Neuroimaging in the Courtroom: Promises and Pitfalls

by Zachary Shapiro

This is the first post of two that will discuss the use of neuroimaging in the courts. The first piece will talk about a few promising avenues of future research, while the second piece will discuss some of the pitfalls.

Mapping the brain is the next great frontier for scientific research. The recent decision by President Obama to initiate the Brain Activity Map, directing federal funding to a project with the aim of creating a working “map” of the human brain, highlights how our understanding of the brain will increase in the coming years.[1] As our understanding of the brain increases, many institutions will face difficult questions about how such understanding should change long held practices. An excellent example of an institution that has been, and will continue to be, shaped by advances in neuroimaging is the American criminal justice system.

Neuroimaging initially was deployed as a way to detect anatomical abnormalities, such as tumors and strokes, in the brain. The rise of functional neuroimaging, using modalities such as fMRI, PET Scans, and EEGs, has allowed scientists to begin to picture how the brain works in real time. As the field advances, neuroimaging is finding applications in areas that seem to be totally separate from medicine.

Neuroimaging has already made its way into the courtroom, and theoretical and immediate uses abound, especially for criminal law. Criminal law traditionally focuses on the mens rea, or guilty mind, of the defendant. Theoretically, neuroimaging could help us understand the complex neurological pathways that produce certain behaviors, while determining what factors are at play in a given “guilty mind.”

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Worth Reading This Week

By Nicolas Terry

Medical Malpractice and the “Continuous Act” Exceptions to the Statute of Repose

By Alex Stein

Cefaratti v. Aranow, — A.3d —- (Conn.App. 2014) is a textbook decision on the “continuous act” exceptions to the statute of repose. This decision of the Connecticut Appeals Court draws an important – but oft-missed – distinction between “continuous wrong” and “continuous treatment.”

Back in 2003, the plaintiff underwent open gastric bypass surgery in an attempt to cure her morbid obesity. Her follow-up treatment and monitoring took place between 2004 and the summer of 2009. All these procedures have been carried out by the same surgeon, the defendant, at a hospital in which he had attending privileges as an independent contractor.

The plaintiff testified at her deposition that on each of her post-operative visits, she told the defendant that she was experiencing abdominal pain. In August 2009, after being diagnosed with breast cancer by another physician, the plaintiff had a CT scan of her chest, abdomen, and pelvis, which revealed the presence of a foreign object in her abdominal cavity. This object was a surgical sponge that the defendant negligently left when he operated the plaintiff in 2003. Following that discovery, the plaintiff filed a malpractice suit against the defendant. Continue reading

Information Blocking and Interoperability

By Nicolas Terry

The “Cromnibus” spending bill signed by the President on December 16 rightly upset Senator Warren and not just for providing luxury cars to a feckless Congress. However, in general the bill ignored healthcare. There was no new money for those ACA “villains” CMS and IRS and only a little more for NIH (resulting in net reductions all around given inflation). Of course constituencies have to be pandered to, so there was a symbolic $10 million cut from the moribund IPAB. Meanwhile, the CDC did well, HRSA picked up a few telemedicine dollars, but ONC didn’t get everything it wanted. However, look closer and it seems that during the convoluted legislative process someone threw a meaty wrench into the gears of an already flailing meaningful use program.

As I have discussed at length here and here the meaningful use subsidy program for EHRs may have delivered hundreds of thousands of mediocre electronic health records systems into provider offices but has failed to deliver effective data sharing. ONC knows this is an issue, is aware of and discussed the JASON report, has its own “10-year vision” and emphasizes interoperability in its recently released Health IT Strategic Plan (Disclosure: I serve on the HIT Committee Consumer Workgroup, but these views are mine alone). But, some kind of showdown has been brewing for a while. Have the HITECH billions been wasted? Was the regulatory problem in meaningful use or in certification? Are the HIT developers to blame or health care providers? (Answer: Yes). And, the AMA being “appalled” aside, what happens now that the meaningful use carrots have begun morphing into sticks? Continue reading

Check out the latest news from the Petrie-Flom Center!

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Check out the December 19th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

Harvard Law School 2013-05-03 Petrie-Flom Center Food ConferenceOutbreak: Developing New Medical Products for Epidemics, A lecture by Peter Hutt                                                                                                            Thursday, January 15, 2015, 12:30pm                           Hauser Hall 102,                                                   1575 Massachusetts Avenue, Cambridge, MA

The recent outbreak of Ebola has called attention to the substantial difficulties associated with developing and testing new products for time-sensitive epidemics. What are the legal, ethical, and economic barriers to getting essential treatments and preventative measures from the lab into the hands of patients – and how can they be overcome?

