 Katherine Koch, who's a visiting assistant professor of law at IIT Chicago Kent College of Law and a faculty member in our McLean Center and a special advisor for the New York State Task Force on Life and the Law. She received her law degree from Harvard where she was editor-in-chief for the recent development section of the Journal of Law, Medicine and Ethics. In 2012 she was appointed to the American Bar Association Special Committee on Bioethics and the Law and she currently serves as co-chair of a law affinity group for ASBH at our McLean Center. She teaches law and ethics to the McLean Center Fellows and as she pointed out to me a few moments ago, most importantly for at least some members of the audience she received her undergraduate degree from Princeton and she will speak to us on the topic of adherence to altered standards of care in the public health crisis. Well, thank you. It's a privilege to be here and to be part of this. Of all the public health crises that we prepare for, an influenza pandemic is one of the most likely to actually occur. Influenza pandemics have occurred four times in the last century. Most recently the global H1N1 pandemic of 2009. I have no conflicts of interest. I do have a disclosure which is everything I have to say is my own personal opinion and does not represent the views of the New York State Task Force on Life and the Law. I was hoping they would but keep your eyes and ears open. Okay, so that's it. If a similar scenario to the influenza pandemic of 1918 which killed between 50 million and 130 million people were to occur today, we would quickly encounter a situation where there would be a significant shortage of ventilators. And even if there were enough ventilators to go around, there would likely be a dearth of staff and health care providers to administer ventilator therapy. The complex legal issues raised by a lack of resources in a public health emergency create vulnerabilities for individual facilities as they draft their plans and their own policies. And they therefore have often requested detailed procedural advice from local and state governments. In turn, these governments are increasingly recognizing the need for a plan established in advance and shared with the public in order to allocate scarce resources. Thus, at this stage, at least 19 states have ventilator allocation plans. Pretty much following the draft guidelines that were issued in the state of New York in 2007 in order to most effectively distribute ventilators in a pandemic. And now at least seven states also have plans for allocation of ventilators for pediatric or neonatal patients. Most of these plans do follow the framework that were established by the 2007 New York State guidelines. They usually have the stated goal of saving the most lives and they generally include three primary elements, exclusion criteria, a clinical scoring system to determine access and a reevaluation of the ventilated patient at set intervals using the same criteria. Beyond the practical considerations in allocating scarce resources, emergency conditions obviously give rise to significant ethical and legal questions related to standards of care that can and should be provided in an emergency. Emergency conditions implicate the scope of both patient and physician autonomy. In particular, the physician may have conflicting obligations to both give the best care to their individual patient as well as to save the most lives. So as special advisor to the New York State Task Force on Life in the Law, I've been working with the Task Force and the Department of Health in developing revised guidelines from the 2007 guidelines for the allocation of ventilators in a pandemic. In particular, I have been advising the Task Force on two particular specific legal impediments to effective and efficient implementation of the guidelines. The first due process issues and questions and the second liability. So I'm going to focus today on the second of these issues, legal liability for adhering to clinical allocation protocols in a public health emergency, which is contingent on whether the healthcare provider abides by the appropriate standard of care. Following such allocation protocols means that healthcare providers may deviate from what's considered the ordinary medical standard of care. In other words, triage in a pandemic may permit a radical departure from the accepted standards acknowledged by the profession as defining acceptable and appropriate medical practice. With regard to the concept of the standard of care, it's important to make to note the ongoing debate in the academic and policy spheres regarding the adoption of a modified legal standard of care or the standard that must be followed in order to avoid legal liability. It is frequently argued that establishing a new crisis or modified standard of care is actually unnecessary in an emergency because by definition, the legal standard is inherently flexible and adaptable to changing circumstances. This is consistent with analyses by scholars such as George Annis, Shona Hoffman and Mark Rothstein who are all quoted above. Mark Rothstein has stated, in stark contrast to suggestions by some altered standards of care advocates, the current standard of care applied to all medical malpractice cases is sufficiently flexible and situation specific that it need not be altered. So in a pandemic, as we know, the medical standard of care may shift in accordance with the changing circumstances and needs. In a non-crisis setting, the prevailing medical standard of care focuses on the needs of each individual patient and is centered on the principle of autonomy as embodied by the doctrine of informed consent. It necessitates that doctors, nurses and other health care practitioners offer care at the bedside to individual patients, not to populations. However, conditions of a public health emergency directly affect the dynamics of the doctor-patient relationship as it exists in normal non-crisis settings. During a public health emergency, non-emergency medical care may be impossible or at least inadvisable due to one, resource issues, limitations, and two, the goal of saving the most lives overall. Thus, clinical protocols such as the ones discussed here represent significant departure from standard non-emergency medical practice. So how do we maintain the core elements of the doctor-patient relationship, even in emergency situations? Well, first and foremost, an ethically sound allocation system must