Wednesday, December 10, 2014
Professionals like researchers, doctors, ethicists, and lawyers are largely responsible for the regulations and ethical guidelines that govern human subject research. Nearly everyone appointed to the groups that develop and apply research ethics standards is a professional. Although ordinary citizens are sometimes included in research ethics deliberations, they play a minor role.
Most surprising, and to me, disturbing, is the omission of people who know what it is like to be a research subject. Few people with direct experience as subjects have been involved in the creation and application of human research rules and guidelines. I believe their exclusion has deprived the oversight system of morally relevant information.
Monday, December 8, 2014
HealthLawProf Blog would like to thank our wonderful November guest bloggers, Professor Jean Macchiaroli Eggen, Assistant Professor Marc D. Ginsberg, Associate Dean and Professor of Law Joan H. Krause, Professor Maya Manian, and Assistant Professor Jessica L. Roberts. Here is a short recap of their posts:
Professor Jean Macchiaroli Eggen posted the following: Is Nanotech the Next Asbestos?, Low-Level Exposures to Chemicals in Drinking Water: Are They Actionable?, In Honor of Veterans Day: Resolving the Complex Legal Issues of the Iraq and Afghanistan Burn Pit Litigation, and Will the Neuroscience Revolution Change Tort Law?: Some Thoughts on the Mental Disabilities* Rule in Negligence Law.
Assistant Professor Marc D. Gnsberg posted the following: The Locality Rule And A National Standard Of Care, Enforceability of Voluntary Binding Arbitration of Medical Negligence Claims, Admissibility of Forensic Autopsy Reports in Homicide Prosecutions, and Informed Consent.
Associate Dean and Professor of Law Joan H. Krause posted the following: United States v. Nayak: The Application of Honest Services Mail and Wire Fraud to the Health Care Industry (Part I), United States v. Nayak: The Application of Honest Services Mail and Wire Fraud to the Health Care Industry (Part II), The Complicated Relationship Between Integration and Health Care Fraud, and The Right to Try Meets the Reality of Drug Approval.
Professor Maya Manian posted the following: The 2014 Midterm Elections and Access to Reproductive Healthcare, The Criminalization of Pregnant Women, Health Exceptions in Anti-Abortion Legislation, and Young v. UPS: Will the Supreme Court Deliver a Healthy Ruling for Pregnant Workers?.
Assistant Professor Jessica L. Roberts posted the following: Healthism? The EEOC, Employer Wellness Programs, and Discrimination on the Basis of Health Status, Executive Power and the Employer Mandate, and Turkey for Me, Turkey for You: The FDA Kicks Off the Holiday Season by Finalizing Two Anti-Obesity Rules.
Guest Blogger Associate Dean and Professor of Law Joan H. Krause: The Right to Try Meets the Reality of Drug Approval
Whether it be a social media campaign to convince a company to provide an experimental anti-viral drug to a young cancer patient suffering from a life-threatening infection or the debate over appropriate treatment for high-profile Ebola cases, access to potentially life-saving but unapproved medications remains a controversial issue. Two recent articles, published on the same day, illustrate the difficulty of trying to balance desperate patients’ willingness to try unproven therapies with the very real concerns faced by manufacturers undergoing the drug approval process. The first was a Kaiser Health News article describing the passage of “Right to Try” laws in five states. The second was a brief note in the Los Angeles Business Journal that shares of CytRx Corporation, a biopharmaceutical R&D company, had fallen 9% after the company announced that the FDA had placed a partial clinical hold on its clinical trials after a patient’s death.
Friday, December 5, 2014
Most of the time, we teach and write about health issues from a distance. We don’t deal with matters like access to health care and enrolling in clinical trials ourselves. But every so often, a personal event disrupts this situation. We find ourselves facing the very issues we are used to considering from a comfortable, professional point of view.
This happened to me and six of my medical ethics colleagues, Dan Brock, Norman Fost, Arthur Frank, Leon Kass, Patty Marshall, and John Robertson. After many years of writing and teaching about serious illness and ethics, serious illness and ethics became something personal. Five of us were diagnosed with life-threatening cancers and three had spouses in that situation (one of us faced both situations).
