Unorthodox Treatments Lead to License Suspension - State Bd. of Med. Examiners v. Burzynski, 917 S.W.2d 365 (Tex. App. 1996)
Banning Use of Laetrile Does Not Violate Right to Privacy - People v. Privitera, 23 Cal. 3d 697, 591 P.2d 919, 153 Cal. Rptr. 431 (Cal. 1979)
|||IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA FIRST APPELLATE DISTRICT
|||September 28, 2001
|||RIC SCHIFF ET AL., PLAINTIFFS AND APPELLANTS
MICHAEL PRADOS, DEFENDANT AND RESPONDENT
|||San Francisco Superior Court Honorable David Garcia (San Francisco County
Super. Ct. No. 982109)
|||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.
|||CERTIFIED FOR PUBLICATION
|||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
|||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.
|||Some residual tumor remained after Crystin's chemotherapy and radiation
was completed in April or May of 1993. Toward the end of that period, the
Schiffs began doing independent research and read of antineoplaston treatment
for cancer offered by Dr. Stanislaw Burzynski. *fn1
Dr. Smith was unfamiliar with Dr. Burzynski's treatment, and urged the Schiffs
to consult Dr. Prados. Mr. Schiff recalls that when he met with Dr. Prados
in July of 1993, Dr. Prados was adamantly opposed to Dr. Burzynski's treatment.
Dr. Prados had testified against Dr. Burzynski in court, and thought that
antineoplastons were toxic and ineffective. They discussed alternatives
Dr. Prados regarded as preferable options, including Crystin's participation
in clinical trials. Mr. Schiff states that Dr. Prados explained Phases I,
II and III of clinical trials, indicating that "we don't really know
what the outcome[s] of these medicines are. We are experimenting with them
to see." *fn2
|||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.
|||Mr. Schiff acknowledges that, during his investigation of antineoplastons,
he found that others besides Dr. Prados, including the American Medical
Association and the American Cancer Society, were critical of Dr. Burzynski
and his treatment. Although many people called Dr. Burzynski a "fraud,"
Mr. Schiff, a police officer with fraud investigation experience, received
favorable reports from Dr. Burzynski's patients. Mr. Schiff states that
a number of considerations were material to his decision to have Crystin
treated with antineoplastons, including:
|||(1) most patients with rhabdoid brain tumors survived only six months
to one year after diagnosis;
|||(2) there was no case in the medical literature of anyone having been
cured of a metastasized rhabdoid brain tumor by the chemotherapy and radiation
treatment Crystin received;
|||(3) there was evidence that antineoplastons had been effective in treating
|||(4) the FDA had authorized Dr. Burzynski to conduct trials of antineoplastons
as an investigational drug in clinical studies of some cancers and in special
exception cases; and
|||(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
|||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.
|||Dr. Prados then moved for summary judgment, or summary adjudication of
the duty issue, on the grounds:
|||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
|||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.
|||"In Cobbs v. Grant, supra, 8 Cal.3d 229, the California Supreme Court
held that a physician has a duty to disclose to a patient `the available
choices with respect to proposed therapy and . . . the dangers inherently
and potentially involved in each.' (Id., at p. 243.) Under Cobbs, the scope
of a physician's duty to disclose is measured by the amount of knowledge
a patient needs in order to make an informed choice. (Id., at p. 245.) At
minimum, a physician must disclose `the potential of death or serious harm'
known to be inherent in a given procedure and an explanation in lay terms
of the complications that might occur. (Id., at p. 244; see also Arato v.
Avedon [(1993) 5 Cal.4th 1172, 1190].) In addition to these `minimal' disclosures,
the physician must also reveal to the patient `such additional information
as a skilled practitioner of good standing would provide under similar circumstances.'
(Cobbs v. Grant, supra, 8 Cal.3d at pp. 244-245, and quoted in Arato v.
Avedon, supra, 5 Cal.4th at p. 1190.)" (Spann v. Irwin Memorial Blood
Centers (1995) 34 Cal.App.4th 644, 656, fns. omitted.)
