Informed consent is our next subject this morning. And this may be the type of informed consent you've been taught. Maybe you've been taught a little bit more. But I'm going to drill down from the legal point of view and the clinical point of view so you really understand what informed consent is, because it's a legal issue. And even though you won't be sued just based on lack of informed consent, on another basis you will be sued as a secondary allegation if you have a medical negligence sued if your informed consent wasn't thorough and complete. So I'd like you to see the nuances here from the lawyer's point of view. It'll make you a better doctor, make you a better communicator with your patients. And you won't just be talking routine risk benefits alternatives and that sort of thing that you might think is adequate informed consent. So informed consent is an affirmative duty to provide specific information, full disclosure, but not every bit of laundry listing of every possible risk, every possible alternative. You have to be reasonable and provide the patient what they need to know to make a reasonable judgment on whether or not to go ahead with the proposed treatment. It's a requirement to provide adequate information. So adequate information from whose point of view? The patient's point of view, not your point of view. It provides autonomy to patients so that they are taking charge of their health care. It was originally a form of battery. Lack of informed consent was considered a form of battery, unwanted touching. So you did to them something that you didn't discuss. They didn't say okay. And it then developed into an adequate information to make a reasonable choice. But now it's really negligence theory applied to informed consent with the duty of the providers to obtain proper informed consent before they do anything. So it's evolved. There's a reasonable patient standard that's applied to informed consent. No longer a reasonable provider standard, and I'll show a little bit more detail on that in a moment. But the reasonable patient standard has four elements, again, from the lawyer's point of view, which you need to meet to escape an allegation of lack of informed consent. First one, the health care provider failed to inform the patient of a material fact. So if the plaintiff, the patient states that the doctor didn't tell me a very material fact, had I had that fact, I would have made a different decision. That's a breach of informed consent standards. Two, the patient consented to the treatment. So the patient had to have not heard the material fact and gone ahead to consent, and they wouldn't have consented had they had that material fact. It's very, very specific. Third thing is a reasonably prudent patient under similar circumstances would definitely not have consented had they heard that material fact. So you're spitting the detail here. Those material facts are the critical part of informed consent, and that it's not just lack of that material fact and the consent, but that the treatment that was done because of lack of informed consent, because of lack of material fact, the patient made a choice that they wouldn't have made, and they were harmed. So there has to be harm. It can't just be lack of informed consent. That's why there aren't suits, really, that go anywhere in the courts because of just pure lack of informed consent. There has to be some harm attached to it. The form is not enough. So don't think that you can just go into the exam room, talk to the patient about an anterior cervical fusion, and say, here, sign this, and our secretary or a nurse will sign you up for the operation. The form is not enough. You need to basically provide the language verbally and the form. You might provide other additional information, educational information. All that's very helpful to fulfill your requirement to provide what you have to do for your patient and so that you know the patient's getting all the information necessary. But don't just give them a form. And the laundry list on the form is not going to save you either. You have to verbalize things. And the laundry list on the piece of paper that has some things that you might have left out in your verbalization doesn't protect you. If the patient says, well, they handed me this form. I was under duress. I had to sign it. I needed the surgery. He never told me that I could die with this procedure, or she never told me that I could end up paralyzed with this procedure. Yeah, it was on the form, but I didn't read it or I don't remember it. You have to verbalize it. So that's the point of that. Then the other thing in informed consent, and it's very critical vis-a-vis what we discussed earlier in terms of practice ownership of safe harbor elements, surgery center, physical therapy. You have to disclose ownership interests. So if you're telling a patient, we can do your surgery in the surgery center across the hall, that's not enough. You have to say, we can do your surgery in the surgery center across the hall, and I own a portion of that, and you can choose not to go there or go to a hospital or another surgery center if you want. So you need to disclose ownership. That's part of informed consent. So in some states, as I mentioned, the reasonable provider standard still exists, but mostly it's a reasonable patient standard. The reasonable provider standard is actually an important thing because it does protect good medicine. It kind of tells you what you need to tell patients, and you might defend yourself by saying I was being very reasonable what I told the patient. If you tell too much, you can say that you would have scared the patient off. So a reasonable provider might not have said certain things, even though from a reasonable patient point of view, they might have wanted to know those points to feel like they've gotten all the material facts. But anyway, the reasonable provider standard is generally not the standard used in a court case when an informed consent allegation is on the list of charges against you along with medical negligence. The reasonable patient standard is decided by a jury. It's what 12 members of a jury think is reasonable from the patient's point of view. It's very, in legalistic terms, it's what a reasonably prudent person in the position of the patient, in other words, the jury in the position of the patient, deciding what they would need or the patient's representative if