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
Judge temporarily blocks executive orders targeting LGBTQ, HIV groups
Lambda Legal filed the lawsuit in federal court
A federal judge on Monday blocked the enforcement of three of President Donald Trump’s executive orders that would have threatened to defund nonprofit organizations providing health care and services for LGBTQ people and those living with HIV.
The preliminary injunction was awarded by Judge Jon Tigar of the U.S. District Court for the Northern District of California in a case, San Francisco AIDS Foundation v. Trump, filed by Lambda Legal and eight other organizations.
Implementation of the executive orders — two aimed at diversity, equity, and inclusion along with one targeting the transgender community — will be halted pending the outcome of the litigation challenging them.
“This is a critical win — not only for the nine organizations we represent, but for LGBTQ communities and people living with HIV across the country,” said Jose Abrigo, Lambda Legal’s HIV Project director and senior counsel on the case.
“The court blocked anti-equity and anti-LGBTQ executive orders that seek to erase transgender people from public life, dismantle DEI efforts, and silence nonprofits delivering life-saving services,” Abrigo said. “Today’s ruling acknowledges the immense harm these policies inflict on these organizations and the people they serve and stops Trump’s orders in their tracks.”
Tigar wrote, in his 52-page decision, “While the Executive requires some degree of freedom to implement its political agenda, it is still bound by the constitution.”
“And even in the context of federal subsidies, it cannot weaponize Congressionally appropriated funds to single out protected communities for disfavored treatment or suppress ideas that it does not like or has deemed dangerous,” he said.
Without the preliminary injunction, the judge wrote, “Plaintiffs face the imminent loss of federal funding critical to their ability to provide lifesaving healthcare and support services to marginalized LGBTQ populations,” a loss that “not only threatens the survival of critical programs but also forces plaintiffs to choose between their constitutional rights and their continued existence.”
The organizations in the lawsuit are located in California (San Francisco AIDS Foundation, Los Angeles LGBT Center, GLBT Historical Society, and San Francisco Community Health Center), Arizona (Prisma Community Care), New York (The NYC LGBT Community Center), Pennsylvania (Bradbury-Sullivan Community Center), Maryland (Baltimore Safe Haven), and Wisconsin (FORGE).
U.S. Federal Courts
Judge blocks Trump’s order for prison officials to withhold gender affirming care
ACLU represents plaintiffs in the case
A federal judge on Tuesday temporarily blocked the enforcement of President Donald Trump’s executive order compelling officials with the Bureau of Prisons to stop providing gender-affirming hormone therapy and accommodations to transgender people.
News of the order by Judge Royce Lamberth of the U.S. District Court for the District of Columbia, a Republican appointed by former President Ronald Reagan, was reported in a press release by the ACLU, which is representing plaintiffs in the litigation alongside the Transgender Law Center.
Pursuant to issuance of the executive order on Jan. 20, the the BOP announced that that “no Bureau of Prisons funds are to be expended for any medical procedure, treatment, or drug for the purpose of conforming an inmate’s appearance to that of the opposite sex,” while also prohibiting clothing and commissary items the agency considers incongruous with a person’s birth sex, and requiring all BOP staff to misgender transgender people.
Two transgender men and one transgender woman, each diagnosed with gender dysphoria by prison officials and prescribed hormone therapy, were either informed that their treatment would soon be suspended or were cut off from their treatment. On behalf of America’s 2,000 or so transgender inmates, they filed a class action lawsuit against the Trump administration and BOP in March.
The ACLU noted that while Lamberth’s order did not address surgeries, it did grant the plaintiff’s motion for a class certification and extended injunctive relief to the full class, which encompasses all persons who are or will be incarcerated in BOP facilities and have a current medical diagnosis of gender dysphoria or who receive that diagnosis in the future,” per the press release.
“Today’s ruling is made possible by the courageous plaintiffs who fought to protect their rights and the rights of transgender people everywhere,” said Shawn Thomas Meerkamper, managing attorney at the Transgender Law Center. “This administration’s continued targeting of transgender people is cruel and threatens the lives of all people. No person—incarcerated or not, transgender or not—should have their rights to medically necessary care denied. We are grateful the court understood that our clients deserve basic dignity and healthcare, and we will continue to fight alongside them.”
“Today’s ruling is an important lifeline for trans people in federal custody,” said Michael Perloff, senior staff attorney at the ACLU of D.C. “The ruling is also a critical reminder to the Trump administration that trans people, like all people, have constitutional rights that don’t simply disappear because the president has decided to wage an ideological battle.”
U.S. Federal Courts
Immigration judge dismisses Andry Hernández Romero’s asylum case
Gay makeup artist from Venezuela ‘forcibly removed’ to El Salvador in March
An immigration judge on Tuesday dismissed the asylum case of a gay makeup artist from Venezuela who the U.S. “forcibly removed” to El Salvador.
The Immigrant Defenders Law Center represents Andry Hernández Romero.
The Los Angeles-based organization in a press release notes Immigration Judge Paula Dixon in San Diego granted the Department of Homeland Security’s motion to dismiss Hernández’s case. A hearing had been scheduled to take place on Wednesday.
Hernández asked for asylum because of persecution he said he suffered in Venezuela because of his sexual orientation and political beliefs. NBC News reported Hernández pursued his case while at the Otay Mesa Detention Center in San Diego.
The Trump-Vance administration in March “forcibly removed” Hernández and other Venezuelans from the U.S. and sent them to El Salvador.
The White House on Feb. 20 designated Tren de Aragua, a Venezuelan gang, as an “international terrorist organization.”
President Donald Trump on March 15 invoked the Alien Enemies Act of 1798, which the Associated Press notes allows the U.S. to deport “noncitizens without any legal recourse.” Hernández is one of the lead plaintiffs in a lawsuit that seeks to force the U.S. to return those sent to El Salvador under the 18th century law.
The Immigrant Defenders Law Center says officials with U.S. Immigration and Customs Enforcement and U.S. Customs and Border Protection claimed Hernández is a Tren de Aragua member because of his tattoos. Hernández and hundreds of other Venezuelans who the Trump-Vance administration “forcibly removed” from the U.S. remain at El Salvador’s Terrorism Confinement Center, a maximum-security prison known by the Spanish acronym CECOT.
Homeland Security Secretary Kristi Noem earlier this month told gay U.S. Rep. Robert Garcia (D-Calif.) during a House Homeland Security Committee hearing that Hernández “is in El Salvador” and questions about his well-being “would be best made to the president and to the government of El Salvador.” Garcia, along with U.S. Reps. Maxwell Alejandro Frost (D-Fla.), Maxine Dexter (D-Ore.), and Yassamin Ansari (D-Ariz.), were unable to meet with Hernández last month when they traveled to the Central American country.
“DHS is doing everything it can to erase the fact that Andry came to the United States seeking asylum and he was denied due process as required by our Constitution,” said Immigrant Defenders Law Center President Lindsay Toczylowski on Thursday in the press release her organization released. “We should all be incredibly alarmed at what has happened in Andry’s case. The idea that the government can disappear you because of your tattoos, and never even give you a day in court, should send a chill down the spine of every American. If this can happen to Andry, it can happen to any one of us.”
Toczylowski said the Immigrant Defenders Law Center will appeal Dixon’s decision to the Board of Immigration Appeals, which the Justice Department oversees.
The Immigrant Defenders Law Center, the Human Rights Campaign, and other groups on June 6 plan to hold a rally for Hernández outside the U.S. Supreme Court. Protesters in Venezuela have also called for his release.
“Having tattoos does not make you a delinquent,” reads one of the banners that protesters held.
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