April 2013—CDC Public Health Law News

Pandemic and All Hazards Preparedness Reauthorization Act. On March 13, 2013, President Obama reauthorized the Pandemic and All Hazards Preparedness Act (PAHPA). Originally passed by Congress in 2006, PAHPA provides programs and flexibilities aimed at supporting communities in public health preparedness. Learn more about PAHPA, public health preparedness.

ASLME Health Law Professors Conference. The American Society of Law Medicine and Ethics (ASLME) is happy to announce the 36th Annual Health Law Professors Conference will be held June 6–8, 2013, in Newark, New Jersey. The conference will be co-sponsored by ASLME and Seton Hall University. Find more information about the conference.

Model Aquatic Health Code and National Environmental Health Aquatic Symposium. The first edition of the Model Aquatic Health Code will be released for final comment at the National Environmental Health Aquatic Symposium as a special preconference to the 2013 National Environmental Health Association Annual Educational Conference & Exhibition. The preconference will be held Monday, July 8th from 1 to 5 p.m. and is free with any one-day conference registration. The main conference will be held July 9–11 in the Washington, D.C. area. Make a reservation for the preconference by contacting Jill Schnipke at JSchnipke@neha.org. Find more information and register for the main conference.

NALBOH Annual Conference. The National Association of Local Boards of Health (NALBOH) is hosting NALBOH 21st Annual Conference, Responsible Governance for a Brighter Public Health Future, which will take place August 14–16, 2013 in Salt Lake City, Utah. The conference will provide board of health members and other public health professionals with information on public health governance functions, engaging citizens, and the role of effective leadership in healthy communities. Registration will open April 20, 2013. Find more information about NALBOH and the 21st Annual Conference.

New CIFOR tools for foodborne disease detection and outbreak response. New documents from the Council to Improve Foodborne Outbreak Response (CIFOR) give tools to public health agencies and jurisdictions to improve their legal preparedness to conduct surveillance for foodborne diseases and respond to outbreaks. These documents provide guidance for outbreaks both within agencies' jurisdictions and across multiple states and other jurisdictional boundaries. There are three documents, each of which designed to address a discrete but related research need and audience: Analysis of State Legal Authorities, Practitioners' Handbook on Legal Authorities, and Menu of Legal Options. Find more information and access the new CIFOR legal tools.

New York: Babies' herpes linked to circumcision practice

CNN   (04/08/2013)   Brittany Brady

According to the New York City Department of Health and Mental Hygiene (DOH), two more infants have contracted herpes simplex virus type 1(HSV-1) after undergoing metzitzah b'peh, an ultra-Orthodox Jewish type of circumcision.

Though circumcision is a regular part of Jewish religious practice, metzitzah b'peh is uncommon and limited to a small number of ultra-Orthodox Jews. During the uncommon ceremony, the foreskin of the infant is removed and the person performing, the mohel, the procedure takes a mouth full of wine, places his mouth briefly over the wound, sucking a small amount of blood out of the wound. The blood and wine are then disposed of, antibacterial ointment is applied and the wound is bandaged.

HSV-1 is common among adults and may be present in their saliva, though many adults may not show symptoms. "While the HSV-1 can cause the common cold sore in adults, HSV-1 infection in newborns is very serious," said a DOH statement. (HSV-1 is different from the usually sexually transmitted herpes simplex virus type 2.) Forty percent of babies with neonatal herpes produce a fever, but 70 percent of such cases have suffer skin lesions.

In September 2012, the DOH passed a regulation requiring parental consent on a form elucidating the health risks related to the procedure. In the face of the law Jewish groups and three rabbis filed suit in the U.S. District Court in Manhattan arguing that "the government cannot compel the transmission of messages that the speaker does not want to express—especially when the speaker is operating in an area of heightened First Amendment protection, such as religious ritual."

Commissioner of the city's health department, Dr. Thomas A. Farley, says the consent requirement is "lawful, appropriate and necessary. . . The city's highest obligation is to protect its children; therefore, it is important that parents know the risks associated with the practice . . . There is no safe way to perform oral suction on any open wound in a newborn.

[Editor's note: Learn more about neonatal herpes simplex virus infection following metzitzah b'peh.]

National: Judge orders 'morning-after' pill be sold over-the-counter to those under 17 

ABC News   (04/05/2013)   Sydney Lupkin

Currently, women under 17 must have a prescription to purchase emergency contraception, such as Plan B One-Step or the "morning-after" pill. Women 17 and older can obtain the drug without a prescription, but it is only available behind the pharmacy counter and an ID must be shown at purchase. On April 5, however, District Court Judge Edward Korman ruled that the emergency contraception should be sold over-the-counter, without regard to age.

The Food and Drug Administration (FDA) spent 10 months reviewing the drug's scientific data before recommending over-the-counter sales. In December 2011, Health and Human Services Secretary Kathleen Sebelius overruled the FDA's recommendation that emergency contraception be sold over the counter. Secretary Sebelius indicated that there were still questions regarding the drug's safety for young teens.

The morning-after pill contains the synthetic hormone levonorgesterel and works by preventing a fertilized egg from attaching itself to the uterine wall. The pill is not intended as a primary form of contraception, but is intended for when primary forms of contraception fail, as when a condom breaks during intercourse. The morning-after pill cannot terminate an existing pregnancy and, therefore, must be taken within 72 hours of unprotected sex.

[Editor's note: Learn more about the Secretary Sebelius' statement regarding Plan B One-Step and read the U.S. District Court Opinion in Tummino v. Hamburg, Commissioner of Food and Drugs. [PDF - 177KB]]

California: Judge rules state prisons will remain under federal oversight
California prisons haven't improved mental healthcare enough, court says
Los Angeles Times   (04/05/2013)   Paige St. John
[Editor's note: Read the U.S. District Court's April 5, 2013 opinion in Coleman v. Brown.]

Connecticut: Bi-partisan law adds more than 100 weapons to assault weapon ban
Connecticut gun law: Breakdown of when new rules go into effect
New Haven Register   (04/07/2013)   Mary E. O'Leary
[Editor's note: Read Connecticut's firearms laws.]

Kansas: Department of Health promises new regulations won't allow HIV quarantine
Kan. Agency's promise ends dispute on AIDS measure
San Francisco Gate   (04/04/2013)   John Hanna
[Editor's note: Read Sub HB 2183 and the Kansas Department of Health and Environment's press release regarding the Bill.]

Kansas: Law creating adult stem cell center at Kansas University before Governor
Creation of adult stem cell center at KU Med sent to Brownback for consideration
Lawrence-Journal World   (04/08/2013)   Scott Rothschild

Massachusetts: DHS chief to finalize medical marijuana guidelines before leaving
Mass. public health chief to step down after finalizing regulations for medical marijuana
Science Recorder   (04/07/2013)   James Fluere

Michigan: AG pursues grand jury charges in fungal meningitis outbreak that killed 48
Attorney General Bill Schuette Files for Grand Jury investigation
The Huffington Post   (03/26/2013)   David Sands

Montana: Bill to legalize sale of unpasteurized milk passed by Montana House
Raw milk bill sails through House, to be heard by state Senate committee this week
The Missoulian   (04/08/2013)
[Editor's note: Find more information and read House Bill 574.]

