Single strand ribonucleic acid.

The Secret World of mRNA: HDT Bio Corp v. Emcure and Access to Next-Gen mRNA

By Aparajita Lath

The future of public health in an “RNA world” is on trial in a trade secrecy dispute worth $950 million currently being fought before the District Court of the Western District of Washington, Seattle between HDT Bio Corp. and Emcure Pharmaceuticals.

The trade secrets at issue concern an improvement over existing mRNA technology called “self-amplifying RNA” or “saRNA.” saRNA are effective at much smaller doses and lower costs. The saRNA technology is being used to develop vaccines for COVID, Zoster, Zika and Rabies.

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see saw with earth as fulcrum and a pile of vaccines weighing down one side with nothing on the other side.

What Happened to the COVID-19 Vaccine Patent Waiver?

By Sarah Gabriele

In June 2022, after almost two years of debate over a potential COVID-19 vaccine patent waiver, the World Trade Organization adopted the Ministerial Decision on the TRIPS Agreement (“WTO Decision”), which provided for a partial waiver of intellectual property rights.

More specifically, the WTO Decision waived patent rights on vaccines and allowed for the use of protected clinical trial data for regulatory approval of vaccines. However, after almost four months since the adoption of the WTO Decision, there is still a large gap in vaccination rates worldwide.

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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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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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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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Lawyer and client in courtroom.

Liability for COVID-19 Vaccine Harms: We Need to Do Better

By Dorit Reiss

COVID-19 vaccines are extremely safe, and serious harms are rare. But rare does not mean the risk is zero; thus, we need a way to determine which people have plausible claims of harm from the vaccines, and we must then compensate them quickly and generously. However, the regular torts system is not a good option for adjudicating these claims. Fortunately, we already have a better system — no-fault compensation — available to address the problem.

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Gavel lying in a courtroom.

The Impossibility of Legal Accountability for COVID-19 Torts

By Chloe Reichel and Valerie Gutmann Koch

Since the first days of the COVID-19 pandemic, employers, businesses, and other entities have anticipated litigation around tort claims associated with the novel coronavirus. Early in 2020, scholars here began to grapple with questions of tort liability relating to the pandemic response. However, nearly three years later, it appears that the warnings of a “tidal wave” of lawsuits were vastly overstated.

In this symposium, we asked torts scholars to reflect on questions surrounding whether and how individuals and entities might be held liable for the harms associated with SARS-CoV-2 infection, particularly as infection has grown increasingly widespread and COVID mitigations have become more limited or entirely eliminated.

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Austin, Tx/USA - May 23, 2020: Family members of prisoners held in the state prison system demonstrate at the Governor's Mansion for their release on parole due to the danger of Covid-19 in prisons.

Federal Failures to Protect Incarcerated People During Public Health Crises

By Rachel Kincaid

As the COVID-19 pandemic persists, and as we face the reality that future pandemics are coming (or have already begun), it’s a fitting time for the United States to take stock of how the carceral system has exacerbated the harms of COVID-19, and for policymakers to seriously consider what can and should be done differently going forward.

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