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Bicher v. Superior Court

California Court of Appeals, Third District, Sacramento
Feb 29, 2008
No. C052927 (Cal. Ct. App. Feb. 29, 2008)

Opinion


JAMES H. I. BICHER, Petitioner, v. THE SUPERIOR COURT OF SACRAMENTO COUNTY, Respondent MEDICAL BOARD OF CALIFORNIA, Real Party in Interest. C052927 California Court of Appeal, Third District, Sacramento February 29, 2008

NOT TO BE PUBLISHED

Super. Ct. No. 04CS01313

NICHOLSON, Acting P.J.

In this writ proceeding, we face a conflict between a doctor who rendered apparently beneficial but unconventional care, and the state’s obligation to protect the public against potential harm from medical practices that do not conform to the accepted standard of care. The Medical Board of California (Board) disciplined petitioner for treating two terminal cancer patients in a manner it determined fell below the standard of care in numerous respects, even though the evidence indicated the treatments provided the patients with some palliative relief. The trial court acknowledged this paradox but concluded the Board did not abuse its discretion when it disciplined petitioner, holding that the Board’s findings were supported by the weight of the evidence.

Our review is limited to determining whether substantial evidence supports the trial court’s independent conclusion. The facts themselves are not in dispute. The primary disputed issue is whether substantial evidence supports the trial court’s determination of the standards of medical care that apply in this instance. With the case so framed, we have little room to question whether the standards of care in this instance should bend to account for a doctor who provides palliative relief to terminally ill patients by means of procedures not used by other doctors under similar circumstances. We conclude sufficient scientific evidence and expert testimony support the Board and the trial court’s determinations of the standards of care, and we affirm the trial court’s judgment.

FACTUAL BACKGROUND

This case involves petitioner’s use of a cancer treatment known as hyperthermia. Hyperthermia heats a malignant tumor. Raising the tumor’s temperature increases oxygen levels at the tumor site, which in turn makes the tumor more responsive to radiation treatments. Hyperthermia is almost always administered in conjunction with radiation treatments.

Optimally, hyperthermia will raise the tumor’s temperature to between 101 and 105 degrees Fahrenheit. The temperature is measured either with surface probes or internally using a temperature probe, such as a thermocouple, inside a catheter placed at the tumor site.

Two types of hyperthermia are currently in use. The type to be given depends on the location of the tumor. If the tumor is within 1.25 inches of the skin’s surface, it may be treated with superficial hyperthermia. This is done with microwaves, radio frequencies, ultrasound, or even circulating hot water. If the tumor is deeper than 1.25 inches, it must be treated with ultrasound or radio frequencies different from those used for superficial hyperthermia.

Hyperthermia is a relatively safe procedure. It has no carcinogenic potential and rarely causes any harm or discomfort. At worst, five percent of patients may suffer superficial burns from the procedure, but these usually heal rapidly and leave no mark. However, hyperthermia is not safe for treating lung cancer.

Petitioner is an expert in the fields of radiation oncology and hyperthermia. His clinic in Southern California is one of only five or six major institutions in the United States, and 15 institutions in the world, that perform hyperthermia.

Petitioner is deeply committed to the use of hyperthermia. He claims, based in large part on his own research, that hyperthermia given alone, without radiation, as well as in conjunction with radiation provides beneficial effects to the patient. He asserts that hyperthermia can be given every day if needed and as often as twice a day in two different areas.

Petitioner also claims that by giving hyperthermia treatments, he can lower the per-treatment amount of radiation he gives to the patient while obtaining the same results as he would by treating with standard doses of radiation without hyperthermia. Petitioner opines that by treating a patient in this fashion, he extends the time a patient can receive radiation, and in some cases increases the total amount of radiation a patient can receive, without the patient suffering adverse effects. Petitioner claims to be the only physician in Southern California who treats cancer with daily hyperthermia treatments and reduced, or fractionalized, doses of radiation.

As more fully explained below, not all practitioners agree with petitioner, and hardly any use hyperthermia as frequently as petitioner does on a patient. Expert testimony indicated the accepted practice is to use hyperthermia only in conjunction with radiation treatments and not more frequently than once every three days. Experts also claimed hyperthermia does not allow a doctor to reduce the doses of radiation a patient would otherwise receive under standard protocol.

Both petitioner and the practitioners who disagree with him stand by their positions whether hyperthermia is used as a palliative treatment or a curative treatment. Palliative treatment is not designed to cure or eliminate the disease. Rather, it reduces the signs and symptoms of the disease and, thereby, the patient’s suffering. Curative treatment is treatment used with the intent of eliminating the disease entirely.

