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What Does Informed Consent Mean?

Medical patients have the right to know the risks of any medical procedure before they agree to receive treatment. Only when the patient understands the risks and benefits can they give meaningful consent to undergo medical care. If the doctor does not inform the patient of the risks and something goes wrong, the doctor may be liable for medical malpractice. Talk to an experienced medical malpractice lawyer about your rights after a medical error.

What is Informed Consent?

Every medical procedure carries some level of risk. It is important for a patient to have the necessary information to be able to agree to be treated. When a doctor performs a medical procedure, they are generally required to give the patient the necessary information, including: 

  • Risks
  • Benefits
  • Side effects
  • Possible complications
  • Reasonable alternatives
  • Consequences of declining care

When the patient has this important information, they can then make a meaningful and voluntary decision about their care. Unfortunately, patients are not always given the full information or not allowed a chance to review the consent agreements. Some doctors gloss over the risks or use boilerplate forms that do not apply to the individual procedure. Other doctors may pressure the patient to agree to sign the form, despite their concerns. If the doctor does not provide the necessary information or obtain informed consent, they may be liable for the patient’s injuries. 

Meaningful and Voluntary Agreement for Medical Treatment

Informed consent is more than just a signature on a medical form. Informed consent requires providing essential information to allow for someone to make a voluntary and knowing decision about their medical care. This should include facilitating understanding of the information, answering questions, and providing additional resources if they would help the patient understand the medical treatment they will receive. The basic elements of informed consent include:

  1. Nature of the procedure 
  2. Risks
  3. Benefits
  4. Alternatives

Meaningful consent may also require the doctor or health care provider to continue giving the patient information about updates, changes, and whenever the doctor has an unexpected or unanticipated outcome. Consent should also allow the patient to be able to say “no.” Voluntary consent means that the patient can decide not to participate as long as they understand the consequences of not receiving treatment. 

Doctors and patients do not always stand on level ground. Many doctors treat patients like they are above them, or they know what’s best even if the patient disagrees. A doctor-patient relationship should be built on mutual respect and understanding. Doctors should respect a patient’s decision, even if it is not what the doctor would have done. Without respect, informed consent could be tainted by coercion or undue influence. 

Problems With Implied Consent

The Joint Commission is a nonprofit organization that accredits health care organizations and hospitals. In 2016, the Joint Commission put out a safety advisory on issues with informed consent, titled: Informed Consent: More Than Getting a Signature. In the paper, the commission identified a number of barriers to understanding the information involved, including: 

  • A lack of basic information on the consent form
  • Ineffective provider-patient communication
  • Lack of shared decision-making between patient and provider
  • Lack of consideration of the health literacy of patients
  • Lack of consideration of cultural issues of patients

One research study found that in almost three-quarters of consent forms, the 4 basic elements of informed consent were not included.  

Coercion and undue influence can be a problem for informed consent. In many cases, doctors are unaware of how coercive they can be in urging a patient to just sign the waiver. According to a report from the Food and Drug Administration (FDA), “Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance.”

Types of Informed Consent Agreements

An informed consent agreement is generally part of the paperwork a patient has to sign when undergoing care. It may be a few pages long and look like a confusing legal document, which may be true. Some of the consent information may include language like: 

  • All surgical procedures have risks, including bleeding, infection, and death.
  • I understand that I am opting for an elective treatment that may not be urgent or medically necessary.
  • I have been informed of the risks of the procedure, nature of the procedure, likelihood of success, and expected benefits. 
  • The procedure has been explained to me and I have been told the reasons for the procedure. 
  • The potential side effects and potential complications have been explained. 
  • I have been informed of reasonable alternative methods of treatment and their risks and benefits. 
  • I have been informed of the consequences of declining the medical procedure and reasonable alternatives. 
  • I am aware that the practice of medicine is not an exact science and I acknowledge that no guarantees have been made to me as to the results.
  • I knowingly and willingly consent to the treatment with the full understanding and disclosure of the risks associated with the care. 

At the bottom of the form is usually a line for the signature of the patient or parent or guardian of a minor patient, and the date. 

Why Would a Patient Deny Treatment?

There are many reasons why a patient would deny medical treatment after they are informed of the risks and benefits of the procedure. Even life-saving medical procedures may have risks or concerns that could allow the patient to decide not to continue. Some common reasons why a patient would deny treatment include: 

  • The risks outweigh the benefits
  • A less invasive procedure could be attempted first
  • Religious or cultural reasons related to medical care
  • Personal values
  • Financial concerns
  • Misunderstanding the benefits, risks, and alternatives
  • Pressure from friends, partners, or family members
  • Lack of mental capacity to understand the consequences of their decision

Another common reason some people deny treatment is because of the patient’s advanced age or poor health condition. Many older people voluntarily enter into advance care directives or living wills. Advanced-care directives (ACDs) often include do not resuscitate (DNR) orders. This means that if the patient stops breathing or goes into cardiac arrest, medical professionals will not provide cardiopulmonary resuscitation (CPR). 

