HealthLawProf Blog

Published This Week

Ellen A. Waldman, Bioethics Mediation at the End of Life: Opportunities and Limitations, 15 Cardozo J. of Conflict Resol. 449 (2014). 

George P. Smith, Applying Bioethics in the 21st Century: Principlism or Situationism, 30 J. of Contemp. Health L. & Pol'y 37 (2013).

Deirdre M. Smith, Dangerous Diagnoses, Risky Assumptions, and the Failed Experiment of 'Sexually Violent Predator' Commitment, Okla. L. Rev. (forthcoming).

Richard L. Kaplan, Desperate Retirees: The Perplexing Challenge of Covering Retirement Health Care Costs in a YOYO World, 20 Conn. Ins. L. J. 433 (2014).

 

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New ACL Educational Tool Helps LGBT Residents of Long Term Care Facilities

Hat tip to Kim Dayton over at the Elder Law Prof Blog who posted this announcement: 

The U.S. Department of Health and Human Services’ Administration for Community Living (ACL) is proud to announce the release of a new online learning tool: Building Respect for LGBT Older Adults. The tool is designed to increase awareness of the issues faced by lesbian, gay, bisexual, and transgender (LGBT) individuals living in long term care (LTC) facilities.

 

After completion of the online training, program participants will be prepared to:

• Increase visibility of the issues facing LGBT individuals in LTC facilities.
• Provide easy access to information on serving LGBT individuals in LTC facilities.
• Encourage LTC facilities to provide opportunities for staff to take the online training.
• Change the way individuals and facilities approach older LGBT adults.

The Building Respect for LGBT Older Adults tool was developed in collaboration with the HHS Office of Public Affairs, the Centers for Medicare & Medicaid Services, and the ACL-funded National LGBT Resource Center, with input from aging and LGBT advocates.Read more. 

 

Additional LGBT Resources for the Aging Services Network

 

Since 2010, the ACL Administration on Aging has funded Services and Advocacy for Gay, Lesbian, Bisexual and Transgender Elders (SAGE) to develop and operate the National Resource Center on LGBT Aging (NRC), the country's first and only technical assistance resource center aimed at improving the quality of services and supports offered to LGBT older adults. This resources clearinghouse website was recently revamped and includes great local and national resources, as well as a new database of all the organizations that have received one of NRC’s trainings. Also, the NRC’s most popular guide, A Practical Guide to Creating Welcome Agencies is now available in Spanish titled Servicios Inclusivos Para Personas Mayores LGBT. Request a copy today!

 

Also, read the Presidential Proclamation -- Lesbian, Gay, Bisexual, and Transgender Pride Month, 2014.

NY Court Upholds Social Distancing Policy Requiring Unvaccinated To Stay Out of School

An excellent post by my colleague Ross Silverman, cross-posted from Bill of Health

By: Ross D. Silverman, JD, MPH (Twitter: @phlu)

Fairbanks School of Public Health and McKinney School of Law, Indiana University, Indianapolis.

This has been a big year for outbreaks of Vaccine-Preventable Illnesses (VPIs) in the United States. While we are only halfway through 2014, there have been more measles cases this year than we have seen since before 2000, when the Federal government officially declared the United States “measles free” (in other words: there are no more domestically-generated measles cases; all of our outbreaks are imported). We’ve also seen large mumps and whooping cough outbreaks. You can follow all the disease outbreak action, both here and worldwide, via the Council on Foreign Relations’ very cool interactive map.

States use their police power authority under the Constitution to try to minimize our risk of exposure to VPIs. First, every state requires that children demonstrate proof of immunization against many VPIs as a condition of entry into schools, preschools and day cares. States also permit exemptions to these laws – every state allows a child who may be medically susceptible to injury from vaccines to receive an exemption (with proper documentation of vulnerability), and most states allow parents to apply for an exemption based on either religious or broader philosophical grounds. A combination of factors, including: a nearly two decade trend of increasing numbers of families obtaining exemptions and clustering in particular communities (or avoiding vaccine requirements by taking advantage of law loopholes, such as if a state’s vaccine law does not cover private schools); waning effectiveness of vaccination protections over time (as has been seen with whooping cough); increased international travel facilitating ready reimportation of VPIs from abroad; and many more immunocompromised individuals living in our communities; have slightly weakened our overall protection against VPI outbreaks.

