Reversing its previous deference to corporate speech interests, the U.S. Court of Appeals for the D.C. Circuit came down in favor of consumer protection in a July 29 decision. In American Meat Institute v. U.S. Dept. of Agriculture, the court upheld a federal government regulation requiring meat companies to disclose the countries of origin for their products. If your beef comes from Argentina or Canada, you will know that from its label.
More importantly, the court gave the Food and Drug Administration greater freedom to reduce tobacco use in the United States. In explaining its reasoning, the court repudiated the logic of an earlier decision by the court that rejected the FDA’s graphic warnings for cigarette packs. According to the meat labeling opinion, the cigarette warning decision did not allow sufficient leeway for the government to mandate warnings or other informational disclosures to consumers.
Perhaps the U.S. Supreme Court will restore the D.C. Circuit’s previous balance, but for now, the tide has turned in favor of the public’s health.
In the wake of the Hobby Lobby decision, the US Department of Health and Human Services announced on Friday proposed rules regarding exemptions for those objecting to the contraceptive mandate. Whenever I read about conscientious objections to health care services made by providers, patients, or indeed, employers, I am reminded that all objections are not equal.
As Mark Wicclair, and others, have written, studies show that medical professionals may object to services based on clinically false information. For instance, certain pharmacists reported that they objected to emergency contraception on the mistaken belief that Plan B was the same thing as RU-486 (mifepristone, or the “abortion pill”). Similarly, a prominent general practitioner admitted to making decisions regarding the prescription of oral contraception without fully understanding the mechanisms of operation that prevent pregnancy. If medical professionals make decisions based on ignorance, one can suspect that lay employers and patients do as well.
This suggests that individuals often lack the information necessary to truly assess their stance on morally controversial services. While the law does (and should) play a role in protecting conscience, it seems unsatisfying when such protection is granted to those holding underdeveloped views, and at the expense of (and detriment to) those seeking legal medical services.
Health law practice is undergoing radical restructuring in the wake of major changes in the health care system and the reorganization of the legal profession. The health care system is being transformed as the Affordable Care Act (ACA) and other factors promote the integration of clinics and hospitals, put greater emphasis on patient-centeredness, create incentives for value-based care, mandate public reporting on costs and outcomes, and provide subsidized coverage. These changes in the health care system come at a time when the legal profession is also undergoing significant transformations. In the corporate law sector, we see a major shift in the role of corporate general counsel and corresponding changes in the practice of outside corporate firms: General Counsel positions (GCs) are becoming more powerful and corporate firms are shifting from overall representation of companies to specialist niches. At the same time there is increased concern about access to justice for under-represented individuals while new programs to address unmet legal needs are emerging. Health care lawyers are caught up in this dual transformation as the nature and the setting for their practices change and they are called on to play new roles and develop new skills.
Art Caplan has a new video on Medscape laying out the principles behind rationing limited supplies of experimental ebola treatments. As he explains:
I believe the answer to the question of who should receive the drug is: people we can both learn from and potentially help the most. I believe those are the 2 values we use when trying to ration access to an experimental drug. If we do not learn whether something is safe and effective, then we have missed an opportunity, even in the middle of an epidemic, to find out whether it is worth giving out drugs that are new, untested, and unapproved. People who should be included are those who can be observed and kept under surveillance — not for a day or a week but probably for months and years. That favors people who are not in rural villages. That favors people who will have access to hospital facilities. Those criteria will drive the selection of who receives a new, unapproved drug.
It is important that the WHO committee affirmed the morality of compassionate use. This addresses the concern that any use of unapproved drugs is inherently exploitative. But there are huge ethical issues that still remain unaddressed and unanswered regarding experimental interventions.
In the wake of the Canadian government’s offering 1,000 doses of an experimental Ebola vaccine to the stricken nations, he also extends the argument from allocation of treatment to allocation of prophylaxis in this opinion piece in NBC News Health:
It is ethically appropriate in the midst of a deadly contagious epidemic to try both untested treatments and experimental preventative vaccines that have shown some promise in animals and no safety issues. But with only 1,000 doses of vaccine available, who should get them? And what do they need to be told?
