By Emily Largent
In 2013, M.C. (a minor child), by and through his adoptive parents, filed a complaint in federal district court against the physicians who recommended and performed M.C.’s sex assignment surgery and the South Carolina Department of Social Services (SCDSS) officials who authorized it. This was the first lawsuit of its kind filed on behalf an intersex child who was given sex assignment surgery while too young to give informed consent.
By way of background, M.C. was born with ovotesticular difference/disorder of sexual development (DSD). Ovotesticular DSD is a condition in which an infant is born with the internal reproductive organs of both sexes; the external genitalia are usually ambiguous but can range from normal female to normal male. Shortly after birth, M.C.’s biological parents expressed their desire to relinquish their parental rights, and M.C. was placed in the custody of SCDSS. A team of physicians subsequently evaluated M.C’s condition and recommended to SCDSS officials that M.C. undergo sex assignment surgery in order to make his body appear female. SCDSS consented to the surgery, which was performed in April 2006.
M.C. was adopted in December 2006. Initially, his adoptive parents raised M.C. as a female in accordance with his assigned gender. M.C., however, refused to be identified as a girl. His adoptive mother has described being “really sad that that decision [regarding surgery] had been made for him. . . . And it’s becoming more and more difficult just as his identity has become more clearly male.” M.C. is now living as a boy with the support of his family, friends, school, and others.
By Nicolas Terry
This week Abigail Moncrieff joins us to discuss the King v. Burwell oral arguments, the story behind the amicus brief she authored, and what it was like to hear Justice Kennedy talk about the very issue she raised.
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 and Podbean, or search for The Week in Health Law in your favorite podcast app.
Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us at @nicolasterry @FrankPasquale
Yesterday, the Supreme Court heard oral arguments in King v. Burwell, and the Justices seemed split on the central issue of whether the Affordable Care Act (ACA) permits health insurance subsidies to flow to citizens of states that have chosen not to establish their own insurance exchanges. Trying to predict the outcome of a case like this is notoriously difficult, but I do want to highlight briefly an important difference between the Court three years ago, when it decided NFIB v. Sebelius, and the Court yesterday.
In NFIB, seven Justices declared that the ACA’s Medicaid expansion was unconstitutionally coercive, concluding that the Secretary of Health and Human Services could not condition existing Medicaid funds on a state’s failure to expand Medicaid. However, the Secretary was instead permitted to offer additional funds to states choosing to expand Medicaid, effectively making the expansion optional. The Court at the time understood that this outcome could result in a national patchwork, in which certain states would adopt the Medicaid expansion and others would not. Continue reading
Isaac D. (“Zack”) Buck is joining Bill of Health as a regular contributor.
Zack is an assistant professor at Mercer University School of Law in Macon, Georgia, where he teaches torts and various health law courses. His scholarship focuses on how the enforcement of health care fraud and abuse laws impacts American quality of care. In 2013, he was selected as a Health Law Scholar as part of the ASLME Health Law Scholars Workshop at Saint Louis University School of Law, and he has participated in the new scholars programs at both AALS and SEALS.
Before joining Mercer, Professor Buck was a visiting assistant professor at Seton Hall University School of Law in Newark, New Jersey, where he taught bioethics, mental health law, and health care fraud and abuse. He also has served as a visiting professor at Hamline University School of Law in St. Paul, Minnesota, where he has taught health care fraud and abuse. He formerly practiced law at Sidley Austin LLP in Chicago. Zack holds a J.D. from the University of Pennsylvania Law School, where he served as an Arthur Littleton and H. Clayton Louderback Legal Writing Instructor and an associate editor of the University of Pennsylvania Journal of International Law. He also holds a Masters of Bioethics from the University of Pennsylvania School of Medicine Center for Bioethics and a B.A. with highest distinction from Miami University (OH).
The “Right to Try” – Compassionate Use of Experimental Medicine
5th Annual Cathy Shine Lecture
Thursday, March 19, Noon – 1 p.m.
