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IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

FIRST APPELLATE DISTRICT, DIVISION FOUR

RIC SCHIFF AND PAULA SCHIFF,

Plaintiffs and Appellants,

v.

MICHAEL J. PRADOS,

Defendant and Respondent.

AMICUS CURIAE BRIEF OF THE
AMERICAN PREVENTIVE MEDICAL ASSOCIATION
IN SUPPORT OF APPELLANTS

Appeal From The San Francisco County Superior Court
Honorable David A. Garcia, Judge
SFSC Case No. 982109

Jonathan W. Emord David Harris
Emord & Associates P.C Sinnot, Dito, Moura & Puebla
Burke Professional Center 660 South Figueroa Street
5282 Lyngate Court Suite 2300
Burke, Virginia 22015 Los Angeles, California 90017
(202) 466-6937 (213) 996-4200

Attorneys for Amicus Curiae
American Preventive Medical Association
TABLE OF CONTENTS


I. Background and Interest of Amicus Curiae

II. Introduction

III. When a Patient Is Terminally Ill and Conventional Treatments Have Proven Ineffective, Meaningful Informed Consent Requires Physician Disclosure of Experimental Treatments That May Prove Efficacious

A. Development of Informed Consent Doctrine in California

B. Context of the Circumstances, Not a Bright Line Exclusionary Rule, Determines What Information Must Be Disclosed in Order for There to Be Meaningful Informed Consent

IV. Where a Patient's Illness Is Terminal and Conventional Treatments Are Ineffective, a Direct Legal Duty Arises to Disclose Experimental Treatments That May Prove Efficacious

V. Mandating Disclosure of Potentially Efficacious Experimental Treatment Is the Minimum Burden That Health-Care Professionals Must Meet When Treating
Terminally Ill Patients For Whom Conventional Treatments Have Failed

VI. Holding the Tumor Board Liable Is Consistent With Public Policy

VII. Conclusion

TABLE OF AUTHORITIES

FEDERAL CASES

Canterberry v. Spence
464 F.2d 772 (D.C. Cir. 1972)

Arato v. Avedon
(1993) 5 Cal.4th 1172

Christensen v. Superior Court
(1991) 54 Cal.3d 868

Cobbs v. Grant
(1972) 8 Cal.3d 229

Rowland v. Christian
(1968) 69 Cal.2d 108

Truman v. Thomas
(1980) 27 Cal.3d 285, 291

OTHER STATE CASES

Sard v. Hardy
(1977) 281 Md. 432; 379 A.2d 1014

Wilkinson v. Vesey
(1972) 110 R.I. 606; 295 A.2d 676

MISCELLANEOUS

Barry R. Furrow, Liability and Quality Issues in Health Care 337, (1991)

Peter H. Schuck, Rethinking Informed Consent
103 Yale L.J. 899 (1994)

Surgical Rates Vary Across The Nation (visited September 19, 2000)

Agranovich AL, Ang LC, Griebel RW, Kobrinsky NL, Lowry N, Tchan, Malignant Rhabdoid Tumor of the Central Nervous System with Subarachnoid Dissemination, Surg Neurol 410 (may 1992)


I. Background and Interests of Amicus Curiae

APMA is a non-profit organization located in Virginia with more than 500 members including more than 75 members residing in California. APMA was founded in October of 1992 and is dedicated to ensuring nationwide consumer access to preventive therapies and the rights of health-care providers to offer those therapies. Through amicus curiae participation, APMA seeks to protect its members' interests in a case likely to affect the delivery of preventive therapies. APMA is vitally invested in the outcome of this case. APMA members include licensed health professionals who do business in California either directly or through a subsidiary or affiliate organization. APMA members provide a variety of health-care services in California, including medical care for the terminally ill. Accordingly, this case concerns matters of critical importance to APMA.

II. Introduction

This Court has granted the American Preventive Medical Association ("APMA") permission to appear as amicus curiae to address the issue of whether informed consent in the treatment of a terminal illness can be meaningful without the disclosure of potentially efficacious experimental treatments in those instances where conventional treatments have proven ineffective.

The trial court erred in granting summary judgment in this case. Disclosure of potentially efficacious experimental treatments is the minimum legal duty oncologists must bear in the treatment of terminally ill patients for whom conventional treatments have proven ineffective. That is also the minimum duty society must place upon those the state licenses to treat the terminally ill in such circumstances.

