What Is Informed Consent in Medical Malpractice? Legal Guide

Understanding Informed Consent in Medical Malpractice

Informed consent is a fundamental principle of medical ethics and law that requires healthcare providers to obtain a patient's voluntary agreement before performing any medical procedure, treatment, or test. The concept of informed consent is based on the principle that every competent adult has the right to make decisions about their own body and medical care. When a healthcare provider fails to obtain proper informed consent before performing a procedure, and the patient is injured as a result, the provider may be liable for medical malpractice.

The doctrine of informed consent requires more than simply getting a patient to sign a consent form. It requires that the healthcare provider engage in a meaningful conversation with the patient about the proposed treatment, including the nature of the procedure, the expected benefits, the material risks and potential complications, alternative treatments and their risks and benefits, and the consequences of refusing treatment. The patient must have the opportunity to ask questions and must voluntarily agree to the treatment without coercion or undue influence.

Informed consent claims represent a significant category of medical malpractice cases. These claims arise when a patient suffers an injury from a medical procedure and alleges that they would not have consented to the procedure if they had been properly informed of the risks. Unlike traditional medical malpractice claims, which focus on whether the healthcare provider performed the procedure competently, informed consent claims focus on whether the patient was given adequate information to make an informed decision about their care.

Elements of an Informed Consent Claim

To succeed in an informed consent medical malpractice claim, the plaintiff must prove several elements.

Duty to Disclose

The healthcare provider had a duty to disclose material information about the proposed treatment. This duty exists whenever a healthcare provider recommends a procedure, treatment, or test that carries material risks. The duty to disclose applies to physicians, surgeons, dentists, and other healthcare providers who recommend and perform medical procedures.

Breach of Duty

The healthcare provider failed to disclose material information that a reasonable patient would have considered important in making their decision. This can include failure to disclose known risks of the procedure, failure to discuss alternative treatments, failure to explain the expected benefits and outcomes, and failure to discuss the consequences of refusing treatment.

Causation

The patient would not have consented to the procedure if they had been properly informed of the risks. This is often the most difficult element to prove because it requires showing that a reasonable patient in the plaintiff's position would have declined the procedure if they had been given adequate information.

Injury

The patient suffered an injury as a result of the procedure. The injury must be one of the risks that should have been disclosed. If the patient suffered an injury that was not a known risk of the procedure, the informed consent claim may not be viable, although a traditional malpractice claim based on negligent performance of the procedure may still be available.

What Must Be Disclosed

The scope of the disclosure required for informed consent varies by jurisdiction, but generally includes the following categories of information.

Nature of the Procedure

The healthcare provider must explain the nature of the proposed procedure in terms that the patient can understand. This includes a description of what the procedure involves, how it is performed, and what the patient can expect during and after the procedure.

Material Risks

The healthcare provider must disclose the material risks associated with the procedure. A risk is considered material if a reasonable patient would consider it important in making their decision about whether to undergo the procedure. Material risks include both common risks with relatively minor consequences and rare risks with serious consequences. The provider does not need to disclose every conceivable risk, but must disclose those that are significant enough to affect a reasonable patient's decision.

Benefits of the Procedure

The healthcare provider must explain the expected benefits of the procedure, including the likelihood of success and the expected improvement in the patient's condition.

Alternative Treatments

The healthcare provider must discuss alternative treatments that are available, including their risks and benefits. This includes the option of no treatment and the expected consequences of declining the proposed procedure.

Prognosis Without Treatment

The healthcare provider must explain what is likely to happen if the patient declines the proposed treatment. This information is important for the patient to weigh the risks of the procedure against the risks of not having the procedure.

Standards for Evaluating Informed Consent

Courts use two different standards for evaluating whether a healthcare provider provided adequate informed consent.

Professional Standard

Under the professional standard, also known as the physician-based standard, the adequacy of the disclosure is measured by what a reasonable healthcare provider in the same specialty would have disclosed under similar circumstances. This standard relies on expert testimony from other healthcare providers to establish what information should have been disclosed.

Patient Standard

Under the patient standard, also known as the reasonable patient standard, the adequacy of the disclosure is measured by what a reasonable patient would have wanted to know in order to make an informed decision. This standard focuses on the patient's perspective rather than the provider's perspective and does not necessarily require expert testimony to establish the standard of disclosure.

The majority of states now follow the patient standard, which is generally considered more protective of patient rights. However, some states still follow the professional standard, and a few states use a hybrid approach.

Exceptions to Informed Consent Requirements

There are several recognized exceptions to the informed consent requirement.

Emergency Exception

In emergency situations where the patient is unconscious or otherwise unable to give consent and delay in treatment would result in serious harm or death, the healthcare provider may proceed without informed consent. The emergency exception is based on the presumption that a reasonable person would consent to life-saving treatment.

