Catherine I. Hanson, State Bar No. 104506
Gregory M. Abrams, State Bar No. 135878
Astrid G. Meghrigian, State Bar No. 120896
221 Main Street, Third Floor
San Francisco, California 94105
Telephone (415) 541-0900
Facsimile. (415) 882-5143

Attorneys for Amicus Curiae
California Medical Association


SUPERIOR COURT OF THE STATE OF CALIFORNIA
IN AND FOR THE COUNTY OF SACRAMENTO

ROBERT SINAIKO, M.D.,
Petitioner,

v.

MEDICAL BOARD OF CALIFORNIA
Respondent.
Case No. 99 CS 02275
BRIEF OF AMICUS CURIAE CALIFORNIA MEDICAL ASSOCIATION IN SUPPORT OF PETITIONER
Date Action Filed: October, 1999
Trial Date: Not set
Dept: 41, Judge Ronald Robie
TABLE OF CONTENTS

I. INTRODUCTION 1
II. THE OPINION'S ANALYSIS OF DR. SINAIKO'S EXPERTS' CREDIBILITY IS UTTERLY INADEQUATE 1
III. NEGLIGENCE CANNOT BE FOUND, LET ALONE DISCIPLINE BE IMPOSED, IF THERE IS A REPUTABLE MINORITY OF THE PROFESSION THAT BELIEVES THE PRACTICES AT ISSUE WERE APPROPRIATE 4
IV. THE ILL EFFECTS OF COST RECOVERY RUN AMOK 5
A. The Medical Board of California's Role is to Provide Public Protection Through the Provision of Objective, Evenhanded Review of Medical Care 6
B. The Medical Board's History of Cost Recovery Establishes that It Serves An Improper Purpose 8
V. CONCLUSION 13

TABLE OF AUTHORITIES
...(list available upon request)



I.     INTRODUCTION

The fundamental issue in this case is whether the Medical Board of California's disciplinary process contains adequate safeguards to prevent the erroneous deprivation of a fundamental right of a physician's fundamental right to practice medicine, and thus the ability to maintain trusted relationships with patients that are so essential to the provision of quality care. The California Medical Association (CMA) is extremely concerned that the Medical Board has not properly safeguarded against an improper deprivation here. Among other things, the Medical Board:

  1. dismisses more than ten highly qualified physician experts testifying on behalf of Dr. Sinaiko as being of "questionable credibility" without an analysis as to why their testimony was allegedly "not based on generally accepted scientific and medical principles as required by such cases as Daubert v. Merrell Dow Pharmaceutical, Inc….";

  2. improperly turned clinical debate into a disciplinary action; and

  3. conditioned its provision of a constitutionally mandated hearing on accusations seeking to deprive a physician of his license upon his willingness to risk paying back the agency its staggering nearly one hundred thousand dollars worth of investigation, enforcement, and prosecution costs should his defense on all charges not ultimately prevail.

    [NOTE: The fact that the Medical Board subsequently reduced this penalty is irrelevant to the magnitude of the chilling effect this cost recovery system imposes; as is evident from the Medical Board's decision, the reduction was entirely discretionary, and the amount of the reduction was entirely arbitrary.]

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II.   THE OPINION'S ANALYSIS OF DR. SINAIKO'S EXPERTS' CREDIBILITY IS UTTERLY INADEQUATE

In order for a physician to be found guilty of unprofessional conduct or other violation of the Medical Practice Act, the Medical Board must establish by clear and convincing evidence to a reasonable certainty that the respondent physician was guilty of the charges alleged in the Accusation. The Board's decision in this case does not clearly show that the Medical Board met its burden in its findings against Dr. Sinaiko.

