October 19, 2012
Worth Reading This Week
- Tim Jost, The Internal Revenue Service’s Implementation and Administration of the Democrat’s Health Care Law, SSRN/Hastings Center Report
- Leslie Francis, When Patients Interact with EHRs: Problems of Privacy and Confidentiality, SSRN/Houston Journal of Health Law and Policy
- Ernest Young, Sorrell v. IMS Health and the End of the Constitutional Double Standard, SSRN/Vermont L.Rev.
- Michelle Mello & Glenn Cohen, The Taxing Power and the Public's Health, NEJM
Tools for Teaching the Fungal Meningitis Outbreak
I’m sure many of us are talking about the contaminated steroid injections which have spread a fungal form of meningitis Exserohilum rostratum across the country. The CDC, which as is usually the case is doing an excellent job of providing clear and current information, reports that as of “October 17, 2012, a total of 47 patients have laboratory-confirmed fungal meningitis.” They offer some reassuring information—that “this form of fungal meningitis is not contagious” and some scary information—that there are 257 cases and ten deaths in 15 states and that incubation periods last up to a month.
The most recent legal news is that the pharmacy was visited
earlier this week by the FDA’s criminal investigative unit and that the first law suit has already been filed in Minnesota Federal District Court by a woman who received a vaccine from the pharmacy but who does not know yet if she has meningitis.
The incident provides an opportunity to watch these two agencies work quickly with local health departments in reaction to a crisis. The FDA estimates “that approximately 14,000 patients may have received injections with medication from three implicated lots of methylprednisolone and nearly 97% of these patients have been contacted for further follow-up.” This is a copy of the letter they have received.
Since I don’t teach Public Health Law until next semester, I’ve used the event as an in-class exercise in Torts. I showed a brief video clip on the story and asked the students to consider what kinds of information they could collect to prove standard of care should they be hired by either a patient or the pharmacy. I was very pleased that they developed a list
that included things like consulting pharmacists who might be expert witnesses as well as researching the existence of laws controlling lab safety.
This story is, of course, a moving target and is likely to serve as a rich source of teaching material as details emerge. In the larger picture, it should raise awareness about the growing problem of both adulteration and contamination of pharmaceuticals. The Economist publisheda very interesting piece this week, Bad Medicine, The World’s Drug Supply Is Global. Governments Have Failed To Keep Up, that puts the issue in a global context.
JSBStarting with the statistic that “In America 80% of drugs’ active ingredients come from abroad (drug imports there more than doubled from 2002 to 2010, accounting for 40% of finished medicine)” it tells a very interesting, if frightening, story of how countries around the world are addressing, and not addressing, the dangers inherent in not just compounding but manufacturing.
Some of the things we teach in Health Law courses are far from our students' experiences, but I found that all my students were not only aware of this story, they were quite familiar with the concept of getting a steroid injection for pain from a sports or other injury.
October 18, 2012
Better, Simpler Disclosure
This is an apt answer to the question: "What would an ideal food label look like?:"
Even the simplest information — a red, yellow or green “traffic light,” for example — would encourage consumers to make healthier choices. That might help counter obesity, a problem all but the most cynical agree is closely related to the consumption of junk food.
Of course, labeling changes like this would bring cries of hysteria from the food producers who argue that all foods are fine, although some should be eaten in moderation. To them, a red traffic-light symbol on chips and soda might as well be a skull and crossbones. But traffic lights could work: indeed, in one study, sales of red-lighted soda fell by 16.5 percent in three months.
Having recently spent time at a roundtable with transparency advocates (including one author of this excellent book), I can attest to the fact that only the clearest signals tend to get through the noise of an era of information overload.
Misuse of federal Medicaid funding
Recommended reading regarding Governor Romney's gaming of Medicaid funding:
This week's edition of ACA Challenges
Earlier this week, Jonathan Adler wrote in the National Review Online that challenges to the individual mandate were just beginning.
And today, Oklahoma's September challenge to the ACA is making headlines. As I have described before, one of the new theories by which Jonathan Adler and the Cato Institute are seeking to thwart the ACA is by challenging the IRS rule that permits tax subsidies in exchanges created by the federal government, which Cato claims is not supported by the text of the ACA. (State exchanges are supposedly the only avenue for obtaining tax subsidies for private insurance purchases.) Oklahoma has brought this challenge to life in federal district court, and Cato's interest in this and other challenges was apparently reiterated by Professor Adler during a Cato-organized panel on Wednesday.
Also earlier this week, MedPage tallied the number of contraception coverage-related complaints at 35. One such challenge was rejected earlier this month by the Eastern District of Missouri, but that does not seem to have thwarted the pile-on, which is evidenced by a new complaint filed in the District Court for the District of Columbia.
October 17, 2012
Marijuana initiatives in the upcoming election
In a year of a presidential election, initiatives are likely to get lost in the shuffle unless they have implications for the race at the top--as did the state efforts to ban same-sex marriage did some years ago. This election season features a number of efforts to legalize marijuana.
