’s controlled substances registration could be revoked if he or she recommended medical marijuana to a patient. Smith’s probation condition proscribes his medical advice to another medical provider, which is entirely different. Opp. at 14-15.

[6] Smith also is prohibited from performing any patient treatment involving the use, management, or surgical procedure related to intrathecal pumps. AR 9859-860. This term is not at issue in Smith’s First Amendment argument.

[7] The Board argues without evidence that it was unaware of these dangerous sub-standard practices when it imposed its disciplinary penalty in the 2020 Decision. Not until the hearing on the 2020 Accusation, including Smith’s defense of the case, did the Board have a full understanding of the serious deficiencies in Smith’s practice of intrathecal therapy. Opp. at 17.