The most ethical way to distribute limited experimental vaccine, is, as the WHO ethics group noted, with an eye toward collecting information on safety and efficacy. Rather than just handing out vaccine to a small group of people in countries that have seen Ebola outbreaks, it is important to learn as much as possible about whether the vaccine has any efficacy in humans and is safe.
The Petrie-Flom Center is pleased to welcome our new 2014-2015 Student Fellows. In the coming year, each fellow will pursue independent scholarly projects related to health law policy, biotechnology, and bioethics under the mentorship of Center faculty and fellows. They will also be regular contributors here at Bill of Health on issues related to their research.
Amidst news from Spain that a 75-year-old Catholic priest has received the experimental treatment ZMapp for Ebola, Art Caplancritiques what he describes as the “bad science” behind choosing its recipients:
ZMapp is not the answer to the Ebola epidemic ravaging West Africa. There is no chance of getting a significant amount of this drug made for many months. Deploying more health care workers, face guards, moon suits, gloves and antiseptic, along with restrictions on travel and burying the dead, is the only way to get the epidemic under control. [...]
The fact that a 75-year-old has been given the scarce drug is especially disturbing, not because he is 75 but because 75-year-olds do not have strong immune systems — something very important in battling a virus like Ebola. Moreover 75-year-olds often have other medical problems that complicate the ability of scientists to figure out if the drug is safe and if it is really working.
In testing unapproved, highly risky drugs like ZMapp, it is crucial that recipients not be so sick that they may well die regardless of whether they get the drug or not. Indeed, the recipients ought not be very sick so that side-effects can be seen and efficacy determined. To do that, doctors need to be able to monitor experimental subjects for months to make sure the drug does not damage their livers or cause any other fatal side-effect. So not every person infected with Ebola makes for the best recipient — younger, those more recently infected and those who can be closely monitored are among the “best” candidates.
You can read more of Art Caplan’s perspective on NBC News Health here.
We are excited to introduce Jonathan F. Will as a regular contributor to Bill of Health.
Jonathan is an Associate Professor of Law and is the founding director of the Bioethics & Health Law Center at Mississippi College School of Law. He is also on the affiliate faculty of the Center for Bioethics and Medical Humanities at the University of Mississippi Medical Center. Jonathan teaches upper level courses in Health Law and Bioethics, and has been voted 1L Professor of the Year for his section of Civil Procedure five times since joining MC Law’s faculty in 2009. In addition to commenting for the American Journal of Bioethics, his recent work focuses on reproductive rights and the implications of the nationwide personhood movement.
Much attention has been paid recently to the contradicting decisions issued on the Halbig and King cases, which challenged the Obamacare subsidies offered to individuals purchasing insurance on federal exchanges. In a piece for Politico Magazine, Abbe R. Gluck finds a weakness in the Halbig plaintiffs’ arguments, in their own words. As Gluck writes:
What’s less known, however, is that in the 2012 constitutional case, these same challengers filed briefs describing Obamacare to the court in precisely the way they now say the statute cannot possibly be read. Namely, they assumed that the subsidies were available on the federal exchanges and went so far as to argue that the entire statute could not function as written without the subsidies. That’s a far cry from their argument now that the statute makes crystal clear that Congress intended to deny subsidies on the federal exchanges.
I am not a fan of the “gotcha” flavor that some aspects of this case have taken on, but the challengers’ 2012 statements are relevant as a legal matter because what the government has to prove to win—as a matter of black-letter law under the Chevron doctrine—is that the statute is ambiguous. (Chevron says that federal courts defer to the relevant agency’s reading of the statute when a federal statute is unclear—here, that agency is the IRS.)