Several of these would legalize possession of small amounts of marijuana, whether or not for medical use. Colorado Amendment 64 is a constitutional amendment to legalize possession of less than an ounce of marijuana by state residents over the age of 21, http://ballotpedia.org/wiki/index.php/Colorado_Marijuana_Legalization_Initiative,_Amendment_64_(2012). Oregon Measure 80, the Oregon Cannabis Tax Act, would legalize growing and selling marijuana, http://www.oregonlive.com/politics/index.ssf/2012/07/marijuana_legalization_measure.html. Washington I-502 would create exceptions to state law enforcement for adults possessing less than an ounce of marijuana. Growers and sellers would be required to obtain state licenses, and sales would be taxed--with revenue going to state drug prevention programs.It would also establish a 5 nano-gram/millileter of blood limit for adults driving and a zero tolerance policy for those under 21, http://www.huffingtonpost.com/2012/10/15/dea-drug-czars-states-leg_n_1967363.html.
Massachusetts has a medical marijuana statute on the ballot, which would eliminate state civil or criminal penalties for medical use of marijuana. It would also create state-regulated centers and in certain hardship cases allow patients to grow their own marijuana for personal use, http://ballotpedia.org/wiki/index.php/Massachusetts_Medical_Marijuana_Initiative,_Question_3_(2012) In Arkansas, the Arkansas Medical Marijuana Act (Issue 5) would suspect state penalties (including those relating to licensure) for qualifying patients with debilitating illnesses, establish a system of dispensaries, and permit locations to enact zoning restrictions.
Unusual lineups are emerging with respect to these efforts. In Washington, the sheriff of King County (Seattle) has endorsed the initiative. Although the initiative is supported by groups seeking to legalize marijuana, it is opposed by groups supporting Washington's existing medical marijuana law. In Colorado, religious groups are reportedly divided, law enforcement opposes the measure, and the NAACP favors it. There are appeals to states' rights conservatives to support the measures, too.
There are some signs that controversy over these measures is spilling over into the presidential race, especially in Colorado. Opponents of the measures are calling on Attorney General Holder to come out against them.
New Scholars in Residence Program – A New Pilot Program for Public Health Lawyers
With funding from the Robert Wood Johnson Foundation, the Network for Public Health Law and the Foundation are establishing Scholars in Residence – a new pilot program for public health lawyers. The flyer for the Program is here.
Scholars in Residence is an exciting new opportunity for six public health law scholars who want to bring their expertise to the front lines of public health practice. The scholars will be affiliated with a host site such as a state, local or tribal health department for six months, including a minimum of one month on-site that may be completed during a sabbatical, a non-teaching semester or during the summer. Working with a mentor, Scholars in Residence participants will be able to shape their experience and develop a project that brings their unique expertise to a problem or issue confronting the host site. A full description of this program is available here.
Each scholar will receive a stipend of $34,000. The stipend will cover the fellowship award and all related expenses, including travel to and lodging at the host site, travel to and lodging at two required meetings – an orientation session in June 2013 and a graduation celebration in December 2013 - plus any additional direct costs incurred related to this program.
Professor Fran Miller of Boston University School of Law serves as the Faculty Lead for the Scholars in Residence program.
This pilot project will start recruiting in fall 2012 with the residency beginning in June 2013. Please contact Judy Schector for more information.
October 15, 2012
Picking up Technical Knowledge
As I teach in some technical fields, I often get questions from students about “how much tech do I need to know to succeed in this field?” For example, the Health Law Survey includes many complex medical situations; my seminar Health Information, Privacy, and Innovation covers standards for certifying “meaningful use” of health information technology; and even the intro to IP course tends to include some forbidding patent cases in it. I think this advice from Michal Tsur and Leah Belsky is reassuring:
[S]uccessful tech companies require a variety of skillsets – from design and community management to operations and business development- both at the entry level and in leadership positions. Significant technical skills can also be learned both on the job and outside of traditional academic education. Take Marissa Mayer vs. Sheryl Sandberg. While Mayer, the current CEO of Yahoo may have graduated Stanford with a CS degree, Sandberg, Facebook’s COO, rose through the business ranks at Google, gaining enough product knowledge on the job to become one of the leading operators and innovators in the space.
Having just reviewed the offerings at Coursera this fall, I can definitely vouch for the idea that many tech skills are “on offer” outside the classroom. I’ve also heard from former students who picked up some tech management skills; for example, one learned software programming skills in order to deal with the massive paperwork in a litigation involving many small disputes. I’m also hoping to teach law students how to work with computer scientists and quantitative analysts in a spring course titled “Data Analysis and Advocacy,” which I’ll be co-teaching with a professor from my university’s Department of Mathematics and Computer Science. I know that Michigan State & Daniel Katz have really blazed a trail here; I’m hoping to apply some computational legal studies ideas in courses on health and IP law. If anyone has any suggestions on doing so, I’d love to hear them.
X-Posted from Madisonian.
Media on Health Care Round-up
For some interesting recent articles in the media on health care topics, see