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U.S. Federal Courts

Judge’s nationwide abortion pill ban ‘could open the floodgates’

Medicines for gay, bi, and trans Americans could be next

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Judge Matthew Kacsmaryko’s ruling would ban the nationwide sale and distribution of the abortion pill mifepristone. (Screen capture via YouTube)

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,ā€ U.S. Department of Health and Human Services Secretary Xavier Becerra said during an appearance on CNN’s ā€œState of the Unionā€ Sunday. ā€œYou’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.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 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.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.

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.

ā€œAs 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.ā€

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U.S. Federal Courts

Second judge blocks Trump’s anti-trans military ban

Federal courts in D.C. and Washington State have now issued injunctions

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President Donald Trump (Washington Blade photo by Michael Key)

The U.S. District Court for the Western District of Washington on Thursday became the second court to issue a nationwide injunction blocking the enforcement of President Donald Trump’s executive order barring transgender people from military service.

The order in Schilling v. Trump from Judge Benjamin Hale Settle comes after Judge Ana Reyes of the U.S. District Court for the District of Columbia blocked implementation of the ban earlier this month in Talbott v. Trump.

Friday was the date by which the Pentagon was to begin identifying and separating transgender service members from the armed forces, per Trump’s executive action.

The lead attorneys in Talbott v. Trump, GLAD Law Senior Director of Transgender and Queer Rights Jennifer Levi and Shannon Minter, legal director of the National Center for Lesbian Rights, shared statements about the injunction in a press release by NCLR.

ā€œGiven the thousands of brave and decorated transgender servicemembers facing unthinkable harms as the result of this ban, we are heartened but not surprised by today’s decision,ā€ Levi said. “President Trump’s executive order and Secretary [Pete] Hegseth’s implementation represent a policy that cannot be constitutionally justified. Thousands of transgender servicemembers currently serving have clearly demonstrated they meet all military standards, with many deployed to critical missions worldwide, proving their capabilities beyond question.”

Levi continued, “These dedicated servicemembers and their families have earned our nation’s gratitude and respect, and the government has a responsibility to honor the commitments it has made to them. This is about keeping faith with Americans who have risked everything to defend our freedoms.”

ā€œIn both Talbott and Shilling, it was abundantly clear to the court that it must act swiftly to protect our troops from an unconstitutional and indefensible ban that would disrupt the lives and dismantle the careers of thousands of transgender servicemembers and their families,” Minter said. “The harms associated with this ban are gut-wrenching.ā€

Minter continued, ā€œIn each of these cases, the government did not even attempt to claim that any evidence supported its position. There is no reason to discharge individuals who are serving capably and honorably.ā€

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U.S. Federal Courts

Federal judge hears case that challenges Trump passport executive order

State Department no longer issues passports with ‘X’ gender markers

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A federal judge in Boston on Tuesday heard oral arguments in a lawsuit against President Donald Trump’s executive order that bans the State Department from issuing passports with “X” gender markers.

Ashton Orr, Zaya Perysian, Sawyer Soe, Chastain Anderson, Drew Hall, Bella Boe, and Reid Solomon-Lane are the plaintiffs in the class action lawsuit the American Civil Liberties Union, the ACLU of Massachusetts, and the private law firm Covington & Burling LPP filed in U.S. District Court for the District of Massachusetts. The lawsuit names Trump and Secretary of State Marco Rubio as defendants.

Former Secretary of State Antony Blinken in June 2021 announced the State Department would begin to issue gender-neutral passports and documents for American citizens who were born overseas.

Dana Zzyym, an intersex U.S. Navy veteran who identifies as nonbinary, in 2015 filed a federal lawsuit against the State Department after it denied their application for a passport with an ā€œXā€ gender marker. Zzyym in October 2021 received the first gender-neutral American passport.

The State Department policy took effect on April 11, 2022.

Trump signed the executive order that overturned it shortly after he took office. Rubio later directed State Department personnel to ā€œsuspend any application requesting an ā€˜X’ sex marker and do not take any further action pending additional guidance from the department.ā€  

ā€œEven before Donald Trump was inaugurated, it was clear to me he wanted to control the lives and identities of transgender people like myself,ā€ said Orr, a transgender man who lives in West Virginia, in a press release the ACLU released before U.S. District Judge Julia Kobick heard the case. ā€œLike many others, I rushed to update my passport hoping I could get an accurate version. Now, the State Department has suspended my application and withheld all my documents from me, including my passport, my birth certificate, and even my marriage license.”

Li Nowlin-Sohl, a staff attorney for the ACLU’s LGBTQ and HIV Project, described the Trump-Vance administration’s passport policy as “openly discriminatory and animated by a transparent desire to drive transgender people out of public life altogether.”

Germany, Denmark, Finland, and the Netherlands are among the countries that have issued travel advisories for trans and nonbinary people who plan to visit the U.S.

WorldPride is scheduled to take place in D.C. from May 17-June 8. InterPride, the organization that coordinates WorldPride events, on March 12 issued its own travel advisory for trans and nonbinary people who want to travel to the U.S.

It is unclear when Kobick will issue her ruling. 

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U.S. Federal Courts

Court halts removal of two transgender service members

Case challenging anti-trans military ban proceeds in D.C.

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Laila and Logan Ireland (Photo courtesy of the couple)

A federal court in New Jersey issued a temporary restraining order on Monday that will halt the separation of two transgender service members from the U.S. military while their case in D.C. challenging the Trump-Vance administration’s ban moves forward.

The order by Judge Christine O’Hearn pauses proceedings against Staff Sgt. Nicholas Bear Bade and Master Sgt. Logan Ireland, who “have been pulled from key deployments and placed on administrative absence against their will because of the ban,” according to a joint press release Monday by the National Center for Lesbian Rights and GLAD Law, which are representing the service members together with other litigants in Ireland v. Hegseth and in the case underway in the U.S. District Court for the District of Columbia, Talbott v. Trump.

“That court granted a preliminary injunction March 18 barring the Department of Defense from implementing the ban, finding that it discriminates based on sex and transgender status; that it is ‘soaked in animus;’ and that, due to the government’s failure to present any evidence supporting the ban, it is ‘highly unlikely’ to survive any level of judicial review,” the groups noted in their press release.

Ireland spoke with the Washington Blade in January along with other trans service members and former service members who shared their experiences with the military and their feelings on the new administration’s efforts to bar trans people from the U.S. armed forces.

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