Video Transcript:
Hi I’m Jeff Segal, a neurosurgeon and founder of Medical Justice. Today we’re going to chat briefly about informed consent in the era of personalized medicine.
A couple of years ago, I heard a speaker discuss personalized medicine. This speaker, a woman was diagnosed with breast cancer. She had estrogen positive hormone markers. Modulate the hormones and treatment would be more predictable. One problem, she was pregnant and she wanted to keep the baby. This woman saw no less than 8 doctors. They all told her the same thing: terminate the pregnancy and aggressively treat the cancer. Save your life.
Doctor after doctor also told her that if the cancer quickly took her life, her unborn child would die anyway. The woman did not like this choice. She was intelligent, articulate and focused. She wanted a different path. Her perfect outcome was save her child and save her life. She understood this really was a risky path but was her path.
I heard this story years after it played out. She found a doctor who took her entire wish list into account. The good news, she delivered a healthy baby and she remains cancer free years later. This woman understood the risk benefits and options on a deep level. She explained her biggest challenge was finding a doctor who would partner with her. She said the last thing on her mind was suing the doctor but in the harsh medical legal climate, many doctors did not really believe her. That’s precisely where robust informed consent process can help both the doctor and the patient.
Jeff,
I would love to believe a good informed consent would protect you but I am concerned it would not. This woman had a good outcome from her risky dicision but what if she had not? Consider the alternate ending below:
The patient continues with the pregnancy. At 8 months she has a seizure secondary to a brain metastasis. During the seizure she is anoxic for a period but survives. The baby is born with severe cerebral palsy requiring 24 hour care. The mother has surgery for removal of the brain met only to present with bone and liver mets 6 months later. She dies a painful death during which the families finances are decimated by her and her baby’s care!
I don’t have to tell you what happens next. I doubt it would matter much what the consent for said either! I can hear it now. “Doctor how could you allow this Mother to place herself in mortal danger when her judgement was clearly clouded by her desire to keep her unborn baby?”
Hopefully I am wrong! If so, please enlighten me.
I am not sure if I see the point – to me this was lucky outcome of a high risk game not an informed consent problem. One can only speculate on what would happen if there would be a different outcome. I do not think informed consent offers any legal protection but surely in its absence you stand no chance.
Informed consent is also “informed refusal.” Here, the mother has refused the option most practitioners recommended: maximize treatment to mother. But first terminate the pregnancy.
If the doctor has gone through the exercise of explaining this option in detail – and the patient explicitly refuses – as long as the second option was “reasonable” in view of the mother’s constraints, I believe the informed consent would spare the doctor being speared by a lawsuit.
The classic example is illustrated by surgery on Jehovah’s Witness. There, the patient explicitly refuses blood transfusion – even at risk of life or limb. If the doctor honors the patient’s request, even if the patient dies, the doctor is typically immune from suit. Conversely, if the doctor transfuses against the patient’s wishes, even if the patient’s life is saved, he/she is at risk for being sued.
But, this discussion must be robust, complete, and explicitly documented before the feces hits the fan in the operating room.
Informed consent, even if properly done, will not always protect you from lawsuits, especially frivolous ones. But it should protect you from losing the vast majority of lawsuits. However, if a physician is truly negligent, no informed consent will protect you.