Polar chart depicting state conscience protection laws for abortion (46 states), sterilization (17 states), contraception (16 states), or emergency contraception (5 states).

New Dataset: Conscience Protections for Providers and Patients

Scholarship and public debate about law’s role in protecting health care providers’ conscience rights often focus on who should be protected, what actions should be protected, and when and whether there should be any limitations on conscience rights.

But the how of these legal protections is rarely addressed – that is, when health care providers decline to participate in medical services that violate their deeply-held beliefs, exactly what consequences do state laws protect them from? The new dataset I’ve just released on LawAtlas answers this question in the context of reproductive health conscience laws, and reveals some surprising trends.

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American Opioid Litigation: A Conversation with Professor Elizabeth Chamblee Burch

Professor Elizabeth Chamblee Burch

In my last post about recent developments in American aggregate opioid litigation, I teased about a future segment documenting a fantastic conversation with Professor Elizabeth Chamblee Burch. This post delivers that promise. Professor Burch is Fuller E. Callaway Chair of Law at the University of Georgia School of Law and an expert in complex litigation, mass torts, multidistrict litigation, and civil procedure.

Readers can access her impressive scholarly contributions on these topics here.

As Professor Burch elucidates in her research, the United States civil justice system has witnessed the waning of class certification cases and, concomitantly, the rise of multidistrict litigation (MDL) to resolve high-stakes, aggregate civil disputes.

This trend includes the massive national multidistrict litigation currently pending in the United States District Court for the Northern District of Ohio (Opioid MDL). Unlike class certification litigation, which is governed by Federal Rule of Civil Procedure 23, the MDL process is subject to the 1968 Multidistrict Litigation ActRead More

Can Anesthesiologists Adopt a Public Health Law Framework to Improve Medication Safety?

Recent studies have highlighted the inherent susceptibility for medication errors by anesthesia providers in the perioperative environment. In a prospective survey at Massachusetts General Hospital, investigators identified a concerning potential error rate of 1 in 20 medication administrations, many of which resulted in patient harm.

To those of us who toil daily in the trenches of the operating room, this come as no surprise, for we are the only type of healthcare provider that prescribes, dispenses, premixes, repackages, relabels and administers the medications, independently and without secondary verification or use of technologic support. In one sense this may seem to be an advantage, for if there are fewer intermediaries, such as pharmacists or registered nurses, there are fewer humans to make a mistake. On the other hand, more intermediaries or additional verification might identify previously unrecognized errors. Read More

US servicemembers pictured from behind, saluting

“Homecoming” to a History of Servicemember Experimentation

Much ado has been made about Amazon’s new hit, “Homecoming,” which recently received three Golden Globe nominations, including one for best drama series. The psychological thriller, directed by “Mr. Robot” creator Sam Esmail and starring Julia Roberts, has been characterized as “an irresistible mystery-box drama” and “the good kind of ‘what the hell is going on here?’ TV.” Tim Goodman described the show, which was adopted from Eli Horowitz and Micah Bloomberg’s Gimlet Mediacult hit” podcast of the same moniker, as a “dazzling” play “on memory, the military industrial complex, conspiracy and unchecked government privilege.”

The series revolves around novice caseworker Heidi Bergman’s (Roberts) experiences administering the Tampa, Florida-based Homecoming Transitional Support Center (HTSC). HTSC is a privately-run, Department of Defense (DoD) contract facility, which purports to assist combat-traumatized servicemembers readjust from the battlefield and reintegrate to civilian life. Indeed, Bergman opens the drama’s aptly-titled pilot, “Mandatory,” by explaining to her “client,” three-tour-combat-veteran Walter Cruz (Stephan James), that the treatment facility is “a safe space for you to process your military experience and re-familiarize yourself with civilian life in a monitored environment, which, just means getting you situated now that you’re back home, rear-wise, health-wise, basically, I just work for you.” Read More

Forced Christian Arbitration Agreements Trivialize Health Care

It is no secret that more and more for-profit companies and non-profit organizations are using binding religious arbitration agreements as a means to bypass legal liability. It has been reported that entities that have little or no religious purpose, such as bamboo floor vendors and vocation cabin rental agencies, have quietly inserted binding arbitration clauses into everyday agreements. In the event of a dispute the consumers or victims cannot take these entities to a secular court, but rather to a religious tribunal that claims to be capable of settling any dispute using their interpretations of the Bible. A common reaction against these questionable practices follows this line of critique: shouldn’t religious arbitration, if tolerated at all, only be used for disputes concerning religious or spiritual matters on which the secular courts cannot adjudicate? What does buying bamboo floors or renting a vocation cabin have anything to do with Christian doctrines?