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Guest Blogger Associate Dean and Professor Alicia Ouellette with Coauthor Meredith Dedopoulos, 3L at Albany Law School- The World Cup and Health: If You Can’t Stand the Heat, Don’t Play in Manaus

More than a week into the 2014 World Cup, a Brazilian judge has issued an order requiring FIFA[1] to give players water breaks to protect their health.  Yet the judge’s ruling is unlikely to alleviate any of the health risks of playing in the scorching conditions of Brazil because in order for water breaks to be mandatory, the temperature must meet FIFA’s benchmark of 90 degrees Fahrenheit.  Since most of the games have been played in conditions just below this threshold, the players remain unprotected from heat-related conditions that threaten their health and their participation in the rest of the tournament.   

The heat and humidity in the Amazon city of Manaus, which will host four group stage games, have been particularly brutal.  Italian midfielder Claudio Marchisio described what it was like during the match between England and Italy: “At times it felt like having hallucinations due to the heat.”  The conditions were not unexpected.  Located in the Amazon jungle and accessible only by boat or plane, Manaus averages temperatures between 75 and 87 degrees Fahrenheit, with a similar percent humidity.  From the time it was announced as the host city for this match in December 2013, press coverage, especially in England, focused on the oppressive tropical climate and concerns about how the players would adapt. 

The tropical conditions of Manaus pose serious health risks, not just for players but for spectators as well.  Heat and humidity—and their effect on perspiration—can cause dehydration, decreased muscle and nerve functioning, and increased fatigue.  In extreme cases, heat exhaustion can lead to heat stroke, which can result in death.  Former Brazilian player Mirandha warned England’s players that it would be “difficult to breathe” there.  To prepare for these conditions, in the weeks leading up to kick-off, the England team trained in the warm climates of Portugal and Miami, wearing extra layers during practice to simulate what it would feel like in Manaus.  Both the England and the Italian teams exercised in heat-acclimatization chambers.  All of these efforts were designed to ready the players and their bodies for the climate that awaited in Manaus, which England coach Roy Hodgson admitted every team had wanted to avoid before the draw.

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Waiting for Hobby Lobby

Since the likelihood is that many readers of this blog will be asked to comment about whatever opinion the Supreme Court issues this week, here’s a quick refresher.   The Hobby Lobby and Conestoga Wood Specialty cases are challenges to the Affordable Care Act's requirement that employers who choose to offer health insurance to their employees must provide policies that include ten essential benefits-including contraception.  The U.S. Supreme Court has heard oral arguments and read the briefs—it’s likely that whatever opinion is issued will reflect at least some of the arguments presented to the Court.    

This case is about the Affordable Care Act’s requirement that employers who offer their employees health insurance must  offer policies that provide ten essential benefits, including contraception.  Hobby Lobby and Conestoga Wood are privately held, for-profit companies whose owners have sincerely held religious objections to providing four specific kinds of contraception.  They believe these contraceptives terminate rather than prevent pregnancy.  Many religious organizations and companies have gotten exemptions to these requirements, but this case considers whether private, for-profit companies should qualify as well.

The cases raise (at least) three major issues:

1.Does the Religious Freedom Restoration Act apply to corporations even though it uses the word “person?” (Can companies have religious beliefs?)

2. Is providing insurance that covers birth control a “substantial burden?” on these two company’s' religious beliefs?

3. Does the government have a compelling reason for requiring companies that provide insurance to offer policies that cover all the forms of contraception specified in the ACA?

