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Informed Consent in the Legal System


gavel and stethoscopeA common call that we receive comes from a patient who feels that she did not receive “informed consent” from her physician.  The patient had a procedure or took prescribed medication, and something went wrong.  There was a complication or side effect, the patient doesn’t feel the doctor told her this might happen, and now she’s very unhappy.

That unhappiness does not necessarily translate into a successful medical malpractice claim, even if the patient truly wasn’t told about the complication or side effect.  That’s because informed consent in a legal sense means something more than a lack of information. 

Each state has slightly different legal requirements, but in Massachusetts, a patient bringing a claim for lack of informed consent must prove four things:

  1. that he wasn’t informed about a risk or complication;
  2. that the risk or complication is something that a reasonable patient in his position would want to know about;
  3. that the risk or complication actually occurred; and
  4. that if the patient had known about the risk or complication, neither he nor a reasonable patient in his position would have agreed to the treatment, procedure or medication in question.

That last part is a major stumbling block in many cases.  Most patients understand that surgeries carry certain risks and that medications may have side effects.  Yet every day, patients have surgery and take medications, fully understanding that the outcome may not always be what they hope or expect.  Informed consent, in the legal sense, provides a remedy only if the patient can prove that she wouldn’t have had the treatment or taken the medication if she’d been aware of the risks.  The patient’s word isn’t enough; the patient also has to prove that a reasonable patient wouldn’t have had the treatment either.  And in many cases, that’s quite difficult.

The purpose of the legal cause of action for informed consent is not to guarantee that no complications will occur, or even to provide compensation if there is a complication.  It is simply to make sure that patients understand what might go wrong when they get medical treatment and have the opportunity to decide whether the anticipated benefit of the treatment outweighs the possible risks.  As a practical matter, unless the risks are very great, or the potential benefits very small, most patients would choose the treatment.

A cause of action for informed consent is most likely to be successful when there are reasonable and legitimate alternatives to the doctor’s chosen course of treatment.  Some examples include situations where a proposed surgery is truly elective or cosmetic, where there are options for both medical and surgical treatment, or where something about the patient’s individual situation makes a usual treatment less appealing.

A final note:  in most jurisdictions, the doctor’s obligation to inform the patient applies not just to surgical procedures.  Doctors must tell patients about the different treatment choices or medications available to them, including the alternative of no treatment, or doing nothing.  This principle often becomes important during certain labor and delivery situations, where the mother may need to decide whether to have labor induced, whether to undergo a trial of labor, or whether to allow labor to continue in the face of fetal heart rate abnormalities.  Patients have the right to make these decisions in an informed manner.