Thursday, November 13, 2014
Megan S. Wright, Christopher T. Robertson, Heterogeneity in IRB Policies with Regard to Disclosures About Payment for Participation in Recruitment Materials, 42 J. of Law, Med. & Ethics 375 (2014).
I. Glenn Cohen, Regulating the Organ Market: Normative Foundations for Market Regulation, 77 L. & Contemp. Probs. 101 (2014).
Anna B. Laakmann , The Hatch-Waxman Act's Side Effects: Precautions for Biosimilars, Loyola of Los Angeles L. Rev. (Forthcoming).
HealthLawProf Blog would like to thank our wonderful October guest blogger, Research Fellow and Lecturer in Law Tara A. Ragone. Here is a short recap of her posts:
Continued Debates regarding Antitrust Concerns and Professional Licensing Boards, State Quarantines: Balancing Public Health with Liberty Interests, Valuable Internet Resource Focused on Healthcare Cost Containment and Competition, and Experimenting with Transparency and Decision Support to Inform Health Plan Selection.
A number of studies have suggested that education, wealth, and other socioeconomic factors are more important than health care in promoting a person’s health. Earlier this week, NPR reported on a study of welfare payments that reinforces the link between income and health. Researchers studied children whose families received benefits through the Mothers Pension Program between 1911 and 1935. Compared to children in families that did not receive program benefits, the children of recipients lived longer, and their longer lives might reflect the fact that they stayed in school longer and earned higher incomes during their working days.
[cross-posted at Bill of Health]
Tuesday, November 11, 2014
Guest Blogger Professor Jean Macchiaroli Eggen - In Honor of Veterans Day: Resolving the Complex Legal Issues of the Iraq and Afghanistan Burn Pit Litigation
Every war results in battlefield casualties and injuries. Every war also results in unanticipated health consequences to military service personnel, persons assisting the military, and civilians. In recent history, the Vietnam War was marked by the short- and long-term health consequences of Agent Orange; the 1991 Gulf War left veterans returning home manifesting symptoms of the mysterious “Gulf War Syndrome;” and the ongoing wars in Iraq and Afghanistan have resulted in the adverse health effects of exposure to fumes from burn pits and other environmental contaminants. The burn pits are open areas in which trash, discarded munitions, and other materials were burned – usually by private contractors working under contract for the U.S. Government – before troops moved out of the area. The term is also used generally to encompass the separate water treatment activities of the contractors. The list of illnesses alleged to be caused by these exposures includes various cancers, cardiac conditions, and numerous other organ conditions as well as generalized symptoms. The U.S. Department of Veterans Affairs has set up a health registry for veterans and current servicemembers who were deployed in the Middle East.
Guest Blogger Professor Maya Manian: The 2014 Midterm Elections and Access to Reproductive Healthcare
The Republican landslide in the 2014 midterm elections signals difficult times ahead for securing women’s access to reproductive health care. The conservative wave in state legislatures after the 2010 midterm elections led to an onslaughtof anti-abortion legislation, the effects of which continue to be felt today. For example, sweeping anti-abortion legislation in Texas has shut down over half the state’s abortion clinics so far, leaving many Texas women hundreds of miles from the nearest clinic.
Reproductive health care access—especially access to abortion and contraception—now faces threats from multiple levels of government. First, increasingly conservative state legislatures will continue assailing abortion access with legislation claiming to protect women’s health, such as admitting privileges requirements, that in fact serve no health-protective purpose and instead aim at shuttering abortion clinics. In one of the most heavily fought voter initiatives this election cycle, Tennesseevoters approved a ballot measure thatstripped protection for abortion rights from the state constitution. The measure will unleash anti-abortion forces in the state legislature, who are poised to enact new laws hindering access to abortion care. Of course, state laws will still be subject to scrutiny under the federal constitution in the federal courts—and this is where the Republican takeover in the U.S. Senate comes into play.
