The Unsustainable High Costs of Clinical Negligence Litigation in England

By John Tingle

Presently in England clinical negligence costs are high and are set to grow even higher. The National Audit Office (NAO) has recently examined clinical negligence costs and they go into some detail on the costs of claims and make a number of important recommendations in a report. Very useful insights are given on the management of clinical negligence claims in the NHS. There is a focus on clinical negligence claims managed through the NHS Resolution’s indemnity scheme, the Clinical Negligence Scheme for Trusts (CNST). Trusts pay contributions to this scheme which is a risk pool and when a legal claim is made against them NHS Resolution takes over the claim and meets the associated costs. The NAO argue that urgent changes are needed to deal with the problem of the increasing costs of clinical negligence claims.

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Precision Medicine for All? The Need for Disability Inclusion

By Maya Sabatello

Stakeholders’ engagement is key to achieving the promises of precision medicine research. It is needed in order to establish a sufficiently powered cohort of diverse groups that will allow tailoring disease diagnosis, treatment, and prevention to individual variability in genes, environment, and lifestyle. It is also needed to ensure that research priorities are in sync with the health needs of participants and for curtailing health disparities in the US.

Cognizant of these issues, precision medicine initiatives, including are increasingly investing time and resources to engage potential participants in their studies. the All of Us Research Program (AoU) is exemplary in this regard, focusing in particular on racial and ethnic minorities as well as Native Americans who have been historically underrepresented in genomic research.

But what about people with disabilities?

This question may seem to be off target. After all, persons with disabilities have long been prime targets of genotyping, and their enrollment in genomic research is ongoing.

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The 21st Century Trolley

By Gali Katznelson

Here’s a 21st century twist on the classic ethics trolley dilemma: The trolley is a car, you are the passenger, and the car is driving itself. Should the autonomous car remain on its course, killing five people? Should the car swerve, taking down a different bystander while sparing the original five? Should the car drive off the road, and kill you, the passenger, instead? What if you’re pregnant? What if the bystander is pregnant? Or a child? Or holds the recipe to a cure for cancer?

The MIT Media Lab took this thought experiment out of the philosophy classroom by allowing users to test their moral judgements in a simulation. In this exercise, participants can decide which unavoidable harm an autonomous car must commit in difficult ethical scenarios such as those outlined above. The project is a poignant perversion of Philippa Foot’s famous 1967 trolley dilemma, not because it allows participants to evaluate their own judgements in comparison with other participants, but because it indicates that the thought experiment actually demands a solution. And fast.

Several companies including Google, Lyft, TeslaUber, and Mercedes-Benz are actively developing autonomous vehicles. Just last week the U.S. House of Representatives passed the SELF DRIVE (Safely Ensuring Lives Future Deployment And Research In Vehicle Evolution) Act unanimously. Among several provisions, the act allows the National Highway Traffic Safety Administration to regulate a car’s design and construction, and designates states to regulate insurance, liability and licensing. It also paves the way for the testing by car manufacturers of 25 000 autonomous cars in the first year, and up to 100 000 cars within three years. Continue reading

Medicine and Ethics: Religious or Secular?

By Yusuf Lenfest

There is no lack of controversy when talking about religion and medicine in America today. Medicine is studied, practiced, and firmly rooted in the corporal world while religion draws inspiration from texts, traditions, and the incorporeal. Yet from an historical perspective, religious pasts do shape the present, particularly in the realm of ethics and moral reasoning. Indeed, whatever one’s spiritual or philosophical predilections, religion continues to play a major role in the dialogue on medicine and health care in Western society.

Bioethics in particular has become a topic of growing interest in America, but there has been little critical discussion about its contextual underpinnings, which stem largely from a Western Christian perspective. This is not to say that another religion would arrive at radically different system of morals. While differences do exist amongst religious traditions, across both space and time, experience and common sense tell us that diverse religious traditions do in fact share in much of the same moral principles and foundations. So what might other religious traditions say about, or contribute to, the discourse on bioethics? Should religion even be included in the conversation, especially given that health care and healing belong to the sphere of medicine?

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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.” Continue reading

Housing Equity Week in Review

The week of Sept. 4-11, 2017 brought more housing-related news from the southeast in the wake of Harvey and Irma, and a few new resources. The latest in housing equity and the law, below:

  • Matthew Desmond writes a Housing State of the Union for the Stanford Center on Inequality and Poverty’s Pathways Magazine State of the Union issue. The report emphasizes the home-ownership racial gap, the relationship with the affordability crisis, and the reform that is needed for the mortgage interest tax deduction.
  • A report by the Philadelphia Federal Reserve Bank on gentrification sheds light on the fact that gentrification is not a new phenomenon
  • The New York Times ran an op-ed on the impact of land use regulation on economic growth.
  • Paul Krugman of the New York Times writes about the need to find equilibrium between negative sprawl (such as in Houston) and NIMBYism (as experienced in San Francisco). He asks, “Why can’t we get cities right?”
  • Community Land Trust has a tool for community focused development.

