In light of the measles outbreaks in California and now in Nevada, many, including myself, have wondered how we’ve come to this point where a completely preventable disease seems to threaten the lives of so many. While there are recognized legitimate reasons to opt-out of receiving vaccinations, such as for medical and religious reasons, several states allow for opting-out based only on personal beliefs against a scientifically proven fact. As California suffers from the greatest measles outbreak in this country in over a decade, lawmakers have begun to consider repealing the personal belief exemption. If repealing the provision proves to be impossible, seeing as how the parents of over 10,000 kindergarteners in California have already chosen to take advantage of the exemption for non-religious reasons, it may be necessary to consider other strategies to encourage a rate of vaccination high enough to maintain herd immunity within our communities.
Jacobson v. Massachusetts was a seminal case in public health law from the early 20th century because it held that the State could mandate vaccinations, or other public health measures, when necessary to protect public health and safety. The Court recognized some limits to this intrusion of liberty, such as when an individual would suffer harm from the measure or when the individual would be unduly burdened — as in the case of someone with strong religious beliefs against the measure. Furthermore, the Court articulated some general standards: the measure must have a real and substantial relation to the public health goal and the burden caused must not be disproportionate to the benefit. The public health measure in Jacobson met these standards — it compelled smallpox vaccination during an outbreak or required payment of a nominal monetary fine for those who refused to comply without a legitimate reason. As Jacobson had no medical reason to opt-out of receiving the vaccination and had not asked for a religious exemption, the Court found that he was required to either be vaccinated or to pay the fine. His skepticism toward the medicine and doubt in the government were not enough. Jacobson’s reasoning sounds strikingly familiar to the reasoning of many who choose to opt-out today, yet today the science is even more advanced and the benefits of vaccination are even clearer.
On January 20, 2015, Michael J. Davidson, MD, a cardiothoracic surgeon, was fatally shot on the premises of the Brigham and Women’s Hospital in Boston, Massachusetts. In the year leading up to this tragic day, a total of 14 active shooter incidents occurred in hospitals throughout the United States, leaving 15 fatalities in their wake. This reality and its potential amplification by copycats has reignited the debate over the adequacy of current and future hospital security arrangements. In this Viewpoint, we discuss the evolving frequency of hospital-based active shooter incidents, the relevant legal framework, and the role of hospitals and physicians in countering this threat.
As defined by the US Department of Homeland Security, an active shooter incident is one wherein “an individual is actively engaged in killing or attempting to kill people in a confined and populated area.” By several accounts, the overall prevalence of this otherwise rare occurrence is increasing. A study by the Federal Bureau of Investigation (FBI) reveals the overall number of active shooter incidents to have increased from 6.4 per year (2000-2006) to 16.4 per year (2007-2013). Similar rates have been reported for the hospital setting wherein the average number of active shooter incidents has increased from 9 per year (2000-2005) to 16.7 per year (2006-2011), claiming 161 lives in the process. It would thus appear that the frequency of hospital-based active shooter incidents has evolved to constitute at least a monthly occurrence. […]
The political paralysis plaguing gun laws notwithstanding, hospitals are not without recourse in seeking to mitigate the threat of active shooter incidents. On the local advocacy front, advancing and enacting bills for gun-free zones in health care settings constitutes a worthy effort in that a comparable federal statute remains unlikely. Concurrently, selective locale-specific enhancement of hospital security arrangements may increase deterrence, thereby mitigating risk and civil liability. […]
Next week the Court hears a major challenge to Obamacare, King v. Burwell. Readers of this blog know the case has deep importance for health care. But it also is a big case for law. I have previously detailed why the case is the big test for the Court’s current text-oriented statutory-interpretation philosophy known as textualism. Today, in Politico, I explain why the case is also fundamentally about state rights. The question is whether the Court’s many federalism-protecting doctrines–which, let’s not forget, the Court applied against the Government in the last Obamacare case–whether those federalism doctrines, like the Court’s textualist rules, are sufficiently legitimate and objective such they will apply regardless of which side they happen to support, even in a case as politicized as this one. After all, isn’t that the point of having a rule of law in the first place?
