- Seema Mohapatra, Using Egg Freezing for Non-Medical Reasons: Fertility Insurance or False Hope? – Legal, Ethical, and Policy Considerations, SSRN
- Alyna Chien & Meredith B. Rosenthal, Medicare’s Physician Value-Based Payment Modifier — Will the Tectonic Shift Create Waves? N Engl J Med
- Cathy Schoen et al, Access, Affordability, And Insurance Complexity Are Often Worse In The United States Compared To Ten Other Countries, Commonwealth Fund/Health Affairs
- Jan Walker et al, The Road toward Fully Transparent Medical Records, N Engl J Med
The November 2013 issue of the Yale Law Journal features a very interesting comment on an important issue at the intersection of health law and policy. A First Amendment Approach to Generic Drug Manufacturing, by Connor Sullivan, argues that the First Amendment principles underlying the Supreme Court’s opinion in Sorrell v. IMS Health Inc. provide a viable legal avenue for challenging the FDA regulations that prevent generic drug manufacturers from sending letters warning physicians of the risks of their drugs.
These FDA regulations became a source of legal controversy when the Supreme Court heard PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), a case concerning whether the FDA’s requirement that generic drug manufacturers use the same labels as brand name manufacturers preempts state tort laws that allow injured parties to challenge the sufficiency of a generic manufacturer’s warnings. The Court held that the FDA requirements did pre-empt state tort law on the theory that a generic drug manufacturer could not comply with both the FDA labeling requirements and state tort law at the same time because state tort law might require different, greater warnings than the brand name manufacturer of that same drug used. The Court noted the unfortunate inconsistency that had befallen the plaintiffs in the case; had they taken the brand name drug, they could challenge the labeling requirements of the brand name manufacturer, which has the flexibility under federal law to change their labeling scheme. But because the plaintiffs took the generic version of the same drug, their suit was foreclosed.
We might intuitively assume that these plaintiffs could simply sue the brand name manufacturer; after all, it is their poor labeling scheme that the plaintiffs were challenging by noting the deficiencies in the generic manufacturer’s similar label. But the law is not so wise. After many attempts and subsequent failures to convince a court of such an argument, the law has virtually foreclosed any mechanism for an injured party to recover from a brand name manufacturer for the labeling deficiencies that are passed onto a generic manufacturer. Indeed, Sullivan cites to Gardley-Starks v. Pfizer, Inc., 917 F. Supp. 2d 597, 604 n.4 (N.D. Miss. 2013), which noted that “sixty-six decisions applying the law of twenty-three different jurisdictions [have held] that brand name manufacturers of a drug may not be held liable under any theory for injuries caused by the use of a generic manufacturer’s product.”
In sum, the combination of FDA rules and a Supreme Court pre-emption decision has created a real inconsistency in how people experience the tort laws as applied to their drug manufacturers. After the jump, I’ll explain Sullivan’s idea for solving this problem.
- Alyna Chien and Meredith Rosenthal, Medicare’s Physician Value-Based Payment Modifier — Will the Tectonic Shift Create Waves? N Engl J Med
- Brendan Maher, The Affordable Care Act, Remedy, and Litigation Reform, SSRN/American University L.Rev.
- Thad Pope, Making Medical Decisions for Patients without Surrogates, N Engl J Med
- World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, 7th Rev. 2013, JAMA
- Thomas Gallagher et al, Talking with Patients about Other Clinicians’ Errors, N Engl J Med
- Arti Rai, Biomedical Patents at the Supreme Court: A Path Forward, SSRN/Stan. L.Rev. Online
- Allison Hoffman, An Optimist’s Take on the Decline of Small-Employer Health Insurance, SSRN/Iowa L.Rev.
- Jessica Mantel, The Myth of the Independent Physician: Implications for Health Law, Policy, and Ethics, SSRN/Case Western Reserve L. Rev.
The Petrie-Flom Center and Harvard Law School are delighted to announce our partnership with Duke University, Stanford University, and Oxford University Press to launch a new peer-reviewed, open access, online journal in 2014: Journal of Law and the Biosciences (JLB).
JLB will become the preeminent outlet to publish cutting-edge scholarship wherever law and the biosciences intersect. The journal will take a broad and interdisciplinary view of these areas, publishing articles on topics generally considered part of bioethics or neuroethics, such as the ethical, legal, and social implications of reproductive technologies, genetics, stem cell research, neuroscience, or human biological enhancement. At the same time, JLB will be a home for work that speaks directly to legal issues where the biosciences can be involved, such as food and drug regulation, biosciences patent law, scientific evidence, and criminal responsibility.
- Cynthia Ward, Mental Illness and Danger to Self, SSRN
- Nicole Huberfeld, With Liberty and Access for Some: The ACA’s Disconnect for Women’s Health, SSRN/Fordham ULJ
- Robert Huckman & Mark Kelley, Public Reporting, Consumerism, and Patient Empowerment, NEJM
- Joanna Shepherd, Selective Contracting in Prescription Drugs: The Benefits of Pharmacy Networks, Minn J L Sci & Tech
Call for Papers: Intersections in Reproduction:
Perspectives on Abortion, Assisted Reproductive Technologies,
and Judicial Review
Abortion and reproductive technologies have historically occupied separate realms in law, policy, and academia. In spite of some obvious and natural overlap, scholarship exploring the relationship between abortion and assisted reproduction is sparse. In 2014, Judith Daar (Whittier Law School) and Kimberly Mutcherson (Rutgers Law-Camden) will co-guest edit an issue of the Journal of Law, Medicine & Ethics devoted to articles reflecting on this relationship. JLME is a peer-reviewed journal published by the American Society of Law, Medicine & Ethics.
The guest editors are open to a wide range of scholarship from authors steeped in various aspects of reproductive justice, reproductive rights and reproductive technologies who can explore the future of assisted reproduction and abortion as matters of scholarly concern and legal regulation, especially when viewed as part of a larger movement for reproductive rights and reproductive justice. The term reproductive technologies should be interpreted broadly in this context to go beyond IVF and include a range of techniques used in conjunction with assisted methods of conception.
Questions papers might choose to tackle include, but are in no way limited to:
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and Edmond J. Safra Center for Ethics at Harvard University co-sponsored a conference exploring the issue of financial conflicts of interest at research universities in November 2012. The conference resulted in a final report, which is now available for download on the Petrie-Flom Center’s website. From the report:
In the latter 1990s, the Department of Health and Human Services (DHHS) Office of the Inspector General (OIG) and the now-named Government Accountability Office (GAO) sharply questioned the trustworthiness of research universities as stewards of federal research funds and overseers of the research, especially research that involved human subjects, when the institutions themselves increasingly had financial interests in research conducted by their faculty scientists. This was the first time the federal government had expressed concerns about institutional fCOIs in research universities and academic medical centers.
These concerns have only intensified in the ensuing years as research universities have been exhorted with increasing urgency to become ever more deeply engaged with industry in accelerating the translation of their faculties’ inventive research into tangible public benefits. Defining, let alone mitigating, institutional fCOIs in research universities becomes especially challenging as the institutions, in response to expanding and intensifying public expectations, progressively accrete missions that may themselves not be concordant.
This Symposium, organized by Professor David Korn and co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and Edmond J. Safra Center for Ethics at Harvard University, was intended to examine, clarify, and deepen our understanding of institutional fCOIs in the contemporary research university, and thereby help to identify effective measures that will ensure the continuing trustworthiness of these vital institutions.
For more, download the full report here.
Legal academics who work across disciplines sometimes find themselves in the uncomfortable position of explaining to their stunned colleagues the process by which second- and third-year law students, armed with author c.v.s, decide what gets published and where.
Well, get ready to get your schadenfreude on. For the past 10 months, John Bohannon, a contributing correspondent for Science magazine, has been conducting a sting of (other) science journals and their peer review processes. Much like the famed Sokal hoax, Science submitted to 304 journals a bogus paper written by a fictitious researcher from a nonexistent institution. The paper described “the anticancer properties of a chemical that [the fictitious researcher] had extracted from a lichen,” and according to Bohannon, “[a]ny reviewer with more than a high-school knowledge of chemistry and the ability to understand a basic data plot should have spotted the paper’s short-comings immediately” and rejected it promptly. And yet, over half of the journals accepted the paper. Recall that the bogus paper purports to report on the discovery of the anticancer properties of lichen. Let the prospect of bogus cancer research published in peer reviewed medical journals sink in. Continue reading
- Jacob Sherkow & Hank Greely,The Future of Gene Patents and the Implications for Medicine, JAMA Intern Med.