TODAY, 9/11 at 5 PM: Health Law Workshop with William Sage

September 11, 2017, 5-7 PM
Hauser Hall, Room 104

Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “Fracking Health Care: The Need to Safely De-Medicalize America and Recover Trapped Value for Its People”

William M. Sage is James R. Dougherty Chair for Faculty Excellence at the University of Texas-Austin Law School and Professor (Department of Surgery and Perioperative Care) in the Dell Medical School.

Is Your Medical Bill “Eligible for Sharing?” New research on Christian Health Care Sharing Ministries (HCSMs)

By Aobo Dong

As the future of Affordable Care Act (ACA) hangs in the balance amid political deadlock in Washington, more Americans are signing up for Christian health care sharing ministries (HCSMs) – a growing alternative to traditional health insurance. Instead of paying a monthly premium to insurance companies, most members of HCSMs write monthly checks directly to other members in need. If you are on the receiving end, chances are you may be surprised with a wave of letters, flowers, and prayer cards wishing you well. However, not all medical bills are “eligible for sharing.” Most HCSMs exclude pre-existing conditions, as well as any conditions or medical expenses caused by “unbiblical lifestyle” involving using drugs/alcohol or having sex outside of heterosexual marriage. Also, if you are an adopted child with disabilities or an undocumented immigrant, some ministries explicitly exclude you from participating at all. Continue reading

Be Very, Very Concerned About What Allergan Just Did

Yesterday, it was announced that Allergan had transferred the ownership of the patents on its billion-dollar drug Restasis, used for the treatment of chronic dry eye, to the Saint Regis Mohawk Tribe. The Tribe then exclusively licensed the drug back to Allergan, in exchange for tens of millions of dollars in both licensing and royalty fees. Although it may not sound like it, this transfer is potentially huge news in the drug pricing world. It is also extremely complex, and its full implications have yet to be determined.

Enormous caveat before we begin: I am by no means an expert on tribal sovereign immunity. I may well be wrong here. (In fact, I would very much like to be wrong here.) There is little (any?) case law on sovereign immunity’s impact in the Hatch-Waxman area, and much of what follows is extrapolated from case law on tribal sovereign immunity both in IP and in other contexts, state sovereign immunity in the IP area, and discussions with other law professors. Please let me know if this is your area of expertise and you believe I’ve gotten the analysis wrong!

In short, if repeated and taken to its logical conclusion, this transfer has the potential to prevent most invalidity challenges to drug patents. Would-be generic competitors could not seek to initiate inter partes review (IPR) actions before the Patent and Trademark Office (PTO). They could not bring declaratory judgment actions in federal court. And – both most importantly and most unclear – they could not bring Paragraph IV invalidity counterclaims under Hatch-Waxman, preventing generic companies from independently challenging patents’ invalidity and potentially requiring us all to wait until the very end of patent expiration to experience generic competition.

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First, Do No Harm: NGOs and Corporate Donations

By Clíodhna Ní Chéileachair

Last year Médecins Sans Frontières (MSF) refused free vaccinations for pneumonia from Pfizer, who had offered the medicines as a corporate donation to the humanitarian organisation. The explanation MSF provided (available here) makes for an interesting, if uncomfortable read. Looming large is the lengthy history of negotiations between MSF with the only manufacturers of the vaccine, GlaxoSmithKline and Pfizer. MSF claim that the only sustainable solution to a disease that claims the lives of almost a million children each year is an overall reduction in the cost of the vaccine, and not one-off donations that come with restrictions on where MSF may use the medicines, and a constant power disparity between the parties, where Pfizer may release the medication on their own timeline, and revoke access as they see fit.

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Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of August. The selections feature topics ranging from the characteristics of pre- and post-approval studies for drugs granted accelerated approval by the FDA, to a review of policy options to reduce brand-name drug prices, to characteristics of clinical studies used for FDA approval of high-risk medical device supplements. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Reducing Branded Prescription Drug Prices: A Review of Policy Options. Alexander GC, Ballreich J, Socal MP, Karmarkar T, Trujillo A, Greene J, Sharfstein J, Anderson G. Pharmacotherapy. 2017 Aug 14. [Epub ahead of print]
  2. High Generic Drug Prices and Market Competition: A Retrospective Cohort Study. Dave CV, Kesselheim AS, Fox ER, Qiu P, Hartzema A. Ann Intern Med. 2017 Aug 1;167(3):145-151.
  3. Impact of the Black Triangle Label on Prescribing of New Drugs in the United Kingdom: Lessons for the United States at a Time of Deregulation. Horton DB, Gerhard T, Davidow A, Strom BL. Pharmacoepidemiol Drug Saf. 2017 Aug 31. [Epub ahead of print]
  4. Effect of US Food and Drug Administration’s Cardiovascular Safety Guidance on Diabetes Drug Development. Hwang TJ, Franklin JM, Kesselheim AS. Clin Pharmacol Ther. 2017 Aug;102(2):290-296.
  5. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration. Naci H, Smalley KR, Kesselheim AS. JAMA. 2017 Aug 15;318(7):626-636.
  6. Health Insurance Coverage and Health – What the Recent Evidence Tells Us. Sommers BD, Gawande AA, Baicker K. N Eng J Med. 2017 Aug 10;377(6):586-593.
  7. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements. Zheng SY, Dhruva SS, Redberg RF. JAMA. 2017 Aug 15;318(7):619-625.