Robert D. Truog is Professor of Medical Ethics, Anaesthesiology & Pediatrics at Harvard Medical School and a Senior Associate in Critical Care Medicine at Children’s Hospital Boston. Dr. Truog received his medical degree from the University of California, Los Angeles and is board certified in the practices of pediatrics, anesthesiology, and pediatric critical care medicine. He also holds a Master’s Degree in Philosophy from Brown University and an honorary Master’s of Arts from Harvard University. Dr. Truog’s major administrative roles include Director of Clinical Ethics in the Division of Medical Ethics and the Department of Social Medicine at Harvard Medical School, Director of the Institute for Professionalism and Ethical Practice at Children’s Hospital, and Chair of the Harvard Embryonic Stem Cell Research Oversight Committee (ESCRO). Dr. Truog has published more than 200 articles in bioethics and related disciplines, including recent national guidelines for providing end-of-life care in the Intensive Care Unit. He is Principle Investigator on an R0-1 grant from the NIH to improve end-of-life care in pediatric intensive care units. In his role as Director of the Institute for Professionalism and Ethical Practice, he conducts research and develops educational initiatives related to communication and relational skills. He lectures widely nationally and internationally. His writings on the subject of brain death have been translated into several languages, and in 1997 he provided expert testimony on this subject to the German Parliament. Dr. Truog is an active member of numerous committees and advisory boards, and has received several awards over the years, including The Christopher Grenvik Memorial Award from the Society of Critical Care Medicine for his contributions and leadership in the area of ethics.
We often talk, in bioethics, about individual autonomy. Yet our most challenging ethical, legal and clinical controversies in health care often center around family roles and responsibilities: How should we handle parents’ refusals of medically recommended treatment or, conversely, parents’ requests to medicate or surgically alter their children? What should be known, and by whom, about a child’s genome, especially when genetic information effects other family members? What weight should be given to family interests in decisions about a child’s health care? How should we think about 3-parent embryos? Gamete donors? Gestational mothers? What rights and responsibilities should fathers have with regard to decisions about abortion and adoption, for example, as well as health care decisions for their offspring? Health care decisions might be messier, but maybe they would also be better if we gave more attention to family matters, and how families matter.
This multidisciplinary program has been developed to inform and deliberate with ethicists, health care providers, attorneys and the public about changes in conceptions of the family and medical technologies and practices that challenge moral conventions and contemporary law. Faculty experts and participants will engage in thoughtful discussion regarding a broad range of ethical and legal issues that arise from new ways of creating and new ways of understanding families and providing health care for expectant parents, growing fetuses, infants, children, adolescents….and their families.
The fragmented nature of regulatory authority over food in the United States is well known. More than a dozen federal agencies are responsible for the safety of the nation’s food supply. The Food and Drug Administration (FDA) and the Department of Agriculture (USDA) have the lion’s share of responsibility, together overseeing over 80 percent of the nation’s food safety.
Generally, the USDA regulates meat, and the FDA regulates everything else, but overlaps, exceptions, gaps, and therefore examples of resulting absurdities abound: the FDA regulates frozen pizza, unless it has pepperoni. The FDA regulates seafood, unless it’s catfish. The USDA has jurisdiction over packaged open-face meat sandwiches, but if the sandwiches are closed, authority shifts to the FDA.
This division in regulatory authority is neither planned nor rational. It is instead a historical accident, originating in the early twentieth century. When the Pure Food and Drug Act and Meat Inspection Act were passed on the same day in 1906, both targeting the adulteration of the food supply, their oversight was assigned to different departments within the USDA. The fissure widened when the FDA was moved out of the USDA in 1940. This divided regulatory framework is not the only reason for the fragmentation of regulatory authority over food in the US, but it is a main driver.
The President’s Proposal for a Single Food-Safety Agency
The President’s 2016 Budget, released last week, attempts to put the pieces back together and consolidate control over food safety. It proposes a new agency within the Department of Health and Human Services (HHS) that will incorporate the food safety functions of the FDA and the Food Safety and Inspection Service (FSIS) of the USDA.
Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology &Global Health Policy, University of California, Irvine School of Law
As the majority of state legislatures get back in session, it is clear there will be no dearth of “anti-choice” legislation proposed and considered throughout the country.
In Texas, Representative Matt Krause (R-Fort Worth) is pushing a new law that would provide representation to fetuses in court hearings. This law responds to Marlise Munoz’s case, a brain-dead pregnant woman left on life support for two months because doctors refused to honor her family’s request to remove her from life support. Doctors claimed they were prohibited from doing so because Texas law prohibits withdrawing or withholding life-sustaining treatment from pregnant patients, regardless of their previously-expressed wishes.
South Dakota Representative Isaac Latterell (R-Tea) is sponsoring House Bill 1230, which seeks to ban dilation and evacuation (D and E) procedures sometimes used in second-trimester abortions. The bill uses inflammatory and graphic language (for example, making it illegal to “knowingly behead a living unborn child”), arguably intended to provoke disgust over the procedure to increase support for the bill. HB 1230 includes criminal penalties and physicians violating the law may be charged with a Class 1 felony and face fifty years imprisonment.
Fifty Ohio legislators have introduced House Bill 69, a “fetal heartbeat” law that would outlaw abortion after a heartbeat can be detected. This can occur as early as six weeks gestation, before some women even know they are pregnant. Continue reading →
There is a delicate balance between preserving individual rights and protecting public health when it comes to vaccines, experts argued at a panel discussion at Harvard Law School on Wednesday.
In the wake of the recent outbreak of measles in California, the panel emphasized the need for Americans to be more informed in their decisions for or against vaccination. While allowing an opt-out option to remain in place, the panel proposed making the opt-out process for vaccines more difficult. […]
The sale of cigarettes and tobacco products at retailers with pharmacies has received considerable attention over the past year. The national debate reignited in February 2014, when CVS/pharmacy announced that we would quit the sale of cigarettes and tobacco products in our 7,800 pharmacies nationwide. In September 2014, we announced we were officially tobacco free — one month earlier than planned. This was met with kudos from the media, public health officials, and even the President of the United States.
But one question that did not receive anywhere near that level of attention was whether or not our actions would make a difference in the prevalence of smoking and, ultimately, in the public health.
One factor influencing the decrease in participation may be parental concerns. A recent survey of parents conducted jointly by ESPNw and the Aspen Institute characterized these concerns finding a large percentage of parents were worried about the risk of injury, behavior of coaches, cost, time commitment, and the emphasis on winning over having fun. Concussions and head injuries were the most worrisome injury for parents in this study. Despite this concern, very few parents reported keeping their child from participating in sports due to this risk. The AMSSM position statement characterizes the preoccupation with specialization and competition within sports at such a young age as a risk factor for injury and burnout. Continue reading →
Frank Pasquale and Nicolas Terry are pleased to announce The Week in Health Law Podcast. We (and our guests) enjoy a commuting-length discussion about some of the more thorny issues in Health Law & Policy.
Pound Hall, Room 102, Harvard Law School, 1563 Massachusetts Avenue, Cambridge, MA
Trans and intersex individuals face a series of legal, medical, and social challenges. This panel explores these overlapping issues, including: healthcare coverage of treatments such as gender reassignment therapy, the legal recognition of trans identities, intersexuality, and asexuality. Join us for a wide-ranging panel discussion.
Noa Ben-Asher, Visiting Associate Professor of Law, Harvard Law School
Elizabeth F. Emens, Isidor and Seville Sulzbacher Professor of Law, Columbia Law School
Gerald L. Neuman, J. Sinclair Armstrong Professor of International, Foreign, and Comparative Law, Harvard Law School
Medical tourism is a growing, multi-billion dollar industry involving millions of patients who travel abroad each year to get health care.
Some seek services like hip replacements and travel to avoid queues, save money, or because their insurer has given them an incentive to do so. Others seek to circumvent prohibitions on accessing services at home and go abroad to receive abortions, assisted suicide, commercial surrogacy, or experimental stem cell treatments.
How safe are these procedures? How do you ensure that you will be protected if anything should happen?
