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.
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.