Thursday, December 4, 2014
HealthLawProf Blog is very pleased to welcome our first guest blogger for the month of December, Professor of Law Rebecca Dresser. The following is her short bio:
Rebecca Dresser is the Daniel Noyes Kirby Professor of Law and Professor of Ethics in Medicine at Washington University in St. Louis. Since 1983, she has taught medical and law students about legal and ethical issues in end-of-life care, biomedical research, genetics, assisted reproduction, and related topics. Before coming to Washington University, she taught at Baylor College of Medicine and Case Western Reserve University. In 2003, she was a Visiting Research Scholar at the University of Tokyo, where she taught a short course in law and bioethics. Dresser received her law degree from Harvard Law School. Her book, When Science Offers Salvation: Patient Advocacy and Research Ethics, was published by Oxford University Press in 2001. She also edited and contributed to Malignant: Medical Ethicists Confront Cancer (Oxford University Press, 2012). She is a co-author of The Human Use of Animals: Case Studies in Ethical Choice (Oxford University Press, 2d Edition, 2008) and Bioethics and Law: Cases, Materials and Problems (West Publishing Co., 2003). Dresser has written numerous journal articles, as well as commissioned papers for the National Academy of Sciences and National Bioethics Advisory Commission. She is Chair of the Hastings Center Fellows Council and an “At Law” columnist for the Hastings Center Report. From 2002-2009, she was a member of the President’s Council on Bioethics. In 2011, she was appointed to a four-year term on the National Institutes of Health Recombinant DNA Advisory Committee.
Guest Blogger Professor Jean Macchiaroli Eggen - Will the Neuroscience Revolution Change Tort Law?: Some Thoughts on the Mental Disabilities* Rule in Negligence Law
Over the past several decades research in neuroscience, through the use of functional neuroimaging and other techniques, has sought to explain a vast array of human thought processes and behaviors, and the law has taken a keen interest in these studies. Neuroscience has offered tantalizing insights into human cognition and decision making. Criminal law has been the most frequently discussed area of the law to take an interest in and incorporate neuroscience research, most notably in matters related to juvenile sentencing. E.g. Miller v. Alabama, 132 S. Ct. 2455, 2464-65 (2012) (noting that neuroscience has demonstrated a fundamental difference between juvenile and adult brains and holding that mandatory life imprisonment without parole for persons under the age of eighteen was unconstitutional); Roper v. Simmons, 543 U.S. 551 (2005) (prohibiting the death penalty for older juveniles based, in part, on brain development studies).
Guest Blogger Professor Maya Manian - Young v. UPS: Will the Supreme Court Deliver a Healthy Ruling for Pregnant Workers?
In Young v. United Parcel Service, argued before the U.S. Supreme Court on December 3, 2014, the Court will decide whether the federal Pregnancy Discrimination Act (PDA) protects pregnant workers from suffering economic harms due to pregnancy-related health conditions. The PDA provides that pregnant women “shall be treated the same for all employment-related purposes … as other persons not so affected but similar in their ability or inability to work.”
In 2006, Peggy Young became pregnant while working as a delivery truck driver for UPS. Her healthcare provider recommended that she not lift more than twenty pounds, but Young’s job description required hauling much heavier packages. Based on the medical advice she received, Young requested a temporary accommodation of a lightened load similar to accommodations UPS already granted other workers. Young’s supervisor denied her request and sent her on an unpaid leave, during which she lost her healthcare benefits.
Wednesday, December 3, 2014
Are you attending AALS 2015? The Hamline University Health Law Institute cordially invites you and a guest to a reception honoring members of the Association of American Law Schools (AALS) Section on Law, Medicine and Health Care.
When: Friday, January 2, 2015, from 6:30 to 8:00 p.m. at:
Where: Lebanese Taverna
2641 Connecticut Avenue NW
Washington, DC 20008
Please RSVP here by December 20.
We look forward to seeing you,
Guest Blogger Assistant Professor Jessica L. Roberts - Turkey for Me, Turkey for You: The FDA Kicks Off the Holiday Season by Finalizing Two Anti-Obesity Rules
Last Thursday was Thanksgiving, the gateway meal to the notoriously high-fat, high-sugar, high-calorie American holiday season. One recent estimate speculates that Americans consume approximately 4500 calories during Thanksgiving dinner, with about 45% of those calories coming from fat. While traditional wisdom holds that most Americans gain between seven and ten pound over the holidays, several studies have indicated that on average we gain only one pound. However, that happy news comes with a few qualifiers: one, overweight people gain about five pounds over the holidays (instead of the average one) and two, once we gain that extra pound, we never lose it, leading to gradual weight gain over the course our lifetimes. Thus, maintaining a healthy weight is more of a marathon than a sprint. Although countless websites are replete with tips for avoiding holiday bloat, the real battle happens long after the menorahs and wreaths go back into the closet.
David Orentlicher, Aging Populations and Physician Aid in Dying: The Evolution of State Government Policy, 48 Ind. L. Rev. 111 (2014).
