Green parking meter reads "expired."

How the Unpredictable Long-Term Effects of COVID-19 Infection Pose a Challenge That Tort Law Cannot Meet

By Jennifer S. Bard

The longer the pandemic continues, the more obvious it is how effective the sweeping federal and state laws shielding medical providers from malpractice associated with COVID-19 have been. Few cases have been brought, and so far there is no record of successful judgements or settlements.

Even without these statutes, proving negligence in COVID-related cases would be exceptionally difficult, given the ever-evolving virus and treatment options. Still today it would be hard to prove that any good faith attempt at care was unreasonable and that there was a causal link to greater harm — both necessary to demonstrate negligence.

But, at some time in the relatively near future, this will change. The declared public health emergency will end, and with it the federal and remaining state blanket liability protections. A standard of care will develop and issues involving the prevention, diagnosis, and treatment of COVID-19 will become the subject of tort litigation.

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Businessman's hands typing on laptop keyboard in morning light

Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 3

By Alison Bateman-House, Hayley M. Belli, and Sage Gustafson

This series is adapted from a webinar hosted by PRIM&R on August 5, 2021: IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance. Read Part 1 and Part 2.

Part 3: What’s an IRB to do?

EA is considered treatment, not research. EA was not established as a means to collect research data, even though certain safety data must be collected and shared with the FDA and the sponsor. But, once sponsors decide to capture/share EA-derived data above and beyond that needed to report SAEs, what should IRBs do when reviewing such plans: view this as research, and thus hold it to (higher) research standards, or continue to view this as treatment?  This distinction is important for patients’ rights and welfare.

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Pile of envelopes with overdue utility bills on the floor.

The Unfurling Crisis of Unfunded Isolation, Testing, and Treatment of Infectious Disease in the US

By Steven W. Thrasher

For many politicians in the United States, the summer of 2022 was a time of trying not to think about the coronavirus pandemic—though, if they were concerned about the risk that they, their neighbors, and their constituents were facing, they should have been paying very close attention. By August, there were about 500 to 600 COVID deaths a day, accounting for more than a “9/11’s worth” every week, a level of death twice what it had been in the summer of 2021.

But for gay men in the United States, the summer of 2022 was a time of worrying about a whole new viral epidemic: monkeypox. The variant of the MPX orthopoxvirus circulating globally in 2022 has behaved very differently than it had in previous outbreak, acting as a sexually transmitted infection and moving almost exclusively through the bodies of gay men.

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SAINT LOUIS, MO. - August 2, 2021: A protestor holds a sign reading "Evictions Are Violence" at a protest held days after the federal eviction moratorium expired.

U.S. Eviction Policy is Harming Children: The Case for Sustainable Eviction Prevention to Promote Health Equity

By Emily A. Benfer

Without a nationwide commitment to sustainable eviction prevention, the United States will fail the rising number of renter households at risk of eviction. Worse still, the country will set millions of children on the path of long-term scarring and health inequity.

A staggering 14.8% of all children and 28.9% of children in families living below the poverty line experience an eviction by the time they are 15. For children, eviction functions as a major life event that has damaging effects long after they are forced to leave their home. It negatively affects emotional and physical well-being; increases the likelihood of emotional trauma, lead poisoning, and food insecurity; leads to academic decline and delays; and could increase all-cause mortality risk.

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Lima, Peru - March 8 2019: Group of Peruvian woman supporting the movement girls not mothers (niñas, no madres). A social campaign for abortion rights for underaged raped girls.

Grassroots Mobilization Needed to Defend Abortion Access

By Camila Gianella

On August 3, Kansas voters spurned the recent decision in Dobbs v. Jackson Women’s Health Organization by rejecting a proposed constitutional amendment that, in line with the ruling, aimed to ban abortion in the state.

What happened in Kansas shows the central role of social and political mobilization in securing abortion rights. In Kansas, Dobbs caused an unprecedented mobilization of women voters.

On the other hand, without such mobilization, access to abortion can suffer – even if the law protects sexual and reproductive health and rights (SRHR). In the case of Peru, my country, which is often cited as an example of the internationalization of SRHR norms through supranational litigation, internationally recognized legal victories have often fallen short of the high expectations they created. Despite the success of international bodies, abortion rights in Peru have not been expanded. Further, there are attempts at the legislative level to advance a total ban on abortion.

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Grassy field with white picket fence encircling it.

Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’

By Aparajita Lath

Some COVID-19 vaccine manufacturers in the US have refused to share vaccine samples for research purposes, creating an access issue with the potential to delay comparator studies, follow-on research, and new vaccine / drug development.

This issue may be the latest example of the tragedy of the “anticommons” in biomedical research.

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hand holding cell phone in open palm with pharmaceutical icons - pills, vial, and shopping cart - above.

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

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, andAaron 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 September. The selections feature topics ranging from an examination of Park doctrine prosecutions of executives of pharmaceutical and medical device companies, an analysis of patent thickets covering biologic drugs, and a discussion of product hopping strategies among manufacturers of inhalers. A full posting of abstracts/summaries of these articles may be found on our website.

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Surgeon at work in the operating room.

Litigation and Patient Safety: The Importance of Good Communication Strategies

By John Tingle

Good record keeping and communication practices are essential prerequisites for safe and proper patient care. Serious patient injury, including death, can result from poor record keeping and other communication failures.

A fundamental issue in England’s National Health Service (NHS) patient safety culture development, however, is whether health care staff implement the necessary communication changes in light of  adverse health care events. In fact, failure to learn from errors is a persistent patient safety theme that has featured strongly in various health regulatory, patient safety, and crisis inquiry reports going back over 20 years.

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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.

The Supreme Court Threatens to Undermine Vaccination Decisions Entrusted to the States

By Donna Gitter

In 2021, the Supreme Court articulated in Tandon v. Newsom a legal principle that threatens to upend over a century of legal precedent recognizing the authority of state governments to ensure public health by mandating vaccines.

The ruling lays the groundwork for courts to force states to include religious exemptions to mandatory vaccines whenever they include secular exemptions, such as medical ones.

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Vintage history book and magnifying glass on wooden background.

The New Search for Reproductive Justice in Old Laws

By Katie Gu

In the post-Dobbs fight to safeguard reproductive healthcare, a new spotlight has been placed on two existing federal laws: the Health Insurance Portability and Accountability Act (HIPAA) and the Emergency Medical Treatment and Active Labor Act (EMTALA). 

Guidance documents issued over the summer by federal agencies emphasize how these laws can be used to protect reproductive health privacy and access.

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