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When it comes to negligence in healthcare, medical malpractice lawsuits are often the first type of claim that comes to mind. However, informed consent claims are also common and may arise from the same medical situation.
In this blog, we’ll review important legal distinctions between medical malpractice and informed consent violations in the context of voiding cystourethrography (VCUG).
What Is a Lack of Informed Consent Claim?
Every medical procedure comes with certain risks and complications. Under the law, healthcare providers must inform patients of the risks of any proposed test or treatment. This is known as “informed consent.”
If your child’s provider withheld a risk from you before performing a pediatric VCUG, you may be eligible for compensation in a lack of informed consent claim.
What Is the Difference Between Medical Malpractice & Informed Consent Violations?
While medical malpractice and informed consent violations are similar, they are considered distinct claims under the law. Lack of informed consent claims commonly accompany medical malpractice cases, but may also be filed separately. This means you can file a lack of informed consent claim without also filing a medical malpractice claim, so long as you meet the burden of proof in your case.
The primary difference between medical malpractice and informed consent violations is the standard of proof required for each case. In the legal setting, the “burden of proof” refers to specific legal elements the patient (plaintiff) must prove to successfully recover damages.
Medical Malpractice
Medical malpractice cases have a higher standard of proof compared to informed consent violations. To establish liability in a medical malpractice lawsuit, the patient must prove the following elements:
Duty of care: The medical professional (defendant) owed the patient a duty of care.
Breach of duty: The defendant deviated from the accepted standard of care by acting negligently.
Causation: The defendant’s negligence caused the plaintiff’s injuries.
Damages: The breach of duty resulted in compensatory harm to the plaintiff.
Lack of Informed Consent
While medical malpractice claims require patients to prove that the provider departed from the standard of care, this isn’t the case in a lack of informed consent claim. Instead, the patient must prove the following:
The physician did not present the risks and benefits of the proposed treatment.
With full information, the patient would have declined the treatment.
The treatment, even though appropriate and carried out skillfully, was a substantial factor causing the patient’s injuries.
What Risks Are Providers Required to Disclose?
Under the informed consent doctrine, doctors are required to disclose all important risks of a proposed treatment—no matter how unlikely they are to occur. This generally includes potential complications and benefits, the magnitude and frequency of associated risks, alternative treatment options, anticipated results, and other reasonable and necessary information for informed decision-making.
The disclosed risks should be tailored to each patient’s individual history and medical needs and communicated in clear, understandable language. Keep in mind that legal definitions and processes vary from state to state, making it critical to consult a qualified attorney in your area before pursuing a claim.
Depending on your case and state of residence, one of the following legal concepts may be used to determine a potential informed consent violation:
The “reasonable practitioner” standard: Whether a reasonable provider would consider important to the patient’s decision.
The “prudent patient” standard: Whether the physician has disclosed what reasonable person in the patient’s shoes would want to know to make an informed decision.
Are There Exceptions to the Informed Consent Doctrine?
Yes, some exceptions may apply in certain circumstances. A doctor may forgo informed consent 1.) in emergency situations that necessitate immediate action to save a patient’s life, or 2.) if the doctor reasonably believes that disclosure would cause psychological harm or endanger the patient. Even in these rare circumstances, the provider must explain why disclosing a risk would have caused more harm to the patient than withholding it.
I Wasn’t Informed of the Risks of My Child’s VCUG. Can I File a Lawsuit?
If you believe your child’s doctor violated the informed consent doctrine by performing a VCUG, you may be entitled to take legal action. Some common signs to consider include:
You were unaware of the psychological risks associated with VCUG.
Often, ionizing radiation is the only risk disclosed prior to pediatric VCUGs. This is widely observable across the internet, with Dayton Children’s Hospital describing fluoroscopy as “very safe” with minimal radiation that “[is] not considered dangerous.” Likewise, the Boston Children’s Hospital designates a separate category for “VCUG risks,” yet ionizing radiation is the only risk mentioned on their website.
However, the psychological risks associated with VCUGs are severe and well-documented throughout decades of critically appraised literature, including multiple studies where VCUG patients were used as proxies for child sexual abuse victims.
Put simply, providers have every reason to disclose the risk of child sexual abuse (CSA) symptoms due to serious associated health outcomes, including PTSD, schizophrenia, depression, anxiety, suicidality, self-injurious behaviors, chronic pain, borderline personality disorder (BPD), and eating disorders.
The risk of psychological harm caused by VCUGs is well-evidenced in literature dating back to 1989, making this a critical point of conversation for the majority of parents and families during the informed consent process. If your doctor neglected to mention the risk of sexual and medical trauma, you may have grounds for a lawsuit.
Your doctor failed to inform you about alternative treatments, including no treatment.
There are several safe alternatives to VCUG. If your pediatrician failed to cover alternative treatment measures, such as ceVUS (radiation-free), renal-bladder ultrasound (non-invasive), and other alternative measures, you may be eligible to file a medical malpractice or lack of informed consent claim. This includes the option of no treatment (“wait-and-see” approach).
You were unaware of parental restrictions during the exam.
Many parents are surprised by undisclosed details when they arrive on VCUG test day, such as being unable to accompany their child into the exam room, not understanding the level of pain involved, being forced out of the exam room in the middle of the procedure, or being unaware of critical VCUG stages, such as the need for ionizing radiation or involuntary catheterization without sedation.
Consequently, many parents suffer secondary trauma as a result of their child's test, leaving families to carry heavy burdens that could have been prevented with a mutually respectful informed consent process. If you, your child, or other loved one is exhibiting signs of post-traumatic stress after undergoing or witnessing a VCUG procedure, this could be a sign of an informed consent violation.
Join the Unsilenced Movement
Whether you're a former patient recovering from a pediatric VCUG or a parent seeking more information about their child's condition, the Unsilenced Movement is committed to empowering families to exercise their right to informed consent and advocating for overdue reform in pediatric urology. Help us hold the medical community accountable for inflicting known harm by raising awareness about the real and lasting impacts of VCUG trauma. Because kids deserve better. #MoreThanATest
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