 From the McLean Center and the Center for Health and the Social Sciences Chess and the Bucksbaum Institute, David Meltzer and I are delighted to welcome you to today's lecture in the 2019-2020 series on the present and future of the doctor-patient relationship. I'm so happy to introduce today's speaker, Professor Valerie Gutman Cook. Valerie Gutman Cook is the Director of Law and Ethics here at the McLean Center. She's also the Jeharus Visiting Fellow at DePaul University College of Law. In the past, Valerie was a visiting professor at IIT Chicago-Kentz College of Law and a special advisor to the New York State Bioethics Commission Task Force on Life and the Law. As a scholar of bioethics, public policy, and health law, Professor Cook concentrates on how medical and technological advances have informed, sometimes have transformed, various areas of law, identifying ways in which law and policy is or is not equipped to address changes in technology and practice. Widely published and peer-reviewed literature, some of Professor Cook's recent work. Works include eliminating liability for informed consent to medical treatment, another paper Research Revolution or status quo, the new common rule, and research arising from direct to consumer genetic testing. Her work has appeared in journals like the Hastings Center Report, the American Journal of Bioethics, the Journal of Law, Medicine, and Ethics. Professor Cook earned her law degree from Harvard Law School where she was the co-editor of a section of the Journal of Law, Medicine, and Ethics. Currently, she serves as the chair of the American Bar Association's special committee on Bioethics and the Law and is co-chair of the Law Affinity Group for the American Society for Bioethics and the Humanities. As you see above me, Professor Cook's talk today is entitled, 21st Century Legal Challenges to the Doctor-Patient Relationship. Please join me in giving a warm welcome to Valerie Cutman Cook. Hopefully, you can all hear me if I speak into this mic. Well, thank you so much, Dr. Siegler, Dr. Meltzer. Thank you for having me. As always, it's a great honor to be part of this lecture series. So my talk is a 21st Century Legal Challenges to the Doctor-Patient Relationship. Another potential title might be Legal Interference in the Doctor-Patient Relationship, but we'll get to that shortly. I have nothing to disclose. So bear with me while I tell a legal story that's somewhat on the periphery of the Doctor-Patient Relationship, and I am going somewhere with this. In the summer of 2013, the U.S. Supreme Court decided a case associated with molecular pathology versus myriagenetics, Inc. It decided in that case that naturally occurring but isolated DNA segments cannot be patented. The case involved patent claims covering BRCA1 and BRCA2 tumor suppressor genes. Myriad, a for-profit company, held patents on the isolated BRCA1 and BRCA2 genes as well as synthetically created complementary DNA, or CDNA. Due to Myriad's patents and its refusal to license those patents to others, physicians who sought the test for their patients had no choice but to use Myriad's services. Patients could not seek confirmation of their results from a second testing company, nor could anybody else do any sort of research utilizing these genes. And without competition, Myriad could charge anything it wanted for its tests. So thus at some point, some patients were unable to afford the high price tag that sometimes ran upward of $4,000 per test. In 2012, the year before this decision took place, the company made more than $400 million in revenue from its BRCA tests, a 15% increase from the previous year, indicating it was continuing to increase its profits utilizing these tests based on its patents. In response to this monopoly on the genetic test for BRCA1 and BRCA2, a group of doctors, scientific researchers, and patients, women's health organizations, sued Myriad, arguing that the genes should not be patentable. By 2013, the case had been working its way through the court system. You are not expected to actually be able to read that. It's supposed to show how long and complicated the road was to the Supreme Court to decide this case. And during all of this long complicated case law, the court heard a lot of testimony. It heard significant expert testimony about genetics and read significant expert reports about genetics, medicine, science. And when the decision was finally before the Supreme Court, the justices unanimously held that naturally occurring genes cannot be patented but see DNA can be. Some call that splitting the baby, but that's another talk. Justice Thomas wrote the opinion for the Supreme Court on behalf of seven of the eight justices. And he wrote, quote, we hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but see DNA is patent eligible because it is not naturally occurring. Although Justice Thomas' opinion is relatively short by Supreme Court standards, it's a mere 18 pages, it devotes some amount of detail to explaining and exploring fundamental scientific and technical concepts such as transcription, translations, mutations, etc. In a separately worded opinion, which was a single paragraph, Justice Scalia concurred with the judgment of the majority of the other seven justices who joined Thomas' opinion. In other words, he stated he agreed with the outcome of the case that the DNA segments at issue were not patent eligible. However, he explicitly and intentionally distanced himself from the Court's scientific analysis, which was based on significant expert testimony and the interpretation of the lower courts. Instead, he stated that he did not join in the, quote, portions of the rest of the opinion going into fine details of molecular biology. He continued, I am unable to affirm these details on my own knowledge or even my own belief. So Scalia's concurrence was interpreted by some as a sign of his humility and as a breath of fresh air. Others saw it as him deliberately sticking his head in the sand by refusing to even attempt to understand or acknowledge basic scientific concepts. So Judge Posner of the Seventh Circuit based in Illinois fell into the second camp, the head in the sand camp. Just four months later, he used an absolutely unrelated and rather routine legal case to chastise Scalia and other lawmakers and judges who refused to engage in scientific or medical analysis, as supported by expert testimony and evidence. In that case, an Illinois prison inmate alleged that a nurse practitioner and a correctional counselor were deliberately indifferent to his hypertension and were not providing his prescribed