Judicial Opinions - Bill of Health

LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

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

March 19, 2021March 19, 2021 Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Beatrice Brown, Neeraj Patel, 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.

Below are the citations for papers identified from the month of February. The selections feature topics ranging from an evaluation of utilization and spending on different formulations of opioid use disorder medication buprenorphine, to an analysis of the impact of the 2012 circuit court ruling in United States v. Caronia on subsequent government enforcement of off-label marketing restrictions, to an assessment of key features of the relationship between public and private actors in the context of biomedical innovation during the COVID-19 pandemic. A full posting of abstracts/summaries of these articles may be found on our website.

Los Angeles, California / USA - May 1, 2020: People in front of Los Angeles’ City Hall protest the state’s COVID-19 stay at home orders in a “Fully Open California” protest.

5 Questions About COVID-19 and Religious Exemptions

March 17, 2021March 16, 2021 Chloe Reichel Leave a comment

By Chloe Reichel

On February 26^th, the Supreme Court of the United States issued a shadow docket decision that could foretell sweeping limitations for public health measures, both within and outside the COVID-19 pandemic context.

The Court’s ruling in the case, Gateway City Church v. Newsom, blocked a county-level ban on church services, despite the fact that the ban applied across the board to all indoor gatherings. This religious exceptionalism is emerging as a key trend in recent Supreme Court decisions, particularly those related to COVID-19 restrictions.

To better understand what these rulings might mean for public health, free exercise of religion, the future of the COVID-19 pandemic, and potential vaccine mandates, I spoke with Professor Elizabeth Sepper, an expert in religious liberty, health law, and equality at the University of Texas at Austin School of Law.

The Patent Trial and Appeal Board Returns to the Supreme Court

March 15, 2021March 12, 2021 The Petrie-Flom Center Staff Leave a comment

By Gregory Curfman

For the second time in the span of just three years, the Patent Trial and Appeal Board (PTAB) within the U.S. Patent and Trademark Office (USPTO) is under scrutiny by the Supreme Court.

How the Supreme Court decides this latest PTAB case, United States v. Arthrex, will have important implications for patent law and for administrative law more generally.

WASHINGTON, DC - OCT. 8, 2019: Rally for LGBTQ rights outside Supreme Court as Justices hear oral arguments in three cases dealing with discrimination in the workplace because of sexual orientation.

It’s Time to Update the ACA’s Anti-Discrimination Protections

February 2, 2021January 28, 2021 Jenna Becker Leave a comment

By Jenna Becker

Assuming that the Affordable Care Act (ACA) withstands its most recent challenge in California v. Texas, the Biden administration should prioritize as a future reform the codification of clearer nondiscrimination standards.

The ACA’s Section 1557, which provides anti-discrimination protections, has been fraught with challenges. Section 1557 incorporates nondiscrimination protections from four separate civil rights statutes. This vague language allows administrations to offer widely differing interpretations of healthcare anti-discrimination protections.

In a 2016 rule, the Obama administration interpreted Section 1557 broadly, including protections based on gender identity and sexual orientation, as well as specific language access requirements. Many of these protections were eliminated in a 2020 rule promulgated by the Trump administration.

It’s time to end these fluctuating standards. The Biden administration should work with Congress to add clearer nondiscrimination protections to the ACA.

The False Dilemmas of the Fifth Circuit’s HIPAA Ruling

January 22, 2021January 21, 2021 Leslie Francis Leave a comment

By Leslie Francis

In a caustic opinion issued on January 14, the Fifth Circuit vacated penalties assessed by the U.S. Department of Health and Human Services (HHS) against the University of Texas M.D. Anderson Cancer Center for HIPAA security breaches.

As has happened to many other health care entities, M.D. Anderson had employees who were not careful with their laptops and thumb drives (and the data therein). A laptop with the unencrypted protected health care information of nearly 30,000 patients was stolen. Unencrypted thumb drives with information on another almost 6,000 patients were lost. M.D. Anderson disclosed the security breaches to HHS, which assessed civil monetary penalties for violation of HIPAA’s encryption and disclosure rules. M.D. Anderson then filed a petition for review, which resulted in the Fifth Circuit holding that the agency action was arbitrary and capricious for failure to consider an important aspect of the problem.