Tuesday, November 25, 2014
Guest Blogger Associate Dean and Professor of Law Joan H. Krause: The Complicated Relationship Between Integration and Health Care Fraud
On October 17, CMS announced a one-year extension of the interim final rule on Final Waivers in Connection With the Shared Savings Program. The interim rule, published on November 2, 2011, established waivers of the Stark self-referral prohibitions, the Anti-Kickback Statute, and some civil monetary penalties provisions for certain entities participating in the Medicare Shared Savings Program (MSSP) created by the Patient Protection and Affordable Care Act. Per the interim rule, HHS was required to consider comments and publish a final rule within three years; that deadline has now been extended until November 2, 2015. In announcing the delay, CMS explained that feedback from the initial stages of the MSSP suggested that modifications were necessary before the waiver rule could be finalized.
Monday, November 24, 2014
I'm editing the newsletter for the AALS Section on Law, Medicine and Health Care. I'd love to get news from folks who are AALS members--or news from others that might be relevant to AALS members. I've asked for replies by December 20th, so I can get the newsletter out before the AALS meeting in January.
You can send me all that good stuff here: https://www.surveymonkey.com/s/XWKYJVY
On Friday, November 21, 2014, House Speaker John Boehner, on behalf of the GOP-run House of Representatives, filed a lawsuit alleging that the Obama administration abused executive power with respect to the Affordable Care Act (ACA). The suit, filed against the secretaries of the Treasury and HHS and their respective departments, makes two central claims: one, that the White House acted unlawfully by twice delaying the implementation of the employer mandate and two, that the funds tied to the ACA’s cost-sharing program were not authorized by Congress.
In the recent midterm elections, Tennesseevoters approved a ballot measure thatstripped protection for abortion rights from the state constitution. Legislators have wasted no time in proposing new bills to restrict access to abortion. Tennessee state representative Rick Womick, a Republican, has quickly filed an anti-abortion bill that would impose mandatory ultrasounds and waiting periods for women seeking abortion care. Abortion providers already routinely perform an ultrasound as part of pre-procedure abortion care and give the woman the option to view the ultrasound image—a step that rarely changes a woman’s mind about choosing abortion. The crucial difference between general medical practice and the proposed Tennessee legislation (which is similar to mandatory ultrasound laws in other states), is that the law forces the woman to either view the image or listen to a description of the image regardless of her wishes. Abortion foes push mandatory ultrasound legislation to shame and demean women seeking abortion care.
AALS Annual Meeting Program: An Examination of Patient Dumping By Hospitals After Thirty Years of EMTALA
The Section on Law and Mental Disability is very pleased to announce the exciting panel An Examination of Patient Dumping By Hospitals After Thirty Years of EMTALA.
Our speakers will be:
1. Martin Castro, Chair of the U.S. Commission on Civil Rights;
2. Hernan Vera, President & CEO, Public Counsel (the largest pro bono law firm in the country);
3. Richard Elliott, M.D., PhD., Professor and Director, Professionalism and Medical Ethics, Mercer University School of Medicine (a nationally recognized forensic psychiatrist specializing in EMTALA and mental health disabilities);
4. Katharine Van Tassel, Director of the Public Health Law & Science Center and Health Law Programs and Professor of Law, University of Akron School of Law; and,
5. Moderator Barry Kozak, Director, Elder Law Programs, The John Marshall School of Law.
This panel will be presented on Saturday, January 3, 2015 from 1:30 to 3:15 p.m. at the AALS Annual Meeting. Our co-sponsors are the Section on Law, Medicine and Healthcare, the Section on Disability Law and the Section on Civil Rights.
Here is the description:
The Emergency Medical Treatment and Active Labor Act of 1986 (EMTALA) was designed to ensure equal access to emergency treatment by hospitals and to stop the practice of "patient dumping." Patient dumping occurs when patients needing emergency care— typically uninsured, disabled, and minority individuals— are transferred, prematurely discharged, or are denied treatment altogether. Thirty years after EMTALA was passed, patient dumping is still occurring. And healthcare delivery has changed dramatically, with stunning advances in medical science and the advent of major, national movements toward evidence-based medicine care and systems-based quality improvement.
Have these sweeping changes left EMTALA behind, so out of touch with current practice that it is now harming, rather than helping, equal access to emergency care? What impact will the Affordable Care Act have on EMTALA? What impact is EMTALA having on the push for community-based services, the growing use of telemedicine, medical repatriation and the number of the mentally disabled in prisons? This panel will address these questions and others while analyzing a forthcoming report of the U.S. Commission on Civil Rights on EMTALA. The panel will also share teaching materials on covering EMTALA in doctrinal courses.
The Report of the U.S. Commission on Civil Rights on EMTALA and Patient Dumping was released in September of 2014 and can be found here.
