LASST's Pathogen Research Amicus Brief Project

LASST’s Pathogen Research Amicus Brief Project

At Legal Advocates for Safe Science and Technology, we believe in the power of basic science research to improve the human condition. From developing life-saving vaccines and therapeutics to advancing our understanding of infectious diseases, basic science research has been and will continue to be crucial for protecting and enhancing human health and wellbeing. But there are cases where scientific research undertaken with the best intentions nonetheless entails risks that outweigh its potential benefits, especially when the research is conducted on pathogens with pandemic potential (PPPs) or pathogens with enhanced pandemic potential (PEPPs). As part of our mission to make advances in science and technology safer for people and the planet, LASST has been researching how courts are addressing scientific research on PPPs and PEPPs. There are multiple ongoing cases where courts are addressing allegations about PPP and PEPP research in the context of litigation alleging versions of the theory that the SARS-CoV-2 virus and the COVID-19 pandemic it caused originated from a lab at the Wuhan Institute of Virology (WIV).^[1] So far, courts have been dismissing these cases, and some are writing opinions that could lead to a body of legal precedent that would make it much harder to hold people and institutions accountable in the future for even grossly irresponsible pathogen research. LASST is therefore partnering with scientists and policy professionals in relevant fields to file amicus curiae (friend of the court) briefs to help educate courts so that they can make more informed and nuanced decisions that will help disincentivize unreasonably dangerous research in the future.

PPP and PEPP research, and why courts matter

Research on PPPs carries obvious risks. Alison Young’s Pandora’s Gamble does an excellent job of detailing how much more common accidents at scientific laboratories are than one might guess. When work is conducted with a PPP in a lab, the result of even a minor accident can be a pandemic that affects everyone in the world. And labs designed to conduct research on the most dangerous pathogens are proliferating, a trend being tracked by the Global Biolabs project. PEPPs are defined as “a type of [PPP] resulting from experiments that enhance a pathogen’s transmissibility or virulence, or disrupt the effectiveness of pre-existing immunity, regardless of its progenitor agent, such that it may pose a significant threat to public health, the capacity of health systems to function, or national security.”^[2] In other words, PEPPs are created by researchers manipulating PPPs in one or more ways that could make them even more capable of causing a pandemic if they were to escape from a laboratory. PEPP research could be the act of creating a PEPP from a PPP or involve research on a PEPP that has already been created in a lab.

Why does it matter how courts view pathogen research? Right now, most regulation of PEPP research focuses on federally-funded research. For example, in May 2024, the White House released the United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (USGP), which sets a policy on PEPP research at the federal level. But that policy applies only to “federal departments and agencies that fund or sponsor intramural or extramural research at research institutions in the United States and internationally.”^[3] This means that privately funded research is not covered. The Policy also “relies on an honor system as there are no proposed external inspection or auditing systems.”^[4] The primary federal regulatory framework that applies to privately-funded research on pathogens is the Federal Select Agent Program (FSAP), which “regulates the possession, use, and transfer of biological select agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products.” But the FSAP is based on an enumerated list of existing biological agents and toxins that is only updated every two years and is therefore limited in both scope and flexibility.

Because federal regulation would not apply to most privately-funded PEPP research, common law mechanisms like tort law, including the law of strict liability for abnormally dangerous activities, provide the only legal counterweights pushing back against privately funded labs that might otherwise be willing to push the boundaries of such research too far, putting everyone in the world at risk. Courts therefore have an important role to play in developing that common law.

LASST’s approach to the project and position on the law

The purpose of the project is not to change the ultimate outcome of any case concerning the origins of the COVID-19 pandemic. LASST’s goal is instead to help courts to better understand the risks associated with PPP and PEPP research so that, even if they do not credit the lab leak theories being advanced in COVID-19 origins cases, they nevertheless write opinions that maintain common law guardrails on future research where the dangers outweigh the potential benefits. While LASST’s primary goal is educating the courts about the underlying scientific issues and not pushing for a particular outcome in any given case, we do take the position that PPP and PEPP research conducted at an inappropriate biosafety level^[5] should be considered an abnormally dangerous activity subject to strict liability. Applying a strict liability standard to an activity means that the person or entity conducting the activity will be held liable for any harm the activity caused, even if they were not negligent in conducting the activity.^[6] We believe a body of law that applies a strict liability standard when irresponsibly unsafe research causes harm could serve an important role in disincentivizing unreasonably dangerous research in the future.

The McKinniss amicus brief

We have filed the first amicus brief in the case of Kathleen McKinniss et al. v. EcoHealth Alliance Inc. et. al., currently on appeal in state court in New York.^[7] The plaintiffs in that case include individuals who were harmed by contracting SARS-CoV-2 or who had family members die from the virus. The defendants include EcoHealth Alliance and several individuals. Plaintiffs’ complaint includes a claim for strict liability, among other causes of action. The trial court dismissed all of the plaintiffs’ claims, including the strict liability cause of action. In dismissing the strict liability cause of action, the court opined:

There is not a high degree of risk that people will be injured because of scientific research or that the harm from scientific research will be great. Indeed, laboratory accidents are rare. Additionally, a laboratory is an appropriate place to carry on scientific research.

