- Haavi Morreim, Dumping the ‘Anti-Dumping’ Law: Why EMTALA Is (Largely) Unconstitutional and Why It Matters, SSRN/Min. J L Sci Tech
- David Orentlicher, Health Care Reform and Efforts to Encourage Healthy Choices by Individuals, SSRN/N Carolina L Rev
- Kevin Outterson, New Business Models for Sustainable Antibiotics, SSRN/Centre on Global health Security Working Group Papers
- Diana Winters,The Magical Thinking of Food Labeling: The NLEA as a Failed Statute, SSRN
Jennifer is the Alvin R. Allison Professor of Law and Director, Health Law Program, 2003 and an Associate Professor (adjunct), Department of Psychiatry, TTU School of Medicine. She was formerly Associate Dean for Faculty Research and Development. She is the Director, Health Law Program and JD/MD Program at the law school. In 2009 Professor Bard was elected as a member of the American Law Institute and was also awarded the Texas Tech University President’s Excellence in Teaching Award. In 2008 she received the award for the Best First Year Teacher from the Phi Alpha Delta Law School Honors Fraternity. She is the chair-elect of the American Association of Law School’s section on Law, Medicine, and Health Care. She is also the Book Review editor of the Journal Of Legal Medicine.
Representative publications: Continue reading
For those of you following the contraceptives coverage mandate litigation:
Later this month, the Supreme Court will hear two cases from for-profit corporations, Hobby Lobby Stores and Conestoga Wood Specialties, challenging the Affordable Care Act’s (ACA) requirement to cover contraceptives on religious grounds. On Tuesday, March 11, two weeks before the hearings, the Kaiser Family Foundation will host a public briefing and panel discussion from 9:30am-11:00am ET in its Washington, DC office to discuss the implications of these court cases on the ACA, corporate and individual religious protections, and civil rights. For those unable to attend, a live webcast will be hosted on kff.org.
Welcome and Introduction Alina Salganicoff, Ph.D. (Moderator),Vice President and Director, Women’s Health Policy, Kaiser Family Foundation
An Overview of the Contraceptive Coverage Requirement and Legal Challenges Laurie Sobel, J.D., Senior Policy Analyst, Women’s Health Policy, Kaiser Family Foundation
The Religious Freedom Restoration Act and its Application to These Cases Marci A. Hamilton, J.D., Paul R. Verkuil Chair in Public Law at the Benjamin N. Cardozo School of Law, Yeshiva University
Possible Rulings and Outcomes Tom Goldstein, J.D., Publisher SCOTUSblog, Partner Goldstein & Russell, P.C.
Panel Discussion on Implications
When: Tuesday, March 11, 9:30am-11:00am ET, (Registration and breakfast beginning at 9:00am)
Where: Barbara Jordan Conference Center, Kaiser Family Foundation Offices, 1330 G Street, NW, Washington, D.C., (one block west of Metro Center)
Live Webcast: A live webcast will be available on kff.org.
Tuesday, March 11, 2014, 12:00pm
Wasserstein Hall 3018, Harvard Law School, 1585 Massachusetts Ave.
The DSM is the reference used by clinicians, researchers, and insurers to diagnose and classify mental disorders, with the intent to provide specific, objective criteria by which to assess symptoms and determine whether to pay for treatment. The American Psychiatric Association released the manual’s fifth edition in May 2013, nearly twenty years after the fourth edition, to substantial public and professional criticism. Please join us for a discussion of the new revisions and their implications for patients, medical practice, research, and the law.
- Steven E. Hyman, Director of the Stanley Center for Psychiatric Research at the Broad Institute and Harvard University Distinguished Service Professor of Stem Cell and Regenerative Biology
- Anne Becker, Maude and Lillian Presley Professor of Global Health and Medicine, Harvard Medical School
- Nita Farahany, Professor of Law, Professor of Genome Sciences & Policy, and Professor of Philosophy at Duke University
- Moderator: I. Glenn Cohen, Professor of Law, Harvard Law School; Faculty Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics
This event is free and open to the public. Lunch will be provided. For questions, contact email@example.com or 617-496-4662.
This event is supported by the Oswald DeN. Cammann Fund.
