The misconceived reverence for life

By Nikola Biller-Andorno, MD, PhD

Times and again, individuals have asked courts in the United Kingdom, Ireland and other countries for permission to have someone help them end their lives. Diane Pretty, Tony Nicklinson and, most recently, Marie Fleming are among those who suffered from a serious disease that prevented them from acting on their wish by themselves. Their requests, highly publicized and intensely debated, were all turned down.

There are concerns about the legalization of assisted suicide, such as the danger of abuse, that merit attention. One of the core arguments against physician involvement is that medicine is about saving lives, not about ending them. This argument, with its underlying notion of an unconditional reverence for life, is flawed.

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The Tylenol Debate: Can Hospitals be Sued for Excessive Markups on Medications and Devices?

By Alex Stein

Steven Brill’s TIME MAGAZINE blockbuster article, Bitter Pill: Why Medical Bills are Killing Us, uncovers the CHARGEMASTER: a publicly undisclosed pricelist accountable for what we see in hospital bills. What we see there doesn’t look good: it includes acetaminophen sold for $1.50 a tablet (you can buy 100 of those for the same price at Amazon); $77 for a box of sterile gauze pads (Amazon’s prices vary between $6 and $11); $18 for a single diabetes test strip (sold for 54 cents by Amazon); $108 for antibacterial Bacitracin ointment (Amazon’s prices vary between $2.50 and $6.50); and so forth. Charges for stay, scans, surgeries, canes, and wheelchairs skyrocket as well.

The American Hospitals Association (AHA) rejects Brill’s analysis. According to AHA, the chargemaster aggregates the hospital’s overall costs on delivering quality care to patients: “In order to take medications in a hospital, even over-the-counter medicines, they must be prescribed by a doctor (a little bit of cost for the doctor), that order gets transmitted to the pharmacy (a little more cost), the order gets filled by a pharmacist or pharmacy tech who retrieves just one Tylenol pill and individually packages that one pill (still more cost), the pill gets transported from the pharmacy to the nursing unit where the patient resides (a little more cost), then the pill is retrieved by a registered nurse who personally gives the pill to the patient and then must document the administration of that pill in the patient medication administration record (a little more cost). All of this process to give a patient a single dose of Tylenol in a hospital bed [must also be] in compliance with all pertaining regulations (a little more cost).”

This post will not try to resolve the Tylenol Debate. Nor will it say anything about the government as a plausible substitute for the eccentric chargemaster. Instead, I will raise a legal question: Can patients sue hospitals for excessive markups on medications and devices?

My answer to this question is a qualified YES. Entrepreneurial and business aspects of running a hospital fall under states’ consumer protection laws (Brookins v. Mote, 292 P.3d 347 (Mont. 2012)). Those aspects certainly include billing (Jaramillo v. Morris, 750 P.2d 1301, 1304 (Wash. App. 1988); Ambach v. French, 216 P.3d 405 (Wash. 2009)). The key question here is whether an excessive markup on medications and devices amounts to deceit or an unfair trade practice. If it does, the hospital would be in violation of the relevant state consumer protection law. This might happen to hospitals whose billing practices—to which patients gave no informed consent—are particularly aggressive. Those hospitals might face class action suits and the prospect of paying treble damages. They also may be stripped of the special protections given to defendants in medical malpractice suits (that include shortened limitations and repose periods for filing suits, caps on damages, and charitable immunities). For my account of the competition between medical malpractice and consumer protection rules, click here.

Brill and other participants in the Tylenol Debate call on the government to start regulating hospital prices. My short advice to hospitals: get rid of unconscionable markups forthwith.

Call for Applications: Petrie-Flom Center Academic Fellowship, 2014-2016

The Petrie-Flom Center invites applications for 2014-2016 Academic Fellowships.

PURPOSE: The Academic Fellowship is a postdoctoral program specifically designed to identify, cultivate, and promote promising scholars early in their careers. Fellows are selected from among recent graduates, young academics, and mid-career practitioners who are committed to spending two years at the Center pursuing publishable research that is likely to make a significant contribution to the field of health law policy, medical innovation policy, or bioethics. For more information about current and past fellows, please visit the Fellowship Programs section of our website.

ELIGIBILITY: By the start of the fellowship term, applicants must hold an advanced degree in a discipline that they intend to apply to issues falling under the Center’s umbrella. The Center particularly encourages applications from those who intend to pursue careers as tenure-track law professors, but will consider any applicant who demonstrates an interest and ability to produce outstanding scholarship at the intersection of law and health policy, bioethics, or biotechnology during the term of the fellowship. Applicants will be evaluated by the quality and probable significance of their research proposals, and by their record of academic and professional achievement.

APPLICATION: Applications will be accepted from September 16, 2013 through November 18, 2013.