medication. Judge Posner used the opinion, in that case, Jackson versus Pollyon, as a vehicle to criticize lawyers, judges and lawmakers who fail to understand and learn the science or medicine that actually underlie their decisions. After criticizing the lower court's judge's application of the evidence on record, he stated, quote, this lapse is worth noting because it is indicative of a widespread and increasingly troublesome discomfort among lawyers and judges confronted by a scientific or other technological issue. To demonstrate the flawed belief that lawyers and science don't mix, Posner cited a number of legal scholars and judges beginning with Scalia's concurrence in the myriad case. But Posner didn't just go after Scalia. He cited some of the greatest and most well-known judicial theorists to support his criticism of judges' understanding of science and medicine. So he cited Justice Rehnquist in probably the most famous evidentiary case, case dealing with the rules of evidence to bear. Where he had said, the various briefs found in this case deal with definitions of scientific knowledge, scientific methods, scientific validity and peer review. In short, matters far afield from the expertise of judges. Posner also criticized Judge Lernan Hand, who also has probably the best name of any judge in the history of the United States. Judge Lernan Hand had said that I cannot stop without calling attention to the extraordinary condition of the law, which makes it possible for a man without any knowledge of even the rudiments of chemistry to pass upon such questions as these. So Posner used the Jackson versus Napoleon opinion to criticize Scalia, Lernan Hand, Justice Rehnquist, but in a fun little extra twist to this story, the Jackson versus Napoleon case had its own concurring decision, a concurring opinion. Somebody who was also on the panel, the third judge on that panel, that agreed with the outcome of the case, but disagreed with the reasoning. And so Judge Bauer wrote his own concurring opinion. And in that, again, he wrote a two-paragraph concurrence. In a very short concurrence, and there he declined to address or even consider the medical analysis in which the other judges engaged. So it's unclear on what basis he actually, just like Scalia, concurred with the decision. He explained, quote, but as Judge Posner points out, many lawyers decided against medical school because of lack of interest in the clinical aspects of medicine or a deeper interest in the less scientific aspects of law. I was one of those who chose law as opposed to medicine. So thank you for bearing with me as I told you this story that seems to not be super related to the doctor-patient relationship. But rather, I use these two cases, the myriad decision and the Jackson versus Napoleon decision, to raise a number of important questions that arise again and again when we consider the intersection of law, medicine, and specifically the doctor-patient relationship. What is the role of the law in medicine? And specifically, what is the role of law within the doctor-patient relationship? Should judges and lawyers stick to the law and not get mixed up in medicine and science? Can a court even come to a decision if it declines to address or even understand such matters of science and medicine? How can lawyers, judges, and lawmakers make, interpret, or enforce laws if they don't understand the technologies or the medicine that underlie them? For example, Scalia didn't try to understand the science underlying Miriam's patents on what basis could he even concur with the majority's decision? Or in contrast, do legislatures, judges, and lawmakers have an obligation to learn about unopined on these issues? Courts are presented with complicated and nuanced cases with multiple and sometimes conflicting interests and values. Resulting conflicting evidence and expert testimony. We want to make sure that courts and lawmakers get things right and not make their decisions on faulty assumptions or understandings. And what if lawmakers, rather than staying out of medicine or at least trying to understand and respect the principles underlying the doctor-patient relationship, pursue their own goals or political agendas. At the expense of medical and scientific reason. So we're gonna see shortly some of those exact cases. But backing up a little, let's briefly look at how the law has historically involved itself in the doctor-patient relationship. While I'm talking about challenges in the 21st century, there's no breaking point on January 1st, 2000. There's a history here, so I'd like to go back a little bit. As a general rule, the doctor-patient relationship has been treated by the law as relatively sacrosanct. Values of confidentiality, honesty, and trust have held positions of primacy. But it's also important to recognize the law has always involved itself in the doctor-patient relationship. And in a number of legal cases in the 20th century, in which courts focused on the rights and interests of patients, the law shifted from emphasizing a traditionally beneficence-focused model toward one focused on patient autonomy. For example, the legal doctorate of informed consent, which is intended to further patient autonomy and self-determination, stepped in to shape what doctors can or should say to patients. In 1974, in the Seminole case, Canterbury versus Spence, the court famously changed the standard disclosure requirements for a proposed medical intervention, from the community standard to the reasonable patient standard. The earlier rule only expected disclosure of what the physician deemed appropriate. In other words, the scope and nature of the proposed intervention. The new standard, the reasonable patient standard, mandated disclosure by physicians of the things that a reasonable patient would consider material to an informed voluntary decision. These include the specific risks, benefits, and alternatives to the proposed treatment, and stands in rather stark contrast to the previously accepted standard of disclosure. In Truman versus Thomas, just a few years later, the court found that a physician aired in not informing a patient who repeatedly refused a diagnostic pap smear of the risks of refusing such a test. Some scholars have argued that that case effectively modified the duty to inform patients to a duty to convince patients. In Gates versus Jensen, the Supreme Court of Washington modified the standard of care for the practice of ophthalmology, essentially leading to mandatory administration of glaucoma testing to all patients, regardless of whether physicians believed they were medically necessary. The court argued that it was stepping in to protect patients because the profession standard had become inaccurate, inadequate, sorry. And in 1996, in Johnson versus Cocomor, the Wisconsin Supreme Court required that physicians make disclosures beyond those directly related to the risks, benefits, and alternatives of a proposed medical intervention. There, a surgeon failed to inform his patient of his relative inexperience in performing the specific intervention that he was going to perform. And therefore, the court said that he failed his duty of informed consent. However, even with the evolution from a beneficence model to an autonomy focused model, the state has still been generally reluctant to interfere in the sanctity of the doctor's office. The DPR has been historically considered to be private, intimate, and voluntary. These last two decades have witnessed an unprecedented and much more extreme interference in the doctor-patient relationship. The law has increasingly challenged the values historically considered to be inherent to the doctor-patient relationship. So an example first of what happens when lawmakers get it wrong. A California state law was passed back in 1997 that intended to ban human reproductive cloning, which was ostensibly a reasonable goal. However, because the drafters, the legislature, did not really fully understand the biology behind human reproductive cloning, it inadvertently made it a crime for doctors to pretty much use any fertility treatment, even those that have nothing to do with cloning. And you can start to imagine what it was actually trying to outlaw or ended up outlawing inadvertently. And unfortunately, lawmakers and courts have other agendas, political or otherwise, that conflict with the well-being of patients or the ethical practice of medicine. Legislators have a storied history in passing laws that either misapply or misunderstand medicine and science or that result in overreaching policies that harm rather than help patients. It seems we are seeing more and more examples of situations in which lawmakers and courts pursue their own agendas or goals at the expense of scientific reason or medical knowledge. In those cases, we see the state interfering in the doctor-patient relationship, particularly where courts or legislatures view the medical intervention or condition as somehow outside the traditional values of the nation. However, we define what those values are. In many of these instances, the state has legislated the substance of the doctor-patient communication by attempting to control, mandate, or limit physician speech. This is often done in the context of informed consent discussions. So some examples of the regulation of the substance of the doctor-patient relationship seems somewhat innocuous, or at least no more invasive than state intervention in the informed consent disclosures in the mid-20th century, as we just discussed. So for example, a Washington state law, which was passed in 2007, provides that any physician who uses a patient decision aid that's certified through the process of the Affordable Care Act will be immune from suits under state informed consent law. The ACA certification process is aimed at ensuring that these decision aids are highly quality and accurately outline the benefits, harms, and uncertainties of various medical treatments. The law was intended to improve doctor-patient communication and lead to more fully-informed, preference-sensitive decisions. But some laws that intervene in the context of the discussion between doctor and patient seem less clearly aimed at improving the health and well-being of patients. A prime example is the 2011 passage of the Florida Firearm Owners Privacy Act, or FOPA, as it was called. And this was a law that made it illegal for physicians to ask patients about and their parents, because this is mostly in pediatric settings, about gun ownership in the home, or to even advise parents and their patients and their families about gun safety. That conversation was off limits. This law was presumably passed to protect gun owners' privacy. And as you can imagine, it was supported by the NRA. In passing FOPA, the legislature directly contradicted the recommendations of the American Academy of Pediatrics. The AAP had recommended that physicians ask patients' families about gun ownership in the home. And these recommendations have been based on evidence, a 2008 study that found a substantial increase in gun safety, and therefore potentially a reduction in child mortality when parents were counseled by pediatricians about safe gun storage. So in response to a challenge to this law, a district court judge, a lower court judge, issued a permanent injunction in 2012, which meant that FOPA was barred from being enforced. The judge stated there, the state, through this law, inserts itself into the doctor-patient relationship, prohibiting and burdening speech necessary to the proper practice of preventative medicine, thereby preventing patients from receiving truthful, non-misleading information. This it cannot do. This law shields practitioner's speech in a way that impairs the provision of medical care and may ultimately harm the patient. So this case became known as the Docs versus Glocks case, and it was appealed to the 11th Circuit Court of Appeals. The first time the court heard the appeal, it overturned the lower court's opinion, upholding the statute. But finally, in February of 2017, six years after the law was passed, the full panel of the 11th Circuit Court of Appeals struck down the law. The court observed that, quote, the Florida legislature in enacting FOPA relied on six anecdotes and nothing more. In deciding there was not enough evidence to support the law, it asked whether, quote, in a state with more than 18 million people as of 2010, six anecdotes was enough to establish an interest in silencing doctors. Despite this outcome, a number of other states have similar laws in the works. Between 2011 and 2014, 12 other states had introduced legislation restricting physician counseling about gun storage and gun safety. And in 2017, two more states joined that movement. For example, West Virginia's proposed law, quote, would have amended the State Medical Practice Act to define asking about gun ownership as gross negligence and medical incompetence. Despite the court's decision to strike the law down in docs versus glocks, based on its concern about chilling physician speech within the doctor-patient relationship, courts aren't always so willing to contradict the actions of the legislature, even when the law at issue challenges the traditional values of the doctor-patient relationship. Often, these laws are aimed at regulating the informed consent discussion when a patient seeks or a physician recommends a specific procedure. These laws result less in autonomous informed choice and more on mandated disclosures that may not be grounded in medical or scientific evidence. So most notably, states have intervened in the communication between doctor and patient in the passage of so-called informed consent laws. And I have that in quotations intentionally, and mandated ultrasound laws in the provision of abortions. For example, Kentucky passed a law that requires doctors to perform an ultrasound and describe the physical features of the fetus, as well as to play the sound of fetal heartbeat before performing an abortion, regardless of what the patient wishes. This is so-called ultrasound informed consent act, states that a woman cannot give her informed consent unless the doctor does all of those things, even if the woman covers her eyes and ears and doesn't see or hear anything of the required disclosures, which really raises the question of whether there's any informed going on, let alone consent at all. So the law was challenged by the only licensed abortion clinic in the state and three physicians who argued that the law interferes with the doctor-patient relationship. In an amicus brief in support of cert to the Supreme Court, 137 biophysicists, including the McLean setters, Dr. Ross, stated that the proposed law, quote, violates the core moral principles of respect for patients and their autonomy, beneficence and non-maleficence that are widely recognized as foundational to biomedical effects. Further, they argued that the law violates, quote, the trust between physicians and their patients and creates a risk that doctors will be legally compelled to cause harm and distress to their patients. Ultimately, the Supreme Court denied cert keeping the law in place, so the Kentucky law is still good law. And Kentucky was not the first state to pass a law mandating certain disclosures and discussions within the doctor-patient relationship when a patient seeks illegal abortion. The first abortion-specific informed consent law was South Dakotas, which was passed in 2011. That law requires abortion providers to tell patients seeking abortions that, quote, the abortion will terminate the life of a whole separate unique living human being with whom she has an existing relationship and that abortion carries with it a statistically significant risk of, quote, depression and related psychological disorders or increased risk of suicidal ideation and suicide. Patients must then sign each page of the informed consent document. By 2016, at least 14 states had passed similar informed consent laws that required disclosures not based in science and medicine, but instead are premised on political beliefs. Many require doctors to warn patients that abortion might cause depression or suicide. And scholars have warned that about consequences beyond the possible fines, criminal fines and or losing one's license for not having the mandated conversation under these state laws. For example, failure to warn patients about post-abortion depression could expose physicians to medical malpractice liability nationwide, despite the fact there is broad consensus within the medical community that most abortion procedures do not result in serious risks of depression, suicide or suicidal ideation. In other cases, the state has attempted to legislate patient care by outright forbidding the provision of certain therapies or medical procedures that, but for the laws, but for the state intervention, would ordinarily be treated as a medical decision to be made between the doctor and the patient. So one of the most famous examples of this is the 2003 so-called Partial Birth Abortion Act, which was passed by Congress in order to ban a specific form of abortion that lawmakers believe to be particularly gruesome. Note that, of course, Partial Birth Abortion is not a medical term, but a term established by Congress through the testimony they heard. The law didn't, importantly, ban abortion past a certain point in a woman's pregnancy. Rather, it banned a particular method by which an abortion is obtained. So the law made the physician who performs the Partial Birth procedure criminally liable as well as civilly liable to the patient's husband and or parents. In passing the law, Congress heard years of testimony. It heard testimony from organizations such as ACOG, the AMA, as well as tons of physician testimony. And the overwhelming majority of this testimony supported the argument that, at least in some instances, the banned procedure is safer for the safety and welfare of the woman than any other procedure available at that time in a woman's pregnancy. Congress ignored the medical justification for why a patient might decide with the advice of her physician to undergo this procedure. Instead, relying on the testimony of a small handful of doctors, of whom only a couple had actually performed abortions and of whom only a couple were OBGYNs. The law has no health exception for the health or safety of the woman, so where the banned procedure would be the safest option. And instead, Congress concluded that, quote, a moral, medical, and ethical consensus exists that the practice of performing a partial birth abortion is a gruesome and inhumane procedure that is never medically necessary and should be prohibited. Notably, banning this procedure does not save a single baby, but it does or may impose a greater risk on the patient who may then be forced to choose a more risky procedure, even if the woman's health was at risk at the first place due to the pregnancy. When the law was challenged by physicians who performed these procedures, the Supreme Court upheld the law as constitutional. Despite acknowledging that Congress's legislative findings, its findings based on the extensive testimony it heard were inaccurate. It held that the lack of a health exception for women was acceptable due to the concern that doctors would apply an exception too broadly. And the Supreme Court concluded that in the face of, quote, medical uncertainty, meaning a handful of physicians who testified that the procedure was never medically necessary, lawmakers could overrule doctors' medical judgment. And the law's capacity to interfere with the ability of physicians to advise patients regarding appropriate treatment options is not limited, of course, to the abortion context. For example, just this last month, the South Dakota House of