HealthLawProf Blog is very pleased to welcome our fourth guest blogger for the month of November, Professor of Law Maya Manian. The following is her short bio:
Maya Manian, professor of law at the University of San Francisco School of Law and a visiting scholar at the Columbia Law School Center for Gender and Sexuality Law for the 2014-2015 academic year, focuses her research on access to reproductive healthcare and explores the relationship between reproductive rights and gender equality. She publishes and presents regularly on abortion rights and related constitutional issues. Her publications include "Lessons from Personhood’s Defeat: Abortion Restrictions and Side Effects on Women’s Health" (Ohio State Law Journal, 2013); "Functional Parenting and Dysfunctional Abortion Policy: Reforming Parental Involvement Legislation” (Family Court Review, 2012); “The Irrational Woman: Informed Consent and Abortion Decision-Making” (Duke Journal of Gender Law & Policy, 2009); “Rights, Remedies, and Facial Challenges” (Hastings Constitutional Law Quarterly, 2009); and “Privatizing Bans on Abortion: Eviscerating Constitutional Rights Through Tort Remedies” (Temple Law Review, 2007). She previously served as a Blackmun Fellowship Attorney at the Center for Reproductive Rights in New York City, where she was a visiting scholar for a series of events during the 2011–2012 academic year. Professor Manian received her undergraduate degree from the University of Michigan and her law degree magna cum laude from Harvard Law School, where she served on the Harvard Law Review.
Monday, November 10, 2014
As NPR reported this morning, researchers in England may soon use genetic therapy to treat diseases that result from defects in mitochondrial DNA.
Mitochondria create energy for cells, and they have their own genes, distinct from the genes that help determine our looks, behavior, and other traits. Because mitochondrial activity is critical to normal cell functioning, abnormalities in mitochondrial DNA can be devastating. Some babies die in a matter of hours.
But because the therapy involves genetic manipulation, it is controversial. While critics are right to insist that we proceed carefully with genetic therapy, many of their arguments are misguided.
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 I)
Since the early 1900’s, the federal mail and wire fraud statutes have been applied to schemes to defraud victims not just of money or property, but also of “intangible rights” such as the right to the “honest services” of an employee or public servant. 18 U.S.C. §§ 1341, 1343, 1346. This expansive theory of honest services fraud has been applied to public officials and private businessmen, although only rarely to physicians or others in the health care system. In 2010, the Supreme Court used the case of former Enron CEO Jeffrey Skilling to impose significant limits on the reach of the honest services fraud theory. Skilling v. United States, 561 U.S. 258 (2010). Skilling itself had nothing to do with health care, arising instead from a prosecution for conspiracy, securities fraud, wire fraud, false representations to auditors, and insider trading in connection with Enron’s massive financial meltdown. Yet in rejecting Skilling’s vagueness challenge to the honest services wire fraud theory underlying his conspiracy conviction, the Court read the statute to limit honest services prosecutions to cases involving bribery and kickbacks – activities with particular salience in the health care context. In a 2012 article, I predicted that while Skilling generally was viewed as narrowing the scope of honest services fraud, the decision might have the paradoxical effect of inviting additional prosecutions in the health care industry.
HealthLawProf Blog is very pleased to welcome our third guest blogger for the month of November, Associate Dean and Professor of Law Joan H. Krause. The following is her short bio:
Professor Krause received her B.A. with Honors in Political Science from Yale University, where she graduated summa cum laude and was elected to Phi Beta Kappa. She received her J.D. with Distinction from Stanford Law School, where she was elected to the Order of the Coif and served as Senior Articles Editor for the Stanford Law & Policy Review. Before attending law school, Professor Krause worked as a medical writer/editor. After law school, Professor Krause clerked for the Honorable Dorothy W. Nelson of the United States Court of Appeals for the Ninth Circuit. As an Associate in the Health Practice Group of Hogan & Hartson L.L.P. in Washington, D.C., Professor Krause’s work focused on regulatory and administrative health care matters, with an emphasis on health care fraud and abuse. After serving as an Assistant Professor at Loyola University Chicago School of Law from 1997-2001, Professor Krause became an Associate Professor at the University of Houston Law Center in 2001 and was appointed George Butler Research Professor of Law in 2005. She served as Associate Director and then Co-Director of the University of Houston Health Law & Policy Institute from 2003-2009. Professor Krause joined the faculty of UNC School of Law in 2009 and was named Dan K. Moore Distinguished Professor of Law in 2011 and Associate Dean for Faculty Development in 2012. Professor Krause teaches the Health Law survey courses, Criminal Law, Fraud & Abuse, and Women & Health Law. Her research interests include health law, criminal law, and women and the law.