Oklahoma: Dental Board contacts patients potentially infected at dentist practice
Lawyer defends record of Oklahoma dentist in HIV-exposure scare
Yahoo! News   (03/04/2013)   Steve Olafson

Washington: Permanent receptacles for unused prescription drugs open
Prescription drug take back program opens
Port Orchard Independent   (04/08/2013)   

National: Six states will not enforce provisions of the Affordable Care Act
Alabama will not enforce health care law provisions
Prattville Progress   (04/06/2013)   Mary Orndorff Troyan

National: Some small businesses opt for the penalty under the Affordable Care Act
Some small businesses opt for the health-care penalty
Wall Street Journal   (04/08/2013)   Emily Maltby and Sarah E. Needleman

Stephanie Morain

Title: Doctoral candidate in Health Policy at Harvard University

Organization: Harvard School of Public Health

Education: MPH, Columbia University's Mailman School of Public Health

Michelle Mello

Title: Professor of Law and Public Health

Organization: Harvard School of Public Health

Education: JD, Yale Law School; PhD, University of North Carolina at Chapel Hill; MPhil, University of Oxford

CDC Public Health Law News (PHLN): What was your career route to the Harvard School of Public Health?

Mello: I came here straight out law school. I was on the cusp of accepting an offer to practice health law at a firm in Washington, but a position serendipitously opened up at Harvard that seemed like a great fit, and it was. Prior to law school, I did a doctoral degree in health policy and before that, I spent two years in England as a Marshall Scholar. It looks like a strategic trajectory, but in fact I never planned on an academic career.

PHLN: Ms. Morain, when is your projected graduation date and how do you plan on applying your degree after graduation?

Morain: I anticipate finishing up my dissertation work within the next year. Post-graduation, I hope to be able to continue academic research on public health policy, with a continued focus on the role of law in public health, as well as how we should consider public and stakeholder opinion in policymaking.

PHLN: Why is law an important aspect of public health?

Mello: Law is the mechanism through which organized, official activity to promote public health can be implemented. It undergirds everything the government does to assure the conditions for people to be healthy and to encourage them to live healthful lives. These days it's fashionable to talk about market solutions to social problems, and those have a place in public health, too. But it has always been the case, and I believe always will be, that government has an important role to play in combating health problems. It needs law to do it.

PHLN: You recently co-authored an article, "Survey Finds Public Support for Legal Interventions Directed At Health Behavior To Fight Noncommunicable Disease," which was published in the March 2013 edition of Health Affairs. Ms. Morain, as the study's leader, what was the inspiration for the study?

Morain: Over recent decades, we've really seen a sea change in the leading causes of morbidity and mortality in the U.S., with noncommunicable disease accounting for a far more substantial proportion of the disease burden than it did previously. This change has challenged us to really examine what the role of public health should be, and how far government should go to promote and protect health, and for what types of health conditions. The new emphasis of public health departments on policies to address such conditions as obesity, diabetes, and heart disease offered a great lens by which to explore how the public viewed the role of government in public health, which we believe is an important consideration in this broader inquiry into how law can and should be used for public health goals.

PHLN: How did you identify which types of laws you wanted investigate through the study?

Morain: We had two primary goals in our selection of laws for this study. The first criterion was that we wanted the laws to be relevant for policymakers and officials, so we looked to current or proposed policies that aimed to reduce noncommunicable disease rates by modifying individual behaviors. Second, we wanted to empirically evaluate the relationship between public support and the extent to which interventions constrain personal liberty. To do that, we identified policies that could be placed along a spectrum of increasing degrees of constraint. For example, in the area of childhood obesity prevention, we compared a legal requirement for more public school instruction about the health risks of obesity to making possession of junk foods in schools a disciplinary offense.

PHLN: What is the difference between a punitive public health law and an intervention that positively incentivizes helps people make more healthful choices?

Morain: The UK's Nuffield Council on Bioethics proposed an "intervention ladder" that may be useful in helping to think about the different ways laws can influence people's choices. At the bottom of the ladder are approaches for which the state places no restrictions on individual freedom. Examples would include approaches that would only monitor the current situation (or do nothing at all). Just up from this level would be policies that would provide information to individuals or take action to enable choice to individuals. For example, to encourage smoking cessation, a state might provide information on the risks of smoking, or provide nicotine patches or free smoking-cessation classes to support behavior change. At the other end of the ladder would be policies that would guide choices through disincentives, such as through policies that would add surcharges to insurance premiums for smokers. Finally, at the far end of the ladder would be policies that would restrict or even eliminate choice altogether, such as by limits on the sale or use of tobacco products.

