The Doctor’s Lawyer: Informed consent – worth $8.5 million

As a physician, you are legally required to obtain informed consent of every step of a treatment plan—even if you are not the physician performing the procedure. Without informed consent, you expose yourself to a lawsuit in negligence. In the recent case of Denman, the lack of informed consent cost $8.5 million in damages. What happened? The patient, D, was 54 years old at the time he underwent the third step in a multi-step course of elective medical treatment to cure an anterior ventricle malformation (AVM). Complications from the procedure resulted in a brain bleed, causing a traumatic brain injury that left D densely hemiplegic on his left side, fully dependent and only able to communicate by writing or gesturing. MD was the primary wage earner in his family, with a wife and two daughters (one of his daughters was disabled).In 2010, D suffered a stroke or seizure. He was diagnosed with an AVM in his brain and a flow-related aneurysm. He underwent Gamma Knife stereotactic radiosurgery in 2011, but it did not resolve the AVM. However, following the radiosurgery, D’s AVM remained stable. In 2014, his case was reviewed by a multidisciplinary AVM team consisting of Drs. A and B. A treatment plan was formulated, meant to cure D’s AVM. His AVM was assigned a 4 out of 5 on the Spetzler-Martin Grading scale, which ranks AVMs according to risk and difficulty of the surgical treatment (SMG 4 AVM). Dr. A met with D and discussed the risks of a single embolization procedure, which was only the first step in the treatment plan. Dr. A informed D that the risk of stroke or death, associated with the single treatment was 3% to 5 %. D provided his consent to proceed. Read: The Doctor’s Lawyer: A suspension means no workIt is important to understand that although the plan was a multi-step approach, Dr. A did not discuss the risks of the entire plan with D. Rather Dr. A only discussed the risks associated with the first embolization. Dr. A also did not advise D that further treatment would likely be required, following the single embolization. Even though Dr. A did not perform any procedures on D, the court found that Dr. A was negligent for failing to obtain informed consent. Not only was Dr. A ’s risk assessment inadequate, but he did not advise D of the risks of the entire treatment plan, at the time D provided his consent for the first step in the multi-step process. Dr. C performed the first embolization but only partial embolization was achieved. Dr. C performed a second embolization, and again, only partial embolization was achieved. There was also no record that informed consent was obtained after the first and before the second embolization. In 2015, Drs. B and C proposed to D, the third step in the process; a third embolization procedure (by Dr. C) followed by a microsurgical resection of the AVM (by Dr. B). Dr. C informed D that the risk of an adverse outcome from the combined treatment was 10% to 15% of which 3% to 5% “would be a severe, life-threatening complication.” Dr. B informed D that the risk of the combined procedure was around 10% and “that this included deficits ranging from minor to disabling.” D signed the consent form. Dr. C performed the third embolization. In post-op, D showed signs of complications. Dr. B performed emergency surgery to stop the bleeding which was causing the complication and to remove the AVM. The surgery left D paralyzed. At trial, the court accepted expert evidence that the cumulative upfront risk of proceeding with the multi-step plan of treatment attracted a 30% to 50% risk of permanent neurological deficit. Had D not proceeded with the treatment plan, he would have faced a 40% to 60% risk of spontaneous bleed spread over a lifetime, and of which only a fraction of that would have resulted in serious harm. At trial, Dr. C also admitted that he was unaware of Dr. B’s known 25% adverse outcome complication rate for AVM surgical resections. The court also noted that Dr. B had never resected an SMG 4 AVM prior to D’s procedure. The risk assessment provided to D by Drs. B and C “was not only lacking, it was misleading and inaccurate.” This made both Drs. B and C liable in negligence for failing to obtain informed consent. The court found that had D been given adequate disclosure of the risks and risk comparison; neither he nor a reasonable person would have undertaken the course of treatment in the first place. What does this mean? Where a treatment plan involves multiple procedures, physicians have a duty to disclose the risks of those multiple procedures before proceeding with any of it. If physicians don’t, the court can impose liability in negligence. As the court explained in this case, any reasonable patient: “Would want to know what interventions would likely be required to effect a cure and the risks or range of risks associated with the expected course of treatment.”\Further, physicians are required to ensure the patient is provided with adequate disclosure about the risks of proceeding without treatment. The court found that had Dr. A adequately explained the risk assessment to D of proceeding without treatment of his (stable) AVM, he would not have undergone the procedure in the first place. Patients must be given adequate disclosure about the entire treatment plan at the outset in order to “weigh the relative or comparative risks and benefits between undergoing the plan of treatment and deferring treatment,” even if that means postponing treatment to a later date.In this case, the physicians involved expected that D would have to undergo a series of procedures, including a surgical resection. But, at the time D provided his consent, he had not been made adequately aware of the risks of the entire plan. Rather, he was misled as to the risks associated with a single embolization. The court found that D ought to have been informed of the real risks associated with each procedure at the time he provided his consent to proceed with the first embolization. This is because, as the physician team expected, the first two embolizations did not reduce D’s risk of spontaneous bleed. There was no point in undergoing the first embolization, unless he was prepared to ultimately undergo all three and the surgical resection. When considering this treatment plan, and in the context of the actual risk assessment and comparison, the court found that had D been adequately informed, he would not have undergone the treatment in the first place (and hence not have suffered the injury).The bottom line The law of informed consent is clear that physicians have a legal duty, without being questioned, to provide adequate information to the patient about the nature of the treatment, the expected benefits and any material, special or unusual risks. Further, the law requires physicians to discuss all viable options to manage the patient’s condition and compare the risks and benefits of each option. It is often too easy for physicians to consider procedures that they perform all the time and think it’s no big deal. It’s a big deal to the patient. It is also a grave mistake, as it was in this case, to rely on the physician who may come before or after you, to explain the full picture to the patient. It is your duty to ensure that the patient has been adequately informed of the entire process and at each step along the way. Finally, what is equally crucial is that you record that discussion, fulsomely, in the patient record. Some may read this and think: but it takes too much time! Well, a lawsuit takes more. Brooke Shekter is an associate with TTL Health Law.

The Doctor’s Lawyer: Informed consent – worth $8.5 million

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