Reactions to Myriad, two weeks later

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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

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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

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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. Read More

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

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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

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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

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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?

astein 19 Comments

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

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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

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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 Review, Michigan 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

The Petrie-Flom Center Staff 11 Comments

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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