PHLN: How do both types of public health laws improve public health?

Mello: These different types of legal interventions all aim to exert influence on people's health-related behaviors, thereby affecting risk factors for adverse health outcomes. One of the most interesting areas of research at this point in time is studying how well they do that—are "carrots" better than "sticks?" How big does an incentive or sanction need to be to influence different types of health behaviors? What kind of undesirable side effects do different approaches have? We're just beginning to shed light on these questions.

PHLN: Broadly, what did you learn from the study?

Morain: In this study, we found that the public supports legal interventions aimed at noncommunicable diseases such as obesity, cardiovascular disease, and diabetes. However, the support for specific policies is inversely related to the degree to which they constrain individual liberty. In addition, we found that people's perception of the public health policymaking process influenced their levels of support. When people felt that they were able to influence public health priorities and that public health officials understood their values, they were more likely to support public health policies to address noncommunicable disease conditions.

PHLN: Were any of the results particularly striking? If so, why?

Morain: I think one of the most surprising results was how high the levels of support were for government action on public health efforts across a range of noncommunicable diseases. While considerable media attention has been devoted to discussion of the "nanny state," we found that the majority of individuals do, in fact, support government intervention to address these disease conditions—and in some cases, actually want the government to do more.

Mello: Interestingly, that was even true where respondents were members of the group that we might think of as being "targeted" by legal interventions—like diabetics or overweight people. An interesting exception was smokers, who tend to disproportionately oppose laws that target their behavior.

PHLN: Why is public attitude towards specific types of laws, specifically public health laws, an important aspect of building public health capacity?

Morain: As a practical matter, policymakers may take public opinion on health issues into consideration because people are more likely to comply with regulations they view as legitimate, and this compliance can influence whether or not an intervention is successful. There are also normative reasons why policymakers may want to take public opinion into consideration, such as respecting democratic values.

PHLN: Do you have any other projects reviewing individual perceptions and attitudes toward public health laws and policies? If so, what are they and how might your research be used to improve public health?

Morain: Currently, we're exploring how this data might be able to shed light as to how a person's public health policy preferences are motivated by considerations about the policy's likely impact on him/her. While there is a widespread belief that self-interest plays a strong role in influencing political behavior, prior research suggests that self-interest actually has a limited influence, and that other factors such as political attitudes may play a stronger role in shaping policy-related attitudes and behaviors. Identifying whether personal characteristics like smoking or other health behaviors drives policy support can help policymakers evaluate the likely levels of support for different policy alternatives, and the support among different subsets of the population. In addition, knowing what features influence support can inform how policymakers should frame interventions so as to maximize support.

PHLN: What role does public health law research play with regard to legislating on public health issues?

Mello: Not as much as it should. Ideally, laws should be based on evidence that a legal approach is effective or at least plausible. In practice, that isn't always true—sometimes because evidence doesn't (yet) exist, sometimes because it exists but isn't accessible to policymakers, and sometimes because other influences, like politics, carry more weight. There is growing community of public health law researchers aiming to change that by generating knowledge about what works in public health law and bringing it to the policy community. We've still got a lot of work to do, but the Robert Wood Johnson Foundation's (RWJF) Public Health Law Research program has really helped move this mission forward.

PHLN: How can individuals learn more about evidence-based legislation and how it relates to creating laws that have positive outcomes for public health?

Mello: RWJF's Public Health Law Research program is dedicated to building the evidence base for laws that improve public health. Their program funds research, works to improve public health law research methods, and makes this information accessible to the public, policy-makers and the media. In 2010, RWJF launched a companion program, the Network for Public Health Law, which connects public health officials, advocates, policy-makers, lawyers, and other practitioners and provides them with training and technical assistance in the use of law and policy as public health tool. Both of these programs are valuable resources for information about evidence-based legislation.

