Informed Consent

Informed consent is a legal doctrine in America that is defined in all 50 states as a consent to treatment (for example, a consent to an operation) obtained after adequate disclosure.
This definition is simple in theory but complex in operation. The problem is, "What is adequate disclosure?" Adequate disclosure varies from state to state.
Informed consent is defined in most states as a consent obtained after telling the patient the following:

• diagnosis;
• nature of proposed treatment;
• name of the procedure;
• description in layman's terms;
• risks associated with that treatment;
• alternatives and associated risks; and
• risk of no treatment.

Problems with informed consent usually arise in the discussion of the risks associated with the treatment. For example, if a physician says there are ten risks and an eleventh risk occurs, a suit often is filed claiming the patient would not have consented to the operation had the patient known of that eleventh risk.

To understand the nuances of informed consent and to see how the courts can create a labyrinth of legal complexity, it is worthwhile to review the informed consent experience in Louisiana.

Louisiana Uniform Consent Law of 1975 Louisiana attempted to solve the problem of informed consent in 1975 with the passage of La. R.S. 40:1299.40. This law states that consent shall be presumed to be valid and effective, in the absence of proof that execution of the consent was induced by misrepresentation of material facts, if

• the physician told the patient the nature and purpose of the procedure or procedures, together with the known risks, if any, of death, brain damage, quadriplegia, paraplegia, the loss of function of an organ or limb, and of disfiguring scars associated with such procedures;
• the physician acknowledges that such disclosure of information has been made and that all questions asked about the procedure or procedures have been answered in a satisfactory manner; and
• the consent is signed by the patient.

 Incidentally, the risks listed in this law were supposed to be the whole universe of risks that needed to be told to the patient. The burden then shifted to the patient to ask any other questions about risks.

Hondroulis Decision/1989

 The Louisiana Uniform Consent Law of 1975 was upheld by the Louisiana courts on many occasions. However, on June 19, 1989, the Louisiana Supreme Court ruled in the Hondroulis v. Schumacher case, 553 So2d 398 (La. 1989), that "loss of function of an organ" was too generic and the doctor needed to be more specific. For example, the doctor in the Hondroulis case used the standard wording in the statute, which included "loss of function of an organ", and the patient lost the function of the bladder after a lumbar laminectomy. The court said that the doctor had to mention loss of function of the bladder specifically. The court said not all risks needed to be mentioned, just the "material" risks. The court said a risk is material "when a reasonable person in what the doctor knows or should know to be the patient's position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy."

Louisiana Medical Disclosure Panel/1990 - Present

 After the Hondroulis case, physicians, on the advice of their attorneys, began listing many risks because they could not be sure what risks the court later might determine with the retrospectoscope to be "material." In some cases, physicians listed over 100 risks. Finally, in 1990 the Louisiana legislature, taking an idea developed originally in the Texas legislature, passed R.S. 40:1299.40 E which created the Medical Disclosure Panel. The task of the Medical Disclosure Panel is to define what risks must be disclosed for any given operation or therapy. The Panel consists of six physicians, three attorneys from the Louisiana Trial Lawyers' Association, one attorney from the Louisiana Defense Counsel Association, and one dentist who specializes in oral and maxillofacial surgery. Since its creation, the Medical Disclosure Panel has released the risks for 127 procedures. The work of the Panel continues and the members meet bimonthly. Although the risks developed by the Medical Disclosure Panel are not legally binding in other states, it is worthwhile to review those risks when investigating what risks might be "material" for any given procedure or therapy.

 Although I was the Chair of the Louisiana Medical Disclosure Panel during its first 10 years, the official way to get copies of the risks and the approved consent form is to call the Louisiana Department of Health and Hospitals (DHH) in Baton Rouge, Louisiana. The contact person (as of this updated note of January 19, 2007) at DHH is John Newsom, phone 225-342-3807, email: jdnewsom@DHH.LA.GOV

 A few important points about informed consent. It is the responsibility of the physician who is performing the operation or administering the medical treatment to get the informed consent. The Medical Disclosure Panel's list and recommended consent form is optional, not mandatory. Physicians who do not use the Medical Disclosure Panel's risks and consent form are bound by the law of R.S. 40:1299 (Uniform Consent Law Sections A, B, and C), and the Hondroulis case interpretation of that law. Informed consent under this older version of informed consent is valid as an oral consent as well as a written consent. However, written consent always is advised as oral consent is difficult to prove.

Copyright ©1995 Donald J. Palmisano, M.D., J.D.

 "Material Risks" as determined by the Louisiana Medical Disclosure Panel as of Jan. 1996. The release of procedures and risks from the Louisiana Medical Disclosure Panel during the first 10 years of its existence was approximately every two months. The listing of risks on this web page is not meant to be the official listing; the offical listing should be obtained from the Louisiana Dept. of Health and Hospitals or the Louisiana Register. Remember, this law and listed risks are for Louisiana Physicans only. However, all physicians may find a review of these listed risks helpful as they formulate the "Material Risks" for procedures and treatments for their patients.

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