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. Read More

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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OHRP Suspends Compliance Action Against SUPPORT Study Sites Pending Public Hearing & Guidance

By Michelle Meyer

UPDATE: A class action lawsuit has been filed in federal court against UAB providers and IRB members on behalf of infants enrolled in the SUPPORT study (through their parents). The Amended Complaint, which was filed May 20, can be found here. In addition, here are two more sets of reactions to the SUPPORT study in the NEJM, both in defense of it, from a group of prominent bioethicists and from NIH. Here is a new post from John Lantos at the Hasting Center’s Bioethics Forum blog. And here is coverage of the most recent developments in the New York Times. I’ll continue to aggregate links as warranted.

Regular readers may recall that recently, OHRP sent a determination letter to one of multiple sites (the University of Alabama at Birmingham (UAB)) involved in an RCT (the SUPPORT study) of optimal oxygen levels for premature infants (prior coverage here, here, and here). OHRP’s criticism itself led to considerable criticism among many research ethicists and physician-researchers (see, e.g., here, here, and here), as well as the SUPPORT researchers themselves (here), while others defended OHRP to varying degrees (here, here, and here).

Now, in a new letter to UAB, OHRP clarified that it has no objections to the study design; its objections, instead, pertain to what parents were told in the informed consent documents. Then, in a remarkable move, it announced that it is suspending its compliance actions against UAB, and plans no further action vis-a-vis other SUPPORT sites, pending its issuance of new guidance to address the risks that must be disclosed when conducted clinical trials like SUPPORT. OHRP promises not only the usual notice and comment period following the draft guidance but also an open public meeting, presumably in advance of the draft.

As the OHRP letter itself suggests, the fight within the research ethics community over the SUPPORT study can be seen as part of a larger conversation about the future of human subjects research regulation in the learning healthcare system. OHRP’s guidance-making process in this matter will clearly be one to watch.

More Commentary on Why Patients May Be Discriminated Against

Given my recent piece in the New England Journal on discrimination against patients, particularly obese patients in the context of the Americans with Disabilities Act, I found this NY Times story particularly interesting: Disability and Discrimination at the Doctor’s Office. The Times story focuses on patients who are disabled in more traditional ways, but indicates that the main culprit behind the medical discrimination they may experience is not animus, but rather lack of proper equipment, which can be quite expensive.  Luckily, there may be hope on the horizon, thanks to the ACA.

Pharmacist Conscience Clauses

By Joanna Sax

Multiple states have statutes that protect a pharmacist from liability for refusing to fill a prescription for an FDA approved medication.  Other states have laws that require pharmacists to fill prescriptions regardless of their personal beliefs.  The debate surrounding conscience clause legislation falls at two opposing spectrums.  Opponents to conscience clauses argue that refusal to fulfill a prescription for a non-medical reason interferes with the doctor-patient relationship and disproportionately effects women because it is often employed with prescriptions for birth control.  Supporters of conscience clause legislation argue that pharmacists have a constitutional right and that their personal beliefs should be respected.

These two sides will never meet.  They will continue to argue notions of fairness and each side will dig-in their heels.

I’ve proposed a different approach to analyze whether pharmacist conscience clauses are beneficial to society using welfare economics.  In short, the pharmacist conscience clauses serve as an affirmative defense in an action for professional negligence.  Pharmacist conscience clauses can be analogized to a no-care regime and arguably not maximize the well-being of individuals.  To see more of my argument of analyzing conscience clauses using an economic approach, you can check out my article here.

Medical Malpractice, the Affordable Care Act and State Provider Shield Laws: More Myth than Necessity?

By Mary Ann Chirba and Alice A. Noble

Given the ambitions and reach of the Affordable Care Act, confusion about its intended and inadvertent impact is inevitable. Since its enactment in 2010, the ACA has raised legitimate and less grounded concerns among various stakeholders ranging from individuals and employers facing coverage mandates to States deciding whether and how to implement the Act’s Medicaid expansions. One item has received far less attention even though it weighs heavily on any provider engaged in the clinical practice of medicine: the ACA’s impact on medical malpractice liability. The Act does little to address medical malpractice head on. Nevertheless, physicians and other providers, the states and even some members of Congress have expressed concern that the Act will increase a provider’s exposure to medical malpractice liability.

