Friday, November 21, 2014
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.
Monday, November 17, 2014
Commentators have been weighing in since the Supreme Court decided it would hear King v. Burwell, the case challenging the ability of millions of Americans to receive subsidies to purchase health insurance on federally operated Exchanges under the ACA. Debate swirls over whether a decision striking down these subsidies will gut the ACA or not, but at the very least a ruling in favor of the petitioners would have grave consequences for ACA and the millions that currently receive these subsidies.
There is, however, more at stake in the King case than the ACA. If the Court takes this opportunity to cut down the ACA, it does so at the cost of the principle of separation of powers and the Supreme Court’s institutional legitimacy and credibility.
Guest Blogger Assistant Professor Jessica L. Roberts: Healthism? The EEOC, Employer Wellness Programs, and Discrimination on the Basis of Health Status
Not too long ago, the Department of Labor championed employer wellness programs as vehicles for both promoting public health and cabining health-care spending. Yet judging from recent litigation, the Equal Employment Opportunity Commission (EEOC) feels less sanguine about the potential effects of these kinds of initiatives.
On October 27, 2014, the EEOC filed a complaint against Honeywell, Inc., alleging that the company violated the Americans with Disabilities Act and the Genetic Information Nondiscrimination Act by requiring employees (and their spouses in the case of family coverage) to undergo biometric testing—i.e., measuring employees’ heights, weights, and waist circumferences and screening their blood pressure, cholesterol, and glucose levels—in conjunction with its employer-provided health benefit plan. The EEOC maintained that, despite Honeywell’s protestations to the contrary, failing to take these tests would incur significant penalties, thereby making participation in the wellness program not truly voluntary. It asked the Minnesota Federal District Court for a temporary restraining order and a preliminary injunction enjoining Honeywell from imposing penalties on employees and their spouses who opted out of testing. Just last week, on November 3, the judge denied the request.
HealthLawProf Blog is very pleased to welcome our fifth guest blogger for the month of November, Assistant Professor of Law Jessica L. Roberts. The following is her short bio:
Jessica L. Roberts is an Assistant Professor of Law at the University of Houston Law Center where she teaches Foundational Issues in Health Law, Disabilities & the Law, and Genetics & the Law. Professor Roberts is a pioneer in the area of discrimination on the basis of health-related information. Her work has appeared, or is forthcoming, in the William and Mary Law Review, the Iowa Law Review, the Minnesota Law Review, the Vanderbilt Law Review, the Notre Dame Law Review, the University of Illinois Law Review, the University of Colorado Law Review, the American Journal of Bioethics, and the Journal of Law and the Biosciences. She is a graduate of the University of Southern California and the Yale Law School.
Friday, November 14, 2014
Guest Blogger Assistant Professor Marc D. Ginsberg: Admissibility of Forensic Autopsy Reports in Homicide Prosecutions
Law and medicine are center stage in a controversy percolating in the state and federal courts concerning the admissibility of forensic autopsy reports in homicide prosecutions when the examining pathologist (who performed the autopsy and prepared the report) is unable to testify at trial. At issue is the intersection of hearsay and the Confrontation Clause. Since Crawford v. Washington, 541 U.S. 36 (2004), the courts have been attempting to define “testimonial” hearsay, which, despite the application of a recognized exception to the hearsay rule, no longer trumps the Confrontation Clause. Crawford changed the standards announced in Ohio v. Roberts, 448 U.S. 56 (1980).
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: