Abortion Pill Dispute Centers on Central Question: Who Can Sue?

The parties in the fight over access to the abortion pill sharply disagree on whether anti-abortion doctors and groups can show they will suffer harm.The future of access to abortion pills may turn on a basic legal question: Who has a right to bring a lawsuit?Among the anti-abortion doctors involved in the case before the Supreme Court seeking to restrict availability of the pill is Dr. Christina Francis, who leads one of the anti-abortion groups suing the Food and Drug Administration to curtail distribution of the drug, mifepristone. She says she has experienced moral injury in treating patients who have taken the medication.Left unclear is whether that reaches a necessary threshold to bring a lawsuit in federal court — that the plaintiffs would suffer concrete harm if mifepristone remained widely available. Lawyers call this requirement standing.The F.D.A. “is forcing me to be complicit in an action that I have a moral objection to,” Dr. Francis, who is the head of the American Association of Pro-Life Obstetricians and Gynecologists, said in an interview on Friday.Those statements are echoed by other anti-abortion doctors involved in the lawsuit, including an Indiana doctor and state legislator who has called for stronger punishments for abortion providers and a California doctor who helped pioneer an abortion pill reversal method that has not been supported by scientific evidence.None of the anti-abortion doctors are required to prescribe the drugs or regularly treat abortion patients, but they say that they might encounter such patients in emergency rooms and that even treating side effects could cause them hardship. That, they say, would subject them to “enormous stress and pressure,” forcing them to choose between their consciences and their professional obligations.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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Supreme Court Expected to Decide on Abortion Pill Access: What to Know

The court is expected to weigh in on whether a commonly used pill, mifepristone, should remain widely available. Here is what’s at stake.WASHINGTON — The future of a commonly used abortion pill is at the center of a pitched legal battle before the Supreme Court, which is poised for the second time in a year to consider a major effort to severely limit access to abortion.The court is expected to decide by Friday night whether to grant the Biden administration’s emergency request to maintain the Food and Drug Administration’s approval of the pill, mifepristone, after a lower court limited the availability of the drug while an appeal moves forward.Justice Samuel A. Alito Jr. had paused the lower court’s ruling, but that freeze is set to expire at midnight. That means the justices are likely to decide before then, although they could extend the deadline or fail to act.When the justices overturned Roe v. Wade in June, the conservative majority said that the political branch, not the courts, should make decisions on abortion policy. But the issue has quickly made its way back to the Supreme Court, in a case that may have wide-ranging consequences even in states where abortion is legal, as well as for the F.D.A.’s regulatory authority over other drugs.Here’s what could happen next.What’s at stake?At issue is the availability of mifepristone, part of a two-drug regimen that now accounts for more than half of the abortions in the United States. More than five million women have used mifepristone to terminate their pregnancies in the United States, and dozens of other countries have approved the drug for use.Federal judges have questioned steps the F.D.A. has taken to expand the drug’s distribution, and the U.S. Court of Appeals for the Fifth Circuit, in New Orleans, imposed significant barriers to access last week, even as it said that it would allow the pill to remain on the market.Its decision essentially turns back the clock to 2016, when the F.D.A. added a series of guidelines that eased access to the pill. The restrictions would include blocking patients from receiving the drug by mail.Experts say removing the mail option would have significant consequences: Patients would have to take time off work, pay travel costs to get to a medical office and endure the stigma of going out in public to seek an abortion.The case could also pave the way for all sorts of challenges to the F.D.A.’s approval of medications. Legal experts said medical providers anywhere in the country might be enabled to challenge government policy that might affect a patient, as did the anti-abortion medical coalition that filed the original lawsuit against the pill.What happens next?When the Biden administration asked the Supreme Court to intervene, the application was assigned to Justice Alito, who oversees the Fifth Circuit. Justice Alito issued an order last Friday temporarily ensuring that the pill would remain widely available. The order was extended on Wednesday for another two days.That the court said Wednesday that it would give itself more time to consider the pill’s availability suggests that there may be disagreement among the justices.The justices are likely to decide whether to grant the administration’s request and have several options: ensure full access to mifepristone; impose significant restrictions, but stop short of sharply curtailing the drug’s availability; or suspend the pill from the market entirely, as a federal judge in Texas did in the original case.Whatever the justices do in the interim, the litigation will continue, probably in the appeals court. But the Supreme Court may take the unusual step of leapfrogging the appeals court and hearing the case itself right away.If the Supreme Court decides not to act on the Biden administration’s request, the Fifth Circuit’s decision remains in place.How did we get here?The dispute traces back to a lawsuit by an umbrella group of medical organizations and a few doctors who oppose abortion, challenging the F.D.A.’s approval of the pill more than two decades ago.The suit, filed in the Amarillo division of the U.S. District Court for the Northern District of Texas, came before a single federal judge: Matthew J. Kacsmaryk, a Trump appointee who is known as a longtime opponent of abortion.The plaintiffs have claimed that the pill is unsafe and that the agency’s approval process for the drug was flawed. The F.D.A. has forcefully countered those claims, contending that the drug is very safe and effective. It has cited a series of studies that show that serious complications are unusual and that less than 1 percent of patients need hospitalization.In his preliminary ruling, Judge Kacsmaryk said that the Food and Drug Administration had improperly approved the drug. But he gave the agency a week to seek emergency relief before his ruling would take effect.The Biden administration immediately appealed, and a divided three-judge panel of the U.S. Court of Appeals for the Fifth Circuit said that mifepristone could remain available as the lawsuit makes its way through the courts.But in addition to prohibiting sending the pills by mail, the panel blocked health care providers who are not doctors from prescribing them.What about the Washington State case?A second case about the abortion pill is proceeding in a federal courtroom in Washington State, after Democratic attorneys general of 17 states and the District of Columbia filed a lawsuit challenging the renewed F.D.A. restrictions on access to mifepristone.Less than an hour after Judge Kacsmaryk issued his ruling, Judge Thomas O. Rice of the U.S. District Court for the Eastern District of Washington, an Obama appointee, blocked the agency from curbing the availability of mifepristone in those 17 states and the District of Columbia. Although his order did not affect the entire country, the states in that lawsuit represent a majority of states where abortion remains legal.Legal experts say the direct conflict between the Washington State case and the Fifth Circuit’s decision to block specific parts of the F.D.A.’s rules for the abortion drug potentially increases the chances the Supreme Court will quickly address the merits of the dispute.Adam Liptak

