Your Malpractice Advisor

Malpractice: Your Informed Consent May Not Be Good Enough

Lee J. Johnson, JD


February 10, 2011

In This Article

What Risks Should Be Disclosed in Your Informed Consent?

There are 2 legal standards that can be applied and it varies from state to state: the "reasonable practitioner" standard and the "reasonable patient" standard. In the first, you must disclose those risks that would be disclosed by a reasonable practitioner in the relevant specialty. In the second and tougher standard, you must disclose those material risks that a reasonable patient would need to know to make an informed decision.

To adhere to those standards, a good key is to select those risks that could be "material" to the patient's decision-making. The relevant question is: "What potential results would a person need to know to make an informed decision to consent or refuse consent?"

"Material risks" include those that have a high severity or a high frequency. For the less serious risks, a rough rule of thumb could be if the risk event occurs in 3% of the cases. For the more serious risks; 1% would be sufficient to be a material risk. Examples of high severity would be death, paralysis, brain damage. But there are always extenuating circumstances. One oncologist was successfully sued for failure to disclose a one in a million risk because the plaintiff's attorney discovered that he had written a paper on the subject.

You need to also be careful not only about which risks you disclose, but the way you disclose them. For example, if you gloss over them like the fast-talking announcers in the radio commercial, saying, "Oh, by the way, there's a risk of death, heart attack, aneurysm, brain damage, leprosy, and rash, but those are rare," and you quickly move on to a different subject, you may be accused of not doing a sufficient job of allowing for discussion of the side effects.

Many doctors have a natural reluctance to discuss the more serious risks as the discussion often scares patients. But it is in the patient's best interest to know the serious risks. And it is in the doctor's favor to protect him too if there is a lawsuit. For example, imagine a plaintiff being asked, "You mean you consented to the procedure knowing there was a risk for death and are now saying you wouldn't have consented had you know about a risk for infection?"

Another advantage of telling the patient the risks is that the patient can be prepared for possible side effects and advised what to do. For example if he gets a rash from lamotrigene, the patient must be told to stop the med; if fever or lymph node enlargement occurs, to go to the emergency department right away.


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