Please join the Petrie-Flom Center for a discussion of these issues by Peter Barton Hutt, Partner at Covington & Burling, LLP, and Lecturer on Law at HLS. Rachel Sachs, Petrie-Flom Center Academic Fellow, will respond.

For more on news and events at Petrie-Flom, see the full newsletter.

Access to Drinking-Water as a Fundamental Human Right

by Martín Hevia

Access to drinking-water is obviously necessary to lead a healthy life. However, in Latin America, many lack access to this vital resource.

Very recently, in December 2, the Argentine Supreme Court discussed the legal status of access to drinking-water in the Argentine legal system (the case is “Kersich, Juan Gabriel y otros c/Aguas Bonaerenses y otros s/amparo”). The Argentine Constitution does not explicitly recognize a right to have access to drinking-water. The Court discussed the claim of citizens of 9 de Julio against “Aguas Argentinas,” which was allegedly providing water with levels of arsenic higher than those allowed by Argentine law. In deciding the case, with the vote of 4 of the 5 Supreme Court judges, the Court reached two important conclusions.

First, invoking General Comment 15 on the right to water of the UN Committee on Economic, Social, and Cultural Rights, the Court concluded that Access to drinking water is a fundamental human right: it is necessary to lead a life with dignity, as well as necessary to fulfill other human rights, mainly, the right to health. The Court also invoked human rights treaties incorporated to the Argentine Constitution such as the Convention on the Rights of the Child - its Article 24.2.c mandates providing clean drinking water to combat disease.

Second, the Court held that the provision of drinking-water is a community interest. Thus, the right to access to drinking water is a “collective right” (the Spanish term is “derecho de incidencia colectiva”): drinking water is one of the elements of the environment, which is collective good under Section 41 of the Argentine National Constitution.

Although the Court discussed the particular claim of the inhabitants of 9 de Julio, and it ordered lower courts to analyze again the case on the basis of the aforementioned two conclusions, it is worth asking about the legal implications of this decision for the Argentine legal system. The decision of the Court expressly recognizes access to drinking water a collective constitutional right. This means that, from now on, inhabitants of Argentina will be able to file collective claims to demand both the Federal and the Provintial States that they make access to drinking-water a priority. Not doing so will entail not taking the Constitution seriously.

Worth Reading This Week

By Nicolas Terry

Debate over Resident Duty Hours

by Vadim Shteyler

On the wards, resident duty hour restrictions were a frequently recurring topic of heated discussion. Effective July 1, 2011, the Accreditation Council for Graduate Medical Education (ACGME) implemented new limitations on resident work hours for all ACGME-accredited residency training programs, furthering the existing limitations from 2003 reform. Current policies restrict workweeks to 80 hours. Residents must get at least four days off every four weeks. Shifts are reduced from 30 consecutive hours to 16 consecutive hours for first-year residents and to 24 hours for all other residents. First-year interns must have eight hours off between shifts. And residents after 24-hour call must have at least 14 hours off.

Proponents argue that exhaustion contributes to medical errors, such as the death of Libby Zion (whose tragedy prompted the conversations and the policies limiting duty hours). Longer hours can lead to poorer quality of life, ultimately harming patient care. And inefficiencies in the more frequent handoffs are reasons to focus attention on handoffs rather than lengthen shifts.

Opponents have an unlikely ally, many residents and physicians. During my rotations, many argued that fewer hours on the wards translates to less real-life patient exposure and under-preparedness for independent practice. Continue reading

The Constitutionality of Damage Caps in Pennsylvania

By Alex Stein

In its recent decision, Zauflik v. Pennsbury School Dist., — A.3d —- (Pa. 2014), the Supreme Court of Pennsylvania upheld the constitutionality of the statutory $500,000 cap on tort compensation payable by the local government. This decision was delivered in a case involving a student who lost her leg in an accident in which a school bus accelerated out of control onto a sidewalk and struck her (along with other nineteen students). The jury awarded the student $14,036,263.39 ($338,580 for past medical expenses, $2,597,682 for future medical expenses, and $11.1 million for past and future pain and suffering), but the court reduced the award to $500,000.