Representatives passed HB 1057, otherwise known as the Vulnerable Child Protection Act, which was a bill that would ban doctors from prescribing hormones or puberty blocking medication or performing transgender surgeries on anyone under the age of 16, even with parental consent. A physician that provides such procedures would face criminal liability. The bill's sponsor called gender reassignment surgery, quote, a crime against humanity. The minority leader of the South Dakota House of Representatives responded that the bill would compromise the relationship and trust between doctors and patients. He stated, quote, I trust the doctors here in my state. They don't want us telling them how to do their jobs. That is the doctor's and the parent's decision of how to best treat each child on an individual basis. The bill, but not the issue of gender reassignment surgery, is tentatively dead as of this just last week. As one transgender individual who testified against the bill stated, quote, it's gone. I don't have to worry about it until next year. This year alone, though, at least six states have proposed measures to restrict transgender minors access to gender reassignment treatments, either classifying the act as child abuse or like South Dakota, making it a criminal offense to administer such treatments. So what are we to do with laws that are based on faulty assumptions or understandings or politically motivated laws that do not serve the medical best interests of patients? Examples such of these have been relied upon to demonstrate that legislators, lawyers, and judges should not police the practice of medicine. We should be wary of letting non-experts decide how medical decisions can and should be made. Citing cases like the ones I've been discussing as well as some others, in July 2012, five professional societies whose members together make up the majority of clinical care in the US. So that's the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the American College of Surgeons publish a statement in the New England Journal of Medicine objecting to, quote, inappropriate legislative interference with a physician-patient relationship and reiterating the importance of putting patients' best interests first. These five professional bodies claimed that the legislature intentionally interfered in the practice of medicine, stating that, quote, lawmakers increasingly intrude into the realm of medical practice, often to satisfy political agendas without regard to establish evidence-based guidelines for care. The editorial continued, stating that, quote, legislators in the US have been overstepping the proper limits of their role in the healthcare of Americans to dictate the nature and content of patients' interactions with their physicians. For better or worse, laws are blunt instruments. By their nature, they must target the entire doctor population rather than the single, the lone bad actor. The law doesn't or cannot acknowledge or address the nuances involved in the practice of medicine, nor does the law address exceptions to rules very well. So in that same editorial, the five professional societies argued, quote, legislative mandates regarding the practice of medicine do not allow for the infinite array, excuse me, I just spilled water all over my nose. Let's try that again. Do not allow for the infinite array of exceptions cases in which the mandate may be unnecessary, inappropriate, or even harmful to the individual patient. But it is clear that the law is and will continue to be involved in the doctor-patient relationship. So how can we ensure the appropriate level of legal involvement in the DPR? Well for one, it seems clear that lawmakers and judges cannot make legal decisions that impact medicine without making some effort to at least understand the underlying science first. The myriad example, while not directly representative of interference in the doctor-patient relationship is a prime example of conflicting legal interpretation of complex scientific information. Frustratingly, despite Scalia's refusal to become familiar with the science underlying the decision, he still directed the case's outcome, which affects not just the one company, not just myriad and the patient's physicians and researchers who were affected by that decision and were affected by myriad's monopoly on the isolated genes, but also anyone seeking to patent genetic material, seek to administer genetic testing or seeking genetic testing or anyone attempting to do genetic research. In other words, the myriad decision does not exist in a vacuum. It has precedential value that affect future parties like almost all legal cases. So judges and lawmakers then have an obligation to learn the medicine or science that underlie the cases or situation in front of them so they can get it right, not just for the parties to that particular case, but to future individuals in similar circumstances. The argument that the law should have at least some role in the doctor-patient relationship also is consistent with the history of bioethics in the United States. Sorry. So the law's involvement in setting medical or ethical standards of care has been historically entrenched. In fact, the history of bioethics suggests that the law has been and should be entangled with bioethical inquiries. Regardless of where you identify the birth of modern bioethics, whether it's the 1949 establishment of the Nuremberg Code after the Nazi atrocities or the development of the common rule in the wake of Henry Beecher's seminal revelations of the unethical research occurring in New York State that was published in 1966 in the New England Journal of Medicine or whether you place it at the 1976 court opinion in the case of Nancy Quinlan. Law has been integral to bioethics from the very start. And as one scholar noted, this entanglement continues. As Charity Scott, who's a law professor at Georgia State University explains, quote, during the second half of the 20th century, most difficult issues in healthcare, which have raised profound ethical dilemmas have been addressed by law. So lawmakers have helped define the rules for the appropriate and ethical conduct of medicine. The law has helped make ethical standards enforceable. So those that might be enticed to break rules, either intentionally or inadvertently are deterred from potential bad actions. And the law has sought to make standards consistent, both substantially and procedurally, so that they are applied fairly and predictably. As Charity Scott explains, quote, law pervades medicine because ethics pervades medicine. And in America, we use the law to