Dr. Robert Klitzman will lead the conversation. He is a professor of psychiatry in the College of Physicians and Surgeons and the Joseph Mailman School of Public Health and the director of the Masters of Bioethics Program at Columbia University.
This event is part of Carnegie Council’s Global Health Series.
Wasserstein Hall, Room 3019
Harvard Law School
1585 Massachusetts Ave.,
Cambridge, MA 02138
Do criminal penalties have any deterrent effect on drug addicts – people who already are willing to throw away their jobs, relationships, or even lives for their “fix”? What does brain science tell us about addicts’ capacities to exert self control and to be held criminally responsible? This panel discussion brings together a leading neuroscientist of addiction, a criminal law scholar, and a former judge to ask whether the law should reconsider aspects of responsibility and punishment in light of new science about self-control.
Joshua Buckholtz, Assistant Professor, Harvard University Department of Psychology
Amanda Pustilnik, Senior Fellow in Law and Applied Neuroscience, Petrie-Flom Center/Center for Law Brain and Behavior, and Associate Professor of Law at the University of Maryland School of Law
The Supreme Court of New Mexico has recently delivered an important decision protecting peer reviewers’ statutory entitlement to confidentiality. Yedidag v. Roswell Clinic Corp., — P.3d —- (N.M. 2015), 2015 WL 691333. The Court ruled that peer reviewers can sue violators of their confidentiality right and recover compensatory and even punitive damages. This ruling applied the common law criteria for identifying statutory violations as a breach of contract. Based on those criteria, the Court categorized peer reviewers as members of the class protected by the peer review statute, who deserve remedies for violations of their confidentiality right. The Court also estimated that the criminal penalty imposed by the statute on the right’s violators was too lenient to discourage violations. The Court projected that allowing peer reviewers to sue violators will compensate for the resulting shortfall in deterrence. As a conceptual matter, the Court decided that peer reviewers’ confidentiality entitlement is a “mandatory rule of law incorporated into physician-reviewer employment contracts.” Continue reading →
This problem is not unique to UCLA. The University of Pittsburgh Medical Center had a duodenoscope-related outbreak in 2012. Last month, Virginia Mason Medical Center in Seattle acknowledged that 32 patients were sickened by contaminated endoscopes from 2012 to 2014. Eleven of those patients died. From January 2013 to December 2014, the FDA received 75 Medical Device Reports (MDRs) related to possible microbial transmission from duodenoscopes.
The FDA issued a safety communication yesterday, February 19th, which warned doctors that the complex design of duodenoscopes may impede effective reprocessing. Reprocessing is a multi-step process to clean and disinfect or sterilize reusable devices. The FDA noted that multi-drug resistant infections have been associated with reprocessed duodenoscopes “even when manufacturer reprocessing instructions are followed correctly.” (UCLA stated that its scopes had been sterilized in line with the manufacturer’s standards.) Nevertheless, the FDA urged medical providers to carefully follow manufacturers’ cleaning instructions and talk to patients about the benefits and risks of undergoing procedures involving duodenoscopes.
February 23, 2015 5:00 PM Griswold Hall, Room 110 (Harvard Law School) 1525 Massachusetts Ave., Cambridge, MA [Map here.]
Professor Kapczynski’s presentation, “Order Without Intellectual Property Law: The Flu Network as a Case Study in Open Science,” is available upon request. Please contact Jennifer Minnich (firstname.lastname@example.org) if you would like a copy.
Amy Kapczynski is an Associate Professor of Law at Yale Law School and director of the Global Health Justice Partnership. She joined the Yale Law faculty in January 2012. Her areas of research including information policy, intellectual property law, international law, and global health. Prior to coming to Yale, she taught at the University of California, Berkeley, School of Law. She also served as a law clerk to Justices Sandra Day O’Connor and Stephen G. Breyer at the U.S. Supreme Court, and to Judge Guido Calabresi on the U.S. Court of Appeals for the Second Circuit. She received her A.B. from Princeton University, M. Phil. from Cambridge University, M.A. from Queen Mary and Westfield College at University of London, and J.D. from Yale Law School.