Friday, August 12, 2011
According to BNA Reports:
In a 2-1 decision, the U.S. Court of Appeals for the Eleventh Circuit Aug. 12 struck down a key provision of the federal health reform law, but stopped short of declaring the entire statute unconstitutional (Florida v. HHS, 11th Cir., No. 11-11021, 8/12/11).
The court held in a 304 page ruling that Congress exceeded its powers under the U.S. Constitution's commerce clause when it enacted the individual mandate, a provision scheduled to take effect in 2014 that would require most Americans to buy health insurance or pay a penalty.
In an opinion by Chief Judge Joel F. Dubina, joined by Judge Frank M. Hull, the court said Congress could do many things under the commerce clause, but one thing it could not do was “mandate that individuals enter into contracts with private insurance companies for the purchase of an expensive product from the time they are born until the time they die.”
“The federal government's assertion of power, under the Commerce Clause, to issue an economic mandate for Americans to purchase insurance from a private company for the entire duration of their lives is unprecedented, lacks cognizable limits, and imperils our federalist structure,” the court wrote.
The Eleventh Circuit, however, declared the mandate severable from the remainder of the Patient Protection and Affordable Care Act (PPACA). In invalidating the entire act, the court said, the U.S. District Court for the Northern District of Florida placed too much weight on the fact that the act lacks a severability clause. The proper test, it said, was whether Congress would have enacted the statute in the absence of the individual mandate provision.
The decision sets up a circuit split, as the U.S. Court of Appeals for the Sixth Circuit July 7 held the individual mandate constitutional. In another split decision, the Sixth Circuit said in Thomas More Law Center v. Obama that the individual mandate “falls within Congress's power to regulate activities that substantially affect interstate commerce.” Thomas More Law Center filed a petition for review with the Supreme Court July 26. The circuit split ups the odds that the U.S. Supreme Court will grant review in at least one of the cases.
I am reprinting this posting for the many health law professors interested in or inspired by feminist legal theory:
Feminist Legal Theory Collaborative Research Network
January 2012 Conference
Invitation and Call for Papers
The Feminist Legal Theory CRN is a newly-constituted group that seeks to bring together scholars across a range of fields who are interested in feminist legal theory. The inaugural meeting took place at the Law and Society Association meeting in June 2011; the next meeting will be held at George Washington University Law School on Wednesday, January 4, 2012, the day before the AALS annual meeting.
Paper proposals on any topic pertaining to legal feminism are being accepted until September 23, 2011. For instructions on registering, submitting a proposal, or participating in this and other activities of the Feminist Legal Theory CRN, please see the detailed information posted here: http://www.feministlawprofessors.com/2011/08/invitation-call-papers-feminist-legal-theory-collaborative-research-network-january-2012/ .
Daniel A. Farber, Environmental Disasters: An Introduction, SSRN
Ed Richards, Legal Strategies to Manage Obesity and Increase Physical Activity, SSRN
Joanna Sax, Financial Conflicts of Interest in Science, SSRN
Leonard Glantz & George Annas, Impossible? Outlawing State Safety Laws for Generic Drugs, NEJM
Thursday, August 11, 2011
Limiting Use of Antibiotics in Food Animal Production After Recall of 36 Million Pounds of Turkey Containing Antibiotic-Resistant Salmonella
Finding antibiotic-resistant Salmonella in ground turkey prompted Cargill's 36 million pound turkey recall. It also triggered a new sense of urgency on the part of lawmakers to encourage the FDA take action on a draft guidance, "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals," otherwise known as "Guidance #209."
Previously blogged about here and here, recent estimates indicate around 80 percent of all antibiotics in the U.S. are given to food animals causing a huge and growing problem with antibiotic resistant bacteria. According to Food Safety News,
Guidance #209, as it was released last summer, recommends two principles: (1) The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that are considered necessary for assuring animal health, and (2) The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation.
The letter from the lawmakers urges that the FDA make "speedy progress forward" on Guidance #209 regulations to help preserve the efficacy of antibiotics for human health:
We recommend that you strengthen Guidance #209, finalize it quickly, and move on to regulations. Given the rise of antibiotic resistant pathogens, we cannot wait any longer for the finalization of Guidance #209.
