Court Opinions: US Supreme Court Unanimously Reverses Mifepristone Ruling

Editor’s Note: Law Week Colorado edits court opinion summaries for style and, when necessary, length.

FDA v. Alliance for Hippocratic Medicine


In 2000, the Food and Drug Administration approved a new drug application for mifepristone tablets marketed under the brand name Mifeprex for use in terminating pregnancies up to seven weeks. To help ensure that Mifeprex would be used safely and effectively, the FDA placed additional restrictions on the drug’s use and distribution, such as requiring doctors to prescribe or to supervise prescription of Mifeprex, and requiring patients to have three in-person visits with the doctor to receive the drug. 

In 2016, the FDA relaxed some of these restrictions: deeming Mifeprex safe to terminate pregnancies up to 10 weeks, allowing healthcare providers, such as nurse practitioners, to prescribe Mifeprex and approving a dosing regimen that required just one in-person visit to receive the drug. In 2019, the FDA approved an application for generic mifepristone. In 2021, the FDA announced that it would no longer enforce the initial in-person visit requirement. 

Four anti-abortion medical associations and several individual doctors moved for a preliminary injunction that would require the FDA either to rescind approval of mifepristone or to rescind the FDA’s 2016 and 2021 regulatory actions. Danco Laboratories, which sponsors Mifeprex, intervened to defend the FDA’s actions.

The district court agreed with the plaintiffs and in effect enjoined the FDA’s approval of mifepristone, thereby ordering mifepristone off the market. FDA and Danco appealed and moved to stay the district court’s order pending appeal. As relevant here, the U.S. Supreme Court ultimately stayed the district court’s order pending the disposition of proceedings in the 5th Circuit Court of Appeals and the Supreme Court. On the merits, the 5th Circuit held the plaintiffs had standing. It concluded that the plaintiffs were unlikely to succeed on their challenge to the FDA’s 2000 and 2019 drug approvals, but were likely to succeed in showing that the FDA’s 2016 and 2021 actions were unlawful. 

The Supreme Court granted certiorari with respect to the 2016 and 2021 FDA actions.

The high court held the plaintiffs lack Article III standing to challenge the FDA’s actions regarding the regulation of mifepristone.

It reversed the judgment and remanded the case.

Justice Brett Kavanaugh delivered the opinion for a unanimous court. Justice Clarence Thomas filed a concurring opinion.

Vidal v. Elster

Drawing on a 2016 presidential primary debate exchange between then-candidate Donald Trump and Senator Marco Rubio, Steve Elster sought to federally register the trademark “Trump too small” to use on shirts and hats. An examiner from the Patent and Trademark Office refused registration based on the “names clause,” a Lanham Act prohibition on the registration of a mark that “[c]onsists of or comprises a name . . . identifying a particular living individual except by his written consent.” The Trademark Trial and Appeal Board affirmed, rejecting Elster’s argument that the names clause violates his First Amendment right to free speech. The federal circuit reversed.

The U.S. Supreme Court held the Lanham Act’s names clause does not violate the First Amendment. It noted that because the names clause does not single out a trademark “based on the specific motivating ideology or the opinion or perspective of the speaker,” it does not facially discriminate against any viewpoint. The court went on to explain that because of the uniquely content-based nature of trademark regulation and the longstanding coexistence of trademark regulation with the First Amendment, a solely content-based restriction of trademark registration need not be evaluated under heightened scrutiny.

In this case, the court wrote it saw no reason to disturb this longstanding tradition, which it asserted supports the restriction of the use of another’s name in a trademark. But it cautioned the decision in this case is narrow. 

The high court reversed the federal circuit.

Justice Clarence Thomas announced the judgment of the court and delivered the opinion of the court, except as to Part III. Justices Samuel Alito Jr. and Neil Gorsuch joined that opinion in full. Chief Justice John Roberts Jr. and Justice Brett Kavanaugh joined all but Part III and Justice Amy Coney Barrett joined Parts I, II–A and II–B. Kavanaugh filed an opinion concurring in part, in which Roberts joined. Barrett filed an opinion concurring in part that Justice Elena Kagan joined, Justice Sonia Sotomayor joined as to Parts I, II and III–B, and in which Justice Ketanji Brown Jackson joined as to Parts I and II. Sotomayor filed an opinion concurring in the judgment, in which Kagan and Jackson joined. 

Starbucks Corp. v. McKinney

After several Starbucks employees announced plans to unionize, they invited a news crew from a local television station to visit the store after hours to promote their unionizing effort. Starbucks fired multiple employees involved with the media event for violating company policy.

The National Labor Relations Board filed an administrative complaint against Starbucks alleging that it had engaged in unfair labor practices. The board’s regional director then filed a petition under Section 10( j) of the National Labor Relations Act seeking a preliminary injunction for the duration of the administrative proceedings that would, among other things, require Starbucks to reinstate the fired employees. 

The district court assessed whether the board was entitled to a preliminary injunction by applying a two-part test that asks whether “there is reasonable cause to believe that unfair labor practices have occurred,” and whether injunctive relief is “just and proper.” Applying this standard, the district court granted the injunction and the 6th Circuit Court of Appeals affirmed.

The U.S. Supreme Court held that when considering the NLRB’s request for a preliminary injunction under Section 10( j), district courts must apply the traditional four factors articulated in Winter v. Natural Resources Defense Council.

The Supreme Court vacated the judgment and remanded the case.

Justice Clarence Thomas delivered the opinion of the court, in which Chief Justice John Roberts Jr. and Justices Samuel Alito Jr., Sonia Sotomayor, Elena Kagan, Neil Gorsuch, Brett Kavanaugh and Amy Coney Barrett joined. Justice Ketanji Brown Jackson filed an opinion concurring in part, dissenting in part and concurring in the judgment.

In her opinion dissenting in part, Jackson wrote, “I cannot join the majority in ignoring the choices Congress has made in the NLRA about how courts should exercise their discretion in light of the National Labor Relations Board’s authority over labor disputes. Because the majority chooses the simplicity of unfettered judicial discretion over the nuances of Congress’s direction, I respectfully dissent in part.” 

Previous article62 Pass Colorado’s First LLP Exam
Next articleMichael Zehner Returns to Brownstein as a Shareholder

LEAVE A REPLY

Please enter your comment!
Please enter your name here