MARK R. GEIER
MARYLAND STATE BOARD OF PHYSICIANS
Woodward, Graeff, Moylan, Jr., Charles E. (Retired, Specially Assigned), JJ.
Mark R. Geier ("Dr. Geier"), appellant, seeks review of the decision of the Maryland State Board of Physicians (the "Board"), appellee, to revoke his license to practice medicine. The Board revoked his license after it determined that he violated numerous provisions of the Medical Practice Act (the "Act"), Md. Code (2009 Repl. Vol.) §§ 14-401 et seq., of the Health Occupations Article ("HO"), including HO §§ 14-404(a)(3)(ii) (unprofessional conduct in the practice of medicine), 14-404(a)(11) (willfully making or filing a false report or record in the practice of medicine), 14-404(a)(22) (failing to meet standards, as determined by peer review, for the delivery of quality medical care), 14-404(a)(40) (failing to keep adequate medical records), and 14-404(a)(12) (willfully failing to file or record any medical report as required under law, willfully impeding or obstructing the filing or recording of the report, or inducing another to fail to file or record the report).
Dr. Geier petitioned for judicial review in three jurisdictions, the Circuit Court for Baltimore City, the Circuit Court for Baltimore County, and the Circuit Court for Montgomery County. After Dr. Geier voluntarily dismissed his petitions in Baltimore City and Baltimore County, the Board moved to dismiss the remaining petition on res judicata grounds, pursuant to Md. Rule 2-506(c), which provides "that a notice of dismissal operates as an adjudication upon the merits when filed by a party who has previously dismissed in any court of any state or in any court of the United States an action based on or including the same claim." The Circuit Court for Montgomery County denied the Board's motion to dismiss, and it affirmed the Board's decision on the merits.
On appeal, Dr. Geier presents 12 questions for this Court's review, which we have consolidated and rephrased, as follows:
1. Was there substantial evidence in the record to support the Board's findings that Dr. Geier: (1) engaged in unprofessional conduct in the practice of medicine, pursuant to HO § 14-404(a)(3)(ii); (2) willfully made a false record in the practice of medicine, pursuant to HO § 14-404(a)(11); and (3) failed to meet appropriate standards for the delivery of quality medical care, pursuant to HO § 14-404(a)(22)?
2. Did the ALJ abuse its discretion in admitting the testimony of the State's expert witness, Dr. Linda Grossman?
3. Did the ALJ properly exclude from evidence two exhibits offered by Dr. Geier?
4. Did the Board properly reject Dr. Geier's contention that the State was required to admit into evidence two peer review reports?
5. Did the circuit court properly deny Dr. Geier's request to supplement the administrative record?
6. Did the circuit court abuse its discretion in denying Dr. Geier's motion for a stay?
The Board, although it did not file a cross-appeal, lists in its brief the following additional question for review:
Was Dr. Geier's petition for judicial review in the Circuit Court for Montgomery County barred on res judicata grounds under [Md.] Rule 2-506(c) after Dr. Geier voluntarily dismissed two other petitions for judicial review that he had filed to contest the Board's decision?
For the reasons that follow, we conclude that the Board's question presented is not properly before this Court. With respect to the issues raised by Dr. Geier, we shall affirm the judgment of the circuit court.
FACTUAL AND PROCEDURAL BACKGROUND
On October 3, 2006, the Board notified Dr. Geier that it had received a complaint against him regarding his use of the drug Lupron to treat autistic children. The complainant, who was neither a patient of Dr. Geier's, nor a parent of a patient, alleged that, in treating autistic children, Dr. Geier was: (1) practicing outside of the scope of his expertise and the prevailing standard of care for autism; (2) experimenting on children without a rational scientific theory or the supervision of a qualified review board; and (3) failing to provide appropriate informed consent regarding the potential side effects of Lupron and similar drugs.
On April 27, 2011, the Board issued an order for summary suspension of Dr. Geier's license to practice medicine, concluding that the "public health, safety or welfare imperatively required emergency action." On May 16, 2011, the Board issued charges against Dr. Geier pursuant to the Act. Dr. Geier requested hearings on both the order for summary suspension and the charges.
On June 17, 20, 21, 23, 27, and 30, 2011, an Administrative Law Judge ("ALJ") held a hearing on the Board's order for summary suspension. On September 26, 2011, the ALJ issued a proposed decision upholding summary suspension of Dr. Geier's license.