|||"With respect to . . . alternative treatments, under the doctrine
of informed consent `there is no general duty of disclosure with respect
to nonrecommended procedures . . . .' (Vandi v. Permanente Medical Group,
Inc. (1992) 7 Cal.App.4th 1064, 1071, italics added.) Instead, `the failure
to recommend a procedure must be addressed under ordinary medical negligence
standards. [Citation.]' (Id., at p. 1070.) That is, a physician must disclose
alternative treatments only to the extent it is required `for competent
practice within the medical community.' (Id., at p. 1071.) The standard
of care prevailing in the medical community must be established by expert
testimony. (Ibid.)" (Spann v. Irwin Memorial Blood Centers, supra,
34 Cal.App.4th at p. 658.)
|||The Schiffs' experts have declared that the standard of care required
a physician in Dr. Prados's position to disclose antineoplaston treatment
as an alternative to the recommended chemotherapy and radiation, but whether
or not those declarations would ordinarily create a triable issue, no such
disclosure was required unless antineoplastons were an "available"
treatment alternative in Crystin's case. Although the "availability"
of an alternative treatment does not appear to have been litigated in any
reported decision, many opinions have echoed the statement in Cobbs v. Grant,
supra, 8 Cal.3d at p. 243, that the duty of disclosure extends only to "available
choices." (Arato v. Avedon, supra, 5 Cal.4th at p. 1183; Thor v. Superior
Court (1993) 5 Cal.4th 725, 738; Truman v. Thomas (1980) 27 Cal.3d 285,
291; Warren v. Schecter (1997) 57 Cal.App.4th 1189, 1200; Spann v. Irwin
Memorial Blood Centers, supra, 34 Cal.App.4th at p. 656; Jambazian v. Borden
(1994) 25 Cal.App.4th 836, 844; Traxler v. Varady (1993) 12 Cal.App.4th
|||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
|||The case that has come closest to addressing an availability issue is
Spann v. Irwin Memorial Blood Centers, supra, 34 Cal.App.4th 644. In Spann,
the plaintiff's decedent was infected with the HIV virus from transfusions
of blood products (plasmapherisis) she received to treat a blood disease
(TTP). The defendant blood bank allegedly failed to obtain the decedent's
informed consent to the plasmapherisis treatment because it did not disclose
steps that could have been taken to reduce the risk of infection, like a
program to reduce the pool of donors from which the transfused blood products
were obtained. The blood bank was not negligent for failing to offer such
a program because none existed for TTP patients undergoing plasmapherisis
at the time. (Id. at pp. 655, 658.) Although the ruling was not couched
in terms of "availability," the court held that the blood bank
"had no duty to `disclose' a program which did not exist and which
it had no professional duty to maintain." (Id. at p. 658.)
|||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
|||Health and Safety Code section 109300 provides that the "sale, offering
for sale, holding for sale, delivering, giving away, prescribing or administering
of any drug, medicine, compound, or device to be used in the diagnosis,
treatment, alleviation, or cure of cancer is unlawful and prohibited unless
(1) an application with respect thereto has been approved under Section
505 of the federal Food, Drug and Cosmetic Act, or (2) there has been approved
an application filed with the [Medical Board of California] setting forth
[specified information]." *fn5 Violating
this prohibition is a crime. (§ 109370; People v. Privitera (1979) 23 Cal.3d
697, 701 [prosecution for conspiracy to distribute laetrile to cancer patients].)
|||This prohibition does "not apply to the use of any drug, medicine,
compound, or device intended solely for legitimate and bona fide investigational
purposes by experts qualified by scientific training and experience to investigate
the safety and therapeutic value thereof unless the [State Department of
Health Services] shall find that the drug, medicine, compound, or device
is being used in diagnosis or treatment for compensation and profit. In
order to qualify for an exemption under this section there shall be on file
with the federal Department of Health, Education, and Welfare a current
and unrevoked investigational new drug application issued pursuant to subdivision
(i) of Section 505 of the federal Food, Drug, and Cosmetic Act (21 U.S.C.
Sec. 355(i)), or [alternative conditions are satisfied, including testing
to establish that the drug may be safely administered, and a written filing
with the Medical Board of California]." (§ 109325.)
|||The "legitimate state interest" expressed in these statutes
(see People v. Privitera, supra, 23 Cal.3d at p. 705) is set forth in section
109250, which states in part: "Various persons in this state have represented
and continue to represent themselves as possessing medicines, methods, techniques,
skills, or devices for the effective diagnosis, treatment, or cure of cancer,
whose representations are misleading to the public, with the result that
large numbers of the public, relying on the representations, needlessly
die of cancer, and substantial amounts of the savings of individuals and
families relying on the representations are needlessly wasted. [¶] It is,
therefore, in the public interest that the public be afforded full and accurate
knowledge as to the facilities and methods for the diagnosis, treatment,
and cure of cancer available in this state and that to that end there be
provided means for testing and investigating the value or lack thereof of
alleged cancer remedies, devices, drugs, or compounds, and informing the
public of the facts found, and protecting the public from misrepresentation
in these matters." (Italics added.)
|||Under these statutes, a cancer drug is not legally "available in
this state" unless:
|||(1) the FDA has approved an application under section 505 of the federal
Food, Drug and Cosmetic Act (21 U.S.C. § 355) which permits the drug to
be marketed (§ 109300; see 21 C.F.R. § 314.1, et seq. (2001)); or
|||(2) at a minimum, a current and unrevoked IND is on file with the FDA
pursuant to section 505(i) of the federal law (21 U.S.C. § 355(i)) which
permits the drug to be clinically tested in humans (§ 109325; see 21 C.F.R.
