U.S. Federal Courts
Judge’s nationwide abortion pill ban ‘could open the floodgates’
Medicines for gay, bi, and trans Americans could be next
White House Press Secretary Karine Jean-Pierre told reporters on Monday that last week’s decision by a Texas court to ban the nationwide sale and distribution of the abortion pill mifepristone “could open the floodgates for other medications to be targeted and denied to people who need them.”
Following that ruling by Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas, American Medical Association President Jack Resneck raised similar concerns in a statement warning that “upending longstanding drug regulatory decisions by the U.S. Food and Drug Administration (FDA)” would position “other drugs at risk of being subject to similar efforts.”
“This ruling makes every medication on the market a potential target for political grandstanding,” Whitman-Walker Institute Executive Director Kellan Baker told the Washington Blade by email.
“Now that Judge Kacsmaryk has decided that he knows more about medical evidence than the FDA, the entire foundation of the FDA’s essential role in safeguarding access to medications is now subject to political attack,” Baker said.
“You’re not talking about just mifepristone,” U.S. Department of Health and Human Services Secretary Xavier Becerra said during an appearance on CNN’s “State of the Union” Sunday. “You’re talking about every kind of drug. You’re talking about our vaccines. You’re talking about insulin. You’re talking about the new Alzheimer’s drugs that may come on.”
Likewise, in an interview on Pod Save America that aired Tuesday, law professor Leah Litman agreed drugs like HIV medications, along with vaccines like those targeting HPV and COVID, or birth control pills, could be next.
Medicines for trans youth and adults, in some cases, have been targeted with legislation passed by conservative states to restrict access to guideline directed medically necessary interventions for the treatment of gender dysphoria.
And last year, another Texas court ruled that employers can deny health coverage for PrEP, a medication used to prevent the transmission of HIV.
More litigation lies ahead, along with more uncertainty
Ruling in Alliance for Hippocratic Medicine v. FDA, Kacsmaryk had issued a stay on the Food and Drug Administration’s conclusion that mifepristone is safe and effective, a finding the agency reached in 2000 that has since been buttressed by more than two decades of clinical evidence.
It was roundly denounced as unscientific, the product of the judge’s longstanding and well documented ideological opposition to abortion.
The Biden administration was prepared for Kacsmaryk’s decision, Jean-Pierre said: Attorney General Merrick Garland immediately pledged the Justice Department to appeal and seek a stay (of Kacsmaryk’s ruling) pending the outcome of additional litigation. And then on Monday the Department asked the U.S. Court of Appeals for the Fifth Circuit to halt implementation of the ruling.
Other powerful legal actors had also been on notice. On Monday, New York Attorney General Letitia James led a coalition of state attorneys general in challenging Kacsmaryk’s ruling with an amici brief filed to the 5th Circuit.
Casting additional uncertainty into the mix was a separate ruling, just hours after Kacsmaryk’s, by Judge Thomas Rice of the U.S. District Court for the Eastern District of Washington, who ordered the FDA to make no changes to the availability of mifepristone.
The case in Washington was brought by attorneys general from 17 states and the District of Columbia in anticipation of Kacsmaryk’s ruling, and the split decision means the matter is likely to be settled by the U.S. Supreme Court.
Some legal observers have speculated that the Biden administration may be pushing for this outcome, hedging that even with its 6-3 conservative supermajority the justices are likely to reject Kacsmaryk’s analysis of the relevant facts on substantive or procedural grounds.
Still, and notwithstanding the fate of other medications or vaccines in the hands of Kacsmaryk or his ideological allies on the federal bench, the Texas court’s ruling raises other major questions.
For example, can a federal judge circumvent the congressionally ordained power of America’s federal administrative agencies? If so, under which circumstances? How about the practice of forum shopping, by which litigants deliberately move to have their cases adjudicated by judges they expect will be most sympathetic? And what will all of this uncertainty mean for the global biopharmaceutical industry and the future of drug discovery in America?
One solution that was proposed by at least two Democratic members of Congress, Rep Alexandria Ocasio-Cortez (N.Y.) and Sen. Ron Wyden (Ore.): the Biden administration should simply ignore Kacsmaryk’s ruling.
“I believe the Food and Drug Administration has the authority to ignore this ruling, which is why I’m again calling on President Biden and the FDA to do just that,” Wyden said in a statement Friday.
“If they don’t,” warned the senator, “the consequences of banning the most common method of abortion in every single state will be devastating.”
“The courts rely on the legitimacy of their rulings, and what they are currently doing is engaging in an unprecedented erosion of their legitimacy,” Ocasio-Cortez told Anderson Cooper during an interview on CNN Friday.
On Twitter, the congresswoman addressed the backlash against her comments, explaining that Republicans have also ignored court orders in cases where they felt they were unlawful.
GOP are losing their mind over this, but there’s precedent – including their own.
— Alexandria Ocasio-Cortez (@AOC) April 9, 2023
Courts ordered Trump to fully restore DACA. They ignored it w/ Republican support.
GOP operate in complete contempt for the law until they’re in a position to shred Constitutional & human rights. https://t.co/kfxsdF5eKG
On Monday, the White House circulated an open industry letter signed by more than 200 pharmaceutical industry executives, which echoed criticisms of Kacsmaryk’s ruling that noted his lack of formal education or training in science or medicine.
The executives’ letter also argued the decision presents systemic risks to the drug discovery pipeline.
