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Assumption of the Risk as a Defense in Alternative-Med Cases

By Barbara D. Goldberg

The doctrine of assumption of the risk, while generally inapplicable to conventional medical malpractice actions, may provide an appropriate defense in an action involving alternative medicine, depending on the extent to which the patient was aware of the alternative nature of the treatment.

Federal and State Legislation

In 1991, the Senate appropriated funds to establish the Office of Alternative Medicine ("OAM") under the auspices of the National Institutes of Health, in order "to more adequately explore unconventional medical practices." OAM's stated purpose is to "facilitate the evaluation of alternative medical treatment modalities" for the purpose of determining their effectiveness and to help integrate effective alternative treatments into mainstream medical practice.1 The Senate Appropriations Committee report on the creation of OAM acknowledged that "many routine and effective medical procedures now considered commonplace were once considered unconventional."2

In 1996, the State of Washington became the first in the nation to require health care insurers to pay for "non-traditional" care.3 Also in 1996, Utah enacted legislation recognizing naturopathy as a health care option, becoming the ninth state to do so.4 Naturopathic physicians use a wide range of natural, non-toxic therapies such as homeopathy, clinical nutrition, herbal medicine, physical manipulation, exercise, and stress reduction. At the present time, at least 35 states license acupuncturists; 27 states license massage therapists; 14 states license naturopaths; and 4 states license homeopaths.5

New York's Alternative Medical Practice Act of 1994 ("AMPA")6 was enacted in response to "the potential for abuse that exists in a peer review system that does not have any peers."7 The principal purpose reflected in the legislative history was "to safeguard patient rights and guarantee legitimate due process for non-conventional physicians".8

. . .[I]n the case of a physician who practices non-conventional medicine -- i.e., treatments which differ from customary or prevailing approaches, such as homeopathy, chelation therapy, herbal medicine and vitamin therapy -- the review process established in statute may not always provide for a fair and impartial hearing. Since there are no non-conventional physicians who serve on the board for professional medical conduct, no legitimate peer review exists when issues involve clinical practice that is foreign, innovative, or has been shown to be effective, but has not yet achieved general acceptance in the United States.

The AMPA provides in pertinent part that the law regulating physicians shall not be construed to affect or prevent a "physician's use of whatever medical care, conventional or unconventional, which effectively treats human disease, pain, injury, deformity or physical condition" (emphasis added). The New York legislature recognized that "[a]ccording to the community of non-conventional doctors they are judged prejudicially by conventional doctors who discount their treatments and often impose upon them penalties more severe than those assessed against conventional doctors found guilty of equivalent charges".9 The Legislature also recognized that there are "legitimate nonconventional medical treatments," and sought to eliminate "institutional disincentives to the use of such treatments."10

Obviously, defense counsel representing alternative physicians should determine whether there is any legislation in the particular state pertaining to the practice of alternative medicine. A legislative recognition, as noted in the AMPA, of the "potential for abuse that exists in a peer review system that does not have any peers" may convince the court to adopt a "reasonableness" standard of care, as opposed to a "departure from accepted practice" standard. While the AMPA primarily addresses disciplinary proceedings, the same potential for abuse and bias is present in a medical malpractice action where the standard of "accepted practice" is defined by conventional physicians.

Not only does the legislative history of various statutes recognize the potential validity of unconventional remedies, but the very existence of the statutes reflects a legislative intent to encourage the development of effective unconventional therapies. Such legislation also responds to a long history of attempts by organized, orthodox medicine to suppress medical alternatives, such as an attempt to exclude osteopaths from a state medical society on the ground that osteopathy was a cult,11 or a state medical board's attempt to ban acupuncture.12

Use Of A "Reasonableness" Standard Where There Is
No "Accepted Practice" For The Particular Specialty

Arguably, for a court myopically to apply an "accepted practice" standard, as defined by conventional practitioners, would be at odds with the express legislative intent reflected in the AMPA and similar statutes. "Accepted practice," where an alternative or complementary treatment is involved, should be defined by a practitioner familiar with the particular technique or treatment. Otherwise, if the defendant's treatment is unique, a reasonableness standard provides the only fair basis for evaluating the defendant's conduct.

