Consent

Informed Consent

Before a drug is prescribed, it is a legal requirement for doctors to obtain informed consent by educating a patient (parent, guardian or caregiver) about the risks (e.g., side effects), benefits and alternative products and/or services for treating the health condition, which often requires a doctor to provide them with a consent form (e.g., Medication Consent Form) to sign if they feel informed before a drug is prescribed, and they’ve chosen to use that drug to treat their health condition.

There are four things a doctor must make sure a patient understands before informed consent can be obtained:

  1. Nature of the procedure or intervention;
  2. Risks and benefits of the procedure or intervention;
  3. Reasonable alternatives;
  4. Risks and benefits of alternatives.

Patients should demand informed consent, which rarely happens. Some of the reasons why are explained on the Champions for Change page. 

Robert Whitaker, founder of Mad in America, candidly shares his views on informed consent in psychiatry in this video clip from an interview with filmmakers of the 2020 documentary Medicating Normal.

Legal Precedent

Patients who are harmed by an adverse drug reaction without the doctor obtaining informed consent could file civil lawsuits. In Boise, Idaho, for example, the Supreme Court of Idaho considered a case to be medical malpractice and, on appeal, vacated the summary judgment from a District Court that the Idaho Department of Health & Welfare and a physician’s assistant were not negligent for not obtaining informed consent from Terri Mattson for prescribing the SSRI (selective serotonin reuptake inhibitor) antidepressant Prozac as an outpatient for mental health services.

A couple of months after starting Prozac, Terri had a follow-up appointment with the physician’s assistant. When she woke up that day, she took a firearm from her gun cabinet, drove to a liquor store, bought a bottle of vodka, and drank the entire bottle on her way to the appointment. In the Department’s parking lot just before her appointment, she took the gun and shot herself in the head. Terri survived the suicide attempt but suffered extensive injuries. Subsequently, she and her husband filed the lawsuit. The May 2023 Supreme Court opinion sent the case back to the District Court for further proceedings, which was precedent setting in the United States. The lawsuit was settled out of court for an undisclosed amount in early 2024.