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Schneider case follows this comment.
Schneider case follows this comment.
Can a patient choose or consent to unorthodox treatment?
A patient can choose an unorthodox treatment in lieu of those therapies offered by allopathic medicine, but a physician needs to be careful when dealing with this patient.
Use an 'Assumption of Risk' form rather than a standard 'Informed Consent' form. Chart that the patient choose alternative therapy with knowledge that choosing it may expose the patient to unknown risks.
The 'Assumption of Risk' puts the burden of failure on the patient. An 'Informed Consent' risks giving the impression that the physician is offering alternative medicine and, thereby, himself shouldering the potential liability of unexpected and unwanted outcomes.
POINT: Choose assumption of risk rather than informed consent when a patient insists on alternative medicine in lieu of, or in addition to, medical treatment at the accepted standard of care. This is also the recommendation of malpractice insurance carriers.
The Schneider case is in federal court because of diversity jurisdiction. However, the subject, medical malpractice, is governed by state law, in this instance the law of New York.
After being diagnosed with breast cancer Mrs. Schneider refused surgery and sought an alternative medicine type of treatment that did not involve surgery or chemotherapy.
She found Dr. Revici who treated patients with non-toxic and non-invasive methods not recognized by the medical community. He used selenium.
Both plaintiff (Mrs. Schneider) and defendant called expert witnesses. The expert called by Mrs. Schneider said the medical community recognized Dr. Revici "as a quack, we recognize his treatment as snake oil. We consider him, in quotes, one of the cruelest killers in the United States."
Prior to beginning treatment, Mrs. Schneider signed a form titled CONSENT FOR MEDICAL CARE that embodied a covenant not to sue.
The court recognized that a covenant not to sue (exculpatory contract) could be valid when the patient is undergoing experimental treatment.
In situations where an exculpatory contract (covenant not to sue) might be unenforceable as a matter of public policy, an 'assumption of risk' by the patient who chooses alternative medicine instead of allopathic treatment may act as a bar to recovery.
While condemning Dr. Revici's form for its lack of clarity compared to a form approved in another case, the court said there was sufficient evidence in the record for the jury to have been given the opportunity to decide whether Mrs. Schneider had, in fact, assumed the risk of the unorthodox treatment. The court said that an assumption of risk would operate as a total bar to recovery.
Lesson: If urged by a patient to try alternative or complementary medical treatments do not use 'informed consent' as authorization to proceed. Use a clear and unambiguous 'assumption of risk' form. This, by the way, is also the recommendation of medical malpractice insurers.
In the case below bold type has been added for ease of scanning. Some discussion of evidentiary rules has been omitted.
UNITED STATES COURT OF APPEALS, 2nd CIRCUIT
817 F.2d 987 (2nd Cir. 1987
EDITH SCHNEIDER AND HERMAN SCHNEIDER, PLAINTIFFS-APPELLEES,
EMANUEL REVICI, M.D., AND INSTITUTE OF APPLIED BIOLOGY, INC., DEFENDANTS-APPELLANTS
Appeal from judgment entered in the United States District Court for the Southern District of New York (Motley, J.) in an action for medical malpractice arising out of unconventional, non-surgical treatment for breast cancer.
Emanuel Revici, M.D. and the Institute of Applied Biology, Inc. (the "Institute") appeal from a judgment entered in the United States District Court for the Southern District of New York (Motley, J.), in a diversity action arising from Dr. Revici's treatment of plaintiff Edith Schneider's breast cancer with unconventional, non-invasive cancer therapy, after she had been advised by numerous doctors to undergo a biopsy and had refused to do so. Edith Schneider and her husband asserted four claims against Dr. Revici and the Institute: (1) fraud, premised on Dr. Revici's alleged promise to cure Mrs. Schneider of breast cancer; (2) medical malpractice; (3) a claim for lack of informed consent under N.Y. Pub. Health Law § 2805-d; and, (4) a derivative claim asserted by Mr. Schneider for loss of consortium. After the district judge refused to charge the jury on the affirmative defense of express assumption of risk, the jury returned a verdict for the plaintiffs on the medical malpractice claim, and a loss of consortium claim. It awarded Edith Schneider and her husband $1,000,000.00 and $50,000.00 respectively. Because the jury found that Mrs. Schneider was equally responsible, through her own culpable conduct, for the damages she suffered, the awards were halved to $500,000.00 and $25,000.00, pursuant to New York's comparative negligence statute, N.Y. Civ. Prac. L. & R. 1411.
On appeal, Dr. Revici and the Institute challenge the district court's refusal to charge with respect to an alleged covenant not to sue and express assumption of risk as affirmative defenses, either of which would serve as a total bar to recovery. Appellants also contend that numerous evidentiary rulings were erroneous. Because we hold that express assumption of risk was available as a total defense to this action under New York law, we reverse and remand this case for determination of that issue only.