 It is likely that this decision will address (I almost said clarify, but who knows?) the limits of a law passed by Congress in 1993 to over-rule an earlier Supreme Court Decision, Employment Division v. Smith, holding that so long as a law passed by the federal government “applied to everyone” everyone was required to follow it even if it interfered with their sincerely held religious beliefs.  In that case, Native American employees of a drug rehabilitation clinic challenged their firing for the use of Peyote as unconstitutional since using the drug was part of their sincerely held religious belief.  At that time the Supreme Court held that so long as a law applied to everyone, everyone had to follow it even if it infringed on some people’s beliefs.

Until now, there has never been a case where a “company” had religious beliefs.     There are legal advantages to doing business as a company rather than as an individual or a partnership.  The main one is that the owners aren’t personally responsible for the company’s debts or actions.  If the company goes bankrupt, the owner’s personal assets aren’t at stake.  If the company gets sued, the owner won’t have to pay the judgment.

  A few reminders about how ACA works—no company in the United States has to provide health insurance to its employees.  If it chooses not to, the employees would be eligible to buy subsidized health insurance through the exchanges. Because it employees more than 50 people, Hobby Lobby would have to pay the government $2000 per employee to cover the cost of the subsidized insurance-this called the Employer Shared Responsibility Provision. These payments are postponed until 2015, i.e. they haven’t happened yet, but this how the Kaiser Foundation says they will work.

 Kaiser estimates that this is at least half of what it would cost employers to provide health insurance meeting the minimum ACA standards.  This led Justice Sotomayor to suggest that during the oral argument that Hobby Lobby simply drop all health insurance coverage. What the affordable care act did was set standards for insurance just like there are standards for food and drug products.    The effect is there are no “junk” plans.  Every health insurance plan has to cover 10 essential benefits including vaccinations, annual exams, contraception and pregnancy costs.  So the rule isn’t on the companies that buy insurance, it’s on the insurance available to buy.  It’s the same as not being able to buy a car without seatbelts.

Unlike the Affordable Care Act decision that once decided effectively resolved a dispute and faded away, it is likely that whatever the result the decision here will be the basis of considerable analysis and is likely to be an important addition to the body of precedent interpreting the First Amendment’s Free Exercise clause.

 The new law, a short one and worth reading in full, the Religious Freedom Restoration Act, essentially reverses Employment Division v. Smith by stating that even if a law applies to everyone, if it substantially burdens anyone’s sincerely held religious beliefs the government has to show a compelling reason for the law and has to show that the law is the least restrictive way of achieving the law’s goals.

 

Until now, there has never been a case where a “company” had religious beliefs.     There are legal advantages to doing business as a company rather than as an individual or a partnership.  The main one is that the individual’s owners aren’t personally responsible for the company’s debts or actions.  If the company goes bankrupt, the owner’s personal assets aren’t at stake.  If the company gets sued, the owner won’t have to pay the judgment.

 At this point, there isn't much more to do but wait.   It's hard to break the speculating habit since many of have spent the past three years spinning scenarios.

For example, it’s unclear how far a decision that a private company could be exempt from federal laws that go against its religious beliefs would go.  For example, a company with a religious belief that women shouldn’t work outside the home might claim that it would not have to follow laws prohibiting sex-discrimination.

 Within the health insurance field it’s also unclear how far a company could pick and choose—for example, could a company decline to cover immunizations or blood transfusions.

 It seems likely that a company could choose to cover contraception for married employees but not unmarried employees.   Stay tuned, we will probably know more tomorrow—or at least by June 30^th.

Published This Week

Thaddeus Mason Pope and Melinda Hexum, Legal Briefing: Informed Consent in the Clinical Context, 25 J. of Clinical Ethics 1 (2014).

Charlotte A. Moser, Dorit Rubinstein Reiss, and Robert L. Schwartz, Funding the Costs of Disease Outbreaks Caused by Non Vaccination, SSRN.

Robert F. Card, Reasonability and Conscientious Objection in Medicine: A Reply to Marsh and an Elaboration of the Reason‐Giving Requirement, 28 Bioethics 320 (2014).

