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Public Health Law Map - Beta 5 - Medical and Public Health Law Site

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usual in the community, <strong>and</strong> in others it has lowered the level of disclosure.<br />

This law was passed to reduce the threat of informed consent litigation. It is<br />

difficult to determine if it has been effective because there was very little informed<br />

consent litigation in Texas before the law was passed. What it has done is make it<br />

easier to sue physicians who do not comply with the statutory requirements. It has<br />

also reduced the effectiveness of informed consent as a risk management tool.<br />

Rather than using the consent process to ensure that the patient underst<strong>and</strong>s what is<br />

to be done, physicians simply have patients sign the promulgated forms.<br />

The best risk management advice for physicians in states with statutory disclosure<br />

st<strong>and</strong>ards is to tell the patient everything a reasonable person would want to know<br />

<strong>and</strong> then be sure that the patient signs the appropriate statutory consent forms.<br />

Physicians should ask their attorney if their state has any statutory disclosure<br />

requirements. If so, these should always be complied with. They are not, however, a<br />

substitute for obtaining a full informed consent.<br />

d) Fraud<br />

Fraud arises when a physician intentionally misleads a patient about the risks <strong>and</strong><br />

benefits of a treatment. It becomes a serious legal (<strong>and</strong> criminal) issue when a<br />

patient is induced to accept subst<strong>and</strong>ard care by forgoing beneficial treatment or<br />

submitting to an unorthodox treatment. Concerns about fraud often arise when a<br />

physician begins to specialize in an unorthodox treatment. The most common<br />

examples are weight loss clinics that employ unusual <strong>and</strong> unapproved regimens,<br />

such as giving patients human chorionic gonadotrophin injections or pesticide pills.<br />

A patient who can establish fraud may be entitled to punitive damages. Fraudulent<br />

dealings may also subject the physician to criminal prosecution <strong>and</strong> the loss of his<br />

or her license. One physician who was involved with a fraudulent weight loss clinic<br />

was successfully prosecuted under the federal racketeering laws. [United States v.<br />

Bachynsky, 934 F.2d 1349 (5th Cir. 1991).]<br />

4. The Commonsense Approach<br />

The doctrine of informed consent is a special case of the broader notion of<br />

assumption of risk. Whenever a person knowingly engages in a risky activity, that<br />

person consents to the risks of the activity. For this consent to be effective, (1) the<br />

person must know the risks that are being assumed; (2) he or she must assume these<br />

risks voluntarily; <strong>and</strong> (3) it must not be against public policy to assume the risks.<br />

When a person makes a formal agreement (usually written) to accept the risks of an<br />

activity, that agreement is called a waiver. A properly executed informed consent is a<br />

waiver of the risks of medical treatment. To be effective, a waiver of the risks of<br />

medical treatment must meet the same three criteria as other waivers. Informed<br />

consent serves an additional, perhaps more important, purpose. In the process of<br />

discussing the risks, benefits, <strong>and</strong> potential alternatives to a given treatment, the<br />

physician <strong>and</strong> the patient have an opportunity to ensure that there are no<br />

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