For more information, see the full call for applications here or contact Administrative Director Cristine Hutchison-Jones.

Introducing Guest Blogger Alex Stein

Alex Stein is Professor of Law at Brooklyn Law School. Prior to joining Brooklyn Law, Professor Stein was on the faculty at Cardozo (2004–16) and the Hebrew University of Jerusalem (1991–2004). Alex also held visiting professorial appointments at Columbia, Miami, and Yale Law Schools. In Fall 2016, he visited Harvard Law School, where he taught Torts and a seminar on Medical Malpractice. Alex’s specialty areas are Evidence, Medical Malpractice, Torts, and general legal theory. He authors three books, An Analytical Approach to Evidence (with Ronald J. Allen et al.) (6th ed. 2016), Foundations of Evidence Law (Oxford University Press, 2005) and Tort Liability under Uncertainty (Oxford University Press, 2001) (with Ariel Porat), and over sixty articles of which many have appeared in leading journals including Harvard Law Review, Columbia Law Review, University of Pennsylvania Law ReviewMichigan Law Review, Virginia Law Review, Georgetown Law Journal, Northwestern University Law Review, Texas Law Review, Vanderbilt Law Review and Oxford Journal of Legal Studies. Alex was one of the founding editors of Theoretical Inquiries in Law. In 2013, he launched an e-journal STEIN on Medical Malpractice that covers all significant developments in medical malpractice laws across the United States and attracts 27,000 visitors every year. He graduated from the Hebrew University of Jerusalem and earned a Ph.D. from the University of London.

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Guest Post: No liability for failure to vaccinate? The case has not been made: A Response to Mary Holland

As of Friday, June 28, this post is closed to further comments. We want to thank the many readers who have engaged in a vigorous and civil discussion on the recent posts to the Bill of Health that engage questions related to the debate over vaccines. In general, we do not moderate discussions on the site. However, due to an increasing number of comments that violate our policies regarding abusive and defamatory language and the sharing of personal information, we are closing these posts to comment.

By Dorit Rubinstein Reiss, LLB, Ph.D.

Dorit Rubinstein Reiss (LLB, Ph.D.) is Professor of Law at UC Hastings College of the Law. She has published articles on regulation and administrative law and teaches tort law. She is also a member of the Parents Advisory Board of Voices for Vaccines and writes the blog Before Vaccines

In a guest post on this blog, Mary Holland, JD, suggests that there are no grounds for imposing tort liability on parents for failure to vaccinate alone, even if it led to another person being infected. Holland’s post is courteous and matter-of-fact, and there are certainly arguments for that position, especially the argument that common law rarely imposes a duty to act. But Ms. Holland did not make that case.

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Concussions, the N.F.L., & the Manufacture of Doubt

{SHAMELESS SELF-PROMOTION ALERT}

A new article of mine is out in the Journal of Legal Medicine entitled “Mild Traumatic Brain Injury, the National Football League, and the Manufacture of Doubt: An Ethical, Legal, and Historical Analysis.”  I’ve written on the subject before, but in case anyone is interested, here is the Abstract of the current paper:

This paper integrates legal, historical, and ethical approaches in analyzing the National Football League’s conduct regarding the risks its players face of experiencing concussions and the long-term neurodegenerative pathologies to which such injury is linked.  Given that millions of children and adolescents play American football, and that the NFL concedes its behavior is a strong determinant of football culture, concussion issues are crucial matters of population health.  Examining over 500 pages of testimony generated during Congressional hearings in 2009 and 2010, the paper links claims issued by leading NFL representatives to past efforts by industrial actors to manufacture doubt.  The paper therefore argues that the history of public health is crucial to framing just public health policy in the present.  The paper applies two frameworks drawn from public health ethics to argue first that a robust process of public reason is stymied by the NFL’s insistence on privately holding information relevant to its attitudes, practices and beliefs regarding concussions, and second, that the unequal distribution of ‘football prevalence’ exposes already disadvantaged groups such as African-Americans to higher risks of concussions and neurological disease.  The paper concludes that this latter possibility may contravene mandates of social justice, and, if so, would be ethically suboptimal.

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Bioethicist Edmund Pellegrino Has Passed

By Christopher Robertson

On June 13, 2013 Dr. Edmund Pellegrino died at the age of 92.  (Obituaries are available here and here.)  For bioethicists this is a time to reflect, but in particular affiliates of the Petrie Flom Center will recall that one of the very first events that that the PFC hosted was a distinguished panel to discuss the concept of human dignity in bioethics, featuring Martha Nussbaum, Nick Bostrom, Dan Brock, and Edmund Pellegrino.  (I recall attending the event as a student.)  The webcast is still available, at the bottom of the page, here.  This event commemorated the release of the Presidential Bioethics Advisory Commission’s new book on the topic of human dignity.  Dr. Pellegrino chaired the PBAC, and his contribution to the book is available online here.

