Suing Psychiatrists: Causation, Spoliation, Alternative Liability, and Lost Chance

By Alex Stein

Almonte v. Kurl, 46 A.3d 1 (R.I. 2012), is a must-read malpractice decision. This decision is about a patient who was brought to a psychiatrist for involuntary committal evaluation after undergoing an acute episode.  The psychiatrist examined the patient, but opened no committal process. As a result, the patient was released to commit suicide, apparently with the same gun that he threatened to use in the episode that triggered the evaluation.

The Rhode Island Supreme Court affirmed the trial judge’s determination that the psychiatrist’s failure to open the committal process amounted to malpractice. The psychiatrist was nonetheless able to summarily defeat the wrongful death action filed by the patient’s family.

How could that happen? Continue reading

Politics after a SCOTUS decision

Some SCOTUS opinions stir up politics and legislation (think: Roe v Wade). Others tend to end the process. When the Court is interpreting a federal statute, if they get it “wrong” it is of course possible for the elected branches to reverse them. But for some of these issues, political stalemate in Congress gives the Justices the last word, perhaps for decades.

Which makes the Roberts Court both activist and powerful.

For more, see “Political gridlock empowers US justices” in today’s Financial Times, quoting me.

@koutterson

Introducing Guest Blogger Seema Shah

Seema Shah is a faculty member in the Department of Bioethics in the NIH Clinical Center with a joint appointment in the Division of AIDS.  Her research focuses on the ethics of international research, the ethics of research with children, and the intersection of law and bioethics.  She currently serves as a consultant for the Division of AIDS on its clinical sciences review committee and as an ethics consultant for the Clinical Center.  She has published in the field of bioethics in peer-reviewed journals such as the Journal of the American Medical Association, the American Journal of Bioethics, and the Lancet.  More recently, she has focused on controversies surrounding the determination of death and organ transplantation, with an article on the topic in the American Journal of Law and Medicine.

Ms. Shah earned her bachelor’s and juris doctor degrees from Stanford University.  She previously served as a federal law clerk in the Eastern District of California and a predoctoral fellow in the NIH Department of Bioethics.  She has lectured on the ethics of human subjects research at conferences run by PRIM&R, ASBH, ASTMH, and internationally in such locations as Mali, South Africa, Singapore, and Vietnam.

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Non-Medical Exemptions: Weighing Public Health and Individual Rights

By Y. Tony Yang, ScD, LLM, MPH

More and more frequently, the media are reporting two potentially related and troubling developments: an alarming increase in outbreaks of deadly infectious vaccine-targeted diseases and the growing refusal by parents to allow their children to be vaccinated. (See this recent U.S. News & World Report article on cases in New York). Public health officials may therefore fairly ask whether their state vaccine exemption laws are unnecessarily and unintentionally sowing the seeds for a public health crisis and, if so, how their laws could be changed soon to head off avoidable epidemics.

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Too Young For Sex, But Old Enough For The Sex Offender Registry, Part III

By Michele Goodwin

I conclude Part III in this series from Uganda—a nation recovering from what one doctor describes as a “genocide” from HIV and AIDS. Parts I and II can be found here and here.

As a society, do we really care that teens and preteens have sex? On the one hand we care too much—so much so that the criminal law is the central form of regulating teen sex. This form of regulation is derived from statutes that treat all sexual behavior alike, even though consent and context may drastically vary.  In Law’s Limits: Regulating Statutory Rape Law, found here, I articulate why the criminal law approach, filtered through the judiciary, leads to absurd results. These absurd results include the extralegal punishments inflicted on youth who are punished for participating in consensual sexual activity, such as lifelong registration as a sex offender. These types of consequences and outcomes are problematic because they are morally wrong and foster significant harms across a series of areas, including creating social status harms, by reifying racial and homosexual stereotypes. The criminal law approach also leads to cruel and unusual punishments in an era where sex offender registries are increasingly the norm and a condition of release from prison.  On inspection, such punishments are disproportionate and unjustified.

On the other hand, maybe we care too little about teen sexuality. The notorious Steubenville, Ohio rape case bears this out (where the rape victim suffered backlash and threats), as do the high rates of HIV, sexually transmitted diseases, and syphilis infections among teens, and teens’ relatively high use of alcohol and drugs prior to sex. Parents fail to talk to their children about sexuality when children most need to understand it: prior to commencing sexual experimentation. Empirical data shows that fathers barely speak to their daughters about sex and these omissions may impact their daughters’ sexual attitudes and behaviors. Governors and prosecutors sometimes demonstrate selective interest in teen sexuality—when it involves specific ethnic populations or the poor. This failure to care enough is manifested in the criminal law approach to shaping teen sex norms, rather than the public health where it is most justified.

So, how might we move forward? Continue reading

Reactions to Myriad, two weeks later

By Nicholson Price

Two weeks after the Supreme Court held isolated naturally occurring DNA unpatentable in Association for Molecular Pathology v. Myriad Genetics, Inc., there’s been quite a lot of commentary about the case’s implications for the biotech industry and medical science.  I’ll just mention a few here, with the certainty that there will be more to come.  On the practical side, Quest Diagnostics has already announced plans to offer testing for BRCA1 and BRCA2.