Therapeutic Privilege

The therapeutic privilege allows a healthcare provider to withhold information from a patient if the provider reasonably believes that disclosure would be so harmful to the patient that it would be counterproductive to the patient's care. This exception is narrowly construed and is rarely successful as a defense.

Patient Waiver

A patient may voluntarily waive their right to informed consent by telling the healthcare provider that they do not want to know the risks and want the provider to make the treatment decision. The waiver must be voluntary and informed.

Common Knowledge

Healthcare providers are not required to disclose risks that are common knowledge or that the patient already knows. For example, a provider does not need to explain that surgery involves cutting the skin or that anesthesia involves being put to sleep.

Settlement Values in Informed Consent Cases

Settlement values in informed consent medical malpractice cases vary widely based on the severity of the injury and the strength of the evidence.

Minor Injuries

Cases involving minor injuries from procedures performed without adequate informed consent typically settle in the range of $25,000 to $100,000. These cases involve relatively minor consequences that resolve with additional treatment.

Moderate Injuries

Cases involving moderate injuries, such as nerve damage, infection, or prolonged recovery, typically settle in the range of $100,000 to $400,000. These cases involve more significant consequences that may require additional surgery or extended treatment.

Serious Injuries

Cases involving serious injuries, such as permanent nerve damage, organ damage, or significant disfigurement, typically settle in the range of $400,000 to $1,000,000. These cases involve permanent consequences that significantly affect the patient's quality of life.

Catastrophic Injuries

Cases involving catastrophic injuries, such as paralysis, brain damage, or wrongful death, can settle for $1,000,000 to several million dollars. These cases involve the most severe consequences and the highest damages.

Proving an Informed Consent Claim

Proving an informed consent claim requires careful preparation and strong evidence.

Medical Records

Medical records are critical evidence in informed consent claims. The records should document the informed consent discussion, including the risks disclosed, the alternatives discussed, and the patient's questions and responses. If the medical records do not document an adequate informed consent discussion, this can support the plaintiff's claim that adequate consent was not obtained.

Consent Forms

Consent forms are important but not dispositive evidence. A signed consent form does not necessarily prove that adequate informed consent was obtained if the form is generic, does not list specific risks, or was signed without a meaningful discussion. Conversely, the absence of a signed consent form does not necessarily prove that informed consent was not obtained if the provider can demonstrate that a verbal discussion took place.

Expert Testimony

Expert testimony is typically required to establish the standard of care for informed consent, the risks that should have been disclosed, and whether the provider's disclosure was adequate. In states that follow the professional standard, expert testimony from a provider in the same specialty is required. In states that follow the patient standard, expert testimony may still be helpful but is not always required.

Patient Testimony

The patient's testimony about what they were told and what they would have decided if they had been properly informed is important evidence. The patient must credibly testify that they would not have consented to the procedure if they had known about the specific risk that materialized.

How to Protect Your Rights

Understanding your rights regarding informed consent can help you protect yourself and strengthen any potential claim.

Ask Questions

Before any medical procedure, ask your healthcare provider to explain the procedure, the risks, the alternatives, and the expected outcomes. Do not hesitate to ask questions until you fully understand the information.

Request Written Information

Ask for written information about the procedure and its risks. Written materials can supplement the verbal discussion and provide a reference for you to review at your own pace.

Take Notes

Take notes during the informed consent discussion or bring a family member or friend who can take notes for you. These notes can be valuable evidence if a dispute arises later.

Do Not Feel Pressured

Do not feel pressured to consent to a procedure before you are ready. You have the right to take time to consider your options, seek a second opinion, and make a decision that is right for you.

Conclusion

Informed consent is a fundamental right that protects patients' autonomy and ensures that they can make informed decisions about their medical care. When healthcare providers fail to obtain proper informed consent and patients are injured as a result, the providers may be liable for medical malpractice. Understanding the elements of an informed consent claim, the standards for evaluating consent, and the evidence needed to prove your case can help you protect your rights and pursue fair compensation.

Use our free settlement calculator to estimate the potential value of your medical malpractice claim based on your specific injuries, medical costs, and circumstances.

The Evolution of Informed Consent Law

The doctrine of informed consent has evolved significantly over the past century. Early medical practice operated under a paternalistic model where physicians made treatment decisions for their patients without necessarily explaining the risks and alternatives. The modern doctrine of informed consent emerged in the mid-20th century as courts recognized that patients have a fundamental right to make informed decisions about their own medical care. The landmark case of Canterbury v. Spence in 1972 established the reasonable patient standard, holding that the adequacy of disclosure should be measured by what a reasonable patient would want to know rather than what a reasonable physician would disclose. This shift from the physician-based standard to the patient-based standard represented a fundamental change in the doctor-patient relationship and significantly expanded patients' rights.