The administrative hearing lasted 26 days. Many experts were brought to the stand by both sides. Resolution of this case rested heavily, if not entirely, on expert testimony. The testimony of more than ten expert witnesses for Dr. Sinaiko, each highly qualified, were simply dismissed with a cryptic comment by the administrative law judge that they were:

" . . . of questionable credibility in that their testimony was not based on generally accepted scientific and medical principles as required by such cases as Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993) 509 U.S. 579." (ALJ Decision, paragraph 79.)
As Doctor Sinaiko has argued in his opening memorandum in the mandamus action, application of the notion of "generally accepted scientific and medical principles" is entirely inappropriate in a Medical Board disciplinary proceeding. The Board, after reconsideration, appears to have accepted the ALJ's finding, when it stated that Doctor Sinaiko's experts, "while credible in their fields, were not qualified to provide expert testimony as to the matters at issue." Board Decision at ¶77.

The Board's decision offers no analysis of the experts individually, and no explanation was offered as to where or how their testimony failed to be based on "generally accepted scientific principles," or why they "were unqualified" to provide expert testimony. Given the nature of these experts' qualifications as set forth below, much doubt is cast as to whether this opinion could ever have reached the "clear and convincing standard" necessary to find the respondent physician guilty of unprofessional conduct.

The record in this case should reflect the following experts for Dr. Sinaiko:

  1. Philip R. Lee, M.D., twice assistant Secretary for Health and former Chancellor of UCSF, among many other prestigious posts.

  2. Glen Elliott, M.D., Chief of Adolescent and Child Psychiatric at Langley Porter Psychiatric Institute, UCSF; researcher in the area of pediatric psychiatric conditions including ADHD, author of numerous scientific articles, senior associate editor of the Journal of Child and Adolescent Psychopharmacology.

  3. Henrick Blum, M.D., Dean of the School of Medicine at UC Berkeley; past president, American Public Health Association.

  4. Vincent Marinkovich, M.D., board certified in Allergy and Immunology, and Pediatrics; Associated Clinical Professor of Pediatrics at Stanford University School of Medicine.

  5. Carol Jessop, M.D., board certified in Internal Medicine; Assistant Professor of Medicine at UCSF School of Medicine; currently Chief of Inpatient Medicine at Alta Bates Hospital, Berkeley, California.

  6. Fred Blackwell, M.D., board certified, American Board of Orthopedic Surgery; City Physician, City of Oakland.

  7. Jeffrey Silvers, M.D., board certified, American Board of Infectious Diseases, American Board of Infection Control, and American Board of Internal Medicine; Chief of Infectious Diseases at San Leandro Hospital; Medical Director of Quality Improvement at San Leandro Hospital.

  8. Deborah Sedberry, M.D., board certified by American Board of Pediatrics; private practice, developmental and behavioral pediatrics; Director of Pediatric Pain Management Services at Children's Hospital, Oakland; Assistant Clinical Professor, Department of Pediatrics, UCSF.

  9. Paul Radensky, M.D. (University of Pennsylvania), JD (Harvard Law School, Magna Cum Laude); board certified by the American Board of Internal Medicine; partner in health law development at McDermott, Will & Emery in Miami, Florida.

  10. Jack Pulec, M.D., board certified by American Board of Otolaryngology; Editor-in-Chief, Ear, Nose & Throat Journal; member, Editorial Review Board, Otolaryngology-Head and Neck Surgery; Council member of the American Academy of Otolaryngologic Allergy.

It is astonishing that so many experts with such strong credentials should be dismissed as "not qualified to provide expert testimony as to the matters at issue" without substantial further assessment in the Board's decision. How and why are they not qualified? Can it be that all of the testimony and opinions offered by these experts was not qualified or otherwise admissible? To simply state that a long list of apparently highly qualified experts were "unqualified" without explaining how their entire body of testimony was for naught, avoids the Board's responsibility to arrive at a verdict by clear and convincing evidence. This lack of substantiation casts doubt on the credibility of the Board's process of review and on the entire hearing process itself.

Somehow, this case was important enough for the Medical Board to spend $99,000 of its resources before the hearing, and spend 26 days (and spend more money) in the hearing itself. It is not too much for the medical community to expect the Medical Board to issue written decisions in such cases that are thorough and that unequivocally demonstrate the Medical Board has complied with its mandate to present clear and convincing evidence of the unprofessional conduct alleged against the respondent physician. Indeed, if the Medical Board is free to dismiss an accused physician's witnesses with cavalier statements that they are "not credible" or "not qualified" without articulating any basis for that conclusion, it is unclear how physicians can ever defend themselves successfully against Medical Board accusations.