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Guest Post: Crack Down on Those Who Don’t Vaccinate?: A Response to Art Caplan

As of Friday, June 28, this post is closed to further comments. We want to thank the many readers who have engaged in a vigorous and civil discussion on the recent posts to the Bill of Health that engage questions related to the debate over vaccines. In general, we do not moderate discussions on the site. However, due to an increasing number of comments that violate our policies regarding abusive and defamatory language and the sharing of personal information, we are closing these posts to comment.

By Mary Holland, J.D.

Mary Holland is Research Scholar and Director of the Graduate Legal Skills Program at NYU Law School. She has published articles on vaccine law and policy, and is the co-editor of Vaccine Epidemic: How Corporate Greed, Biased Science and Coercive Government Threaten Our Human Rights, Our Health and Our Children (Skyhorse Publishing, 2012). 

Dr. Art Caplan recently posted an editorial, “Liability for Failure to Vaccinate,” on this blog. He argues that those who contract infectious disease should be able to recover damages from unvaccinated people who spread it. If you miss work, or your baby has to go to the hospital because of infectious disease, the unvaccinated person who allegedly caused the harm should pay. Dr. Caplan suggests that such liability is apt because vaccines are safe and effective. He sees no difference between this situation and slip-and-fall or car accidents due to negligence. Arguing that “a tiny minority continue to put the rest of us at risk,” he suggests that public health officials can catch the perpetrators and hold them to account through precise disease tracing.

Dr. Caplan’s assertions to the contrary, vaccines are neither completely safe nor completely effective. In fact, from a legal standpoint, vaccines, like all prescription drugs, are “unavoidably unsafe.”  [See, e.g., Bruesewitz v. Wyeth, 562 U.S. __ (2011).‎] Industry considered its liability for vaccine injury so significant that it lobbied Congress for the 1986 National Childhood Vaccine Injury Act, providing doctors and vaccine manufacturers almost blanket liability protection for injuries caused by federally recommended vaccines. [See Authorizing Legislation.] The liability risk was so serious that the federal government created a special tribunal under the 1986 Act, the Vaccine Injury Compensation Program, to pay the injured. Moreover, the Supreme Court in 2011 decided Bruesewitz v. Wyeth, prohibiting any individual from filing a civil suit for a defectively designed vaccine in any court in the country. Industry’s extraordinary protection against liability for vaccine injury does not correspond with glib statements, like those of Dr. Caplan, that vaccines are safe and effective. On the contrary, the law acknowledges that vaccines cause injury and death to some, with no screening in place to mitigate harm.  Read More

The First Amendment Meets Public Health Again — The US AID Case

By Wendy Parmet

Sometimes it seems as if the First Amendment is the leading legal threat to public health. Not today. In Agency for International Development v. Alliance for Open Society International the Supreme Court in a 6-2 decision struck down on First Amendment ground the so-called “anti-prostitution pledge” imposed by § 7631(f) of the  Leadership Act which prohibited the award of anti-HIV grants to groups or organizations that do “not have a policy explicitly opposing prostitution and sex trafficking” constituted an unconstitutional condition. Critical to the Chief Justice Roberts’ opinion was the fact that § 7631(f) did not simply limit grantees’ ability to use federal funds to support prostitution. Rather, it compelled a “grant recipient to adopt a particular belief as a condition of funding.”  According to the Court, the government can limit what grantees do with federal funds, but it cannot restrict what they believe.

Although the Court ‘s opinion focused on core First Amendment issues, rather than the public health impact of the anti-prostitution pledge, its decision should remind us of the complex and sometimes ambivalent relationship between public health and the First Amendment. Since the early years of the HIV epidemic, the First Amendment has been a crucial public health ally, limiting government’s ability to censor controversial but critical public health information. In many other cases, however, such as those challenging regulations aimed at tobacco or pharmaceutical advertising, a robust interpretation of the First Amendment seems to hinder public health protection. For public health law advocates, a key question is whether the First Amendment can be interpreted so as to protect health in both sets of circumstances. Equally critical is understanding how we can achieve public health goals without relying on the regulation of speech. Alliance for Open Society may offer some clues, but it clearly does not provide the answers.

WSJ on Health Law Jobs

By Christopher Robertson

The Wall Street Journal has a new article this week celebrating the flood of new jobs for lawyers created by the Affordable Care Act.  The WSJ article rattles off a dozen or so examples of legal questions that arise from the new legislation and litigation, providing lots of fodder for a health law class.  This comes after a provocative session at ASLME’s health law professors conference last week, discussing an effort by the American Health Lawyer’s Association to create a model law school curriculum, starting with a survey course and broadening into a range of courses that could constitute a “certificate program.”