Informed Consent Is More Than a Signed Form

The Case

In response, the doctor noted that the patient had signed a consent form, which had been explained in her language. The doctor asked the court to dismiss the case against her because there could not be a lack of informed consent if the patient signed the consent form.

The Decision

The court refused to let the physician off the hook in this case, noting that although the doctor had testified in her deposition that she’d verbally informed the patient about the most common side effects of IUD removal, and she obtained a signed consent form, she admitted that she did not offer the patient alternatives, such as an ultrasound-guided removal, a hysteroscopy, or removal in a hospital setting. The court noted that the patient’s deposition indicated that she was not informed of the risks of removal or how the device would be removed. She was only told that it had to be removed.

Additionally, the court noted that the consent form contained only generic language and didn’t specifically address IUD removal. The court declined to dismiss the case against the physician, and the case is currently awaiting trial.

The Bottom Line

Simply signing a consent form doesn’t mean that a patient has knowingly consented to something—particularly when the language in the consent form is vague or generic. Physicians and health care workers should develop informed consent forms that are as specific to the procedure as possible. It is always worth taking the few extra minutes involved to ensure that a patient truly understands what they are consenting to.

Reference:

Huang v Yan-Rosenberg, 2023 NY Slip Op. 30236, 6 (NYS Ct 2023). https://law.justia.com/cases/new-york/other-courts/2023/2023-ny-slip-op-30236-u.html

Ann W. Latner, JD, is a freelance writer and attorney based in New York. She was formerly the director of periodicals at the American Pharmacists Association and editor of Pharmacy Times.