The Board initiated administrative proceedings to discipline petitioner for the manner in which he used hyperthermia and radiation as palliative treatments on two terminal cancer patients, Elizabeth F. and James K., in 1998 and 1999, and for the alleged inadequate medical records he made of their treatments. The Board also accused petitioner of false and misleading advertising on his Web site. We review the facts surrounding each of the charges.

This actually is the second of three disciplinary actions the Board has brought against petitioner. The first began in 1993 when the Board claimed petitioner departed from the standard of care by treating terminally-ill cancer patients with daily hyperthermia treatments. The parties stipulated to a settlement, and the Board revoked petitioner’s license, stayed revocation, and placed him on probation for 18 months. The Board filed this action in 2002. The Board claims it initiated a third action against petitioner in 2005, challenging his use of hyperthermia and radiation on five cancer patients. The third action allegedly was resolved in July 2006; the Board revoked petitioner’s license, stayed revocation, and placed him on probation for two years.

1. Petitioner’s treatment of Elizabeth and James and his medical records for each

Petitioner never promised either Elizabeth or James a cure. He told them they had stage IV cancer and were going to die. The only question was when and how. His purpose in treating them was to prevent adverse side effects.

a. Elizabeth

Elizabeth was 51 years old and suffering from breast cancer when she first sought consultation from petitioner on April 16, 1998. About one year earlier, she found a small lump in her left breast. Because she feared physicians, she treated herself with diet and supplements. At Elizabeth’s first appointment, petitioner examined her and found a large mass in her left breast occupying most of the breast and nodules in the chest wall.

Except for undergoing an ultrasound, Elizabeth had refused all forms of traditional treatment prior to meeting with petitioner, including radiological studies, biopsy, radiation, and chemotherapy. She continued to do so when she first met petitioner. Without the aid of any test results, petitioner considered the tumor to be malignant and believed Elizabeth required immediate palliative treatment. Because she refused radiation and because he had no proof of cancer, he began treating her with hyperthermia alone.

A biopsy performed two weeks later after obtaining Elizabeth’s consent confirmed petitioner’s diagnosis, and he began treating Elizabeth with radiation and hyperthermia daily. On some days, Elizabeth received two hyperthermia treatments.

Petitioner had prepared a treatment plan for Elizabeth. However, the plan did not indicate the precise location of where he would place the temperature probes to measure the heat of the tumor.

By May, Elizabeth’s conditions worsened. Her skin at the left lateral abdomen became involved. Petitioner began treating that area with radiation and hyperthermia treatments. However, he failed to document in Elizabeth’s records the existence of cancer on her skin or the need for treating that area.

Elizabeth was having more difficulty breathing. A CT scan disclosed she was suffering from a large pleural effusion. She consented to undergo a thoracentesis to drain the fluid and one chemotherapy treatment to treat the metastatic growth at the pleura. However, after the thoracentesis, the pleural effusion returned, and Elizabeth refused additional chemotherapy.

By mid-June, Elizabeth’s breast tumor was 95 percent resolved. She continued to undergo daily hyperthermia and radiation treatments. On some days, she received hyperthermia treatments without radiation. In the nearly 12-week period between April 16 and July 7, 1998, Elizabeth received a total of 105 hyperthermia treatments in both daily and twice-daily sessions. Despite the improvement in the breast tumor, the cancer had metastasized into her lungs. She died on August 31, 1998.

During Elizabeth’s treatment, petitioner took some port films of the various locations on her body that he treated, but he did not take them as often as usually required. He also did not take a port film of Elizabeth’s chest wall. Several other treatment records generated when he administered hyperthermia were not printed and placed in Elizabeth’s file.

A port film is an x-ray of the positioning of the patient with respect to the radiation being administered.

b. James

61-year-old James, the second cancer patient, was suffering from colorectal cancer when he first consulted with petitioner on October 27, 1998. By then, he had already undergone two major surgeries and been told by another oncologist that his disease was incurable. He refused chemotherapy.

As he did with Elizabeth, petitioner prepared a treatment plan for James. This plan also did not indicate where exactly the temperature probes were to be placed on James.