- Mark Rothstein, Tarasoff Duties after Newtown, SSRN/JLME
- Frank Wharam, Dennis Ross-Degnan, & Meredith Rosenthal, The ACA and High-Deductible Insurance — Strategies for Sharpening a Blunt Instrument, NEJM
- Thomas Buchmueller, Colleen Carey & Helen Levy, Will Employers Drop Health Insurance Coverage Because Of The Affordable Care Act? Health Affairs
- Lisa Heinzerling, The FDA’s Plan B Fiasco: Lessons for Administrative Law, SSRN/Georgetown LJ
- Katherine Neuhausen, Michael Spivey, & Arthur Kellermann, State Politics and the Fate of the Safety Net, NEJM
- Christopher Robertson, When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment, SSRN/BU L.Rev.
- Henry Aaron & Kevin W. Lucia, Only the Beginning — What’s Next at the Health Insurance Exchanges?NEJM
- W. Nicholson Price II, Making Do in Making Drugs: Innovation Policy and Pharmaceutical Manufacturing, SSRN/BC L.Rev.
- Chris Feudtner et al, Risks (and Benefits) in Comparative Effectiveness Research Trials, NEJM
- Michael McCue, Mark Hall and Xinliang Liu, Impact Of Medical Loss Regulation On The Financial Performance Of Health Insurers, Health Affairs
- Joseph Newhouse & Alan Garber, Geographic Variation in Health Care Spending in the United States, Insights From an Institute of Medicine Report, JAMA
- Michael Lauer & Ralph D’Agostino,The Randomized Registry Trial — The Next Disruptive Technology in Clinical Research? NEJM
- John Golden & William Sage, Are Human Genes Patentable? The Supreme Court Says Yes And No, Health Affairs
- Susannah Rose, Patient Advocacy Organizations: Institutional Conflicts of Interest, Trust, and Trustworthiness, JLME
- Ryan Abbott, Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety, SSRN/Iowa L.Rev.
- Katherine Baicker & Helen Levy, Coordination versus Competition in Health Care Reform, NEJM
- Vickie Williams, Life-Sciences Dual Use Research of Concern, Public Health, and the Doctrine of Unconstitutional Conditions, SSRN/St. Louis U. J. Health L. & Policy
- Jean Eggen, Medical Malpractice Screening Panels: An Update and Assessment, SSRN/J Health & Life Sciences Law
- Myungho Paik, Bernarn Black, & David Hyman, The Receding Tide of Medical Malpractice Litigation Part 1: National Trends, SSRN/J Empirical Legal Studies
By Scott Burris
In documenting how often public health law research does influence legislation, I’ve used syringe exchange programs as an example of evidence NOT guiding policy. Despite the consensus in health research that increasing access to sterile syringes has helped reduce HIV, state drug paraphernalia laws, and pharmacy regulations remain a barrier, as does the lack of strong and stable funding for the programs that are working. The case was just made again in an article in the Annals of Health Law. Rachel Hulkower and Leslie Wolf retell the story of the federal funding ban, going over the evidence yet again, and argue that state inaction would best be overcome with money: replacing the federal ban with a positive endorsement and real funding. (As long as we are in an optimistic mood, I would add strings – no HIV funding for states that don’t remove legal barriers to syringe access. This would balance the scales a bit for Congress’ past sin in requiring state recipients of HIV funds to provide for criminalization of exposure and transmission.)
But today I type to tell a happier story. This summer, the state of Nevada passed a statute authorizing syringe exchange and pharmacy sales. There are now 16 jurisdictions whose laws explicitly authorize syringe exchange programs (CA, CO, CT, DC, DE, HI, MA, MD, ME, NJ, NM, NV, NY, RI, VT, WA) and the number of states that require a prescription for retail purchase without exception has dwindled to ONE (Chris Christie’s New Jersey – Delaware, the other hold out, changed its law this year.) But the important thing is not the next halting steps in this slow trend, but the quality of Nevada’s legal contribution. This is going to get a little bit wonky in parts, but let me just take you on a quick tour of this marvelous statute, which drew from a model created several years ago by the Canadian HIV/AIDS Legal Network.