resolve ethical dilemmas in healthcare. So for better or worse, the law gives teeth to moral and ethical principles. Ethics tells us what we ought to do, while law tells us what we must. In other words, it's been posited that the law is a societal consensus statement on ethics. And at their core, the legal rules that govern medicine are often based on religious philosophical and ethical principles. So under this interpretation of the relationship of law and ethics, law evolves to reflect society's evolving views. Another law professor, Senator Johnson, also notes the extended involvement of law in the practice of medicine over the last century. She states that, quote, more than simply detecting and punishing the maverick doctor, legal efforts to control physician behavior over the past several decades has aimed at transforming the practice of medicine. This effort intended to work fundamental change in both the physician-patient relationship and the relationship of medicine to the market. But how do we address cases where courts defer to inaccurate and sometimes just wrong medical or scientific legislative findings of Congress? And how do we address cases where lawmakers intentionally interfere in the sanctity of the doctor-patient relationship for their own political goals or other agendas? I don't have a lot of hard answers for you, but I do have a little bit of a wish list. So here it is. First, as I just mentioned, we need to ensure that lawmakers and judges are educated in the underlying medical knowledge necessary to make legal decisions. Second, blind judicial deference to the legislature to appropriately analyze and interpret medical and scientific evidence may perpetuate decisions based on faulty data and information. As we have seen in many instances, law and policymakers may be no more equipped to appreciate and apply the complexities and understand the high stakes. Thus, judges shouldn't be so overtly deferential to legislative decision-making like the Supreme Court was in Gondales versus Carhart or the partial birth abortion case where those decisions are faulty or not in patients' best interests. Education and obligation may shield judges and lawmakers from overstepping. Thus, lawmakers and judges must be acutely aware of the motives behind the laws they support and enforce. Third, while the law will continue to play a role in overseeing the practice of medicine as a profession, lawmakers must tread lightly when governing what may or must be said or what may or must be done within the doctor-patient relationship. For example, laws like the Washington state informed consent law, which encourages the use of patient decision aids, which is intended to improve doctor-patient communications may in fact be acceptable. However, as a general rule, the law should be reticent to regulate or interfere in the doctor-patient relationship. Laws such as the Florida firearms statute that are promulgated for policy or political reasons beyond the best interests of the patient and protecting the doctor-patient relationship should be closely scrutinized. While the laws that seem the most insidious address medical interventions and discussions at what some might see as the periphery of standard medical care, for example, they deal with guns, abortions, gender, we should be concerned about the lines we allow the law to draw. We must be vigilant when lawmakers seek goals other than ensuring the safety or health of patients. We must work hard to disentangle the political motivations of the few from the well-being of the many. Thank you. It's quite possible I'm the only lawyer to go under time. I was really struck by the comments about lawyers or judges, rather, not understanding technical knowledge. And it occurs to me that that issue isn't unique by any means to Madison. They're questions about climate change, about whether a package, a carton of a given thickness should break under a given thing. They must deal with this all the time. All the time. And so I was wondering if you could describe how the knowledge of judges, these writings about judges knowledge differ in this medical context compared to other contexts where knowledge would be relevant. And if that's something you've explored yet. So I haven't explored it in a lot of detail. I'm definitely not empirically. But you're absolutely right that this is not unique to the medical field. And as we saw from the Marriott decision, while that case does have some significant medical implications, it allows doctors to now get second opinions for the BRCA tests and things like that and allows a little bit more physician-patient choice in the matter. It's technically not considered a medical case. It's considered an intellectual property case. And so but what I do think is somewhat unique from my anecdotal understanding of how judges consider technical concepts is that judges in the medical context seem much more comfortable owning their lack of knowledge and almost wearing it as a badge of honor for some of these cases. Often I think, for example, in the climate change cases and other cases, it's almost that they just disagree. But they do at least opine. They actually say that they have an opinion on the matter. It might not be based on the best information and the best evidence. But at least they're making that effort to do that. I'm not saying that it's better or worse. It's just I would say that might be the greatest distinction between that and the medical field. Where here we see repeatedly judges saying, I'm not a doctor. I don't do this. The other thing with IP specifically is there are courts that almost specialize in intellectual property. Not intentionally so, but because a majority of patent cases, for example, whether those are devices pharmaceuticals, et cetera, they all tend to be heard in just a handful of jurisdictions. And so the judges almost become experts in not just the law of intellectual property, but also how technology works and the type of folks that are more willing to engage in that analysis. So IP is almost other than the merry decision. It's almost a special case, while other types of cases medical and otherwise are these more technical cases. It's just random what judge you're going to get and what kind of judge you're going to get. And obviously, there's form shopping where parties will bring their case in different jurisdictions depending on who they think is actually going to hear their case and who's going to be more friendly to their side. But yeah, that's generally sort of how it works. Social living requires law, because all of us are individual and self-protective and