Mark Sheehan, Vernon Marti, and Tony Roberts, Ethical Review of Research on Human Subjects at Unilever: Reflections on Governance, 28 Bioethics 284 (2014).

 

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Summer Institute for Informed Patient Choice

From June 25^th, through June 27^th, 2014, the Dartmouth Center for Health Care Delivery Service, along with the American Society of Law, Medicine and Ethics (ASLME), and The Dartmouth Institute for Health Policy and Clinical Practice will host the Summer Institute for Informed Patient Consent (SIIPC). The aim of the conference is to bring together policy-level delegates; law, medical, and ethics leaders, and patient advocates to help advance the ability of the health care delivery industry to ensure that patients are aware of, understand, and can make use of evidence pertaining to their wellbeing.

The conference will include more than 20 confirmed speakers from law, medicine, bioethics, and patient advocacy; two poster presentations; and numerous opportunities for cross-disciplinary networking and discussion. ASLME will apply for 18 (based on a 60 minute hour) CLE credits on your behalf upon request and will designate this live educational activity for a maximum of 18 Category 1 CME Credits.

Registration is $395 and the deadline to register will be closing on Thursday, June 19^th, 2014. For more information, visit SIIPC.

Guest Blogger Professor Erin Fuse Brown: The Health Implications of Piketty’s Inequality

Thomas Piketty’s book, Capital in the 21^st Century, is all the rage. His main claim is that in capitalistic systems, wealth (return on capital) generally grows faster than economic growth, such that capital wealth will dominate income earned from labor. The result is ever-increasing income inequality. Piketty claims the current rise of inequality and wealth concentration is a predictable result of our capitalistic system, leading us toward a system of “patrimonial capitalism” where the economy and society are controlled by those with inherited wealth rather than by the talented or meritorious.  There are many politically charged debates raging about Piketty’s data or conclusions, but there are also many implications for those of us who care about health.

In short, Piketty’s conclusions about rising inequality may bode ill for our health.  Bill Gardner at the Incidental Economist has explained that social inequality is bad for those at the bottom of the income scale, citing Sir Michael Marmot’s famous Whitehall studies demonstrating that lower social status is correlated with worse life expectancy and health outcomes. However, not only is economic or social inequality bad for those at the bottom, as it turns out, inequality may be bad for everyone’s health.

 

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Guest Blogger Professor Seema Mohapatra: E-Cigs and Advertising

Joe Camel All Over Again! E-cigarette Advertising Regulations Needed

A recent advertising campaign for MarkTen e-cigarettes declared “Let it Glow,” which seems to channel the uber-popular Disney movie Frozen.  E-cigarettes are turning out to be the next big thing—and it seems that the lessons of Big Tobacco have not necessarily been learned, especially with regards to advertising.   E-cigarettes are the battery-operated, heat-producing mechanisms that mimic the appearance of a “real” cigarette, functioning as a nicotine delivery system, without the need for burning tobacco.[1]  Thus, these devices give a similar nicotine intake or “hit” and sensation as a regular cigarette, but supposedly do not deliver many of the harmful carcinogens that are packaged with burning tobacco.[2]   E-cigarettes are vaped, rather than smoked. Seen by some as a possible healthier alternative to cigarettes and a way to help smokers quit, public health advocates worry that they could be a new way to become addicted to nicotine and a first step to cigarette smoking. Some warn that the safety aspects of e-cigarettes are still not certain, and more studies are needed to address the addictive nature of nicotine itself, and the harms that could be caused by other carcinogens found in the e-cigarette vapor.  Certain studies indicate that the liquids used in e-cigarettes could be linked to poisonings, and the CDC has also recently reported that there has been what they called a “dramatic” rise in e-cigarette-related calls to U.S. poison centers.[3]