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Abortion Pill Cases Appear Headed to the Supreme Court

One federal judge said the F.D.A.’s approval of the drug mifepristone was invalid, while another federal judge ordered the agency to keep the pill available. The legal fallout is just beginning.WASHINGTON — The dramatic dueling rulings by two federal district judges on Friday about access to a widely used abortion pill set up a lower court conflict that legal experts say will almost certainly send the dispute to the Supreme Court.“It really turbocharges the imperative for the Supreme Court to step in and to do so sooner rather than later,” said Stephen I. Vladeck, a law professor at the University of Texas at Austin.A federal judge in rural Texas issued a preliminary ruling on Friday invalidating the Food and Drug Administration’s 23-year-old approval of the abortion pill mifepristone, which could make it more difficult for patients across the country to access the medication. Less than an hour later, a federal judge in Washington State issued a ruling in another case that contradicted the Texas judge by ordering the F.D.A. to make no changes to the availability of the drug in the 18 states involved in that suit.For now, mifepristone continues to be available. The Texas judge, Matthew J. Kacsmaryk, an appointee of President Donald J. Trump, stayed his order for seven days to allow the F.D.A. time to seek intervention from an appeals court. But “the two decisions are in conflict and the conflict between them is not sustainable,” said Samuel L. Bray, a law professor at the University of Notre Dame.The Justice Department has already filed a notice that it is appealing the Texas ruling to the U.S. Court of Appeals for the Fifth Circuit.The department has not yet said whether it will file an appeal in the Washington State case. That lawsuit, filed against the F.D.A. by 18 Democratic attorneys general, challenged restrictions that the agency imposes on the prescribing and dispensing of mifepristone. The judge in the case, Thomas O. Rice, an appointee of President Barack Obama, did not lift the existing restrictions in his ruling on Friday but did order the F.D.A. not to do anything to limit current access to mifepristone.Mifepristone, the first pill in the two-drug medication abortion regimen, continues to be available for now.Allen G. Breed/Associated PressTypically, parties to cases will wait for an appeals court ruling before seeking emergency review from the Supreme Court, Mr. Vladeck said. But the Justice Department could ask the highest court to examine the case even sooner.“Formally, the Supreme Court can step in literally the moment D.O.J. files an appeal in the Fifth Circuit,” he said.As startling as the two rulings are, legal experts said dueling injunctions were not unheard-of and that the courts were able to handle them. “Our judicial system, the way it’s set up, it expects there will be conflicts with courts,” said Amanda Frost, a law professor at the University of Virginia School.When a direct conflict arises, courts can look for ways to narrow injunctions or for other solutions so that a party is not put into an impossible situation, she said. She cited a conflict in Florida over buffer zones at abortion clinics — areas kept clear from anti-abortion protesters to allow for unimpeded access by patients and doctors.In 1993, an injunction was issued in Florida to protect the Aware Woman Center for Choice — one of dozens of similar injunctions issued by state and local judges as abortion clinic operators sought help on how to deal with protests. In the fall of 1993, within weeks of each other, the Florida Supreme Court upheld the injunction and the U.S. Court of Appeals for the 11th Circuit, in Atlanta, struck it down.The Supreme Court took the case and upheld the core of the Florida state court injunction.In 2015, the issue of same-sex marriage led to another collision between courts. After a federal judge in Alabama declared the state’s prohibitions against same-sex marriage unconstitutional, the chief justice of the Alabama Supreme Court ordered the state’s probate judges not to issue marriage licenses to gay couples.Later that year, the Supreme Court ruled in Obergefell v. Hodges that the Constitution guaranteed a right to same-sex marriage.