You Signed a Waiver

Just because you signed a waiver does not mean that you gave informed consent. In general, the hospital or medical office uses a waiver as evidence that the doctor provided the necessary information and the patient agreed to receive treatment. However, the medical procedure may not have matched up with what was on the waiver. Generally, you can still sue for malpractice if you signed a waiver, where:  

  • The waiver did not contain the risks involved with the procedure performed
  • The doctor deviated from the standard of care of a reasonable doctor 
  • The patient did not knowingly and voluntarily sign the waiver
  • The doctor misrepresented the medical procedure

If you claim that you suffered an injury after the medical procedure, the doctor or the hospital may simply tell you that you consented to the procedure and make it seem like you have no other options. Don’t let the doctor decide whether or not you have a claim. Talk to a medical malpractice law firm about your case and they can help you evaluate your legal options for recovery. 

Some informed consent agreements go too far and try to avoid any liability for any injury, even when the doctor has been reckless in their treatment. Exculpatory language that may not be enforceable could include: 

  • I waive any possibility of compensation, including any right to sue, for injuries that I may receive as a result of this treatment or procedure.

Can I Change My Mind After I’ve Signed the Waiver?

Just as you have the right to refuse treatment, you have the right to change your mind after you’ve signed the consent form. Even if treatment has already begun, a doctor should listen to your wishes and act in accordance with your rights. Some patients have second thoughts after agreeing to the procedure, especially after sitting down and reading the waiver or talking to friends or family members. Do not feel pressured to do something you don’t want to do, even if you think the doctor will get made. You have rights as a patient, including the right to be heard and the right to decide your own medical care. 

Informed Consent and Anesthesia

Anesthesia is one of the most common medical procedures. Anesthesia can be used for most types of surgery, including plastic surgery. Anesthesia is administered so the patient is not conscious during treatment and immobile for the benefit of the surgeons. However, there are a number of risks associated with anesthesia, including: 

Before scheduling a surgery with anesthesia, your doctors and healthcare professionals should make sure the patient understands the procedure, risks, and risks associated with general anesthesia. Informed consent helps the patient understand that the surgery and anesthesia are separate procedures and each carries its own risks and dangers. 

Proving an Informed Consent Case

To prove negligence in a medical malpractice case, the plaintiff must prove there was a duty of care, deviation from the standard, the breach caused the injury, which resulted in harm. In an informed consent case, the breach can be demonstrated through lack of informed consent. If the doctor begins treatment without disclosing the nature of the procedure, risks, benefits, and alternatives, the patient may have grounds to bring a claim of medical malpractice against the physician.

COVID-19 Informed Consent

The COVID-19 pandemic has resulted in the increased use of COVID-19 informed consent forms. The coronavirus can be highly transmissible and many people in health care settings were exposed to the virus, and later exposed patients seeking medical care for other conditions. With the increased risk of contracting COVID in a hospital, doctor’s office, or medical clinic, many healthcare providers introduced COVID-19 consent forms. The consent forms are often used for non-emergency procedures, including plastic surgery

For example, the American Society of Plastic Surgeons provided a COVID-19 informed consent reference form. The form included the following information: 

  • I understand that I am opting for an elective treatment/procedure/surgery that is not urgent and may not be medically necessary.
  • I understand there is an inherent risk of becoming infected with COVID-19 by virtue of proceeding with this elective treatment/procedure/surgery. 
  • I understand that COVID-19 may cause additional risks, some or many of which may not currently be known at this time.
  • I understand all the potential risks, including but not limited to the potential short-term and long-term complications related to COVID-19, and I would like to proceed with my desired treatment/procedure/surgery.

Generally, these COVID-19 informed consent forms are intended to avoid liability for a doctor’s office that may have transmitted COVID-19 to a patient during medical treatment for some other procedure. 

Can You Recover Damages After a Medical Complication That You Were Never Warned About?

If your doctor performed a medical procedure without advising you of the nature of the procedure, risks, benefits, or alternatives, the doctor may have failed to obtain informed consent. If a risk or complication of the procedure caused an injury, the doctor may be liable for damages. Damages in a medical malpractice claim can include: 

  • Medical expenses
  • Corrective surgery
  • Follow-up medical care
  • Loss of income
  • Emotional distress
  • Pain and suffering

To recover damages in a medical injury claim, an experienced medical malpractice law firm can file a lawsuit in court to make sure you are compensated for your losses. A medical malpractice lawsuit in Chicago, Philadelphia, Baltimore, or anywhere else in the country can be a complex claim and an experienced med mal attorney may be in the best position to give you legal advice about your rights, legal options, and possibilities for recovering damages. 

If you have any questions about recovering damages after a medical error injury, talk to experienced trial attorneys who can review your case and help you understand your legal options. Contact Gilman & Bedigian online or at 800-529-6162 for a free consultation.

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