Monday, 10/24, HLS Health Law Workshop with Lindsay Wiley

October 24, 2016 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Social Norms, Legal Foundations, and Noncommunicable Disease Prevention”

To request a copy of the paper in preparation for the workshop, please contact Jennifer Minnich at

Lindsay Wiley is Associate Professor of Law at the Washington College of Law at American University. She teaches torts, health law, and public health law. Her research focuses on access to health care and healthy living conditions in the U.S. and globally. She serves on the Board of Directors of the American Society for Law, Medicine, and Ethics and the National Conference of Lawyers and Scientists. Prior to joining the faculty at WCL, Professor Wiley was the Global Health Law Program Director at the O’Neill Institute for National and Global Health Law at Georgetown University. She had also previously worked at the Center for Law and the Public’s Health at the Johns Hopkins Bloomberg School of Public Health, the American Society for Law, Medicine, and Ethics, and Gordon, Feinblatt, Rothman LLC in Baltimore, MD. She received her AB and JD from Harvard, where she served on the Harvard Law Review, and her MPH from Johns Hopkins.

MONDAY (10/24): Health Care after the Election

presidential_nominees_slideHealth Care after the Election
October 24, 2016 12:00 PM
Wasserstein Hall, Milstein West AB (2019)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA


As we approach the 2016 presidential election and change of administration, there are many questions about the future of health policy that the 45th President and Congress will have to address starting in 2017. This event brings together health care experts from both sides of the aisle to discuss what health care will – and should – look like under the next administration.

Possible topics for discussion include:

  • The Affordable Care Act
  • Drug pricing
  • Delivery system reform
  • Innovation and research funding/NIH
  • Mental health
  • Public health

Continue reading

Voluntary Firearm Waiting Periods Could Save Thousands of Lives

Suicide is one of today’s most pressing public health issues. It’s the second most common cause of death for those ages 15-34, and claims over 40,000 lives every year. Of those, a staggering 20,000 are the result of firearms. To put that in perspective, there are about 30,000 gun deaths overall in the United States each year, which means that self-inflicted fatalities make up over 60% of total domestic gun deaths. Of the most prevalent means of attempting suicide, firearms are by far the most lethal. Firearm suicide attempts end in death more than 85% of the time, whereas attempts by drug overdose — the most common method — are only fatal 3% of the time.

While suicides by firearm have been on the rise in recent years, there may be an easy way to substantially reduce their incidence. A new study out of the University of Alabama Birmingham by Vars, et al., suggests that allowing individuals at risk of suicide to put themselves on a voluntary “Do-Not-Sell’ list, which would result in a waiting period before they could acquire a firearm, could be effective in preventing suicide attempts. The researchers surveyed 200 patients at both in- and out-patient psychiatric facilities who had disorders associated with anxiety and depression, and found that nearly half of them would put themselves on a list which would preclude them from quickly accessing firearms in the event that they were contemplating suicide. This is particularly notable given that these were all Alabama residents — a state that ranks in the top 10 of Guns and Ammo’s list of the best states for gun owners. In other states with more robust gun control and fewer gun enthusiasts, the Do-Not-Sell rate could very well be higher.

Continue reading

NEXT WEEK (10/27): Concurrent Surgeries – Medical, Legal, and Ethical Issues

concurrent_surgeriesConcurrent Surgeries – Medical, Legal, and Ethical Issues
October 27, 2016 12:00 PM
Pound Hall 101, Ballantine Classroom
Harvard Law School, 1563 Massachusetts Ave., Cambridge, MA

Concurrent, or overlapping, surgeries involve the simultaneous scheduling of substantial portions of two or more surgeries under the supervision of a single surgeon, requiring delegation of responsibility to trainees and assistants if necessary. The practice is not uncommon, especially at teaching hospitals, but patients often have no idea that their doctor may also be operating on someone else at the same time. This panel discussion will describe the practice, its risks and benefits, and recommended approaches to preserve patient trust and safety.