“In both cases, the Supreme Court steps into the issue,” Ms. Frost said. “There was a period of time during which there was a conflict, and the world didn’t fall apart. There is built into our system the understanding that there will be conflicts.”The federal judge in Texas, Matthew J. Kacsmaryk, an appointee of President Donald J. Trump, has written critically about Roe v. Wade and has long supported conservative causes.Senate Judiciary Committee, via Associated PressIf the Texas case reaches the Supreme Court, it could have implications far beyond access to abortion pills. The court could be asked to consider the effects of the Texas ruling not only for abortion but also for the F.D.A.’s authority to approve and regulate other drugs.Legal experts said Judge Kacsmaryk’s decision appeared to be the first time a court had ordered a drug’s approval to be revoked over the objection of the F.D.A. and that such a ruling could open the door to legal challenges against other drugs, such as vaccines, morning-after pills and other medications at the center of controversial issues. The ruling could also undermine the confidence that pharmaceutical companies place in the agency and influence the companies’ decisions about which drugs to develop and market, experts said.Because of those broader implications for federal authority and commercial interests, some legal experts said that all six conservative justices on the Supreme Court might not automatically uphold an order that would undercut the F.D.A.’s authority.Ameet Sarpatwari, a lawyer and assistant professor of medicine at Harvard Medical School, said that at least a couple of the conservative justices had judicial track records that suggested they might reject the Texas ruling because of “the sort of incredible disturbance of a district judge’s national injunction coupled with the extreme volatility that that’s going to lead to in the pharmaceutical market.”The Texas case has drawn additional scrutiny because it was filed in Amarillo, a single-judge division overseen by Judge Kacsmaryk. The judge has written critically about Roe v. Wade and has long supported conservative causes, including working for a conservative legal organization and serving on the board of an organization that seeks to offer pregnant women alternatives to abortion.The lead plaintiff, the Alliance for Hippocratic Medicine, is a consortium of anti-abortion groups that are not based in Amarillo, but the alliance was incorporated there in August 2022, not long after the Supreme Court overturned Roe v. Wade.Forum shopping, as it is called, is a common legal strategy used increasingly by both the right and the left to seek out a friendly judge or sympathetic court and press for a nationwide stay or injunction on a hot-button, partisan issue. Experts agree that these tactics have increased with political polarization.“There’s nothing inherently wrong about trying to find a court that you think is more inclined to your way of thinking about a case,” Mr. Bray said. “What makes these unusual is that, if in one case, you can win everything, then the stakes go up.”Concerns about Judge Kacsmaryk’s personal views on abortion playing a role in the case were heightened by the language in his ruling on Friday, legal experts said.“This does not read like a judicial opinion, it reads like an activist complaint,” Dr. Sarpatwari said. “There were several ways in which Judge Kacsmaryk could have come to the same outcome without this degree of vitriol and this reassessment of every action that the F.D.A. took.”He continued: “I think that actually weakens his case, because it shows a real lack of credibility in the sense that most of the F.D.A. decisions are very carefully backed by evidence and he’s opened himself up to tremendous criticism that he’s ignoring about 95 percent of the science that’s out there.”Greer Donley, an associate professor at the University of Pittsburgh School of Law, concurred with that assessment. “It’s pretty clear from the tone that he wasn’t attempting in any way to be evenhanded in his language,” she said. “He was showing his cards.”In his ruling, the judge often used the language of the anti-abortion movement.Mifepristone “ultimately starves the unborn human until death,” Judge Kacsmaryk wrote. He added that the F.D.A. mandated “a two-step drug regimen: mifepristone to kill the unborn human, followed by misoprostol to induce cramping and contractions to expel the unborn human from the mother’s womb.”

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