You explained the risks and benefits of bone marrow transplantation versus chemotherapy to a woman with leukemia. This was part of an IRB-approved trial. You told her that the transplant has the highest chance of cure of the disease but also the highest risk of immediate death. She understood what you said and signed the consent for transplantation. She dies as a result of the bone marrow transplant and her husband sues you for wrongful death. What will be the most likely outcome?
a. He loses the lawsuit because BMT is the standard of care for this patient’s age and disease.
b. He wins because he was not informed.
c. He wins because chemotherapy has less risk of death.
d. He loses it. Because the patient was fully informed about the risks and benefits of both alternatives.
e. He loses because the trial was IRB-approved.
D - He loses it because the patient was fully informed about the risks and benefits of both alternatives. The key issue in terms of liability for adverse effects to patients is whether the patient was fully informed of the risks of the therapy before the treatment was given. If a major adverse effect or even death occurred, but the patient knew and understood this and still chose to proceed, then there is no liability. The patient was fully informed of what could happen. If a minor adverse effect occurred such as hair loss and the patient was not fully informed that this could occur, then there is wrongdoing. Again, the issue is whether or not the patient gave consent or had the opportunity to make another choice. The patient’s family does not need to be informed. The patient must be informed. IRB approval alone does not shield you from liability. The key issue is whether the patient was given the opportunity to make a free choice.
A man is buying a car. The one in the store he chooses has a cup holder he likes. They deliver a car with a much better engine, but without a cup holder. The dealer is liable because the customer must be given a choice. Maybe he will only buy a car with a cup holder he likes. You cannot say, “This car without the cup holder is a much better car.” It depends on being informed, not on what occurs.