By Alex Stein
Two days ago, the Appellate Court of Connecticut affirmed the dismissal of an indigent plaintiff’s action to void a statute requiring plaintiffs to support malpractice suits against medical professionals by an opinion letter from a similar healthcare provider. The plaintiff claimed that this statute, Conn. General Statutes § 52–190a, is unconstitutional insofar as it applies to indigent plaintiffs who cannot afford paying medical experts’ fees. The plaintiff filed this action against the State of Connecticut, a number of state legislators and courts, and the Connecticut Medical Insurance Company. He asked the court to grant him declaratory judgment, injunctive relief, and compensation.
The court dismissed the action due to the presence of the sovereign and legislative immunities and the plaintiff’s failure to show a violation of his constitutional entitlement. The Appellate Court affirmed that decision. Traylor v. Gerratana, — A.3d —-, 2014 WL 839165 (Conn.App. 2014).
In most states, similar merit-affidavit requirements presented no constitutional problems. Arkansas, Oklahoma, and possibly Florida are exceptions. Expert testimony is a must in nearly every medical malpractice case: proof of malpractice and causation is virtually never possible without an expert. Asking plaintiffs to upfront their expenditure on that testimony doesn’t strike me as too onerous.
The merit-affidavit requirement does not worsen the dismal situation of indigent plaintiffs. There is no reason to believe that a plaintiff who cannot hire an expert ahead of trial would somehow become able to do so when his case goes to trial. At both points in time, he will depend on charity and litigation funding. The legal system should eliminate this dependency and the consequent denial of access to justice to the poor. Things are bad enough when the haves come out ahead most of the time. Allowing a malpractitioner to go scot free when the patient he injured is too poor to file a suit will make things much worse.
Hand-washing is one of the mainstays of public health and of good clinical practice. Images of surgeons with their hands raised in the air, as they enter the OR to have a nurse help them don sterile latex gloves after having meticulously washing their hands, have been immortalized by pop-culture representations of medicine. Indeed, learning the “surgical hand-wash” is one of the glorified coming-of-age rituals for med students. It quite literally initiates aspiring physicians into being legally and morally allowed to cut people open for their own benefit.
Proper hand-washing is crucial for non-surgical clinical practice as well. At my hospital, clinicians are supposed to wash or sanitize their hands as soon as they enter a patient’s room, and after they have made any contact with a patient. And although the procedure for “clinical hand-washing” is much less thorough than its surgical counterpart, there’s still an evidence-based, 11 step process that WHO officially recommends in its annual “SAVE LIVES: Clean Your Hands Campaign.“
The rationale for all this rigor in medical practice is pretty obvious, and any hospital-based physician who doesn’t have overly dry skin without moisturizing is probably shirking an important responsibility. However, the clinical obsession over asepticism has spilled over to mainstream culture, but not without some controversy.
Relax: I’m not going to get into the debate over the hygiene hypothesis. I’m also not even going get back on the bacterial-resistance soapbox (except for one quick point–although asepticism in clinical settings certainly does help prevent resistance, it might be counterproductive beyond the clinical setting as wiping out benign bacteria might simply open more ecological space for nastier bugs).
I just want to point out that simple repugnance is probably a better explanation for the hygiene-neurosis of current times than any legitimate public health concern. Normal people today would probably have seemed like obsessed germophobes fifty years ago. What’s interesting is there’s lots of neat evidence that even the most visceral types of disgust are socially constructed. For example, Norbert Elias’ treatise on snot in “The History of Manners” (1982) describes dinner-table behavior that was deemed perfectly polite by in the most sophisticated European social circles of previous centuries, but which would probably make even the coarsest sailor of today vomit in disgust. I’ll leave you with some highlights, taken from pages 143-148 of this wonderful (yet long, two volume) work by Elias.
By Chloe Reichel
The majority of people in La Crosse, Wisconsin have advance directives. The initiative to increase the utilization of advance care planning began as a way of helping patients, but resulted in large decreases in health care expenditures.
Due to Texas’ recently passed regulations on abortion clinics, two clinics closed this week. Abortion clinics in Texas are required to have a physician with admitting privileges at a hospital within 30 miles of the clinic under the new regulations.
A new law passed recently in Arizona would limit access to medication used for medical abortions. Planned Parenthood of Arizona filed a lawsuit this Wednesday to contest the law.
An HIV-positive baby treated with aggressive drugs immediately after birth was reportedly cured of the disease. This is the second such case of this treatment working, and is a promising development for the future of HIV treatment.
