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. Read More
Patient harm is the 14th leading contributor to the global disease burden, according to a new report by WHO, OECD, and the World Bank.
In resource-constrained health care environments, it is important not to reinvent the wheel and waste money when existing, proven patient safety solutions already exist in other countries. Global patient safety knowledge sharing, and learning helps all countries, regardless of income level and this needs to be encouraged. Read More
Dr. Susan Hockfield, the first female President of the Massachusetts Institute of Technology, has written a beautiful and powerful book, “The Age of Living Machines,” articulating her vision of the merging of engineering and biology. This merger, she argues, has potential to lead to a scientific revolution that she believes will create the future. The ability to distill complicated concepts into concise, understandable prose, is a skill with limitless value, regardless of the subject matter. Dr. Hockfield is clearly a master in this art, and why should we be surprised that the past Provost of Yale and President of MIT would possess such skill and aplomb.
In her book, Dr. Hockfield, an accomplished biologist who was recruited early in her distinguished career by Nobel Laureate James Watson to the iconic Cold Spring Harbor Laboratory, lays out the case for Convergence 2.0. This is, of course, the sequel to Convergence 1.0, the confluence of physics and engineering, which produced the electron and the information technology revolution, leading to breathtaking innovation that has altered virtually every aspect of human life. Read More
By Alicia Ely Yamin and Jonathan Chernoguz
To complement the Petrie-Flom Center’s annual conference this year, Consuming Genetics, the Global Health and Rights Project at Petrie-Flom (GHRP) convened a small meeting of feminists, students, and other activists. On May 16, Harvard University’s Global Health Education and Learning Incubator , which co-sponsors GHRP, hosted the forum in conjunction with Marcy Darnovsky and Katie Hasson of Center for Genetics and Society (CGS).
Focusing on “Gene Editing, Ethics, Rights and Health Equity Issues,” and in particular the irrevocability of germline gene editing, the meeting began with Marcy Darnovsky, Executive Director of CGS asking, “How might we begin the discussion from [the perspective of] human rights, feminism, equity, and social justice, rather than from the science and biotechnology?”
This question echoed some of those posed during the Consuming Genetics conference, for example, by Jonathan Kahn in interrogating the equivocation of social diversity and empirical diversity in genomic research. Read More
By Alexandra Hess
Alabama, Georgia, and Ohio have passed laws in recent weeks that ban many, if not all, abortions in their state. These bans are the latest additions to the litany of laws and policies that severely limit or totally prevent access to abortion for women in the United States.
“Fetal heartbeat” bans, like those enacted in both Ohio and Georgia, are some of the most restrictive types of gestational limitations on abortion in the U.S. They prohibit abortion at the point a fetal heartbeat is detectable by ultrasound—as early as six weeks’ gestation. This is often a point before many discover they are pregnant. Ohio and Georgia are not the first states to have enacted fetal heartbeat bans, however, and current legislative trends suggest they will not be the last. In 2019 alone, lawmakers have proposed heartbeat bans in at least 14 other state legislatures. Read More
By Faith Khalik
During the case’s first hearing in January 2018, Judge Dan Aaron Polster told lawyers that he expected to see a settlement that would reduce the adverse public health impact of the opioid crisis, instead of just “moving money around.” The amicus brief submitted by PHLW et al. proposes just that: a settlement that includes a framework for addressing the opioid crisis and has a meaningful positive impact on public health.
Specifically, the brief proposes the creation of a nonprofit foundation to monitor the settlement’s implementation, participate in development and implementation of evidence-based programmatic initiatives, and administer funding for local treatment and prevention resources.
An endowment at the DePaul University College of Law funds a faculty fellowship program for scholars to create and disseminate scholarship and teach courses where two dynamic legal fields are increasingly intersecting—health law and intellectual property/information technology, broadly construed.
The fellowship is designed to encourage scholars interested in entering a career in legal academia in these fields. The Jaharis Faculty Fellow will work with and be mentored by faculty from DePaul’s nationally-ranked Mary and Michael Jaharis Health Law Institute (JHLI) and Center for Intellectual Property Law & Information Technology (CIPLIT®). Read More
After going back and forth for what felt like years, my curiosity won. I ordered the test and shipped off my sample. Three weeks later, the email arrived in my inbox. I logged into my online portal, scrolling past the bolded message informing of my “slightly increased risk” of Alzheimer’s Disease, instead, narrowing in on what I was looking for: how would 23andMe explain genetic risk alongside my results?
In theory, genetics offers an elegant, linear way to predict one’s future—setting up a narrative in which having “the Alzheimer’s gene” destines one to a very specific medical fate. The realities of genetics, however, are far more complex. Environmental factors, among others, mediate gene expression and diseases are usually the result of various (often unidentified) genes working together. Even considering Alzheimer’s, a disease with highly penetrant variants, my risk remains probabilistic, not destined.
By Jacob T. Elberg
The health care industry and the white-collar defense bar have eagerly awaited guidance from the Department of Justice regarding the impact of corporate cooperation and self-disclosure on the resolution of civil False Claims Act (FCA) cases, the primary tool for government action in response to corporate misconduct in the health care industry.
Statements from DOJ officials raised anticipation over the past several months that guidance would be forthcoming. The guidance arrived on May 7, 2019, and focuses on answering the question of what conduct will constitute cooperation in the eyes of DOJ.
Unfortunately, the announcement fails to answer the question industry and the defense bar have been asking: how much credit will be given for cooperation and self-disclosure? Read More
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 Act. Read More