Increase in Advertising – and the Product as a Smoking Cessation Aid

There has been a dramatic increase in the amount of advertising for e-cigarettes, in all forms of media.  For example, in the United Kingdom, one ad ended with the message “experience the breakthrough,” and features a man and woman passing through smoke, with a voiceover calling the experience “pure satisfaction.”[4]  Although the manufacturer claimed that this message advertises the product as a smoking cessation device, the Advertising Standards Authority (“ASA”) thought otherwise  and banned the advertisement.   The ASA stated that the language was likely to be interpreted as “[a] breakthrough alternative as a substitute for tobacco,” and “[i]n this context, the product was likely to be understood as a smoking cessation aid.”[5]   At least one study has supported this theory,[6] finding that e-cigarettes did not help people quit, and concluding that “e-cigarettes as a cessation tool is flimsy at best,” indicating a need for more research.[7]

In the United States, advertising for e-cigarettes has been left unregulated by the Federal Trade Commission, in direct contrast to advertising for cigarettes.  Several senators[8] oppose the widespread use and advertising of e-cigarettes, and asked the FTC to investigate the claims manufacturers are using in their advertising, saying, among other things, that there is a need to immediately address the “false and deceptive claims” by the manufacturers.[9]

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Guest Blogger Professor Wendy Mariner: Take Care of Your Health at Penn State . . . Or What?

Last summer, Pennsylvania State University was rocked back on its heels by faculty protesting a controversial new wellness program, “Take Care of Your Health.” [See Inside Higher Education.] By November, Penn State had paused the program and formed a Health Care Task Force (6 faculty, 2 staff, and 5 administrators) to explore alternative ways to control health care costs – the wellness program’s goal.

The Task Force submitted its report in late April 2014, criticizing the wellness program’s rollout for lack of transparency and poor communication – a glaring error in the wake of the Sandusky scandal. The Task Force was asked to present alternative health cost control measures for further consideration. It did a pretty good job on that score, mentioning putting third party health plan administration fees and pharmacy benefit plans out for new bids, using reference-based pricing for health care services, and using the American Board of Internal Medicine Foundation’s Choosing Wisely as a model for providing information about treatment choices and costs, among other options.

With respect to wellness programs, the Task Force determined:

workplace wellness programs appear to have, at best, a small but statistically significant short-run impact on some employee health behaviors, most notably smoking cessation and weight loss, but the longer run effects are still unclear. And, to the extent that these programs generate cost savings, they seem to arise from intensive disease management [for employees with chronic diseases]. Lifestyle management programs appear to be, at best, a breakeven proposition, and in many cases may cost more than they save in health care costs. 

Without explicitly recommending against instituting a wellness program, it concluded, “The mixed success of such programs that is noted in the academic review section, in conjunction with the negative response to the recent “Take Care of Your Health” initiative at Penn State, suggests that this option would need careful thought and consultation if implementation were being considered.”

 

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Guest Blogger Associate Dean and Professor Alicia Ouellette- Legal Issue or Culture War: Conversion Therapy in the Courts and Beyond

Last week, the Texas Republican Party adopted into its 2014 platform a passage that endorses so-called conversion or reparative therapy— a controversial but long-standing practice designed to alter an individual’s sexual orientation from homosexual to heterosexual.  Not only did the party “recognize the legitimacy and value of counseling which offers reparative therapy and treatment to patients who are seeking escape from the homosexual lifestyle,” it declared that “No laws or executive orders shall be imposed to limit or restrict access to this type of therapy.”[1]

The action by the Texas GOP raises the stakes in an increasingly contentious battle.  Therapists of various stripes have attempted to convert homosexuals into heterosexuals since at least 1869.  Early efforts took extreme forms.  These included testicular transplants, hormone treatments, exorcisms, and various forms of aversion therapy— including electric shock or nausea-inducing drugs administered simultaneously with the presentation of homoerotic stimuli.  In its modern form, conversion therapy involves psychoanalysis, talk therapy, and hypnosis.  These forms of conversion therapy “are rooted in Freud’s idea that people are born bisexual and can move along a continuum from one end to the other.”[2]  Modern conversion therapists differ from their Freudian predecessors in that they theorize that humans are innately heterosexual and that it is environmental factors— early sexual abuse, overbearing mothers, and detached fathers—that cause homosexuality.[3]  As such, these practitioners believe that “sexual orientation can be reshaped.” [4]