In affirming that ruling, the Pennsylvania Supreme Court rejected a number of constitutional challenges against the statutory cap. Continue reading

Art Caplan: Support Nurse Who Resisted Force-Feeding at Guantanamo

Art Caplan has a new piece supporting the nurse who resisted force-feeding at Guantanamo, on NBC News:

Lost in all the talk about the CIA’s history of brutal interrogation tactics after Sept. 11 is this: A real live case involving a U.S. Navy nurse on trial for what he did not do at the notorious Guantanamo prison.

The nurse, in his 18th year in the Navy, volunteered to serve at Guantanamo, where some of those being held prisoner went on hunger strikes. They were following a long tradition going back to the H-Block Irish hunger strikers in Britain who found no other way to protest their internment and prison conditions but to refuse food.

The Navy brass at Gitmo decided that these prisoners were going to eat. They dragged them out of their cells, put them in full body restraints, shoved a tube through their nose and down into their stomachs and force-fed them with artificial food.

Read the full article here.

How Should the FDA Regulate Fecal Transplantation Safely and Effectively?

Last week’s issue of the New Yorker featured a terrific article about fecal microbiota transplantation, or FMT.  Much of the article focused on OpenBiome, a nonprofit stool bank spun off from MIT that screens donors, processes samples, and ships them to hospitals around the country.  For those who are unfamiliar with FMT, it is a startlingly effective treatment for recurrent C. difficile infection.  C. diff infections have become among the most common hospital-acquired infections in the United States, causing more than 300,000 hospitalizations and 14,000 deaths annually.  And unfortunately, many of these infections are resistant to antibiotics, with resistance rates rising rapidly.  But FMT may provide a way forward: a recent randomized trial (antibiotics versus antibiotics plus FMT) was stopped early, when 94% of patients in the FMT group were cured, as compared to roughly 30% of those in the antibiotics groups.

Coincidentally, I’ve been working with OpenBiome over the past few months on an interesting question that the New Yorker article touched on only briefly: how should the FDA regulate FMT to best ensure its safety and efficacy?  At present, the FDA is proposing to regulate FMT as a biologic drug.  However, many (including OpenBiome’s co-founder, Mark Smith) have argued that it ought to be regulated like human tissue, which from a scientific standpoint it resembles more closely than it does a small molecule drug, given the challenge of characterizing stool’s active ingredients and providing consistency across batches.  OpenBiome’s Policy Director, Carolyn Edelstein, and I are currently working on a paper examining the pluses and minuses of the FDA’s current approach.  I want to briefly summarize a few key points of our paper here, but essentially we argue that classifying FMT as a drug is simultaneously underregulatory and overregulatory.  Our primary goal is to ensure that patients have access to safe, effective treatments – and that means the FDA should be more involved in regulating some aspects of FMT, and less involved in others.

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The ACA’s Cerberus

By Kelsey Berry

Following the Midterm Elections, the fate of the Affordable Care Act in a Republican-controlled Congress has been much speculated about. Jonathan Oberlander just published a piece in the New England Journal of Medicine arguing that we should be less concerned about Congress, and more concerned about the Supreme Court’s potential to shake the foundations of the law.

Congress, he claims, may be wary to threaten popular provisions of the health care law now that many constituents have benefited from them. Even if ACA beneficiaries may not recognize that they are benefiting from the contentious law, the very methods available to Congress to dismantle the law — i.e., chipping away at specific provisions — may produce greater awareness of the law’s contents and even provoke opposition toward efforts to undermine it. Moreover, Obama’s veto power may keep the law stable enough through 2 more years of implementation that by the time we risk having a Chief Executive who opposes the law, the law’s benefits will be more entrenched and successes more obvious, further straining repeal or dismantle efforts. In short, it looks to Oberlander as if the core of the law (if not some of the peripheral provisions) is safe from Congressional action, and potentially even getting safer.

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Worth Reading This Week

By Nicolas Terry

The Right to Try Meets the Reality of Drug Approval

By Joan H. Krause

[Cross-posted at HealthLawProf Blog]

Whether it be a social media campaign to convince a company to provide an experimental anti-viral drug to a young cancer patient suffering from a life-threatening infection or the debate over appropriate treatment for high-profile Ebola cases, access to potentially life-saving but unapproved medications remains a controversial issue. Two recent articles, published on the same day, illustrate the difficulty of trying to balance desperate patients’ willingness to try unproven therapies with the very real concerns faced by manufacturers undergoing the drug approval process. The first was a Kaiser Health News article describing the passage of “Right to Try” laws in five states. The second was a brief note in the Los Angeles Business Journal that shares of CytRx Corporation, a biopharmaceutical R&D company, had fallen 9% after the company announced that the FDA had placed a partial clinical hold on its clinical trials after a patient’s death.