Guest Blogger Assistant Professor Marc D. Ginsberg: Enforceability of Voluntary Binding Arbitration of Medical Negligence Claims
Is a physician entitled to condition medical treatment upon the patient’s “agreement” to submit future medical negligence claims to arbitration and waive the right to a jury trial? Is such an “agreement” ethical and enforceable? These are issues of concern in Florida, which has a statute, F.S.A. § 766.207, providing for voluntary binding arbitration of medical negligence claims. However, the recent appellate opinion in Santiago v. Baker, 135 So. 3d 569 (Fla. App. 2d Dist. 2014) supports non-statutory arbitration, which the patient had not requested.
In Santiago, the parents of a child suffering from severe birth injuries sued a physician and clinic for medical negligence arising from prenatal care. An arbitration agreement was signed by the child’s mother (but not by the father) before conception occurred. The clinic successfully requested arbitration pursuant to the agreement. The parents did not request arbitration and never requested the application of the Florida arbitration statute. The parents appealed the order compelling arbitration.
Saturday, November 8, 2014
As a law and bioethics scholar who often works with a political scientist (my husband John Francis, to be exact), I've regretted the limited extent to which these fields interact. The American Political Science Association (APSA) has a section that might be of significant interest to blog readers--the section on health politics and policy. They've issued a call for papers for the next APSA meeting (the weekend just before Labor Day, in San Francisco). Here's their call:
Division 48: Health Politics and Policy
Division Chair: Frank J. Thompson, Rutgers University-Newark
The conference theme, "Diversities Reconsidered...," comes naturally to the section, which has long served scholars with a spectrum of conceptual, theoretical, empirical, and normative perspectives, who have employed diverse methodologies to advance knowledge. The section invites proposals for papers, panels, and roundtables focused on health politics and policy, broadly defined. We welcome submissions not only on the politics of health care (e.g. the challenges of implementing Obamacare) but on preventive policies (e.g., initiatives to fight obesity or foster cleaner air). To maximize opportunities for health papers being accepted, we recommend two steps. First, be sure to submit your proposal to a second APSA section as well as this one. This will facilitate co-sponsored panels. Second, we encourage panel submissions that directly address the diversity theme of the conference (e.g., rigorous research concerned with health disparities that engage diverse populations and worldviews). This may open up opportunities for augmenting our section allotment of panels with convention theme sessions. In addition, we welcome submissions from those who wish to serve as chair or discussant.
The APSA is quite competitive; submissions are due by Dec. 15th.
Friday, November 7, 2014
I. Glenn Cohen, Front Matter, Preface, and An Introduction to: Patients with Passports Medical Tourism Law and Ethics, Patients with Passports: Medical Tourism, Law and Ethics (Oxford Univ. Press 2015).
Guest Blogger Professor Jean Macchiaroli Eggen - Low-Level Exposures to Chemicals in Drinking Water: Are They Actionable?