Petitioner administered both radiation and hyperthermia to James. James received 80 radiation treatments over a period of 198 days, or about 28 weeks. His cumulative dose of radiation totaled 8,015 radiation units (cGy or “rads”). Daily treatments began with radiation dosages of 180 cGy for the first six treatments, decreased to 150 cGy for 14 sessions, decreased to 120 cGy for 27 treatments, decreased to 50 cGy for 27 treatments, and further decreased to 25 cGy for the remaining treatments. Over the same period of time, James also received 162 hyperthermia treatments.

Petitioner testified he treated James “mostly for palliation.” The tumor continued to shrink and did not regrow. Petitioner believed his treatments gave James a “normal life” from January to October of 1999 where he was free of pain. James even went to Hawaii on vacation.

James’s medical records, however, indicate the tumor markers in his blood progressively increased from December 1998 through November 1999. A MRI performed in October 1999 showed the cancer had spread to James’s spine. From November, his condition continued to deteriorate, with symptoms of progressive uremia and anemia, progressive kidney failure, and progressive cancer. Despite this, in November, petitioner wrote in James’s medical record that the “patient is doing well.” James died from these complications on January 1, 2000. At the time of his death, his tumor had shrunk by at least 50 percent and had remained at its smaller size.

Petitioner failed to document some of the hyperthermia and radiation treatments he gave to James. He also failed to take the required number of port films over the course of the treatment.

c. Advertising on Web Site

Besides challenging petitioner’s treatment of Elizabeth and James and the manner in which he maintained their medical records, the Board also accused petitioner of using false advertising on his Web site. The site claimed, among other representations, that hyperthermia could be used to treat the lungs, hyperthermia was effective on its own, and anyone at any age could receive hyperthermia treatments. None of these claims are true.

2. Standards of care for hyperthermia and radiation

At the administrative hearing on the Board’s accusation, the expert witnesses disagreed with each other over the validity of petitioner’s philosophy and whether his treatment of Elizabeth and James fell below the standard of care.

The literature petitioner claimed supported his philosophy was excluded as to the issue of establishing the standard of care. It was admitted only to establish the basis of his beliefs and conduct.

Testifying for the Board against petitioner were Zbigniew Petrovich, M.D., former head of the Department of Radiation Oncology at the University of Southern California; and Leonard R. Prosnitz, M.D., professor in the Department of Radiation Oncology at Duke University.

Testifying for petitioner, besides himself, were A. M. Nisar Syed, M.D., director of the Department of Radiation Oncology & Endocurietherapy at the Memorial Cancer Institute, Memorial Medical Center in Long Beach; Phillip Beron, M.D., medical director of Radiation Oncology at Good Samaritan Hospital in Los Angeles; and Peter Corry, Ph.D., a biophysicist at William Beaumont Hospital in Royal Oak, Michigan.

a. Hyperthermia

Dr. Petrovich claimed that petitioner’s administering hyperthermia by itself to Elizabeth and James violated the standard of care as it existed in 1998. Based on his review of peer-reviewed literature, professional guidelines developed for the practice, and his experience of administering hyperthermia to approximately 200 patients and supervising hyperthermia treatments for another 400 patients, Dr. Petrovich testified the standard of care for palliative treatment of cancer, besides providing pain relief, was to administer radiotherapy or chemotherapy alone or in conjunction with hyperthermia. Except in rare cases not involved here, the standard of care never called for the use of hyperthermia alone, either as a palliative treatment or as a curative treatment. This was because studies showed use of hyperthermia alone eliminated the tumor in only 13 percent of the cases, and because the tumor quickly came back.

Dr. Petrovich also stated that petitioner violated the standard of care by administering hyperthermia more frequently than once very 72 hours. Under the standard of care, hyperthermia should not be administered more frequently than once every 72 hours. With very few exceptions, it should never be given more frequently than every 48 hours.

According to Dr. Petrovich, these standards of care ensured that radiation, even when administered on incurable cancer, achieved its maximum effects thanks to the hyperthermia’s oxygenation of the tumor without submitting the patient to undue hyperthermia treatments. After being heated by hyperthermia, a tumor develops a temporary resistance to any further heat and will stop oxygenating. This phenomenon, called thermotolerance, would last for about 72 hours, rendering any hyperthermia treatments given during that time ineffective in enhancing radiation. Dr. Petrovich had never heard of any doctor in California other than petitioner who gave hyperthermia treatments every day. He had never seen any peer-reviewed data supporting daily hyperthermia.

In his findings of fact, the administrative law judge (ALJ) wrote that thermotolerance reduces the efficacy of radiation. The trial court determined, and the Board agrees, that no evidence in the record supports this particular finding.

Petitioner testified that giving hyperthermia alone was valid because it can alleviate a patient’s pain. He had treated a patient suffering from bone pain with hyperthermia, and found it to be an effective pain relief treatment. He also stated daily administration of hyperthermia was valid because radiation negated thermotolerance, and also because increased tumor temperatures lowered the tumor’s pH level to a point that negated thermotolerance.

In opposition, Dr. Prosnitz testified that there was no scientific evidence to support petitioner’s claim that radiation negated thermotolerance.

Testifying for petitioner, Dr. Syed stated hyperthermia was effective in killing cancer cells when given alone without radiation, and doing so did not violate the standard of care. He also did not believe there was a specific standard of care on whether hyperthermia could be given daily because one school of thought suggested that radiation negated thermotolerance. He believed hyperthermia could be given daily.

However, Dr. Syed was not aware of any peer-reviewed journals that supported daily hyperthermia or twice-daily hyperthermia. He also stated he had never treated any patient’s cancer with hyperthermia alone. In his 18 to 20 years of administering hyperthermia, he has used daily treatments on large, aggressive tumors in no more than five percent of his patients, but had always done so in conjunction with radiation treatments. The most number of hyperthermia treatments he gives to a patient with breast or colon cancer is usually 10 to 12, with a maximum of 20. Dr. Syed acknowledged that the professional literature and common practice, including his own, supported Dr. Petrovich’s testimony that hyperthermia should be administered no more than three times per week.

Dr. Beron, testifying for petitioner, stated that, according to some literature, thermotolerance has not been established so as to preclude daily hyperthermia treatments. Thermotolerance does not exist in every cell line, and such factors as a low pH in the cell or daily fractionated, or reduced, radiation can negate or lower it. Dr. Beron had not personally administered hyperthermia treatments for the past two years, but when he did, he would do it two or three times a week. He has never performed daily hyperthermia treatments.

On the Board’s rebuttal, Dr. Prosnitz disagreed with Dr. Beron’s claims regarding thermotolerance. A great majority of clinicians and researchers believe in thermotolerance and thus do not administer hyperthermia daily. He was not aware of a single published clinical trial that delivered hyperthermia daily.

He also stated there was no evidence advocating the use of hyperthermia alone without radiation. (AR 1389) The purpose of hyperthermia treatments was to increase the oxygen levels in the malignant tumor so that the tumor will respond well to radiation treatments.

Dr. Prosnitz also claimed there was no scientific evidence supporting petitioner’s belief that radiation negated thermotolerance. Further, regarding Dr. Beron’s claim of low pH negating thermotolerance, Dr. Prosnitz said pH levels in human cells cannot be manipulated to reach the levels Dr. Beron suggested.

On petitioner’s surrebuttal, Dr. Corry disagreed with Dr. Prosnitz. He does not perform hyperthermia himself because he is not a physician. He has been advocating daily hyperthermia treatments for the last 20 years. He believes thermotolerance is irrelevant. The cancer cells could be building up resistance to additional heat from daily treatments, but that did not affect the heat’s ability to make the cells more susceptible to radiation. He acknowledged his opinion in favor of daily hyperthermia treatments was in the minority. At the hospital where he works and provides consultations, hyperthermia is given only to patients undergoing radiation therapy. For palliative cases, his hospital does not necessarily administer radiation every day, and it treats with hyperthermia every day that it treats with radiation.

Contrary to petitioner’s practice, Dr. Corry did not recommend hyperthermia be administered alone, although he stated that it would do not harm. He claimed hyperthermia treatments are not used to kill the tumor. With hyperthermia, he expects to kill only a small fraction of the tumor cells. It could make a tumor go away, but the tumor comes back quickly. Thus, he concluded that hyperthermia treatments were not recommended to be given without radiation unless there was no other treatment available. Some patients who had been through multiple courses of radiation, chemotherapy, and surgery with no options left had benefited from hyperthermia treatments alone, giving them several months of a reasonable quality of life before they died. If there was no other treatment available, then hyperthermia alone was acceptable so long as the patient understood the benefits would likely not last very long.

b. Radiation

Regarding the use of radiation, Dr. Petrovich, the Board’s expert, testified the standard of care required radiation to be administered every day (five days per week) over a period of six to eight weeks. Each treatment was to deliver between 180 and 200 cGy, plus or minus 10 percent per treatment, and the total dosage over the course of the treatment was not to exceed 6,000 cGy for breast cancer and between 5,600 and 6,500 cGy for colon cancer. This was the standard of care for both curative treatment and palliative treatment. Petitioner’s treatment of James with radiation for longer than seven weeks, with a total dosage in excess of 6,500 cGy, and with individual doses of less than 180 cGy violated the standard of care.

Dr. Petrovich stated petitioner’s administering individual doses of less than 180 cGy and increasing the total length of time a patient underwent radiation therapy violated the standard of care even for palliative relief because the tumors became resistant to radiation and began to grow back. He called this process repopulation. The standard of care guaranteed the doctor would give the maximum amount of radiation that could be given safely over the least amount of time to minimize the risk of repopulation. According to Dr. Petrovich, petitioner’s radiation treatments on James were “unprecedented.”

Dr. Prosnitz testified “it would be . . . totally incorrect to compromise the radiation and lower the amount of daily doses of radiation because you were getting hyperthermia.”

In opposition, Dr. Syed testified there was no real standard for the number of radiation treatments that could be administered when combined with hyperthermia. The dosage of radiation could be decreased from the standard 180 cGy when it was administered with hyperthermia. This would also allow the patient to receive more radiation treatments and a higher total dosage of radiation.

Dr. Syed acknowledged there was no professional literature supporting his theory. Indeed, he himself does not reduce the radiation dosage below 180 cGy even with hyperthermia unless the patient has received a significant amount of radiation and still has a tumor.

3. Procedural history

The Board accused petitioner in 2002 of treating Elizabeth and James in a grossly negligent, repeatedly negligent, and incompetent manner, all constituting unprofessional conduct in violation of Business and Professions Code section 2234, subdivisions (b) through (d). The Board also charged petitioner with inadequate medical record keeping constituting unprofessional conduct in violation of section 2266, and false and misleading advertising in violation of sections 2271 and 17500.

All undesignated references to sections are to the Business and Professions Code.

Following an administrative hearing, the ALJ issued a proposed decision agreeing with the bulk of the Board’s allegations. The ALJ relied on the Board’s expert witness testimony to establish the standard of care and rejected conflicting testimony proffered by petitioner’s experts. He concluded petitioner violated the standard of care by administering hyperthermia treatments daily, hyperthermia treatments alone, excessive total doses of radiation, inadequate individual doses of radiation, and an excessive number of radiation treatments. Petitioner also failed to maintain adequate medical records, and he used false or misleading advertising.

In closing, the ALJ commented: “Finally, even though [petitioner] deviated from the standard of care in connection with patients [Elizabeth] and [James], his methods were not necessarily clinically ‘incorrect.’ Both patients were suffering from metastatic cancer and were terminal when they presented. Under [petitioner’s] care, one patient experienced a 95% resolution of the original tumor; the other, a 50% resolution. The weight of the evidence determined the standard of care in [petitioner’s] geographic area during the relevant time period, but not the efficacy of [petitioner’s] treatment methods. Although the two patients whose care and treatment were the subject of this action did not survive, a great many others have, some of whom testified at the hearing as to their remarkable stories of recovery.

“It is axiomatic that the standard of care is a fluid concept that shares a symbiotic and inter-dependent relationship with medical progress. Only time will tell whether [petitioner] is a pioneer or a renegade. He deviated from the standard of care in his treatment methods, and for that, his license is disciplined. However, revocation would be punitive. The public health, safety and interest should be adequately protected by the issuance of a properly conditioned probationary certificate.”

The Board adopted the ALJ’s decision as its own. As a result of petitioner’s actions, the Board revoked petitioner’s license, stayed revocation, and placed petitioner on probation for five years.

Petitioner challenged the Board’s decision by filing a petition for writ of administrative mandate. At oral argument, the trial judge was confused by the ALJ’s concluding comment that petitioner’s methods were not “necessarily clinically incorrect” even though he deviated from the standard of care. “To me I don’t know how that is possible,” the court stated. “If you are violating the standard of care by definition it’s clinically incorrect, that is you shouldn’t’ be doing it.”

The court resolved the apparent contradiction by noting the ALJ “goes on to say both patients were suffering from metastatic cancer and were terminally ill, so forth and then there was palliative results. There was helpful results.

“So, it is like [petitioner] deviated from the standard of care in connection with the patients . . ., but his methods were not necessarily clinically incorrect, because they worked.”

The trial court and counsel for the Board then engaged in the following discussion:

“THE COURT: What if the two patients had lived and been cured and the Board -- your theory, of course, would be the Board would still be proper in taking this action, because [petitioner] violated the standard of care.

