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Informed Consent! What Is It Good For? Absolutely Nothing. Say It Again.

Posted on: August 4th, 2017

By: Shaun Daugherty

 

Ok. That may be a bit extreme. After all, it is in the American Medical Association’s Code of Medical Ethics and the concept is addressed in most medical professional organizations guidelines in one form or another. And let’s not forget that it is mandated by statute and common law in most states. So the bottom line is that it is seen universally as a good idea for a medical provider to obtain informed consent from a patient prior to providing therapy, care, or treatment. While the precise legal requirements differ from state to state, the gist is that a medical provider should provide sufficient information for a patient to make an informed decision as to whether to accept the treatment. Generally speaking, the patient should be informed of the diagnosis, the alternative treatment options, the likelihood of success, the major risk/complications associated, and the consequences of just doing nothing.   Fantastic. You have obtained informed consent from your patient. I ask again, what is it good for?

In the legal context, in most situations, if you do not obtain informed consent, a patient has a cause of action to sue a medical provider for lack of informed consent. The theory being that the patient was not given sufficient information to make an educated decision about their care, and if they had been told “X,” they never would have agreed to the procedure. The “X” is usually one of the risks/complications of the procedure that the patient experienced, unfortunately.

On the defense side of a malpractice action, the informed consent has very limited value unless there is actually a claim of lack of informed consent made by the patient. In that scenario, informed consent is a relevant and target point of contention with the written informed consent form front and center for the jury. Without the specific claim being alleged, many courts are ruling that the informed consent forms that are signed by the patients are inadmissible pieces of evidence and are redacted from the records. They are also ruling that informed consent cannot be discussed in any form or fashion unless for the purpose of impeachment. That is, if the patient denies knowing that a particular risk was possible.

The typical scenario is that a patient suffers one of the known risks or complications of a procedure, let’s say a nerve injury during parathyroid surgery, and then sues the provider for the injury that they suffered. The provider says that it is a known risk of the procedure and it was not caused by negligence. The informed consent form will typically have the specific risk listed as one of the possible complications of the procedure and the defense would like to show the form to the jury to say, “see, we told them this was a risk of the procedure.” The claimant wants to keep the issue of informed consent out of evidence because, as the courts have reasoned, they are afraid that the jury could be misled to believe that the patient consented to the injury itself instead of focusing on whether there was a deviation in the standard of care.

One of the practical problems from a defense standpoint is the juries’ expectations with regard to their own common experiences. That is, the average juror of a medical negligence case will be very familiar with informed consent forms and will often look for them in the records during deliberations to either confirm or refute whether something is or is not a known risk/complication. If it is absent from the records, this could become a problem for the defense as the juror may believe that informed consent was not obtained and become a reason to find fault, even though it was not an issue in the case. An otherwise non-existent burden of proof has been created for the defense to disprove an issue that was never part of the case. Defending a medical negligence case can be difficult enough without having to chase phantoms.

We will keep looking for the legal trends and implications to govern ourselves accordingly while medical providers need to keep getting written informed consent as often as possible. After all, informed consent is ultimately good for something, perhaps the most important thing, patient information and decision making.

If you have any questions or would like more information, please contact Shaun Daugherty at [email protected].

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