On Wednesday it was announced that Americans will be allowed to keep insurance plans that are not compliant with the Affordable Care Act. These plans will continue to be offered for the next two years.
Two surveys have found that uninsured Americans largely have not signed up for insurance following the implementation of the Affordable Care Act. Some suggest that the changes to the new healthcare law that have occurred since its adoption may be responsible for these low rates of enrollment.
In Washington state, people who operate medical marijuana dispensaries are worried about the effects of the state’s recent legalization of recreational marijuana. They worry that the increased demand for marijuana will put smaller dispensaries out of business.
Twenty-six states have introduced mandatory programs that emphasize private long-term care over nursing homes. Many states have modeled their plans after Tennessee, but long-term care in this state is suboptimal for many residents.
Check out the March 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.
March 20-21, 2014
Harvard School of Public Health
677 Huntington Avenue
Boston, MA 02115
This event will be webcast. Link will be posted here on March 20 and 21.
To register, click here. There is no charge for registration.
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Sunstein to be Keynote Speaker
We are pleased to announce that Cass R. Sunstein will be the keynote speaker for HCRA’s Risk, Perception, and Response conference. Mr. Sunstein is the Robert Walmsley University Professor at Harvard and founded the Program on Behavioral Economics and Public Policy at Harvard Law School. He is the author of numerous articles and books, includingNudge: Improving Decisions about Health, Wealth, and Happiness (with Richard H. Thaler, 2008) and most recently Simpler: The Future of Government (2013). From 2009 to 2012, he was Administrator of the White House Office of Information and Regulatory Affairs.
How people react to scientific evidence of risk is mediated by many factors, including how risk information is perceived and communicated, how we react to social and cultural influences, and how choices are structured. Examples abound of situations where individuals’ risk perceptions lead them to act in ways that appear contrary to their own interests, overreacting to or neglecting risks. How can situations in which individuals are likely to respond poorly be identified, and what can be done to improve their responses? To increase our understanding of the factors that contribute to these behaviors and to develop better options for fostering sound decisions, the Harvard Center for Risk Analysis commissioned a series of papers that will be presented at this March 20-21, 2014 conference.develop better options for fostering sound decisions, the Harvard Center for Risk Analysis commissioned a series of papers that will be presented at this March 20-21, 2014 conference.
Click here to view the detailed agenda.
By Ching-Fu Lin
Last month, the Food and Drug Administration (FDA) published a draft methodological approach for designating high-risk foods (HRFs) as required by section 204(d)(2) of the Food Safety Modernization Act (FSMA). HRFs identified by the FDA are subject to additional record-keeping requirements, and more frequent foreign inspections and mandatory third-party certification requirements. The FDA is seeking comments, scientific data, and information from stakeholders to revise this draft HRF approach and to create a preliminary HRF list.
Among many available risk tools (e.g. qualitative, semi-quantitative, and quantitative methods), a semi-quantitative risk ranking model has been selected by the FDA as the most appropriate methodology for the HRF list. There are many reasons for choosing this model, including the fact that – as explained by the FDA – it is “data-driven and comprehensive, using explicit criteria related to public health risk; … adaptive to a variety of hazards; and … flexible to consider different foods or categories of food.”
Based on the draft semi-quantitative risk ranking model, the FDA is considering and evaluating a set of seven criteria that match the factors specified in section 204(d)(2)(A) of FSMA: Continue reading
By Deborah Cho
[See Part I here]
Last week, I wrote the first of a two-part series on tips that may be helpful for law students and lawyers interested in or working in health/medical law. I continue with Tip #4 here.
4. If you need to learn about a disease, procedure, or drug that you know nothing about, your best starting point is probably Wikipedia. Google will lead you to some incorrect answers, and diagnose-yourself websites will give you answers that are much too broad to use practically in legal practice. Once you have familiarized yourself with the general topic on Wikipedia, you can then go back to your search engine of choice for more specific terms and weed out the wrong information. Starting on PubMed or GoogleScholar probably isn’t the best idea either because most of what you’re reading will be highly technical and the articles you find will likely be about novel uses or instances of whatever you’re searching. Another fantastic source is UpToDate, an evidence-based Wikipedia-like source for healthcare providers, but many people may not have access to all the information on this site.
