As much fun as it was to talk about ERCPs and taking out stones, it's probably just the opposite, talking about this next topic, which is medical legal aspects of endoscopic practice. But of course, this is an important part of all that we do. So even the most conscientious, well-trained provider is at risk for becoming a defendant or getting involved in a lawsuit. And there's a couple of reasons for that. One is most states have a fairly low bar in terms of evidentiary requirements in order to initiate a malpractice suit. Studies have actually shown that more lawsuits actually result from non-negligent bad outcomes than from actual provider negligence. So because of those two reasons, even if you're doing your best and doing all the right things, you can be drawn into a lawsuit. The good news is that about 80% of cases do go the way of the defendant. The downside is that dealing with a lawsuit extends beyond more than just the defense of the case. Providers can suffer from loss of self-esteem, depression, family stress, issues with credentialing or financial worries, and this is something that we would all rather not get involved with. And it's something we don't typically get a whole lot of training, during most medical training for physicians and APPs, there's just not a lot of in-depth discussions regarding this aside from some of the kind of cursory mindless online things that we have to complete. The clearly most important part of all this is prevention and education. So I'm hoping to pass a little bit of that on to you today. So the objectives are, we're going to start by reviewing some legal terminology. I'll go over the very basics of tort law, and this stuff applies to GI and non-GI world. We'll talk a little bit about how the liability between physicians and APPs works, we'll talk about how to minimize liability in your practice, and then we'll get into some specifics about how medical malpractice works in the field of gastroenterology, and I'll end with a couple of examples of kind of what not to do. So let's just go over some basics so that we're all kind of on the same page for starting out. So some legal terminology, a claim, that's basically an assertion of wrong that forms the basis for a lawsuit. Deposition is the questioning that occurs under oath of the plaintiff defendant witnesses during the discovery phase of the lawsuit. This is the physician's failure to meet standard of care, we're going to talk a little bit more about that. And then standard of care, it actually varies a little bit from state to state on how it's defined, but the general definition is basically the care that a reasonable physician or provider would deliver under similar circumstances. So the basics of tort law, so a tort is basically, it's defined as a civil wrong for which a remedy may be obtained, usually in the form of damages. And the one that typically applies in the field of medicine is the tort of negligence. So the plaintiff's attorney has to basically prove four different things during a lawsuit, and they're spelled out here. So the first is what's referred to as duty of care, and that basically just states that a relationship was established where the physician was agreeing to provide care to the patient. The second part is to demonstrate that that duty was violated, meaning that the provider went away from the standard of care, and that it led to, and that this was the proximate cause of the third part, this was the proximate cause of the patient's injury. And this resulted in damage to the patient. So these are the four things that a plaintiff's attorney has to prove negligence. So how does this apply to non-physician providers? Now, obviously, we're talking about ABPs, but a lot of this does apply to, for example, other people that work in the office, even nurses or front desk people. So these are the ways that the physician can eventually be deemed liable for acts that weren't directly performed by the physician. The first is lack of adequate supervision. So in this case, if the APP either has limited supervision or sometimes just poor documentation of supervision by a physician, this can lead to including the physician. And larger practices probably have an increased risk for this, because there's more providers, and the communication and supervision of the APPs may not be as robust. Untimely referral. So an APP provides care to a patient, but takes on something that is beyond their level of training and skill. Failure to diagnose. This is where the APP misinterprets information or was uncertain about a diagnosis, or perhaps even lacked the appropriate skill to manage a more complicated case. Inadequate examination. So not taking enough time with the history and the examination, failing to verify certain aspects of the information provided by the patient. And then the last one is kind of an interesting one. It's called negligent representation. This is where basically the patient is credibly unaware that the provider, that the APP is not a physician. And sometimes that's intentional on the part of the APP, or it can just be a misunderstanding from the patient's side of things. So there are a number of different, there's three different legal theories that you can use to basically ascribe liability to the physician for errors that are, that errors might undercurr under the care of the APP. The first one is called vicarious liability. And this arises because in most situations, the employee, employer-employee relationship is the typical arrangement between a physician and an APP. And the legal system will use this as the basis for which the physician can be held vicariously liable for actions performed by the APP. And what from the plaintiff's side of things is basically provides another option in terms of financially responsible person to go after in terms of the lawsuit. Negligent supervision, basically, if the designated supervisory physician has a responsibility to oversee the, and approve the APP's work, so that if, you know, if there's some negligence on the part of the APP, the supervising physician may be pulled in if there's, if it's thought that the supervision was, you know, not up to speed. And then finally, negligent hiring. So if an employer hires an APP and the physician is aware, or at least should be aware, that the APP doesn't have