New York County Lawyers Association Opposes Judge Matthew Kacsmaryk’s Ruling in Alliance for Hippocratic Medicine v. U.S. Food & Drug Administration

The New York County Lawyers Association and its Task Force for Reproductive Rights denounce the preliminary injunction issued by Northern District of Texas Judge Matthew Kacsmaryk in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. That injunction purports to invalidate the FDA’s 23-year approval of mifepristone, the first of two drugs administered in the medication abortion regimen. The result of the injunction, if it is not overturned, will be a nationwide ban on the use of this drug—which not only provides critical access to abortion, but is also used to treat miscarriages—disrupting the lives of hundreds of millions of people.

We believe Judge Kacsmaryk is wrong on the law. His order ignores a basic tenet of administrative law:  federal agencies exercise the authority delegated to them by Congress, and a judge may not second-guess an agency’s action unless it was arbitrary and capricious. The FDA’s approval of mifepristone was far from arbitrary and capricious; it was sound and supported by science. Moreover, two decades of use has proven that the drug is safe and effective and that complications are vanishingly rare. In fact, independent studies have proven that mifepristone is safer than Tylenol, penicillin, and Viagra.

Judge Kacsmaryk also ignored the six-year statute of limitations within which a plaintiff must oppose the FDA’s approval of a drug. We find highly dubious the court’s claim that the FDA reopened the statute of limitations in 2021 when it eased regulations on the dispensation of mifepristone and that it somehow “stonewalled judicial review.” Equally dubious (in our view) is the court’s holding that the plaintiffs—a group of anti-abortion organizations and doctors—have been injured by the FDA’s approval of mifepristone and thus have standing to bring suit in federal court in the first place.

Of equal importance, Judge Kacsmaryk’s ruling calls into question the FDA’s authority to approve drugs using a review process that has been recognized as the world’s gold standard. This consequence should concern all Americans, whether or not they believe that abortion is a fundamental right. During the hearing on plaintiff’s motion in this case, lawyers for the Alliance for Hippocratic Medicine could not identify a single other instance in which a federal judge invalidated the FDA’s approval of a drug—because there has never been one. Judge Kacsmaryk is not a scientist, doctor, or public health expert, yet he has stepped into the shoes of one in his ruling. This is hardly a federal judge’s role, regardless of his political or religious beliefs.

Although we were cheered by Judge Thomas O. Rice’s decision in a similar case in the U.S. District Court for the Eastern District of Washington (which ordered the FDA to do nothing to change the availability of mifepristone), NYCLA remains deeply concerned about, and strongly opposes, the frightening substance, flawed legal reasoning, and potentially reverberating consequences of the Texas order.

Last week’s other development in the fight to restrict access to abortion—an Idaho state law that creates the crime of “abortion trafficking,” making it illegal for minors to leave the state to get an abortion without parental consent—is equally chilling (to say nothing of a decision by a college in Idaho to remove from an exhibition a work of art about abortion).

When the issue of abortion is on the ballot, as was the case in last week’s Wisconsin Supreme Court race, American voters continue to resoundingly support the idea that abortion is a fundamental right and that access to it is essential. NYCLA shares that view, and remains committed to ensuring that abortion remains safe, accessible, affordable, and available for anyone who wants or needs one. Our Task Force for Reproductive Rights (chaired by Kate Aufses, Brittney Balser, and Margaret Sanborn-Lowing) will continue to sound the alarm about developments that do the opposite, and to fight for legislation in New York and elsewhere that codifies and solidifies the fundamental right to abortion and other reproductive care.