sustain rather than erode the relationship between patient and provider. Physicians must not abandon patients and patients should not fear abandonment by their own physicians. Patients who do not receive ventilators are still under their physician's care and should be provided with alternative forms of medical intervention and or palliative care. Further, in order to ensure fairness in allocation and application, patients should be evaluated based on universally applied clinical criteria. Thus, under no circumstances will a decision regarding ventilator allocation be based on non-clinical criteria such as race, ethnicity, sexual orientation, socio- economic status, perceived quality of life, ability to pay, or the role in the community. I also recommend that further, due to the concern that even in a pandemic, medical staff may seek to provide ventilator therapy to certain patients, even when the guidelines would indicate that doing so would not save the most lives. The guidelines provide that a patient's attending physician does not determine whether his or her patient receives or continues with ventilator therapy. Instead, a triage officer or triage committee should be making this decision. This role sequestration allows the clinical protocol for ventilator allocation to operate more smoothly. However, even with such protections in place, with a shift in the standard of care, physicians and other health care providers have valid concerns that they're going to be sued for following these guidelines. The threat of both civil and criminal liability will likely discourage physicians, nurses, and health care professionals from deviating from the accepted standard non-emergency medical practice and emergencies, even if such a practice would save lives. It follows, then, that protections for health care workers who appropriately follow the guidelines should be in place so that they need not worry about being sued or going to jail for providing care according to the clinical protocol. And any plan, however, should not immunize wrongdoers and must be politically acceptable in order to ensure community buy-in. And the second point, actually, I thought what seemed a little bit interesting and goes to the point that context is key seems contrary to Peter's earlier comment that guidelines are a guide that you are sorry, guidelines are a guide, but you have to do things differently. In this case, we want to ensure that these guidelines are actually being followed in order to ensure lives. This is not actually time to be doing things differently. So a few things to know about the current status of the law as it applies to this issue. Under most states' common law rules, following voluntary guidelines issued by a governmental agency may be evidence that the health care provider's actions were not negligent. This evidence is then rebuttable in court. Further, at least in many states, there is little statutory protection for individuals and institutions for actions taken during a public health emergency. Moreover, the state itself cannot change federal law. And so therefore, any legal claims at the federal level could still be brought against an individual, even if an individual is following state law. So how can states help protect health care providers from liability, thereby encouraging adherence to the protocols in order to save the most lives overall? Well, providing protections from legal liability actually proves quite complicated, or not surprisingly proves quite complicated. We explored a number of potential solutions to encourage health care providers to adhere to the guidelines while also safeguarding individual patients and allowing those who are truly harmed to seek a remedy. Some of the approaches that I mentioned here could be combined and applied together, and others would be applied separately. In the interest of time, I'm not going to spend a ton of time on each of these, but the ones that we considered and looked at were caps on damages, which essentially is a cap on the amount of money that can be awarded to the plaintiff who suffers harm arising from administration of the guidelines. Although this won't help protect health care providers from court, it will at least limit the cost of defending against a suit. We also explored expedited discovery, which would shorten the amount of time and lessen the burden of preparing for trial, which can be very costly and time consuming. Imposing statutes of limitations, or essentially limitations on the amount of time after an alleged harm has occurred in which to bring suit, may also decrease the number of lawsuits brought against practitioners who follow the guidelines. Another option is to implement what are known as alternative dispute resolution procedures, which may include arbitration, pretrial review panels, or compensation pools, the compensation pools are analogized to the vaccination pools that already exist. Finally, we are considering passage of new comprehensive legislation to provide some immunity to all health care providers and entities, at least for civil, if not criminal claims. We will follow the standard of care that has been established within these clinical allocation protocols. So probably and surprisingly, we do recommend, or I recommend, the last approach that the New York State Legislature, or other states as well, enact new legislation granting a commissioner of health the authority to issue an order recognizing that the clinical allocation protocols will be the medical standard of care in a public health emergency, and therefore modifying appropriate liability rules accordingly. These statutory provisions would provide health care providers who follow the protocol with appropriate legal cover for deviating from the standard of care for negligence in non-crisis circumstances. Moreover, these protocols should be issued as voluntary non-binding guidelines based on sound principle ethical and clinical principles. Thus, because they have been issued as guidelines rather than regulation and legislation, they are flexible enough to be adapted to the actual specific emergency. Therefore, under such legislation that would potentially at least immunize individuals who follow these guidelines, these allocation protocols, doing so would provide conclusive, non-rebuttable evidence of compliance with professional standards. Finally, while the guidelines were written to address the allocation of scarce ventilators during an influenza pandemic, the potential exists for