‘PETA v. Tabak’ Case Summary

Case Name: People for the Ethical Treatment of Animals, Inc. v. Tabak, et al.
Index Number: 8:21-cv-02413
Court: U.S. District Court for the District of Maryland

In September 2021, PETA filed suit against the National Institutes of Health (NIH), then-NIH director Dr. Francis Collins, the U.S. Department of Health and Human Services (HHS), and HHS Secretary Xavier Becerra (collectively, the defendants) challenging NIH’s continuing funding of experiments on animals that purport to study sepsis in humans. PETA’s lawsuit alleges that this funding of such experiments violates the federal Administrative Procedure Act (APA) because the defendants’ statutory mandates are to fund research into human conditions and reduce the use of animals in experimentation and because scientific evidence indicates that such experiments will not lead to treatments for sepsis in humans given the differences in how mice and humans experience the condition. We are therefore asserting that the defendants’ continuing funding of experiments that use animals in this way violates the APA’s prohibition of “arbitrary” and “capricious” agency decisions.

Sepsis is the body’s extreme response to infection and can quickly cause tissue damage and organ failure. In a typical year, sepsis afflicts at least 1.7 million American adults and kills nearly 270,000 of them: One in every three patients who die in a hospital has sepsis.

PETA’s lawsuit alleges that since at least 2013, the defendants have known that mice do not experience sepsis in the same way humans do, as Collins acknowledged in February of that year:

“No wonder drugs designed for the mice failed in humans: they were, in fact, treating different conditions!”

—Former NIH Director Dr. Francis Collins

He was reacting to a landmark 10-year study involving the collaboration of 39 researchers from institutions throughout North America and experts from around the world. They compared data obtained from hundreds of human clinical patients with results from experiments on mice to demonstrate that when it comes to serious inflammatory conditions such as sepsis, burns, and trauma, mice have determinative differences from humans. They pointed out that as of February 11, 2013, “there ha[d] been nearly 150 clinical trials testing candidate agents intended to block the inflammatory response in critically ill patients, and every one of these trials failed.” (Seok J et al., Genomic responses in mouse models poorly mimic human inflammatory diseases, Proc Natl Acad Sci U S A. 2013 Feb 26;110(9):3507-12. doi: 10.1073/pnas.1222878110)

Notably, no new pharmacological treatments have been developed for sepsis despite decades of intensive study. NIH has spent billions of taxpayer dollars on painful, debilitating, and fatal sepsis experiments on animals that fail to help humans.

PETA Secures Denial of a Motion to Dismiss

After we filed suit, the defendants unsuccessfully tried to persuade the court to dismiss the case by arguing, in part, that PETA’s lawsuit complaint did not plead any legally cognizable claims against any of the defendants. The court rejected that argument, stating that the defendants’ awards of research grants qualify as challengeable under the APA and that our complaint adequately alleges that the defendants’ funding of five specific experiments was arbitrary or capricious.

This matter remains in active litigation.