  • Jonathan Saltzman, Reporter, The Boston Globe Spotlight Team (contributor to “Clash in the Name of Care”) – Setting the Stage: Key issues and concerns raised by concurrent surgeries, patient experiences and outcomes
  • Griffith R. Harsh IV, MD, MA, MBA, FACS, Professor of Neurosurgery and Associate Dean, Postgraduate Medical Education, Stanford University – Surgeon’s Perspective: Pros and cons of concurrent scheduling, pressures to schedule this way, potential impact on patients, and the recent statement by the American College of Surgeons
  • I. Glenn Cohen, JD, Professor, Harvard Law School; Faculty Director, Petrie-Flom Center – Legal and ethical perspectives: Institutional risk, medical malpractice, informed consent, and applicable regulations
  • Moderator: Robert Truog, MD, Frances Glessner Lee Professor of Medical Ethics, Anaesthesia, & Pediatrics and Director, Center for Bioethics, Harvard Medical School; Executive Director, Institute for Professionalism & Ethical Practice and Senior Associate in Critical Care Medicine, Boston Children’s Hospital

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and theCenter for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.

Monday, 10/17, HLS Health Law Workshop with Nicholson Price

October 17, 2016 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Regulating Black-Box Medicine.” To request a copy of the paper in preparation for the workshop, please email Jennifer Minnich at jminnich at

Nicholson Price is an Assistant Professor at the University of Michigan School of Law, where he teaches Patents, Health Law, and first-year Property, among other courses. He was previously Assistant Professor at the University of New Hampshire School of Law. From 2012 to 2014 Nicholson was an Academic Fellow at the Petrie-Flom Center, where he studied innovation in the pharmaceutical industry, personalized medicine, and the issues surrounding secondary findings in genomic research. His work has been published in Science, the Harvard Journal of Law and Technology, Nature Biotechnology, the Boston College Law Review, and the Hastings Center Report, among others.

Nicholson received his JD from Columbia Law School in 2011, where he was a James Kent Scholar, was Submissions Editor of the Columbia Science and Technology Law Review, and twice received the Julius Silver Note Prize. He received his PhD in Biological Sciences, also from Columbia University, in 2010. He holds an AB in Biological Sciences from Harvard College. After law school, he clerked for Judge Carlos T. Bea of the U.S. Court of Appeals for the Ninth Circuit, and was a Visiting Consortium Scholar at the UCSF/UC Hastings Consortium on Law, Science and Health Policy.

Loneliness as epidemic

By Wendy S. Salkin

Just a few weeks ago, The New York Times ran an article confirming that, indeed, we are facing an epidemic of loneliness. There is “mounting evidence” that links loneliness to illness, as well as “functional and cognitive decline.” What’s more, loneliness turns out to be a better predictor of early death than obesity.

Neuroscientist John Cacioppo, who has spent much of his career working on loneliness, defines “loneliness” as “perceived social isolation.” Similarly, Masi, et al. (following Russell, et al. 1980) define “loneliness” as “the discrepancy between a person’s desired and actual social relationships.” As Masi, et al., point out, there is a distinction to be made between loneliness, on the one hand, and social isolation, on the other, although the two phenomena may indeed often go together. Whereas social isolation “reflects an objective measure of social interactions and relationships,” loneliness “reflects perceived social isolation or outcast.” Following Peplau & Perlman 1982 and Wheeler, et al. 1983, they go on to point out that “loneliness is more closely associated with the quality than the number of relationships.” (It’s important and timely to note that the 2016 Nobel Laureate in Literature, Bob Dylan, brought out one application of this conceptual distinction in his song, “Marchin’ to the City,” when he sang: “Loneliness got a mind of its own / The more people around the more you feel alone.”)

The health risks posed by loneliness are several and can be severe. Loneliness can contribute to increased risk of coronary heart disease, cardiovascular disease, and stroke. In a 2016 systematic review and meta-analysis in Heart, Valtorta, et al., reported that “poor social relationships were associated with a 29% increase in risk of incident CHD [coronary heart disease] and a 32% increase in risk of stroke.” And in a March 2015 meta-analysis in Perspectives on Psychological Science, Holt-Lunstad, et al., reported that a substantial body of evidence supports the following two claims:

  1. Loneliness puts one at greater risk for premature mortality. In particular, “the increased likelihood of death was 26% for reported loneliness, 29% for social isolation, and 32% for living alone.”
  2. The heightened risk for mortality due to “a lack of social relationships” (whether reported loneliness, social isolation, or living alone) is greater than the risk due to obesity.