At a minimum, the law of informed consent must ensure that each patient is given the information necessary to exercise informed choice in the selection of treatment. In no case is the law of informed consent more indispensable than in the treatment of the terminally ill for whom conventional treatments have failed. The case of cancer patient Crystin Schiff tragically proves the consequences that befall an innocent child when physicians presume not only the ultimate knowledge of treatment but also the ultimate power to exercise treatment choice. It is, in the end, the patient's right to decide which treatment to accept and the physician's duty to inform the patient of potentially efficacious treatments. The medical community is not a dictatorship that reserves unto itself all power over what to introduce into the human body in the fight for wellness. The body remains the private property of the patient and the doctor remains the patient's servant. The physician's duty is to the patient, not the other way around. It is a relationship of trust and guidance, not unilateral control. Informed consent means little if it does not empower patient choice. The Schiffs were denied the right to choose by physicians who presumed it their exclusive province to make treatment choices. Amicus APMA hopes this court will recognize the error of that thinking and correct it by reversing and remanding this case for a jury trial.

The facts of this case make the legal choice a stark one with profound consequences for society. Aware that chemotherapy and radiation therapy had never cured a childhood rhabdoid brain cancer and aware that antineoplastons were a potentially efficacious alternative treatment for that cancer (JA 657:4-9, 677), Dr. Prados and the UCSF tumor board nevertheless withheld information about antineoplastons from the Schiffs and led them to believe that their only choice was to pursue treatment regimes that had never succeeded in curing a single childhood rhabdoid brain cancer. The physicians' failure to disclose deprived Mr. and Mrs. Schiff of the information they needed to exercise a meaningful choice in the treatment of their terminally ill daughter. That failure denied the Schiffs knowledge of the potential risks and potential benefits of antineoplastons and deprived them of an opportunity to compare that experimental treatment with the failed conventional treatments. That failure denied the Schiffs a full and fair opportunity to fight Crystin's cancer on terms they found acceptable.

No terminally ill person - and certainly no terminally ill child - should ever be denied information of a potentially efficacious alternative to a failed conventional treatment. No terminally ill person - and certainly no terminally ill child - should ever be left helpless to believe falsely that a failed conventional treatment is the only alternative when a potentially efficacious experimental treatment is in fact available.

Each of us has a right to expect that those privileged by license to treat the terminally ill will inform patients in such circumstances of potentially efficacious alternatives when conventional treatments have failed. No patient and no caretaker can ever exercise informed choice without such basic information. In short, informed consent is a meaningless shibboleth if it does not mean, at a bare minimum, that the terminally ill have a right to be informed of potentially efficacious experimental alternatives to failed conventional treatments. Patients must never be deprived of information necessary to fight against terminal illness on terms they find acceptable. The choice of which treatment to accept must ultimately be each patient's, and maintaining respect for the patient's right to make that choice must be every physician's irreducible duty and creed.

III. When a Patient Is Terminally Ill and Conventional Treatments Have Proven Ineffective, Meaningful Informed Consent Requires Physician Disclosure of Experimental Treatments That May Prove Efficacious

In order to understand why meaningful informed consent necessarily includes disclosure of experimental treatments that may prove efficacious when conventional treatments have failed one must first look to the history of informed consent and its legal development. When it first arose in the 1950s, informed consent doctrine took one of two approaches - a physician's point of view or a patient's point of view. About half of the states follow the physician's point of view which requires physicians to disclose to patients information which a "reasonable medical practitioner" would provide. See Peter H. Schuck, Rethinking Informed Consent, 103 Yale L.J. 899, 916 (1994); Barry R. Furrow et al., Liability and Quality Issues in Health Care 337 (1991). The other half of the states follow the patient's point of view which requires physicians to disclose to patients all facts, risks and alternatives that a reasonable person in the patient's situation would consider important in deciding whether or not to have a recommended treatment. See generally Canterburry v. Spence, 464 F.2d 772, 787 (D.C. Cir. 1972). The patient's point of view places its emphasis on patient autonomy over physician judgment.