To a large extent, the unfairness of using a standard of practice defined by conventional physicians has been recognized in the area of chiropractic. In cases involving claims of chiropractic malpractice, courts generally require the testimony of a chiropractor to establish the standard of care, recognizing that it would be inherently unfair for an internist or orthopedic surgeon to define the standard of care. The same reasoning should apply to other "schools" of alternative medicine which have a widespread following, such as acupuncture or naturopathy. In cases involving these therapies, the chiropractic cases should provide useful precedent supporting the position that the standard of care should only be defined by another acupuncturist or naturopath. Such an approach is particularly likely to be successful where the practitioners of the particular therapy must be licensed, since the licensing process itself will establish the minimal standard of care.

The problem is that some types of alternative medicine may be virtually unique, and there may not be the equivalent of a recognized "school," as in the case of acupuncture or chiropractic. In this type of case, the only fair standard of care is the general negligence standard of what is "reasonable" under the circumstances.

For example, an alternative practitioner who uses a nutritional therapy to treat cancer will rarely be able to prevail under an "practice" standard if the "accepted practice," as defined by conventional oncologists, is to use radiation and chemotherapy. On the other hand, if a "reasonableness" standard is used, defense counsel may be able to convince the jury that chemotherapy and radiation, which usually involve extremely toxic and debilitating side effects, would not have been effective, or would have resulted only in minimal improvement. Similarly, if the defendant has conducted studies showing that his therapy is effective, the use of a reasonableness standard may enable defense counsel to demonstrate that it was reasonable for the defendant to recommend that therapy rather than the conventional therapy, even if the defendant's therapy is not widely accepted.

The potential unfairness of applying an "accepted practice" standard to a physician who offers an alternative therapy is demonstrated by the recent case of Charell v. Gonzalez..13 There the defendant had developed a nutritional method for treating cancer, which did not involve the use of chemotherapy or radiation. The witnesses called by plaintiff to establish the standard of care, however, were a self-proclaimed crusader against alternative medicine, and the chief of the department of neoplastic diseases at a major metropolitan hospital. Suffice it to say that they did not define "accepted practice" in a manner that included defendant's therapy.

Thereafter, the trial court charged the jury that "[t]he standard to which the defendant in this case is measured is by the degree of knowledge and ability of the average physician treating cancer patients in the New York City Metropolitan area."14 Since most physicians treating cancer patients in the New York City Metropolitan area use chemotherapy and radiation, this charge was necessarily weighted against the defendant, who was found liable.

A reasonableness charge, by contrast, would have permitted a more objective evaluation of the evidence and the plaintiff's claims. The plaintiff, among other allegations, alleged that the defendant was negligent in recommending against chemotherapy and radiation after she had undergone a hysterectomy for endometrial cancer. The treatment which her orthodox physicians had offered her was an experimental protocol of chemotherapy and a radioactive implant, which involved highly toxic side effects, and which counted as "success" a period of four weeks of being free of the disease. At the time this protocol was offered to plaintiff, it had no proven results. The ultimate issue, in determining whether it would have been negligent to recommend against such a program,15 was whether it was "reasonable" to do so, not whether it was a "departure from accepted practice" as defined by a conventional oncologist. Since the standard of care as given to the jury was that of the average physician treating cancer patients in the New York City Metropolitan area, however, they were not directed to focus upon the ultimate issue of reasonableness.

