‘PETA v. Tabak’ Case Summary
Case Name: People for the Ethical Treatment of Animals, Inc. v. Lawrence Tabak, National Institutes of Health, Xavier Becerra, and U.S. Department of Health and Human Services
Index Number: 8:21-cv-02413
Court: U.S. District Court for the District of Maryland
In September 2021, PETA filed suit against Lawrence Tabak, the National Institutes of Health (NIH), Xavier Becerra, and the U.S. Department of Health and Human Services (HHS) (collectively, the defendants) challenging NIH’s continued funding of experiments on animals that attempt to find treatments for sepsis in humans. Our 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 testing on animals and there is no good scientific evidence that such testing will lead to treatments for sepsis in humans given the peculiarities of how they experience the condition. We are therefore asserting that the defendants’ continued 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 an 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 dies in a hospital has sepsis.
Our lawsuit alleges that since at least 2013, the defendants have known that mice do not experience sepsis in the same way humans do, as then–NIH Director Dr. Francis Collins acknowledged in February of that year, exclaiming,
“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; 110[9]:3507-3512. 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 our 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 five specific experiments on mice funded by the defendants and identified in our complaint involved harming mice in a manner unnecessary to the advancement of sepsis research.
We are currently reviewing the voluminous administrative record produced by the defendants in order to determine the extent to which it needs to be modified or supplemented. Once that issue has been settled, the parties will file merits briefs with the court to help it determine whether the defendants’ funding of the experiments named in our complaint violated the APA.