the skill set or the training necessary to do the job, then again, the physician may be involved in the actual lawsuit. All right. So that's all the kind of the important background to know. So based on all that, there are some very important rules that can be applied, and this can apply to, this doesn't just apply obviously to GI, this can apply to any area of medicine, but some general rules to follow to try to limit liability in the physician APP relationship. First is to make sure that the educational requirements are appropriate for the physician that the individual was, began working at. It's very, very important to become knowledgeable of state rules and regulations. The rules for practice are different from state to state, and obviously you want to be practicing within these rules. It's appropriate, it's key that an APP table obtain the proper level of training for whatever it is that they're planning on doing in the practice. And then appropriate supervision is probably the most important one, making sure that the supervisory physician is available when needed to provide input. Regular performance reviews are key. This should be done not just on an annual basis, but whenever specific issues come up that need to be addressed. And I talked about the negligent representation earlier. It's important that when you meet with a patient that you are introducing with an appropriate title, make sure the patient understands exactly who they are seeing. And then set high standards for performance and always seek improvement to try to reach those goals. So we'll just change gears a little bit and talk more specifically about how all this applies to gastroenterology. So this was an important study that was released in 2008. Basically they reviewed a database for claims in gastroenterology from 1985 until 2005. And they looked at a number of different components of each claim. And so this is a nice listing of the reasons why claims were made in gastroenterology. And you can see that even though we're a procedurally based specialty, that wasn't the most common reason for a claim. The most common reason was an error in diagnosis. The next most common was improper performance of a procedure. There was actually no medical misadventure identified in about 400 of these cases. Failure to supervise or monitor a case, medication errors, failure to recognize a complication, those things were all a little bit less likely. So this gives you just kind of a good idea of the sort of reasons why malpractice suits arise in the field of gastroenterology. If you look at just the cases where there was a procedural claim of malpractice, the most common was actually basically colonoscopy, diagnostic procedure of the large intestine. The second most common was procedure of the gallbladder and biliary tract. And again, primarily there we're talking about ERCP. So colonoscopy and ERCP really account for the majority of cases where there's a specific issue regarding to a procedure. If you compare gastroenterology to other specialties, it's actually not that bad. Now keep in mind, this is just the total number of claims. So this doesn't break down by the number of practicing physicians, but gastroenterology actually ranks kind of in the middle to lower side of specialties where they found the number of claims during this interval that they looked at. Now if you normalize versus the number of physicians, which is obviously the most important, the more important number, this is a breakdown of the claim rate per 100 physicians per year. And you can see that CT surgery, OBGYN, general surgery had higher rates of claims rate as compared to gastroenterology. So even though it's a field where we spend a lot of our time doing procedures, the actual number of claims against gastroenterologists is on the lower side. So applying this to what we talked about before, there are specific things that can be done to prevent lawsuits in gastroenterology. Probably one of the most important is to practice evidence-based medicine. In a lawsuit, typically the plaintiff's attorney will use these guidelines to determine what is the standard of care. And so if you have a reason that you're going to deviate from the standard of care, it's very important that you document in your notes exactly why you're going against what's considered the standard of care. Open access endoscopy presents kind of a special set of issues. First off, most of the time you haven't established a physician-patient relationship. And as we know, having a strong rapport with the patient does decrease the chance that a lawsuit would occur. So a lot of times we're meeting this patient the first day they come in for a procedure. So it's important that you have very robust, informed consent that occurs that day. And then you need to do appropriate pre-screening so that these patients who show up for open access endoscopy are appropriate. So for example, our schedulers, when they talk to a patient, they're asking a list of questions regarding chronic medical conditions or use of certain medications that would make the patient not a good candidate for open access endoscopy, in which case those patients can be brought in for an office visit first. Obviously, complications occur. The only way not to have a complication is not to do a procedure. So if you do have a complication, you need to really focus on managing it appropriately, taking care of the patient, making sure your colleagues and your surgical colleagues are taking good care of the patient as well. It's important to be very careful with email communications. Email is discoverable during a trial, and you certainly don't want to be making things that are going to incriminate you, even though it's being done off the patient's electronic health record. Required anesthesia support for frail and elderly patients. And then most important, carefully document informed consent. And this applies to procedures as well as with high-risk medications. As we've talked about with the specific procedures, you want to make sure that the patient understands what the goals and risks of every procedure are and make sure that that is well-documented. Remember, if you didn't document it, it didn't happen. So I'm going to finish up by going through cases. These are not real cases. These are probably kind of