Significantly, the line between the "accepted" and the "unconventional" is not always easy to discern, which is yet a further factor supporting the use of a reasonableness as opposed to an "practice" standard. The history of science and medicine provides numerous examples of therapies which were once rejected as quackery, but are now accepted without question. For example, the stethoscope was "ridiculed and sometimes abused as a piece of pompous quackery" when it was introduced in the early 19th century. Similarly, the opponents of a theory advanced by Dr. Ignacz Semmelweis in 19th century Vienna, that the spread of puerperal fever in maternity wards could be halted if doctors simply washed their hands between examinations, "included some of the most highly respected clinicians in Europe."16 Even in the late 20th century, when Dr. Barry Marshall presented his theory that most gastric ulcers are caused by a bacterium, and not by stress or over-secretion of hydrochloric acid, the scientists at a conference he was addressing "literally laughed," one eminent attendee thinking it "the most preposterous thing I'd ever heard."17 Now, however, the orthodox "fact" that bacteria cannot survive in the stomach has been repudiated.18

Such examples emphasize the point that what is new or innovative may be entirely "reasonable," and therefore should not be judged by the narrow paradigm of "accepted practice."

Assumption Of The Risk

Many patients who seek out alternative physicians are extremely knowledgeable about unconventional remedies and the limitations of conventional treatment. In fact, according to a recent article in New York Magazine, the trend towards alternative medicine has been led by some of the wealthiest, most educated people, who in many instances have tried and rejected various conventional remedies.19

The patient's knowledge and willingness to forego conventional therapy in favor of an alternative treatment may support a defense of assumption of the risk. If the alternative physician has provided a detailed consent form explaining how the treatment differs from conventional treatment and what the risks, benefits, and alternatives are, the applicability of an assumption of the risk defense is obvious. Under such circumstances, the court may find an "express" assumption of the risk, which is a complete defense to the claim of malpractice. In other cases, an "implied" assumption of the risk, which will lead to an apportionment of liability, may be found. A defense of implied assumption of the risk may be based not only on what the patient was told by the alternative practitioner, but also on the patient's own knowledge and prior experience.

These principles are illustrated by a series of New York cases involving alternative treatments for cancer.

In Schneider v. Revici,20 the plaintiff discovered a lump in her breast and rejected advice from her conventional physicians to have it biopsied. She sought treatment from the defendant, who treated cancer patients with "non-toxic," non-invasive methods that had not been adopted by the conventional medical community. After the plaintiff signed a detailed consent form, the defendant began treatment with selenium and dietary restrictions. After several months of treatment, the cancer metastasized and spread to the other breast and the lymph nodes.

The plaintiff subsequently brought suit for fraud, medical malpractice, and lack of informed consent. On the eve of trial, defendant sought leave to raise express assumption of the risk as an affirmative defense. This was denied by the trial judge, on the theory that express assumption of the risk was inapplicable to a medical malpractice action under New York law.

The jury found defendant liable, but also found that plaintiff had been 50% comparatively negligent. On appeal, the Second Circuit held that under New York law, "express assumption of the risk is available as an affirmative defense to a medical malpractice action and if proved, would totally bar recovery by a plaintiff."21 The court went on to state as follows:

. . .we see no reason why a patient should not be allowed to make an informed decision to go outside currently approved medical methods in search of an unconventional treatment. While a patient should be encouraged to exercise care for his own safety, we believe that an informed decision to avoid surgery and conventional chemotherapy is within the patient's right "to determine what shall be done with his own body."

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 B 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 B to allow the jury to consider express assumption of the 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.22

Schneider involved a written consent form, but in the subsequent case of Boyle v. Revici,23 the same analysis was applied to an oral description of the risks of Dr. Revici's unconventional treatment. As in Schneider, the trial court declined to instruct the jury on express assumption of the risk and merely instructed them to reduce any award to the plaintiff by the decedent's comparative negligence. On appeal, the Second Circuit rejected the plaintiff's contention that express assumption of the risk should apply to a case involving unorthodox medical treatment only where, as in Schneider, there was a written consent form signed by the patient:

[a]bsent a statutory requirement that express assumption of the risk requires a writing, we believe that a jury should decide whether a plaintiff has knowingly accepted all of the risks of a defendant's negligence. A defendant's failure to introduce a consent form goes to the weight of the evidence in support of the defendant's argument that an express assumption of the risk has occurred. However, it does not justify keeping the express assumption of the risk issue from the jury.