Boston University Medical Campus Instructional Building
72 East Concord Street, Boston, MA
Free and open to the public
Reception will follow
Is it fair to use social media or personal connections to get experimental drugs? Is it possible to reconcile so-called “right to try” laws—which allow patients access to novel, unapproved treatments—with evidence-based medicine and a drug-approval process charged with ensuring safe and effective medicines? Professor Caplan examines whether the duty to rescue should play a role in regulatory policies, physician advocacy, and corporate behavior in the US. Continue reading
UPDATE: I posted what follows in January, reflecting on the JALSA amicus brief led by Prof. Abigail Moncrieff from BU that argues that petitioners’ interpretation in King v. Burwell would make the ACA unconstitutional by forcing states to choose between establishing exchanges and torpedoing their individual health insurance markets. In other words, “death spirals to the rescue.” It looks like that argument got noticed by Justice Kennedy, who pressed the petitioners hard for a response at oral argument this morning. (See here.) A very interesting development, and congratulations are in order to Abby and the other JALSA signatories (as well as other amici who pressed this argument) for at the very least helping to call attention to an argument that wound up playing big at argument. Will be interesting to see how the opinion comes out!
ORIGINAL POST (Jan. 27, 2015):
We’ve heard a lot about “death spirals” and how they could stand in the way of the Affordable Care Act’s goal of a functioning individual health insurance marketplace. Seth Chandler has an interesting blog devoted to the subject, “ACA Death Spiral.” And those who have been following King v. Burwell, the Supreme Court’s latest ACA case, have been predicting that a ruling against the government there would be disastrous because it would only exacerbate the “death spiral” threat to individual health insurance markets. (See a sum-up of such predictions here.)
But could death spirals save the ACA? According to a fascinating amicus brief filed in the King case by a number of interest groups and co-signed by several prominent law professors and Bill of Health contributors (I understand that Abigail Moncrieff is the driving force behind the brief, joined by Allison Hoffman, Sharona Hoffman, Russell Korobkin, Joan Krause, Stephen Marks, Kevin Outterson, and Theodore Ruger), the answer might be yes. The argument boils down to “death spirals to the rescue.” (Here is a copy: 14-114 bsac JALSA.)
A new post by Tony Caldwell and Christopher Robertson on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.
The Physician Payments Sunshine Act, a provision in the Affordable Care Act, seeks to increase the transparency of the financial relationships between medical device and drug manufacturers, physicians, and teaching hospitals. Launched on September 30, 2014 by the Centers for Medicare & Medicaid Services (CMS), the Open Payments database collects information about these financial relationships and makes that information available to the public.
As of early February, the Open Payments database includes documentation of 4.45 million payments valued at nearly $3.7 billion made from medical device and pharmaceutical manufacturers to 546,000 doctors and 1,360 teaching hospitals between August 2013 and December 2013. This included 1.7 million records (totaling $2.2 billion) without the names of physicians or teaching hospitals who received the payments.
These records were intentionally de-identified by CMS because the records had not been available for review and dispute for 45 days, or because the records were not matched by CMS to a single physician or teaching hospital due to missing or inconsistent information within the submitted records. Future reports will be published annually and will include data collections from a full 12 month period. [...]
Continue reading here.
A new piece by contributor Art Caplan on NBC News:
Guns are a medical issue — no matter how often the NRA denies it. Eight national health groups, including the American Academy of Pediatrics, just released a joint statement echoing that sentiment.
But among the barrage of media questions leveled at politicians on the presidential campaign trail, no one is asking the contenders about firearms. The topic appears to be strangely and entirely off limits.
Everything else seems to be fair game: Do you think President Obama loves this country? What do you think about vaccines? Do you believe in evolution? Did you embellish anything on your resume? Do embryos have rights? Are you too old, fat, short, ill-tempered, religious, atheistic, feminist, or in the pocket of your donors to make a good President? [...]
Continue reading here.
A new piece by contributor Art Caplan in Forbes:
There are lots of reasons why measles, having gone to Disneyland, is enjoying a comeback around the United States and Canada. Unfounded fears of autism scare some parents. Others buy the daffy conspiracy theory that pharmaceutical companies are just pushing vaccination to make a buck. Some parents invoke religious concerns despite that fact that hardly any religions think vaccination is bad and most teach that it is an obligation in order to protect children and the vulnerable in the community.
One key reason behind falling vaccination rates is that if you believe any of the above untruths it is very easy to get an exemption. Most states let you out on religious or philosophical grounds. Every state excuses you or your kids for health reasons. So you might presume those ducking vaccines get approval to dodge vaccination from physicians. Uh uh. In 17 states, D.C. and Puerto Rico naturopaths, healers who believe in a mishmash of nutritional medicine, botanical medicine, naturopathic physical medicine including chiropractic manipulative therapy, rolfing, iridology, and homeopathy among other New Agey philosophies can get licenses in their state. There are thousands practicing in the United States. Put aside the issue of why states are recognizing these ‘healers’ who rely on an evidence base only a few steps above astrology and palm-reading. The fact is in many states a naturopath can excuse a child from vaccination. And since many naturopaths take a pretty dim view of vaccination they give a lot of exemptions. [...]
Read the full article here.
An article in the Harvard Gazette about our panel “Measles, Vaccines, and Protecting Public Health,” convened on February 25, 2015:
The numbers paint a telling picture. In the United States of the 1950s there were between 3 million and 4 million annual cases of measles, a highly infectious virus that causes severe flu-like symptoms and a spreading red rash. Roughly 48,000 of those infected each year were hospitalized, and 400 to 500 died.
By 2000, through an effective and widely used vaccine, measles was essentially eliminated in the United States.
But for the last several years, the Centers for Disease Control and Prevention has reported a significant uptick. Last year, the CDC recorded more than 644 cases from 27 states, the worst since 2000. Only two months into 2015 the United States is facing more than 150 cases reported across the country, many of them tied to a December outbreak at Disneyland in California.
The resurgence involves measles-stricken travelers and American parents who don’t vaccinate their children. [...]
Continue reading here.
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, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.
Below are the papers identified from the month of February. The selections feature topics ranging from an underreporting of deviations from good clinical practice in peer-reviewed medical journals, to the impact of risk evaluation and mitigation strategies on off-label prescribing, to repairing the broken market for antibiotic innovation. A full posting of abstracts/summaries of these articles may be found on our website.
- Chambers JD, Chenoweth M, Cangelosi MJ, Pyo J, Cohen JT, Neumann PJ. Medicare is scrutinizing evidence more tightly for national coverage determinations. Health Aff (Millwood). 2015 Feb 1;34(2):253-260.
- Falit BP, Singh SC, Brennan TA. Biosimilar competition in the United States: statutory incentives, payers, and pharmacy benefit managers. Health Aff (Millwood). 2015 Feb 1;34(2):294-301.
- Hwang CS, Turner LW, Kruszewski SP, Kolodny A, Alexander GC. Prescription drug abuse: a national survey of primary care physicians. JAMA Intern Med. 2015 Feb 1;175(2):302-304.
- Kesselheim AS, Tan YT, Avorn J. The roles of academia, rare diseases, and repurposing in the development of the most transformative drugs. Health Aff (Millwood). 2015 Feb 1;34(2):286-293.
- Outterson K, Powers JH, Daniel GW, McClellan MB. Repairing the broken market for antibiotic innovation. Health Aff (Millwood). 2015 Feb 1;34(2):277-285.
- Rising JP, Moscovitch B. Characteristics of pivotal trials and FDA review of innovative devices. PLoS One. 2015 Feb 4;10(2):e0117235.
- Sarpatwari A, Franklin J, Avorn J, Seeger J, Landon J, Kesselheim A. Are risk evaluation and mitigation strategies associated with less off-label use of medications? The case of immune thrombocytopenia. Clin Pharmacol Ther. 2015 Feb;97(2):186-193.
- Wang B, Liu J, Kesselheim AS. Variations in Time of Market Exclusivity Among Top-Selling Prescription Drugs in the United States. JAMA Intern Med. 2015 Feb 9. [Epub ahead of print]
- Zetterqvist AV, Merlo J, Mulinari S. Complaints, complainants, and rulings regarding drug promotion in the United kingdom and sweden 2004-2012: a quantitative and qualitative study of pharmaceutical industry self-regulation. PLoS Med. 2015 Feb 17;12(2):e1001785.