Paul Cole wrote about how Myriad lines up with international views on gene patenting, and concluded it doesn’t, at least not well – in the E.U. and Australia isolated DNA is patentable.  On the other hand, at least the Federal Court of Australia opinion (also against Myriad Genetics), the court relied in part on its conclusion that “in the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and ‘isolated’ nucleic acid does not exist inside the cell. Isolated nucleic acid is the product of human intervention involving the extraction and purification of the nucleic acid found in the cell.”  The amicus brief filed by Dr. Eric Lander on behalf of neither party, and co-authored by Glenn Cohen here at the Petrie-Flom Center, points out the error of this conclusion, noting that there is a tremendous amount of isolated DNA present in the human body outside of cells.  Glenn posted extensively on this, and the importance of the brief in the Supreme Court’s reasoning, here.

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Special Issue of Jurimetrics on Law and Public Health

By Christopher Robertson

Arizona State University hosted a symposium on “The Intersection of Law, Science, and Policy to Protect the Public’s Health,” published in Jurimetrics, with excellent contributions by Wendy Parmet, David Hymen, Bernie Black, Vickie Williams, and many others.   Here is part of the abstract for the foreward by James Hodge:

Revitalization, revolution, renaissance. In the modern era, these three words depict the foundational changes in the role of law to protect, promote, and preserve the public’s health. Since the early 1990s, public health law has transformed into a distinct, identifiable field through the coupling of phenomenal scholarly vision (including from several scholars in this symposium issue) and public health practitioners’ bold experimentation in novel, applied uses of law to improve public health outcomes. After decades of sheer decline, reluctance, and even reversal of known, effective applications, law and policy have emerged as primary tools for making change in public health. Whether via constitutional interpretation, statutory or regulatory enactments, judicial interventions, or policy adjustments within legal systems, the notion that law can effectively contribute to the public’s health in areas as diverse as tobacco control, obesity prevention, and product safety is now relatively well accepted.

Decrease in the patient’s chances to survive held actionable as a standalone damage in Minnesota

By Alex Stein

On May 31, 2013, the Supreme Court of Minnesota has delivered an immensely important decision: it recognized as actionable a patient’s increased risk of dying resulting from her doctor’s negligent failure to secure timely diagnosis and treatment of cancer. Dickhoff v. Green, — N.W.2d —, 2013 WL 2363550 (Minn. 2013)

This case involved a family physician (the defendant) and her baby patient (the plaintiff). The baby had a lump on her buttock, which the defendant allegedly considered a non-issue for nearly a year. At the 1–year well-baby check, the defendant referred the baby to a specialist, who diagnosed her with alveolar rhabdomyosarcoma (ARS)—a rare and aggressive childhood cancer. The baby subsequently underwent a tumor-removal surgery, chemotherapy and radiotherapy, but remained dangerously ill. Continue reading

OHRP Announces Details of August 28 Public Meeting About SUPPORT and Similar Trials

By Michelle Meyer

Update: In other SUPPORT news today, a second group of bioethicists has written to the NEJM in, ahem, support of OHRP’s original criticisms of the SUPPORT trial. Readers may recall that another group of prominent bioethicists had previously published a letter in the NEJM in support of SUPPORT.

OHRP today announced details of the public meeting it previously said it would convene to address the SUPPORT trial and similar trials comparing two or more standard-of-care interventions in which subjects are randomized.

From an OHRP email:

On June 26, 2013, the Department of Health and Human Services (HHS) announced in the Federal Register an August 28, 2013 public meeting to seek public input and comment on how certain provisions of the Federal policy for the protection of human subjects should be applied to research studying one or more interventions which are used as standard of care treatment in the non-research context.

HHS specifically requests input regarding how an institutional review board (IRB) should assess the risks of research involving randomization to one or more treatments within the standard of care for particular interventions, and what reasonably foreseeable risks of the research should be disclosed to research subjects in the informed consent process.

HHS is seeking participation in the meeting and written comments from all interested parties, including, but not limited to, IRB members, IRB staff, institutional officials, research institutions, investigators, research subject advocacy groups, ethicists, and the regulated community at large.  The meeting and the written comments are intended to assist HHS, through the Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH), in developing guidance regarding what constitutes reasonably foreseeable risk in research involving standard of care interventions such that the risk is required to be disclosed to research subjects.  HHS is seeking input on a number of specific questions but is interested in any other pertinent information participants in the public meeting would like to share.

More details and deadlines after the jump.

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Fetal Pain Laws: Scientific and Constitutional Controversy

By John A. Robertson, University of Texas Law School

A new front has opened in the abortion wars with laws that ban abortion at 20 weeks on the ground that the fetus is then capable of feeling pain.  Led by Nebraska in 2011, ten states have passed such laws, and Texas is now considering such a ban. Although affecting less than 1% of the 1.2 million abortions occurring annually in the United States, abortion between 20-24 weeks may be hugely important for women whose fetus has a lethal or severe genetic anomaly or who otherwise find that they cannot continue the pregnancy. If this challenge to Roe v. Wade ‘s viability line (24 weeks) is upheld, it would be an important victory for anti-abortion groups, spur more states to enact such laws, and signal that the Supreme Court is ready to reconsider other aspects of the abortion right.

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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.  Continue reading

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.”