In the interim, on September 15, 2011, the Board issued amended charges under the Act against Dr. Geier. The amended charges alleged violations of HO §§ 14-404(a)(3)(ii) (unprofessional conduct in the practice of medicine); (a)(11) (willfully making or filing a false report or record in the practice of medicine); (a)(12) (willfully failing to file or record any medical record as required under law); (a)(18) (practicing medicine with an unauthorized person or aiding an unauthorized person in the practice of medicine); (a)(19) (gross overutilization of health care services); (a)(22) (failure to meet appropriate standards for the delivery of quality medical care); and (a)(40) (failure to keep adequate medical records).
On December 6, 7, 8, 9, and 15, 2011, the ALJ held a hearing on the amended charges. At the hearing, by agreement of the parties, the entire record of the prior summary suspension hearing, including all testimony presented and all exhibits admitted, were incorporated into evidence. On March 13, 2012, following the hearing, the ALJ issued a 126-page proposed decision, recommending that the amended charges be upheld with regard to HO §§ 14-404(a)(3)(ii), 14-404(a)(11), 14-404(a)(22), and 14-404(a)(40) and dismissed with regard to HO §§ 14-404(a)(12), 14-404(a)(18), and 14-404(a)(19). The ALJ recommended that Dr. Geier's license be revoked.
In April 2012, Dr. Geier filed exceptions to the ALJ's proposed decision. On May 23, 2012, the Board held an exceptions hearing. On August 22, 2012, the Board issued a Final Decision and Order, ordering that Dr. Geier's license be revoked.
The Board found, among other things, that Dr. Geier treated patients with Lupron, a medication that was not approved by the U.S. Food and Drug Administration ("FDA") for use on children in the absence of precocious puberty, and that Dr. Geier did not perform an adequate examination to determine if the patients had precocious puberty. Although it noted Dr. Geier's opinion that Lupron therapy was appropriate for purposes not approved by the FDA or the American Academy of Pediatrics, and his testimony that he treated patients who met his profile with Lupron, it found that, with the exception of one patient who was the subject of the hearing, "none of these patients met even Dr. Geier's profile for Lupron therapy."
The Board also found that Dr. Geier
prescribed chelation therapy to patients who failed to display the need for chelation. He began this therapy without documenting a reason for the treatment and without adequate documented informed consent. He violated the standard of quality care by so doing. He also violated the standard of quality care by prescribing for patients . . . a drug not approved for any use in the United States.
(Footnotes omitted). The Board found that Dr. Geier "egregiously violated basic medical standards in his treatment of these patients by not evaluating them properly, lying about which drug he was prescribing, and failing to evaluate in any realistic medical way whether his intensive and very expensive treatment was effective."
The Board concluded that Dr. Geier violated multiple provisions of the Act, stating as follows:
Dr. Geier committed unprofessional conduct in the practice of medicine within the meaning of [HO] § 14-404(a)(3)(ii) when he had parents sign a consent form that falsely implied that he was conducting an experimental protocol approved by an Institutional Review Board [("IRB")] when in fact that review board was, as the ALJ put it, "a façade covering the intentions of a group that did not believe that they were bound by federal or state law and had no intention of being so bound." He committed further unprofessional conduct when he had a parent sign a consent form for the use of one drug for chelation therapy when in fact another drug, a drug not approved for use in the United States, was intended to be used and was in fact used. His violations of the standard of care, especially his treating of some patients without examining them and his reaching diagnoses in the absence of required diagnostic tests, were so egregious as to amount to unprofessional conduct in themselves.
By willfully reporting false credentials when he applied for the renewal of his medical license, Dr. Geier made a willfully false statement in the practice of medicine within the meaning of [HO] § 14-404(a)(11).
By failing to properly evaluate patients before treating them with an intensive regimen of drug therapy, by providing the parents with inadequate or falsified consent forms, by failing to properly evaluate whether his treatment was working, by ordering continued therapy to a patient for whom there was no possibility of monitoring the effects, and by failing to keep adequate records, Dr. Geier failed to meet the standard of quality care required by [HO] § 14-404(a)(22).
By failing to document adequately the reasons these treatments were initiated, halted or modified, by failing to maintain clear evidence of informed consent, or even in some cases failing to document even the manner in which the patients were contacted, Dr. Geier failed to keep adequate medical records within the meaning of [HO] § 14-404(a)(12). This charge was based on the fact that the Board's analyst, having subpoenaed Dr. Geier's medical records for a certain patient and having received records that appeared on their face to be incomplete, wrote to Dr. Geier, emphasizing that all medical records for this patient should be produced. The Board's letter also required Dr. Geier to respond in writing if no additional records were submitted. Dr. Geier did not produce any records; neither did he respond in writing as required. According to the testimony provided at the hearing, there were no additional records regarding this patient.