The Policeman at the Elbow: The Neuroscience of Addiction, Self-Control, and Criminal Responsibility
Wednesday, March 4, 2015
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
- Judge Nancy Gertner, Senior Lecturer on Law, Harvard Law School
Part of the Project on Law and Applied Neuroscience.
Senator Elizabeth Warren (D-MA) recently introduced a new bill, the Medical Innovation Act, which would require pharmaceutical companies who settle with the government after committing certain illegal activities to reinvest additional money into the NIH. Senator Warren views the bill as a “swear jar” for drug companies, seeking to target those who commit certain types of wrongdoing, including violating the anti-kickback statutes or defrauding Medicare and Medicaid, in order to increase government support for research at a time when the NIH’s budget has been falling. Scholars and researchers who have lamented the shrinking of the NIH’s budget will find much to love in the bill, and they may even wish it had gone farther.
The Medical Innovation Act would be triggered under the following set of circumstances: drug companies (1) who sell at least one drug whose annual net sales exceed $1 billion, (2) where that drug can be traced at least in part to federally funded research (the Act refers to such products as “covered blockbuster drug[s]”), and (3) who enter into a settlement agreement of at least $1 million with the government after committing certain types of wrongdoing, would pay an additional penalty. As a threshold matter, the Act will not affect companies unless they appear to have broken the law. But even where companies have committed various forms of wrongdoing, the Act would not affect smaller drug companies, those who developed their drugs without the aid of the federal government, those who engaged in minor wrongdoing (and therefore only have small settlements), or those who take the government to trial rather than settling.
Affected companies would be required to pay an additional fine on top of the value of their settlement, paying 1% of the company’s profits multiplied by the number of covered blockbuster drugs sold by that company each year for five years. Because the annual profits attributable to these companies are typically very high, even with the Act’s various carve-outs, Senator Warren estimates that if the Act had existed for the past five years, it would’ve provided an additional $6 billion every year to the NIH, a full 20% increase in its budget. Going forward, this number might be smaller, if some companies respond to the Act’s incentives by committing less wrongdoing (a positive development in itself) or taking the government to trial (a relatively unlikely outcome, but possible in some cases), but the total amount is still likely to be substantial.
Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
Thailand’s interim parliament recently passed a law prohibiting foreigners from seeking Thai surrogates. The law was proposed and passed in response to several recent scandals and the growing surrogacy industry that has made Thailand one of the top destinations for “fertility tourism.” One of the most publicized controversies was “Gammy’s case,” in which a baby boy born to a Thai surrogate for an Australian man (the baby’s genetic father) and his wife was diagnosed with Down Syndrome. The couple abandoned Gammy but took his healthy twin sister. The Thai surrogate also claimed the parents asked her to abort both children when she was seven months pregnant. And in August 2014, authorities discovered that the 24-year old son of a Japanese billionaire had fathered at least a dozen babies by hiring surrogate mothers through Thai clinics.
The law makes commercial surrogacy a crime and bans foreign couples from seeking surrogacy services. The law does not, however, appear to prohibit non-commercial surrogacy among Thai citizens, provided that the surrogate is over twenty-five years old. Violations carry a prison sentence of up to ten years. Wanlop Tankananurak, a member of Thailand’s National Legislative Assembly, hailed the law, stating that it “aims to stop Thai women’s wombs from becoming the world’s womb.” Continue reading
The latest newsletter from the Yale Interdisciplinary Center for Bioethics is now available online. For an archive of past newsletters, please visit the Center’s website.
By Deborah Cho
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.
Petrie-Flom Faculty Director I. Glenn Cohen has published a new co-authored article in the The Journal of the American Medical Association on active shooter incidents in hospital settings. From the article:
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. [...]
Read the full article here.
By Abbe Gluck
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?
Here is an excerpt and a link. Continue reading
HLS Health Law Workshop: Robert Truog
March 2, 2015 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]
Download the Presentation: “Defining Death: Getting It Wrong for All the Right Reasons”
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.
March 18 – 20, 2015
Harvard Medical School
Joseph B. Martin Conference Center
77 Avenue Louis Pasteur
Boston, MA 02115
A full agenda is available on our website.
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.
Co-sponsored with the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.