Whatever its form or theoretical basis, conversion therapy has fallen out of favor.  In 2009, the American Psychological Association denounced conversion therapy,[5] and it has since been widely recognized that the practice is not effective and may cause or exacerbate psychological harm.  Indeed, virtually every major health and mental health organization, including the AMA, the American Psychiatric Association, and the Pan American Health Organization, have questioned the scientific validity of conversion therapy, cautioned against its use, and warned that it threatens harm to the health and wellbeing of affected people.  The organizational positions reflect the troubling stories told by survivors of conversion therapy, detailing humiliation, self-loathing, rejection, and suicidal feelings, as well as studies, such as this one, finding that conversion therapy patients are significantly more likely than their homosexual peers to report depression and eight times more likely to attempt suicide.

 

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Thank You to May's Guest Bloggers

HealthLawProf Blog would like to thank our May guest bloggers Associate Professor Jonathan Todres, Professor Thomas (Tim) Greaney, Professor Nadia Sawicki and Professor John V. Jacobi. Here is a short recap of their posts:

Associate Professor Jonathan Todres posted the following: Human Rights and the Social Determinants of Health, Tobacco Related Harms Extend to Children Who Harvest It, Health Care and Human Trafficking, and Incorporating Experiential Learning in Health Law Courses.

Professor Thomas (Tim) Greaney posted the following: Antitrust and the Physician Land Rush, and The Affordable Care Act, Antitrust and Competition Policy.

Professor Nadia Sawicki posted the following: "Sanitizing” Lethal Injection, “That’s a Lot of Marijuana”, and How Medicine Learns About the Law.

Professor John. V. Jacobi posted the following: Post-Enrollment: Ensuring Successful Follow-Through for Health Reform, Ensuring Successful Reform Follow-Through, Part 2: Affordability, and Ensuring Successful ACA Follow-Through Part 3: Undocumented Immigrants.

 

Age, Ability, and Healthcare

On Thursday & Friday, July 17 & 18, 2014, Hiram College’s Center for Literature and Medicine and the Northeast Ohio Medical School (NEOMED) will jointly sponsor a Summer Seminar at Hiram College (Hiram, OH) with up to 12 hours of Continuing Professional Education credit for Medicine (AMA PRA Category 1 Credits™) and Pharmacy available.

National leaders in Age Studies, Disability Studies, and Health Humanities will lead small group discussions in sharing experiences and ideas in an intimate setting.

Featured Keynote Sessions led by:

Anne Basting, Ph.D. (Professor of Theatre, University of Wisconsin Milwaukee, Founder and President of TimeSlips Creative Storytelling)

Thomas Cole, Ph.D. (Director, McGovern Center for Humanities and Ethics, University of Texas Medical School at Houston)

Rebecca Garden, Ph.D. (Associate Professor of Bioethics and Humanities, SUNY Upstate Medical University)

Laurie Clements Lambeth, Ph.D. (Award-Winning Poet and Faculty in Medicine and Society at the University of Houston's Honors College)

For more information or to register, visit: www.hiram.edu/age-ability

Published This Week

Lisa Milot, Ignorance, Harm, and the Regulation of Performance-Enhancing Substances, 5 Harv. J. Sports & Ent. L. 92 (2014). 

Eloise Chandler, Anita Stuhmcke, Jenni Millbank, Isabel A. Karpin, Rethinking Consent, Information Giving and Counselling Concerning Stored Embryos in IVF Treatment, 20 J. of L. & Med. 759 (2013).

David Orentlicher, Thaddeus Mason Pope, Ben A. Rich, The Changing Legal Climate for Physician Aid in Dying, 311 J. of the Am. Med. Ass'n 1961 (2014). 

