Odom v. State, Division of Corporations, Business & Professional Licensing ( 2017 )

Notice: This opinion is subject to correction before publication in the PACIFIC REPORTER.
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THE SUPREME COURT OF THE STATE OF ALASKA
DAVID M. ODOM, M.D., )
) Supreme Court No. S-16151
Appellant, )
) Superior Court No. 3AN-14-08082 CI
v. )
) OPINION
STATE OF ALASKA, DIVISION )
OF CORPORATIONS, BUSINESS ) No. 7187 – August 11, 2017
& PROFESSIONAL LICENSING, )
)
Appellee. )
)
Appeal from the Superior Court of the State of Alaska, Third
Judicial District, Anchorage, Kevin M. Saxby, Judge.
Appearances: Lee Holen, Anchorage, for Appellant.
Robert C. Auth, Assistant Attorney General, Anchorage, and
Jahna Lindemuth, Attorney General, Juneau, for Appellee.
Before: Stowers, Chief Justice, Winfree, Maassen, Bolger,
and Carney, Justices.
MAASSEN, Justice.
I. INTRODUCTION
The state professional licensing division brought an accusation of
professional misconduct against a doctor, alleging that he acted incompetently when he
prescribed phentermine and thyroid hormone for one of his patients. The division sought
disciplinary sanctions against the doctor. Following a hearing, an administrative law
judge issued a proposed decision concluding that the division had failed to show that the
doctor’s conduct fell below the standard of care in his field of practice and that no
disciplinary sanctions were warranted. But the Medical Board instead adopted as its
decision the proposal for action submitted by the division and revoked the doctor’s
medical license.
On appeal to the superior court, the case was remanded to the Board for
consideration of the doctor’s own late-filed proposal for action. The Board reaffirmed
its decision to revoke the doctor’s medical license, and the superior court affirmed that
decision.
The doctor appeals to this court. Because the Medical Board’s decision to
revoke the doctor’s medical license is not supported by substantial evidence, we reverse
the superior court’s affirmance of that decision.
II. FACTS AND PROCEEDINGS
David Odom is a bariatric physician1 who has been licensed to practice in
Alaska since 1974. His Fairbanks practice focused on anti-aging, weight loss treatment,
and natural hormone replacement therapy. He is certified by the American Board of
Medical Specialties in anesthesiology and by the American Academy of Anti-Aging and
1
Bariatrics is a branch of medicine that deals with the causes, prevention,
and treatment of obesity. Bariatrics, THE SLOANE-DORLUND ANNOTATED MEDICAL­
LEGAL DICTIONARY (1987).
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Regenerative Medicine,2 and he has been admitted to practice in six states besides
Alaska. The disciplinary action in this case is his first.
A. Dr. Odom’s Treatment Of S.Q.3
In April 2007 Dr. Odom began seeing S.Q. for weight loss treatment and
hormone evaluation. He noted at her first appointment that she had an “irregularly
irregular” heartbeat; she reported that in 2002 she had been diagnosed with peripartum
cardiomyopathy, though it was currently asymptomatic. Cardiomyopathy is a disease
of the heart muscle that can lead to sudden cardiac arrest and death;4 peripartum
cardiomyopathy by definition begins during the final month of pregnancy or within a few
months after giving birth.5
Dr. Odom recorded his initial impressions: thyroid deficiency, hormone
imbalance, cardiomyopathy, and obesity. S.Q. signed an informed consent form for
weight loss treatment and another for hormone supplement therapy. Dr. Odom
scheduled weekly appointments for S.Q. from April through June 2007, continuing
monthly into September, so he could monitor her progress.
2
Dr. Odom is not board-certified in bariatrics, but the Medical Board does
not require physicians to be board-certified in the fields in which they specialize. See
Alaska State Medical Board, Practicing a Specialty without being Board-Certified in that
Specialty (Jan. 24.2008), http://www.commerce.alaska.gov/web/portals/5/pub/MED_
Guide_Speciality_Practice.pdf.
3
We use the patient’s initials to protect her privacy.
4
Cardiomyopathy, STEDMAN’S MEDICAL DICTIONARY (28th ed. 2006).
5
Cardiomyopathy, peripartum, STEDMAN’S MEDICAL DICTIONARY (28th ed.
2006); see also Peripartum cardiomyopathy, AMERICAN HEART ASSOCIATION.
http://www.heart.org/HEARTORG/Conditions/More/Cardiomyopathy/
Peripartum-Cardiomyopathy-PPCM_UCM_476261_Article.jsp. (last updated Sept. 30,
2016).
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The obesity treatment plan included a prescription for phentermine, a
central nervous system stimulant that suppresses appetite.6 Dr. Odom also prescribed a
natural thyroid hormone drug — Armour Thyroid7 — for hypothyroidism.8 He
instructed S.Q. to start the thyroid drug at a dose of 120 milligrams daily, increasing to
180 milligrams after two weeks and 240 milligrams after four weeks; after that she could
adjust the dosage herself based on her symptoms.
At S.Q.’s September 14, 2007 visit — her last to Dr. Odom’s clinic — she
was found to have lost 33 pounds, dropping below the weight considered clinically
obese. She reported, however, that she had experienced jitteriness while taking a
240 milligram dose of Armour Thyroid, so Dr. Odom reduced the dose to 180 milligrams
a day. S.Q. appears to have stopped taking both medications soon afterward; she last
filled her phentermine and Armour Thyroid prescriptions on September 10, when she
received a thirty day supply of each, and some pills were never used.
A month later S.Q. visited her cardiologist, who reported that she “has had
a remarkable year and with careful adjustment of her diet, successfully lost 30 pounds.”
In early 2008, according to her husband, she “looked better and happier than she had in
6
Phentermine was once commonly prescribed in combination with
fenfluramine as an appetite suppressant called fen-phen; fen-phen was withdrawn from
the market following reports that connected its use with certain types of heart disease.
See In re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Prod. Liab. Litig.,
582 F.3d 524, 529 (3d Cir. 2009). Phentermine remains an FDA-approved drug.
7
Armour Thyroid contains two thyroid hormones, levothyroxine and
liothyronine, as well as several inactive ingredients.