maybe called self-righteous. So ultimately, there has to be some kind of a law that would then. Now, this wish list, I would say, almost impossible. Impossible to have everyone understand something which is not in their own area. How could the judges understand the medical knowledge? And once they understand, they go based on their bias. Why should we have four maybe on the Democratic side and four on the Republican side? On even Supreme Court, that they are more elite and yet they are biased. So that one is impossible. Well, this doesn't mean I'm biased. The second one, avoid blind differences of fact. And so to find the facts also is extremely difficult. How do we determine fact based on our understanding of what is fact? And then disengage medicine from politics if you ask the government, say, to pay for medicine. I mean, parents pay for their kids, but they still tell them what to spend it. So I would say we have to put that wish list aside, if you wouldn't mind. Like a wish list. But part of the problem is that once we don't make law within ourselves, somebody else has to make it. If we in the societies don't develop what professionalism is and what honesty is and how to deal with it, then a court has to come and make it because we have to get along. Absolutely. So I think the first point that judges or people to is a very important one. Everybody comes with their own biases, opinions, perspectives. And it would be ignorant to think that we could separate individual personality from the outcome of cases. So that's absolutely true. As far as the question of ensuring understanding, judges are not supposed to be coming to decisions and juries. Certainly you're not supposed to be coming to decisions, especially at the trial court level, based on their own opinion and sort of just invent something out of thin air. And so they hear significant amounts of expert testimony. They hear, they receive reports from experts, experts stand up and actually sit in the locks and explain the science and the medicine to the jury, to the judges. If you look at the incredible amount of resources at the court's disposal when it comes to being able to make these decisions, I mean, it's stacks and stacks of documents and papers. The hard part, then, is separating out fact from fiction, deciding what you believe, how you believe it. Because, again, these are fact finders, as you pointed out. And so there's going to be bias. And the problem with the legal system, of course, is that it is, at its very nature, there's going to be two sides. There's supposed to be adversaries. It's intentionally adversarial, which is not really how medicine is supposed to work. It's not how science is supposed to work. And so there's always sort of an overstatement and sort of an entrenchment of views that somehow make facts sort of get interpreted in different ways than they normally would otherwise. These are not peer-reviewed studies at the end of the day, even if it's the peer-reviewed studies that are coming in that are being presented to the jury or to the judges. So the question about how do they come up with decisions? Well, they're not coming out of it up from thin air. They are presented with so much evidence and so many facts and so much information. So hopefully we can try to figure out ways to ensure understanding of that information. One way, for example, is the development of bench books. So we see this in the vaccination context where academic institutions or others will put together documents explaining how disease works and vaccinations work and things like that and how the law applies generally to those things so that when the judge is presented with a case like that, they have almost their own little encyclopedia of that issue that they can rely upon that's supposedly and hopefully unbiased and you don't have sort of that drive from both sides. That's one potential approach. The other question about, you know, sort of, I feel like you sort of raised the question about self-regulation and professionalism. There are ways, and I always advocate this, I do a talk that sort of has similar overtones during the summer to the fellows about who should be making these decisions, not rather than whether the law should be involved at all but who and how. And there are a number of ways that I do believe that professional societies, individual physicians and others should and have an obligation to be involved and be the ones educating the fact-finders and the experts, sorry, and the lawmakers. There's all sorts of professional organizations that do this kind of work. There are legislative advocacy sites you can get involved in, political action committees, state medical societies, there's amicus briefs as we've seen, you know, our colleagues join in. There are lots of other ways that we can get involved as well and I strongly advocate for that. Could you comment on the possible role of civil disobedience in the face of legal interference in the doctor-patient relationship? Well, I am not your lawyer and I cannot give you legal advice. I cannot defend you if you do something you're not supposed to do. Now that I've made those disclaimers. Civil disobedience has been effective in the past in certain circumstances. Of course, it comes with it, incredible risk. You know, so a lot of the time when you have folks that engage in civil disobedience, they are prepared legally in advance knowing full well what the legal implications are but historically, and I'm afraid this is on video now, but historically it has on occasion been effective in changing policy. I wonder if I could pick up on these last two points, the one about avoiding deference to the legislature and disentangling medicine from politics. The vast majority of the cases that you've referred to, and I think it is the vast majority of cases relating to medicine tend to be state cases. Yes, the federal government in Scalia case in the Dick Posner Seventh Circuit, the Eleventh Circuit down in Florida, and there have been a half dozen or eight important Supreme Court decisions. The vast majority of state-based and as you showed yourself with reference, let's say to gun discussions or with reference to abortion policies, you have 12, 14, 16 states that have quite separate views on the matter from perhaps the other states that don't have such policies. I just don't see so long as medicine remains largely state-based rather than federally controlled as it has been for, I guess forever in the United States, how you could achieve the separation from the legislature or disentanglement from politics. Absolutely, so as a general rule, the