In this case, Dr. Revici presented evidence that [the patient] had expressly assumed a risk in opting for the unconventional cancer treatment. The credibility of that evidence should have been an issue for the jury. Accordingly, we reverse the judgment of the district court and remand for a new trial.24

In Charell v. Gonzalez, the jury found that the plaintiff had not "expressly" assumed the risks of defendant's treatment. As a practical matter, the "risks" amounted to the risks of foregoing conventional treatment, since the defendant's treatment was non-invasive and was not harmful to the patient in any manner. The jury, however, did find that the plaintiff had impliedly assumed the risk, and apportioned 49% of the liability against her. This finding was upheld by the Appellate Division, which stated that

. . .we are of the view that, based upon the evidence that plaintiff refused the treatment plan recommended to her by conventional oncological specialists and elected instead to follow defendant's alternative protocol, the jury's finding that plaintiff impliedly accepted a substantial part of the risk entailed by the alternative protocol is sustainable, notwithstanding the jury's concurrent finding that defendant did not discharge his duty to advise plaintiff respecting the risks of pursuing the alternative protocol.25

While Charell did not involve a detailed written consent form, as in Schneider, (had there been one, the jury might well have found an express assumption of the risk), there was evidence that the plaintiff was extremely knowledgeable about alternative medicine in general and defendant's practice in particular. Long before seeking treatment from the defendant, she had attended a lecture that he had given, listened to an audiotape of another lecture that a friend had provided, and on her own had implemented many other alternative practices. In addition, she was familiar with orthodox cancer treatments, since various members of her family had had cancer.

These cases demonstrate that both express and implied assumption of the risk are viable defenses in a case involving alternative medical treatment. While the specific elements of assumption of the risk will vary from state to state, it should at the very least be considered as a defense, particularly where, as in Charell, the plaintiff is highly knowledgeable concerning unconventional medical treatment.

Punitive Damages

As indicated, physicians who offer an unconventional treatment are particularly vulnerable to punitive damage claims. In general, to support a claim for punitive damages, a plaintiff must prove that the defendant was guilty of reckless, wanton, or intentional conduct that borders on criminality and transcends mere negligence. Claims for punitive damages have been rare in conventional medical malpractice cases, simply because the applicable standard of wanton or reckless conduct is almost antithetical to the concept of a physician attempting to treat a patient. The physician may negligently provide the wrong treatment, or negligently miss a diagnosis, but usually the physician is not trying to hurt the patient or acting with reckless indifference to the patient's welfare. Typically, those cases where punitive damage claims have been allowed have involved conduct amounting to the abandonment of a critically ill patient, or an assault on a patient.

Of course, in cases involving non-conventional treatment, there may be no shortage of orthodox physicians willing to testify that the alternative physician's failure to recommend conventional treatment in the first instance, or advise a return to conventional treatment once the patient's symptoms worsened, was "reckless". In such cases, the same policy considerations discussed above which support the use of a reasonableness standard, rather than the narrow standard of "accepted practice," also militate against the allowance of a punitive damages claim.

If the court nevertheless allows the plaintiff to seek punitive damages, it will be essential for trial counsel to demonstrate that, even though the alternative physician did not advise a return to conventional therapy, he nevertheless exhibited concern and responded to the patient's symptoms within the context of his own treatment. Evidence showing that there is a scientific basis for the defendant's therapy, that the defendant believed in his therapy, and that the defendant was not motivated by economic concerns will be highly relevant in this regard.