§ 312.1, et seq. (2001)); or
|||(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.
|||Dr. Burzynski states in a declaration:
|||"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."
|||Dr. Burzynski's declaration suggests that there was an IND on file from
March of 1989 under which Crystin's treatment with antineoplastons could
have been authorized. However, that suggestion is untenable in light of
Dr. Burzynski's previous deposition testimony and other evidence. (See Jacobs
v. Fire Ins. Exchange (1995) 36 Cal.App.4th 1258, 1270 [court may disregard
declaration prepared in connection with summary judgment motion that conflicts
with declarant's deposition testimony]; Preach v. Monter Rainbow (1993)
12 Cal.App.4th 1441, 1451.)
|||A March 1989 letter from the FDA to Dr. Burzynski indicates that the IND
then on file was for investigation of the use of antineoplaston capsules
for the treatment of advanced breast cancer. Dr. Burzynski confirmed in
his deposition that Crystin's treatment could not have been authorized under
this IND because she needed large doses of antineoplastons which were equivalent
to hundreds of capsules and had to be administered intravenously:
|||"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.
|||[¶] Q: Yes, sir.
|||[¶] A: But it would be possible for special exception with capsules because
this protocol had been approved already.
|||[¶] Q: I see.
|||[¶] Was Cryssie Schiff ever treated with capsules?
|||[¶] A: No, she was treated with injections.
|||[¶] Q: Why?
|||[¶] 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
|||[¶] A: That's right."
|||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 Schiffs' other argument for recognition of a duty in this case-that
Dr. Prados was obligated to advise them of antineoplastons because that
treatment was available in Texas-must also be rejected. A comparable argument
failed in Spencer By And Through Spencer v. Seikel (Okla. 1987) 742 P.2d
1126. The plaintiff in Spencer consulted an Oklahoma physician for prenatal
care. The fetus was diagnosed with a condition impairing brain development
when the fetus was viable and could not, by Oklahoma statute, be aborted.
After the child was born with brain damage, the mother sued the doctor on
the theory that he had negligently failed to inform her that an abortion
might have been available outside Oklahoma. The court agreed with the doctor
that he had no duty to disclose information about an alternative treatment
that was not legally available to the plaintiff in Oklahoma. The plaintiff
was "correct in her assertion that physicians in Oklahoma are held
to national standards of care but those standards do not impose upon physicians
a duty to know or disclose the laws of other states which are contrary to
laws in the state wherein they practice." (Id. at p. 1129.) "[I]nform[ing]
patients of treatment alternatives not available in Oklahoma but available
in other states is beyond what the law expects from physicians. Searching
for legal alternatives is a job more suitable for lawyers." (Ibid.)
|||The merits of this reasoning are well illustrated here. When Crystin's
treatment was being determined it was unclear whether Dr. Burzynski's use
of antineoplastons was permissible under Texas law. The Texas Board of Medical
Examiners had alleged that Dr. Burzynski's dispensing of antineoplastons
without FDA approval violated a Texas statute, similar to section 109300,
which provided that: "`[a] person shall not sell, deliver, offer for
sale, hold for sale or give away any new drug unless . . . an application
with respect thereto has been approved and the approval has not been withdrawn
under Section 505 of the federal Act.'" (State Bd. of Med. Examiners
v. Burzynski, supra, 917 S.W.2d at p. 369.) Dr. Burzynski relied on another
Texas statute, which provided that "[a] physician licensed to practice
medicine under this Act may supply patients with any drugs, remedies, or
clinical supplies as are necessary to meet the patients' immediate needs."