Lalit Ambastha, Shruti Kaushik, Method of Treatment: A Patent Perspective, SSRN.

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Guest Blogger Professor Erin Fuse Brown: Hospitals Using ACA to Justify Cuts in Charity Care

A couple weeks ago, the New York Times reported that some hospitals around the country are starting to curb their charity care and financial assistance to uninsured patients who they believe should purchase coverage on the ACA exchanges. This is a troubling trend that threatens to weaken the fragile health care safety net for low- and moderate-income individuals.

The hospitals in the article have taken a range of actions including charging charity care patients a copay or coinsurance for their care or reducing the income threshold for eligibility for financial assistance. The hospitals justify their actions, saying that because the ACA marketplaces and subsidies now make insurance widely available, individuals ought to purchase their own coverage.

There are several problems with this trend. First, cost-sharing doesn’t work for the poor and the chronically ill. Rather than causing these patients to consume the appropriate amount of care or to purchase insurance coverage, even small amounts of cost-sharing may make these individuals avoid needed and cost-saving care. Second, cutting back on charity care is particularly harmful for individuals in states that are not expanding Medicaid, because individuals under 100% of poverty in those states are ineligible for ACA premium subsidies as well as Medicaid. Third, hospitals may be trying use stingy financial assistance policies to push self-pay or uncompensated care patients to the safety net or religious hospitals in the community that already provide a disproportionate share of the uncompensated care, even while disproportionate share payments under Medicare and Medicaid are shrinking.

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SCOTUS Embraces Regulatory Synergy in POM Wonderful

A great post by my colleague Diana Winters, cross-posted from Bill of Health

By Diana R.H. Winters

While today’s unanimous (sans Justice Breyer, who recused himself) decision by the Supreme Court in POM Wonderful LLC v. Coca-Cola Co. was certainly not a surprise, especially after the clear tenor of the oral argument, the case may have some implications for FDA law going forward. In this case, POM Wonderful sued Coca-Cola under the Lanham Act, alleging that the label on Coca-Cola’s pomegranate blueberry juice was false and misleading, and that this deception caused it to lose sales. Coca-Cola argued that because its label complied with the Food, Drug, and Cosmetic Act, POM’s Lanham Act claim should be precluded. The district court and the Ninth Circuit agreed.

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Guest Blogger Professor Seema Mohapatra: Tennessee’s Criminalization of Drug Use by Pregnant Women

Studies show that pregnant women who use drugs are unlikely to receive adequate prenatal care, and therefore are more likely to have poorer pregnancy outcomes than other pregnant women.  Although there may be confounding factors that explain these disparities, the lack of prenatal care definitely limits a woman’s face-to-face interaction with a physician.  Such interactions may allow physicians to offer health-promoting interventions to these women, including those that may help these women overcome addiction.  One of the reasons that addicted women avoid prenatal care during pregnancy is the (unfortunately well-founded) concern that they may face adverse consequences due to their drug use.  

Despite these concerns, Tennessee seems to be proceeding with an controversial new piece of legislation, SB 1391, which will be effective July 1, 2014, that allows for a pregnant mother to be convicted of assault “for the illegal use of a narcotic drug while pregnant, if her child is born addicted to or harmed by the narcotic drug, or for criminal homicide if her child dies as a result of her illegal use of a narcotic drug taken while pregnant.”  This law comes after Tennessee had seemingly eased back on the criminalization of expectant mothers in 2013 when it enacted the Safe Harbor Act, incentivizing treatment for prescription drug abusers, opening treatment opportunities for expectant mothers seeking help, and helping to ensure they would not lose custody of their child because of drug abuse.  However, this new legislation reinstates criminal penalties. 

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Guest Blogger Professor Wendy Mariner: Who Has Jurisdiction Over Sugary Drinks?

On June 4, 2014, the New York Court of Appeals heard the New York City Board of Health’s appeal of the decision striking down its Portion Cap aka Soda Ban rule.[1] (The choice of name reflects one’s position on the issue.) That rule would prohibit certain businesses from selling “sugary drinks” in containers larger than 16 ounces. (“Sugary drinks” do not include milk products, fruit juices or alcoholic beverages.) The trial court struck down the rule as beyond the Board’s jurisdiction, violating separation of powers,[2]and the Appellate Division unanimously affirmed.[3]

The high court’s decision may not appear until July, but the case highlights issues central to public health regulation today: general grants of administrative authority, expanding definitions of public health, and increasing attention to the role of individual behavior in chronic disease development.

For now, let’s focus on the jurisdictional issue. Let’s begin with the assumption that a legislative body like the New York City Council could enact such a rule. (Whether it would make a significant dent in obesity rates and whether that would save the city money are different questions.) Let’s also assume that the rule’s opponents care far less about the public’s health than about their own revenues. The question before the court was simply whether the Board of Health had the jurisdiction to do what the City Council could – but did not – do. In other words, is the rule the type of action that an administrative body can take or did the Board usurp the City Council’s legislative authority?

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Guest Blogger Associate Professor Seema Mohapatra: The Soda War Continues

Today, the New York Court of Appeals heard arguments on Former Mayor Michael Bloomberg’s 2012 proposed restriction on the sale of large sizes of sugary drinks by certain businesses in New York City. The New York City Department of Health and Mental Hygiene (DOHMH) and Board of Health argued before the Court to reinstate the rule, which would restrict the sale of soda and other sugary beverages larger than 16 ounces. Based on preliminary reports, they may have had a promising audience (at least, based on Chief Judge Jonathan Lippman’s questions). According to the New York Daily News, Lippman described the portion cap as a “relatively modest regulation” and “questioned why it was any different from previous efforts to ban trans fats or add fluoride to water.”[1] Lippman further asked the attorney representing the American Beverage Association and other opponents of the ban, “Put aside the hype about what they are doing, what is so revolutionary?” This is in line with the arguments that the Board of Health and DOHMH made in their brief before the Court of Appeals. They argued that the Board has legislative authority in the area of public health, "which is demonstrated through its previous requirements of fluoridation of city water, posting calorie counts on menus, restricting trans fat use in restaurants, and banning the use of lead paint in residences." Although sometimes referred to as the Big Gulp ban, and the basis of endless fodder for late night television gags, the proposed rule actually did not actually ban any soda and did not apply to convenience stores, grocery stores, corner markets, gas stations and the like. Rather the portion cap rule limits the serving size for “non-diet soft drinks, sweetened coffee and tea, energy and sports drinks, hot chocolate, and sweetened juices, but excludes alcoholic beverages, milkshakes, fruit smoothies, mixed coffee drinks, mochas and lattes, and 100 percent fruit juices."[2]

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Published This Week

Zenon Zabinski, Bernard S. Black, The Deterrent Effect of Tort Law: Evidence from Medical Malpractice Reform, SSRN.

Hanneke Verwey, Pieter Carstens, Informed Consent to Cosmetic Surgery – Does a Broader Duty of Disclosure Exist?, 76 J. of Contemp. Roman-Dutch Law 642 (2013).

Isabell Hensel, Gunther Teubner, Horizontal Constitutional Rights as Conflict of Laws Rules: How Transnational Pharmagroups Manipulate Scientific Publications, SSRN.

Eric Vogelstein, Competence and Ability, 28 Bioethics 235 (2014).

Jenni Millbank, Eloise Chandler, Isabel A. Karpin, Anita Stuhmcke, Embryo Donation for Reproductive Use in Australia, 20 Journal of Law and Medicine 789 (2013).

Isabel A. Karpin, Jenni Millbank, Anita Stuhmcke, Eloise Chandler, Analysing IVF Participant Understanding of, Involvement in, and Control Over Embryo Storage and Destruction in Australia, 20 Journal of Law and Medicine 811 (2013).

Bianca Phillips, Telemedicine: Why the Law Must Change to Promote a Better Healthcare System, 11 Privacy L. Bull. (2014).