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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IRBs Advise Physician Involvement in Informed Consent

By Nadia N. Sawicki

Much has been written about the Supreme Court of Pennsylvania’s recent decision in Shinal v. Toms, in which the court held that a physician’s duty to obtain informed consent, as codified in Pennsylvania’s MCARE Act, is non-delegable. According to the court, a physician faced with an informed consent suit cannot defend himself on the grounds that the patient was adequately informed of the risks and benefits of treatment by a physician assistant, nurse, or other intermediary acting under the physician’s direction. Pennsylvania is not the first state to adopt this view – courts in other jurisdictions (Connecticut, Louisiana, South Dakota, Texas, New Mexico) have similarly held that the duty to secure informed consent rests with the treating physician alone.

The MCARE (Medical Care Availability and Reduction of Error) Act was passed in 2002 to reform Pennsylvania’s medical malpractice laws, and refers to the duties and rights of “physicians” and “patients.” Shinal, likewise, addressed the issue of informed consent in the context of medical treatment. Thus, I was very surprised to learn that some commercial institutional review boards (IRBs), in reliance on the Pennsylvania Supreme Court’s decision, have been advising clinical trial investigators to revise their consent forms and processes to ensure that physician-investigators – and not recruitment coordinators, nurses, or other study staff – secure the consent of research participants.

Schulman, one of the most well-known commercial IRBs, recently posted about the Shinal case on its website; while noting that the case focused on medical malpractice “and does not address consent in the research context,” it advised investigators to “discuss with their legal counsel the impact of this decision on their consent process.” Sterling IRB had a similar post, advising investigators to “consider drafting consent form updates to clearly require that only physician members of the research team may obtain informed consent from a research subject.” In an e-mail that went directly to investigators and study staff, Sterling also suggested that they submit updated consent forms that “make clear that the only person who can obtain consent is the PI/physician.” A recent article in the Journal of Clinical Research Best Practice, titled “What Impact will the Shinal Case have on Informed Consent in Clinical Research?,” offered a more detailed analysis of the case, and concluded that “there is little to suggest that courts would not uniformly apply the same informed consent standards used in the medical practice to clinical research.” Read More

CAVEAT HOSPITIA: Suits Alleging Negligent Credentialing Against Hospitals Get Exemption from Tort Reform

By Alex Stein

Policymakers and scholars interested in medical malpractice and torts generally should read Billeaudeau v. Opelousas General Hospital Authority, — So.3d —-, 2016 WL 6123862 (La. 2016). In this recent and important decision, the Louisiana Supreme Court ruled that suits alleging negligent credentialing against a hospital sound in regular negligence, rather than medical malpractice, and consequently fall outside the purview of the state’s Medical Malpractice Act (MMA) and its limitations on liability. The Court made this decision in connection with the state’s cap on damages recoverable in medical malpractice actions, La. Rev. Stat. § 40:1231.2(B)(1), which limits the total amount that courts can award the victim to $500,000, plus interest and cost, on top of the victim’s future expenditures on medical care and support. For many victims of medical malpractice and their families this cap amount is meager, but the Court nonetheless upheld its constitutionality back in 1992. See Butler v. Flint Goodrich Hosp., 607 So.2d 517 (La. 1992).

The Court has now decided that suits alleging negligent credentialing against hospitals are not subject to this cap and that successful plaintiffs consequently will recover full compensation for any proven damage. Read More

President Trump’s Tort Reform

By Alex Stein

President Trump’s budget for Fiscal Year 2018 proposes a thoroughgoing reform of our medical malpractice system [Executive Office of the President of the United States, Major Savings and Reforms, Budget of the U.S. Government, Fiscal Year 2018, at 114 (2017) (hereinafter, the “Budget”)]. The reform’s stated goals are “[to] reduce defensive medicine … limit liability, reduce provider burden, promote evidence-based practices, and strengthen the physician-patient relationship.”

To achieve these goals, the reform will introduce the following measures:

  • a cap on non-economic damage awards of $250,000 (adjustable to inflation);
  • a three-year statute of limitations;
  • allowing courts to modify attorney’s fee arrangements;
  • abolition of the “collateral source” rule (to allow judges and jurors to hear evidence of the plaintiff’s income from other sources such as workers’ compensation and insurance);
  • creating a safe harbor for clinicians who follow evidence-based clinical-practice guidelines.

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The First Human Body Transplant – Ethical and Legal Considerations

By Ana S. Iltis, PhD

brain_glowingprofileTo what lengths should we go to preserve human life? This is a question many are asking after hearing that three men plan to make medical history by conducting the first human head transplant. Or, rather, whole body transplant. Italian neurosurgeon Dr. Sergio Canavero and Chinese surgeon Dr. Xiaoping Ren plan to provide a Russian volunteer, Valery Spiridonov, a new body. During the procedure, Spiridonov’s body and head would be detached and, with the help of a crane, surgeons would move the head and attach it to the donor body.  But is this ethical? What role might law and regulation play in monitoring them or in assessing their conduct after the fact?

Critics call the plan crazy, unethical, and sure to fail. The likelihood of success is very low and the risk of Spiridinov dying is high. Spiridonov says that as soon as animal studies confirm the possibility of survival, the risks will be worth taking. He has Werdnig-Hoffmann Disease, a genetic disorder that destroys muscle and nerve cells. He is confined to a wheelchair and has lived longer than expected. Body transplantation offers him the best chance at a life worth living. Read More