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The patient was diagnosed with endometrial cancer in 1991. Her treating gynecological oncologist performed a hysterectomy to remove the tumor. At the time of the operation, her cancer had progressed to stage three. Because of the grade of the tumor, her doctor suggested either radiation therapy or an experimental protocol of radiation plus chemotherapy.
In the hope of finding an alternative to traditional cancer treatment, the patient contacted the defendant doctor. The defendant performed preliminary testing on the patient’s hair to determine the extent of the cancer activity in her body. Based upon this testing, he implemented a treatment plan which included nutritional supplements and the daily administration of coffee enemas.
The patient asked the defendant at her initial appointment whether others had done well on his treatment protocol. She was still considering whether to undergo chemotherapy. The patient claimed that the defendant told her not to bother with chemotherapy. Based upon the consultation, as well as a seminar she attended that featured the defendant physician, the patient believed that the defendant’s method of treatment had been tested and provided hope. She therefore decided not to undergo either radiation or chemotherapy.
After receiving nine months of the alternative treatment, the patient developed severe back pain, and discovered that the endometrial cancer had metastasized to her spine. She believed that the area of the metastasis would have been radiated under the traditional treatment protocol. To treat the cancer in her spine, the patient then underwent chemotherapy and radiation treatment. Although her cancer was successfully treated this time, she sustained cancer-induced retinopathy. The patient is now blind in both eyes.
At trial, the patient claimed that the defendant physician had no reasonable basis for believing that the alternative treatment she received could be successful. The patient also claimed that she was entitled to punitive damages because the defendant acted recklessly and wantonly when he discouraged her from undergoing medically accepted cancer treatment.
The defendant claimed that he properly informed the patient about the experimental nature of his treatment plan. However, he failed to have the patient sign an informed consent form. He also claimed that since the patient was fully aware that his work was experimental; she assumed the risk that it might not work. The defendant testified that the patient had made the decision to forgo radiation and chemotherapy before she even consulted him. Finally, the defendant claimed it was the chemotherapy, not the cancer recurrence, that caused the patient’s blindness. However, the defendant’s expert could not provide any data to support his theory of the cause of blindness.
At trial, the judge instructed the jury that if they believed that the patient assumed the risk that the treatment would fail, the amount of her damages should be reduced based upon her degree of fault. If the jury believed that the patient had some knowledge about the experimental nature of the defendant’s protocol when she was treated, then the jury could infer that she assumed the risk that the treatment may not work.
The jury awarded the patient $4,550,000 in compensatory damages, including damages for pain and suffering and loss of earnings. This award was reduced by 49% because the jury found an implied assumption of the risk by the patient. The jury also awarded the patient $150,000 in punitive damages.
The Scharell decision indicates that a physician who proposes alternative treatment must take special care to fully inform the patient of its experimental nature. To properly illustrate compliance with the duty to inform, a physician should provide written informed consent forms for the patient to review and sign. These informed consent forms should contain information about the experimental nature of the protocol, the number of patients who have been treated on the protocol, and the overall success rate of such treatment. Although the court believed that the patient had some knowledge that the experimental treatment she underwent was not generally accepted in the medical profession, this implied knowledge does not discharge a physician’s duty to warn.
Practitioners may be placed in the uncomfortable position of having a seriously ill patient inform them of a decision to pursue an alternative form of treatment, rather than the standard recommendation generally accepted by the medical profession. In such a case, the physician should inform the patient that if the alternative treatment is pursued and the results are not satisfactory, the patient may return for follow up care. This is what happened in the Sharell case, and an action against the traditional physician was not pursued.
A more difficult situation arises if the patient requests to receive both conventional and non conventional treatment simultaneously. In that event, the physician needs to inquire about the treatment aspects of the non-conventional treatment to determine if there are known conflicts. If there are, the physician needs to inform the patient of this problem and probably, not agree to provide the care he is recommending. If the provider is unsure if conflicts between treatments exist, the patient should be told that as well. These conversations would then be carefully documented in the patient chart.
As provider networks begin to incorporate alternative treatment, the traditional physician will face increasing interaction with other types of providers in the care of a single patient. Careful communication in these situations, and documentation of the advice given to patients is critical for good risk management.
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