Ms. Goodwin is manager of clinical risk and patient safety at Cambridge Health Alliance, Cambridge, MA.
Informed consent in medicine generally refers to one of two things: the process by which a provider obtains consent through discussion of risks, benefits, and alternatives with patients, and the actual form that is signed by the physician and the patient. Both are critical pieces to any medical malpractice litigation where a claim for lack of informed consent has been pled.
Brianne Goodwin, JD, RNInformed consent in medicine generally refers to one of two things: the process by which a provider obtains consent through discussion of risks, benefits, and alternatives with patients, and the actual form that is signed by the physician and the patient. Both are critical pieces to any medical malpractice litigation where a claim for lack of informed consent has been pled.
The Texas Medical Association sets forth very clearly that “informed consent is more than a form; it is a process,” a process that includes discussion, education, obtaining written consent, and chart documentation (bit.ly/TMAinformedconsent). How this process is conducted and what it entails will vary between institutions and practices, not only due to differences in patient population and procedures performed, but also because state law varies on what is required for informed consent.
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The American Medical Association identifies six basic features of informed consent: the diagnosis/condition, the nature and purpose of the procedure or treatment, the risks and benefits of said procedure or treatment, the alternatives, the risks and benefits of the alternatives, and the risks and benefits of not having the procedure or treatment (bit.ly/Forbesinformedconsent). To succeed on a claim of lack of informed consent, the plaintiff would have to prove that the physician failed to disclose some part or parts of these six components. Most often, this type of claim centers around the disclosure (or lack thereof) of risks. Depending on the state where the case is brought forth, the standard of review will be different and precedential case law may also have an impact.
The actual consent form and its contents are a critical piece of the informed consent process and of evidence at trial. Earlier this year, a jury awarded over $8 million to a plaintiff for damages resulting from a urologic procedure that was performed by only one physician listed on the consent form, and not the physician that the patient specifically requested perform the procedure.
In this case, two physicians were listed at the top of the informed consent as authorized to perform the procedure; one was a chief of urology, the other a fellow. The patient had specifically requested that the chief perform the procedure, but instead the fellow did all of it, and the patient suffered injuries.
The judge instructed the jury that the consent form allowed the primary doctor to have another doctor assist him with the procedure, but did not allow the other doctor to perform the procedure in the absence of the primary doctor. In other words, Doctor A and B could perform the procedure together, but if Doctor A was the primary physician who the patient requested, Doctor A could not delegate the surgery to Doctor B. This case and decision has received a lot of attention from attorneys on both sides of the bar as it may open the door for an influx of lawsuits alleging procedures were performed by physicians that the patient did not consent to.
The two standards of review for informed consent claims are the reasonable physician standard and the reasonable patient standard (bit.ly/Consentexperience). A majority of states follow the reasonable physician standard. Under this standard, a physician must disclose the risks that a reasonable medical professional would have disclosed under similar circumstances. This standard looks to what physicians commonly disclose when dealing with a similar medical or surgical case.
A minority of states follow what is known as the reasonable patient standard. This standard looks to whether a reasonable person in the patient’s position would consider the information material to his/her decision as to whether to agree to allow the physician to perform the surgery upon him/her.
These standards may sound similar, but they are very different. What a reasonable person in a patient’s position would find pertinent in deciding whether to proceed with a procedure by a specific doctor is not necessarily what a reasonable physician of like training and experience would have disclosed in the same circumstances. Do you know what standard your jurisdiction follows? If not, a call to your liability carrier or your institution’s general or malpractice defense counsel may be beneficial.
Previously adjudicated cases can also impact what needs to be disclosed through the informed consent process. A surgeon’s level of experience, for example, has been the subject of litigation with regard to informed consent. A number of states following the reasonable patient standard have decided that the experience level of the surgeon may be a fact that a reasonable patient would consider in making a decision on a surgical procedure (bit.ly/Consentexperience). On the other hand, some of the reasonable physician states have adjudicated that there is no affirmative duty to disclose this information in order to obtain informed consent.
Other cases have decided that physicians are required to disclose any personal or economic interests that may influence their judgment in choosing a treatment or procedure (Virtual Mentor 2012; 14:563-6). A Wisconsin case from 2012 held that physicians are required to disclose all diagnostic tests that may rule out a possible condition, even if the physician has already ruled out the condition or diagnosis (bit.ly/Wiscstatement).
In sum, the moral here is to know your jurisdiction and honor the consent form. Between the two standards of review and the countless cases that have been litigated, each state has its own nuances concerning informed consent. Seeking guidance on how to best tailor informed consent discussions and documenting them properly in the record is recommended. Ensuring that whoever is listed on the consent form actually performs the surgery or procedure is critical, and not doing so can be very costly.
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