Unfortunately, these questions cannot adequately challenge the religious reasoning behind Christian arbitration agreements. This is due to the counter-intuitive fact that, according to relevant biblical texts, disputes settled in a so-called Christian arbitration tend not to be about important spiritual matters, but trivial matters instead. Here is the text pertaining to lawsuits among Christian believers:

“When one of you has a grievance against a brother, does he dare go to law before the unrighteous instead of the saints? Do you not know that the saints will judge the world? And if the world is to be judged by you, are you incompetent to try trivial cases? Do you not know that we are to judge angels? How much more, matters pertaining to this life! 4    (1 Corinthians 6: 1-4)

At first look, these verses seem to make a strong case for Christian arbitrations. However, upon a closer look, it could be argued that Christians can still settle disputes with others in court under certain circumstances. Verse 1 suggests that Christians shouldn’t “dare to go to law before the unrighteous instead of the saints,” but it only excludes the court system if we assume that the judges at the civil courts are all “unrighteous sinners”. What if they’re not? What if some judges turn out to be devout Christians in private or possess “righteous” and “saintly” qualities? The remaining verses all point to the scope of judging powers the believers are entitled to, since they are to judge the entire world and even angels. Nonetheless, the structure of these rhetorical questions is meant to convince the believers that because they are qualified to judge angels, trivial earthly matters should be a piece of a cake. Since the disputes between Christians are not at all about angels or the whole world, these lines essentially imply that the matters that fall under the purview of Christian arbitrations are precisely trivial matters pertaining to this life on earth, not complicated spiritual affairs. Read More

The Accessibility Police: How the ADA Education and Reform Act Hinders ADA Enforcement and Burdens Americans with Disabilities

By Shailin Thomas

Recently, the House of Representatives voted on and passed the ADA Education and Reform Act of 2017 — an update to the Americans with Disabilities Act of 1990 (42 U.S.C. § 12101 et seq.). The bill changes the process by which private citizens with disabilities and disabling medical conditions can bring lawsuits to enforce statutory access requirements for places of public accommodation. Under Article III of the ADA, “No individual shall be discriminated against on the basis of disability in the full and equal enjoyment of the goods, services, facilities, privileges, advantages, or accommodations of any place of public accommodation.” 42 U.S.C. § 12182. This covers attempts to explicitly discriminate against those with disabilities, refusals to make reasonable modifications to accommodate them, and failures to remove physical barriers to access for them — unless removing those barriers is not “readily achievable.” 42 U.S.C. § 12182(b)(2)(A). One of the primary enforcement mechanisms for these provisions is private litigation brought against non-compliant establishments by those negatively affected by violations. See 42 U.S.C. 12188.

As of late, however, there has been growing concern in Congress that this private enforcement avenue is too often abused by plaintiffs bringing unjustified or opportunistic lawsuits, and this is the issue the ADA Education and Reform Act of 2017 seeks to address. Under the proposed bill, lawsuits can no longer be immediately brought against non-compliant establishments. Instead, someone aggrieved by a failure of adequate access must send formal, written notification to the establishment and provide at least four months for the owner to begin dismantling the offending access barrier. Only then — if the owners fail to start the necessary improvements for four months — can a lawsuit be brought. Proponents of the bill believe these additional barriers will curb frivolous and abusive ADA lawsuits brought to enforce accessibility requirements against unsuspecting businesses unaware of their violations.

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“Right to Try” Does Not Help Patients

Co-Blogged by Christopher Robertson and Kelly McBride Folkers (research associate at the Division of Medical Ethics of the NYU School of Medicine)

In 2014, Arizonans overwhelmingly voted in favor of a ballot referendum that claimed to allow terminally ill patients the “right to try” experimental drugs that have not yet been approved by the Food and Drug Administration (FDA). Despite the policy’s broad support, it has yet to help a single patient in Arizona obtain an experimental drug that they couldn’t have gotten before. Thirty-seven other states have also passed right to try bills, but likewise have seen little real impact for patients.

