DOCUMENTING CONSENT

Consent to medical care should always be obtained in writing. The consent should specify the treating physician and the proposed treatment and should require the patient's signature, a witness's signature, and the date. A written consent is much likely to result in litigation than an oral consent. The more carefully consent is documented, including the risks and alternatives to therapy, the less chance of a successful suit based on failure of consent.

The best example of this is the case of Karp v. Cooley. This case concerned the care rendered Haskel Karp by Dr. Denton Cooley. Mr. Karp suffered from advanced cardiovascular disease and was a candidate for a heart transplant. It was decided that Mr. Karp could be maintained on an artificial heart if his own heart failed before a heart donor could be found. This was an extremely dangerous experimental procedure that had never been tried in a human before. The entire procedure was explained to Mr. Karp, and a detailed consent form was signed. This form described the procedure, its experimental nature, and its great risks. Mr. Karp's heart failed, and the artificial heart was installed. The experiment had limited success, and Mr. Karp died. Mr. Karp's window brought suit against Dr. Cooley, alleging, among other things, that Mr. Karp did not understand what was being proposed to him and thus did not give a knowing consent. The court found that Mr. Karp did give an informed consent and found for the defendant, Dr. Cooley. In its opinion, the court stressed the importance of the written, detailed consent form as evidence of Mr. Karp's consent.

Most consent litigation involves oral rather than written consent. The patient remembers nothing of the explanation of the therapy and sues the physician when an unexpected complication occurs. While most of these suits have also involved claims of negligence, the informed consent issue could have been avoided with a proper written consent. The patient may claim not to understand the consent form, but this is a weak defense if the patient reads English. If the patient does not read English but speaks English, a witness should attest that the consent was read to the patient and that the patient signed the form after it was read and explained. This could also be used for a blind patient if a Braille form is not available. A deaf patient should have an interpreter to help with questions, and this interpreter should also sign the consent form.

The nonEnglish-speaking patient is a special problem. If possible, the consent form should be in the language that the patient reads. This fairly simple for Spanish speakers because of the large number of Spanish speakers in this country. If a Spanish consent form is unavailable, the procedure should be carefully explained by a translator or a Spanish-speaking physician. The translator or physician should then fill out a special consent form that explains the situation and records what the patient was told. This procedure should also be followed with patients who speak other languages. While it is difficult to obtain proper consent under these circumstances, this makes it even more important to document carefully the consent.