Continue reading

Organs and Overdoses: The Numbers (Part I)

By Brad Segal

The surging opioid epidemic is a threat to the nation’s public health. This year the CDC reported that mortality from drug overdose reached an all-time high, with the annual death toll more than doubling since 2000. Yet in the backdrop of this epidemic, the country also faces ongoing shortages of a different sort–too few organs for transplantation. Every day, approximately 22 people die while waiting for an organ to become available. To some it is not a surprise–or at least not inconceivable–that the fastest-growing source of organ donors is being fueled by the national spike in drug overdoses. This first post will help delineate the scope and scale of the situation. My follow-up will discuss the ethical considerations and ramifications for public policy.

To start: the numbers. The Organ Procurement and Transplantation Network (OPTN) makes domestic transplant data publicly available online, which currently extends from 1994 to September 30th, 2016. Two decades ago, 29 organ donors died from a drug overdose.* In just the first nine months of this year, that number has climbed to 888 donors. Even with a quarter of the calendar year left to be counted, 2016 has already surpassed previous record set in 2015 (Figure 1).


Figure 1

One might question whether this trend is an illusion–perhaps a rise in the incidence of donors who had overdosed reflects an increasing number of transplants. But the data suggest the opposite. Also plotted in Figure 1, the percentage of total organ donors who died from overdose (maroon diamonds, right-sided Y axis) has not remained constant–instead, the percentage has steadily increased. Two decades ago, overdose caused the deaths of 0.6% of all organ donors; this year, it is the cause of death among 12.0% of organ donors nationwide. The rising percentage means that not only are more victims of drug overdose donating organs, but that the pool of organ donors is increasingly composed of such individuals. Continue reading

Medical Errors – The Third Leading Cause of Death in the US

Source: James, PhD, became involved in the movement to bring greater attention to patient safety and rampant medical errors by way of tragedy. In 2002, Dr. James lost his 19-year-old son as a result of problematic care provided by cardiologists at a hospital in central Texas. A toxicologist by training, Dr. James taught himself cardiology in order to piece together the events that led to the death of his son despite an extensive evaluation by a team of cardiologists. His journey is chronicled in his book, “A Sea of Broken Hearts: Patient Rights in a Dangerous, Profit-Driven Health Care System.” From there, Dr. James became an advocate for patient safety and a crusader against medical errors. His website is called Patient Safety America.

Major media outlets around the globe extensively covered the recent British Medical Journal article showing that medical errors are the third leading cause of death in the US.  In 2013, Dr. James published a related paper in the Journal of Patient Safety that showed how nearly 440,000 lives per year are lost to medical errors in the American healthcare system.

I wanted to provide Bill of Health readers with a summary of how Dr. James’s paper in many ways pre-saged and perhaps even exceeds the recent BMJ article. A KevinMD article provides further context in this debate.

Continue reading

Allison Hoffman on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

twihl 5x5

Subscribe to TWIHL here!

We start with a special request to TWIHL listeners this week: please consider donating to Partners in Health’s Haitian hurricane relief efforts. It’s always a good time to donate to, but especially now, in the wake of apocalyptic levels of destruction. In the southwest peninsula, over one million people are cut off from food, clean water, and medical care.

Our guest this week is Allison Hoffman, Professor of Law at UCLA School of Law and an expert in health care law and policy.  Professor Hoffman’s work examines the Affordable Care Act, Medicare and retiree healthcare expenses, and long-term care.  We discussed Allison’s recent work on long-term care, including the soon-to-be-published piece “Reimagining the Risk of Long-Term Care,” in the Yale Journal of Health Policy, Law, and Ethics. This is a particularly important topic in the wake of the collapse of the CLASS Act–an infrequently-lamented but very important shortcoming of the ACA.

Our lightning round was a veritable derecho of regulatory detail, addressing the Teladoc case, arbitration travails in nursing homes (and a rule designed to end some of them), HHS guidance on HIPAA and cloud computing, ONCHIT on data blocking, the politics of physicians, and Kansas’s asset verification debacle.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Religious Hospitals Should Fully Fund Their Employees’ Pensions

By Shailin Thomas

In July, the Ninth Circuit held that Dignity Health, a faith-based hospital system in the southwest United States, was not exempt from the employee pension requirements of the Employee Retirement Income Security Act (ERISA). The hospital system decided in 1992 that it would consider itself a church for the purposes of ERISA, and therefore would qualify for ERISA’s church exemption and not have to provide fully funded or insured pensions for its employees. As a result of this decision, it underfunded its employees’ pensions to the tune of $1.2 billion.

The Ninth Circuit was the second to make such a ruling after the Seventh Circuit issued a similar decision against Advocate Health Care in March. Many thought these rulings would lead the Supreme Court to leave the issue alone, but that may not be what SCOTUS has in mind. Associate Justice Anthony Kennedy recently granted Dignity reprieve from complying with the Ninth Circuit decision while he and the other justices decide whether to hear the case. Hopefully, this signals that the Court is planning to extend the Ninth Circuit’s decision, ensuring that hospital systems with religious affiliations across the country fulfill their responsibilities to their employees and provide them with the pensions they deserve.

Dignity Health is not a church. While it did have an official relationship with the Catholic Church until 2012, at the end of the day Dignity Health is a medical services juggernaut. It is the fifth-largest hospital system in the country, with 39 acute care hospitals and over 250 ancillary facilities spread across Arizona, Nevada, and California. Its annual revenue is approximately $10.5 billion. It’s so big that in 2012 it was included in an antitrust investigation by the California Attorney General’s Office to assess the impact of hospital consolidation on health care pricing in California.

Continue reading

A Common Morality?

By Seán Finan

600px-lab_mouse_mg_3244Last week, a patent application in India was refused, apparently on the basis that the invention under review could have been used to counterfeit money. This practice of denying patents on the basis of public policy or morality is almost as old as the practice of granting patents. For example, the State of Monopolies was enacted in England in 1624 to prohibit monopolies where they would be “mischievous to the State”. In many other jurisdictions, patents on food and medicines were prohibited, on the basis that the public good served by these products outweighed any claims of monopoly rights by the inventor. The other approach is preferred in the US. Cases like Diamond v Chakrabarty removed much of the normative question from American patent law and it has been strongly argued that a patent application “is not an ethical event.”

Whether a patent can be refused on the basis of morality is a difficult enough question, but the problem is compounded once the “morality” in question is not confined to a single jurisdiction. The harmonization of patent law across Europe in the last fifty years has forced the European Patent Office (EPO) to consider how to make a moral judgement on behalf of all the contracting states to the European Patent Convention. Its approach has been neither consistent between cases nor consistent with the underlying treaties. I would like to give a quick sketch of the contrast between the European legal framework and its manifestation in the decisions of the EPO.

Continue reading

Learning from adverse health care events in Scotland

By John Tingle

We can learn a lot from how other countries deal with patient safety issues and it can save us from reinventing the wheel at some financial cost.Healthcare improvement Scotland  (HIS) is the national healthcare improvement organization for Scotland and is part of NHS Scotland. The organization provides some excellent patient safety resources. The work of HIS involves supporting and empowering people to have an informed voice in managing their own care and shaping how services are designed and delivered. Delivering scrutiny activity, providing quality improvement support and providing clinical standards, guidelines and advice. HIS produce a rich range of programmes and publications that are relevant to all those concerned with patient safety and health quality in England, USA and elsewhere.

A recent report from HIS focuses on the adverse event lessons learned by health boards and the improvements they subsequently put into place after the events,Learning from adverse events – Learning and improvement summary: May 2016 There is some very good thinking in the report which should be essential reading for all staff involved in patient safety policy development.

Continue reading

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division. Below are the abstracts/summaries for papers identified from the month of September.