“Right to try” has moved to the federal stage, as the U.S. Senate unanimously passed such a bill last August without even holding a hearing. The House Energy & Commerce Subcommittee on Health considered the bill in an October hearing, but it failed to garner much enthusiasm among committee members. Vice President Mike Pence has advocated for a federal right to try law, and he recently met with FDA Commissioner Scott Gottlieb and House leadership to encourage pass of the bill this year. Read More

TODAY, 11/20 at 5 PM: Health Law Workshop with Thaddeus Pope

November 20, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

“From Informed Consent to Shared Decision Making: How Patient Decision Aids Can Improve Patient Safety and Reduce Medical Liability Risk.”  Download the presentation here.

Thaddeus Mason Pope is Professor of Law and Director of the Health Law Institute at the Mitchell Hamline School of Law. Pope joined Hamline University School of Law in January 2012 after serving as associate professor of law at Widener University School of Law. There, his research focused on medical futility, internal dispute resolution, tort law, public health law, and normative jurisprudence. He authors a blog on medical futility, reporting and discussing legislative, judicial, regulatory, medical, and other developments concerning end-of-life medical treatment.

Pope also taught at Albany Medical College and the University of Memphis. Prior to joining academia, he practiced at Arnold & Porter and clerked on the U.S. Court of Appeals for the Seventh Circuit. Pope earned a JD and PhD in philosophy and bioethics from Georgetown University.

An Analysis of Five Years of Cerebral Palsy Claims in the UK

By John Tingle

NHS Resolution, an arm’s length body of the Department of Health that manages clinical negligence and other claims brought against the NHS in England, have just published a report on cerebral palsy legal claims. These claims are complex and result in large awards of compensation. In 2016-17, whilst the obstetrics specialty accounted for only 10% of the 10,686 claims received, they represented 50% of the £4,370 Million value of claims received.

Once case may cost £20 Million or more for one child. The report shows that the same errors are often being repeated and that key patient safety lessons go unlearned. The report analyses the data held by NHS Resolution on its claims management system on compensation claims for cerebral palsy that occurred between 2012-2016.There were 50 claims between this period that were suitable for review with a potential financial liability greater than £390 Million. This figure excludes the costs of defending the claim and the wider cost impact on the NHS as a whole. The results of the report are split into two parts. Part one looks at the quality of the serious incident (SI) investigation reports and part two looks at arising clinical themes. Read More

Democratized Diagnostics: Why Medical Artificial Intelligence Needs Vetting

Pancreatic cancer is one of the deadliest illnesses out there.  The five-year survival rate of patients with the disease is only about 7%.  This is, in part, because few observable symptoms appear early enough for effective treatment.  As a result, by the time many patients are diagnosed the prognosis is poor.  There is an app, however, that is attempting to change that.  BiliScreen was developed by researchers at the University of Washington, and it is designed to help users identify pancreatic cancer early with an algorithm that analyzes selfies.  Users take photos of themselves, and the app’s artificially intelligent algorithm detects slight discolorations in the skin and eyes associated with early pancreatic cancer.

Diagnostic apps like BiliScreen represent a huge step forward for preventive health care.  Imagine a world in which the vast majority of chronic diseases are caught early because each of us has the power to screen ourselves on a regular basis.  One of the big challenges for the modern primary care physician is convincing patients to get screened regularly for diseases that have relatively good prognoses when caught early.

I’ve written before about the possible impacts of artificial intelligence and algorithmic medicine, arguing that both medicine and law will have to adapt as machine-learning algorithms surpass physicians in their ability to diagnose and treat disease.  These pieces, however, primarily consider artificially intelligent algorithms licensed to and used by medical professionals in hospital or outpatient settings.  They are about the relationship between a doctor and the sophisticated tools in her diagnostic toolbox — and about how relying on algorithms could decrease the pressure physicians feel to order unnecessary tests and procedures to avoid malpractice liability.  There was an underlying assumption that these algorithms had already been evaluated and approved for use by the physician’s institution, and that the physician had experience using them.  BiliScreen does not fit this mold — the algorithm is not a piece of medical equipment used by hospitals, but rather part of an app that could be downloaded and used by anyone with a smartphone.  Accordingly, apps like BiliScreen fall into a category of “democratized” diagnostic algorithms. While this democratization has the potential to drastically improve preventive care, it also has the potential to undermine the financial sustainability of the U.S. health care system.

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