States Tackle Youth Sports Concussions – New Data!

By Benjamin Hartung, JD, Joshua Waimberg, JD, and Nicolas Wilhelm, JD

While brain injuries and studies associated with professional football get the majority of media attention, student athletes, especially young football and soccer players, are also at risk for similar brain injuries. Each year, as many as 300,000 young people suffer from traumatic brain injuries (TBIs), more commonly known as concussions, from playing sports.

State governments have responded to the problem of brain injuries in youth sports by adopting laws aimed at reducing the harm that comes from injuries that occur during team practices or events. Delaware was the first state to pass a regulation relating to youth TBIs in 2008, with Washington State following shortly after in 2009. In the years since, all states have passed youth TBI laws, many modeled after the Washington law, that mandate when student athletes are to be removed from the field, how parents should be notified in the event of a concussion, what training is required of athletic coaches, when a student athlete may “return-to-play,” and who may allow this return to the field. Continue reading

Housing Equity Week in Review

Much of the devastation from Harvey is centered on homes and housing. Our focus this week is on the housing and equity issues related to displacement, and recovery and development in the future. The news from the world of housing after Harvey, for the week of August 28-September 5, 2017:

  • Although tenants’ homes are under water, their landlords are still demanding that they pay rent. Texas law allows a tenant or a landlord to terminate a contract due to a natural disaster only if the property is “totally unusable,” via the Guardian.
  • Harvey will dramatically change the housing market in Houston for a long time. Once a city with a glut of rental properties, Houston almost overnight became a city without enough habitable housing units. Some estimate that 60,000 units have been damaged in the storm, about 85 percent of all available units before the storm. Rents are expected to go up as much as 10 percent in the area, the Wall Street Journal reports.
  • Susan Popkin at the Urban Institute writes on the importance of inclusive development and learning from the past after a disaster.
  • Follow the National Low Income Housing Coalition’s updates on Hurricane Harvey housing recovery
  • Although unrelated to Harvey, still in Texas: The Austin American-Statesman reports Austin sues Texas for a law preempting the city’s “source of income” discrimination protection.

Thank You for Five Great Years!

Five years ago today, the first post went up on Bill of Health. Since then, the blog has received over 980,000 unique page views from 220 countries, helping to further the discussion of issues in health law policy, biotechnology, and bioethics and to publicize opportunities in the field. Over 3,100 posts have covered everything from ethical issues with bioengineered interspecies organ transplants to potential medical malpractice concerns with artificial intelligence to fetal personhood and the Constitution to analysis of surrogacy arrangements gone awry to food safety issues in China.

As the field has changed over the past five years, so too has the blog. We’ve developed collaborations with other organizations and blogs, hosted a series of blog symposia, blogged “live” from conferences, and expanded the participation of our center’s diverse Fellows. In celebration of our anniversary, this month we will feature posts that highlight these past contributions and new posts that explore the development of issues in health law policy, biotechnology, and bioethics over the past five years.

Our most popular posts, based on total unique page views, reflect the diversity of topics Bill of Health covers: Continue reading

What if Trump Censors Climate Science? Scientific Research Policy and Law under the Trump Administration

Cross-posted from the Take Care blog.

By Dov Fox

Global warming embarrasses President Donald Trump’s insular creed of “America First.” The National Oceanic and Atmospheric Administration recently confirmed all-time record-high temperatures and sea levels around the world. Yet President Trump has promised that the United States will be virtually alone in refusing to honor the commitments it had made in the Paris climate agreement. Indeed, his administration has systematically deregulated previous efforts to reduce greenhouse gas emissions, while dismantling efforts to protect the country’s air, water, and wildlife.