The law of informed consent has been the subject of scholarship for many years, and with good reason. Informed consent is central to the physician-patient relationship, emphasizing patient autonomy. The springboard for the doctrine may have been Canterbury v. Spence, 464 F.2d 773 (D.C. Cir. 1972). Canterbury speaks to the intent of informed consent to apply to a specific treatment or therapy which is recommended for a specific diagnosis.
My most recent law review article, to appear in the Wayne Law Review, addresses the expansion of informed consent to a doctrine of full disclosure, requiring the physician to disclose the differential diagnosis and various tests/treatments to explore the differential diagnosis. The paper focuses on the experiences in Wisconsin, Washington State and Alaska.
Friday, November 21, 2014
Southern Illinois Health Care/Southern Illinois University Medical Legal Partnership Master of Laws Fellowship
Through the generosity of Southern Illinois Healthcare (SIH), lawyers can apply to receive a Master of Laws degree (LLM) in Health Law and Policy from the Southern Illinois University School of Law, while working with Land of Lincoln Legal Assistance Foundation as a SIH/SIU Medical Legal Partnership LLM Fellow. The Southern Illinois Medical Legal Partnership, founded in 2002 as one of the first in the nation, is a nationally award-winning rural collaboration, working with over 18 medical partners in 10 counties. The SIH/SIU MLP LLM Fellow will gain an in depth understanding of the policies and regulations that affect the health care industry, while receiving practical experience eliminating barriers to health care by integrating legal assistance into the medical setting. The Fellowship is for one year, from the Fall 2015 semester through the Summer 2016 semester.
Cassandra Burke Robertson, Private Ordering in the Market for Professional Services, 94 B.U. L. Rev. 179 (2014).
Marc A. Rodwin, Compensating Pharmaceutical Injuries in the Absence of Fault, 69 Food & Drug L.J. 447 (2014).
Michael L. Perlin, Meredith Schriver, 'You Might Have Drugs at Your Command': Reconsidering the Forced Drugging of Incompetent Pre-Trial Detainees from the Perspectives of International Human Rights and Income Inequality, SSRN.
Tuesday, November 18, 2014
Guest Blogger Associate Dean and Professor of Law Joan H. Krause - United States v. Nayak: The Application of Honest Services Mail and Wire Fraud to the Health Care Industry (Part II)
In a prior post, I discussed the Seventh Circuit’s decision in United States v. Nayak, one of the first major “honest services” mail and wire fraud cases to arise since the Supreme Court decided Skilling v. United States in 2010. In Skilling, the Court found clear Congressional intent to limit honest services prosecutions to “offenders who, in violation of a fiduciary duty, participated in bribery or kickback schemes.” (Skilling at 407, emphasis added) As I warned in a 2012 article, the Court’s focus on bribery and kickback activity within the context of a fiduciary duty might have wide-ranging consequences in the health care field given the nature of the physician-patient relationship.
The structure of honest services cases differs from that of more traditional forms of mail and wire fraud, which usually involve perpetrators who defraud victims of money or property. In contrast, these “intangible rights” cases eliminate the requirement that the victim suffer a financial loss to the perpetrator. Nonetheless, such fraud is actionable only when the perpetrator in fact owes a heightened duty to provide “honest services” to the victim. While Skilling grounded that duty in a fiduciary relationship, the majority offered little guidance as to which aspects of the relationship were most important. As Justice Scalia noted in his concurrence: “None of the ‘honest services’ cases . . . defined the nature and content of the fiduciary duty central to the ‘fraud’ offense. There was not even universal agreement concerning the source of the fiduciary obligation – whether it must be positive state or federal law . . . or merely general principles, such as the ‘obligations of loyalty and fidelity’ that inhere in the ‘employment relationship.’” (Skilling at 416-17)
In a recent New York Times editorial, Lynn Paltrow and Jeanne Flavin bring to light the chilling reality of the criminalization of pregnant women in the United States. Stories of prosecutions of pregnant women in other countries, such as El Salvador, have received significant attention. Yet, similar stories within our own borders remain under the radar even while we constantly debate the issue of abortion.
As Paltrow and Flavin point out, the push to restrict women’s access to abortion and expand rights for fetuses impacts more than just those women specifically seeking abortion care. Anti-abortion measures threaten the rights of all pregnant women, even those who want to be pregnant. As Paltrow and Flavin’s peer-reviewed study on criminal prosecutions of pregnant women demonstrates, prosecutors and judges have relied on anti-abortion reasoning to arrest, detain, and force medical treatment on pregnant women who suffered from miscarriages, depression, or simply wanted to make their own medical decisions about how to proceed with childbirth.