By Kate Greenwood
Cross-Posted at Heath Reform Watch
Lately it seems that each passing day brings another article about the cost of orphan drugs. Earlier this week at FiercePharma, Tracy Staton reported that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has asked Alexion Pharmaceuticals to justify the price of its drug Soliris which is, per Staton, “the most expensive drug in the world” at around $569,000 a year. Specifically, NICE seeks “‘clarification from the company on aspects of the manufacturing, research and development costs’” of the drug. According to Staton, this latest development in a review process characterized by “halting progress” is “a departure from NICE’s usual calculations, which typically focus on quality-of-life years and the like.”
Pushback by NICE and other payers notwithstanding, the orphan drug market is growing. As I blogged about here, in 2013 EvaluatePharma estimated that “the worldwide orphan drug market is set to grow to $127 [billion], a compound annual growth rate of +7.4% per year between 2012 and 2018[,]” which “is double that of the overall prescription drug market, excluding generics, which is set to grow at +3.7% per year.” In a recent article in the New England Journal of Medicine, venture-capital investors Robert Kocher and Bryan Roberts note that “more than half of the 139 drugs approved by the FDA since 2009 are for orphan diseases” and suggest that there is a risk of “systematically underinvesting in other important areas of medicine.”
Kocher and Roberts’ explain that one reason that orphan drugs attract investment is that their development costs are low. The problem or potential problem of underinvestment in diseases like depression and diabetes could therefore be addressed, they contend, by bringing the cost of developing treatments for these common conditions in line with the cost of developing treatments for rare diseases. And, they argue, one promising approach to doing so is to reduce clinical trial costs by reducing the size of clinical trials. Continue reading
By Alex Stein
In a recent case, Lawrence v. Mountainstar Healthcare, — P.3d —-, 2014 WL 685594 (Utah App. 2014), Utah’s Court of Appeals sharpened the distinction between two categories of doctors’ statements: (1) “we messed up” statements that acknowledge a complication or fault; and (2) statements expressing the doctor’s benevolence and apology for what happened to the patient. The Court held that fault statements are admissible as a party admission, whereas apology statements are privileged under Utah’s “apology rule”: Utah Code Ann. § 78B–3–422, Utah R. Evid. 409. The “apology rule” renders privileged care-providers’ statements that express “apology, sympathy, commiseration, condolence, or compassion; … and a general sense of benevolence”; or describe “the sequence of events relating to the unanticipated outcome of medical care.”
The Court carried out this analysis in connection with a patient’s malpractice suit against a hospital. The Court ruled that the patient was entitled to adduce the hospital’s “we messed up” statements that acknowledged its nurse’s negligence (but nevertheless dismissed the patient’s appeal).
This decision presents an interesting puzzle. Under Utah law, when a doctor approaches his patient’s spouse and says “I am sorry we messed up,” this sentence will be redacted into the privileged “I am sorry” and the unprivileged “We messed up.” This approach motivates doctors to formulate their apologies narrowly and never apologize spontaneously. But calculated apologies are not what the “apology rule” wanted to incentivize. Calculated apologies are lacking the genuine apologies’ virtue and benefit the patient and her family only when the doctor is insincere. This undesirable consequence is an example of what T.M. Scanlon calls “the teleological paradox” in his book What We Owe to Each Other (1998).
[Ed. Note: On Friday, February 21, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean's Office at Harvard Law School) co-sponsored a conference at HLS called "New Directions for Food Safety: The Food Safety Modernization Act and Beyond." This is the final installment in a series of blog posts from the event; video will follow shortly.]
Dov Fox had a terrific post about taxes on compensation for those who donate eggs and sperm a few weeks ago in reaction to Perez v. Commissioner. I don’t have any particularly new thoughts on this area, but for those of you who haven’t already seen it, I wanted to share the excellent mini-symposium that recently concluded over on the Faculty Lounge on this topic. Kim Krawiec organized, and there’s a series of great posts by several scholars, pointing out, among other things, the strangeness of the fact that there’s still quite a lot of uncertainty about these issues, even though they’ve been around for a while and are not particularly rare. In any case, it’s very much worth reading, even for those who aren’t normally tax wonks.
American University Washington College of Law’s seventh annual Health Law & Policy Summer Institute will run from June 16 to June 28. The Institute’s flexible schedule includes day, evening, and online courses focusing on: (1) pharmaceutical law, (2) bioethics, (3) health care fraud and compliance, and (4) the economics of health care reform.
The O’Neill Institute for National and Global Health Law at Georgetown University is pleased to present two programs this summer: (1) Emerging Issues in Food and Drug Law and (2) U.S. Health Reform – The Affordable Care Act. Now in its third year, the Summer Programs will convene leading practitioners, policymakers, advocates and academics in global food and drug law and US health reform for a series of interactive lectures, panel discussions, and case studies. Held during consecutive weeks, July 14-18 (Emerging Issues in Food and Drug Law) and July 21-25 (US Health Reform – The Affordable Care Act), interested participants may attend one or both programs. Additional details, including schedule, speakers, online application, and program fees may be found here. Questions may be directed to firstname.lastname@example.org.
The Hamline University School of Law Health Law Institute is pleased to offer a variety of condensed health law courses taught by academic and industry experts in Saint Paul, MN. Courses include: (1) Health Care Compliance Institute, (2) Biotechnology Policy, (3) Elder Law, and (4) Health Care Fraud and Abuse. Courses will run from May 27th through June 28th. Additional information, including the application and course descriptions can be found here.
“The Right to Life and the Inter-American Court of Human Rights”
When: March 5, 2014, 12:00-1:00 p.m.
Where: Wasserstein Hall 3007, Harvard Law School, 1585 Massachusetts Ave.
Please join us for a brown bag talk with Professor Paola Bergallo, Faculty of Law, Universidad de San Andrés, Buenos Aires, and HRP Visiting Fellow. Bergallo served as an expert witness in the landmark case Artavia Murillo et al. (“In Vitro Fertilization”) v. Costa Rica, which discusses human rights definitions regarding the right to life, among other health and human rights matters. Professor Gerald Neuman of Harvard Law School will moderate.
This event is being co-sponsored by Harvard Law Students for Reproductive Justice and HLS Advocates for Human Rights.
Official Press Release:
Atlanta – Georgia State University College of Law and its Center for Law Health & Society have selected 10 faculty fellows to participate in the Future of Public Health Law Education: Faculty Fellowship Program. The program is funded by the Robert Wood Johnson Foundation to foster innovations and build a learning community among those who teach public health law at professional and graduate schools. For more information, visit law.gsu.edu/phlfellowship.
The fellows, chosen from across the country, will develop interdisciplinary courses and programs in public health law at their respective universities during the fellowship year. Their projects will strengthen interdisciplinary education in public health law and promote collaborations with public health agencies and organizations in the fellows’ communities.
The fellows are:
In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year. While the approval represents a major step forward, the PillCam is unlikely to supplant current procedures just yet.
The colon has traditionally been examined via optical colonoscopy, a procedure perceived by many to be uncomfortable and embarrassing that involves insertion through the rectum of a 5-6 foot long flexible tube as part of an examination that can take 30 to 60 minutes. Air must be pumped in through the rectum in a process called “insufflation.” Sedatives and pain medication are generally used to help relieve discomfort. In contrast, the PillCam COLON contains a power source, light source, and two tiny cameras encapsulated in an easy-to-swallow pill that produces no pain or even sensation as it moves through the colon. Reflecting the absence of discomfort, one report from a clinical researcher noted that a few patients have insisted on X-rays to confirm that the device had passed in their stool (FDA Consumer). The pill takes about 30,000 pictures before passing naturally from the body, which usually occurs before the end of its 10-hour battery life.
The safety record of capsule endoscopy, the category to which the PillCam COLON belongs, so far appears to compare favorably with the alternatives. Capsule endoscopy may be less likely to produce accidental colonic perforations or other serious complications, which occur in less than 1% of traditional colonoscopies despite the best efforts of the treating physician. Tears of the colon wall can in turn “rapidly progress to peritonitis and sepsis, carrying significant morbidity and mortality.” (Adam J. Hanson et al., Laparoscopic Repair of Colonoscopic Perforations: Indications and Guidelines, 11 J. Gastrointest. Surg. 655, 655 (2007)). Splenic injury or other serious complications also occur rarely with optical colonoscopies. Unlike “virtual colonoscopy,” which uses computed tomography (CT) to peer into the body, capsule endoscopy does not involve bombarding the body with radiation. A leading study published in the New England Journal of Medicine reported no serious adverse events among 320 subjects given the PillCam COLON, and concluded that use of the device was “a safe method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation.” Continue reading