In response, the American Medical Association has drafted model legislation to shield providers from newly created malpractice claims resulting from the ACA. It would prevent malpractice claimants from using federal or state practice guidelines, quality measures, reimbursement criteria and the like to establish or define the standard of care without expert testimony. In Congress, a version of this model, H.R. 1473, was introduced in the House of Representatives in 2012, and again in April of 2013 [link: https://beta.congress.gov/bill/113th-congress/house-bill/1473/cosponsors].

In April, the governor of Georgia signed H.B. 499 [link: https://www.legis.ga.gov/legislation/en-US/display/20132014/HB/499] into law, becoming the first state to pass legislation based on the AMA model act.

This came on the heels of a Medical Association of Georgia Advocacy Brief [link: https://www.mag.org/sites/default/files/downloads/issue-brief-provider-shield2-2013.pdf] stating that the ACA’s “guidelines” concerning health care quality measures; payment adjustments; hospital value-based purchasing; and value-based payment modifiers “will raise [the medical malpractice] standard to unreasonable levels by exposing physicians to a number of new liabilities….” [Emphasis added]

It is too early to tell whether states will follow Georgia’s lead and enact similar measures. What is clear is that such “standard of care protection” or “provider liability shield” legislation raises interesting questions about the ACA’s impact on state medical malpractice law.

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Tough Advice to Swallow from the NYT Ethicist

Take a look at the answer this physician received about breaking his promise of confidentiality to a patient.  The New York Times’ Ethicist describes this as a modern problem, but it seems to me this is age-old.  And although the confession was not medical, the nature of the doctor-patient relationship and the historical trust it has cultivated can’t be ignored.  The Ethicist says he expects vehement disagreement, and that’s one thing he’s right about for sure.

Discrimination Against Obese Patients

Following up on a blog post I did here several months ago, take a look at – and a listen to – some additional commentary I have in this week’s New England Journal of Medicine.

The gist?  The law prohibits many, but not all, grounds for discrimination against potential patients.  Race, religion, sex, and disability are among the most uniformly protected categories, whereas less than half of states prohibit health care discrimination based on sexual orientation or gender identity, for example. Moreover, the rejection of patients because they smoke, play contact sports, or engage in other risky behavior is legally within the realm of physician discretion, as is discrimination based on other characteristics not protected by law.

So what about obesity discrimination by healthcare providers?  Perhaps one of the last comparatively socially acceptable bases for discrimination, weight has not traditionally been treated as a protected category under civil rights laws. But one possible strategy is to consider the scope of prohibitions against disability discrimination. This is actually a pretty unsettled area of law – but the bottom line, to the extent there is one, is that rejection of an overweight or obese patient who is neither impaired to the extent of being disabled nor regarded as disabled would be legally permissible under the Americans with Disabilities Act.  Rejection of an obese patient who is disabled could also be permissible, so long as the disability was not the reason for the rejection.  The only problem would come up if a disabled obese patient were to be rejected on that basis, and could prove that to be the case.  So this may not be the most helpful approach to address obesity discrimination in the healthcare context, and in my opinion, reliance on simple medical professionalism and the commitment to caring for those in need has much more to offer.                          

Sleep No More: Sleep Deprivation, Doctors, and Error or Is Sleep the Next Frontier for Public Health?

[Cross-Posted at Prawfsblawg]

How often do you hear your students or friends or colleagues talk about operating on very little sleep for work or family reasons? In my case it is often, and depending on the setting it is sometimes stated as a complaint and sometimes as a brag (the latter especially among my friends who work for large law firms or consulting firms). To sleep 7-8 hours is becoming a “luxury” or perhaps in some eyes a waste – here I think of the adage “I will sleep when I am dead” expresses that those who need sleep are “missing out” or “wusses.” My impression, anecdotal to be sure, is that our sleep patterns are getting worse not better and that many of these bad habits (among lawyers) are learned during law school.