- Frank Pasquale & Tara Adams Ragone, The Future of HIPAA in the Cloud, SSRN
- Linda Fentiman, Sex, Science, and the Age of Anxiety, SSRN/Nebraska L.Rev.
- Kate Greenwood, ‘Litigant Regulation’ of Physician Conflicts of Interest, SSRN/Ga. St. L.Rev.
- Dayna Matthew, Reining in the Rogue Squadron: Making Sense of the ‘Original Source’ Exception for Qui Tam Relators, SSRN/Washington and Lee L.Rev.
- Elizabeth Sepper, Doctoring Discrimination in the Same-Sex Marriage Debates, SSRN/Ind. LJ
- Wendy Mariner, Did Legal Education Fail Health Reform? And How Health Law Can Help, Ind. H L Rev.
- Nathan Cortez, The Mobile Health Revolution? SSRN
- Stacey Tovino, Gone Too Far: Federal Regulation of Health Care Attorneys, SSRN/Oregon L.Rev.
By Scott Burris
A couple weeks ago, I was in a conference room at a global health organization, all ready to give my talk on monitoring and evaluating legal health interventions. The chief of the organization’s formidable M&E operation was my host, and after briefly going through my bio he wound up his introduction by describing me as “the guy who will be telling us how to measure the un-measurable.”
In that one flourish, he captured the biggest barrier to more and better research on the impact of laws and legal practices on health: the cultural belief that law is different from other forms of individual and institutionalized human behavior and belief, so that it, alone, must perforce remain an evidence-free zone. This is certainly a tragedy of low expectations if ever there was one. Uncertainty is part of any hard decision, but if people in the organization I was visiting were talking about defining the optimum treatment regimen for a particular disease, they would take for granted that the deliberations of the decision-makers would be guided by a substantial evidence base. Yet when the question is what package of laws and legal practices create the best environment for preventing the same disease, or encouraging people to seek treatment, they see nothing strange about proceeding entirely on intuition and experience.
As Evan Anderson and I have recently written, the importance of law to health, and the overall success in properly evaluating its impact, belie this continued cultural prejudice. Law can be hard to evaluate, but so are most other influences on our behavior and environment. In a number of areas of legal intervention, researchers have found ways to measure the hard-to-measure and produce credible findings that have shaped policy. They have done so in ways that respect the prosaic realities of practical science work: developing reliable measures and data and deploying them within robust designs is not the work of individuals, it’s not cheap, and it is not quick. Where legal evaluation has thrived, it has done so because enough money was available for long enough to support multiple lines of inquiry by multiple teams of researchers. Careers, or stands of careers, could be built, and competition and disagreement could drive rigor and relevance.
This week, PHLR is celebrating one very tangible result of investment in the field: the publication of Public Health Law Research: Theory and Methods, which was conceived by the PHLR Methods Core and edited by Alex Wagenaar and me. The book, which was written both as a methods class text book and a general reference work, is an important piece of field-building, in that it tries to define the basic good practices of PHLR. But I think it does more: Alex, whose work on crash law exemplifies all that legal monitoring and evaluation can be, has led the production of a book that we can drop on the desk of every person in every funding and health services organization who thinks that measuring law is measuring the un-measurable.
- Jennifer Arlen, Reality Check: How Malpractice Facts Changed Malpractice Liability Theory, SSRN/2011 Empirical Studies Of Judicial Systems
- David Magnus & Art Caplan, Risk, Consent, and SUPPORT, NEJM
- Victor Fuchs, The Gross Domestic Product and Health Care Spending, NEJM
- Elizabeth Bennion, A Right to Remain Psychotic? A New Standard for Involuntary Treatment in Light of Current Science, SSRN/Loy LA L.Rev.
- Samantak Ghosh, The Taking of Human Biological Products, SSRN/Calif L. Rev
- Mark Rothstein & Abigail Shoben, Does Consent Bias Research? SSRN/Am.J.Bioethics
- David Hyman, Why Did Law Professors Misunderestimate the Lawsuits against PPACA? SSRN/U. Ill. L. Rev.
- Aaron S. Kesselheim, et al, Distributions of Industry Payments to Massachusetts Physicians, NEJM