Source: https://biotech.law.lsu.edu/cases/consent/schiff_v_prados.htm
Timestamp: 2019-04-25 03:59:09+00:00

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Counsel for Appellants: Law Offices of Edward J. Nevin Edward Joseph Nevin. Law Offices of Daniel U. Smith Daniel U. Smith Ted W. Pelletier. Counsel for Respondent: Greines, Martin, Stein & Richland Jennifer L. King Martin Stein. Anderson, Galloway & Lucchese Sonja M. Dahl Thomas J. Donnelly. Counsel for Amici Curiae: Susan L. Penney California Medical Association. Catherine I. Hanson California Dental Association and California Healthcare Association on behalf of Respondent.
 The opinion of the court was delivered by: Kay, J.
 A doctor's obligation to obtain a patient's informed consent to medical treatment includes "a duty of reasonable disclosure of the available choices with respect to proposed therapy and of the dangers inherently and potentially involved in each." (Cobbs v. Grant (1972) 8 Cal.3d 229, 243.) We hold that, as a matter of law, a treatment that cannot legally be administered in this state is not "available" within the meaning of this rule, and thus that a physician cannot be held liable for failing to disclose the existence of such a treatment.
 This appeal arises in a wrongful death action filed against Dr. Michael Prados and others including the Regents (Regents) of the University of California at San Francisco (UCSF) by Ric and Paula Schiff, the parents of Crystin Schiff, who died at the age of six, two and one half years after she was diagnosed with a brain tumor. There are two theories of liability: negligence in the provision of Crystin's medical treatment; and failure to obtain the Schiffs' informed consent to her treatment. This appeal is limited to the informed consent issue, and is taken by the Schiffs from the judgment in favor of Dr. Prados on that issue after his motion for summary judgment was granted.
 Crystin was admitted to UCSF on January 22, 1993, with a malignant rhabdoid tumor, a rare and aggressive form of cancer, in her brain and around her spinal cord. Dr. Prados is the head of UCSF's neuro-oncology (brain tumor) service and moderator of its neuro-oncology tumor board. UCSF is one of the most prominent brain cancer treatment centers in the world, and one of the few national hospitals to have a neuro-oncology tumor board. The board is comprised of physicians from various medical disciplines involved in the diagnosis and treatment of cancer. The patient's oncologist presents the facts of the case to the tumor board members, who attempt to arrive at a consensus as to the best course of treatment. The tumor board members have no direct patient contact; the patient's oncologist acts as a conduit and conveys the board's thinking to the patient.
 Crystin had surgery on the tumor on January 25, 1993. Although most of the tumor mass was removed, residual tumor remained in the brain and around the spinal cord. Dr. Prados states that when Crystin's case was discussed by the neuro-oncology tumor board, he advised that he had not treated her type of tumor, and recommended contacting doctors he knew in other states who had experience with such tumors. Dr. Prados indicates that several possible treatment options were discussed during the conferences, including aggressive chemotherapy and radiation, and that he expressed concern over the potential toxicity of that course of treatment.
 Mr. Schiff testifies that only two options were presented after Crystin's oncologist, Dr. Byron Smith, consulted with the tumor board following Crystin's surgery: having her undergo intensive chemotherapy and radiation, or "taking her home and letting her die." According to a February 1, 1993, UCSF Department of Radiation Oncology report signed by radiologists Wara and Scholz, they discussed Crystin's "poor prognosis" with the Schiffs, and recommended that she receive aggressive chemotherapy and radiation. The note states that short-term risks, including sepsis and the possibility of death, as well as long-term risks, including loss of I.Q. and stature, were explained to the Schiffs, and that the Schiffs wished to proceed with the therapy.
 Mr. Schiff states that, in their conversations with Dr. Wara, he and Mrs. Schiff "both made it clear we were interested in knowing the benefits and risks of the proposed treatment, and knowing of any alternative treatment or options that might possibly be advantageous to our daughter." Dr. Wara told him that he "proposed to administer an aggressive dose [of radiation], but that it would not kill her. He said that there was a 15% chance he could cure her." Dr. Wara "assured [Mr. Schiff] that the radiation therapy would likely extend Crystin's life." The Schiffs understood that radiation and chemotherapy would be very difficult for Crystin, and they asked Dr. Smith to look into other options, and to ask the tumor board about all possible therapies. Dr. Smith advised that none of the physicians he consulted, including Dr. Prados, knew of any appropriate alternative treatments. Dr. Smith had "no doubt" that the proposed chemotherapy and radiation treatment would not cure Crystin, but noted that there were clinical cancer studies in progress, and felt that given the rapid advances in medical science something beneficial to Crystin might be developed if her life could be extended.
 Mr. Schiff took Crystin to Dr. Burzynski's Houston, Texas clinic in August of 1993, and decided during the visit to begin Crystin on antineoplaston treatment. Mr. Schiff and Crystin remained in Houston for eight or ten days, and then returned home to California with a supply of antineoplastons, which were administered to Crystin intravenously. After Crystin and Mr. Schiff returned from Houston, a relative there obtained antineoplastons from Dr. Burzynski's clinic and mailed them to the Schiffs in California.
 The Schiffs understood that Crystin's antineoplaston treatment was not approved by the FDA, that the State of Texas was prosecuting Dr. Burzynski or trying to take away his license, and that Dr. Burzynski could not legally transport antineoplastons across state lines. At the time, a federal injunction prohibited Dr. Burzynski from distributing antineoplastons in interstate commerce, but did not prevent their distribution in Texas. The Texas State Board of Medical Examiners had filed a disciplinary action against Dr. Burzynski in 1988 alleging that his use of antineoplastons violated Texas statutes, but hearings in the Texas case did not begin until May of 1993, and the administrative law judge had not yet rendered a decision when Crystin went to Dr. Burzynski's clinic.
 (5) Phase 2 clinical trials of certain antineoplastons were in the process of being established.
 Dr. Burzynski testifies that he did not begin conducting FDA approved Phase 2 clinical trials until April of 1994; before then, his "Phase 2" trials "were done outside of the FDA jurisdiction." Dr. Burzynski states that in September 1993, shortly after Crystin's visit to the clinic, the FDA accepted an investigational new drug application (IND) authorizing him as principal investigator to conduct trials at his clinic of antineoplastons in children with brain tumors. *fn3 He further states that he received a "special exception" from the FDA on October 4, 1993, authorizing him to treat Crystin's brain tumor with intravenous antineoplastons. *fn4 However, it took several more months and pressure from members of Congress solicited by the Schiffs before the FDA approved a treatment protocol for Crystin. Dr. Burzynski wrote Dr. Smith on March 30, 1994, stating that the protocol had been approved, and thus that Dr. Smith could be appointed as a co-investigator for Crystin's antineoplaston treatment. Dr. Smith testifies that he did not believe that antineoplastons would be effective, but agreed "for humanitarian purposes" to monitor Crystin's treatment as co-investigator because it would reduce the costs of the treatment to the Schiffs, and make it unnecessary for Crystin to travel to Houston.
 In March 1994, the administrative law judge in the Texas disciplinary proceeding ruled that Dr. Burzynski's use of antineoplastons was lawful in Texas. In August 1994, the Texas Board of Medical Examiners rejected that decision, ruled that Dr. Burzynski's use of antineoplastons without FDA approval violated Texas law, and ordered him to treat patients only under an FDA IND or special exception. Dr. Burzynski sued to overturn the Board's order and obtained an injunction against its enforcement.
 Crystin continued on antineoplaston treatment until December 2, 1994, when she appeared to be cancer free. When she was taken off antineoplastons she deteriorated rapidly, and an MRI confirmed that the brain tumor had reappeared. Mr. Schiff indicates that every doctor with whom they consulted at that point, including Dr. Prados, recommended against resumption of Dr. Burzynski's treatment. Mr. Schiff states that Dr. Prados recommended that other chemotherapies in Phase 1, 2, or 3 clinical trials be considered in lieu of antineoplastons. The Schiffs elected to put Crystin back on antineoplastons near the end of December 1994. Subsequent tests showed that her tumor had completely regressed.
 Crystin died on July 29, 1995. The immediate cause of death was aspiration pneumonia brought on by radiation necrosis; an autopsy showed no evidence of any residual or recurrent malignant rhabdoid tumor. In Dr. Prados's view, Crystin's "profound neurological deterioration" at the time of her death "likely result[ed] from effects of the aggressive radiation treatments she had earlier undergone, possibly combined with chemotherapy effects, and/or the potential unknown effects of the antineoplaston treatment." The Schiffs have presented expert testimony that Crystin's death was caused by excessive radiation, that antineoplastons cured her cancer, and that she would not have died if she had been treated with antineoplastons instead of the radiation and chemotherapy she received.
