- Mary Crossley, Giving Meaning to ‘Meaningful Access’ in Medicaid Managed Care, SSRN/Ky LJ,
- Robert Kocher and Bryan Roberts, The Calculus of Cures, N Engl J Med
- David Hyman and William Kovacic, Why Who Does What Matters: Governmental Design, Agency Performance, the CFPB and PPACA, SSRN
- Shi-Ling Hsu, A Cost-Benefit Analysis of Sugary Drink Regulation in New York City, SSRN
Patent applicants seeking to gain global patent protection beyond their home country borders need a better comparative knowledge of key elements of the patent laws of the several countries. Professor Timo Minssen in his superb doctoral thesis directly challenges the seemingly identical statutory and treaty standards for patentability in Europe and the United States in his comparative study of the laws of Europe and the United States with respect to the treaty standard of an “inventive step.” Timo Minssen, ASSESSING THE INVENTIVENESS OF BIOPHARMACEUTICALS UNDER THE EUROPEAN AND U.S. PATENT LAWS (Goteborg, Sweden: Ineko AB 2012). Professor Minssen’s doctoral thesis represents required reading for anyone seeking to unmask the subtle differences between American and European practice (emphasis added).
- Tim Jost, Beyond Repeal — A Republican Proposal for Health Care Reform, N Eng J Med
- Larry Gostin, Legal and Ethical Responsibilities Following Brain Death,
- The McMath and Muñoz Cases, JAMA
- Erin Fuse Brown, Irrational Hospital Pricing, SSRN/Houston J H L & P
- Joseph Hall and Deven McGraw, For Telehealth To Succeed, Privacy And Security Risks Must Be Identified And Addressed, Health Affairs
- Abbe Gluck, A Legal Victory for Insurance Exchanges, N Eng J Med
- George Annas & Sherman Elias, 23andMe and the FDA, N Eng J Med
- Joseph Kvedar Molly Joel Coye and Wendy Everett, Connected Health: A Review Of Technologies And Strategies To Improve Patient Care With Telemedicine And Telehealth, Health Affairs
- Jonathan Darrow, Pharmaceutical Efficacy: The Illusory Legal Standard, SSRN/Wash & Lee L.Rev.
Laura Brennan, Ross Brownson and Tracey Orleans have come out with an important paper reviewing the evidence on policy and environmental strategies for reducing childhood obesity. Twenty-four strategies and 2000 published and gray literature documents are covered. This is a menu of more-or-less evidence backed ideas for intervention.
Sam Harper and colleagues come out with an interesting new argument for primary seat belt laws, based on a disparities analysis. Looking through the lens of education level, they (well, we, since I am one of the authors) find that, while primary enforcement has a powerful affect at every educational level, the impact is greater on people with less education. Thus, existing SES differentials in seat belt use could be reduced if all states (finally) went to primary enforcement.
Even kids like paternalism? Well, that may not be the best interpretation of this next study. Williams and McCartt surveyed New Jersey teenagers about three GDL requirements that are unique to that state: minimum licensing age of 17; application of full GDL rules to beginners younger than 21; and requiring license status decals on vehicle plates of GDL drivers. 84% liked licensing at 17, and 77% approved applying Gthe rules even to older novices. The decal policy was approved by only 23% — but a PHLR study showed it works, so I say get used to it.
Two new tobacco law studies round out the week’s harvest. Heikki et al. map the diffusion of health warning regulations since 1966, showing a big impact of the FCTC. Finally, in a paper that may start some arguments, Kevin Callison and Robert Kaestner report that adult smokers may not be as responsive to cigarette taxes as many believe. They suggest it will take increases on the order of 100% to get a further 5% reduction in smoking rates. Well, I’m okay with that.
Over on the George side of things, Peter Jacobson and Wendy Parmet have posted a thoughtful response to Larry Gostin’s Bloomberg commentary in the Hastings Center Report. They are helping us move away from a habitual application of the paternalism critique and reminding us that public health can play in the democracy sandbox pretty well.
Check out the February 7 edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
This week, PHLR launched its SciVal Experts PHLR Community website. The core of the site is publications and other information for 300 leading public health law researchers doing empirical evaluations of the impact of laws and legal practices on health. The SciVal system allows visitors to find experts by topic, to trace their institutional and individual networks, and to find the latest publications in the field.
We encourage you to visit the site and explore for yourself, but we’ll also begin periodically sharing batches of publications on this blog.
- Bill Sage and David Hyman, Let’s Make A Deal: Trading Malpractice Reform For Health Reform, Health Affairs
- Jennifer Pomeranz, A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels, SSRN/Am J L Med.
- Alicia Ouellette, Context Matters: Disability, the End of Life, and Why the Conversation Is Still so Difficult, SSRN/NYLS L.Rev.
- Roy Spece et al, Would Disclosures of Conflicts of Interest Change Patients’ Decisions and, If So, Would that Make Them ‘Material’ Information? SSRN
Rapid advancements in the fields of neurology and neuroscience over the past decade have enabled unprecedented progress toward the development of brain-modulating technologies and therapeutics. Central to these advancements are cross-disciplinary translational research efforts to engineer systems that can reliably deliver electrical, ultrasound, or magnetic impulses to specific deep cortical areas and neural circuits, with the ultimate goal of influencing abnormal patterns of neural activity implicated in disorders of the brain and nervous system (Famm et al. 2013). As knowledge of the brain’s dynamic synaptic networks and microcircuitry expands, it is anticipated that deep brain stimulation (DBS) technologies will begin to target neural activity with increasingly greater precision and functional efficiency (Warner-Schmidt 2013). While research in these domains carries tremendous promise for treating many neurologic and psychiatric conditions that have long been considered refractory to traditional treatments (Lozano and Lipsman2013; Nestler 2013; Warner-Schmidt 2013), they introduce a complex array of ethical, social, and legal questions.
Read the full article here.
- Stephanie Greene, After Caronia: First Amendment Concerns in Off-Label Promotion, SSRN/San Diego L. Rev.
- Bill Sage et al, How Policy Makers Can Smooth The Way For Communication-And- Resolution Programs, Health Affairs
- Tim Jost, Implementing Health Reform: Four Years Later, Health Affairs
- Nancy E. Morden et al, Choosing Wisely — The Politics and Economics of Labeling Low-Value Services, N Eng J Med
- Bill Sage, Putting Insurance Reform in the ACA’s Rear-View Mirror, SSRN/Houston L. Rev.
Following a request by the European Competition Law Review (Sweet Maxwell), I have today submitted a review of the recent publication “Pharmaceutical Innovation, Competition and Patent Law – A Trilateral Perspective”, edited by Max Planck Director Josef Drexl and Finnish scholar Nari Lee (Edward Elgar 2013, 322 p., ISBN 978 0 85793 245 7). The full contribution (6 pp.) is curently undergoing peer-review.
In summary, I conclude that the editors, who also contributed with excellent papers, have succeeded very well in the difficult task of structuring, systemizing and arranging a compilation of very interesting papers written by high profile authors. This has resulted in a very readable book providing a superb overview and up-to-date analysis of recent developments that have such a substantial impact on a significant area of law and practice. But are there any flaws?
Considering the numerous useful case law citations, as well as the wide scope of the book, it is a little unfortunate that the book does not contain a table of cases or a bibliography of material cited by the respective authors. Also it might perhaps have been beneficial to include some contributions from the pharmaceutical industry, private practice or NGOs. There is of course no doubt that all papers have been written by very competent authors and address real-world issues with much devotion to facts, details and commercial realities. But additional contributions by the industry or “field workers” would probably have enriched the numerous debates that are placed in such an extraordinarily complex environment at the interface of business realities, competition, technological innovation, and access to health care.
- Alta Charo, Physicians and the (Woman’s) Body Politic, N Engl J Med
- Karen Jordan, The Contraceptive Mandate: Compelling Interest or Ideology? SSRN
- Rodney Smith, Solving the Concussion Problem and Saving Professional Football, SSRN/TJ L. Rev.
- Michael Frakes & Anupam Jena, Does Medical Malpractice Law Improve Health Care Quality? SSRN
- Amy Fairchild et al, The Renormalization of Smoking? E-Cigarettes and the Tobacco “Endgame,” N Engl J Med
- Evelyn Tenenbaum, The Union of Contraceptive Services and the Affordable Care Act Gives Birth to First Amendment Concerns, Albany LJ Sci & Tech
- Sharon Long et al, The Health Reform Monitoring Survey: Addressing Data Gaps To Provide Timely Insights Into The Affordable Care Act, Health Affairs
- Kevin Outterson,The Drug Quality and Security Act — Mind the Gaps, N Engl J Med
As the holidays approach, I have a chance to catch up on reading. The Sept-Oct issue of the Hastings Center Report had a paper by Larry Gostin on Michael Bloomberg’s health policy career in New York, and I have seen some of a series of responses by other scholars that will appear in due course. With his usual facility, Gostin recounts the story of Bloomberg’s health department and its innovations in policy – it’s a great piece for a health law class. The piece is also typical Gostin in its framing of the issue of paternalism as a key driver of opposition to many of Bloomberg’s initiatives. And if it is typical Gostin, it is really representative of our field, since Gostin has both drawn on and helped reinforce a widely held belief that the politics of public health are strongly driven by a tension between individual liberty (inscribed legally in civil rights and culturally in individualism and antipaternalism) and public health.
In this framework, paternalism is a premise, not a hypothesis. Gostin writes, “The societal discomfort with Bloomberg’s agenda is grounded, at its core, in distrust of government influence on how autonomous adults conduct their lives.” He describes how health policy-makers are driven to rely on the harm principle to justify policies by “American antipathy toward paternalism.” Yet, and this is also typical of the discourse in our field, he also follows the Sunstein-Thaler line that ultimately denies the empirical assumptions upon which anti-paternalist claims depend: “The public health approach rejects the idea that there is such a thing as unfettered free will, recognizing instead that the built environment, social networks, marketing, and a range of situational cues drive complex behaviors.”
Public health law has been stuck here for a while, accepting that public health policy has and always will be subject to the arbitrary dominion of a mass delusion of autonomy. I think this log-jam is starting to break – and that proponents of effective health laws should be doing all they can to properly discredit and abandon this old trope. A few signs:
- Jonathan Oberlander and Krista Perreira, Implementing Obamacare in a Red State — Dispatch from North Carolina, N Eng J Med
- Sara Rosenbaum, The Enduring Role Of The Emergency Medical Treatment And Active Labor Act, Health Affairs
- Nicole Huberfeld, Dynamic Expansion, SSRN
- Leemore Dafny, Hospital Industry Consolidation — Still More to Come? N Eng J Med
- 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.