A. Development of Informed Consent Doctrine in California

California has adopted the patient's point of view on informed consent. See Cobbs v. Grant, (1972) 8 Cal.3d 229. In Cobbs, the California Supreme Court held a duty of "reasonable disclosure of the available choices with respect to proposed therapy, and of the dangers inherently involved in each" an integral part of the physician's overall obligation to the patient. Id. at 243. The Cobbs' Court further stated: "The patient's right of self-decision is the measure of the physician's duty to reveal. That right can be effectively exercised only if the patient possesses adequate information to enable an intelligent choice. The scope of the physician's communications to the patient, then, must be measured by the patient's need, and that is whatever information is material to the decision." Id. at 245. Therefore, a physician has a legal duty to disclose to the patient all material information. In the Schiff case, Dr. Prados and the UCSF tumor board violated the patient's right of self decision by depriving the patient and her parents of basic information about a potentially efficacious experimental alternative to the failed approach of chemotherapy and radiation.

B. Context of the Circumstances, Not a Bright Line Exclusionary Rule, Should Determine What Information Must Be Disclosed in Order for There to Be Meaningful Informed Consent

Three years after Cobb, the California Supreme Court stated that "material information is that which the physician knows or should know would be regarded as significant by a reasonable person in the patient's position when deciding to accept or reject the recommended medical procedure." Truman v. Thomas, (1980) 27 Cal.3d 285, 291; see also Sard v. Hardy, (1977) 281 Md. 432, 444; [379 A.2d 1014]; Wilkinson v. Vesey, (1972) 110 R.I. 606, 627 [295 A.2d 676]. To be material, a fact must also be one which is not commonly appreciated. See Truman, 27 Cal.3d at 291; see also Spence, 464 F.2d at 788. Furthermore, if a physician knows or should know of a patient's unique concern or lack of familiarity with medical procedures, those factors expand the scope of required disclosure. See Truman, 27 Cal.3d at 291. Moreover, when a given procedure inherently involves a known risk of death or serious bodily harm, at a minimum a doctor has a duty to disclose the potential risks of harm and to explain in lay terms the complications that might occur. See Cobbs, 8 Cal.3d at 244. The physician is also required to disclose any additional information a skilled practitioner in good standing would provide under similar circumstances. See id. at 244-245. This Court has repeatedly stated that juries are the proper arbiter of whether the information disclosed to a patient is adequate or commonly known and whether there are unique circumstances that require further physician-patient disclosure. See Arato v. Avedon, (1993) 5 Cal.4th 1172, 1186-1187; Truman, 27 Cal.3d at 293-294; Cobbs, 8 Cal.3d at 244-245. The Court has rejected the notion of using bright line rules to determine materiality. See Arato, 5 Cal.4th at 1186.

In this case, the parents of Crystin, the child with a rhabdoid brain cancer, were told only that she could be treated with chemotherapy and radiation. Aware of a potentially efficacious experimental treatment available in FDA-approved clinical trials in Texas (i.e., antineoplstons), Crystin's doctors never disclosed the existence of the treatment alternative to her or to Mr. and Mrs. Schiff. Crystin's parents thus believed they had only two choices - no treatment, which would quickly lead to death, or chemotherapy and radiation, which would likely lead to death as well. It is undisputed that chemotherapy and radiation treatments for rhabdoid brain cancer have not proven effective and that chemotherapy and radiation may in fact hasten death. JA 657:4-9, 677. Crystin's parents have testified that if they were told about the experimental treatment they would have tried it instead of conventional chemotherapy and radiation known to be ineffective. JA 769:2-6. Thus, these circumstances clearly indicate that the disclosure of the potentially efficacious experimental treatment was a material piece of information that Dr. Prados failed to disclose. According to well-established case law a jury should have determined, but was not allowed to determine, the materiality of disclosure. See Arato, 5 Cal.4th at 1186. Thus, this Court should reverse and remand for a jury trial.

IV. Where a Patient's Illness Is Terminal and Conventional Treatments Have Proven Ineffective, a Direct Legal Duty Arises to Disclose Experimental Treatments That May Prove Efficacious

Since the Court has stated that there is no bright line rule on materiality, the necessity of submitting the issue to the jury is paramount. The jury must be allowed to assess whether or not the information withheld was material. See id.

