Your doctor has to comply with restrictions regarding the treatment that they provide you. Generally speaking, they should only use drugs and treatments approved by the Food and Drug Administration (FDA) for a specific purpose.
Sometimes, doctors administer a drug for an off-label purpose, meaning they use it for something other than the approved and tested use. Other times, they may recommend or administer treatments that are still in the research and investigation stage.
Typically, patients undergoing experimental treatments have to sign a waiver asserting that they have given informed consent. However, there are several scenarios in which you may have signed that form but did not truly give informed consent.
When the doctor didn’t tell you the drug or treatment was experimental
It is surprisingly common for doctors to include an informed consent form in a stack of papers and never explained to the patient that a specific treatment option is not yet approved by the FDA. You may have signed that form as one of many without even realizing that you were effectively giving up your right to hold the doctor accountable if anything should go wrong with the treatment not yet evaluated for safety or efficacy.
When the doctor didn’t disclose side effects or success and failure rates
Understanding that the treatment you will undergo is experimental is only part of being informed about the situation and your risks. You also need to know what side effects the treatment causes. Both the most common side effects and the most severe ones are matters that your doctor should educate you about when discussing the possibility of you pursuing this treatment plan.
You also received accurate information about how frequently the treatment has succeeded and its current estimated failure rate. If you realize that the majority of people who undergo this procedure must have a revision later or that only a tiny fraction of patients respond positively to the drug, you may want to pursue alternative options with fewer risks or a better success rate.
Just like having you sign a form isn’t truly an indicator of obtaining your informed consent, neither is handing you a pamphlet or telling you to research the treatment yourself. You deserve full information from your doctor and an honest conversation so that you can make the right decision that puts your well-being first.
Holding a doctor or medical facility accountable after a poor outcome may require a medical malpractice claim related to a lack of informed consent.