“As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval,” the group wrote.
“Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.”
Maryland
4th Circuit dismisses lawsuit against Montgomery County schools’ pronoun policy
Substitute teacher Kimberly Polk challenged regulation in 2024
A federal appeals court has ruled Montgomery County Public Schools did not violate a substitute teacher’s constitutional rights when it required her to use students’ preferred pronouns in the classroom.
The 4th U.S. Circuit Court of Appeals in a 2-1 decision it released on Jan. 28 ruled against Kimberly Polk.
The policy states that “all students have the right to be referred to by their identified name and/or pronoun.”
“School staff members should address students by the name and pronoun corresponding to the gender identity that is consistently asserted at school,” it reads. “Students are not required to change their permanent student records as described in the next section (e.g., obtain a court-ordered name and/or new birth certificate) as a prerequisite to being addressed by the name and pronoun that corresponds to their identified name. To the extent possible, and consistent with these guidelines, school personnel will make efforts to maintain the confidentiality of the student’s transgender status.”
The Washington Post reported Polk, who became a substitute teacher in Montgomery County in 2021, in November 2022 requested a “religious accommodation, claiming that the policy went against her ‘sincerely held religious beliefs,’ which are ‘based on her understanding of her Christian religion and the Holy Bible.’”
U.S. District Judge Deborah Boardman in January 2025 dismissed Polk’s lawsuit that she filed in federal court in Beltsville. Polk appealed the decision to the 4th Circuit.
U.S. Federal Courts
Federal judge in Md. rules against White House passport policy
Lambda Legal represents transgender, nonbinary people in lawsuit
A federal judge in Maryland on Tuesday ruled in favor of six transgender people who are challenging the Trump-Vance administration’s passport policy.
President Donald Trump once he took office signed an executive order that banned the State Department from issuing passports with “X” gender markers. A memo the Washington Blade obtained directed State Department personnel to “suspend any application where the applicant is seeking to change their sex marker from that defined in the executive order
pending further guidance.”
The Trump-Vance administration only recognizes two genders: male and female.
The lawsuit that Lambda Legal filed in U.S. District Court for the District of Maryland in Baltimore in April alleges the policy “has caused and is causing grave and immediate harm to transgender people like plaintiffs, in violation of their constitutional rights to equal protection.”
Seven trans people — Zander Schlacter, Jill Tran, Lia Hepler-Mackey, David Doe, Robert Roe, Peter Poe, and Kris Koe — filed the lawsuit.
Roe is a U.S. Foreign Service Officer who currently lives in Europe. Lambda Legal, who represents him and the six other plaintiffs, notes Chief Judge George L. Russell III dismissed Roe’s case because the State Department has yet to deny him “an accurate passport.”
“Like every other court that has considered this executive order, the court finds its stated purpose does not serve an important governmental interest that is exceedingly persuasive; further, the discriminatory means employed are not substantially related to the achievement of those objectives,” said Russell in his ruling.
Lambda Legal Counsel Carl Charles described Russell’s decision as “a crucial victory for our clients and transgender people nationwide who have been trapped by this administration’s cruel and discriminatory policy.”
“The court recognized that forcing inaccurate identity documents on transgender Americans causes immediate and irreparable harm,” said Charles in a press release. “Our clients can now travel with dignity and safety while we continue fighting to overturn this discriminatory policy entirely.”
The American Civil Liberties Union earlier this year filed a separate lawsuit against the passport directive on behalf of seven trans and nonbinary people.
A federal judge in Boston in April issued a preliminary junction against it. A three-judge panel on the 1st U.S. Circuit Court of Appeals last week ruled against the Trump-Vance administration’s motion to delay the move.
U.S. Federal Courts
AGs sue White House over push to restrict gender-affirming care in blue states
14 states, DC joined the lawsuit filed Friday
A group of 15 Democratic attorneys general and Pennsylvania Gov. Josh Shapiro (D) have accused the Trump-Vance administration of unlawfully pressuring health providers to withhold access to gender-affirming medicine for minors in places where these treatments remain legal.
In a complaint filed in the U.S. District Court for the District of Massachusetts on Friday, the attorneys general outlined multiple ways in which, they claim, the administration has overstepped its authority to restrict care that is protected under state law, such as by threatening providers with meritless lawsuits and federal investigations.
On the first day of his second term, President Donald Trump directed the Justice Department to pursue enforcement actions to proscribe medically necessary gender related interventions, which were characterized in his executive order as “chemical and surgical mutilation.”
Thereafter, the DOJ has issued subpoenas, demanded private patient data, and suggested that criminal charges might be coming — actions that have no legal basis, and instead constitute efforts to strong-arm Democratic states into alignment with the administration’s position on gender-affirming care for minors, according to the complaint.
As a result of these pressures, the attorneys general argue, providers have reduced or eliminated services while patients have reported cancelled appointments and uncertainty over whether they can continue receiving treatment.
Their lawsuit asks the court to block the administration’s actions and halt the enforcement of the executive order along with another that prohibits the federal government from recognizing transgender people or acknowledging that gender identity does not always correspond with one’s sex at birth.
The 15 attorneys general are from Massachusetts, California, New York, Connecticut, Illinois, Delaware, D.C., Hawaii, Maine, Maryland, Michigan, Nevada, New Jersey, New Mexico, Rhode Island, and Wisconsin.