A recently filed complaint in California Superior Court will likely bring renewed attention to the growing debate about low levels of chemicals in drinking water and whether and to what extent low-level exposures may be deemed injuries in tort law. In City of Hughson v. Dow Chemical Company (Case No. 14-542221) (filed Oct. 16, 2014), the City alleged that the public water supply was contaminated with 1,2,3-trichloropropane (“TCP”), a chemical byproduct of the manufacture of certain commercial products for use in agriculture and other industries. The complaint alleged that the groundwater used to supply its drinking water was contaminated with TCP generated by various companies named as defendants. EPA has not regulated TCP, though it is on the Contaminant Candidate List. The state of California has issued an advisory notification level for TCP and established a Public Health Goal for the chemical, and the State Water Resources Control Board is in the process of developing a maximum contaminant level (“MCL”) for TCP. The City’s tort action seeks, among other relief, the costs of designing, constructing, and operating treatment facilities and equipment to remove the TCP and to ensure compliance with state and federal drinking water standards. The complaint alleges that levels of TCP in the drinking water have sometimes risen above the state Public Health Goal. It does not allege that any citizens have become ill from exposure to TCP. The case raises some thorny issues:
Wednesday, November 5, 2014
Guest Blogger Research Fellow and Lecturer in Law Tara A. Ragone: Continued Debates regarding Antitrust Concerns and Professional Licensing Boards
Earlier this year, I blogged about developments concerning antitrust liability and professional licensing boards. In particular, I noted that the North Carolina Board of Dental Examiners had asked the United States Supreme Court to review the Fourth Circuit’s decision upholding the Federal Trade Commission’s ruling that the Board was not entitled to state action immunity because it was not actively supervised by the state. I also highlighted a then-forthcoming article in the University of Pennsylvania Law Review by Professors Aaron Edlin and Rebecca Haw that explored whether the actions of state professional licensing boards should be subject to antitrust scrutiny.
Tuesday, November 4, 2014
I hope it is ok to post an announcement about a very exciting symposium at the University of Utah S.J. Quinney College of Law, where I teach. On Friday, Nov. 7th, we are hosting our annual Law Review Symposium, Legal Borders and Mental Disorders: The Challenge of Defining Mental Illness. The all-day event, organized by Professor Teneille Brown, brings together nationally recognized experts in law and mental health to explore the difficulty of defining mental disorders, and the impact that this has on the law. What counts as a mental disorder? Is it when your behavior is statistically unusual, when it impairs your functioning, or when others think it is antisocial? For clinical treatment and research, having reliable and discrete labels can help. But what about for the law? Should the law rely on the same diagnoses as psychiatrists do? Doesn’t the law value very different things? How should the law respond to changes in clinical diagnostic structures, such as the 2013 revision of the Diagnostic and Statistical Manual (or, “DSM”) developed by the American Psychiatric Association for clinical use--the first substantial revision to the manual in over 30 years.
You can watch the program live here, beginning at 8:30 am MT.
The conference program (all times are MT) is as follows:
9:15 a.m. – Introduction to the Diagnostic and Statistical Manual (DSM): How Psychiatrists Use It
Jan Terpstra, MD
9:45 a.m. – Panel: When Changes to the DSM Affect Health and Education Benefits
Rebecca Johnson, Medical Sociology PhD Candidate, Princeton University
Stacey Tovino, Lincy Professor of Law, Lehman Professor of Law, William S. Boyd School of Law, UNLV
11:00 a.m. – Panel: The Role of Psychiatric Diagnosis in Civil Commitment and Sentencing
Sara Gordon, Associate Professor of Law, William S. Boyd School of Law, UNLV
Michael Perlin, Professor of Law, New York Law School
Nancy Haydt, JD
Conference Kaynote: Professor Elyn Saks, Orrin B. Evans Professor of Law, Psychology, and Psychiatry and the Behavioral Sciences, University of Southern California Gould School of Law, will deliver a lunchtime address beginning at 12:45 p.m.
1:45 p.m. – Panel: The Future of the DSM: the ethical and legal implications for revolutionizing the “psychiatric bible”
Jennifer Bard, Alvin R. Allison Professor of Law and Director, Health Law Program, Texas Tech University School of Law
Teneille Brown, Professor of Law, S.J. Quinney College of Law, University of Utah
For further information, check out the law school's website here.