“MS. CASTRO: Correct.

“THE COURT: What if he had a pattern of cure rate that was significantly higher not just for these two patients, but for all of his patients. We’re talking about a good number of folks. He would still be violating the standard of care, fair statement?

“MS. CASTRO: Yes, your Honor.”

In its written decision, the court adopted the standards of care set forth by the Board’s experts, concluded Elizabeth and James had received medical care of dubious value, and denied the petition in its entirety. It entered judgment in favor of the Board.

Petitioner’s only method of challenging the trial court’s decision is by extraordinary writ. (§ 2337.) We issued an alternative writ.

DISCUSSION

Petitioner argues substantial evidence does not support the trial court’s determination that he violated the standard of care by administering (1) hyperthermia treatments daily; (2) hyperthermia treatments alone; and (3) excessive total doses of radiation resulting from an excessive number of radiation treatments that included inadequately low individual doses of radiation. Petitioner also argues substantial evidence does not support the trial court’s conclusion that he (4) failed to maintain adequate medical records, and (5) used false or misleading advertising on his Internet Web site.

With the facts not in material dispute, the outcome of this case hinges on whether substantial evidence supports the trial court’s determination of the appropriate standard of medical care for each form of treatment. Although the trial court applied its independent judgment to the evidence, we determine whether substantial evidence supports the trial court’s findings, including the court’s formulation of the standard of care. (Fukuda v. City of Angels (1999) 20 Cal.4th 805, 824.)

The Supreme Court has routinely defined the standard of care in medical malpractice cases as requiring a physician “to possess and exercise, in both diagnosis and treatment, that reasonable degree of knowledge and skill which is ordinarily possessed and exercised by other members of his profession in similar circumstances.” (Landeros v. Flood (1976) 17 Cal.3d 399, 408 (Landeros), italics added.)

However, a court lacks the specialized knowledge necessary to determine the generally adopted standard in the medical profession. “The question remains one of fact, to be decided on the basis of expert testimony: ‘The standard of care against which the acts of a physician are to be measured is a matter peculiarly within the knowledge of experts; it presents the basic issue in a malpractice action and can only be proved by their testimony [citations], unless the conduct required by the particular circumstances is within the common knowledge of the layman.’ [Citation.]” (Landeros, supra, 17 Cal.3d at p. 410.)

Where the doctor’s conduct falls outside the common knowledge exception, such as petitioner’s conduct, expert evidence as to the prevailing standard of care and the propriety of petitioner’s conduct under that standard “‘“is conclusive and cannot be disregarded.”’” (Flowers v. Torrance Memorial Hospital Medical Center (1994) 8 Cal.4th 992, 1001.)

We also need not look for actual harm to the patients in order to sustain the trial court’s findings of negligence and incompetence. A requirement of actual harm “would prohibit the imposition of discipline on a licensee until harm to patients had already occurred. We reject this argument because it overlooks the preventative functions of license discipline, whose main purpose is protection of the public [citation], but whose purposes also include prevention of future harm [citation] and the improvement and rehabilitation of the physician [citation]. To prohibit license discipline until the physician-licensee harms a patient disregards these purposes; it is far more desirable to discipline before a licensee harms any patient than after harm has occurred.” (Griffiths v. Superior Court (2002) 96 Cal.App.4th 757, 772, italics in original, fn. omitted.)

I

Daily Hyperthermia Treatments

The trial court concluded petitioner violated the standard of care by administering hyperthermia treatments to Elizabeth and James on a daily basis. The trial court determined the standard of care for administering hyperthermia required patients be treated no more than three times a week with periods of 48 to 72 hours between treatments.

The court relied upon the Board’s experts to determine the standard of care. They testified that thermotolerance reduced hyperthermia’s ability to enhance radiation therapy if hyperthermia was administered more frequently than every two or three days. The extra treatments were thus unnecessary. The court acknowledged petitioner’s disagreement with this view of thermotolerance, but noted petitioner’s experts’ opinions on this point were theoretical and not grounded in scientific studies reported in the literature. It also noted that of all the testifying experts, Dr. Syed was the only expert who had used hyperthermia daily, and he did so with only five percent of his cases and in conjunction with radiation.

Petitioner claims substantial evidence does not support the court’s finding. He argues the Board’s opinions on thermotolerance are not based on human studies. He asserts the same non-clinical studies show thermotolerance affects only hyperthermia’s ability to kill cancer cells directly and does not affect hyperthermia’s enhancing effect on radiation. He emphasizes the record shows that hyperthermia is a relatively benign procedure with minimal risks.