8
Hypothyroidism is the “[d]iminished production of thyroid hormone,
leading to clinical manifestations of thyroid insufficiency.” Hypothyroidism, STEDMAN’S
MEDICAL DICTIONARY (28th ed. 2006).
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a long time.” But on March 6, 2008, about six months after she had stopped seeing
Dr. Odom, she suffered cardiac failure and died.
B. The Licensing Division’s Investigation
In 2009 S.Q.’s husband filed a complaint with the State of Alaska Division
of Corporations, Business, and Professional Licensing, suggesting a link between
Dr. Odom’s treatment of S.Q. and her death. The Division launched an investigation and
sent S.Q.’s medical records to Dr. Patrick Nolan for review. Dr. Nolan, an
endocrinologist,9 concluded that it was inappropriate for Dr. Odom to have prescribed
phentermine given S.Q.’s cardiomyopathy; that Dr. Odom had prescribed “too much
thyroid” hormone; and that Dr. Odom had inappropriately prescribed thyroid hormone
“for weight loss.” Dr. Nolan also opined that the “excess thyroid [hormone] and
phentermine could have contributed to [S.Q.’s] death.”
Dr. Odom challenged these conclusions, asserting that Dr. Nolan, as an
endocrinologist, had a starkly different view of weight loss and natural hormone
replacement therapy than doctors who, like Dr. Odom, practice anti-aging and bariatric
medicine. Dr. Nolan responded by declaring Dr. Odom’s practice “dangerous”
and “clearly . . . a threat to the public’s well being,” though his explanation was terse; he
said in his supplemental report, “I simply refuse to argue with [Dr. Odom’s approach to
treatment] as clearly the evidence is in favor of modern endocrinology and against Dr.
Odom.”
In April 2012 the Division filed an accusation alleging that Dr. Odom had
provided substandard care by failing “to conduct an adequate examination of S.Q.,”
9
Endocrinology is the “science and medical specialty concerned with the
internal or hormonal secretions and their physiologic and pathologic relations.”
Endocrinology, STEDMAN’S MEDICAL DICTIONARY (28th ed. 2006).
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prescribing “phentermine to a patient with an established diagnosis of cardiomyopathy,”
and prescribing “excess thyroid hormone” in combination with phentermine “for weight
loss.” The Division did not contend that Dr. Odom’s treatment caused S.Q.’s death; in
this appeal the Division, through its attorney at oral argument, agreed “absolutely” that
there was no causal connection.10
C. The Administrative Proceedings
An administrative law judge (ALJ) held an evidentiary hearing on the
Division’s accusation over four days in October and November 2012. The Division
presented the testimony of S.Q.’s husband, her mother, the Division investigator, and
Dr. Nolan, who testified as an expert. Dr. Odom testified on his own behalf and also
presented the expert testimony of Dr. David Bryman, a bariatric physician, and Dr. Neal
Rouzier, an emergency medicine, family practice, and anti-aging physician.
The ALJ issued a proposed decision in April 2014. He concluded that the
Division had failed to prove “that Dr. Odom’s examination was below the standard of
care”; had failed to prove “that to prescribe phentermine to S.Q. was below the standard
of care”; and had failed to prove “that Dr. Odom prescribed thyroid hormone as a weight
loss treatment, or that the dosages he prescribed were excessive and fell below the
standard of care.” The ALJ therefore concluded that no disciplinary sanction was
warranted.
10
According to the administrative law judge, “[t]estimony at the hearing
established that the medication prescribed by Dr. Odom would have long since been
eliminated from [S.Q.’s] system, and she had been treated by her cardiologist on several
occasions since her last visit to Dr. Odom some six months before her death.” The Board
did not modify this finding, and the Division does not challenge it.
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D. The Parties’ Proposals For Action And The Medical Board’s Decision
As permitted by AS 44.64.060(e),11 the Division submitted a proposal for
action in May 2014 that disputed the ALJ’s findings and recommended that the Medical
Board impose disciplinary sanctions. The Division argued that Dr. Odom’s practice fell
below the standard of care when he prescribed phentermine to a patient with
cardiomyopathy and when he prescribed “four times the recommended dosage” of
thyroid hormone to S.Q. for “supposed hypothyroidism, when her thyroid levels were
in fact normal.” The Division asserted that its proposed conclusions, though contrary to
those of the ALJ, could be reached “based on the evidence contained in the [ALJ’s]
proposed decision (including the product literature), and the Board’s own medical
expertise.”
The Medical Board was scheduled to meet to decide Dr. Odom’s case in
June 2014, and it received the ALJ’s proposed decision and the Division’s proposal for
action beforehand. A problem with the mail prevented Dr. Odom from filing his own
proposal for action, and though he tardily filed an opposition to the Division’s proposal,
the Medical Board did not review it.
At its June meeting the Medical Board discussed Dr. Odom’s case in
executive session; the members then voted unanimously, on the record, to “reject the
11
“[W]ithin 30 days after the proposed decision is served, a party may file
with the agency a proposal for action . . . [recommending that the agency] do one or
more of the following: (1) adopt the proposed decision as the final agency decision;
(2) return the case to the administrative law judge to take additional evidence or make
additional findings . . . ; (3) exercise its discretion by revising the proposed . . . sanction
. . . and adopt the proposed decision as revised; (4) in writing, reject, modify, or amend
a factual finding in the proposed decision . . . ; [or] (5) in writing, reject, modify, or
amend an interpretation or application in the proposed decision of a statute or regulation
directly governing the agency’s actions . . . .” AS 44.64.060(e).
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proposed decision by the hearing officer and, instead, adopt the Division’s Proposal for
Action” as its final agency decision. As a sanction, the Medical Board ordered “the
revocation of Dr. David Odom’s Alaska medical license.”
E. Dr. Odom’s Appeal To The Superior Court And Remand
Dr. Odom appealed the Medical Board’s decision to the superior court. The
court held that substantial evidence supported the Board’s factual and disciplinary
findings, but it found a violation of Dr. Odom’s due process rights in the Board’s failure
to consider his late-filed opposition to the Division’s proposal for action; the superior
court therefore vacated the Board’s decision and remanded the matter to the Board for
reconsideration.
