RESCHEDULED: Crimes of Passion: New Neuroscience vs. Old Doctrine

Crimes of Passion: New Neuroscience vs. Old Doctrine
April 9, 2018 12:00 PM
Wasserstein Hall, Milstein East C (2036)
Harvard Law School, Cambridge, MA

The criminal law often sees love and passion turned into violence. How does this happen? And how should law respond? Many doctrines, most notably the “heat of passion” defense – which historically has been used disproportionately to excuse the crimes of men against women – rely on a distinction between defendants who acted “emotionally” instead of “rationally.” But modern neuroscience has debunked the idea that reason and emotion are two entirely different mental states. This panel will explore how law should respond to this neuroscientific challenge to long-held doctrine.

Panelists:

  • Lisa Feldman-Barrett, PhD, University Distinguished Professor of Psychology and Director of the Interdisciplinary Affective Science Laboratory at Northeastern University; Research Scientist, Department of Psychiatry, Northeastern University; Research Neuroscientist, Department of Radiology, Massachusetts General Hospital; Lecturer in Psychiatry, Harvard Medical School; Faculty Affiliate, the Center for Law, Brain & Behavior, Massachusetts General Hospital
  • Jeannie Suk Gersen, JD, PhD, John H. Watson, Jr. Professor of Law
  • Judge Nancy Gertner (ret.), Senior Lecturer on Law, Harvard Law School and Managing Director, Center for Law, Brain & Behavior, Massachusetts General Hospital
  • Moderator: Judith Edersheim, JD, MD, Co-Founder and Co-Director of the Center for Law, Brain and Behavior, an Assistant Clinical Professor of Psychiatry at Harvard Medical School, and an attending Psychiatrist in the Department of Psychiatry at  Massachusetts General Hospital

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Undisclosed Arbitration Clause in the Doctor-Patient Agreement Held Unenforceable

By Alex Stein

STEIN on Medical Malpractice has published a survey of noteworthy court decisions in the field for 2017. This survey includes an important decision, King v. Bryant, 795 S.E.2d 340 (N.C. 2017), that examines the validity of a doctor-patient agreement to arbitrate disputes over medical malpractice.

A front desk employee at a surgeon’s practice provided the patient with several intake forms to complete and sign while he waited to meet the surgeon. The forms included an agreement to arbitrate medical malpractice disputes, which the patient signed without reading (together with other documents) because he believed it to be “just a formality.” After an unsuccessful surgical procedure, the patient sued the surgeon in court for medical malpractice. The surgeon filed a motion to stay the action and enforce the arbitration agreement. The trial court denied the motion after finding the arbitration agreement unconscionable. The Court of Appeals affirmed that decision and the surgeon appealed to the North Carolina Supreme Court. Read More

Call for Papers: Wiet Life Sciences Scholars Conference

Loyola University Chicago’s nationally acclaimed Beazley Institute for Health Law and Policy is pleased to invite original research submissions for the annual Wiet Life Science Law Scholars Conference to be held on Friday, September 7, 2018.

The conference is designed to provide an intellectual venue for life science professors, scholars, and practitioners to convene and discuss current research and scholarship.  The phrase “life science law” intends to capture diverse disciplines that involve significant issues of life science research and development, spanning food and drug law, health law, intellectual property (IP) law, biotechnology law, environmental law, administrative law, and antitrust law.  Our goal is to foster recognition of life science law as a cohesive, dynamic area of legal study and strengthen connections among national life science law scholars.

Loyola is currently soliciting 750-1,000 word abstracts reflecting early or mid-stage ideas for the purpose of workshopping with other conference scholars.  Modeled after successful events for law professors and scholars in other areas, we will organize scholars in topical panels of three to five authors with approximately 15 minutes allotted to each abstract presentation, followed by 15 minutes of intensive discussion with scholar attendees.  Author abstracts will be distributed one week prior to the conference to scholar participants; authors may also submit draft articles for distribution.  Scholars are expected to review materials of fellow panel members.

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Rachel Sachs on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

​This week’s episode features a welcome return from Rachel Sachs, Associate Professor of Law at the Washington University in St. Louis School of Law. Rachel’s primary research interests lie at the intersection of patent law and health law, with a particular focus on problems of innovation and access and the ways in which law exacerbates or ameliorates these problems. She is a prolific scholar who has a knack for identifying cutting-edge research. We focus on her most recent publication, Delinking Reimbursement. We discuss various aspects of the drug price phenomenon, attempting to find some explanations for our current predicament, while exploring some possible solutions.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

Health in the Headlines: Reporting on Health Policy in the Trump Era

Health in the Headlines: Reporting on Health Policy in the Trump Era
April 4, 2018 12:00 PM
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Join the Center for Health Law and Policy Innovation for a panel discusison with leading health care journalists about the rapidly shifting health policy landscape in Washington DC. The panel will discuss the high drama of a tumultuous year in health policy that has seen repeated congressional attempts to repeal the Affordable Care Act, the resignation of a cabinet secretary amidst scandal, and a steady effort to undermine Obama-era priorities. Further, the panel will explore the role of journalism in modern policy-making, and how social media impacts the dialogue.

