Two federal court rulings last week over a medication commonly used in abortions have opened a slate of legal questions post-Dobbs.
On March 7, a Texas federal court pulled the Food and Drug Administration’s approval of mifepristone, a medication used for abortions. But for Colorado, the ban that takes effect Friday won’t impact residents thanks to a ruling out of a Washington federal court.
Mifepristone was approved by the FDA in 2000 and is the first of a two-pill treatment for abortions under 10 weeks. It’s also used to manage miscarriages. Data published last year by the Guttmacher Institute found that over half of abortions in 2020, 53%, were medicated, rather than procedural abortions, using mifepristone.
Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas on April 7 granted an injunction to stay the FDA’s Sept. 28, 2000 approval of mifepristone, finding its approval was rushed and incomplete.
The order doesn’t go into effect until April 14, seven days after it was issued, to allow the federal government to request emergency relief from the 5th Circuit Court of Appeals. U.S. Attorney General Merrick Garland in a press release April 7 said the Department of Justice plans to appeal to the ruling and on April 10 the DOJ filed an official notice of appeal to the 5th Circuit.
The Texas ruling came in response to a lawsuit filed in November 2022 by a group of doctors and medical associations asserting the FDA skirted numerous requirements leading up to its approval of mifepristone, and in the years since its approval the FDA made changes (like approving a generic version, reducing the number of office visits required and increasing its use from seven weeks to 10 weeks) that disregarded potential dangers of the medication.
Colorado’s attorney general said the Texas ruling is unprecedented.
“We’ve never seen a FDA ruling based on serious scientific analysis with 20 years of actual experience confirming that judgment to then be questioned later by a single district judge in what can only be called an extraordinarily problematic opinion,” said AG Phil Weiser who added Colorado has filed an amicus brief with the 5th Circuit in support of overturning the ruling.
On the same day, Judge Thomas Rice of the U.S. District Court for the Eastern District of Washington partially granted a request from 17 states and D.C. to prevent the FDA from “altering the status quo and rights” to access the drug in Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania and Washington D.C. The order does not affect states that weren’t involved in the court proceeding.
Colorado was part of the coalition of attorneys general that filed a lawsuit in February arguing the drug’s placement under the FDA’s risk evaluation and mitigation strategies category, which include medications with “serious safety concerns” and requires providers to meet additional requirements to administer them, is unduly burdensome, harmful and unnecessary to patients and providers.
Weiser said that when his office became aware of the Texas challenge and looked into mifepristone’s status with the FDA, they felt the current REMS category went too far in classifying the drug. “As it’s now turned out, that has given us a ruling holding in place a status quo and preventing Colorado from being affected adversely by this Texas court ruling,” said Weiser.
The two rulings were released less than 20 minutes apart, leaving questions about how they will interact. The DOJ on April 10 filed a motion for clarification with Rice in light of the Texas order requesting further information on how the FDA should comply with it if the injunction goes into effect.
District courts coming down on different sides of the same issue isn’t new, but Weiser said the two rulings are in a conflict that will need to be settled by appellate courts. “We believe, at this moment in time, the Washington ruling, the more protective of the two, governs,” he added.
Chelsea Augelli, a family law attorney and member of the Colorado Women’s Bar Association public policy committee, said that reproductive healthcare, including access to abortions, is a public policy topic CWBA has prioritized. While the Texas ruling won’t impact Colorado directly, Augelli said its impact on neighboring states may affect patients and providers here.
“We are providing abortion services for so many other citizens of other states that it’s even causing a backlog for women in Colorado to get an abortion,” said Augelli.
The U.S. Supreme Court overturned nearly 50 years of precedent in last summer’s Dobbs v. Jackson Women’s Health that struck down earlier holdings in Roe v. Wade and Planned Parenthood v. Casey. Both of those former rulings found states can’t ban or enact undue burdens on pre-viability abortions.
Since then, states have adopted numerous laws enshrining or banning abortion. Last year, Colorado lawmakers passed the Reproductive Health Equity Act codifying abortion access into state law.
Augelli said CWBA and other groups have advocated this session for additional bills to protect providers and patients receiving abortions in Colorado, including one to protect providers, create insurance coverage and ban centers that falsely advertise abortion services.
“The most recent legislation that was passed, really does address that. And I hope that other states join in that effort to provide this mutual protection to providers [and] patients,” said Augelli who added there’s a new slate of questions about the enforcement of abortion laws across state lines.
Weiser said the Texas lawsuit and court ruling are direct results of the Dobbs ruling and predicts it’s the first of many similar court challenges to reproductive health care including the morning-after pill and contraceptives. He said that while his office plans to take an active role in advocating for reproductive health care, the impacts of Dobbs go beyond courts.
“The problem that Dobbs has now unleashed is it has taken away rights that people have depended on and people believe in and it’s now up to the political process to establish that right,” said Weiser.