  1. Bouvy JC, Huinink L, De Bruin ML. Benefit-risk reassessment of medicines: a retrospective analysis of all safety-related referral procedures in Europe during 2001-2012. Pharmacoepidemiol Drug Saf. 2016;25(9):1004-14.
  2. Gupta R, Kesselheim AS, Downing N, Greene J, Ross JS. Generic Drug Approvals Since the 1984 Hatch-Waxman Act. JAMA Intern Med. 2016;176(9):1391-3.
  3. Kister I, Corboy JR.Reducing costs while enhancing quality of care in MS. Neurology. 2016 Sep 2. [Epub ahead of print]
  4. Kleijnen S, Lipska I, Leonardo Alves T, Meijboom K, Elsada A, Vervölgyi V, d’Andon A, Timoney A, Leufkens HG, De Boer A, Goettsch WG. Relative effectiveness assessments of oncology medicines for pricing and reimbursement decisions in European countries. Ann Oncol. 2016;27(9):1768-75.
  5. Lin D, Lucas E, Murimi IB, Jackson K, Baier M, Frattaroli S, Gielen A, Moyo P, Simoni-Wastilla L, Alexander GC. Physician attitudes and experiences with Maryland’s prescription drug monitoring program (PDMP). Addiction. 2016. [Epub ahead of print]
  6. Oye KA, Eichler HG, Hoos A, Mori Y, Mullin TM, Pearson M. Pharmaceuticals Licensing and Reimbursement in the European Union, United States and Japan. Clin Pharamcol Ther. 2016. [Epub ahead of print]
  7. Mailankody S, Prasad V. Thinking Systematically About the Off-Label Use of Cancer Drugs and Combinations for Patients Who Have Exhausted Proven Therapies. Oncologist. 2016;21(9):1031-2.
  8. Sanders GD, Neumann PJ, Basu A, Brock DW, Feeny D, Krahn M, Kuntz KM, Meltzer DO, Owens DK, Prosser LA, Salomon JA, Sculpher MJ, Trikalinos TA, Russell LB, Siegel JE, Ganiats TG. Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine. JAMA. 2016;316(10):1093-103.
  9. Xu J, Gill R, Cruz M, Staffa J, Lurie P. Effect of US Food and Drug Administration-Approved Pediatric Labeling on Dispensing of Extended Release Oxycodone in the Outpatient Retail Setting. JAMA Pediatr. 2016. [Epub ahead of print]

Lisa Ikemoto on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

twihl 5x5

Subscribe to TWIHL here!

Our guest this week is Lisa C. Ikemoto, the Martin Luther King, Jr. Professor of Law at UC Davis Law School. Lisa has written on specimen management, stem cell research, and many other topics in bioethics and health law and policy.

Our conversation included Lisa’s important insights on ways that race and gender mediate access to and impacts of biomedical technology use and health care.  Her recent work addresses reproductive tourism, the ways in which human gamete use links the fertility and biotechnology industries, and the privatizing effects of informed consent.  Lisa is a Bioethics Associate of the U.C. Davis Health System Bioethics Program, and a Faculty Associate of the U.C. Davis Center for Science and Innovation Studies.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

‘Concussion’ distorts the scope of traumatic brain injury

By Brad Segal 

I just watched the movie Concussion (2015) as an assignment for one of my bioethics courses. The movie is about a physician, Dr. Bennet Omalu, as he unravels the association between playing in NFL and an acquired neurodegenerative disease, a condition he calls, “chronic traumatic encephalopathy” (CTE). At one point Dr. Omalu tries to convince a prominent researcher that, despite suffering head traumas similar to those of football players, animals like the woodpecker have the means of avoiding CTE;

“The woodpecker’s tongue comes out the back of the mouth through the nostril and goes around the top of its head. Basically, it’s one big safety belt for the brain.” (source)

The tongue shoots out through the nostril? As a medical student, I found this trivial aside absolutely fascinating. But when I tried to learn more I quickly realized–to my dismay–that most experts would balk at this characterization. Woodpeckers don’t develop CTE for a variety of reasons, including; (1) smaller mass means less force from deceleration; (2) no head rotation during each peck as to decrease angular forces, and; (3) their skulls have a physiologic protective cushion. I won’t delve further into the weeds about where exactly the movie’s assertions depart from reality, but to put it generously, this crucial argument totally misrepresents the science.