In this case, the patient had a terminal illness, a rhabdoid brain cancer. Traditional treatments were known to be ineffective. In order to meet their duty, Dr. Prados and the UCSF tumor board needed to disclose to Crystin's parents the existence of a potentially efficacious experimental treatment - antineoplastons. Dr. Prados and the UCSF tumor board knew that chemotherapy and radiation had never succeeded in curing a childhood rhabdoid brain cancer. JA 657:4-9. They also knew that chemotherapy and radiation could kill Crystin before she would have died from the cancer, and that Crystin, a young child, was even more susceptible to harm from chemotherapy and radiation than an adult. They also knew of the existence of antineoplastons, and of its potential efficacy in treating childhood rhabdoid brain cancer. JA 752-754; 771:1-7. Under these circumstances, Dr. Prados and the UCSF tumor board violated their minimum legal duty of disclosure and denied the parents of Crystin a meaningful treatment alternative.

V. Mandating Disclosure of a Potentially Efficacious Experimental Treatment Is the Minimum Burden That Health-Care Professionals Must Meet When Treating Terminally Ill Patients For Whom Conventional Treatments Have Failed

The only burden that Dr. Prados and the UCSF tumor board had in this case was one of disclosure of readily available information material to the exercise of treatment choice. Disclosure of readily available information is a very low burden to place on a physician. APMA is not asking that physicians search out and know every treatment available in the world for every condition. Rather, APMA asks the court to apply a rule of reason: A pediatric oncologist who treats a child who has a terminal brain cancer for which conventional treatments have failed should be required to inform the parents of the child of a potentially efficacious alternative of which the physician is aware. That would appear to be the minimum society should expect of oncologists in that circumstance. A contrary determination makes the terminally ill cancer patient in like circumstances a victim whose choice of how to fight shall be largely predetermined due to lack of information and whose chance to survive shall be frequently dashed by any physician who cares not to inform the patient of potentially efficacious alternatives to failed conventional treatments.

Appellants seek to enforce existing case law, which requires a physician to know what a reasonable physician in his profession, and practice area, should know. Liability would be imposed only in situations where the physician knew of relevant information, or should have known of it due to his or her position, but failed to disclose that information.

In this case, Dr. Prados is head of the UCSF tumor board and has had detailed experience with brain cancer. JA 890-891. In fact, Dr. Prados had two patients, Pamela Winningham and Jeffrey Keller, who had been successfully treated with antineoplastons four years before Crystin's treatment. JA 752/754, 812. Furthermore, in May 1991, Dr. Burzynski told Dr. Prados that antineoplastons had put Keller's tumor "in complete remission for over six months already." JA 812. Dr. Prados has admitted that Keller's antineoplaston treatment was "efficacious," was "the most likely explanation" for the remission, and "seemed to … shrink his tumor." JA 752-754. UCSF also knew of the potential efficacy of antineoplastons in treating childhood rhabdoid brain cancer. In an admission summary for Keller, a UCSF doctor wrote that because "radiation" and "chemotherapy" had "failed" with Keller, he was "started on antineoplast[o]ns (AS2-1 and AS-10)" and "seem[ed] to be having an excellent response to antineoplast[o]n therapy." JA 808-809. Additionally, in 1991, the National Cancer Institute had determined that antineoplastons could "shrink… brain tumors to almost complete remission," with "some patients" surviving for "years" with "no serious toxicity." JA 831:4-10. Therefore, in this case, Dr. Prados did not have to conduct any research activity - he already knew of antineoplastons existence and their efficacy. Thus, requiring Dr. Prados and the UCSF tumor board to disclose the existence of antineoplastons to Crystin's parents is a very low burden in light of the life saving potential of that disclosure and the substantial likelihood that conventional chemotherapy and radiation would fail.

VI. Holding the Tumor Board Liable Is Consistent With Public Policy

California courts have specified eight factors in determining whether public policy supports recognizing a duty to disclose: (1) "the foreseeability of harm to the plaintiff; (2) the degree of certainty that plaintiff suffered injury; (3) the closeness of the connection between the defendant's conduct and the injury suffered; (4) the moral blame attached to the defendant's conduct; (5) the policy of preventing future harm; (6) the extent of the burden to the defendant; (7) the consequences to the community for imposing a duty; and (8) the availability, cost and prevalence of insurance for the risk involved." Christensen v. Superior Court, (1991) 54 Cal.3d 868, 885-886; Rowland v. Chrsitian, (1968) 69 Cal.2d 108, 113.

