The Law of Informed Consent
Tuesday, May 21, 2013
Prior to initiating any medical procedure, a health care provider should obtain the patient's "informed consent." What constitutes informed consent varies from state to state, but usually includes a discussion with the patient about the following:
- Patient's diagnosis and condition
- Nature, purpose and likelihood of success of the intended procedure
- Reasonable alternatives
- Benefits, risks and uncertainties of the procedure and each alternative
- Risks and benefits of failure to have the procedure performed
Consent may be either express or implied. Express consent is generally obtained when the health care provider specifically advises the patient regarding the risks and alternatives to a procedure. In contrast, implied consent might be assumed, depending on the circumstances, such as when a patient comes in for a relatively simple and non-invasive procedure. Either way, if a health care provider fails to verify a patient's understanding through a written, signed consent form, and the patient is later injured, there may be a basis for a lawsuit based on the lack of informed consent.
Results of Failure to Obtain Informed Consent
A patient's claim for lack of informed consent falls under the category of medical malpractice. Such claims may be based on principles of "battery" (i.e., intentional harmful or offensive contact without consent, resulting in damages) or negligence (the provider's conduct fell below an accepted standard of care).
Damages Must Be Established
The failure to inform the patient of all important aspects of a procedure is not the only prerequisite for a successful medical malpractice claim. Damages must also be established, and usually the patient must demonstrate that the patient would not have consented to the procedure had he been properly informed. Specifically, the patient must have suffered an injury or harm that was not discussed prior to the procedure as a potential risk. Damages may also include harm suffered by a patient which resulted from being subject to a risk for which the patient did not consent. In addition, the provider may not exceed the scope of the consent, such as performing a procedure not previously discussed with the patient.
State Law Variations
Although most states require health care providers to inform patients of material aspects of medical procedures, the nature and extent of the required disclosure, as well as the law governing it, can vary significantly by state. It is also important to remember that even where state statutes have specific language regarding informed consent, as with other laws, courts often issue decisions that may effectively modify a statute's strength or applicability.
The relevant Florida statute includes general rules of informed consent. Florida's statute provides that physicians (as defined in the statute) and dentists may be free from liability with respect to informed consent if they adhere to the following requirements:
- The manner in obtaining consent from the patient was within the applicable standard of care (generally accepted medical practices); and
- A reasonable patient would have understood the medical procedure, along with the alternatives and consequences; or
- In the event consent is not expressly obtained, the patient would have reasonably, "under all the surrounding circumstances," elected to have the procedure performed
In addition, in Florida, where consent is obtained in writing by the patient or an authorized representative, there is a rebuttable presumption that the patient provided informed consent.
The Texas statute is based on standards and language developed by the Texas Medical Disclosure Panel, a group of nine professionals (three lawyers and six health care providers) all licensed to practice in Texas. The individual members of the panel are chosen by the commissioner of health and determine which "risks and hazards related to medical care and surgical procedures" are required to be disclosed to patients. They also determine in what manner such information must be disclosed.
The general rule regarding informed consent in Texas is that the health care provider must disclose the risks and hazards of the specific procedure to be performed. If the health care provider discloses such information in a manner set forth by the Texas Medical Disclosure Panel, it "shall be considered effective." Such requirements include that the disclosure is to be made in writing (including the specific risks and hazards), signed by the patient (or authorized representative) and a competent witness.
Unlike Florida and Texas, there is no general provision within California statutes addressing informed consent. Rather, California law covers this issue in a manner similar to Texas by including a discussion of informed consent specific to individual medical procedures.
Exceptions to Informed Consent and Other Issues
The existence and extent of exceptions to the informed consent requirement also vary. However, in most states, in emergency situations such as where the patient is unconscious and has a life-threatening condition, informed consent may not be required. In such circumstances, the general rule is that a health care provider should administer treatment without delay. The law regarding consent for minors or disabled persons is also different among states, as is the statute of limitations (i.e., the length of time in which a patient must bring a claim).
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