 After a hearing in February 1995, a Texas trial court overturned the Board of Medical Examiners' decision against Dr. Burzynski; the Board appealed from that decision. In November 1995, Dr. Burzynski was indicted by a federal grand jury on multiple counts of violating FDA rules and the injunction prohibiting shipment of antineoplastons across state lines, and on multiple counts of insurance/mail fraud. In February 1996, a Texas Court of Appeals reinstated the Medical Board's decision against Dr. Burzynski, concluding that Texas law did not authorize distribution of drugs that were not FDA-approved. (State Bd. of Med. Examiners v. Burzynski, supra, 917 S.W.2d at pp. 367-370.) Dr. Burzynski testifies that, later that same month, an FDA protocol was established to incorporate his patients who were then being "treated outside clinical trials" into a large Phase 2 study. All but one count of the federal indictment against Dr. Burzynski were eventually dismissed, and he was acquitted of the remaining count.
 The Schiffs filed their complaint for Crystin's wrongful death against Dr. Prados and others in October 1996, alleging that Dr. Prados did not obtain their informed consent for Crystin's treatment because he failed to advise them of the antineoplaston treatment offered by Dr. Burzynski. Dr. Prados moved for summary judgment or summary adjudication, arguing among other things that he had met the standard of care, and that, as a matter of law, none of his acts or omissions during tumor board conferences created any duty of care to Crystin. The court denied the motion, finding that there were triable issues of fact as to whether, among other things, Dr. Prados had met the standard of care, and had breached a duty to provide the Schiffs with information about antineoplaston treatment.
 that antineoplaston treatment was unavailable because it had not been approved by the FDA when the Schiffs consented to Crystin's chemotherapy and radiation treatment; that he had no duty to inform the Schiffs of a treatment he did not recommend; and that he had no duty to obtain their informed consent because as a tumor board member he had no direct patient contact with them before they consented to Crystin's chemotherapy and radiation.
 The court granted the motion for summary judgment, finding that Dr. Prados had no duty to inform the Schiffs of antineoplastons because they had not been approved by the FDA for Crystin's treatment in January and February of 1993.
 Dr. Julian Whitaker, a California licensed physician, and Dr. Carlos Fernandez, a physician licensed in Texas, have opined for the Schiffs that Dr. Prados breached the professional standard of care applicable in the circumstances by failing to inform the Schiffs of antineoplaston treatment as an alternative to the chemotherapy and radiation proposed for Crystin. Dr. Whitaker indicates that Dr. Prados's failure to disclose "the availability of antineoplastons" at tumor board discussions of Crystin's case "would be regarded by the average physician as morally offensive and unethical."
 Dr. Prados states that "[i]n January 1993, there were many alternative treatments for cancer known to exist, including laetrile, vitamin C, immuno-augmentative therapy, coffee enemas, Chinese herbal medicines, and others." In his view, although "[a]ny patient is free to explore these potentialities," "[t]he standard of care does not require controversial and/or alternative methods which have not been subjected to scientific scrutiny, such as antineoplastons, to mandatorily fall within the range of options discussed during tumor board meetings." Dr. Prados has not cited lack of FDA approval as a reason for failing to mention antineoplastons as an option in Crystin's case.
 Dr. Prados was aware of antineoplastons when Crystin's case was discussed by the tumor board. Dr. Burzynski wrote a letter to Dr. Prados in May 1991 about Dr. Prados's patient, Jeffrey Keller, who had received various treatments, including antineoplastons, after brain tumor surgery. In a June 1991 UCSF admission summary for Keller, Dr. Prados wrote that "[o]verall he has had a dramatic decrease in tumor volume since being on the antineoplastins [sic]." Dr. Burzynski's May 1991 letter also referred to another of Dr. Prados's brain tumor patients, Pamela Winningham. The letter states that Winningham began antineoplaston treatment in May 1988, "went into complete remission" in January 1989, and had been "living a normal life" after her antineoplaston treatment was completed in January 1990. Dr. Prados acknowledges that "one adult patient of mine with quite a different type of tumor [than Crystin] with a much higher survival rate had undergone [antineoplaston] treatment, and may have been helped by it, although he later died."
 Mr. Schiff has averred that, if he had been informed about antineoplastons, he would have elected to have Crystin treated with them rather than the chemotherapy and radiation she received.
 Dr. Prados contends that the "unavailability" of antineoplastons was established in Smith v. Shalala (D.D.C. 1996) 954 F.Supp. 1, but that case is distinguishable. The issue in Smith v. Shalala was whether a cancer patient could enjoin the FDA from prohibiting his receipt of antineoplaston treatment. The court rejected the plaintiff's contention that his constitutional rights were violated by the FDA's determination that, because he had not tried "an available, proven treatment for his illness," he did not qualify to participate in a clinical trial of antineoplastons (Id. at p. 4.) In response to the plaintiff's claim that he "had a fundamental right to `choose among available medical treatments,'" the court explained that, because antineoplastons had "not been approved for general use by FDA" and had been approved "only for limited clinical trials under agency supervision," they were "not `available' as a matter of law." (Id. at p. 3.) The latter statement, in context, meant only that use of antineoplastons was subject to FDA supervision. Since the court was not addressing an issue of informed consent, its observations on the "availability" of antineoplastons are not pertinent here in any event.
 Here, unlike Spann, the alternative treatment in question did exist: one physician in Texas was administering antineoplastons. This case, however, presents the unusual situation where the alternative procedure-injection of antineoplastons into children with brain tumors-was outlawed by statute in California. Thus, we are called upon to determine whether a treatment that is illegal in this state is nonetheless an "available" alternative that a physician could be required to disclose in order to obtain a patient's informed consent.
 (3) specified alternative conditions, including filings with the Medical Board of California, are fulfilled (§§ 109300, 109325).
 There is no evidence in this case that there were any California Medical Board filings for antineoplastons when Crystin's post-surgical treatment was being considered, and antineoplastons were not approved by the FDA for marketing at the time. The only possible question would be whether a current and unrevoked IND was on file for the antineoplaston treatment Crystin required.
 "I had been authorized since March 1989 by the FDA to treat patients clinically with antineoplastons provided that they were enrolled in a Phase II clinical trial or I obtained a special exception that allowed me to administer treatment that did not meet one or more of the requirements for acceptance into the trial. Thus, from the beginning of 1993, I had the opportunity to obtain from the FDA authorization to treat Crystin Schiff. If I were to have made an application for a special exception for Crystin Schiff in January 1993, it is more likely than not that the FDA would have quickly approved such an application . . . . [¶] When Crystin came to me as a patient, I initiated steps to obtain a special exception license by the FDA to treat her with antineoplastons. At the time of my request, the FDA had already accepted in September 1993 an . . . (IND) . . . that authorized me as the Principal Investigator to conduct clinical trials of antineoplastons in children with brain tumors at the Burzynski Clinic. Because this IND was more relevant to Crystin's case, I sought a special exception based on this IND. It would not have been possible to rely on this IND application prior to its acceptance by FDA in September 1993."
 "Q: So before August of '93 are you saying it would have been impossible for a patient to get a special exception?
 [¶] A: Not for intravenous treatment because we did not have any protocol yet approved for [sic] FDA for intravenous treatment.
 [¶] Q: I think it's the way the answer came out. Let me ask you basically the same question.
 [¶] Before August of 1993 it's your understanding that it would have been impossible for a patient to call for this special exception; is that right?
 [¶] A: With intravenous treatment.
 [¶] A: But it would be possible for special exception with capsules because this protocol had been approved already.
 [¶] Was Cryssie Schiff ever treated with capsules?
 [¶] A: No, she was treated with injections.
 [¶] A: Because of the dosage. Her tumor was very aggressive and required heavy dosages. If you would like to administer this orally with capsules, then corresponding dosage should be probably around few hundred capsules a day. So that's why it was administered intravenously.
 [¶] Q: So from a realistic standpoint, given the type of tumor she had, before August of '93 it was from a practical standpoint impossible for her to qualify for this special exception because you wouldn't have recommended capsules?
 Thus, a minimum requirement for Crystin's lawful treatment with antineoplastons in California-a current and unrevoked IND on file permitting such treatment-was not satisfied at the relevant time. Accordingly, the Schiffs have effectively conceded, both at oral argument on the summary judgment motion below and in their appellate briefs, that it would have been illegal to administer antineoplastons to Crystin in California when Dr. Prados allegedly should have disclosed the existence of that treatment. The Schiffs argue that Dr. Prados had a duty to advise them of antineoplastons because that treatment was available in Texas, not because it was available in California. Alternatively, the Schiffs argue that Dr. Prados "should have informed [them] about antineoplastons to give them the choice to investigate whether antineoplastons would become available in California through an FDA-approved clinical trial in time to save Crystin's life." The Schiffs observe that "within several months Crystin was able to get antineoplastons with FDA approval, but by that time she had already received lethal radiation treatment."
 To rule that a physician may have a duty to disclose a treatment that is currently unavailable because the treatment might become available in the future would be to discard the availability requirement altogether. We acknowledge that the concept of meaningful choice is at the heart of the informed consent doctrine (Cobbs v. Grant, supra, 8 Cal.3d at p. 242; Schuck, Rethinking Informed Consent (1994) 103 Yale L.J. 899, 924), that informed consent is generally a jury question (Arato v. Avedon, supra, 5 Cal.4th at pp. 1184, 1186), and that informed consent cases are not ordinarily governed by "bright line" rules (id. at p. 1186). But we are not free to depart from the Supreme Court precedents that limit a physician's duty to disclose alternative treatments to those that are available. (Auto Equity Sales, Inc. v. Superior Court (1962) 57 Cal.2d 450, 455).
 Nor are we free to ignore the lines the Legislature has drawn concerning available treatments. (See Daum v. SpineCare Medical Group, Inc. (1997) 52 Cal.App.4th 1285, 1305 [although the Arato court declined to prescribe specific disclosures to patients, courts must adhere to requirements imposed by the Legislature and the FDA for informed consent to participation in clinical trials].) The Legislature has specified the IND as a minimum prerequisite for the provision of a cancer treatment. An IND is typically preceded by years of pre-clinical research to develop data showing that a drug is reasonably safe for human testing. (CDER Handbook, supra, p. 7; Note, Reform of the New Drug Approval Process (1997) 49 Admin. L. Rev. 477, 484.) The IND requirement thereby furthers the patient welfare goals of the cancer treatment laws. (§ 109250 [need "for testing and investigating the value or lack thereof of alleged cancer remedies" to avoid problems associated with unproven treatments].) That there was an IND on file permitting antineoplaston capsules to be administered to breast cancer patients did not necessarily establish that it was reasonably safe to give injections equivalent to hundreds of capsules to children with brain tumors.
 The protracted proceedings required to resolve the legality of antineoplaston treatment under Texas law demonstrate why Dr. Prados could not reasonably be held responsible for assessing the point. The Schiffs suggest that Dr. Prados cannot claim that antineoplastons were unavailable for Crystin's treatment because he knew of other brain tumor patients who had been treated with them. However, Dr. Prados could not have been expected to know whether the treatment those patients received was permitted by Texas law.
 Moreover, even if Texas had allowed Crystin's treatment with antineoplastons, such treatment was, for legitimate policy reasons, outlawed in California. It would be contrary to the public policies reflected in our cancer treatment statutes to require a physician to discuss treatments those statutes proscribe. We note also that cancer drugs in FDA-approved clinical trials are not "unavailable" under our analysis. (§ 109325.) Thus, contrary to the Schiffs' suggestion at oral argument, our decision will not serve to discourage participation in such trials.
 Accordingly, while we are mindful of the tragic loss the Schiffs have suffered, we are unable to endorse the duty they advocate.
 The Schiffs' remaining argument, advanced without any authority, is that summary judgment cannot be granted on their informed consent claim against Dr. Prados because that claim is integral to their negligence case against the Regents for giving Crystin excessive radiation. The Schiffs object that if they are "forced to go to trial against the Regents without the informed-consent claim, the jury will not learn of the existence of the antineoplaston treatments, allowing the Regents to argue (falsely) that the radiation was not excessive because there existed no alternative treatment to kill the tumor." However, it is inappropriate to speculate about future evidentiary rulings in the litigation of claims not involved in this appeal. For present purposes, it is sufficient that "the summary judgment statute plainly contemplates circumstances in which one defendant is entitled to judgment even though others are not." (24 Hour Fitness, Inc. v. Superior Court (1998) 66 Cal.App.4th 1199, 1208.) Dr. Prados is entitled to summary judgment on the informed consent claim, and the negligence action against the Regents must be resolved on its own separate merits.
 *fn5 Unless otherwise indicated, all further statutory references are to the Health and Safety Code.

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