In this case, UCSF doctors collectively treated Crystin and named Dr. Byron Smith her primary doctor. JA 782:3-4. Dr. Smith was inexperienced in treating rhabdoid brain tumors. He therefore sought and relied upon the advice of UCSF's tumor board for "identifying treatment alternatives." JA 789:2-11. The tumor board, in fact, recommended that Crystin be treated with chemotherapy and high dose radiation, the conventional treatments. Those treatments, however, have not been demonstrated effective against even a single childhood rhabdoid tumor. See Exhibits A & B; JA 657:4-9. Indeed, the conventional wisdom is that neither chemotherapy nor high dose radiation will alter the likelihood of patient death in such circumstances.

Given the above facts, there is a high level of foreseeability and certainty that Crystin would be harmed by failing to disclose potentially efficacious experimental treatments. Furthermore, Crystin's injury came about as a direct result of Dr. Prados' failure to disclose the experimental treatment. Morally, it is indefensible for a physician with knowledge of a potentially life saving treatment to withhold such information from the parents of the terminally ill child. By finding that Dr. Prados had a duty to disclose, this court can reduce the likelihood that another parent, in the same circumstances, will be deprived of access to a potentially life saving treatment. The community benefits from the finding of such a duty because it increases the likelihood that terminally ill cancer patients and their caretakers will be informed of information essential to the exercise of informed choice in the fight against terminal disease, information that can prolong and save life. Finally, physicians are well insured for such risks and would not personally suffer from such a legal finding of liability.

The conventional treatments for a rhabdoid brain tumor are chemotherapy and high dose radiation. If this were the only known treatment then Dr. Byron, or for that matter any physician, would not need the services of a tumor board. Clearly, the tumor board's purpose was to look at particular cases and make recommendations for other possible therapies. It has already been stated that Dr. Byron was inexperienced in treating rhabdoid brain tumors and that he relied upon the tumor board for "identifying alternative treatments." JA 789:2-11. Thus, in responding to Dr. Byron's request, the tumor board had an obligation to disclose to Dr. Byron potentially efficacious experimental alternative treatments and to advise him of their potential risks and benefits. A finding of no duty would obfuscate the need for and purpose of the tumor board in such circumstances. Therefore, this court should find that the board had a legal duty to provide information on alternative treatments for Crystin's rhabdoid brain cancer - a duty which it breached.

VII. Conclusion

A simple disclosure by Dr. Prados and the UCSF tumor board to the parents of Crystin Schiff could have saved her from undergoing the chemotherapy and high dose radiation that ultimately killed her and has never cured a single childhood rhabdoid brain cancer. Simple disclosure of potentially efficacious alternatives places no extraordinary burden on physicians licensed to treat terminally ill cancer patients for whom conventional treatments have failed. It is their essential duty to enable terminally ill patients to exercise informed choice. In this case, Dr. Prados and the UCSF tumor board knew of antineoplastons and were aware of its successful use in childhood rhabdoid brain cancers. Even if they lacked such knowledge, identifying antineoplastons and other potentially efficacious experimental treatments requires only a cursory review of the medical literature. Once this information has been identified, discussing it with a terminally ill patient or that patient's guardian serves to further the doctor/patient relationship and ensure that the patient or his or her guardian has all the information necessary to make a serious life decision. A holding otherwise sentences countless future children to the fate of Crystin Schiff.

For the aforementioned reasons, amicus curiae APMA respectfully urges this court to reverse the judgment entered by the trial court and remand this case for jury trial on the question of materiality of Dr. Prados and the UCSF tumor board's failure to disclose the existence of antineoplastons, a potentially life saving treatment, to the Schiffs.


Respectfully submitted,

Jonathan W. Emord
Emord & Associates, P.C
5282 Lyngate Ct.
Burke, VA 22015
Phone: (202) 466-6937

David Harris
Sinnott, Dito, Moura & Puebla
660 South Figueroa Street, Suite 2300
Los Angeles, California 90017
Phone: (213) 996-4200

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