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III.    NEGLIGENCE CANNOT BE FOUND, LET ALONE DISCIPLINE BE IMPOSED, IF THERE IS A REPUTABLE MINORITY OF THE PROFESSION THAT BELIEVES THE PRACTICES AT ISSUE WERE APPROPRIATE

California's Book of Approved Jury Instructions (BAJI), used in civil court cases, provides:

Where there is more than one recognized method of diagnosis or treatment, and no one of them is used exclusively and uniformly by all practitioners with good standing, a physician is not negligent if, in exercising his best judgment, he selects one of the approved methods, which later turns out to be a wrong selection, or one not favored by certain other practitioners. (BAJI Instruction No. 6.03; emphasis added.)

The Board's Decision in this case dismisses Dr. Sinaiko's expert witnesses as a group with a wave of the hand. One infers from this that Dr. Sinaiko's methods of diagnosis or treatment are not "recognized" within the medical community. Is it that Dr. Sinaiko's methods of diagnosis and treatment were "not favored by certain other practitioners" (BAJI Instruction No. 6.03), or are they simply not "recognized" at all by the medical community? The opinion does not answer this question with any assessment or evaluation based on the expert testimony received. The medical community is split into "factions" regarding the methods employed by Dr. Sinaiko. An opinion by the Medical Board in such a case should not bring the appearance that the Medical Board is deciding which "faction" within medicine will be tolerated by the state's physician disciplinary body. Instead, the Medical Board should prove by clear and convincing evidence exactly why the methods of diagnosis and treatment at issue in the case were below the standard of care, which necessarily includes showing why they were not supported by the respondent physician's patently reputable experts. The Board's Decision in this case failed utterly in that task.

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IV.    THE ILL EFFECTS OF COST RECOVERY RUN AMOK

The Medical Board spent nearly $100,000 on the pre-hearing phases of this case and now seeks nearly $50,000 as the cost recovery bill pursuant to Business & Professions Code §125.3. Business & Professions Code §125.3 is unconstitutional as its very purpose is to chill the exercise of the right of individuals, such as Dr. Sinaiko, to vigorously defend themselves. This cost recovery scheme seeks to augment the Board's budget through (1) the physician's remittance of prosecution costs incurred by the Board, and (2) the savings realized by the Board by extorting early settlements and otherwise not having to provide a full hearing. This scheme is unconstitutional on its face.

No one contests that the Medical Board is required by the Constitution's due process guarantee to provide physicians with a meaningful and fair hearing. Yet "cost recovery" schemes, such as Business & Professions Code §125.3 vitiate the very elements so essential to due process-a fair decisional process and an impartial decision-maker. These schemes force physicians and other licentiates to choose between (1) taking the risk of paying for the services of the very individuals who are prosecuting and investigating them if they are unsuccessful at the administrative hearing (a cost they could not possibly predict at the outset), or (2) playing it safe by accepting settlement offers that are unfair or unnecessary to protect the public to avoid potentially exorbitant prosecution costs (in addition to their own attorneys fees). In neither case is the public interest served.

Licensing boards, such as the Medical Board, attempt to justify these flatly illegal schemes to "augment their budgets" or "deter" wrongdoers, yet these excuses cannot save cost recovery provisions such as the one at issue from being constitutionally infirm. These boards can easily augment their budget in the manner the Legislature intended-through the increase of licensure fees. Insofar as "deterrence of wrongdoers" is concerned, the purpose of Medical Board discipline is not to punish, but to protect the public and rehabilitate physicians to the extent possible, so that years of training and trust built from long-standing physician-patient relationships are not needlessly destroyed. To the extent the individual truly is a "wrongdoer" (a debatable question in many cases), deterrence is plainly achieved through the possibility that the individual will be deprived of his/her license, and thus livelihood.

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A.    The Medical Board of California's Role is to Provide Public Protection Through the Provision of Objective, Evenhanded Review of Medical Care
The Medical Board, like other boards responsible for the regulation of health care professionals, has been established for the purpose of ensuring that those professions deemed to engage in activities which have potential impact upon the public health, safety and welfare are adequately regulated in order to protect the people of this state. See Business & Professions Code §101.6. The Medical Board, in particular, is responsible for, among other things, issuing licenses and certificates to physicians, following successful completion of medical school and post-graduate training and passage of an examination (Business & Professions Code §§2000-2515), and in protecting the public through exercise of its disciplinary authority (Business & Professions Code §2229).

As the Medical Board is responsible for regulating private persons who engage in private medical practices, the Medical Board is self-funded. See Daugherty v. Riley (1934) 1 Cal.2d 298. For the purposes of funding the Medical Board in "paying all salaries and other expenses necessarily incurred in carrying into effect the provisions" of the Medical Practice Act, the Legislature established the "contingent fund" to which all monies paid to and received by the Board are credited. See Business & Professions Code §2445. Monies that go into this self-funded "contingent fund" do not in any way involve state revenues, but rather, are comprised solely of physician license fees, application and examination fees, and other regulatory fees, such as "delinquency/penalty/reinstatement fees/miscellaneous." There are special funds that are raised for the Medical Board's regulatory purposes and are set apart for the exclusive use of the Medical Board. Daugherty, supra at 307.

To ensure that the Medical Board has adequate resources to perform its job, the maximum amount of the physician licensing fee in California is set by the Legislature, and "shall be fixed at an amount necessary to recover the actual costs of the licensing program as projected for the fiscal year commencing on the date the fees become effective." (Business & Professions Code §2435.) These fees reflect the Legislature's determination as to what level of funding is necessary for the Medical Board to achieve its public protection goals and the recognition that the costs for the system should be borne equally by all licensees to ensure uniformity in the application of laws. Thus, the Medical Board, like other disciplinary or "prosecuting agencies," has a confined budget and has finite enforcement resources. This system ensures that the Board dedicate its resources on those cases that are in the best interests of the public and not engage in disciplinary activities for insubstantial or misguided reasons.

In carrying out its enforcement activities pursuant to the Medical Practice Act, the Medical Board must act in the public interest which means acting in the best interests of patients and, to the extent possible, physicians. The Legislature has declared that the Medical Board has two purposes in exercising its disciplinary authority. While the protection of the public must be paramount, the Board is expressly charged by the Legislature that it "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." Business & Professions Code §2229. In enacting this provision, the Legislature understood that physicians have a fundamental vested right in their licensure to practice medicine, see Yakov v. Board of Medical Examiners (1968) 68 Cal.2d 67, 74,


[NOTE: Physicians not only have a fundamental vested right in their licensure to practice medicine, but they are also "invested" heavily in their profession on a number of levels. The road to licensure is long and perhaps the most difficult of all professions in our society. The very acceptance into medical school is contingent upon stellar undergraduate performance. Medical school itself is a grinding experience, completed only after years of scientific and clinical study, though only a taste of the hardships yet to come in the years of internship and residency. Residency can encompass anywhere from two to six years, or longer, depending on the specialty chosen. Salary during this training epic is typically very low, barely sufficient to make the payments required to repay the substantial loans received to finance the medical school years. The residency years may be followed by further educational investment in a fellowship, itself providing little pay. Under these circumstances, procedures for removing or restricting the medical license of a person who has made this level of financial and psychological investment should include the fullest protections available.
and that arbitrary deprivations of that right not only result in the loss of livelihood for physicians, but also destroy continuous physician-patient relationships, and thus injure the very people that the Medical Board is supposed to protect-patients. In that regard, continuity of care with the patient's regular physician is not an academic value. Studies have demonstrated the clinical benefits that flow when patients maintain a regular physician, and that regular relationships result in, among other things, fewer and/or shortened hospitalizations and decreased use of emergency departments for care. See Cal. Managed Care Health Improvement Task Force, Rep. to Leg., December 13, 1999, "Physician/Patient Relationship"-a true and correct copy of which is attached to the Declaration of Astrid G. Meghrigian in Support of the Motion for Judicial Notice as Exhibit B. It is no wonder that the medical review of physicians, which involves often highly complicated clinical determinations, must be conducted properly and fairly. If not, it could result in harm to patients by unnecessarily limiting access to care. See, for example, Business & Professions Code §809(a) (noting the dangers of improperly conducted peer review).

Given the Medical Board's dual charge to protect the public and take action wherever possible to aid in the rehabilitation of licensees, and given the complexity of modern medicine, the Medical Board must achieve its mandate through providing objective, even-handed review of medical care with a system that provides full procedural due process. TOP

B.    The Medical Board's History of Cost Recovery Establishes that It Serves An Improper Purpose
Prior to the Legislature's 1992 enactment of the Business & Professions Code §125.3 and despite the Legislature's intention that licensure fees be set at levels which are sufficient to allow the Medical Board to do its job, it was clear that licensing boards could enter into settlements with their licensees, and include as a condition of settlement, that their licensees pay the Medical Board's attorney fees. Significantly, the ability of the Medical Board to engage in this activity was litigated and authorized by the Second District Court of Appeal in Rich Vision Centers v. Board of Medical Examiners (1983) 144 Cal.App.3d 110, 192 Cal.Rptr. 455. There the Court explained that the Board has the implied power to settle licensing disputes, as such activity helps achieve the Legislature's purpose. As explained by the Court:
Settlement negotiations provide the Board better flexibility. Importantly, settlements provide the means to condition the issuance or renewal of licenses in order to best protect the public. Licensing can be tailored to suit the particular situation. Because conditions are voluntarily accepted by the applicant, enforcement problems are unlikely. Id. at 115.

The Rich Vision Court similarly concluded that the Medical Board had the power to condition settlement upon the payment of its attorney fees. The Court explained that the ability to negotiate favorable settlement terms is one of the most "effective tools" for promoting a client's best interests and to successfully use this tool, flexibility is needed

in formulating the terms and conditions of any agreement to maximize the benefit to the client. Settlement negotiations involve give and take, and the final agreement is a compromise. Id. at 116.

With the enactment of Business & Professions Code §125.3, the Legislature completely removed any "give and take" in the negotiation process. No longer could either the Medical Board's attorneys or defense counsel use the payment or non-payment of attorney fees as a "tool for promoting their client's best interest." No longer are the cost recovery conditions voluntary, and indeed, enforcement problems are evident.

Business & Professions Code §125.3 as implemented by the Medical Board, mandates that the Medical Board, in all cases, seek to obtain from a physician found to have committed a violation of the Medical Practice Act, payment of a sum "not to exceed the reasonable costs of the investigation and enforcement of the case," costs which shall include "costs up to the date of the hearing, including, but not limited to, charges imposed by the Attorney General." This provision imposes these costs even if (1) the hearing was requested on non-frivolous grounds, and (2) the physician prevailed on some, but not all, of the charges, and even though (3) they subject the physician to an indeterminate substantial debt at a time when the physician may lose his/her job, and (4) the physician has no way of predicting the outcome of any hearing requested at the time the accusation is filed.

As early as 1993, the Medical Board understood what a powerful weapon cost recovery would be for them in their settlement negotiations, and the impact that this weapon would have in deterring physicians from seeking a full hearing. For example, in a memorandum from the then Chief of Enforcement of the Medical Board's Enforcement Program to the members of the Medical Board's Division of Medical Quality, dated December 3, 1993, stated:

If the respondents (and their attorneys) begin to recognize that as a matter of course the Board will avail itself of the considerable financial benefits of A.B. 2743 (i.e., seek investigation and AG cost recovery up to the point of the administrative hearing), I believe respondents will reevaluate and decide not to contest our more stringent proposed settlement terms, thus resulting in superior, more meaningful stipulations that better protect the public and perhaps further reduce the number and costs of cases which go on to actual hearing while still attaining acceptable levels of public protection.
By early 1994, the Medical Board began its cost recovery program as a routine practice. Since that time, it has been the practice of the Board to include within the accusation a specific standard paragraph which threatens the accused with cost recovery. Id. This paragraph provides:
Section 125.3 of the Code provides in pertinent part that the Board may request the administrative law judge to direct any licentiate found to have committed a violation or violations of the licensing act to pay the Board a sum not to exceed the reasonable costs of the investigation and enforcement of the case.
And these threats worked as the enforcement program obtained significantly more cost recovery dollars the next year. As the Medical Board explained in its report to the California State Auditor, dated February 23, 1995:
. . . investigative cost recovery pursuit is now a routine process of the enforcement program and despite any lag time in case dispositions, the enforcement program policy change has resulted in significantly more cost recovery than in the 1992/1993 and 1993/1994 fiscal periods reviewed by the Auditor. For example, in the 1994/1995 fiscal year (through January 1995), the costs recovery money actually collected pursuant to stipulated decisions is almost $90,000 versus $44,000 for the same period in the 1993/1994 fiscal year.
But, in a report dated March 1, 1995, conducted by the California State Auditor, a more than doubling of recovery costs collected pursuant to stipulated decisions was not enough. The State Auditor concluded that:
Although the Medical Board has the authority to recover costs that it incurs as part of the enforcement and disciplinary process, it is not maximizing its effort to recover such costs. For example, during the fiscal year 1993/1994, the Medical Board spent more than 25 million dollars on enforcement and disciplinary efforts, including the costs of investigations, services provided by the Attorney General's Office, and administrative hearings. Of those costs, we determined that under current law, the Medical Board could have attempted to recover more than 6.3 million.
California State Auditor Report at page 9.

The State Auditor was also critical of the fact that the Medical Board failed to seek legislative amendments to the Business & Professions Code to allow it to recover costs incurred for the administrative hearing. Had the Medical Board done that, it would have been able to recover an additional 3.1 million dollars-an amount which represents approximately half of its enforcement and investigational costs. Id. at 9.

In his report, the State Auditor recommended that to maximize cost recovery efforts, the Medical Board should, among other things:

Be more aggressive in recovering disciplinary costs through stipulated settlements and as part of the proposed disciplinary decisions rendered by administrative law judges. Id. at 18.
The Medical Board, in fact, heeded the State Auditor Report recommendations that cost recovery be further pursued and warned all of its licentiates in its Action Report, the Medical Board's quarterly publication, that it had accepted "a basic assertion by the State Auditor that a far higher proportion of costs of investigations and prosecutions can be secured from those who are disciplined, the wrongdoers, as contrasted to funding of Board operations from licensure fees."

Given what has happened, it is clear that the Medical Board has taken aggressive cost recovery steps, as recommended by the State Auditor. Even though the total annual number of administrative filings from 1992 (when cost recovery was enacted) to the present has remained relatively constant (and, in fact, according to the Medical Board's Annual Report, have gone down), the annual number of settlements with accused physicians has tripled. The need for funding from sources other than license fees does not justify this result-particularly given the fact the number of licentiates during that time period increased substantially, thus generating significantly increased licensure fees. The following chart makes this clear.

FISCAL YEARTOTAL LICENSESADMINISTRATIVE FILINGSSTIPULATED SETTLEMENTS
91-92
103,073
202
84
92-93
102,891
367
103
93-94
102,076448194
94-95
102,622396270
95-96
103,130329263
96-97
104,046367302
97-98
105,528466294
98-99
106,909501324
99-2000
108,068345286

Given the purposes of cost recovery schemes and the substantial increase in the number of stipulated settlements entered into between accused physicians and the Medical Board, it is clear that the Medical Board's cost recovery, in fact, did cause physicians to limit their defense and forego vigorous advocacy. Under these circumstances, it is clear that Business & Professions Code §125.3 is unconstitutional.

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V.    CONCLUSION

For all the foregoing reasons, we urge this Court to take appropriate steps as necessary to inspire the public and the medical community to have confidence that Medical Board discipline imposed is Medical Board discipline deserved, and, at a minimum, reverse the order imposing costs.

Dated: October 29, 2001

Respectfully submitted,

California Medical Association
CATHERINE I. HANSON
GREGORY M. ABRAMS
ASTRID G. MEGHRIGIAN

By:____________________________
Astrid G. Meghrigian
Attorneys for Amicus Curiae
California Medical Association