| Read Time: 4 minutes | General Practice

Many medical procedures have a degree of risk and potential negative side effects. But before a doctor or other healthcare provider can perform these procedures, they must obtain informed consent from the patient.

A professional violates this duty when they fail to properly inform a patient about the risks, benefits, and alternatives of a proposed medical treatment or procedure, and proceed without obtaining the patient’s valid consent.

When a patient suffers harm due to a procedure they didn’t properly consent to because they weren’t informed of the risks or alternatives, they may have grounds for a medical malpractice lawsuit. Read on to learn more about informed consent in medical malpractice, why it is important, and how the medical malpractice team at Baird Mandalas Brockstedt & Federico can help.

If you have questions, please contact us right away.

What Is Informed Consent?

Informed consent in medical malpractice refers to the legal principle requiring healthcare providers to provide patients with relevant information about a proposed treatment or procedure. This information should cover the nature of the treatment, its risks, benefits, potential complications, and available alternatives. The key elements of informed consent include:

  • Disclosure. Healthcare providers must provide sufficient information to enable patients to comprehend the proposed treatment or procedure, its risks, benefits, and alternatives.
  • Patient Comprehension. A patient should be capable of understanding the information provided. If necessary, healthcare providers should use layman’s terms or aids to ensure comprehension.
  • Voluntary Agreement. Patients must voluntarily agree to the treatment or procedure without coercion or pressure from the healthcare provider. This can be done orally but in many cases requires written consent as well.

Why is informed consent important? It allows patients to be properly informed about their health conditions and allows them to make knowledgeable and voluntary decisions about their healthcare.

When Is Informed Consent Required?

Informed consent is generally required in medical settings before performing any treatment, procedure, or intervention, including for:

  • Medical Procedures. This includes surgeries, administering medications, performing diagnostic tests, or any other medical procedure, healthcare providers must obtain informed consent from the patient.
  • Clinical Trials and Research Studies. Participants should understand the purpose of the study, potential risks and benefits, and their rights as participants.
  • Treatment Options. Healthcare providers should inform patients about the risks, benefits, and alternatives of each treatment option, allowing the patient to make an informed decision.
  • Treatment Involving Minors or Incapacitated Individuals. In some cases, informed consent may be obtained from a legal guardian or surrogate decision-maker.

In addition, not every healthcare scenario requires obtaining informed consent before proceeding with treatment. However, the National Institutes of Health says that express written informed consent is needed for the following medical procedures:

  • Most surgeries, even when they are not done in the hospital;
  • Advanced or complex medical tests and procedures, such as an endoscopy or a needle biopsy of the liver;
  • Radiation or chemotherapy to treat cancer;
  • Genetic testing;
  • Most vaccines; and 
  • Certain blood tests.

If a healthcare provider fails to do any of the above, it may be a violation of informed consent. However, an exception to the informed consent rule can pop up in emergency medical situations. In cases where immediate treatment is required to save a patient’s life or prevent serious harm, obtaining formal consent may not be feasible. If this happens, healthcare providers follow protocols allowing them to proceed with treatment without explicit consent, focusing on the patient’s best interests.

Violation of Informed Consent Examples

While many situations can create a violation of informed consent, here are a few general examples.

Failure to Explain 

For example, a patient is scheduled for a specific surgery but the surgeon fails to adequately explain the risks associated with the procedure. The patient wakes up post-surgery to complications they were never informed about, such as nerve damage and extensive pain, knowledge of which may have impacted the patient’s decision. The lack of comprehensive information provided before the surgery constitutes a violation of informed consent.

Pressured into Consenting

In this scenario, a patient visits a clinic seeking treatment for a chronic condition. A doctor strongly recommends a specific medication without explaining potential side effects or alternative options. Feeling pressured and trusting the doctor’s recommendation, the patient agrees without being fully aware of other available treatments or the risks associated with the prescribed medication. This demonstrates coercion and insufficient disclosure of information, constituting a violation of informed consent.

Consent Scope Exceeded

A patient consents to a specific surgical procedure but wakes up to find additional, unrelated surgeries performed without their prior knowledge or explicit consent. The healthcare team decided to address other issues they deemed necessary during the initial surgery without consulting the patient. This unauthorized extension of treatment breaches the boundaries of the initially agreed-upon consent, violating the patient’s autonomy.

Unauthorized Testing

Another violation of informed consent example involves a patient who goes to a lab for specific blood tests ordered by their physician to diagnose a particular condition. The lab technician, without consulting the patient or the physician’s order, decides to perform additional tests on the blood samples. These extra tests were not discussed, explained, or consented to by the patient.

Later, the patient receives bills and results for tests they didn’t authorize or need. The lab technician’s decision to conduct tests beyond the scope of the patient’s consent or physician’s orders constitutes a violation of informed consent.

When to Seek Legal Help

If you experienced an incident where a healthcare professional or other covered worker failed to obtain your informed consent before administering treatment, you may have a claim against that individual and the facility where the treatment occurred.

The first step is to consult with experienced medical malpractice attorneys, like the team at Baird Mandalas Brockstedt & Federico. Be sure to seek help as soon as possible, as there are deadlines to file medical malpractice claims in Maryland. Consulting with an attorney as soon as you can help preserve your rights and give you the best chance at recovery.

Contact Baird Mandalas Brockstedt & Federico

If you are considering a medical malpractice claim for failure of informed consent, the team at Baird Mandalas Brockstedt & Federico can help. Our skilled medical malpractice attorneys can help you understand your rights and options, help you assess and strengthen your case, and be your advocate in negotiations and other proceedings.

With decades of experience and millions earned on behalf of our clients, you can trust us to help make this stressful time a little easier. Call our office today or fill out our online contact form to schedule a consultation about your situation.

Author Photo

Phil Federico is a partner at Baird Mandalas Brockstedt & Federico where he helps lead the Mass Tort / Class Action and Environmental Law practices, transitioning into these areas after beginning his career as a medical malpractice litigator.

Phil has led and been involved in historic and groundbreaking litigation with verdicts and settlements exceeding one billion dollars.

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