practice of medicine is governed at the state level. It's controlled by departments of health who issue licensure and oversee individual practice of medicine. That said, the federal government does have a lot of say in what actually happens and how it happens if you see the partial birth abortion act was a federal initiative, and what really matters is that money talks and the federal government can decide what gets funded and what doesn't in many ways. And so you see the federal government getting involved in a lot of ways when it comes to reimbursement of interventions. For example, the stem cell research, for example, where there's been a writer for 25 years saying that no federal fund should go to any research involving any embryonic stem cell research. That's not so related to the doctor-patient relationship, but it is indicative of how the federal government can control behavior in sort of the scientific and medical context quite regularly. Regarding sort of my second wish list, this blind efforts to fact finding of legislature is more sort of an admonishment to judges so that applies to both states and federal level. So for example, in Gonzalez versus Carhart, I argue that, and many argue, that the Supreme Court needn't have been so blindly deferential to the fact finding of Congress when it was really based on so little. And it was actually, in contrast, the Florida court, the 11th Circuit, that said that the fact finding by the legislature in the FOPA case, in the firearms case, was inadequate. So you can sort of contrast those and say, well, it's actually often, or it can be, the federal government, the federal judges or the Supreme Court, that's being more deferential to what the legislature has decided and found, even maybe more than what happened at the state level. But yeah, all of these are, the question about disentangling medicine for politics. Also, I mean, there's so much happening at the state level, and that's going to, and things don't happen in a vacuum. What happened in South Dakota influenced what happened in the neighboring states across the nation. Kate Shaw and her colleague that I cited earlier in the case about the South Dakota ultrasound and informed consent law, talk about how that law influenced, or could influence, medical malpractice across the country, just depending on what materiality standards are being applied for informed consent. So there's enormous implications that one state can have enormous, and decision can have enormous implications across the board. I totally agree with all of your thoughts. To me, especially as a pediatrician, the other piece of it is, is that they're going to the courts to make decisions for children. Part of the time it's because physicians believe that parents are not making reasonable decisions. And especially when we really do think there's a risk. But I find us going more and more to the courts when we want to withdraw support, life support, and the family doesn't. And I've spoken, well, several months ago I spoke at length with a lawyer who one parent wanted to withdraw life support and the other one did not. And he called me because I had publications and he's like, you can tell me how to get the judge to listen to withdraw life support. And I'm like, yeah, I'm not. I said, if you read my articles, I think you've got the wrong person. And I said, I don't really think you're going to be able to do that. But this lawyer was totally convinced this was going to go to the Supreme Court. I don't think it's going to go to the Supreme Court. But it's interesting to see how lawyers come up with plans and so forth. And then it ends up before a judge that I'm not sure it should have ended up before a judge or any of this. And it just gets really complicated, especially in the land of pediatrics. Absolutely. And you raised a whole area of case law that I didn't talk about, which is where there's disagreement between the doctor and the patient or the doctor and the surrogate or whomever, the proxy decision maker. Most of the case law that I'm addressing here are cases where the law is sort of stepping in to what would otherwise be a copacetic relationship. So now you're addressing what happens when there's a disagreement between the parties. And that's a whole new, whole other area of the law, which becomes even more complicated. We have a lot of case law that you look at the end of life decision making line of cases where the courts have either said, it's not up to us, you should be sending this to an ethics committee. The court in Quinlan kind of actually said that. And then we don't hear about ethics committees for 20 years. In the next case they're talking about, no, it's the judge that should be making the, the impartial perspective of the judiciary. And so now all of a sudden judges are the experts on these things. And it's constantly changing. So who even just who should be making those decisions is not, has not been figured out. And I think, you know, the admonishment to try to avoid the law when possible is taken well. And so yeah, I bet, you know, especially a pediatrics where you have parental consent for their children. I mean, it just, everything gets so messy there. I'm sorry. Yeah. Did the court in the case refer to ethics committees in 1975, 76, there was the dawn of ethics committees and then no one ever talked about them again for about 20 years. Right. Yeah. On this team, the court as it is, despite the fact that they do not know medicine, still they are better and despise to make judgment than if you were dealing with a society of medical doctors. It depends on the situation. It depends on the case. I think there are absolutely times where professional societies and organizations should be regulating or overseeing the practice of their members. But then there are other times where sort of use the, where you're sort of leaving the fox to guard the hen house. So it's absolutely just, it can totally depend. It's so fact specific, but I do, because often what happens is professional societies are very good at governing their members up to a certain point. But sometimes what happens is they do just sort of the bare minimum to keep the law out. And sometimes that's not enough. And so there are occasions where the law does need to think about stepping in, but my question is how? Or how the law, is it with a hammer? Those types of cases tend to be much more problematic. And so we want to not use a heavy hand when we're doing that. And I just want to caution against the law sort of coming in with guns blazing. I want to thank Emily so much for coming. Thank you. Thank you.