Right to Try laws are designed to give patients who have exhausted all other treatment options the right to access investigational medications, devices, and biological products that have met Phase I safety milestones. Right to Try legislation has been enacted in Colorado, Louisiana, Michigan and Missouri, and voters recently approved it by initiative in Arizona. The laws are based on model legislation drafted by the Goldwater Institute, which issued a detailed report on the issue in February 2014. While prohibiting states from blocking patient access to such medications, however, the model legislation does not require manufacturers to provide the products, nor does it require insurance companies to cover the costs. Continue reading

2015 Edition of the International Compilation of Human Research Standards Released

The 2015 edition of the International Compilation of Human Research Standards has just been released and is available online.

The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 113 countries, as well as standards issued by a number of international and regional organizations. Six new countries are included in the 2015 edition: Ghana, Guinea, Liberia, Malaysia, Saudi Arabia, and Sierra Leone.  The 2015 edition also includes hundreds of updates from the previous edition.

The listings are organized into seven categories: Continue reading

Arthur Caplan on Hyperbaric Oxygen Therapy

Art Caplan has a new piece on hyperbaric oxygen therapy over at NBC News:

Hyperbaric oxygen therapy. Have you ever heard of it? The Internet sure has.

Centers and clinics tout the benefits of sitting in a tank breathing 100 percent oxygen at higher than atmospheric pressure for treating autism, infant brain trauma, multiple sclerosis, chronic fatigue, cerebral palsy and many other conditions.

There’s just one problem: There is no solid evidence that hyperbaric oxygen therapy does anything for any of these disorders.

Read the full article here.

Introducing Joan H. Krause

We are pleased to introduce our newest contributor, Joan H. Krause, to Bill of Health.

Joan Krause PhotoProfessor Joan H. Krause is Associate Dean for Faculty Development and Dan K. Moore Distinguished Professor of Law at the University of North Carolina School of Law; professor (secondary appointment) in the Department of Social Medicine, UNC School of Medicine; and adjunct professor of health policy and management in the UNC School of Public Health. She previously served as George Butler Research Professor of Law and Co-Director of the Health Law & Policy Institute at the University of Houston Law Center, where she joined the faculty in 2001. From 1997-2001, Professor Krause was a member of the health law faculty at Loyola University Chicago School of Law. Before attending law school, Professor Krause worked as a medical writer/editor in the pharmaceutical industry. After law school, she served as a law clerk for the Honorable Dorothy W. Nelson of the United States Court of Appeals for the 9th Circuit. Following her clerkship, Professor Krause was an associate in the Health Practice Group of Hogan & Hartson in Washington, D.C., where her work focused on regulatory and administrative health care matters with an emphasis on health care fraud and abuse. She teaches a variety of health law courses, as well as Criminal Law for first-year students. Her research interests include Health Law, Criminal Law, and Women and the Law. Her co-authored book, HEALTH LAW AND BIOETHICS: CASES IN CONTEXT, was published in 2009.

Professor Krause received her B.A. with Honors in Political Science from Yale University, where she graduated summa cum laude. She received her J.D. with distinction from Stanford Law School, where she was elected to the Order of the Coif and served as Senior Articles Editor of the Stanford Law and Policy Review, as well as a Writer and Copy Editor for the Stanford Law Journal.

Representative Publications:  Continue reading

Clinical Trials Regulation in India

An op-ed from our friends Mark Barnes and Barbara Bierer at Harvard’s Multi-Regional Clinical Trials Center on recent legal changes to India’s clinical trial requirements, arguing that using the clinical trial context to promote a social or political policy agenda in India may sacrifice scientific integrity in the service of social justice.  A quick snippet:

The overbreadth of these requirements, and how poorly tailored they are to achieve the specific goal of protecting clinical trial participants from risks directly caused by trials themselves, leaves one wondering whether the regulatory authorities fully comprehend the clinical trial process and the nuances of complex medical and biological processes. One further wonders whether what animates these measures may be less a concern for specific justice in individual cases than the goal of righting social wrongs and achieving social justice, unrelated to but prompted by clinical trial experiences. Achieving social justice and a more just allocation of social resources may be completely laudable – even desirable – as social or political policy, but unconsciously using the clinical trial context to promote this agenda threatens to corrupt science and to undermine health, with results that may create more social distress than social justice.

Read the full piece here.

And more commentary from MRCT on this issue: