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Wednesday December 04, 2024
(WASHINGTON) -- Medical treatments for transgender children, endorsed by major American medical associations and safely used for decades, hang in the balance at the U.S. Supreme Court on Wednesday as the Biden administration and three families with transgender teenagers ask the justices to strike down a state law banning some gender-affirming care for kids.
The landmark case -- U.S. v. Skrmetti -- comes from Tennessee, which is among 26 states that have moved to prohibit administration of puberty-blocking medication and hormone therapy to minors who seek to identify with, or live as, a gender identity inconsistent with his or her sex at birth.
Oral arguments, which began just after 10 a.m., mark the first time the nation's highest court has openly considered a state law targeting transgender people. It is also the first time an openly transgender litigator, ACLU attorney Chase Strangio, is arguing a case in the Supreme Court chamber.
The historic hearing thrusts the justices to the forefront of a cultural debate that has sharply divided the country and tested the limits of science and parental rights.
The outcome of the case could determine access to health care for hundreds of thousands of trans teens and more broadly influence how communities treat transgender people in hospitals, schools and on sports fields.
The government argues that Tennessee's SB1, which was enacted in March 2023, violates the Constitution's Equal Protection clause because it discriminates on the basis of sex to decide who can receive otherwise legal medical treatments available to youth.
"Put simply, an adolescent assigned female at birth cannot receive puberty blockers or testosterone to live as a male, but an adolescent assigned male at birth can," the administration wrote in its brief to the court.
The Tennessee law expressly allows minors who are not transgender to receive gender-affirming treatments to address a "congenital defect, precocious puberty, disease, or physical injury."
Denying discrimination, the state argues its law is a reasonable regulation of medical treatment based on its purpose, meant to protect children from potential long-term health risks and possible irreversible changes to the body.
The law's Republican sponsors claim that contradictory scientific evidence and documented regret among some young people who have transitioned both warrant caution in developing standards of care.
The law also cites a "compelling interest in encouraging minors to appreciate their sex, particularly as they undergo puberty" and preventing them from becoming "disdainful of their sex." The government says the text proves an intent to enforce gender conformity.
Hundreds of Tennessee transgender children were receiving treatments before SB1 was enacted, legislators concluded. It is not known how many suffered alleged harm.
The plaintiffs in the case include 16-year-old LW and her parents Brian and Samantha Williams of Nashville. After several years of successful hormone therapy, LW now has to travel out of state to continue treatments she says have dramatically improved her quality of life.
"I feel normal now," LW said in an exclusive interview with ABC News last month.
"Our state legislature had made such a big deal out of parents rights during COVID, about masks and vaccines -- that that's for parents to decide these medical decisions for their children," noted Samantha Williams. "And then, they made this medical decision for our child."
Nationwide, an estimated 300,000 Americans ages 13 to 17 identify as transgender, according to the Williams Institute at UCLA School of Law. Of those, nearly 100,000 live in states that have banned access to gender-affirming medical treatments for minors.
"It's a case of enormous significance that presents fundamental questions about the scope of state power to regulate medical care for minors, of the rights of parents to make medical decisions for their children⊠and the level of scrutiny that courts should apply to laws that discriminate against transgender people in general," said Deepak Gutpa, a veteran Supreme Court litigator. "This is a major, major constitutional civil rights issue."
More than 60% of Americans say they oppose law banning certain types of gender-affirming medical treatment for minors, according to Gallup.
Major American medical associations have endorsed the treatments for more than a decade as part of "individually tailored interventions" to support trans kids and affirm their sense of self. Not all transgender children seek medical care to facilitate transition to another sex.
"It needs to be part of a very deliberate process that involves medical specialists, who are expert at doing this, and, again, are following the science," said Dr. Ben Hoffman, a pediatrician and president of the American Academy of Pediatrics. "It all begins and ends with science. This is not about any sort of agenda."
Clinical practice guidelines from the American Endocrine Society, based on more than 260 research studies, recommend the use of puberty-delaying medications and waiting until a child reaches adulthood to consider gender-affirming surgery.
The American Academy of Pediatrics says the effects of puberty blockers are not permanent if treatment is discontinued. Many effects of hormone therapy can also be reversed. Long-term risks may include fertility challenges and possible harm to bone density, but the group says those risks require further study.
In contrast to the U.S. medical establishment, several European countries, including the United Kingdom, have reversed course on the use of gender-affirming treatments as a standard-of-care for transgender children, citing insufficient scientific evidence of long-term benefits.
"When you look at the totality of the medical research, to me there is more than enough uncertainty and evidence of bad outcomes for kids who've gone through these treatments when they reach the later stages in life," said Tennessee Senate GOP Leader Jack Johnson.