At a special meeting, the Medical Board “decided not to re-open the
evidence in this case as is its prerogative,” and it reaffirmed its decision to revoke
Dr. Odom’s license. In November 2015 the superior court issued an order affirming the
Board’s decision.
Dr. Odom appealed to this court.
III. STANDARDS OF REVIEW
When a superior court acts as an intermediate court of appeals reviewing
an administrative or agency decision, we independently review the merits of the
administrative decision,12 giving no deference to the superior court’s decision.13 We
review the agency’s factual findings to determine whether they are supported by
12
Jurgens v. City of North Pole, 153 P.3d 321, 325 (Alaska 2007).
13
State, Dep’t of Revenue v. Merriouns, 894 P.2d 623, 625 (Alaska 1995)
(citing Handley v. State, Dep’t of Revenue, 838 P.2d 1231, 1233 (Alaska 1992)).
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substantial evidence.14 Substantial evidence is “such relevant evidence as a reasonable
mind might accept as adequate to support a conclusion.”15 “The substantial evidence test
is highly deferential, but we still review the entire record to ensure that the evidence
detracting from the agency’s decision is not dramatically disproportionate to the
evidence supporting it such that we cannot ‘conscientiously’ find the evidence
supporting the decision to be ‘substantial.’ ”16 The substantial evidence standard
“reflects the prudence of deferring to a state professional board’s special competence in
recognizing violations of professional standards.”17 “But we will not uphold the
imposition of reputationally and economically damaging professional sanctions based
14
Jurgens, 153 P.3d at 325 (citing Lindhag v. State, Dep’t of Nat. Res., 123
P.3d 948, 952 (Alaska 2005); Fields v. Kodiak City Council, 628 P.2d 927, 932 (Alaska
1981)).
15
Storrs v. State Med. Bd., 664 P.2d 547, 554 (Alaska 1983) (citing Keiner
v. City of Anchorage, 378 P.2d 406, 411 (Alaska 1963)).
16
Shea v. State, Dep’t of Admin., Div. of Ret. & Benefits, 267 P.3d 624, 634
n.40 (Alaska 2011) (emphasis in original). “[A] court may [not] displace the Board’s
choice between two fairly conflicting views, even though the court would justifiably
have made a different choice had the matter been before it de novo. But under the
substantial evidence test, a reviewing court is not barred from setting aside a Board
decision when it cannot conscientiously find that the evidence supporting that decision
is substantial, when viewed in the light that the record in its entirety furnishes, including
the body of evidence opposed to the Board’s view.” Id. (quoting Universal Camera
Corp. v. Nat’l Labor Relations Bd., 340 U.S. 474, 488 (1951)).
17
State, Dep’t of Commerce, Cmty. & Econ. Dev., Div. of Corps., Bus. &
Prof’l Licensing v. Wold, 278 P.3d 266, 273 (Alaska 2012).
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on evidence that would not permit a reasonable mind to reach the conclusion in
question.”18
“We review questions of law, including the appropriate standard of proof,
using our independent judgment.”19 We review the agency’s selection of a particular
disciplinary sanction for abuse of discretion.20
IV. DISCUSSION
Alaska Statute 08.64.326(a)(8)(A) authorizes the Medical Board to sanction
a doctor if the Board finds after a hearing that the doctor “has demonstrated professional
incompetence.”21 “Professional incompetence” is defined by regulation to mean “lacking
sufficient knowledge, skills, or professional judgment in that field of practice in which
the physician . . . concerned engages, to a degree likely to endanger the health of his or
18
Id. (citing Wendte v. State, Bd. of Real Estate Appraisers, 70 P.3d 1089,
1091 (Alaska 2003)).
19
Jurgens, 153 P.3d at 325-26 (citing Romulus v. Anchorage Sch. Dist.,
910 P.2d 610, 615 n.3, 618-19 (Alaska 1996)).
20
See AS 08.64.331(a) (identifying sanctions that the Medical Board “may”
impose under various circumstances); AS 44.62.570(b) (identifying judicial inquiry on
appeal as limited to the questions of jurisdiction, “whether there was a fair hearing,” and
“whether there was a prejudicial abuse of discretion”); see also, e.g., Colo. Real Estate
Comm’n v. Hanegan, 947 P.2d 933, 936 (Colo. 1997) (en banc) (“The imposition of
sanctions is a discretionary function which, if within the statutory authority of an agency,
must not be overturned unless that discretion is abused.”); Wasfi v. Dep’t of Pub. Health,
761 A.2d 257, 267 (Conn. App. 2000) (“If the penalty meted out is within the limits
prescribed by law, the matter lies within the exercise of the [agency’s] discretion and
cannot be successfully challenged unless the discretion has been abused.” (alteration in
original) (quoting Gibson v. Conn. Med. Examining Bd., 104 A.2d 890, 895 (Conn.
1954))).
21
See also AS 08.64.101(3).
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her patients.”22 Sanctions for professional incompetence may range from a letter of
reprimand or required education to revocation of a medical license.23 Given the serious
nature of the deprivation, the decision to revoke a medical license should be supported
by clear and convincing evidence.24 We agree with the Washington Supreme Court’s
observation that “an elevated standard of proof militates against the possibility that the
fact finder might deprive an individual of his license based solely on a few isolated
incidents of unusual conduct.”25
Dr. Odom challenges the Medical Board’s decision to revoke his license
as lacking substantial evidence in support of it. His argument targets the Board’s two
underlying findings: (1) that prescribing phentermine to S.Q. was below the standard of
care because of her cardiomyopathy, and (2) that prescribing thyroid hormone to S.Q.
was below the standard of care because the dosage prescribed was excessive and it
should not have been given in combination with phentermine. We agree that the Board’s
decision lacks sufficient support in the evidence.
22
12 Alaska Administrative Code (AAC) 40.970 (2017).
23
AS 08.64.331(a).