Commentators have already pointed out that this decision will reverberate throughout the HIPAA enforcement world. As it does, I hope it is met with scorn, for it trades on the informal logical fallacy of the false dilemma in two noteworthy ways.

Can Schools Require the COVID-19 Vaccine? Education, Equity, and the Courts

January 19, 2021January 15, 2021 The Petrie-Flom Center Staff Leave a comment

By Emily Caputo and Blake N. Shultz

As school systems consider policy options for the spring semester, both vaccination requirements and proposals to address inequities in access to education may be top of mind. However, policymakers should be aware of the possible legal challenges they may face.

The COVID-19 pandemic has created an educational crisis in the United States by disrupting the learning of millions of students across the country. School closures, remote learning, and generalized societal stress have all raised serious concerns about persistent harm to adolescent learning and development — particularly among low-income and minority students.

While the pandemic has exposed widespread inequities in educational opportunity, it has also revealed the relative inability of the courts to promote access to education. A recent California lawsuit illustrates the manner in which students must rely on state-level, rather than federal, protections to ensure equal access to education. And COVID-19 vaccination requirements, which could facilitate a return to in-person education, are likely to result in lawsuits, and may be struck down by a skeptical and conservative Supreme Court.

Abortion rights protest following the Supreme Court decision for Whole Women's Health in 2016

Book Review: Mary Ziegler’s ‘Abortion and the Law in America’

December 2, 2020December 2, 2020 James Toomey Leave a comment

By James Toomey

If you want to understand America, you must understand our politics of abortion. And if you want to understand our politics of abortion, you must read Mary Ziegler’s recent legal history, “Abortion and the Law in America: Roe v. Wade to the Present” (2020).

In comprehensive detail and in a singularly fair and thoughtful way, Ziegler tells the story of American regulation of abortion from the Supreme Court’s historic Roe v. Wade decision to the present, and looks ahead to an uncertain future. Through vignettes of activists who have dedicated their lives to one side of the debate or the other, Ziegler shows that, notwithstanding the superficial constancy of the abortion debate — one side proclaiming the constitutional, essential rights of the fetus, the other the similarly irreducible right of bodily autonomy — the character of the debate, and the kinds of arguments made, have shifted over the course of the last fifty years.

The COVID-19 Pandemic Reveals the Stakes of the Campaign Against Abortion

December 1, 2020November 30, 2020 The Petrie-Flom Center Staff Leave a comment

By Mary Ziegler

Once again, we’re talking about whether abortion counts as health care. The COVID-19 pandemic has sparked new efforts to limit access, from the government’s unwillingness to lift in-person requirements for medication abortion to the introduction of stay-at-home orders blocking access altogether. The campaign to frame abortion as a moral, not medical, issue began decades ago. The pandemic has revealed the broader stakes of this campaign — and what it might mean for access to care well after the worst of the pandemic is behind us.

For antiabortion leaders, there are obvious strategic reasons to insist that abortion is not health care. The stigma surrounding abortion is real and durable. Notwithstanding recent increases, many obstetric programs do not provide comprehensive abortion training (if they provide any training at all). A 2020 study in Plos One found that a majority of patients believed that they would be looked down upon “at least a little” for having had an abortion. This perceived stigma affects those refused abortions — and causes longer-term adverse mental health outcomes. Stigma has long been an effective tool for the antiabortion movement. The pandemic has done nothing to change that.

But, put in historical context, today’s effort to treat reproductive services as unessential means much more. That campaign is part of a broader agenda to undermine the idea of an autonomy-rooted abortion rights — and lay the groundwork for overturning Roe v. Wade.

Feminist Judgments: Rewritten Health Law Opinions: Video with Seema Mohapatra

November 17, 2020November 17, 2020 The Petrie-Flom Center Staff Leave a comment

The Health Law Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts.

The workshop is led by Professor I. Glenn Cohen, and presenters come from a wide range of disciplines and departments.

In this video, Seema Mohapatra discusses the volume she is co-editing with Lindsay Wiley, “Feminist Judgments: Rewritten Health Law Opinions,” which she presented at the Health Law Policy workshop on November 16, 2020. Watch the full video below:

The Artifices of Corporate Speech: Video Preview with Nathan Cortez

October 26, 2020October 26, 2020 The Petrie-Flom Center Staff Leave a comment