We do not resolve conflicts between petitioner’s testimony and that of the Board’s expert witnesses. The Board’s experts clearly testified as to a standard of care with which petitioner failed to comply. Their testimony constitutes substantial evidence in support of the trial court’s formulation of the standard of care. Under that standard, hyperthermia is not to be administered on a daily basis because it subjects the patient to needless treatments.

Contrary to petitioner’s claim, this is not a case like Wheeler v. State Bd. of Forestry (1983) 144 Cal.App.3d 522, where there was a “complete absence in the record” of any standard by which to measure the competence of the challenged conduct. Here, a standard has been clearly stated in the record, and substantial evidence supports the trial court’s adoption of that standard. (Id. at pp. 527-528.)

Petitioner claims there can be no recognized standard of care regarding daily administration of hyperthermia because hyperthermia is rarely practiced, and there have been no studies performed where hyperthermia was administered more frequently than two or three times a week. The studies that have been done on which the Board’s experts based their opinions all proceeded on the assumption that thermotolerance would negate hyperthermia’s effectiveness, and thermotolerance, he asserts, is only theoretical. Thus, he claims there is no standard of care regarding the frequency of hyperthermia, and he cannot be faulted for violating a non-existent standard.

Arguing there is no standard of care does not exonerate petitioner. Rather, it demonstrates that in treating Elizabeth and James, petitioner failed to exercise “that reasonable degree of knowledge and skill which is ordinarily possessed and exercised by other members of his profession in similar circumstances.” (Landeros, supra, 17 Cal.3d at pp. 408, italics added.) The knowledge petitioner claims he has and has used is not ordinarily possessed or used by other doctors in similar circumstances. He is the only one. If there is no standard of care applicable to what he did, then his actions were outside the permissible scope of his medical practice.

We do not wade into the controversy surrounding thermotolerance. The expert testimony that the phenomenon occurred and rendered hyperthermia less effective is substantial evidence supporting the trial court’s determination that daily hyperthermia treatments fell below the standard of care.

II

Hyperthermia Treatments Alone

The trial court ruled petitioner violated the standard of care by administering hyperthermia treatments alone without also administering radiation treatments at the same time. The court noted the Board and petitioner’s experts agreed that hyperthermia alone could potentially reduce the tumor for a short time. They disagreed over whether that benefit brought the use within the standard of care. The court concluded it did not: “The transient relief that the use of hyperthermia alone may provide in a small percentage of cases indicates that such use is not reasonably effective either as a curative or a palliative treatment. Notably, most of petitioner’s experts do not themselves use hyperthermia alone.”

Petitioner argues substantial evidence does not support the court’s conclusion. With regards to his treatment of Elizabeth, petitioner claims the obviously advanced stage of her tumor when she first saw him, along with her refusal to undergo other forms of treatment, justified his giving her hyperthermia alone for palliative purposes, both before he had test results confirming his diagnosis and after. As for treating James, petitioner claims he gave James hyperthermia alone for a two-week period when the side effects from radiation became intolerable. He faults the Board for concluding that giving hyperthermia alone “was somehow more dangerous to the patient than doing absolutely nothing,” particularly when hyperthermia carries only minimal risk.

Substantial evidence supports the trial court’s conclusion. The Board’s experts testified that the sole purpose of hyperthermia was to render radiation treatment more effective. Even Dr. Corry, petitioner’s expert, agreed that providing hyperthermia alone was not an effective treatment of cancer, either as a curative treatment or as a palliative treatment. Administering hyperthermia alone reduced the tumor in only a small fraction of the cases and the tumor would grow back quickly. This evidence supported the trial court’s determination that hyperthermia treatments without radiation were not within the standard of care for either curative or palliative treatments.

III

Radiation

The trial court determined petitioner administered a total of 8,015 cGy of radiation to James over 198 days (about 28 weeks) at doses as low as 25 cGy. This treatment violated the standards of care as testified to by the Board’s experts: 5,600 to 6,500 cGy over a period of six or eight weeks at daily doses of 180 to 200 cGy plus or minus 10 percent. These standards applied whether the radiation was given for curative purposes or palliative purposes. Violating these standards compromised the efficacy of radiation and increased the risk of the cancer cells repopulating.