In October 1981, Dr. Cocoziello discovered a lump in appellee Edith Schneider's right breast during her annual gynecological checkup. Dr. Cocoziello referred Mrs. Schneider to Drs. Snyder and Lichy, who performed a bilateral mammogram and compared the results to one taken in 1978. Dr. Lichy's report indicated the presence of a "one centimeter nodulation" in the right breast, and advised a biopsy, both in the report to Dr. Cocoziello and by telephone to Mrs. Schneider. Joint App. at 1229. Mrs. Schneider told Dr. Lichy that she did not want a biopsy and would seek a doctor who would treat her nonsurgically. Id. Dr. Cocoziello also urged Mrs. Schneider to have a biopsy and referred her to three general surgeons: Dr. Abessi, Dr. Addeo, and Dr. Volke. Mrs. Schneider was examined by Dr. Abessi and Dr. Volke, who both separately advised her to undergo a biopsy and possibly a partial mastectomy, depending upon the analysis of the biopsied tissue. She refused. Id. at 1241.
In November 1981, Mrs. Schneider consulted with Dr. Emanuel Revici, defendant-appellant herein, who is the President and Scientific Director of the Institute. Dr. Revici is a physician and researcher who treats cancer patients with "non-toxic," non-invasive methods that have not been adopted by the medical community. Mrs. Schneider had learned of Dr. Revici and his novel cancer therapy from a radio program. After Mrs. Schneider signed a detailed consent form,*fn1 Dr. Revici diagnosed cancer of the right breast and began treatment with selenium and dietary restrictions. While Mrs. Schneider claims that Dr. Revici never advised either a biopsy or surgery, his records show that in February 1982, and on three later occasions, he recommended that she have the tumor surgically removed. After fourteen months of treatment, the tumor had increased in size, and cancer had spread to her lymph system and left breast. Mrs. Schneider finally underwent a bilateral mastectomy at Memorial Sloan-Kettering Hospital in January 1983, followed by sixteen months of conventional chemotherapy.
Mrs. Schneider brought this diversity action against Dr. Revici and the Institute for damages, alleging common law fraud, common law medical malpractice and lack of informed consent pursuant to N.Y. Pub. Health Law § 2805-d. Mr. Schneider also sued for loss of consortium. On the eve of trial, defendants sought leave either to clarify their Third Affirmative Defense of "culpable conduct" or to amend their answer to include express assumption of risk as an affirmative defense. In a pre-trial order, dated November 11, 1985, the trial judge denied the motion, apparently on the grounds that express assumption of risk is unavailable as a defense to medical malpractice under New York law: “Defendant's request for application of the assumption of risk doctrine . . . is denied. The law of medical malpractice and informed consent are well-established areas of jurisprudence in N.Y. State. This case will be tried in accordance with those well-established principles, including the doctrine of comparative negligence.”
The jury returned a verdict for Mrs. Schneider solely on the medical malpractice claim, and awarded $1,000,000.00 and $50,000.00 to her and her husband respectively. The jury found, however, that Mrs. Schneider was 50 % comparatively negligent, and both awards were thereby halved to $500,000.00 and $25,000.00. On this appeal, appellants contend that the district court erred by refusing to charge as affirmative defenses an alleged covenant not to sue and express assumption of risk, and also erred in certain evidentiary rulings. We hold that, under New York law, express assumption of risk is available as an affirmative defense to a medical malpractice action and if proved, would totally bar recovery by a plaintiff. Therefore we reverse and remand this case to the district court for a new trial of the issue of express assumption of risk.
A. Evidentiary Rulings
Appellants' primary assertion of error in the trial court's evidentiary rulings is that the court refused to allow evidence about the effectiveness of the Revici method of cancer treatment to be introduced at trial. In particular, appellants challenge the exclusion of patient records, and the exclusion of Dr. Revici's book entitled Research in Physiopathology As Basis Of Guided Chemotherapy With Special Application To Cancer (1961).
The trial court excluded records of patients successfully treated by Dr. Revici on the grounds that the issue in medical malpractice is not whether a particular treatment is effective but whether that treatment is a deviation from accepted medical practice in the community. The trial court's statement of the law of medical malpractice is correct. Amsler v. Verrilli, 119 A.D.2d 786, 501 N.Y.S.2d 411 (2d Dep't 1986). However, evidence as to the effectiveness of Dr. Revici's treatment method was relevant to show that he did not make a false representation with intent to defraud. See Bankers Trust Co. v. J.V. Dowler & Co., 47 N.Y.2d 128, 390 N.E.2d 766, 417 N.Y.S.2d 47 (1979). Any error in excluding the patient records was clearly harmless, however, in light of the jury's finding that Dr. Revici was not liable on the claim of common law fraud. Dr. Revici's sole liability was founded on medical malpractice, which is amply supported by the record, and the evidence of the effectiveness of his treatment was not relevant to that issue.
Defendants' expert witness, Gerhard Schrauzer, had testified about the nutritional value of selenium -- testimony directed at negating the fraud claim against Dr. Revici.
To rebut that testimony, plaintiffs called Victor Herbert, M.D., [Plaintiff’s expert witness] who authored two books concerning health and nutrition fads, entitled Nutrition Cultism, Facts and Fictions and Vitamins and Health Foods: The Great American Hustle, and coauthored a book entitled The Health Robbers, about health fraud in the United States.
Dr. Herbert testified that he was a member of the National Council Against Health Fraud, and stated that its goal was to combat "health fraud, misinformation and quackery." He defined a quack as "a person who promotes and sells unproven methods of therapy, falsely representing them to be effective."
Appellants object to the trial court's failure to strike his testimony in the following exchange:
Q: Could you tell us whether Dr. Emanuel Revici is recognized by the National Council Against Health Fraud and in what manner?
A: We recognize him as a quack, we recognize his treatment as snake oil. We consider him, in quotes, one of the cruelest killers in the United States.
B. Covenant Not to Sue
New York law recognizes the efficacy of a covenant not to sue in the context of medical treatment: Specifically, where a patient voluntarily agrees to undergo an experimental and inherently dangerous surgical procedure, the parties may covenant to exempt the physician from liability for those injuries which are found to be the consequences of the non-negligent, proper performance of the procedure . . . . That is to say, that an experimental procedure which, because of its inherent dangers, may ordinarily be in and of itself a departure from customary and accepted practice (and thus possibly actionable as malpractice) even if performed in a non-negligent manner, may be rendered unactionable by a covenant not to sue.
Colton v. New York Hospital, 98 Misc. 2d 957, 414 N.Y.S.2d 866, 876 (Sup. Ct. 1979), and cases there cited. However, New York requires that "a covenant not to sue . . . must be strictly construed against the party asserting it. Moreover, its wording must be 'clear and unequivocal.'" Id. at 874 (citations omitted). The form signed by Mrs. Schneider lacks the precision required by New York law.
In the first place, the form was not labeled a covenant or agreement not to sue but was instead captioned " CONSENT FOR MEDICAL CARE." That caption would lead most patients to believe that they were signing a form only to acknowledge informed consent, rather than forgoing the right to bring suit. Second, the one paragraph of the consent form that bears on legal liability is not "clear and unequivocal." It states: "I therefore release Dr. Emanuel Revici from all liabilities to me, including all claims and complaints by me or by other members of my family." Though this language can be interpreted to mean that the patient is agreeing not to bring suit for any consequences that may arise in the future as a result of Dr. Revici's treatment, or as a result of forgoing traditional treatment, that interpretation is not compelled. To "release . . . from all liabilities" can plausibly be understood only to relinquish claims currently existing, rather than to promise not to sue in the future on claims that may subsequently arise. The ambiguous language of the form prepared by Dr. Revici stands in sharp contrast to the unequivocal language of the form enforced in Colton, which left no room for doubt that the patient was knowledgeably agreeing not to sue the doctor for consequences of the procedure to be performed. The form in Colton included the words " COVENANT NOT TO SUE" in block capitals in the caption and the text, and made clear that it covered future claims that might arise. Id. at 870-71.
C. Assumption of Risk
The doctrine of assumption of risk lies in the maxim, volenti non fit injuria. Based as it is upon the plaintiff's assent to endure a situation created by the negligence of the defendant, it relieves the defendant from performing a duty which might otherwise be owed to the plaintiff.
While assumption of risk, like contributory negligence, barred recovery, it was predicated on a theory of contract rather than on a theory of culpable conduct: the plaintiff's agreement, either express or implied, to absolve the defendant from responsibility. Arbegast, 65 N.Y.2d at 165, 480 N.E.2d at 368, 490 N.Y.S.2d at 754. "Express" assumption of risk resulted from an advance agreement that the defendant need not use reasonable care for the plaintiff's benefit. "Implied" assumption of risk, on the other hand, was founded on plaintiff's unreasonable and voluntary consent to the risk of harm from defendant's conduct with full understanding of the possible harm.
While we do not determine, in the case before us, whether Mrs. Schneider expressly assumed the risk of Dr. Revici's treatment, we hold that there existed sufficient evidence -- in the language of the Consent for Medical Care form that she signed, and in testimony relating to specific consent informed by her awareness of the risk of refusing conventional treatment to undergo the Revici method -- to allow the jury to consider express assumption of risk as an affirmative defense that would totally bar recovery. It was therefore error for the district court to deny the defendants' request for a jury charge on the issue, and we reverse and remand for that reason.
To summarize, we hold that the district court erred in refusing to charge the jury with the affirmative defense of express assumption of risk, and therefore reverse the judgment and remand the case to the district court for a new trial limited to the issue of assumption of risk.