Hogan Lovells wins unanimous Supreme Court victory in widely watched case concerning access to mifepristone

Hogan Lovells wins unanimous Supreme Court victory in widely watched case concerning access to mifepristone

Press releases | 13 June 2024

Washington, D.C., 13 June, 2024 – A Hogan Lovells team led by Appellate partner Jessica Ellsworth secured a unanimous Supreme Court victory in a case of national importance on behalf of Danco Laboratories, maker and distributor of Mifeprex® (mifepristone), the first and only brand name drug approved to terminate early pregnancy.

In a 9-0 decision, the Court ruled the plaintiffs, who were associations and individual doctors opposed to abortion, did not have Article III standing to bring their case. The decision overturns an April 2023 decision by the U.S. District Court for the Northern District of Texas blocking the distribution of the drug. That decision by Judge Matthew Kacsmaryk suspended the U.S. Food and Drug Administration’s (FDA) 2000 approval of the drug and subsequent FDA guidelines regulating its use.

Ellsworth presented oral arguments before the Court in March 2024, alongside United States Solicitor General Elizabeth Prelogar, who is a former member of the Hogan Lovells Appellate practice. Ellsworth, aided by the firm’s FDA regulatory team, including partners Philip Katz and Lynn Mehler, delivered an all-encompassing defense of FDA policies surrounding their two-decade-old approval of mifepristone.

The Court held that the plaintiffs did not have standing to bring their case under Article III of the Constitution, which is a “bedrock constitutional requirement” that limits federal courts' jurisdiction to “cases” and “controversies.” Justice Kavanaugh delivered the opinion of the Court, which concluded that the plaintiffs did not demonstrate that they had suffered an “injury in fact” caused by the FDA.

As the Court explained, the plaintiffs’ “sincere legal, moral, ideological, and policy objections to mifepristone being prescribed and used by others” do not suffice to confer Article III standing, and neither did any of the “several complicated causation theories” the plaintiffs’ advanced seeking “to connect FDA’s actions to the plaintiffs’ alleged injuries in fact.” The Court emphasized that “citizens and doctors do not have standing to sue simply because others are allowed to engage in certain activities—at least without the plaintiffs demonstrating how they would be injured by the government’s alleged under-regulation of others.” Instead, “[c]itizens and doctors who object to what the law allows others to do may always take their concerns to the Executive and Legislative Branches and seek greater regulatory or legislative restrictions on certain activities.”

Hogan Lovells has represented Danco Laboratories, a longstanding client, in this matter since the original decision by Judge Kacsmaryk. In April 2023, Ellsworth and her team won a stay from the Supreme Court under substantial time constraints.

Speaking after the decision was made public, Ellsworth said: “This case is extremely important to our client, and has widespread implications for the pharmaceutical sector. The lower court’s decision threatened to upend the industry by unilaterally overruling the FDA and its ability to independently assess and approve drugs.”

Ellsworth was supported in the case by Appellate partners Cate Stetson, co-head of the Appellate practice, and Jo-Ann Sagar. In addition to Katz and Mehler (head of the Pharmaceuticals & Biotechnology practice), the team also included senior associates Danielle Stempel and Marlan Golden, and associates Dana Raphael (all Washington, D.C.), and Eva Schifini (Los Angeles).