The challengers have spent more than a year arguing that no reasonable reader of text could construe the statute in any way other than denying federal subsidies to insurance purchasers on exchanges operated by the federal government. But what about their statements from 2012—statements then echoed by Justices Scalia, Kennedy, Thomas and Alito in their joint dissent to the Supreme Court’s ruling in the constituitional challenge, NFIB v. Sebelius?
You can read more, including the relevant passages from the NFIB v. Sebelius briefs, here.
The reasons for different treatment are partly about logistics, partly about economics and, partly about a lack of any standard policy for giving out untested drugs in emergencies. Before this outbreak, ZMapp had only been tested on monkeys. Mapp, the tiny, San Diego based pharmaceutical company that makes the drug stated two years ago: “When administered one hour after infection [with Ebola], all animals survived…Two-thirds of the animals were protected even when the treatment, known as Zmapp, was administered 48 hours after infection.”
But privileged humans were always going to be the first ones to try it. ZMapp requires a lot of refrigeration and careful handling, plus close monitoring by experienced doctors and scientists—better to try it at a big urban hospital than in rural West Africa, where no such infrastructure exists. [...]
But it’s about more than logistics. Drugs based on monoclonal antibodies usually cost a lot—at least tens of thousands of dollars. This is obviously far more than poor people in poor nations can afford to pay; and a tiny company won’t enthusiastically give away its small supply of drug for free. It is likely that if they were going to donate drugs, it would be to people who would command a lot of press attention and, thus, investors and government money for further research—which is to say, not to poor Liberians, Nigerians or Guineans. [...]
Art Caplanhas a new opinion piece on NBC News responding to the recent media coverage of Ebola. He makes the case that although this has been the worst recorded outbreak of the disease, citizens of developed countries have little reason to panic:
Ebola is not going to run amok in downtown Boston, Cape May or Myrtle Beach or anywhere else in the U.S. It is running amok in poor African nations because local authorities did not have the will or the resources to respond quickly, because no one confronted local funeral customs that expose people to Ebola, mainly because the world did not care much if hundreds died in poor, politically insignificant nations.
The harsh ethical truth is the Ebola epidemic happened because few people in the wealthy nations of the world cared enough to do anything about it.
We are excited to introduce Diana R.H. Winters as an occasional contributor to Bill of Health.
Diana has been an Associate Professor at Indiana University McKinney School of Law since 2012. She joined McKinney Law from Boston University Law School, where she was a Visiting Assistant Professor and the Health Law Scholar. Before that, Winters was an Assistant Solicitor General in the New York State Attorney General’s Office. Winters is also a founding board member of the Indianapolis (Indy) Food Council. She is currently researching the structure of food regulation, and the judicial review of health and safety regulation. She teaches Torts, Health Law, Environmental Law, and Food Law and Policy.
Bill of Health ContributorArt Caplanand ethicist Kelly McBride have launched a new twice-weekly podcast, Everyday Ethics, in which they explore the moral dimensions of our everyday lives. Recent topics have included conflicts of interest on Dr. Oz, recent “Right to Try” laws, and Jenny McCarthy’s anti-vaccination campaigns.
You can access the podcast online here, or subscribe to it on iTunes.
We’re pleased to formally introduce Dr. Greg Curfman as a contributor to Bill of Health. Dr. Curfman is already a familiar face here as a regular guest, and we’re thrilled to officially welcome him.
Dr. Curfman is currently the executive director of the New England Journal of Medicine, a position he has held for 14 years. In his tenure at NEJM, he has founded and currently directs the Perspective section, which focuses on issues at the interface of medicine and society. His work at NEJM has played a critical role in driving the national dialogue on health care.
A board-certified internal medicine physician and cardiologist, Dr. Curfman is also an assistant professor of medicine at Harvard Medical School. He graduated magna cum laude from Princeton University and received an M.D. cum laude from Harvard Medical School. Dr. Curfman has previously served as the director of the coronary care programs at the Brigham and Women’s Hospital and Dartmouth-Hitchcock Medical Center, and was also medical director at the Cardiovascular Health Center at Mass General.