The problem with all of this is that it’s tempting to watch Concussion and feel better informed about the controversies surrounding professional football and CTE. To be honest, I was mesmerized watching familiar events brought to life on screen, and it all seemed credible as it used the actual names of people involved. Movie reviews by Rolling Stone even suggest that it should be mandatory for football fans, and The New York Times remarks on how it, “sells a complex issue.” Sure, everyone knows Concussion is “for entertainment purposes only,” but can’t stories that are true also be entertaining? However, the seemingly-trivial inaccuracy about woodpeckers was a potent reminder that this film is not a documentary. Concussion should be viewed as it is–a major Hollywood blockbuster starring Will Smith and Alec Baldwin.

Continue reading

CALL FOR ABSTRACTS! 2017 Annual Conference, “Transparency in Health & Health Care: Legal & Ethical Possibilities & Limits”

Medical care prices against a white background

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2017 annual conference, entitled: Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits.

Transparency is a relatively new concept to the world of health and health care, considering that just a few short decades ago we were still in the throes of a “doctor-knows-best” model. Today, however, transparency is found on almost every short list of solutions to a variety of health policy problems, ranging from conflicts of interest to rising drug costs to promoting efficient use of health care resources, and more. Doctors are now expected to be transparent about patient diagnoses and treatment options, hospitals are expected to be transparent about error rates, insurers about policy limitations, companies about prices, researchers about data, and policymakers about priorities and rationales for health policy intervention. But a number of important legal and ethical questions remain. For example, what exactly does transparency mean in the context of health, who has a responsibility to be transparent and to whom, what legal mechanisms are there to promote transparency, and what legal protections are needed for things like privacy, intellectual property, and the like?  More specifically, when can transparency improve health and health care, and when is it likely to be nothing more than platitude?

This conference, and anticipated edited volume, will aim to: (1) identify the various thematic roles transparency has been called on to play in American health policy, and why it has emerged in these spaces; (2) understand when, where, how, and why transparency may be a useful policy tool in relation to health and health care, what it can realistically be expected to achieve, and when it is unlikely to be successful, including limits on how patients and consumers utilize information even when we have transparency; (3) assess the legal and ethical issues raised by transparency in health and health care, including obstacles and opportunities; (4) learn from comparative examples of transparency, both in other sectors and outside the United States.  In sum, we hope to reach better understandings of this health policy buzzword so that transparency can be utilized as a solution to pressing health policy issues where appropriate, while recognizing its true limitations.

Call for Abstracts

We welcome submissions on both the broad conceptual questions described above and more specific policy issues, including: Continue reading

When is a juror too biased?

A new Op-Ed by Bill of Health Contributor Dov Fox on CNN:

The upcoming Supreme Court term promises to be a sleeper. Still down a justice, the court isn’t slated to hear its usual blockbusters on the likes of abortion, affirmative-action or same-sex marriage. But its first day back in session does feature at least one intriguing controversy in the case of Peña Rodriguez v. Colorado.

At the heart of the case are two incompatible visions of what a jury is supposed to be. The first ideal emphasizes objective decision-making. It demands that jurors arrive at verdicts free of any influence beyond the testimony and evidence that’s presented in court. The second ideal stresses jurors’ subjectivity. It insists on a jury of peers that can speak as the voice of the community. How can jurors remain unbiased, however, while relying on the very experiences and perspectives that bias them? […]

Read the full article here.

For more on the connection between jury bias and cognitive neuroscience, see his law review article, Neuro-Voir Dire and the Architecture of Bias.

CMS Prohibits Arbitration Clauses in Long-Term Care Facility Contracts

By Wendy S. Salkin

On Wednesday, the Centers for Medicare and Medicaid (CMS)—an agency within the Department of Health and Human Services (HHS)—released a final rule that “will revise the requirements that Long-Term Care facilities [LTCs] must meet to participate in the Medicare and Medicaid programs” (1). (Almost all LTCs receive funds from Medicare or Medicaid.) This is the first time that these requirements have been “comprehensively reviewed and updated since 1991” (6)—that is, in the past 25 years. One of the most striking changes to the regulation is found in §483.65, where CMS “require[es] that facilities must not enter into an agreement for binding arbitration with a resident or their representative until after a dispute arises between the parties” (12) which means that CMS is “prohibiting the use of pre-dispute binding arbitration agreements” (12). Among the reasons provided by CMS for this change is a recognition of the notable power differential between LTCs and their residents:

There is a significant differential in bargaining power between LTC facility residents and LTC facilities. LTC agreements are often made when the would-be resident is physically and possibly mentally impaired, and is encountering such a facility for the first time. In many cases, geographic and financial restrictions severely limit the choices available to a LTC resident and his/her family. LTC facilities are also, in many cases, the resident’s residence. These facilities not only provide skilled nursing care, but also everything else a resident needs. Many of these residents may reside there for a prolonged period of time, some for the rest of their lives. Because of the wide array of services provided and the length of time the resident and his/her family may have interactions with the LTC facility, disputes over medical treatment, personal safety, treatment of residents, and quality of services provided are likely to occur. Given the unique circumstances of LTC facilities, we have concluded that it is unconscionable for LTC facilities to demand, as a condition of admission, that residents or their representatives sign a pre-dispute agreement for binding arbitration that covers any type of disputes between the parties for the duration of the resident’s entire stay, which could be for many years. (402-403)

As The New York Times reported, when the rule was first proposed in July 2015, it was “aimed at improving disclosure.” But, this final version of the rule “went a step further than the draft, cutting off funding to facilities that require arbitration clauses as a condition of admission.”

Continue reading

The Once and Future Regulation of Biotechnology

By Seán Finan

whitehouse_slideOn 16th September, 2016, the White House released two documents jointly authored by the FDA, the EPA and the USDA. Together, the “Update to the Coordinated Framework for the Regulation of Biotechnology” (the “Update”) and the “National Strategy for Modernizing the Regulatory System for Biotechnology Products” (the “Strategy”) will form the basis for the federal government’s regulatory policy for biotech for the foreseeable future. So, where did these documents come from? What do they contain?


Last year, the federal government asked the FDA, the EPA and the USDA to

  1. Clarify the current roles and responsibilities of the EPA, FDA, and USDA in the regulatory process;
  2. Develop a long-term strategy to ensure that the Federal regulatory system is equipped to efficiently assess the risks, if any, of the future products of biotechnology; and
  3. Commission an expert analysis of the future landscape of biotechnology products


14 months, three public meetings and 900 responses to a Request for Information later, the two documents were released. The Update sets out to respond to the first of the above prompts and the Strategy aims to respond to the second. An answer to the third is still in the pipeline.


The underlying policy is made explicit in the first paragraph of the Strategy’s Executive Summary (p4):

The policy of the United States Government is to seek regulatory approaches that protect health and the environment while reducing regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers

Apart from clarifying the current roles of the FDA, EPA and USDA and setting out the path for future developments, both documents make it clear that they aim

  • to help the public understand how the safety of biotechnology products is evaluated and
  • to help businesses navigate the current regulatory structure.

Continue reading

Medical Malpractice in Pennsylvania: What is MCARE and how does it work?

By Matthew Young

Medical malpractice in Pennsylvania revolves around the MCARE statute. MCARE stands for “Medical Care Availability and Reduction of Error” — an Act passed and signed into law in 2002.

MCARE requires that participating providers and hospitals carry a minimum of $500k in coverage per occurrence or claim. (We will get back to what exactly counts as an “occurrence.”) MCARE also refers to a special fund within the State Treasury that aims to “ensure reasonable compensation for persons injured due to medical negligence.” The MCARE fund pays claims in excess of the $500k in coverage that participating health care providers and hospitals are already required to buy themselves to insure against medical professional liability actions.

How does an injured patient get compensated? Here’s how it works: first, a provider has to tender their $500k. Only after they tender does the MCARE fund offer excess coverage. The excess coverage offered is an additional $500k. So if you sue a provider and a hospital, each self-insured with $500k, you can recover $1 million from the self-insurance, and on top of that, once both the provider and hospital tender, the MCARE fund can layer on an additional $500k for the provider and an additional $500k for the hospital. $500k from the provider + $500k from MCARE for the provider + $500k from the hospital + $500k from MCARE for the hospital = $2 million recovery. Simple enough, right?

Continue reading