broader application beyond ventilator allocation and beyond flu influenza pandemics to other public health emergencies that require allocation of scarce resources. So this general framework and the general framework that exists within many of these states ventilator allocation protocols could be adapted with appropriate modification for those specific emergencies. Papers open for questions. Yes, first, please. Yeah, Joe Cross from WashU and St. Louis. I'm a physician on the head of the Ethics Committee there and serve on our altered standards of care committee. In one of those states that has no official policy, not because it wasn't considered, but because it was brought up and nobody could buy into it. The state legislatures, the more they learned about it and the more they understood it said, you know, this is completely, you know, unpalatable. We cannot even consider this. People will hang us out to dry if we institute these sorts of these sorts of things. And I used to think that physicians would all do the right thing, but I'm not so sure anymore because of certain things such as the ENT fellow after Katrina who was not sued but who was charged with second degree murder for her good faith care of patients who were DNR patients. And I'm wondering that without what you've recommended these good faith protections, as well as other things that have been recommended in terms of compensation for health care workers that volunteer and would suffer adverse consequences, that without those things all our plans in the world will be for naught. Well, and I think that's excited. So the example of what happened during Hurricane Katrina, although different, obviously different circumstances, definitely put the fear of whatever it might be in a lot of health care practitioners. And then we did see on the H1N1 pandemic and a lot of folks were very nervous about following these guidelines without any sort of protection. And so, again, as I mentioned, the notion that these these plants must be politically palatable is imperative, because otherwise, no, there's not going to be political buy-in. There's not going to be anybody who's going to follow it. And there's been a major call, therefore, for public outreach, as far as not just health care practitioners understanding and being able to follow these guidelines, but the public understanding how these things are going to be implemented and how they both the clinical protocol and then what's what appeals process is there? What sort of notice and and appeals process could there be for patients? And so all of that is something that I wish I could speak more to the exact details of the New York state protocol and what's but it's been a major aspect of what we've been doing is this sort of the notion of public outreach and both at the practitioner level and at the public level. Two more questions. If please try to keep them short so we can stay on time. Mark, yes. Valerie, thank you very much. If states like New York and the other 16 or 17 states pass such legislation, why should that mandate that physicians depart from their traditional role as advocates for their patient? I mean, if resources are limited and the states make certain decisions as to who gets the resources, why should not each physician, so long as it meets with the standard of care, be advocating that his or her patient be given a ventilator if needed? It's a it's a wonderful question. It gives me the opportunity to clarify a little bit. As far as the the clinical protocol goes, the idea is that this would not be legislatively mandated, at least in New York state at this stage with the draft guidelines. They are just that. They are flexible guidelines that can be adapted to an individual emergency and the aspects of any specific pandemic. So the idea, though, is that well, if this is the right thing to do, if we are really saying that we need to change our way of treating patients in order to save the most lives, then how do we get practitioners to to actually abide by these flexible, voluntary guidelines? And so the idea that's where the legislation comes in. The legislation then at least protects in some way provides the the provider with cover legal cover for following those guidelines. And so we can't necessarily, although some states have tried, we can't necessarily keep a practitioner from being hauled into court for following the guidelines. But we can do everything we can to protect them so that it's essentially non-rebuddable. But the following the guidelines is essentially non-rebuddable evidence of following the standard of care. Gretchen, last question. Yeah, I'm wondering if you can help me understand the internal consistency of your recommendation that only clinical indications determine ventilator use or treatment use. So if I said that we have four babies and three ventilators, there's a clinical indication for all four babies. Now you're going to have to make a choice about who's going to get the ventilator. Now you can say it's first come, first serve, but you still used a non-clinical reason to determine who's going to get the ventilator. And I don't see how this manages that. I would love to get into the details of the... I can tell you that New York is coming out with pediatric neonatal protocols for allocation of guidelines. And well, it is about resources. And the triage protocol, the way it works, is that at least for adults, there's the clinical exclusion criteria. Then patients are, and I won't go too much into the details of the exact protocol, and I will point you to the guidelines themselves, but it does take you through... Sorry. Where it's an application of it, for adults, for a SOFA score, where these are absolutely clinical criteria upon which it's based. And then each individual is placed into a group, red, blue, green, yellow, I believe. And those who are in the red, this is according to international triage labels. And then those who are in the red group, those are the ones that are the most likely to survive and to benefit from ventilator therapy. And they are going to get a ventilator. And then depending on how that works, then there are time trials based on that. So we're actually... The task force in 2007 considered first come first serve and thought that that was not an option. And went through a lot of other options for allocating this scarce resource and came up with this as the best option because it was able to maintain a clinical approach. Please join me in thanking Val for a very