Informed consent is important for patient safety because, when done correctly, it means a patient or the person caring for the patient has all the information necessary to make the right decision about a procedure, treatment, or diagnostic test. When a patient does not have all the information, specifically about risks, they may end up undergoing a treatment that causes harm and that they would not have consented to if they had all the information.
Medical malpractice suits sometimes cite a lack of informed consent as a breach of duty on the part of a physician and a reason for negligence. In these cases patients believe that they either didn’t have adequate information to make a choice or that they did not actually give consent to have a procedure or treatment. If you think that this has happened to you, a malpractice lawyer can help you determine if you can prove negligence.
What is Informed Consent?
Informed consent is an important step in any type of medical care. It means that the patient is given information about care and consents to receive that care. Simple informed consent happens all the time. When a patient takes and uses a prescription from a doctor, sees a recommended specialist, or allows a blood or urine test to be conducted, he or she is consenting after the doctor makes a simple explanation for why it is being done. This is the kind of consent used for basic types of care that are low-risk.
For any type of medical care that comes with significant risks, the informed consent that must be given is more complex. There is a process that physicians are supposed to go through to make sure the patient can actually give reliable informed consent:
- Providing adequate information about benefits and risks
- Giving the benefits and risks of alternative treatments or care
- Allowing the patient to ask questions and get answers
- Giving the patient time to discuss the decision with family
At this point the patient should be able to make a choice and either consent or not. Often, at this point the patient will be asked to sign a form agreeing to informed consent before the physician will proceed. From the point of view of the medical professionals, informed consent means a patient who is an adult and mentally capable of making health care decisions, has been given every chance to make the best choice. Alternatively, the guardian or person authorized to make decisions for the patient has the ability to make the decision.
When Informed Consent is Not Required
There are cases in which consent does not have to be given before a patient receives medical care, and in these cases it may not be possible to prove negligence because of lack of informed consent. Exemptions include emergencies, situations that are clear and that will not hold up well when a patient claims they did not give informed consent and are suing for malpractice.
Less clear is when a doctor determines a patient is too distressed to be able to make a sound decision. For instance, when a procedure is very risky but the only way to try to save a person’s life, it may be considered acceptable for the doctor to leave out some of the risks or to soften them when getting informed consent.
Failure to Get Informed Consent and Negligence
Except for the exemptions above, when a procedure or treatment carries significant risks, physicians and other medical professionals must get informed consent before proceeding. If it is not given and the patient is harmed by care, he or she may sue, claiming negligence or malpractice. Situations in which there is a failure to get informed consent may include:
- When the doctor does not describe any or all of the risks associated with care
- When consent is taken from a patient that is a minor
- When consent is taken from a patient that is not capable of making an informed decision and who has a legal guardian
- When the patient is misled about the risks of a procedure or treatment or about possible alternatives
- When alternatives are not given as options for care
Failure to get informed consent can be considered negligence if it can be proven that a different doctor in the same situation would have done something differently. Or, it may also be considered negligence if the patient would have made a different decision if given better information. A failure to get signed consent may be proof that there was no informed consent, even if the doctor says that the patient gave verbal consent. Each state has its own laws about what constitutes informed consent, so malpractice cases can vary a lot depending on location.
Consequences of Lack of Informed Consent
The repercussions from failing to get informed consent from a patient can extend from minor side effects from a procedure, treatment, or test, to major disability or death. In many cases, patients say that they would have made a different decision if they had been given all the information about risks and alternatives. Patients who had care they might otherwise have refused could end up with injuries, disability, chronic pain, extended hospital time, more medical bills, and emotional suffering.
Examples of Informed Consent Cases
A landmark case in informed consent occurred after a young patient, 19-year-old Jerry Canterbury, underwent a spinal surgery that left him paralyzed in 1959. Canterbury claimed that the surgeon did not inform him of the risks and described the procedure as routine and ordinary. He was left partially paralyzed and fully incontinent for the rest of his life. He sued the surgeon and the surgeon won, but in 1972, a Court of Appeals decision allowed him to go to trial again. The decision changed how informed consent is given and empowered patients to be able to be more autonomous in their medical care decisions.
In another very tragic case in which the patient alleged lack of informed consent, a mother lost her infant baby. The woman was ready to be induced to deliver her second child. Her first child had been delivered by cesarean section, but she wanted to try a vaginal deliver for the second. While waiting in the hospital to deliver, the mother experienced severe abdominal pain and a cesarean was ordered. It was found that the uterus had ruptured and the baby died not long after. The woman alleged that she was not given full informed consent because she was not aware of the risk of a uterine rupture with vaginal delivery after a previous cesarean. The case was settled in the plaintiff’s favor.
These cases and many others illustrate how important it is for patients to be given all the information they need to give informed consent before receiving medical care. Without being able to make that choice, patients put themselves more completely at the mercy of their doctors and have no partnership in the decision-making process. If you believe you were a victim of negligence by lack of informed consent, let a malpractice lawyer give you advice on what to do next.