PHLN: How can individuals learn more about the Harvard School of Public Health and your department's upcoming events?

Mello: The Harvard School of Public Health has a great website featuring the latest in cutting-edge research in health policy and other areas of public health.

PHLN: If you were not working in public health law, what would you likely be doing?

Mello: I'm interested more broadly in how tort law, or personal injury law, affects people's and companies' behavior. I would love to do more work in that area, outside the health arena. I know I belong doing research rather than practicing law—I think that once you train as a social scientist, you're essentially ruined as a partisan advocate, because your relationship to evidence is forever changed.

PHLN: Please describe any personal information, hobbies, or interests you care to share.

Mello: My other job is taking care of two small boys. There isn't much time for other things at the moment, but lately I've gotten into listening to Supreme Court oral arguments in the car—you can't find a better example of grace under pressure.

PHLN: Have you read any good books lately?

Morain: One of my favorite books recently has been Zoobiquity: What Animals Can Teach Us About the Health and Science of Healing. The book explores the parallels between illness and treatments across veterinary medicine and human medicine, and suggests that both types of medicine could be improved by increasing collaboration. I think it is a book that many in the public health community would find interesting, especially given the persistent threat of zoonotic diseases to human health. It also has some wonderful "who knew" moments, like an exploration of human fainting, and how similar tendencies in animals may actually confer an evolutionary advantage, such as by reducing heart rate to avoid detection by predators.

PHLN: Is there anything else you'd like to add?

Mello: I hope public health officials and legislators are heartened and emboldened by our study findings. The public has been shown to be behind efforts to use law to tackle chronic disease, as long as they're respectful about how they go about it.

Illinois: Only qualified privilege for reporting alleged falsified research
Mauvais-Jarvis v. Wong [PDF - 216KB]
Appellate Court of Illinois, First District, Fourth Division
Case No 1-12-0070, 12-0237 cons.
Filed 03/28/2013
Opinion by Justice Fitzgerald Smith

Ohio: State law unconstitutional violation of home rule re: city's trans fat ordinance
City of Cleveland v. State [PDF - 88KB]
Court of Appeals of Ohio, Eighth District, Cuyahoga County
Case No. 98616
Filed 03/28/2013
Opinion by Judge Eileen A. Gallagher

Federal: Court clarifies legal duty regarding aviation lead emissions endangerment
Friends of the Earth v. United States Environmental Protection Agency
United States District Court, District of Columbia
Civil Action No. 12-0363(ABJ)
Filed 03/27/2013
Opinion by Judge Amy Berman Jackson

Federal: Motion to dismiss granted in counterfeit safety sticker case
In re: Guildmaster, Inc. v. United States [PDF - 46KB]
United States Bankruptcy Court, Western Division of Missouri
Case No. 12-62234, Adversary No. 12-6068
Filed 03/29/2013
Opinion by Judge Arthur B. Federman

United States District Court Judge Edward P. Korman's opinion in Tummino v. Hamburg, Commissioner of Food and Drugs

"'Judges are not like pigs, hunting for truffles buried in briefs.' United States v. Dunkel, 927 F.2d 955, 956 (7th Cir. 1991) (per curiam). It is not my job, in a case in which numerous briefs and motions have been filed, to 'scour [ ] through footnotes in search of some possibly meritorious point that counsel did not consider of sufficient importance to [develop or] include as part of the argument. United States v. Restrepo, 986 F.2d 1462 (2d Cir. 1993).'" wrote United States District Court Judge Edward P. Korman, in his April 4, 2013 opinion in Tummino v. Hamburg, Commissioner of Food and Drugs [PDF - 177KB], regarding judiciary's duty develop or not develop counsels' partial arguments. The Tummino case deals with Plan B One-Step or the "morning-after pill's" availability to women under the age of 17 without a prescription.