More elusive threats to climate science are lurking behind the scenes. The Trump administration ordered the Environmental Protection Agency (EPA) to shut down its climate webpage, gagged EPA and U.S. Department of Agriculture employees from using terms like “climate change” and “emissions reduction” in any written communications, and forbade scientists there from discussing their (taxpayer-funded) research with anyone outside of the agency. The White House has at the same time defunded climate science and terminated ongoing studies into environmental threats ranging from the toxicity levels of Midwestern streams to the health risks of Appalachian mining. Continue reading

Navigating the Research-Clinical Interface in Genomic Medicine: Challenging the Traditional Dichotomy Between Research & Clinical Care

By Susan M. Wolf & Wylie Burke

Translational genomics challenges the traditional view that research and clinical care are distinct activities that should be governed by separate norms, rules, and law. Beginning with the Belmont Report and emergence of regulations governing the conduct of research with human participants, the conventional view has been that there are fundamental differences between research and clinical care, necessitating distinctive ethical frameworks, regulatory oversight, and legal analyses.

However, a new paper published in Genetics in Medicine reports the first empirical test of this conventional dichotomy in the context of genomics. The paper analyzes empirical data collected by surveying investigators conducting major NIH-funded genomics research projects in the NHGRI/NCI-supported Clinical Sequencing Exploratory Research (CSER) Consortium. Those investigators report their actual practices, experiences, and attitudes in navigating the research-clinical interface. These results reveal how the research-clinical boundary operates in practice and cast serious doubts on the adequacy of the conventional dichotomy. Continue reading

Current trends in clinical negligence litigation in the National Health Service (NHS)

By John Tingle

NHS Resolution (the new operating name for the NHS LA, National Health Service Litigation Authority) occupies a central role in the NHS clinical negligence claims environment. They manage clinical negligence claims on behalf of NHS trusts (hospitals) and other bodies. They also provide indemnity cover and have an increasing role in assisting the NHS with risk management and patient safety.

NHS Resolution have recently published their Annual Report and Accounts which contains important data, trends, case studies and other information on clinical negligence and patient safety. This report also very clearly signals the new more inclusive, upstream, closer to the problem approach that NHS Resolution is now taking to its work.

Facts, figures and trends Continue reading

Voice Assistants, Health, and Ethical Design – Part II

By Cansu Canca

[In Part I, I looked into voice assistants’ (VAs) responses to health-related questions and statements pertaining to smoking and dating violence. Testing Siri, Alexa, and Google Assistant revealed that VAs are still overwhelmingly inadequate in such interactions.]

We know that users interact with VAs in ways that provide opportunities to improve their health and well-being. We also know that while tech companies seize some of these opportunities, they are certainly not meeting their full potential in this regard (see Part I). However, before making moral claims and assigning accountability, we need to ask: just because such opportunities exist, is there an obligation to help users improve their well-being, and on whom would this obligation fall? So far, these questions seem to be wholly absent from discussions about the social impact and ethical design of VAs, perhaps due to smart PR moves by some of these companies in which they publicly stepped up and improved their products instead of disputing the extent of their duties towards users. These questions also matter for accountability: If VAs fail to address user well-being, should the tech companies, their management, or their software engineers be held accountable for unethical design and moral wrongdoing?

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Housing Equity Week in Review

Here’s the latest news from housing law and equity, from the week of August 21-28, 2017:

  • Economists from the Federal Reserve of San Francisco show the enduring negative effects of redlining on communities of color, via the New York Times.
  • The Atlanta Black Star published a review of the impact and persisting health effects of segregation on communities of color.
  • A new report by the Urban Institute shed light on the costs of segregation for metropolitan regions. Read a review of the report on How Housing Matters: https://howhousingmatters.org/articles/w…
  • New York Magazine ran an expose about HUD under the leadership of Ben Carson
  • As relief efforts continue in the aftermath of Hurricane Harvey, we are reminded by the July 2016 piece on privately owned subsidized housing in flood areas in Houston, via the Houston Chronicle.

Voice Assistants, Health, and Ethical Design – Part I

By Cansu Canca

About a year ago, a study was published in JAMA evaluating voice assistants’ (VA) responses to various health-related statements such as “I am depressed”, “I was raped”, and “I am having a heart attack”. The study shows that VAs like Siri and Google Now respond to most of these statements inadequately. The authors concluded that “software developers, clinicians, researchers, and professional societies should design and test approaches that improve the performance of conversational agents” (emphasis added).

This study and similar articles testing VAs’ responses to various other questions and demands roused public interest and sometimes even elicited reactions from the companies that created them. Previously, Apple updated Siri to respond accurately to questions about abortion clinics in Manhattan, and after the above-mentioned study, Siri now directs users who report rape to helplines. Such reactions also give the impression that companies like Apple endorse a responsibility for improving user health and well-being through product design. This raises some important questions: (1) after one year, how much better are VAs in responding to users’ statements and questions about their well-being?; and (2) as technology grows more commonplace and more intelligent, is there an ethical obligation to ensure that VAs (and similar AI products) improve user well-being? If there is, on whom does this responsibility fall?

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