24
See Storrs v. State Med. Bd., 664 P.2d 547, 555 (Alaska 1983) (adopting
superior court decision that affirmed Medical Board’s findings of professional
incompetence under a clear and convincing standard); In re Hanson, 532 P.2d 303, 308
(Alaska 1975) (“[T]he serious nature of the proceeding in depriving one of a public
[judicial] office . . . ought, at the very least, to require proof by clear and convincing
evidence.” (alterations in original) (quoting In re Laughlin, 265 S.W.2d 805, 809 (Tex.
1954))).
25
Nguyen v. State, Dep’t of Health Med. Quality Assurance Comm’n, 29 P.3d
689, 696 (Wash. 2001) (citing Addington v. Texas, 441 U.S. 418, 427 (1979); Santosky
v. Kramer, 455 U.S. 745, 764 (1982)).
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A. The Medical Board’s Decision Does Not Support License Revocation.
We begin by explaining why the Medical Board’s decisional document
does not support its conclusion regardless of how we view the evidence of Dr. Odom’s
treatment of S.Q. We note parenthetically that the Medical Board’s adoption of the
Division’s proposal as its final decision was clearly not what the Division had
anticipated; the Division had proposed that the Board amend the ALJ’s decision in some
particulars, and the only sanctions it discussed were a license suspension or alternatively
“a fine, reprimand, probation, education, and permanent restriction on respondent’s
practice, including a prohibition against prescribing phentermine and thyroid hormone
to patients.”
The Board’s procedure was also irregular. The law requires that the Board
support the revocation of a medical license with a written decision and “a brief and
concise statement of the grounds and reasons for the action.”26 The decisional document
of any administrative body, “done carefully and in good faith, serves several salutary
purposes,” such as “facilitat[ing] judicial review by demonstrating those factors which
were considered” and “tend[ing] to ensure careful and reasoned administrative
deliberation.”27 An ALJ’s proposed decision is usually in a form that will serve these
purposes, if it is adopted by the Board.28 And AS 44.64.060(e) sets out other options if
26
AS 08.64.340; see also Peninsula Mktg. Ass’n v. State, 817 P.2d 917, 922
(Alaska 1991) (observing that “agency decisions, in exercise of their adjudicative
powers, must be accompanied by written findings and a decisional document” (quoting
Messerli v. Dep’t of Nat. Res., State of Alaska, 768 P.2d 1112, 1118 (Alaska 1989))).
27
Se. Alaska Conservation Council, Inc. v. State, 665 P.2d 544, 549 (Alaska
1983), superseded by statute on other grounds, Ch. 86, § 1, SLA 2009.
28
See, e.g., In re Bartling, OAH No. 12-0221-MED at 13 (July 19, 2013)
(continued...)
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the Board declines to adopt the ALJ’s proposed decision, including returning the case
to the ALJ for further proceedings, changing the ALJ’s recommended disposition, and
rejecting, modifying, or amending the ALJ’s factual findings (“by specifying the affected
finding and identifying the testimony and other evidence relied on by the agency for the
rejection, modification, or amendment of the finding”).29 The Medical Board’s “non­
adoption options” do not expressly contemplate accepting one party’s proposal for action
as the Board’s decision, as the Board did here; that may work sometimes, but on the
other hand the proposal for action may well be, as it was here, a piece of party advocacy
rather than an ostensibly impartial decisional document that clearly sets out the Board’s
rationale and helps facilitate judicial review.
The document that became the Board’s final decision in this matter thus
contains no findings of its own but asserts that its conclusion can be reached “based on
the evidence contained in the [ALJ’s] proposed decision (including the product literature),
and the Board’s own medical expertise.” But the document also suggests specific
amendments to the ALJ’s decision and invites the Board to enlist the assistance of the
attorney general’s office in making revisions. While a member of the public who has both
the Division’s proposal for action and the ALJ’s recommended decision in hand could
thus — perhaps — stitch together a single decisional document with a coherent narrative,
28
(...continued)
(adopting proposed decision); In re Ilardi, OAH No. 10-0114-MED at 10 (Oct. 28, 2010)
(same).
29
The Medical Board could also prepare its own decision, as in In re Emery,
OAH No. 07-0169-MED (Jan. 30, 2009). See also State, Div. of Corps., Bus. & Prof’l
Licensing, Alaska Bd. of Nursing v. Platt, 169 P.3d 595, 598 (Alaska 2007) (reviewing
Board of Nursing decision adopting hearing officer’s findings of fact and conclusions
of law but adding its own different analysis).
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it is not at all clear that the document’s factual findings would lead to its conclusion. And
the Board’s decision on remand, after considering Dr. Odom’s late-filed proposal for
action, adds no explanation other than the conclusory statement that its earlier decision,
as embodied in the Division’s proposal for action, was supported by substantial evidence.
Most importantly, the document that became the Board’s final decision
expressly states that “[i]mposing a suspension on Dr. Odom’s license would be consistent
with prior Board decisions involving inappropriate prescribing by physicians” (emphasis
added) and supports this statement with a discussion of relevant legal authorities. The
Board, however, revoked Dr. Odom’s license instead, based not on any written
explanation but presumably on its discussion in executive session. By statute, the
Medical Board must be “consistent in the application of disciplinary sanctions,” and “[a]
significant departure from earlier decisions of the board involving similar situations must
be explained in findings of fact or orders made by the board.”30 In professional
incompetence cases, the Medical Board has generally “directed its efforts to imposing
appropriate limits on [the doctor’s] practice or to seeking to upgrade [the doctor’s]
performance.”31 This approach is reflected in the Division’s proposal in this case that the
Board, to be consistent with its precedent, impose a suspension or consider lighter
sanctions as alternatives.
License revocations, in contrast, are more likely to follow revocations in
other states or convictions for crimes such as fraud, felony drug offenses, or sex
30
AS 08.64.331(f).
31
In re Kohler, OAH No. 10-0635-MED at 51-52 (June 7, 2011) (identifying
the specific area in which a doctor was incompetent and restricting him from practicing
in the area of his incompetence).
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offenses.32 We have also affirmed a license revocation based on “a pattern of
inadequacy,”33 but this case involves only Dr. Odom’s treatment of S.Q.; the Division did
not allege or pursue a claim that Dr. Odom acted incompetently in any cases besides this
one. And given the Division’s further concession that Dr. Odom’s treatment of S.Q. had
no causal connection to her death, there is no reason apparent in the Board’s decisional
document why S.Q.’s case alone would warrant a sanction that is inconsistent with the
Board’s precedent.
We conclude that the Board’s final decision fails to comply with its statutory
duty to “be consistent in the application of disciplinary sanctions” or explain the
inconsistency,34 and it therefore does not support the sanction imposed.
B. The Medical Board’s Conclusion That Dr. Odom’s Prescription Of
Phentermine To S.Q. Was Below The Standard Of Care In His Field Of
Practice Is Not Supported By Substantial Evidence.
The Medical Board’s decisional document is legally insufficient not only
with regard to its choice of sanction, but also in its conclusion that Dr. Odom acted
incompetently. One of the reasons the Board gave for adopting the Division’s position
was that it was “unprofessional, incompetent, and below the standard of care for
Dr. Odom to prescribe phentermine to a patient with known cardiomyopathy.” This
32
ALASKA MEDICAL BOARD, SUMMARY OF BOARD ACTIONS - 1997 TO
PRESENT (Feb. 9, 2017), https://www.commerce.alaska.gov/web/portals/5/pub/
MED_1997_to_2017_Board_Action_Summary.pdf.
33
Storrs v. State Med. Bd., 664 P.2d 547, 555-56 (Alaska 1983) (finding a
“pattern of inadequacy” based on five cases over five years in which a doctor
demonstrated an inability to foresee common complications, obtain consultations for
developing complications, and apply diagnostic and corrective measures once
complications arose).
34
AS 08.64.331(f).
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conclusion relied primarily on the testimony of Dr. Nolan, bolstered by product literature
and a reference book. But we conclude that this evidence is far from clear and convincing
and is insufficient to support the Board’s finding of incompetence.
Dr. Nolan, the Division’s only medical witness, testified that he was board
certified in internal medicine and endocrinology.35 He testified that his practice usually
involves patients who have diabetes or some kind of thyroid disease; many of his diabetic
patients “have weight problems,” but he does not use any drug therapy specifically for
weight loss. Indeed, when asked by the Division at the outset of its investigation whether
he “perform[ed] the type of practice which is in dispute in this matter,” he answered “No,”
explaining that he did not prescribe the medicines at issue. He testified at the hearing that
he has not prescribed phentermine “in many years” because he found it to be ineffective
“in the long run” and because “it’s very controversial.”
Dr. Nolan nonetheless did not review any recent studies of phentermine
before forming his opinions in the case and, despite his role as an expert witness, admitted
that he “ha[d]n’t researched it out that carefully.” He testified that he had reviewed the
“package insert”; the online entry for phentermine in the Physician’s Desk Reference,
which contains the same manufacturer-provided information as the package insert; and
Lexicomp’s Drug Information Handbook, which he described as a more reliable
sourcebook prepared by the American Pharmacists’ Association. He described the
package insert as contraindicating the use of phentermine for patients with “cardiac
35
Dr. Nolan described internal medicine as including “a whole list of . . .
different subspecialities: pulmonary disease, cardiology, gastrointestinal, rheumatology,
dermatology, endocrinology,” and he defined endocrinology as the “study of endocrines,
. . . which are the ductless glands in your body: the pituitary, the thyroid, the adrenal,
outlet cells in the pancreas, parathyroid, things like that.” See also Endocrinology,
STEDMAN’S MEDICAL DICTIONARY (28th ed. 2006).
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disease,” and he testified that contraindications in package inserts are clear statements to
physicians not to prescribe a drug under the given circumstances. He also testified that
the Drug Information Handbook contains a “severe warning” against the use of
“stimulants . . . in patients with . . . cardiomyopathy.” Dr. Nolan admitted, however, that
“the package insert [for a drug] may or may not be totally reliable” and that a physician
should not rely solely upon the Drug Information Handbook either. But he also testified
that he had asked seven cardiologists whether they would “consider using phentermine
in a patient with known cardiomyopathy,” and they all answered, “Absolutely not.” He
concluded that Dr. Odom should not have prescribed phentermine to treat S.Q.’s obesity
because of her history of cardiomyopathy, and that doing so was below the standard of
care.
The manufacturer’s literature for phentermine clearly states that the drug is
contraindicated for patients with cardiovascular disease, though whether that includes
S.Q.’s asymptomatic peripartum cardiomyopathy is a debatable issue, one that the ALJ
noted but did not decide.36 The Division argued for a broad interpretation of the
contraindications and warnings as applying to all kinds of heart diseases and conditions,
and the Board ostensibly adopted that interpretation. But we need not consider this issue
ourselves; regardless of whether phentermine’s manufacturer intended cardiomyopathy
to be among the listed contraindications, the evidence disproportionately supports a
conclusion that the contraindications do not establish a relevant standard of care, and
36
Dr. Nolan testified that cardiomyopathy is a form of cardiovascular disease.
Both of Dr. Odom’s experts testified that S.Q.’s condition, peripartum cardiomyopathy,
is a disease of the heart muscle rather than the vascular system, is thus not a
cardiovascular disease, and is not among phentermine’s listed contraindications.
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furthermore that Dr. Odom’s prescription of phentermine to S.Q. was within the standard
of care for physicians who practice in his field.
Dr. Bryman, one of Dr. Odom’s expert witnesses, is a physician licensed in
Alaska and several other states who practices primarily in bariatrics. He has served on
the American Board of Bariatric Medicine and is active in the American Society of
Bariatric Physicians. He testified that he is “very familiar” with phentermine; he has
prescribed it in his practice for over 20 years, has lectured on the drug, and has defended
other physicians’ use of the drug. As the ALJ summarized Dr. Bryman’s testimony,
“phentermine is routinely prescribed for anorectic [appetite-suppressant] purposes by
bariatric physicians nationwide.”
Dr. Bryman also addressed phentermine’s contraindications. He strongly
supported Dr. Odom’s view that contraindications on drug labels generally are not
binding on physicians and do not establish a standard of care,37 and that the product
literature on phentermine in particular was outdated and misleading. While disputing that
cardiomyopathy is a cardiovascular disease, he discussed several studies indicating that
phentermine did not cause the adverse cardiovascular effects the product literature warns
about. Both Dr. Bryman and Dr. Rouzier, Dr. Odom’s other expert witness, testified that
phentermine’s contraindications and warnings regarding its use with cardiac patients were
37
The ALJ cited several federal cases in support of this proposition. See
Planned Parenthood Sw. Ohio Region v. Dewine, 696 F.3d 490, 496 n.4 (6th Cir. 2012)
(“The FDA regulates the marketing and distribution of drugs by manufacturers, not the
practices of physicians in treating patients.”); Weaver v. Reagan, 886 F.2d 194, 198
(8th Cir. 1989) (“FDA approved indications were not intended to limit or interfere with
the practice of medicine nor to preclude physicians from using their best judgment in the
interest of the patient.”); id. (“Once a product has been approved for marketing, a
physician may prescribe it for uses or in treatment regimens or patient populations that
are not included in approved labeling.” (quoting 12 FDA DRUG BULLETIN 1, at 4-5
(1982), http://www.circare.org/fda/fdadrugbulletin_041982.pdf)).
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based on 50-year-old research on amphetamines, a chemically related but fundamentally
different compound with much different effects, and that the drug’s literature had not been
updated despite new studies showing that “phentermine does not have any of those
properties that . . . amphetamines [have].” Dr. Bryman testified that the FDA had recently
approved a new drug containing phentermine based on studies that showed no adverse
cardiovascular effects at all. He testified that about 30% of his own patients had some
form of heart disease and were referred to him by their cardiologists, and that he
prescribed phentermine to patients with cardiomyopathy.
Dr. Bryman noted that S.Q.’s medical records showed no increase in her
heart rate or blood pressure while she was on phentermine, and that in fact, because of her
obesity and cardiomyopathy, she was “a perfect patient for” the drug. He concluded
“with certainty that [Dr. Odom] practiced to the standard of care like a reasonable doctor
would treat a patient and not allow her to continue her obesity and worsen her condition.
So he intervened appropriately, in my opinion, and she got better.” Dr. Rouzier, too,
testified adamantly that the best treatment for S.Q.’s obesity was weight loss and that
phentermine was a safe and effective way to promote it.
The ALJ who presided over the evidentiary hearing noted that the Division
“did not call S.Q.’s treating cardiologist, or any other cardiologist, as a witness, and it did
not admit into evidence any studies of phentermine to support the allegations of the
accusation.” The ALJ contrasted the Division’s expert witness, Dr. Nolan, who “has little
clinical experience with phentermine,” with Dr. Odom’s expert witness, Dr. Bryman, who
had “substantial clinical experience with phentermine, including the use of phentermine
for patients referred by cardiologists.” The ALJ concluded that “the Division has not
shown by a preponderance of the evidence that it was below the standard of care to
prescribe phentermine to S.Q.” We agree with this conclusion, noting that it is even more
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strongly compelled under the applicable clear and convincing evidence standard.38 The
evidence detracting from the Board’s decision is dramatically disproportionate to the
evidence in support of it, meaning that we cannot conscientiously say that the supporting
evidence is substantial.39
Finally, the Division’s proposal for action — the Board’s final decision —
cited an earlier Medical Board decision in support of the proposition that a doctor’s
prescription contrary to manufacturer-provided contraindications can show a breach of
the standard of care. In re Bartling dealt in part with a claim that a doctor had prescribed
an opioid to a patient who was not opioid tolerant, “contrary to FDA warnings” listed on
the product’s packaging.40 The Board concluded that the patient actually was opioid
tolerant and therefore there was no violation of the standard of care.41 But the Board
noted the testimony of two experts that “the warning was a guide, and that in some cases
it is medically appropriate to prescribe [the drug] to a patient who is not opioid tolerant”
despite the warnings.42 And the Board in Bartling did not have to address issues like
those in this case about whether more recent research and clinical experience undermined
38
See Storrs, 664 P.2d at 555; Nguyen v. State, Dep’t of Health Med. Quality
Assurance Comm’n, 29 P.3d 689, 696 (Wash. 2001).
39
See Shea v. State, Dep’t of Admin., Div. of Ret. & Benefits, 267 P.3d 624,
634 n.40 (Alaska 2011).
40
OAH No. 12-0221-MED at 9 (July 19, 2013).
41
Id. at 10.
42
Id.
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the credibility of the product literature. Bartling does not support the Board’s decision
in this case.43
C. The Medical Board’s Conclusion That Dr. Odom’s Prescription Of
Thyroid Hormone Fell Below The Standard Of Care In His Field Of
Practice Was Not Supported By Substantial Evidence.
The Medical Board also adopted as its final decision the Division’s argument
that Dr. Odom’s conduct was “unprofessional, incompetent, and below the standard of
care” when he prescribed thyroid hormone to S.Q. The Board apparently accepted the
ALJ’s relevant factual findings: that Dr. Odom prescribed Armour Thyroid in late June
2007 with a beginning dosage of 120 milligrams a day, increasing to 180 milligrams after
two weeks and 240 milligrams after four weeks, and that he decreased it to 180
milligrams in September after S.Q. reported jitteriness on the 240-milligram dose. While
the ALJ found no breach of the standard of care in this chronology, the Board reached
two much different conclusions: (1) that Dr. Odom prescribed an excessive dosage of
thyroid hormone, and (2) that it was inappropriate to prescribe thyroid hormone along
with phentermine given the risks associated with using the two drugs in combination. Dr.
Odom argues that these findings are not supported by substantial evidence, and again we
43
The Board’s decision also cites cases from other jurisdictions in which
doctors were found to have inappropriately prescribed phentermine to patients with
cardiac problems. Zac v. Riffel, 115 P.3d 165, 170 (Kan. App. 2005) (expert testified
that phentermine should not have been prescribed to a patient with left ventricular
dysfunction); Fletcher v. Pa. Prop. & Cas. Ins. Guar. Ass’n, 27 A.3d 299, 302 (Pa.
Cmmw. 2011) (malpractice damages awarded, in part, because phentermine was
inappropriately prescribed to a patient with coronary artery disease); Ancier v. State,
Dep’t of Health, 166 P.3d 829, 834 (Wash. App. 2007) (doctor inappropriately
prescribed 180,000 medications, including phentermine, over the internet; expert testified
that phentermine is dangerous for patients with cardiovascular disease). None of these
cases address S.Q.’s particular malady, asymptomatic peripartum cardiomyopathy.
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agree with him, particularly in light of the clear and convincing evidence standard
applicable to professional licensing revocations.
The Medical Board adopted the Division’s argument that S.Q. “received too
much thyroid too soon” because “the product literature state[s] that for hypothyroidism,
the usual starting dose [of Armour Thyroid] was 30mg, with increments of only 15mg
every 2 to 3 weeks,” whereas S.Q. started with 120 milligrams and reached 240
milligrams five weeks later. The Board’s decision is supported by the testimony of
Dr. Nolan, who did not prescribe Armour Thyroid in his own practice but opined that Dr.
Odom prescribed too much of it, basing his opinion on what he read in the Drug
Information Handbook and the manufacturer’s literature. Dr. Nolan testified that the
Drug Information Handbook says the “recommended adult dosage” of Armour Thyroid
is “[f]ifteen to 30 milligrams initially.”
But the Drug Information Handbook and the manufacturer’s literature both
use the word “recommended” only in conjunction with pediatric dosages, which range
from 15 milligrams to “over 90” milligrams. The manufacturer’s literature does state that
the “usual starting dose” is 15 to 30 milligrams, to be scaled up by 15 milligrams every
few weeks. And the manufacturer’s literature and the Handbook agree that “[m]ost
patients require 60 to 120 mg/day.” But neither the manufacturer’s literature nor the
Handbook supports the Board’s necessary extrapolation: that S.Q. was among “most
patients” for whom the “usual starting dose” was the only medically appropriate one, and
that prescribing dosages other than the usual ones was necessarily unsafe or below the
standard of care.
Aside from the dosages listed in the Drug Information Handbook and the
manufacturer’s literature, the only evidence of a proper dosage at the hearing came from
Dr. Odom and his expert witness, Dr. Rouzier, who regularly teaches courses in hormone
replacement for “various medical academies” including the American Academy of Family
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Physicians. Dr. Odom testified that the “average” adult dosage is 4 grains
(240 milligrams) per day. Dr. Rouzier testified that the “standard” dosage is between
2 and 4 grains (120 to 240 milligrams) per day. Dr. Rouzier also testified that S.Q.’s
dosages — from 120 milligrams to 240 milligrams then back down to 180 milligrams per
day — were “very appropriate” and “within the range of what’s standard and available
. . . for us to prescribe.” According to Dr. Rouzier, S.Q.’s dosage even at its highest “was
a standard, middle-of-the-range, middle-run dose. Not too high, not too low.” He also
testified that the drug manufacturer makes 4 grain, 5 grain, and 6 grain tablets; the
manufacturer’s literature and the Drug Information Handbook confirm that 4 grain and
5 grain tablets (240 and 300 milligrams) are available, which runs counter to the Medical
Board’s conclusion that S.Q.’s lower dosages were necessarily “excessive.”
Dr. Rouzier’s and Dr. Odom’s estimates of “standard” dosages are indeed
higher than what the Drug Information Handbook lists as usual maintenance doses
(“[u]sually 60-120 mg/day”), but every patient cannot be the usual patient.44 The
manufacturer’s literature adds, “The dosage of thyroid hormones . . . must in every case
be individualized according to patient response and laboratory findings.” Dr. Rouzier
testified accordingly that some patients achieve the best results from taking significantly
higher doses of thyroid hormone than those prescribed to S.Q. According to Dr. Rouzier,
S.Q.’s dosages were within the safe range.
The Division presented some evidence about the risks of excessive thyroid
hormone. The manufacturer’s literature notes that “[e]xcessive doses of thyroid result in
44
Dr. Rouzier explained that “normal” simply refers to “an average of the
population” rather than what might be best for a particular patient. And Dr. Bryman
explained that “normal” can differ between patients at a healthy weight and those who
are obese, just as “normal” will differ between pediatric and geriatric patients.
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a hypermetabolic state,” essentially inducing hyperthyroidism.45 Dr. Nolan testified that
too much thyroid hormone can eventually lead to atrial fibrillation and bone loss, and
Dr. Rouzier testified that extremely high doses could lead to “palpitations [and]
tachycardia.” But Dr. Rouzier also testified that if a patient starts seeing side effects like
jitteriness (as S.Q. did), the dosage can simply be scaled back, and the drug’s effect will
dissipate in less than 24 hours. This is consistent with the manufacturer’s literature,
which suggests that overdoses of Armour Thyroid be treated by simply reducing or
temporarily discontinuing the usual dosage. And the Division failed to establish how
much thyroid hormone is too much.46 Again, we cannot conscientiously say that the
Medical Board’s finding that Dr. Odom prescribed an excessive dosage of Armour
Thyroid is supported by substantial evidence, particularly given the clear and convincing
evidence standard the Division was required to meet.
Similarly unsupported is the Board’s conclusion that S.Q. “received too
much thyroid hormone too soon.” There was little evidence on this issue presented at the
hearing. In Dr. Nolan’s rebuttal testimony he referred to the dosage as being “excessive
to start with,” apparently by referencing only the “usual dosages” entry in the Drug
Information Handbook. But again, there is no basis in the record for inferring that a
physician breaches the standard of care unless he treats every patient as the “usual”
45
Hyperthyroidism is “[a]n abnormality of the thyroid gland in which
secretion of thyroid hormone is usually increased and no longer under regulatory control
of hypothalamic-pituitary centers.” Hyperthyroidism, STEDMAN’S MEDICAL DICTIONARY
(28th ed. 2006).
46
Dr. Nolan testified that in his experience, “most people [taking] around 3
or 4 grains [180 to 240 milligrams] of dessicated thyroid per day will have perturbation
of thyroid function, which is not desirable.” But Dr. Nolan also admitted that he never
prescribes Armour Thyroid, and that he believes the use of Armour Thyroid to be
“substandard and unconventional.” He testified that practitioners in the field of
endocrinology have sought to remove Armour Thyroid from the market.
