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.”
U.S. Federal Courts
Second federal lawsuit filed against White House passport policy
Two of seven plaintiffs live in Md.
Lambda Legal on April 25 filed a federal lawsuit on behalf of seven transgender and nonbinary people who are challenging the Trump-Vance administration’s passport policy.
The lawsuit, which Lambda Legal filed in U.S. District Court for the District of Maryland in Baltimore, alleges the policy that bans the State Department from issuing passports with “X” gender markers “has caused and is causing grave and immediate harm to transgender people like plaintiffs, in violation of their constitutional rights to equal protection.”
Two of the seven plaintiffs — Jill Tran and Peter Poe — live in Maryland. The State Department, Secretary of State Marco Rubio, and the federal government are defendants.
“The discriminatory passport policy exposes transgender U.S. citizens to harassment, abuse, and discrimination, in some cases endangering them abroad or preventing them from traveling, by forcing them to use identification documents that share private information against their wishes,” said Lambda Legal in a press release.
Zander Schlacter, a New York-based textile artist and designer, is the lead plaintiff.
The lawsuit notes he legally changed his name and gender in New York.
Schlacter less than a week before President Donald Trump’s inauguration “sent an expedited application to update his legal name on his passport, using form DS-5504.”
Trump once he took office signed an executive order that banned the State Department from issuing passports with “X” gender markers. The lawsuit notes Schlacter received his new passport in February.
“The passport has his correct legal name, but now has an incorrect sex marker of ‘F’ or ‘female,'” notes the lawsuit. “Mr. Schlacter also received a letter from the State Department notifying him that ‘the date of birth, place of birth, name, or sex was corrected on your passport application,’ with ‘sex’ circled in red. The stated reason was ‘to correct your information to show your biological sex at birth.'”
“I, like many transgender people, experience fear of harassment or violence when moving through public spaces, especially where a photo ID is required,” said Schlacter in the press release that announced the lawsuit. “My safety is further at risk because of my inaccurate passport. I am unwilling to subject myself and my family to the threat of harassment and discrimination at the hands of border officials or anyone who views my passport.”
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 “X” gender marker. Zzyym in October 2021 received the first gender-neutral American passport.
Lambda Legal represented Zzyym.
The State Department policy took effect on April 11, 2022.
Trump signed his executive order shortly after he took office in January. 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.
A federal judge in Boston earlier this month issued a preliminary injunction against the executive order. The American Civil Liberties Union filed the lawsuit on behalf of seven trans and nonbinary people.
U.S. Federal Courts
Federal judge blocks Trump passport executive order
State Department can no longer issue travel documents with ‘X’ gender markers
A federal judge on Friday ruled in favor of a group of transgender and nonbinary people who have filed a lawsuit against President Donald Trump’s executive order that bans the State Department from issuing passports with “X” gender markers.
The Associated Press notes U.S. District Judge Julia Kobick in Boston issued a preliminary injunction against the directive. The American Civil Liberties Union, which represents the plaintiffs, in a press release notes Kobick concluded Trump’s executive order “is likely unconstitutional and in violation of the law.”
“The preliminary injunction requires the State Department to allow six transgender and nonbinary people to obtain passports with sex designations consistent with their gender identity while the lawsuit proceeds,” notes the ACLU. “Though today’s court order applies only to six of the plaintiffs in the case, the plaintiffs plan to quickly file a motion asking the court to certify a class of people affected by the State Department policy and to extend the preliminary injunction to that entire class.”
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 “X” 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 his executive order shortly after he took office in January.
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.
“This ruling affirms the inherent dignity of our clients, acknowledging the immediate and profound negative impact that the Trump administration’s passport policy would have on their ability to travel for work, school, and family,” said ACLU of Massachusetts Legal Director Jessie Rossman after Kobick issued her ruling.
“By forcing people to carry documents that directly contradict their identities, the Trump administration is attacking the very foundations of our right to privacy and the freedom to be ourselves,” added Rossman. “We will continue to fight to rescind this unlawful policy for everyone so that no one is placed in this untenable and unsafe position.”
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
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.
“Given 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,” 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.”
“In 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.”
Minter continued, “In 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.”
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