In Charell, for example, the trial court allowed the plaintiff to claim punitive damages, and the jury assessed punitive damages against the defendant. The trial court upheld the award, concluding that the defendant had a financial interest in certain companies that sold the nutritional supplements he prescribed, and that his practice of prescribing these supplements was intended to enable these companies to make a profit. (In fact, this was not true.) Thus, said the trial court, the "jury was entitled to find that defendant's intent in dealing with plaintiff was motivated by greed and that he was reckless in his care of her."26 The appellate court, however, modified to eliminate the award of punitive damages, finding that the defendant's conduct "was not so wantonly dishonest, grossly indifferent to patient care, or so malicious and/or reckless as to warrant such an award."27

Conclusion

As alternative medicine evolves, the law of medical malpractice must evolve to keep pace with it, if for no other reason than the important public policy concerns prompting the passage of such legislation as the AMPA and the creation of the Office of Alternative Medicine. Patients have a right to the treatment of their choice, and physicians and scientists B unconventional as well as conventional B have a right to attempt to develop new and effective treatments. While widespread changes in the law of medical malpractice as applied to alternative practitioners will no doubt have to come from the state legislatures, it is possible, by use of existing concepts such as the reasonableness standard and the doctrine of assumption of the risk, to provide an effective defense in malpractice cases involving alternative medicine.

  1. NIH Revitalization Act of 1993, public law 103-43, § 209.

  2. Alternative Medicine - Expanding Medical Horizons, - A Report to the National Institutes of Health on Alternative Medical Systems and Practices in the United States (U.S. Printing Office, 1992), p. ix.

  3. Washington House Bill 1046: "Health Care Reform - Revision and Simplification," May 8, 1995.

  4. Utah Senate Bill 72: "Naturopathic Physicians' Licensure," July 1, 1996.

  5. Medical Malpractice Implications of Alternative Medicine, Studdert et al., JAMA, November 11, 1998, Vol. 280, No. 18, p. 1614.

  6. Ch. 558, L. 1994, Education Law § 6527(e).

  7. AMPA, Legislative Sponsor's Memorandum.

  8. New York State Assembly Bill Memorandum, p. 1, ¶2; p. 2, ¶3.

  9. See Legislative Sponsor's Memorandum in Support of S.2626C, July 20, 1994.

  10. N.Y. State Assembly Bill Memorandum, p. 1. ¶2, p. 2 & 3.

  11. Kurk v. Medical Society, 46 Misc.2d 790, 260 N.Y.S.2d 520 (Sup. Ct., Queens County 1965).

  12. Andrews v. Ballard, 498 F. Supp. 1038 (D. Tex. 1980)(declaring medical board's attempt to ban acupuncture a violation of the constitutional right to privacy).

  13. 251 A.D.2d 72, 673 N.Y.S.2d 685 (lst Dept. 1998).

  14. Charell v. Gonzalez, Record on Appeal, p. 1992.

  15. In fact, defendant denied that he had recommended against anything, and took the position that the plaintiff had already made up her mind to reject the experimental protocol when she came to him.

  16. Nuland, Doctors: The Biography of Medicine 227-228, 252 (Vintage ed. 1988).

  17. Glasser, The Light In The Skull: An Odyssey Of Medical Discovery 16 (Faber & Faber Boston 1997).

  18. Id. at 17-18.

  19. "The New Healers," by Nina Burleigh, New York Magazine, April 5, 1999.

  20. 817 F.2d 987 (2d Cir. 1987)

  21. 817 F.2d at 990.

  22. 817 F.2d at 995-996 (citations omitted).

  23. 961 F.2d 1060 (2d Cir. 1992).

  24. 961 F,2d at 1063.

  25. 673 N.Y.S.2d at 687.

  26. Charell v. Gonzalez, 173 Misc.2d 227, 660 N.Y.S.2d 665 (Sup. Ct., N.Y. County 1997).
  27. 673 N.Y.S.2d at 687 (citations omitted).
(Medical Malpractice Law & Strategy, Vol. XVI, No. 8, June 1999 [Leader Publications])
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