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Human Experimentation/Consent and Informed Consent

Is There A Duty To Recommend Quack Cures? - Schiff v. Prados, 92 Cal.App.4th 692, 112 Cal.Rptr.2d 171, 157 Ed. Law Rep. 264, (Cal.App. 1 Dist. 2001)

Related cases:

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)

This is an informed consent case that raises the interesting question of whether a physician can be required to disclose alternative treatments that are illegal.  It is a sad case involving the death of a child, Crystin,  from a untreatable brain tumor and the parents quest for hope in the form of an unproven and illegal treatment, antineoplastons,  being offered by a physician in Houston, Dr. Stanislaw Burzynski.  Defendant Dr. Prados is the head of University of California San Francisco's neuro-oncology (brain tumor) service and moderator of its neuro-oncology tumor board.

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.  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.  Plaintiff's father 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.

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. 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."

Despite these warning about Dr. Burzynski, plaintiffs sought care from him in Houston.  The plaintiffs' knew that the treatments were unapproved by the FDA, that there was a federal injunction preventing the drugs from being shipped in interstate commerce, and that the Texas Board of Medical Examiners was attempting to suspend Dr. Burzynski's license.  They also knew that the American Medical Association and the American Cancer Society were critical of Burzynski, and that many considered him a fraud.  Following treatment in Houston, plaintiffs returned to California, bringing the unapproved drug with them, and a relative later sent more drugs to them in California.  After political pressure from congress persons contracted by Mr. Schiff, the FDA gave Burzynski what the court called a "special exemption" to allow Crystin to be treated with the unapproved drugs.  She died after some months of treatment.

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.  They alleged that had they been informed of the alternative treatment they would have refused the radiation and chemotherapy.  Dr. Prados moved for summary judgment, 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 Dr. Prados had met the standard of care and whether he had breached a duty to provide the Schiffs with information about antineoplaston treatment.  Dr. Prados then moved for summary judgment on 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 of 1993.  The appeals court first noted that there is no duty in California to inform patients of "nonrecommended procedures" (Vandi v. Permanente Medical Group, Inc. (1992) 7 Cal.App.4th 1064, 1071), but that whether a treatment constituted a nonrecommended procedure was left to expert witnesses as a classic standard of care issue.  While the court was silent on the issue, this reliance on standard of care just shifts the debate to one of the selection of witnesses - should plaintiffs be allow to have Burzynski testify as to the value of his treatment?  Unless the judge is willing to use a Daubert analysis to disqualify the plaintiffs' experts, they will be able to get to trial on the informed consent issue.

After an interesting discussion of possible precedents, the court focused its analysis on whether these drugs could be legally administered in California at the time of the informed consent, finding that under California law, 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));

(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)."

Finding that none of the conditions had been met, the court held that as a matter of law the treatment was not available in California and thus defendant could be not held liable for failing to recommend it.  This is an important and interesting case.  It raises difficult issues on the preservation of the standard of care and regulation of fraudulent medical treatments.  The State of Texas did uphold the restrictions on Stanislaw Burzynski's license and the FDA did not allow the shipment of his drug, but he, and others like him, have strong public and even congressional support.  As demonstrated with laetrile, it is difficult for legislators in many states to resist pleas to allow any possible treatment for terminal cancer patients.  This case raises the frightening specter of judges allowing testimony from unorthodox practitioners that their treatments could have saved dying patients, thus forcing legitimate medical practitioners to dignify the existence of such practitioners.  The court implies that had this treatment been legal in California, plaintiffs would have been allowed to go forward and present their case to the jury.  It is hoped that other courts that consider this situation go the next step and develop summary judgment standards for excluding quack testimony so that legitimate practitioners will not have to fight a deluge of claims such as this

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