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patient. Given the strong contrary testimony of Dr. Odom and Dr. Rouzier, we conclude
that substantial evidence does not support the Board’s finding that a starting dosage
differing from those listed in the Drug Information Handbook indicated a breach of the
standard of care.
The Medical Board also accepted the Division’s argument that it was unsafe
for Dr. Odom to combine thyroid hormone and phentermine when prescribing for S.Q.
In support of this argument the Division cited only the product literature for Armour
Thyroid, which reads in part, “Larger doses may produce serious or even life-threatening
manifestations of toxicity, particularly when given in association with sympathomimetic
amines [e.g., phentermine] such as those used for their anorectic effects.” But this
warning is explicitly directed toward the drug’s use “[i]n euthyroid patients,” meaning
patients with normal thyroid gland function.47 Whether S.Q. had normal thyroid gland
function was another disputed issue. Dr. Nolan testified that she did, based on laboratory
tests showing thyroid levels within the normal range. The ALJ’s recommended decision,
however, described the symptoms that led Dr. Odom to his clinical diagnosis of
hypothyroidism and noted the dispute between physicians who rely on lab tests to
determine normal thyroid function and those who “subscribe to an alternative view,
accepted by many clinicians in their field of practice, to the effect that normal laboratory
findings simply reflect the thyroid hormone levels found in the population generally,
rather than the levels that will result in optimal functioning.” But this dispute was
ultimately irrelevant, because, as the ALJ concluded, “the Division’s accusation did not
allege that Dr. Odom misdiagnosed hypothyroidism,” but rather that, assuming S.Q. had
hypothyroidism, he prescribed too much thyroid hormone to treat it.
47
See Euthyroidism, STEDMAN’S MEDICAL DICTIONARY (28th ed. 2006).
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Besides the manufacturer’s literature, Dr. Nolan also testified that “excess
thyroid hormone and [p]hentermine is not a good combination”; “[t]he risks of using
phentermine with high doses of Armour Thyroid in persons with established
cardiomyopathy is not a good idea. It’s just too risky.” But Dr. Nolan did not explain
why the combination was unsafe, nor did his testimony shed light on whether he believes
phentermine combined with lower doses of thyroid hormone would be within the standard
of care.48
Finally, both Dr. Rouzier and Dr. Bryman, who were able to testify from
their own direct experience treating patients in Dr. Odom’s fields of practice, concluded
that Dr. Odom was acting within the standard of care in prescribing phentermine and
thyroid hormone to S.Q. Dr. Rouzier testified, “The only thing that helps [obese,
hypothyroid] patients is weight loss. Get the fat off. . . . How do you do that?
Phentermine and thyroid.”
Having reviewed the record, “we cannot ‘conscientiously’ find the evidence
supporting the [Board’s] decision to be ‘substantial,’ ”49 particularly given the clear and
convincing evidence standard the Division was required to meet. The record does not
support the Medical Board’s conclusion that Dr. Odom prescribed excess thyroid
48
The Board’s decision does not appear to rely on the Drug Information
Handbook for its findings about the use of thyroid hormone and phentermine in
combination. The Handbook does not suggest that combining the two drugs is unsafe.
The Handbook’s section on phentermine advises prescribing physicians to “[a]void
concomitant use” of phentermine with several drugs but not including thyroid hormone,
and the Handbook does not include thyroid hormone in the list of drugs for which
phentermine may increase or decrease the effect or toxicity. Nor does the Handbook’s
section on thyroid hormone warn against combining it with phentermine.
49
Shea v. State, Dep’t of Admin., Div. of Ret. & Benefits, 267 P.3d 624, 634
n.40 (Alaska 2011).
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hormone to S.Q., or that it was unsafe or incompetent to prescribe phentermine in
combination with thyroid hormone.
D. The Medical Board’s Decision Must Be Reversed.
We conclude that the Division failed to prove that Dr. Odom “lack[s]
sufficient knowledge, skills, or professional judgment in that field of practice in which
[he] engages.”50 We note that the legislature has expressly warned against “bas[ing] a
finding of professional incompetence solely on the basis that a licensee’s practice is
unconventional or experimental in the absence of demonstrable physical harm to a
patient.”51 The Division disclaims any intent to violate this statutory directive, but it is
hard to overlook the fact that this case, involving no “demonstrable physical harm to a
patient,” resulted in the Board excessively sanctioning the respondent for an approach that
the evidence showed was commonly taken by physicians in his field of practice.52 We
50
See 12 AAC 40.970 (defining “professional incompetence”).
The Division argues on appeal that “Dr. Odom’s ‘field of practice’ in this
context was the prescribing of controlled substances and other drugs and he was not free
to ignore contraindications or dosage limits merely by claiming that he was a weight loss
or an antiaging physician.” We reject the argument that “the prescribing of controlled
substances” is itself a field of practice; this would presumably allow any medical
professional with prescribing authority to testify about the standard of care for
prescribing drugs in a specialty of which the witness has no knowledge or practical
experience. While the applicable definition of incompetence is regulatory rather than
statutory, it is noteworthy that in the analogous context of medical malpractice cases the
legislature has mandated that only those experts who practice in the defendant’s “field
or specialty” are qualified to offer opinions on the standard of care. AS 09.55.540(a)(1).
It would seem incongruous to require something less when a physician’s license is at
stake.
51
AS 08.64.326(a)(8)(A).
52
As the ALJ properly noted, Dr. Nolan’s opinion was “the view of the
(continued...)
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conclude that the Medical Board lacked sufficient evidence to support its findings and that
the Medical Board abused its discretion by revoking Dr. Odom’s medical license.
V. CONCLUSION
For the foregoing reasons, we REVERSE the superior court’s decision
affirming the decision of the Medical Board to revoke Dr. Odom’s medical license.
52
(...continued)
American Association of Clinical Endocrinologists. Dr. Odom and Dr. Rouzier
subscribe to an alternative view, accepted by many clinicians in their field of practice.”
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