Finally, the Board concluded that Dr. Geier violated HO § 14-404(a)(12). Although the ALJ had concluded that there was no violation of the statute because no records existed that Dr. Geier failed to file with the Board, the Board disagreed. It explained:
The statute elsewhere requires a physician to "cooperate" with the Board's investigation. [HO] § 14-404(a)(33). The most obvious way in which most investigated physicians are asked to cooperate is by filing reports in response to questions posed by an analyst in the course of an investigation. In light of the facts that (1) the statute requires cooperation by the investigated physician; (2) the medical records appeared on their face to be incomplete; and (3) that the analyst required in writing that Dr. Geier respond in writing if there were no additional medical records, Dr. Geier's failure to file a report to the Board to that effect when required by the analyst was a violation of [HO] § 14-404(a)(12).
The Board concluded, however, that this was a "peripheral offense" that was "unrelated to Dr. Geier's actual care of his patients, " and it "pale[d] in comparison to the egregious violations of the standard of care and the egregious unprofessional conduct displayed by Dr. Geier in this case." Accordingly, the Board determined that it would not impose a sanction based upon the violation of HO § 14-404(a)(12).
The Board did impose a sanction, however, for the other violations of the Act. In discussing the appropriate sanction, the Board stated:
Dr. Geier has displayed in this case an almost total disregard of basic medical and ethical standards by treating patients without properly examining or diagnosing them, continuing treatment without properly evaluating its effectiveness, and providing "informed consent" forms that were misleading and in at least one case blatantly false. He provided treatments supposedly according to an investigational protocol, but the investigation was approved only by a sham [IRB], and he applied protocols to patients who did not fit his own profile. He provided treatment by a drug not approved for use in this country while informing parents that a different drug would be used. His actions toward his patients were not those of an honest and competent physician, nor do they appear to be those of an objective and ethical researcher. Dr. Geier made little use of those methodologies that distinguish the practice of medicine as a profession. At the same time, he profited greatly from the minimal efforts he made for these patients. In plain words, Dr. Geier exploited these patients under the guise of providing competent medical treatment. Such a use of a medical license is anathema to the Board. The Board has no hesitation in revoking his medical license.
On September 17, 2012, Dr. Geier petitioned for judicial review. On April 9, 2014, after oral argument, the circuit court affirmed the Board's final decision.
The court initially noted that Dr. Geier did "not address nor refute many of the Board's findings of fact and conclusions of law regarding the violations of the" Act. Those unchallenged determinations included:
[T]he Board's findings that he provided false informed consent to the parent of his patient for use of a drug that was not approved by the FDA for use in the United States, that he failed to properly evaluate his patients prior to treatment and failed to adequately monitor his patients following treatment, and that he failed to adequately document the treatment of his patients.
With respect to the findings that Dr. Geier did challenge, the court concluded that there was substantial evidence to support the Board's decisions that: (1) "Petitioner willfully falsified his license renewal applications"; (2) "Petitioner was performing human research on [one patient] and that an IRB should have been established"; (3) the IRB did not have any members unaffiliated with Dr. Geier and his Institute of Chronic Illness ("ICI"); (4) Dr. Geier violated HO § 14-404(a)(22) and (40); and (5) the Board's expert "was a qualified expert and the Board presented a competent peer reviewer to testify." It further concluded that "the sanction of revoking Petitioner's medical license recommended by the ALJ and imposed by the Board is not arbitrary and capricious."
On April 21, 2014, Dr. Geier moved to alter or amend the court's ruling. On July 9, 2014, the court issued an Amended Memorandum Opinion and Order, reaffirming the Board's decision.
Dr. Geier's Credentials and Practice
Dr. Geier attended medical school at George Washington University. In 1979, after completing medical school, Dr. Geier obtained his medical license from the State of Maryland. Through his medical practice, The Genetic Centers of America, Dr. Geier treated pediatric patients with Autism Spectrum Disorders ("ASD"). Dr. Geier does not have any credentials in pediatrics or autism. Instead, his residency was a one-year program in obstetrics and gynecology, which he completed in 1979.
Medical doctors in Maryland need to renew their license to practice medicine every two years. The License Renewal Form asks the doctor to list "up to two (2) specialty areas only if certified by a recognized board of the American Board of Medical Specialties (ABMS)." On his 2006, 2008, and 2010 license renewal applications filed with the Board, Dr. Geier stated that he was certified by ABMS-recognized specialty boards as follows: in "Genetics/Medical" in 2006; in "Genetics Clinical [General]" in 2008; and in "Genetics, Medical [Ph.D.]" and "Epidemiology" in 2010. Dr. Geier was not Board-certified in any of these specialties. Dr. Geier testified that he selected those categories from the list of ABMS-recognized board certifications because there was no option to state that he was certified by the American Board of Medical Geneticists ("ABMG") as a "genetic counselor." The ABMS's list of recognized physician specialties does not list "genetic counselor" as a medical specialty.