Advancements in nanotechnology have led to a proliferation of nanomaterials for both industrial and consumer use, raising concerns about the potential health effects of exposure to nanoparticles on both workers and the general public. Nanotechnology is generally defined as “the understanding and control of matter at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications.” National Science and Technology Council et al., National Nanotechnology Initiative Strategic Plan 1 (Feb. 2014). On the one hand, these characteristics have led to research into previously unattainable applications, such as pesticides, electronics, and certain drug delivery systems within the human body. On the other hand, such developments have generated questions about health risks when nanoparticles are absorbed into the human body or interact with ecosystems in the environment. Scientists have noted that particles at the nano-scale behave differently than non-nano-scale particles of the same substances. Although the United States Government has been studying the risks of nanomaterials, there is disagreement over the need for discrete regulation of nanomaterials. To date, this is an ongoing debate. In advance of any comprehensive or consistent regulation, workers compensation claims and product liability litigation are likely to emerge.
HealthLawProf Blog is very pleased to welcome our second guest blogger for the month of November, Professor Jean Macchiaroli Eggen. The following is her short bio:
Jean Macchiaroli Eggen is Distinguished Professor of Law at Widener’s Delaware campus. Professor Eggen specializes in toxic torts, torts, and civil procedure. After joining the law faculty of Widener in 1986, she became one of the first legal academics to develop the new discipline of toxic torts and introduce it into the legal curriculum of a law school.
Distinguished Professor Eggen received an A.B. from Connecticut College and an M.A. from Michigan State University, and was a Ph.D. Candidate (ABD) at the University of Michigan. She received a J.D., magna cum laude, from Syracuse University College of Law, where she served as Editor-in-Chief of the Syracuse Law Review, held the prestigious Syracuse University Graduate Fellowship, and received awards for published writing. Following law school, Professor Eggen worked as a tort and environmental litigation attorney at the law firm of Bond, Schoeneck & King in Syracuse, New York. She is admitted to practice in New York.
Monday, November 3, 2014
Guest Blogger Assistant Professor Marc D. Ginsberg: The Locality Rule And A National Standard Of Care
Familiarity with the “standard of care” applicable to physician-defendants in medical negligence litigation undoubtedly arose in our law school study of tort law. When the care and treatment provided by a physician complies with the “standard of care,” the medical services rendered are consistent with the care required of a reasonably well qualified physician in the same or similar circumstances. Modern medicine, with the assistance of technology, improved facilities and (hopefully) universal access to medical knowledge, no longer resembles medicine in the 1800’s. It was in the 1800’s that the “locality rule” originated. The case of Small v. Howard, 128 Mass. 131 (1880), overruled by Brune v. Belinkoff, 235 N.E.2d 793 (Mass. 1968), is thought to be the origin of the rule. The locality rule placed a geographical aspect on the medical standard of care, requiring a physician to comply with the standard of care applicable in a particular locality or community. The rule “protected” the rural physician, who would not have had access to the resources and knowledge of the urban physician.
Saturday, November 1, 2014
HealthLawProf Blog is very pleased to welcome the first of our bloggers for the month of November, Assistant Professor Marc D. Ginsberg. The following is his short bio:
Marc D. Ginsberg, B.A., M.A., J.D., LL.M (Health Law), is an Assistant Professor at The John Marshall Law School (Chicago). He teaches Evidence, Civil Procedure II and Medical Negligence. He joined the JMLS faculty after many years of representing physicians while practicing law in Chicago at Rooks Pitts and its successor firm. His scholarship focuses on medical-legal jurisprudence.
Friday, October 31, 2014
The Journal of Law and the Biosciences (JLB) is the first fully Open Access peer-reviewed legal journal focused on the advances at the intersection of law and the biosciences. A co-venture between Duke University, Harvard University Law School, and Stanford University, and published by Oxford University Press, this open access, online, and interdisciplinary academic journal publishes cutting-edge scholarship in this important new field. The Journal contains original and response articles, essays, and commentaries on a wide range of topics, including bioethics, neuroethics, genetics, reproductive technologies, stem cells, enhancement, patent law, and food and drug regulation. Read the full current issue free online.
Register to receive email alerts each time an issue or article publishes online.