Petitioner claims the evidence does not support these findings. He argues the evidence showed that his spreading the radiation over many weeks by administering lower doses resulted in James receiving the biological equivalent of between 6,000 to 6,700 cGy. He claims that the daily and concurrent hyperthermia treatments effectively doubled the dose of radiation. Thus, the doses of 150 cGy and 120 cGy were within the range set by the standard of care. The other lower doses of 50 cGy and 25 cGy were an attempt to stretch out radiation treatments for palliative purposes.

Unfortunately for petitioner, he and his experts identified no medical literature supporting his position. Indeed, one of petitioner’s expert witnesses, Dr. Syed, testified he does not give radiation doses below 180 cGy, unless the patient has already received a significant amount of radiation and still has a tumor. Petitioner himself explained that of the only 15 groups using hyperthermia in the world, each was just learning how to administer the treatment and relied upon its own judgment because the science had not yet been established. By this statement, petitioner again admits he was not following any recognized standard of medical care in administering hyperthermia and radiation to James.

In petitioner’s own words, his radiation treatments involved “using scientific experimental results in a tough clinical situation,” and that “it’s not really much down to science at the beginning of a new modality to try to use governmental agencies to enforce -- this is. We are just learning. Nobody knows everything, and I am humble of this. I may be wrong. I may be right. I have some successes and I have failures.” (Italics added.)

The Board’s expert witness testimony as to the standards of care for radiation constitutes substantial evidence in support of the trial court’s determination.

IV

Medical Records

The trial court determined petitioner violated the standard of care for failing to keep adequate medical records on Elizabeth and James. Specifically, petitioner failed to record the exact locations and depths of temperature probes used during hyperthermia treatments, failed to take weekly port films or x-rays of the patients’ radiation treatments, failed to include printouts of temperature readings from hyperthermia treatments in the patients’ files, failed to document all of James’s treatments and visits, and failed to document certain details of Elizabeth’s treatment.

Petitioner does not deny these facts, but argues the standards require unnecessary documentation for palliative care, and require additional unnecessary radiation from the port films. These arguments do not overcome the substantial evidence presented as to the standards for record keeping and petitioner’s deviations from that standard.

V

Web Site Advertising

The trial court determined petitioner’s Web site in 1998 contained false and misleading advertising in violation of section 2271. The Web site claimed: the lungs are treatable with hyperthermia, hyperthermia is effective on its own, and anyone at any age can receive hyperthermia treatments.

Substantial evidence in the record confirms the trial court’s finding. Hyperthermia cannot be administered to the lungs. It is generally not effective on its own because the cancer recurs. Anyone cannot receive hyperthermia treatments because hyperthermia is not effective for every tumor. We do not disturb the court’s finding regarding false advertising.

DISPOSITION

A comment from a noted treatise on California malpractice law aptly sums up this case: “[P]ioneering doctors, and countless others, have often had to confront orthodoxy. What by today’s lights appears controversial or even heretical may turn out as tomorrow’s standard of care. A legal policy, even if it recognizes an element of calculated risk in the delivery of many aspects of health care, can work mischievious results which unduly crimps the innovated spirit so often present in the health care community.

“From the perspective of the contending attorneys, a finer line usually separates the suspect practitioner from the conventional professional community . . . . Indeed the defendant-provider may truly function at the cutting edge. If so, however, ample scientific documentation, typically of recent origin and from one or more reputable sources, will be present to fortify the technique or procedure which has gone awry.” (1 McDonald, Cal. Medical Malpractice -- Law and Practice (2003) § 2.5, p. 109, fns. omitted.)

Here, sufficient scientific evidence and expert testimony supported the standards of care determined by the trial court and the court’s decision that petitioner violated those standards. Indeed, the record discloses “ample” scientific support of the opinions of the Board’s experts; the record does not do the same for the opinions of petitioner’s experts.

The alternative writ is discharged and the petition for writ of mandate is denied. Costs in this proceeding are awarded to the Board. (Cal. Rules of Court, rule 8.278(a).)

We concur: RAYE, J., HULL, J.


Summaries of

Bicher v. Superior Court

California Court of Appeals, Third District, Sacramento
Feb 29, 2008
No. C052927 (Cal. Ct. App. Feb. 29, 2008)
Case details for

Bicher v. Superior Court

Case Details

Full title:JAMES H. I. BICHER, Petitioner, v. THE SUPERIOR COURT OF SACRAMENTO…

Court:California Court of Appeals, Third District, Sacramento

Date published: Feb 29, 2008

Citations

No. C052927 (Cal. Ct. App. Feb. 29, 2008)