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 FDAās essential role in safeguarding access to medications is now subject to political attack,” Baker said.
“Youāre not talking about just mifepristone,ā U.S. Department of Health and Human Services Secretary Xavier Becerra said during an appearance on CNNās āState of the Unionā Sunday. āYouāre talking about every kind of drug. Youāre talking about our vaccines. Youāre talking about insulin. Youāre talking about the new Alzheimerās drugs that may come on.ā
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 Iām 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.ā
“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 thereās precedent – including their own.
ā 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 theyāre 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.
āAs an industry we count on the FDAās 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.ā
U.S. Federal Courts
Appeals court hears case challenging Florida’s trans healthcare ban
District court judge concluded the law was discriminatory, unconstitutional
Parties in Doe v. Ladapo, a case challenging Florida’s ban on healthcare for transgender youth and restrictions on the medical interventions available to trans adults, presented oral arguments on Wednesday before the U.S. Court of Appeals for the 11th Circuit in Atlanta.
The case was appealed by defendants representing the Sunshine State following a decision in June 2024 by Judge Robert Hinkle of the U.S. District Court for the Northern District of Florida, who found “the law and rules unconstitutional and unenforceable on equal protection grounds,” according to a press release from the National Center for Lesbian Rights, which is involved in the litigation on behalf of the plaintiffs.
The district court additionally found the Florida healthcare ban unconstitutional on the grounds that it was “motivated by purposeful discrimination against transgender people,” though the ban and restrictions will remain in effect pending a decision by the appellate court.
Joining NCLR in the lawsuit are attorneys from GLAD Law, the Human Rights Campaign, Southern Legal Counsel, and the law firms Lowenstein Sandler and Jenner and Block.
“As a mother who simply wants to protect and love my child for who she is, I pray that the Eleventh Circuit will affirm the district courtās thoughtful and powerful order, restoring access to critical healthcare for all transgender Floridians,” plaintiff Jane Doe said. “No one should have to go through what my family has experienced.ā
“As a transgender adult just trying to live my life and care for my family, it is so demeaning that the state of Florida thinks itās their place to dictate my healthcare decisions,” said plaintiff Lucien Hamel.
“Members of the legislature have referred to the high quality healthcare I have received, which has allowed me to live authentically as myself, as āmutilationā and āan abominationā and have called the providers of this care āevil,ā” Hamel added. “We hope the appellate court sees these rules and laws for what truly are: cruel.ā
āTransgender adults donāt need state officials looking over their shoulders, and families of transgender youth donāt need the government dictating how to raise their children,ā said Shannon Minter, legal director of NCLR. āThe district court heard the evidence and found that these restrictions are based on bias, not science. The court of appeals should affirm that judgment.ā
Noting Hinkle’s conclusion that the ban and restrictions were “motivated by animus, not science or evidence,” Simone Chris, who leads Southern Legal Counsel’s Transgender Rights Initiative, said, āThe state has loudly and proudly enacted bans on transgender people accessing healthcare, using bathrooms, transgender teachers using their pronouns and titles, and a slough of other actions making it nearly impossible for transgender individuals to live in this state.”
Lowenstein Sandler Partner Thomas Redburn said, āThe defendants have offered nothing on appeal that could serve as a valid basis for overturning that finding” by the district court.
āNot only does this dangerous law take away parentsā freedom to make responsible medical decisions for their child, it inserts the government into private health care matters that should be between adults and their providers,” said Jennifer Levi, senior director of transgender and queer rights at GLAD Law.
U.S. Federal Courts
9th Circuit upholds lower court ruling that blocked anti-trans Ariz. law
Statute bans transgender girls from sports teams that correspond with gender identity
The 9th U.S. Circuit Court of Appeals on Monday upheld a lower court’s decision that blocked enforcement of an Arizona law banning transgender girls from playing on public schools’ sports team that correspond with their gender identity.
Then-Gov. Doug Ducey, a Republican, in 2022 signed the law.
The Associated Press reported the parents of two trans girls challenged the law in a lawsuit they filed in U.S. District Court in Tucson, Ariz., in April 2023. U.S. District Judge Jennifer Zipps on July 20, 2023, blocked the law.
Arizona Superintendent of Public Instruction Tom Horne, who was named as a defendant in the lawsuit, appealed the ruling to the 9th Circuit. Democratic Attorney General Kris Mayes is not defending the law.
A three-judge panel on the 9th Circuit unanimously upheld Zipps’s ruling.
“We are pleased with the 9th Circuitās ruling today, which held that the Arizona law likely violates the Equal Protection Clause and recognizes that a studentās transgender status is not an accurate proxy for athletic ability and competitive advantage,ā said Rachel Berg, a staff attorney for the National Center for Lesbian Rights, in a press release.
NCLR represents the two plaintiffs in the case.
U.S. Federal Courts
Federal judge: Military can no longer prevent people with HIV from enlistingĀ
Lambda Legal filed lawsuit on behalf of three servicemembers in 2022
A federal judge on Tuesday ruled the Pentagon can no longer prevent people with HIV from enlisting in the military.
Judge Leonie M. Brinkema of the U.S. District Court for the Eastern District of Virginia in Alexandria issued the ruling in a lawsuit that Lambda Legal filed against the Pentagon in 2022.
“Defendants’ policies prohibiting the accession of asymptomatic HIV-positive individuals with undetectable viral loads into the military are irrational, arbitrary, and capricious,” wrote Brinkema. “Even worse, they contribute to the ongoing stigma surrounding HIV-positive individuals while actively hampering the military’s own recruitment goals.”
Brinkema further stated “modern science has transformed the treatment of HIV, and this court has already ruled that asymptomatic HIV-positive service members with undetectable viral loads who maintain treatment are capable of performing all of their military duties, including worldwide deployment.”
“Now, defendants must allow similarly situated civilians seeking accession into the United States military to demonstrate the same and permit their enlistment, appointment, and induction,” added Brinkema.
Brinkema in April 2022 declared the military’s HIV restrictions unconstitutional.
Nicholas Harrison, a gay D.C. attorney and longtime member of the U.S. Army National Guard who has been living with HIV since 2012, challenged the policy. The Washington Blade reported the April 2022 decision ordered the Pentagon “to discontinue its policy of refusing to deploy and commission as officers members of the military with HIV if they are asymptomatic and otherwise physically capable of serving.”
Harrison became a first lieutenant in the D.C. National Guard on Aug. 5, 2022.
Isaiah Wilkins, one of the three plaintiffs in the lawsuit on which Brinkema ruled on Tuesday, was a member of the Georgia Army National Guard for two years before he left to attend the U.S. Military Academy Preparatory School. NBC News notes Wilkins was “separated” from the USMAPS after he took a medical exam “that revealed for the first time that he was HIV positive.”
āThis is a victory not only for me but for other people living with HIV who want to serve,ā said Wilkins in a Lambda Legal press release. āAs Iāve said before, giving up on my dream to serve my country was never an option. I am eager to apply to enlist in the ArmyāÆwithout the threat of a crippling discriminatory policy.āāÆ
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