Since 2004, Dr. Geier has treated 1, 500 to 2, 000 children with ASD. At issue in this case was his treatment of seven patients, Patients A, B, E, F, G, H, and I.
The ALJ summarized Dr. Geier's practice as follows:
All the Patients were presented to [Dr. Geier] already diagnosed by another physician with autism or a condition on the autism spectrum. All presented with severe symptoms of autism, and all but Patient G presented with adverse behaviors such as aggression and sexual activities, and accelerated signs of puberty at a young age. [Dr. Geier] diagnosed all the children with Precocious Puberty, administered Lupron therapy to all, and chelation therapy to most. . . .
[Dr. Geier] contends that mercury is the ultimate cause of the Patients' aggressive symptoms. Under his theory, the Patients are handicapped by the presence of a [single nucleotide polymorphism ("SNP")] of their [methylenetetrahydrofolate reductase ("MTHFR")] gene that causes them to be more sensitive and less able to excrete mercury than the general population. This build-up of mercury in their systems interferes with the production of glutathione; glutathione is necessary to prevent a build-up of testosterone and testosterone-related androgens and, conversely, the buildup of testosterone also inhibits the production of glutathione. The build-up of testosterone makes the children more aggressive and increases hypersexual behaviors.
Dr. Geier employed two types of therapy: he would medicate his patients with Lupron, a hormone designed to suppress testosterone and estrogen. In many cases, in addition to administering Lupron, he would use chelation therapy, which is intended to remove high levels of heavy metals, such as lead and mercury, from the body.
Although Lupron is approved by the FDA for use on adults for conditions including prostate cancer, the only approved, or "on-label, " use for Lupron in children is for the treatment of precocious puberty. Testimony indicated that, due to the significant potential risks in the use of Lupron, face-to-face monitoring is required at least every three months.
Dr. Geier used the drugs DMSA (dimercaptosuccinic acid) and DMPS (2, 3-dimercapto-1-propane-sulfonic acid) in his chelation therapy. Although DMSA has been approved by the FDA for removing severe levels of heavy metals from the body, DMPS is not approved by the FDA for any purpose. The ALJ noted that "[p]hysicians who prescribe DMPS must inform their patients or their patients' representatives, of its experimental status in the United States, and have a full disclosure/informed consent document" in the patient's medical chart. Chelation therapy also has the potential for significant adverse complications, and therefore, chelation requires a physician to evaluate the patient face-to-face at least once every month. There is not a consensus in the medical community that chelation therapy should be used to treat ASD.
Dr. Geier diagnosed each patient with precocious, or premature, puberty. The criteria for diagnosing precocious puberty includes a complete history and physical examination, which includes: assessing genital development; determining bone age, which is based upon an X-ray of the wrist; completing hormone studies; and "Tanner Staging, " a medical grading of where a child falls in the steps of puberty. In addition, a diagnosis of precocious puberty generally is reserved for girls under the age of eight and boys under the age of nine.
Despite representing to insurance companies that Lupron was being used to treat precocious puberty, Dr. Geier testified that he would offer the patient's parent a two to three month trial of Lupron if laboratory tests showed certain results. Specifically, he prescribed Lupron if the test results showed that the patient had one or more single genetic changes on a particular gene, low glutathione (a "cofactor" for an enzyme that assists the body to excrete mercury), high testosterone, low levels of the hormone DHEA-S, high levels of the hormone DHEA, and adverse behavioral signs of puberty, such as aggression and hypersexual behavior.
Dr. Geier's Patients
a. Patient A
Patient A, a male, was diagnosed with autism when he was four years old. He was referred to Dr. Geier when he was nine years and eight months old. His initial lab testing indicated that he had high testosterone levels and high DHEA, but normal DHEA-S. Dr. Geier diagnosed him with precocious puberty and prescribed Lupron based on his diagnosis. Dr. Geier also prescribed DMPS for chelation therapy, although his laboratory results did not indicate that there was heavy metal poisoning. There was also no written informed consent form and no documentation that the risks of the treatment were discussed.
b. Patient B
Patient B, a male with autism, was six years old when he was initially assessed by Dr. Geier. Dr. Geier did not perform a physical examination of Patient B at the initial assessment, or at any time during Patient B's treatment. Dr. Geier's precocious puberty diagnosis did not include any information about bone age or Tanner Stage assessments. Dr. Geier prescribed both Lupron and DMPS for the patient. The patient's parents were sent a ...