the patient himself or herself cannot give proper informed consent, that the patient's legal representative with, let's say, durable power of attorney who makes medical decisions for a patient who's not fully complacentous or unconscious or something like that. If it's not a total emergency situation, you might have a patient representative doing the informed consent process with you. And then in Washington, we have a particular rule. One of the RCWs states that a failure to secure informed consent has these necessary elements of proof. And it's basically the ones that I listed for you earlier. We've adopted kind of a national standard in what's required to have an informed consent allegation in a lawsuit. So the specific points that are take-home points are adult patients, again, highlighted the key words here, who are capable of rational communication and who aren't using a representative must be provided with sufficient information about the risk, benefits, and alternatives associated with the treatment or procedure in order to make a decision. And then, not just that, but expressly give permission. They have to say, yes, I agree to this, after you answer questions possibly, and they have to sign the consent that they have been provided adequate informed consent. What are the benefits of this? Obviously, you've spent time communicating. That's why handing a form is not enough. Patient relationships in this sort of setting helps to breed more trust, better communication. Fully informed patients are less likely to have unrealistic expectation. What does that convert to if they have unrealistic expectations? The result that they get from the surgery is not what they expect. A lawsuit potentially is a higher chance of occurring. If they weren't given what they feel to be adequate information when they signed up for that procedure. The informed consent process is a way of sharing responsibility. And in this day and age, that's the name of the game, that even in your write-up about when you provided informed consent, don't make it a one-way street. Don't say I provided all the information necessary for the patient to give informed consent. You can say it was a mutual process. The mutuality, the mutual responsibility of the physician and the patient in this setting are the key buzzwords which will help you if there is an allegation of informed consent. If you can prove that you spent the time communicating all these things that we just discussed, and that the physician-patient relationship extended to the decision-making process to go forward with the operation, that's true informed consent. What's informed refusal? So some patients will hear all of this and refuse to go along with what you think is best for them. So what are your responsibilities if they say, thank you, doctor, I don't want that operation? You need to then go to the next step. You don't need to include what happens if they don't do what you recommend initially. But if they refuse, you now have legal duty to tell them what are the consequences of their refusal. So you must warn them of failing to heed medical advice. You must carefully document that in the record that they were given all the information that a reasonably prudent patient requires to make a reasonably informed consent, that your recommendation is to proceed, and that you document that their refusal and the consequences of their refusal are listed. They could die. They can remain paralyzed, et cetera, et cetera. Whatever it is, put that in the chart. You told them that because they refused, they now fully understand that they could end up with XYZ consequence of their refusal. That puts all the weight on their shoulders so that they can't come back to you and say, well, I just didn't want the procedure, but you didn't tell me what could happen to me. So you get the idea here. Go the next level saying, you know, your decision not to go ahead with what we've discussed here has these consequences. And write it down. I've stated that a few times. I threw it in as a final bullet point here. If you just say it, it's not good enough. You need to write it in the medical record. And the general rule, and I'm going to counter this a little bit in one of the later talks today, the general rule is if it's not written in the medical record, it didn't happen because it's just someone's word against your word, and that's not good enough. You have the opportunity to provide a defense document. That's the way you have to look at this in the chart every time you're having a patient interaction on informed consent, and particularly with refusals, that this is now a part of the medical record so that later on it's shown, oh, patient's responsibility. They knew. Doctor cited it, not only verbally to them, but wrote it out in the record. So we'll talk a little bit more about this in terms of the expert witness role in general, but I'm going to throw it out right now just in terms of what an expert witness does when there's an informed consent claim. So just because the jury decides, and it's a reasonable patient standard, not a reasonable provider standard in most states, you still need an expert witness who's a physician in the same specialty, and we'll have a formal discussion about expert witnesses a little later today, but in this situation, when it comes to an informed consent claim, the reasonable provider standard requires an expert witness, and the reasonable patient standard also requires an expert to discuss what the physician's responsibility is insofar as the proximate causation of the lack of informed consent that led to the potentially poor outcome. So expert witnesses still have a role at this level, not just in terms of medical negligence. You need expert testimony to discuss, in the sense of the reasonable provider and the reasonable patient standard, what the risks actually were. Were they covered properly? Were they documented properly? Were the alternatives properly discussed and documented properly, including non-treatment? And if the patient refused, was that documentation all proper? So the expert witness still has a role, no matter what standard is used and whatever the issue is, if there's an informed consent claim. Expert witnesses, of course, are necessary in the medical negligence side of the suit, and we'll talk about that later.

informed consent

legal perspective

clinical perspective

medical negligence

reasonable patient standard