Dr. Curfman regularly publishes on current topics in health law and the regulation of medical products. His publications include: Continue reading →
Today, U.S. District Judge Myron Thompson issued a decision – following a 10-day bench trial – declaring unconstitutional Alabama’s admitting privileges requirement for abortion providers. The decision is remarkable in at least two respects. First, Judge Thompson employs a brilliant interpretation of Planned Parenthood v. Casey that is different from any lower court opinion I have seen and yet that is well-grounded in the decision. (He had already laid out this framework in an earlier ruling on summary judgment.) It resolves a longstanding puzzle about the undue burden standard, namely whether and how a court should factor in the state’s burden of justification for an abortion restriction when it conducts an undue burden analysis. Judge Thompson focuses in on a little-noticed aspect of Casey, namely its reliance on ballot-access case law. The Casey joint opinion analogizes to the states’ “substantial flexibility in establishing the framework within which voters choose the candidates for whom they wish to vote,” in order to explain why “not every law which makes a right more difficult to exercise is, ipso facto, an infringement of that right.” Yet, in describing the state’s power to regulate elections as “similar” to its power to regulate abortion, the Court suggests that its analysis in the ballot access cases is instructive in the abortion context.
Judge Thompson takes up this suggestion. He points out that, in the specific cases that the Casey joint opinion cites, the Court looked at whether the state’s interest in the election regulation was “sufficiently weighty” to justify the restriction it imposed. In Anderson v. Celebrezze, for example, the Court explained that, when analyzing constitutional challenges to specific provisions of a state’s election laws, the Court
must first consider the character and magnitude of the asserted injury to the rights . . . that the plaintiff seeks to vindicate. It then must identify and evaluate the precise interests put forward by the State as justifications for the burden imposed by its rule. In passing judgment, the Court must not only determine the legitimacy and strength of each of those interests, it also must consider the extent to which those interests make it necessary to burden the plaintiff’s rights. Only after weighing all these factors is the reviewing court in a position to decide whether the challenged provision is unconstitutional.
Judge Thompson applies this framework, first analyzing the burden that Alabama’s admitting privileges requirement would impose on abortion access in the state. Finding that the burden would be substantial, he then closely examines the state’s purported justifications for the law and concludes that they are “exceedingly weak.”
The Office of Ethics at Boston Children’s Hospital has an immediate opening for a clinical ethicist.
Applications are being accepted online, at www.childrenshospital.jobs. To locate the position on the website, enter “32902BR” in the box labeled “AutoReqID.”
Boston Children’s Hospital is a 395-licensed-bed children’s hospital in the Longwood Medical and Academic Area of Boston, Massachusetts. At 300 Longwood Avenue, Children’s is adjacent to its teaching affiliate, Harvard Medical School.
Job description: Clinical Ethicist 32902BR
The Clinical Ethicist provides formal and informal ethics consultations. Organizes and participates in clinical ethics rounds, and collaborates with clinical teams, patients and families, to address ethical issues in pediatric health care and research. Develops ethics resources and education and serves as a facilitator for change directed toward strengthening the Hospital staff’s sense of moral responsibility and moral community.
Legal commentators have spent a lot of time this week sparring over statutory interpretation and the contrasting readings of the ACA by the Halbig and King courts. The potential consequences of these cases demonstrate just how high the stakes of this enterprise can be.
With less fanfare, the Second Circuit decided a case yesterday that may too have large consequences for the health and welfare of the public. In NRDC v. EPA, the court reversed a district court’s decision to require FDA to hold hearings on the withdrawal of approval for the use of two antibiotics—penicillin and tetracyclines—in animal feed. This issue has enormous public health consequences, but the consequences of this case extend beyond antibiotic use, to agency practice in general. The opinion sanctions egregious agency delay and a tremendous lacuna in decision making.