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Improving Mental Health Care in the NHS

By John Tingle

The Guardian newspaper recently published it’s investigation into Coroners Prevention of Future Deaths Notices (PFDN’s) issued between 2012-2017 involving people receiving NHS care for mental health conditions. The findings from its investigation are shocking; many cases deaths could have been prevented had better care been given. Some errors identified are classic patient safety errors and these included:

  • Poor communication between agencies and/or staff, non-observation of protocols or policies (or lack of protocols or policies.
  • Lack of appropriate care or continuity of care.
  • Poor record keeping, poor communications with the patient or his or her family.
  • Insufficient risk assessment  and delays.

The investigation revealed 45 cases reported by the coroner where patients were discharged too soon or without adequate support. Seventy-two instances of poor or inappropriate care, 41 cases where treatment was delayed.

Children and young people’s mental health
The Care Quality Commission (CQC) is the the independent regulator of health and social care in England and they have recently reviewed children and young people’s mental health services and have found significant systems failures which could well put children and young people at risk of harm. Mental health problems are the report states, quite common in children and young people with estimates suggesting around 1 in 10 being affected.

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Reproductive Negligence under Maine Law

By Alex Stein

STEIN on Medical Malpractice has published a survey of noteworthy court decisions in the field for 2017. This survey includes an important decision, Doherty v. Merck & Co., Inc., 154 A.3d 1202 (Me. 2017), featuring reproductive negligence.

This decision could benefit from Dov Fox’s excellent article, Reproductive Negligence, 117 Colum. L. Rev. 149 (2017).

The plaintiff, Kayla Doherty, visited a federally-supported health care center in Maine to inquire about birth control options. Her physician recommended an implantable drug manufactured by the defendant, the Merck company. The drug consisted of a single, four-centimeter-long rod inserted under the skin of the inner side of the patient’s upper arm with a syringe-like applicator. The drug works by inhibiting ovulation and is designed to be effective for at least three years unless the rod is removed sooner by a physician. The drug’s applicator, however, occasionally malfunctioned: it had a history of failed insertion attempts that occurred when the rod would remain stuck in the applicator following the procedure (unbeknownst to the treating physician and the patient).

Doherty was a victim of this malfunction. Read More

The Development and Certification of Decision Aids: Promoting Shared Decision-Making for Patients with Serious Illness

The Development and Certification of Decision Aids: Promoting Shared Decision-Making for Patients with Serious Illness
April 18, 2018 8:30 AM – 4:30 PM
Wasserstein Hall, Milstein East AB (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Decision aids can be highly-effective tools to promote shared decision making and support patients in becoming engaged participants in their healthcare.  Join us for the first-ever convening with leaders behind a Washington experiment in certifying decision aids, as state officials, health systems, and on-the-ground implementation experts share lessons learned and discuss policy recommendations for national or statewide approaches to decision aid certification.  

Program Overview

Person-centered care presents a unique opportunity to achieve the Quadruple Aim, especially during serious illness when people are the most vulnerable. Building on the work of NQF and others, it is now clear that healthcare purchasers (states, plans, care providers) committed to person-centered care should also be committed to shared decision-making.

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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 February. The selections feature topics ranging from tertiary patenting of drug-device combinations; to off-label promotion and adherence to FDA guidelines among direct-to-consumer advertisements; to the impact of FDA label changes. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Beall RF, Kesselheim AS. Tertiary patenting on drug-device combination products in the United States. Nat Biotechnol. 2018 Feb 6;36(2):142-145.
  2. Bothwell LE, Avorn J, Khan NF, Kesselheim AS. Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov. BMJ Open. 2018 Feb 10;8(2):e018320.
  3. Chang HY, Murimi I, Faul M, Rutkow L, Alexander GC. Impact of Florida’s prescription drug monitoring program and pill mill law on high-risk patients: A comparative interrupted time series analysis. Pharmacoepidemiol Drug Saf. 2018 Feb 28. [Epub ahead of print]
  4. Fralick M, Avorn J, Franklin JM, Abdurrob A, Kesselheim AS. Application and impact of run-in studies. J Gen Intern Med. 2018 Feb 15. [Epub ahead of print]
  5. Klara K, Kim J, Ross JS. Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines. J Gen Intern Med. 2018 Feb 26. [Epub ahead of print]
  6. Powers JH, Evans SR, Kesselheim AS. Studying new antibiotics for multidrug resistant infections: are today’s patients paying for unproved future benefits? BMJ. 2018 Feb 22;360:k587.
  7. Sobel RE, Bate A, Marshall J, Haynes K, Selvam N, Nair V, Daniel G, Brown JS, Reynolds RF. Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System’s analytic tools. Pharmacoepidemiol Drug Saf. 2018 Feb 2. [Epub ahead of print]
  8. Wallach JD, Ross JS. Gabapentin Approvals, Off-Label Use, and Lessons for Postmarketing Efforts. JAMA. 2018 Feb 27;319(8):776-778.

Jeanne Lenzer on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

​We are joined by award-winning medical investigative reporter Jeanne Lenzer. We discuss her book, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It. Lenzer puts forward strong arguments that the medical device industry is under-regulated, and that whistleblowers are insufficiently protected. Woven through her analysis is the story of one patient’s dangers and difficult journey involving an implanted device together. Related stories about physicians and researchers help leaven the medico-legal loaf with the human impact of this massive industry.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.