The Indiana University School of Law – Indianapolis' Hall Center for Law and Health is launching a major initiative in biomedical and health industry compliance law. To launch the program, the Hall Center is convening an Inaugural Biomedical and Health Industry Law and Compliance Conference on September 21, 2011 at the law school. The focus of the conference is law and compliance, with special emphasis on emerging compliance trends, fraud and abuse, enforcement and pharmaceutical and manufacturing issues. The keynote speaker is Joyce R. Branda, Director of the Fraud Section of the Commercial Litigation Branch at the U.S. Department of Justice, who will speak on “Health Care Reform and Health Care Fraud Enforcement.” More information here.
The Consortium on Law and Values at the University of Minnesota Seeks Applicants for the Associate Director for Research & Education Position
The Consortium on Law and Values in Health, Environment & the Life Sciences builds on the strengths of 19 centers and programs, establishing a national identity for the University of Minnesota as a leading institution working on the societal implications of developments in health, environment, biomedicine, and the life sciences. The Consortium is seeking outstanding applicants for the Associate Director for Research & Education position. The Associate Director conducts research relating to law, biomedicine, the life sciences, and bioethics; collaborates on grants, including identifying funding opportunities; generates original scholarship; teaches and mentors graduate and professional students; and may serve as Faculty Editor-in-Chief of the Minnesota Journal of Law, Science & Technology. Application review will begin September 30. The full position description and application instructions are here. [KVT]
Wednesday, August 10, 2011
According to the WSJ Health Blog, "the U.S. economy added more jobs than expected last month. And the health-care industry showed particular strength, with 31,300 new jobs — higher than the average monthly increase seen in 2007, before the recession hit." [KVT]
The American Society of Law, Medicine & Ethics (ASLME) is proud to announce that online registration is now open for the upcoming national conference entitled “Conflicts of Interest in the Practice of Medicine and Medical Research.”
Researchers, clinicians, and the public are increasingly concerned about the effects of conflicts of interest in medicine. Studies have shown that sources of financial support impact the design and outcomes of biomedical research and the reporting of results. Physicians’ financial relationships can strongly affect the care they provide to patients. Because eliminating potential conflicts of interest is essentially impossible and may even be harmful, some have called for enhanced transparency about conflicts, while others have sought more strict regulation in this field. Innovative perspectives on managing conflicts of interest in medicine have emerged from an array of disciplines, including physicians, lawyers, economists, and other social scientists, but there have been few opportunities for members of these fields to share their ideas in one forum. The ASLME conference seeks to bring these disparate points of view together to inform and shape policy on this topic.
The conference is generously funded by a grant from the Highmark Foundation of Pittsburgh, Pennsylvania, with additional funding contributed by the Jewish Healthcare Foundation and by The University of Pittsburgh School of Law. The conference is scheduled for October 27-28 in Pittsburgh.
Conference Goals: This one-and-a-half day conference will feature an array of recognized national experts from academia who will discuss, debate, and propose best practices and approaches to the problem of conflicts of interest. This conference intends to foster a cross-disciplinary perspective on pertinent issues, and by the end of the conference, attendees will (1) learn about current consensus panel recommendations regarding management of conflicts of interest, (2) be able to describe remaining challenges to regulating conflicts of interest in key areas of research and medical practice, and (3) help fashion recommendations for the key players and identify other key steps in moving forward. The findings of the conference will be published in a special issue ofThe Journal of Law, Medicine & Ethics, a leading health law journal read by many academics and policymakers in this field.
If you have any questions or would like more information about the conference, please email Katie Johnson at email@example.com. [KVT]
In one of the many ways nanotechnology is being used to improve our world, a new line of defense to sexual assault has been developed by scientists. This tool is an easy-to-use sensor that, when dipped into a cocktail, will instantly detect the presence of a date rape drug. When ready for commercial purchase in just a few years, the sensor will be lightweight and discreet, easily transportable in a pocket or purse.
According to ScienceDaily,
With rates of drug-assisted sexual assault growing around the world, it's a dangerous social problem in desperate need of a solution .... According to the U.S. Department of Justice, some 200,000 women were raped in the US in 2007 with the aid of a date rape drug -- and because so many cases go unreported, the actual number is believed to be 80 to 100 percent higher.
Tuesday, August 9, 2011
Move over, Daubert -- here’s an interesting article in the online American Medical News about states tightening up expert testimony in medical liability cases.
Florida is the latest state to pass restrictions on the use of expert witnesses in medical liability cases. Under a law signed July 1 by the governor, out-of-state physicians offering expert testimony must apply for a certificate to testify. The state medical board can discipline them if they provide deceptive testimony.
"Before, there was absolutely no accountability for what [expert witnesses] did in Florida," said Jeff Scott, general counsel for the Florida Medical Assn. With the new law, "you can't come into Florida and testify falsely and hope to get away with it."
At least 30 states have similar expert witness laws. Some statutes, such as Arizona's, require witnesses to practice in the same specialty as the physician defendant. Others, like Maryland's, mandate that doctors spend a certain amount of time actively practicing medicine
Monday, August 8, 2011
the blog is meant as a forum for thoughtful dialogue on pressing issues in health law and policy. It will also be an additional venue for us to keep in touch with our friends and colleagues on current events at the O’Neill Institute, including highlights from our robust research program, graduate degree program, fellowship program, and institute scholarship.
Launched in 2007, the O’Neill Institute at Georgetown University has blossomed into the premier academic research center for national and global health law and policy. Our research encompasses a diverse range of national and global health law topics, from health reform in the US and China, tobacco control globally and in Latin America, global infectious and non-communicable disease prevention, and global health governance. The UN Secretary General recently endorsed the founding vision of the O’Neill Institute—a Framework Convention on Global Health.
Click this link to sign-up for an RSS feed. [KVT]
I had no idea that scorpion stings were so frequent and that there was no treatment -- until now. According to a press release about the new product called Anascorp, produced by a Mexican company called Instituto Bioclon and licensed to Rare Disease Therapeutics:
[v]enomous scorpions (Centuroides) in the U.S. are mostly found in Arizona. Severe stings occur most frequently in infants and children, and can cause shortness of breath, fluid in the lungs, breathing problems, excess saliva, blurred vision, slurred speech, trouble swallowing, abnormal eye movements, muscle twitching, trouble walking, and other uncoordinated muscle movements. Untreated cases can be fatal.
Hat tip to Clifford S. Mintz, PhD over at BioJobBlog. [KVT]
Addressing water quality and quantity issues throughout the world is critical to achieving the United Nations Millennium Development Goals. According to the U.N.World Water Assessment Programme (WWAP) fact page, the availability of accessible, adequate supplies of clean water play a key role in achieving all eight goals. Some of the links between water and the goals are obvious: eradicating extreme poverty and hunger, improving health, reducing mortality, fighting disease, and achieving environmental sustainability, which are a large proportion of the goals, require the availability of water for sanitation, growing crops, and maintaining ecosystems. But even achieving universal primary education and promoting gender equality, goals 2 and 3, rely on water availability: WWAP indicates that children, often girls, are frequently prevented from attending school because they are in charge of collecting domestic water at home, plus there is often a lack of separate toilet facilities at schools.
The United States has a critical role to play in improving international water resource management. A recent presentation to the Universities Council on Water Resources (UCOWR) and National Institutes for Water Resources (NIWR) by the Director of the U.S. Army Corps of Engineer’s Institute for Water Resources, Robert Pietrowsky, available here, describes how the U.S. is accepting this role. Mr. Pietrowsky made a compelling case for the importance of improving water management, pointing out that:
- About one out of six, ~ 1 billion people, lack access to safe water;
- 80% of diseases are carried by water;
- Over 90% of deaths from diarrheal diseases in developing world are children under 5 yrs old;
- A child dies every 20 seconds from waterborne disease;
- 3-5 million people dying annually from this, with $125 billion in workday losses/yr;
- Millions of women and children spend several hours per day collecting water from distant, often polluted sources;
- In just one day, more than 200 million hours of women’s time is consumed collecting water for domestic use;
- 443 million school days are lost each year due to water-related illness.
One of the most encouraging revelations in the presentation is that the U.S. Government is committed to increasing its role in improving world water resources. Much of this is due to the Senator Paul Simon Water for the Poor Act signed into law in 2005, which makes access to safe water and sanitation for developing countries a specific policy objective of U.S. foreign assistance programs. And, following commitments made in Secretary of State Hillary Clinton’s speech on World Water Day 2011, the U.S. Agency for International Development (USAID) is preparing a new water strategy based upon
- Strengthening institutional and human capacity;
- Mobilizing financial support;
- Advancing science and technology & sharing U.S. expertise;
- Building partnerships that deliver meaningful results on the ground; and
- Identifying priority countries and key approaches for achieving U.S. government objectives.
Finally, Mr. Pietrowsky also pointed that the U.S. National Military Strategy offers more justification to address world water needs, since it identified water scarcity as an increasing threat to governance, and water shortage, floods, and natural disasters caused by climate change are also causes of destabilized governments and thus threats to national security. These all justify U.S. involvement in promoting and supporting effective integrated water resource management in other countries. To respond to that need, The IWR has set up an International Center for Integrated Water Resource Management, a consortium operating under the auspices of UNESCO, to address water security and other water-related challenges by regional and global action.
Teaching international environmental law is often depressing when it comes time to cover the role that the US plays in international environmental agreements, since we have refused to become parties to so many of them. For example, the Senate has not ratified the Convention on Biological Diversity, the Kyoto Protocol to the U.N. Framework Convention on Climate Change or the U.N. Convention on the Law of the Sea. Congress has not even passed a climate change bill that would begin to fulfill some of the commitments it made under the UNFCCC, to which the U.S. is a party. However, many U.S. agencies are quietly playing their role in helping to address global environmental problems, and it is good news that the Army Corps of Engineers is taking a lead role in helping improve global water resources.
For most patients, mental capacity to make medical decisions either clearly exists or is clearly absent. But for a number of patients, including those with developing Alzheimer disease, it may not be obvious whether mental capacity is present.
How accurate are physicians at detecting a patient's incapacity? A recent review-of-the-literature study found that physicians “missed the diagnosis in 58% of patients who were judged incapable” in a formal, independent assessment. On the other hand, physicians generally were correct when they made a diagnosis of incapacity. The researchers also found that the best formal assessment tool for measuring capacity is the Aid to Capacity Evaluation. Laura L. Sessums, Does This Patient Have Medical Decision-Making Capacity?, 306 JAMA 420 (2011).
Sunday, August 7, 2011
I would like to thank Katharine Van Tassel for inviting me to contribute to the Health Law Profs Blog as a guest blogger. I am excited to have the opportunity to participate in this forum! Over the next few weeks, I will discuss intellectual property as it relates to global health and trade. I will start with a brief introduction to some of the issues before addressing specific topics in subsequent posts.
How does intellectual property relate to public health? Pharmaceutical companies invest tremendous financial resources in the research and development of new drugs and they seek to recover some of these costs through the market exclusivity they obtain through patent protection. In this way, these private intellectual property rights are seen to stimulate innovation. However, in the debate about the impact of minimum global standards for intellectual property rights, and patents in particular, the issue of health and access to medicines has presented one of the most powerful and compelling arguments against the global development and enforcement of high intellectual property standards.
Prior to the birth of the WTO in 1995, each nation was largely free to determine the appropriate level of intellectual property protection in light of its national goals and interests. The international agreements on intellectual property that pre-dated the WTO, such as the Paris Convention for the Protection of Industrial Property and the Berne Convention for the Protection of Literary and Artistic Works did not prescribe enforceable minimum intellectual property standards. When the WTO Agreement on Trade-Related Intellectual Property Rights (TRIPS) entered into force in 1995, WTO members were required to provide a certain standardized level of intellectual property protection. While implementation delays of 5 years and 9 years were provided for developing and least developed countries respectively, this has not proven to be sufficient. Further, if a member state fails to comply with it obligations under the WTO Agreements, other member states can initiate a dispute using the WTO dispute settlement mechanism.
For instance, in May 2010, Brazil and India filed complaints against the European Union (EU) and the Netherlands at the WTO over the confiscation of generic drugs in transit. The EU border seizures were part of its intellectual property enforcement program. The drugs in question were not patent protected in either the point of origin or the final destination. Brazil and India cited a number of provisions under TRIPS in support of their complaints. Neither of these cases has proceeded to a dispute settlement panel, and the dispute between India and the EU was settled last week.
Prior to these recent complaints, standardized intellectual property rights under the WTO resulted in health-related dispute settlement cases like the 2001 Canada – Patent Protection of Pharmaceutical Products case in which the Government of Canada sought to defend the regime it had in place in order to allow the quick entry of generic drugs into the market. According to the EU, the rights of the patent holder to the full 20-year patent monopoly were not being respected as required by TRIPS. According to Canada, the rights of the patent holder should not take precedence over the public interest in access to low cost medicines. Ultimately, the case was decided primarily based on the interests of the patent holder.
Since that time, the WTO member states have acknowledged, through the Doha Declaration on the TRIPS Agreement and Public Health, the relationship between intellectual property rights and public health.
 Although the General Agreement on Tariffs and Trade (GATT) has been around since 1947, its successor, the WTO did not come into being until 1995. Intellectual property rights were also first merged with international trade framework with the creation of the WTO in 1995.
The Health Law Prof blogging team would like to welcome our guest blogger for the month of August, J. Janewa OseiTutu. Here is a short bio:
J. Janewa OseiTutu is currently a Visiting Scholar at the University of Pittsburgh School of Law and an attorney with the Department of Justice in Ottawa where she provides legal advice to the equivalent of the Department of Commerce. She had advised on legal issues relating to copyright, trademark, and patent law, policy and procedure as well as on legal issues relating to patented medicines and infringement. In addition, Ms. OseiTutu has expertise on geographical indications, traditional knowledge, genetic resources, and has advised on submissions to the World Intellectual Property Organization, been a delegate to the World Trade Organization TRIPS Council, and member of negotiating team in bilateral trade negotiations between Canada and the European Union. From 2009-2011, she was a Visiting Assistant Professor at the University of Pittsburgh School of Law where she taught International Intellectual Property, International Trade and Estates & Trusts. Prior to that she clerked for the Hon. Judge Emile Short, and the Judges of Trial Chamber II at the United Nations International Criminal Tribunal for Rwanda in Tanzania.
Ms. OseiTutu holds an LL.M. (Distinction) in International and Comparative Law from McGill University, with a focus on trade-related intellectual property. She has a J.D. from Queen’s University in Kingston, and a B.A (Hons.) from the University of Toronto. Her scholarship intersects intellectual property law, intangible cultural property, trade law, and international development. She has published articles on intellectual property, bio-piracy and traditional knowledge. Ms. OseiTutu’s recent article, Value Divergence in Global Intellectual Property Law (forthcoming Indiana L.J. 2012), considers the influence of societal values, including values regarding healthcare and education, on domestic views about the appropriate role of intellectual property law in society.
The Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School Seeks Distinguished Candidates for the 2012-2014 Academic Fellowship Program
The Petrie-Flom Center is an interdisciplinary research program at Harvard Law School dedicated to scholarly research at the intersection of law and health policy, including issues of health care financing and market regulation, biomedical research and bioethics. The Academic Fellowship is a postdoctoral program specifically designed to identify, cultivate and promote promising scholars early in their careers. Fellows are selected from among recent graduates, young academics and mid-career practitioners who are committed to spending two years at the Center pursuing publishable research that is likely to make a significant contribution to the field of health law policy, medical innovation policy or bioethics. Our prior fellows have found employment as law professors at Harvard, UC Berkeley, BU, UCLA, Cornell and the University of Arizona. More information on the Center can be found here.
Petrie-Flom fellowships are full-time, two-year residential appointments offering a $60K annual stipend and other research support. Fellows devote their full time to scholarly activities in furtherance of their individual research agendas. The Center does not impose teaching obligations on fellows, though in appropriate cases voluntary teaching opportunities may be made available. For further information on the program and eligibility requirements, please see the full Call for Applications here.
In this article, Kahn describes the technical operation of important portions of the individual healthcare mandate, including the application of the penalty provision. Kahn finds that there are problems with the technical drafting of that provision and that serious gaps and ambiguities abound.
All Tax Analysts content is available through the LexisNexis® services. [KVT]
Saturday, August 6, 2011
Restrictive covenants in employment contracts describe a class of ancillary agreements between employers and employees whereby the employee agrees not to compete with the employer after termination of the contract. Typically the non-compete clause contains a limit on the duration, scope of activity, and geographic area to which it extends. Nationally, there is widespread criticism of the use of restrictive covenants in physician employment contracts because of the potential harm to the public. Here, we offer medical workforce shortages as yet another reason to discourage non-compete agreements in this context. We describe the national and local shortage. We will briefly outline the origin and purpose of restrictive covenants and discuss the state of the law in Hawai‘i, and propose a legislative solution.