Furthermore, the Court notes that scientific research is not the kind of activity where risks cannot be eliminated with the exercise of reasonable care. In fact, Plaintiffs themselves repeatedly assert that if reasonable care was exercised as it should have been, then the release of the COVID-19 virus could have been avoided. Moreover, scientific laboratories regularly mitigate risk through various safety protocols, including those safety protocols required by the federal government. Lastly, the value of coronavirus research and/or scientific research to determine where the next zoonotic disease will come from is extremely valuable to the community and society at large and is not outweighed by any risks.^[8]

We are concerned that this opinion could be read by future courts as a decision that strict liability could never apply to scientific research, no matter how dangerous, which could lead to a body of law that fails to disincentivize even the most irresponsibly dangerous research. The amicus brief explains that there is some scientific consensus that (i) there are real dangers associated with PPP and PEPP research, including the risk of causing a catastrophic pandemic, (ii) lab accidents are not as rare as one might think, and advancing technology is making the likelihood of such accidents more, rather than less, likely, and (iii) that the dangers associated with some PPP and PEPP research almost certainly outweigh the benefits the research might confer on the public.^[9] The brief urges the appellate court to write an opinion that leaves space for future courts to make nuanced decisions about the application of the strict liability standard to scientific research based on the facts and circumstances of the specific research project in question.

Quinn Emanuel Urquhart & Sullivan, LLP has kindly provided pro bono legal representation on the brief, and Drs. Marc Lipsitch, Alina Chan, and Filippa Lentzos have signed on as experts in relevant scientific and policy fields. Each of these experts served on the Task Force for the Pathogens Project organized by the Bulletin of the Atomic Scientists. The amicus brief relies heavily on the final report from the Pathogens Project, entitled “A Framework for Tomorrow’s Pathogen Research.” That report is the careful written work product of the Task Force–an international and interdisciplinary team of experts–and is as close to a consensus opinion as one can find on a topic of sometimes fierce academic and policy debates. The Report’s approach also reflects LASST’s values, taking a nuanced approach that balances the need for responsible scientific research against the dangers inherent in PPP and PEPP research. We hope the appellate court takes the Report’s lessons to heart as it reviews the trial court’s opinion.  

Future briefs?

LASST is tracking the progress of other COVID-19 origins cases across the country, including several others in New York. Depending on how those cases are decided, we may file additional briefs.

A quick note on vaccines and politics

Reading the complaint in the McKinniss case and the allegations in some of the other COVID-19 origins cases, one can get the sense that the litigation is driven at least to some degree by politics and/or anti-vaccine sentiment. We want to be clear that the involvement of LASST and its partners is driven entirely by a desire to help mitigate risks from unreasonably unsafe scientific research. LASST is pro-vaccine, and we view the development and deployment of vaccines as a public health intervention critical to reducing harm from infectious diseases. LASST is also politically independent and willing to work with anyone who can help us further our mission of making advances in science and technology safer for people and the planet.

Reach out!

Are you a scientist or policy professional that would like to have your voice heard in the courts on these or other related issues? Or a lawyer or law firm willing to provide volunteer help or pro bono representation on projects like this? Or are you just interested in getting more information about this project or LASST’s other plans and projects? Feel free to reach out to us at [email protected]. We look forward to hearing from you!

1. ^{^}

    LASST takes no formal position on the cause of the COVID-19 pandemic, but we view the possibility that SARS-CoV-2 originated at the WIV as a credible theory consistent with the available evidence and information, as capably described by Dr. Alina Chan in her piece for the New York Times.

2. ^{^}

    United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential, May 2024, at p. 8. Available at https://www.whitehouse.gov/wp-content/uploads/2024/05/USG-Policy-for-Oversight-of-DURC-and-PEPP.pdf.

3. ^{^}

    Id. at 3.

^{^}

 Chan, A., The world needs a PEPP policy that addresses biosafety loopholes highlighted by the Covid-19 pandemic (forthcoming 2024 in Applied Biosafety). In her commentary, Dr. Chan explains that “[t]he success of the new policy . . . depends on all . . . researchers performing pathogen research possessing the following qualities: (1) the ability to accurately anticipate the intentional or accidental creation of PEPPs, (2) willingness to submit their groups to months of review, training, and potentially investigatory processes without financial support, and (3) the power to understand precisely how their funding and ideas are used by collaborators or contractors” and argues that “these standards cannot realistically be met by all researchers engaging in pathogen research with potential consequences for public health, agriculture, and the environment.”

^{^}

 The reference to “biosafety level” refers to the four biosafety levels outlined in, e.g., the Centers for Disease Control’s Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition.

^{^}

 The most cited "textbook example" of an abnormally dangerous activity to which strict liability has been applied is blasting with dynamite.

^{^}

 Case No. 2023-09276 in the Supreme Court, Appellate Division, 2nd Department, on appeal from Case No. 034252/2022 in the New York Supreme Court for Rockland County.

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Court Order at p. 10.

^{^}

 A recent analysis by Geetha Jeyapragasan at MIT of research designed to identify novel PPPs, known as Pandemic Virus Identification research, concluded that “[t]he overall expected value of identifying a single pandemic-capable pathogen was estimated to be strongly negative” with the benefits of identifying a single PPP being “substantially outweighed by the estimated anthropogenic risks from potential accidental pandemic events and deliberate misuse scenarios.”

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