(Id. at p. 368, italics omitted.) Initially an administrative law judge
sided with Dr. Burzynski, then the Medical Board rejected that decision
and "concluded that it is and always has been illegal for Dr. Burzynski
to use his antineoplastons in Texas" (id. at p. 367), then a trial
court sided with Dr. Burzynski, and then a Texas Court of Appeals finally
resolved the matter in favor of the Board. The appellate court directed
rendition of judgment consistent with the Board's decision because the statute
on which Dr. Burzynski relied was only "intended to allow a physician
to supply drugs to a patient in immediate need without violating the provisions
of the Texas Pharmacy Act" (id. at p. 368) and did "not authorize
physicians to dispense unauthorized drugs" (ibid.). (Accord, Trustees
of the Northwest Laundry v. Burzynski, supra, 27 F.3d at p. 158.)
|||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.
|||The judgment is affirmed.
|||Reardon, Acting P.J.
|||*fn1 The previous year, a federal appellate
court had written: "Stanislaw Burzynski is a physician and researcher
located in Houston, Texas. He advocates an unconventional therapy for the
treatment of cancer using substances distilled from human urine which he
has named `antineoplastons.' According to Dr. Burzynski, when injected into
the body, antineoplastons `reprogram' cancer cells to function normally.
The Burzynski Research Institute, Inc. (BRI) is a research facility founded
by Dr. Burzynski that engages in antineoplaston research and treatment.
Dr. Burzynski and his institute have received national television exposure
on such shows as `20/20' and `Sally Jesse Raphael.' [¶] He also has received
attention from federal and state regulatory authorities. In 1983, the Food
and Drug Administration barred Dr. Burzynski from interstate transactions
involving antineoplaston treatments. The National Cancer Institute and the
Office of Technology Assessment of the United States Congress both have
issued critical reports of the treatment. In 1988, the Texas Department
of Health ordered Dr. Burzynski to cease and desist treating cancer patients
with antineoplaston therapy absent FDA new drug or investigational drug
approval." (Burzynski v. Aetna Life Ins. Co. (5th Cir. 1992) 967 F.2d
1063, 1064; see also Trustees of the Northwest Laundry v. Burzynski (5th
Cir. 1994) 27 F.3d 153, 155 [describing antineoplastons as an "unorthodox"
cancer treatment]; State Bd. of Med. Examiners v. Burzynski (Tex. App. 1996)
917 S.W.2d 365, 366 [same].)
|||*fn2 These trials precede FDA approval
of a drug for marketing. (See Greenberg, AIDS, Experimental Drug Approval,
and the FDA New Drug Screening Process (2000) 3 N.Y.U. J. Legis. & Pub.
Pol'y 295, 304- 306 [hereafter Greenberg].) Phase I trials are generally
conducted on a small number of healthy volunteer subjects, and "are
designed to determine the metabolic and pharmacologic actions of the drug
in humans, the side effects associated with increasing doses, and, if possible,
to gain early evidence on effectiveness." (FDA Center for Drug Evaluation
and Research, The CDER Handbook (1998) p. 8 [hereafter CDER Handbook].)
Phase 2 trials, which usually involve several hundred people, are "early
controlled clinical studies conducted to obtain some preliminary data on
the effectiveness of the drug for a particular indication or indications
in patients with the disease or condition." (Ibid.) Phase 3 trials
are "expanded controlled and uncontrolled trials" on several hundred
to several thousand people "to gather the additional information about
effectiveness and safety that is needed to evaluate the overall benefit-risk
relationship of the drug." (Id. at pp. 8- 9.)
|||*fn3 IND's are required before clinical
trials begin. (CDER Handbook, supra, p. 13.) The FDA "monitors the
study design and conduct of clinical trials to ensure that people in the
trials are not exposed to unnecessary risks." (Id. at p. 7.)
|||*fn4 The "special exception"
Crystin received is described in the record as an exemption for "compassionate
use." Compassionate use exemptions are "granted on a case- by-
case basis pursuant to the request of a patient's primary care physician,"
and are "oriented to the end of treatment rather than to the end of
clinical research." (Greenberg, supra, 3 N.Y.U. J. Legis. & Pub.
Pol'y at p. 316.) "The FDA typically grants those requests that indicate
that `a manufacturer [is] willing to supply the drug, a physician [is] willing
to prescribe it, a patient [is] willing to give informed consent, and [there
is] some basis for believing that the treatment [is] not an outright fraud
or poison.'" (Note, The Catch- 22 for Persons With AIDS: To Have or
Not to Have Easy Access to Experimental Therapies and Early Approval for
New Drugs (1995) 69 So.Cal. L.Rev. 105, 119.)
|||*fn5 Unless otherwise indicated, all
further statutory references are to the Health and Safety Code.
The Climate Change and Public Health Law Site
The Best on the WWW Since 1995!
Copyright as to non-public domain materials
See DR-KATE.COM for home hurricane and disaster preparation
See WWW.EPR-ART.COM for photography of southern Louisiana and Hurricane Katrina
Professor Edward P. Richards, III, JD, MPH - Webmaster
Provide Website Feedback - https://www.lsu.edu/feedback
Accessibility Statement - https://www.lsu.edu/accessibility