It takes a lot of time and financial investment for pharmaceutical companies and medical device manufacturers to secure Food and Drug Administration (FDA) approval for new products. Frequently, there will be several years of clinical trials that occur before the FDA will agree that there is adequate evidence of a treatment’s or device’s safety and efficacy.
For those fighting cancer or coping with a recent injury, waiting an indeterminate amount of time to connect with the best possible treatment may be an unreasonable expectation. Your doctor may suggest that you participate in a clinical trial or undergo an experimental treatment. While such treatments may give you hope in one way, they can put you at risk in another.
Doctors may not give you the full story
When you decide that your best option is to undergo experimental treatments, you take a substantial amount of risk because the FDA has not validated the safety or success rate of the proposed treatment. Whether you are taking a drug for an off-label use or about to undergo a surgery that doctors have performed only a few dozen times previously, you could be at risk of adverse outcomes in addition to the treatment not serving its purpose.
Your doctor should take great pains to ensure that you provide fully informed consent. Handing you a pamphlet or telling you the biggest details about possible failures is not enough. You have a right to know about the common side effects and the most catastrophic reported side effects. You deserve to know not just the success rate, but also the failure rate.
The number of patients who have died or had adverse reactions might actually influence you to pursue a different treatment if you know that information. Doctors excited about the windfall or reputation boost possible when they perform experimental treatments or participate in medical research may gloss over details that would have a major impact on what their patients decide.
Having you sign a form isn’t informed consent
All too often, doctors shove a stack of papers at their patients and tell them they have to sign everything before undergoing treatment. If you signed an informed consent document in addition to a dozen others at one time but the doctor never disclosed side effects and failure rates to you, you may still be in a position to hold them accountable.
You may discover information on your own when researching the treatment or your doctor’s history. Combining that research with your own poor outcome may provide you with the basis you need to pursue a medical malpractice claim when a doctor treated you without first getting informed consent.
