Malpractice: Your Informed Consent May Not Be Good

Enough
Lee J. Johnson, JD
Posted: 02/10/2011
Introduction

You told your patient about the risks of a treatment or procedure before it began. Now he's unhappy about
a bad result and is suing you -- and he could win! What gives?

It's important for doctors to know exactly what they need to tell patients before a recommended treatment;
and it's important to do it the right way.

Many doctors are not aware that it's not only in advance of a major procedure or serious medication
regimen that informed consent is required; it's also required for treatments or procedures that doctors may
believe require no "disclosure" or informed consent. As a result, many doctors are not as vigilant with
informed consent as they should be.

A lawsuit-in-waiting may start long before the summons and complaint, and even before a patient's
treatment begins. What may happen is that the patient has a result he doesn't like, and thinks that he would
not have had the procedure if he had known about this potential result. If the doctor didn't tell him about this
possible outcome; the patient thinks this result must not be a risk of the procedure, but instead could be
caused by the negligence of the doctor.

In a lawsuit for lack of informed consent, the patient usually claims that he was not informed about the risks
of the treatment he received and that he would not have agreed to the proposed procedure had he known
that this could be the result.

The state laws on informed consent do require the physician to disclose to the patient the risks, benefits,
and alternatives of any proposed treatment or procedure. Yet any given treatment or procedure could have
hundreds of associated risks. For any medication, all the side effects that are manifested in the US Food
and Drug Administration studies could be considered "risks." If there are 50 potential side effects, you
should at least describe the "material risks" whenever you prescribe a drug. Clearly, it is not possible for a
physician to discuss every single risk that could possibly occur with every patient.

Physicians could have claims against them for not disclosing the risks of even small things, like mole
removal, blood pressure medication, colonoscopy, CT scan, stitches, flu shots, etc.

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.

Informed Consent Also Involves Options

The law requires that you discuss not only the proposed procedure, but also the alternatives. If you are
recommending chemotherapy, you must disclose the risks of chemotherapy and also the risks of radiation
therapy and surgery. If you don't tell the patient that radiation therapy could prevent later surgery, the
patient may choose that option in ignorance.

One alternative is always to do nothing. You must discuss not only the risks of all the alternatives, but also
the risk of doing nothing.

The doctrine of informed refusal is gaining ground in most states. The significance is that you must also
discuss the risks of not having the recommended treatment or procedure. You must disclose the risks of
doing nothing including the progress of the disease if no treatment is rendered. If the patient makes an
"informed refusal," it must be from a position of knowledge. The defense must demonstrate that the patient
knew all the consequences of the refusal.

An early example of the doctrine of informed refusal is an obstetrician/gynecologist who recommended

amniocentesis. He informed the patient of all the risks of having the amniocentesis, but failed to inform the
patient of the risks of not having the procedure. The patient refused the procedure and gave birth to an
infant with Down's syndrome. The patient sued the physician and won, establishing the requirement that
the physician must inform the patient of the risks of not having the procedure.

In one current case, the obstetrician/gynecologist asked the patient to get a Papanicolaou smear. The
patient refused and ended up dying of cancer. The doctor had put in progress note that he offered it and
she refused but did NOT put that she was aware of consequences of not getting it done, ie, death. The
family sued and told the jury that patient was not a doctor so she just thought nothing bad would happen.
Because the doctor did not clearly put in his notes that the patient was aware of the morbidity/mortality
risks, he lost the case!

How You Should Document

The discussion of the risks must be documented. Write a progress note and use a consent form if the
proposed treatment has material risks. Give the patient materials to read and list of Websites and
document it. The risks mentioned in the materials could arguably be considered part of your consent.

You can write a note that you disclosed the "material risks" and it is not necessary to list the risks
discussed. If you decide to list the risks, you must do so with care. The inherent danger in listing risk is that
you may not write the risk that the patient actually gets. We know that it's impossible to list all the risks. You
may do a thorough job and list 10 risks and the patient may get the 11th.

For example, you tell the patient about chemotherapy nausea, hair loss, and "chemo brain," but you fail to
discuss weakness -- and the patient falls. If you must list risks, make sure you make it clear the list is not
all-inclusive. Say, "Among the risks discussed are..." or "The risks include, but are not limited to, the
following..."

Doctors may be aware of the legal liabilities involved, but many still fail to disclose the "material risks."
There are many reasons for this. One reason is that the physician is concerned that the patient might not
agree to a much needed procedure. Another reason is that the patient may say that he or she does not
want to hear about the risks. In such a case, you must document well that the patient has refused to have
the consent conversation.

Perhaps the primary reason doctors don't discuss the risks is time constraint. Each doctor must decide for
himself how much time to spend in patient discussion to protect himself from the expenses in time and
money involved in a lawsuit. As long as a doctor takes the time to inform the patient and allows the patient
to make the treatment decision, the physician has done much to avoid a potential lawsuit.

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