A federal district court sided with the plaintiffs, temporarily halting enforcement of SB1, but the Sixth Circuit U.S. Court of Appeals reversed. The panel of judges concluded Tennessee had a rational basis for enacting the law.
"Kind of the whole ballgame in the case is the debate about whether there actually is discrimination on the basis of sex," said Erin Murphy, a Supreme Court litigator and former clerk to Chief Justice John Roberts.
"It's really not," Murphy argued. "To say providing testosterone to a biological boy and biological girl is the same thing because testosterone is involved -- it's a different treatment that has different risks."
David Cole, former legal director of the American Civil Liberties Union, which is representing the Williams family, says the court's conservative majority will have to confront the legacy of its decision.
"I think there's no question in 25 years that the court will have recognized that treating people differently because their gender identity is sex discrimination," Cole said.
"The question is whether the court wants to write a decision will be overturned, you know, in the course of the next 10 years or 15 years," he said, "or whether it wants to recognize what is going on, which is sex discrimination."
A decision in the case is expected by the end of June 2025.
Copyright © 2024, ABC Audio. All rights reserved.
(WASHINGTON) -- The Supreme Court on Monday was divided over whether the Food and Drug Administration had unlawfully rejected millions of flavored e-cigarettes for approved sale in U.S. over concerns about nicotine addiction among young people.
During oral arguments in a case that could have a significant impact on public health, the justices grappled with tobacco industry claims that the government had given unclear and shifting requirements for new product applications and failed to provide proper notice to the companies.
"FDA switched its position on what studies were required" to show that the products have benefits to existing smokers that offset risks to youth, argued Eric Heyer, the attorney representing vape manufacturers Triton Distribution and Vapetasia, which are seeking a green light to market e-liquids such as âJimmy the Juice Man Peachy Strawberryâ and âIced Pineapple Express.â
Federal law requires sellers of new nicotine products to provide regulators with scientific evidence to show that the products would promote public health, but the statute does not spell out specifically what evidence is necessary and sufficient. The FDA's guidance on how to meet that requirement is at the center of the case.
"Their argument is that the guidance were actually a moving target, that either they weren't clear or you changed the guidance as time went on," said Justice Clarence Thomas, who appeared sympathetic to vape manufacturers.
"That is their argument," replied Biden administration lawyer Curtis Gannon, representing the FDA, adding, "But I think that the key point is that they knew from the statute that they needed to be making this comparison about what the benefits were with respect to existing smokers and weighing that against the potential costs with respect to nonsmokers and attracting youth."
Justice Neil Gorusch suggested that the companies might not have been given "fair notice" of how they could comply with the law. "Wouldn't due process require an opportunity for notice and a hearing?" he asked Gannon.
E-cigarettes and vapes, which deliver nicotine without some of the harmful effects of smoking, have been booming in popularity. Kid-friendly flavors, such as fruit, candy, mint, menthol and desserts, are not approved by the FDA and are on the market illegally.
While vaping among youth is declining, more than 1.6 million children use the products, according to the Centers for Disease Control and Prevention. Nearly 90% of them consume illicit flavored brands.
Manufacturers have acknowledged that their products may appeal to youth but insist that a âgrowing body of scientific evidenceâ shows that âflavors are crucial to getting adult smokers to make the switch and stay away from combustible cigarettes.â
A federal appeals court sided with the companies last year, saying the agency had acted arbitrarily. If the Supreme Court upholds that ruling, it could clear the way for broader marketing and sale of flavored nicotine products.
The Court's three liberal justices all seemed to share the government's view that FDA did not illegally move the goal posts during the process and that the companies simply lacked the evidence to win approval.
Since 2009, when Congress passed legislation aimed at curbing tobacco use among young people, the government has almost universally denied tobacco company requests to sell flavored nicotine e-liquids, citing risks of addiction among minors.
The FDA said the two companies in this case provided insufficient evidence that the benefits of their flavored e-products in helping tobacco smokers quit exceed the dangers of hooking children.
"I'm so totally confused," Justice Sonia Sotomayor told Heyer. "What [FDA] said is what you provided wasn't sufficient."
Justice Ketanji Brown Jackson said she was "baffled" by Heyer's argument because the FDA had explicitly articulated its standard.
"I guess I'm not really seeing what the surprise is here, or what the change is here," said Justice Elena Kagan. "There's just not a lot of mystery here about what FDA was doing. You might disagree with that, because you think that, in fact, the world of 40-year-olds really wants to do blueberry vaping, but you can't say that FDA hasn't told you all about what it's thinking in this respect."
Justice Brett Kavanaugh, who could be a critical vote in the case, signaled sympathy to the industry's complaint about discretionary government regulation but suggested he wasn't convinced FDA had acted unreasonably.
"If the agency says [your claims of benefits to adult smokers] that doesn't outweigh the harm to youth, we've reviewed everything, we're aware of everything, of course they're aware of everything that's out there, that's kind of the end of it, isn't it?" Kavanaugh asked.
Even if they lose the case, several justices noted, the vape manufacturers could reapply for approval with the FDA in a new application.
While the first Trump administration had taken a hard line against the marketing and sale of sweet and candy-flavored vapes, president-elect Donald Trump said during the campaign that he wants to "save" flavored vapes.
"We don't know exactly what that's going to look like," said Heyer. But, he added, that his clients "can't afford to wait that out."
Nearly a quarter of high school students who use e-cigarettes consume illicit menthol-flavored varieties, according to the 2023 National Youth Tobacco Survey.
Josie Shapiro, the 2024 national youth ambassador for the Campaign for Tobacco-Free Kids who testified before Congress on the dangers of nicotine addiction, said illicit flavored vapes hooked her at age 14.
âI think that by marketing any sort of flavored product as bubble gum or any of the genres of candy, it's going to catch the eyes of children,â Shapiro said. âI'm still addicted, and I'm still trying to fight my addiction. Honestly, the FDA needs to regulate all flavored tobaccos to flavor âtobaccoâ products and get them off the market.â
Public health experts have credited the FDAâs restrictions on flavored nicotine products with helping to drive down the number of teenagers who vape gradually from an âepidemicâ level just five years ago.
The case, Food and Drug Administration v. Wages and White Lion Investments, LLC, will be decided before the end of the Supreme Courtâs term in June 2025.
ABC Newsâ Patty See contributed to this report.
Copyright © 2024, ABC Audio. All rights reserved.
(WASHINGTON) -- With e-cigarettes and flavored vapes booming in popularity, the Supreme Court on Monday will examine whether the Food and Drug Administration unlawfully blocked the marketing and sale of more than a million new sweet and candy-flavored nicotine products in recent years.
The case comes as kid-friendly flavors, such as fruit, candy, mint, menthol and desserts, which are not approved by the FDA and are on the market illegally, have been fueling an explosion in retail sales of e-cigarettes.
While vaping among youth is declining, more than 1.6 million children use the products, according to the Centers for Disease Control and Prevention. Nearly 90% of them consume illicit flavored brands.
Two manufacturers of flavored nicotine-laced e-liquids such as âJimmy the Juice Man Peachy Strawberryâ and âIced Pineapple Expressâ sued the FDA after their product applications were rejected, alleging regulators imposed unclear and unreasonable requirements to win approval.
Triton Distribution and Vapetasia acknowledged that their products may appeal to youth but insisted that a âgrowing body of scientific evidenceâ shows that âflavors are crucial to getting adult smokers to make the switch and stay away from combustible cigarettes.â
A federal appeals court sided with the companies last year, saying the agency had acted arbitrarily. If the Supreme Court upholds that ruling, it could clear the way for broader marketing and sale of flavored nicotine products.
Since 2009, when Congress passed legislation aimed at curbing tobacco use among young people, the government has almost universally denied tobacco company requests to sell flavored nicotine e-liquids, citing risks of addiction among minors.
Under federal law, companies must provide the FDA with reliable and robust evidence to show that the products would promote public health and that, on balance, the benefits to adult smokers would outweigh the risks of youth addiction.
The FDA has said the two companies in this case provided insufficient evidence that the benefits of their flavored e-products in helping tobacco smokers quit exceed the dangers of hooking children.
âIf you ask adults who smoke if they were to switch to e-cigarettes what kind of flavors are they interested in, the majority of responses are tobacco flavor. If you ask kids, they like the fruit or candy flavor,â said Caroline Cecot, an administrative law expert at George Washington University Law School. âThis was a big part of what the FDA was sort of thinking about. And we have this evidence.â
Nearly a quarter of high school students who use e-cigarettes consume illicit menthol-flavored varieties, according to the 2023 National Youth Tobacco Survey.
Josie Shapiro, the 2024 national youth ambassador for the Campaign for Tobacco-Free Kids who testified before Congress on the dangers of nicotine addiction, said illicit flavored vapes hooked her at age 14.
âI think that by marketing any sort of flavored product as bubble gum or any of the genres of candy, it's going to catch the eyes of children,â Shapiro said. âI'm still addicted, and I'm still trying to fight my addiction. Honestly, the FDA needs to regulate all flavored tobaccos to flavor âtobaccoâ products and get them off the market.â
Public health experts have credited the FDAâs restrictions on flavored nicotine products with helping to drive down the number of teenagers who vape gradually from an âepidemicâ level just five years ago.
The case, Food and Drug Administration v. Wages and White Lion Investments, LLC, will be decided before the end of the Supreme Courtâs term in June 2025.
ABC Newsâ Patty See contributed to this report.
Copyright © 2024, ABC Audio. All rights reserved.