worst-case scenarios in many ways. But I think each one of them demonstrates some kind of important thing, kind of takeaway points to hammer home things that we should and shouldn't be doing. So the first case is a 25-year-old female who presented for evaluation of right upper quadrant pain for the last two years. She had had a cholecystectomy for biliary dyskinesia one year ago and had no improvement. Throughout, she's had normal liver chemistries and normal pancreatic enzymes. She had an abdominal ultrasound, which showed a normal-sized common bile duct. She had an abdominal CT, which only revealed evidence of prior cholecystectomy with clips. And so she was referred to the local gastroenterologist for, quote, possible sphincter of OD dysfunction. So the gastroenterologist saw the patient, suggested that the patient start treatment with a low-dose tricyclic antidepressant for possible functional abdominal pain. However, the patient was very insistent that an ERCP be performed because her symptoms fit with the symptoms of sphincter of OD dysfunction that she'd read on the internet. And so an ERCP was performed, and an ERCP with biliary sphincterotomy was performed. And the patient developed severe post-ERCP pancreatitis, was hospitalized for two months, eventually developed a large pseudocyst that required drainage. The physician was sued. The relevant parts of the case was that during his deposition, the physician reported doing about 75 ERCPs during training and 20 ERCPs per year in practice. And the lawsuit was settled out of court in favor of the plaintiff. So this case, I think there are several important take-home points from this that kind of touch on the things that we've already talked about. Probably the most important one is to avoid risky procedures when the indications are weak or absence at all. And in this case, performing an ERCP for somebody with chronic right upper quadrant abdominal pain is really not an acceptable indication for ERCP. Again, complications are something that can be dealt with, and we have to deal with them. But if it's for a procedure where the indication really wasn't there, it's very hard to defend. For example, in this case, had the gastroenterologist referenced kind of one of the landmark studies in ERCP called the episode study, the gastroenterologist would have recognized that ERCP for somebody with chronic abdominal pain and so-called type 3 sphincter avoiding dysfunction, you're almost more likely to harm the patient than you are to actually help the patient. And again, it would be very hard to defend this provider's actions given the evidence-based medicine that is available regarding this topic. And then the last part is to make sure that there's adequate training and expertise given the level of practice. In this case, the numbers of ERCPs that this patient had during training and during while practicing is probably below what most would consider to be an adequate level of training. The second case is a 56-year-old male who presented with epigastric pain and weight loss for two months. The patient was evaluated by a nurse practitioner who arranged an upper endoscopy, which for various reasons was delayed for two months until after the initial consult. That upper endoscopy was normal and the patient was given a once-daily proton pump inhibitor. He again had a delay of two months during which he had continued abdominal pain and eventually developed jaundice. An abdominal CT was performed which showed a pancreatic head mass with dilated bile ducts and multiple liver masses. The supervising physician then saw the patient for the very first time when he performed an ERCP with palliative biliary stenting. Patient died three months later. The family sued the physician in practice for delay in diagnosis and for inadequate supervision of the nurse practitioner. When discovery emails were identified, which showed that the NP had requested the supervising MD's opinion on the patient, but the physician had not responded to the email, the lawsuit was settled out of court in favor of the patient. So again, some important lessons. Supervision is key. In this case, you could argue that the advanced nurse practitioner sought out supervision, but the physician did not respond in an appropriate way. Obviously, avoiding delays in the performance of tests, that can be a real issue these days with some of the demand that's built up during COVID. We are having some issues with trying to make sure we get patients in at an appropriate time. And then this case also illustrates how email communications can lead to bigger problems and are best to be avoided. So with that, I think I have a couple of polling questions to wrap up with. So which of the following can help APPs limit liability? Practicing beyond the scope of your training, obtaining and documenting informed consent for procedures and high-risk medications, communicating privileged conversations via email, avoiding direct contact with patient after procedural complications, which of these is a good practice? Okay, very good. Let's go to the next question. And what is the most common reason for a claim in gastroenterology? Procedural complication, failure to delay in diagnosis, failure to supervise or monitor a non-physician provider, or errors in diagnosis? I'm going to have to tell you right now that this isn't a great question because you could argue that the second and the fourth answers really aren't very different. So I'll accept two or four. Then I'll just share the results so you can see where they landed. That's what the answers look like too. I think the take home from this is that, you know, we think of procedural complications being the reason why gastroenterologists and their practices get sued. But it is a common reason, but it's not the most common reason. And I think I have one more question. What is the most common procedure which generates a claim in gastroenterology? Colonoscopy, upper endoscopy, liver biopsy, or ERCP? Yeah, and those are certainly the two most common reasons. But as I showed you in the large study that was performed, colonoscopy actually does generate more claims. And with that, I'll conclude and hand off the microphone again to Vivek.

endoscopic practice

lawsuits

prevention

liability

physician accountability

gastroenterology practice