One profession that has dealt with these issues at the regulatory level is medicine. In July 2011, the Accreditation Council for Graduate Medical Education (ACGME) – the entity Responsible for the accreditation of post-MD medical training programs within the United States – implemented new rules that limit interns to 16 hours of work in a row, but continue to allow 2nd-year and higher resident physicians to work for up to 28 consecutive hours. In a new article with sleep medicine expert doctors Charles A. Czeisler and Christopher P. Landrigan that just came out in the Journal of Law, Medicine, and Ethics, we examine how to make these work hour rules actually work.

As we discuss in the introduction to the article

Over the past decade, a series of studies have found that physicians-in-training who work extended shifts (>16 hours) are at increased risk of experiencing motor vehicle crashes, needlestick injuries, and medical errors. In response to public concerns and a request from Congress, the Institute of Medicine (IOM) conducted an inquiry into the issue and concluded in 2009 that resident physicians should not work for more than 16 consecutive hours without sleep. They further recommended that the Centers for Medicare & Medicaid Services (CMS) and the Joint Commission work with the Accreditation Council for Graduate Medical Education (ACGME) to ensure effective enforcement of new work hour standards. The IOM’s concerns with enforcement stem from well-documented non-compliance with the ACGME’s 2003 work hour rules, and the ACGME’s history of non-enforcement. In a nationwide cohort study, 84% of interns were found to violate the ACGME’s 2003 standards in the year following their introduction.

Whether the ACGME’s 2011 work hour limits went too far or did not go far enough has been hotly debated. In this article, we do not seek to re-open the debate about whether these standards get matters exactly right. Instead, we wish to address the issue of effective enforcement. That is, now that new work hour limits have been established, and given that the ACGME has been unable to enforce work hour limits effectively on its own, what is the best way to make sure the new limits are followed in order to reduce harm to residents, patients, and others due to sleep-deprived residents? We focus on three possible national approaches to the problem, one rooted in funding, one rooted in disclosure, and one rooted in tort law. I would love reactions to our proposals in the paper, but wanted to float the more general idea in this space.

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Transplant Tourism: Hard Questions Posed by the International and Illicit Market for Kidneys, New Article I Wrote

[Cross-Posted at Prawfsblawg]

The Journal of Law, Medicine, and Ethics has just published an article by me on transplant tourism, that discusses the burgeoning international market for buying and selling kidneys. I review the existing data from Pakistan, Bangladesh, and India, which is pretty deplorable. As I show the vast majority of these sellers are poor and using the money (which is a significnat sum in terms of what they earn, even though in the end only 2/3 is paid) to try to buy themselves out of bonded labor, pay off familial debts, or try to mount a dowry. Many are misinformed or decieved about the health consequences for them and the needs of the person who will receive their kidney. Once they have agreed to sell they are often pressured not to renege. They are often released too soon post-transplant compared to what is optimal for a transplant, and their self-reported health post-transplant is worse. Many experience significant social stigma as a “kidney man” (or woman)and the 20-inch scar (the more expensive way of doing the procedure would reduce the scar size) marks them for life and makes it difficult for them to marry. Most express significant regret and would advise others not to undertake the operation.

Despite these grave facts, as I argue in the paper (and in greater depth for many of these arguments in the chapter on transplant tourism in my new book on medical tourism under contract at Oxford University Press), many of the traditional justifications from the anti-commodification literature — arguments relating to corruption, crowding out, coercion, and exploitation — do not make a convincing case in favor of criminalization. If a ban is justified, I argue the strongest arguments are actually about defects in consent and justified paternalism, on the assumption that criminal prohibition is a second best regulation in the face of the impossibility of a more thoroughly regulated market.

I then examine what means might be used to try to crack down on the market if we concluded we should. I evaluate possibilities including extraterritorial criminalization, professional self-regulation, home country insurance reimbursement reform, international criminal law, and of course better organ retrieval in the patient’s home country.

I will keep writing on this topic, including for my new book, so even though this paper is done feel free to email me your thoughts.