Thu. Oct 31st, 2024

a bottle of Misoprostol tablets are displayed at a family planning clinic on April 13, 2023 in Rockville, Maryland.

Misoprostol, used to treat post-delivery hemorrhages, will become a Schedule IV controlled dangerous substance in Louisiana effective Oct. 1 under a new law. The designation means the medicine will have to be securely stored, raising concerns among doctors who say they rely on immediate access to the medication in life-threatening situations. (Anna Moneymaker/Getty Images)

Health care workers and advocates filed a lawsuit Thursday against the state of Louisiana, on their own and on behalf of their patients, challenging Act 246, a new state law reclassifying mifepristone and misoprostol as controlled dangerous substances. 

The lawsuit was filed in 19th Judicial District Court in East Baton Rouge Parish against the state of Louisiana, Attorney General Liz Murrill, the state Board of Pharmacy and the state Board of Medical Examiners. The plaintiffs include the perinatal organization Birthmark Doulas, family physician Dr. Emily Holt, pharmacist Kaylee Self, and reproductive health advocates Nancy Davis and Kaitlyn Joshua, both of whom were denied pregnancy care in the state.

“This case is about the unconstitutional regulation of medications that people need for non-abortion reasons simply because those medications may also be used for an abortion,” the lawsuit said. 

It is the first lawsuit filed in response to the controversial law, which took effect Oct. 1. It targets mifepristone and misoprostol because they can both be used for medication abortion, although they each have multiple other uses. Additionally, elective abortions are almost entirely banned in the state and have been since the summer of 2022. 

“We are seeking to have this law invalidated because it violates the Louisiana Constitution in two separate ways,” says Ellie Schilling, one of the attorneys representing the plaintiffs.

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Schilling said her team is arguing the law violates the equal protection clause in the state constitution by discriminating against people on the basis of physical condition. People who need mifepristone and misoprostol — and those requesting, prescribing and filling the medications — are treated differently than people with similar medical conditions who need treatment with drugs with the same low-risk profile, she explained 

“In some cases, that discrimination is life-threatening,” the lawsuit reads.

Schilling said that because the drugs don’t have the potential to cause addiction and dependency, there’s no justification to make them Schedule IV drugs under the new law. 

The second argument plaintiffs make is that the process to approve the law didn’t comply with the Louisiana Constitution because the drugs were reclassified through an amendment to a bill about coerced abortion. Article III of the constitution prohibits any change to a bill that is not “germane” to its original version.   

“The original purpose of the legislation was to create a crime of coerced abortion,” Schilling said, “meaning to criminalize people providing an abortion-producing drug to someone else without their knowledge for the illegal purpose of causing an abortion without their consent. But the amendment is regulating those drugs when [they] are being prescribed and used for a totally valid legal purpose that is unrelated to abortion.”

Some Louisiana patients struggle to fill reproductive care prescriptions under new drug law

The amendments were “extremely problematic” because they were added late in the process, without any proper vetting to look into the potential impacts of the law, Schilling said. The amendments were added to the bill from state Sen. Thomas Pressly, R-Shreveport, during a House criminal justice committee meeting after it had passed the Senate and.

“Once introduced, the amendment was adopted by the committee within minutes and without any opportunity for the public or medical experts to weigh in on the propriety of such a drastic change to the bill or to the Uniform Controlled Dangerous Substances Law,” the lawsuit reads.

The amendments caused an outcry in the Louisiana medical community, with nearly 300 doctors signing a letter against the measure. The bill was signed into law by Gov. Jeff Landry in May and became Act 246. 

Its impact has already been felt across the state. Hospitals have changed their protocol for how they handle the medications now that they are controlled substances. 

Misoprostol, which is often used to help stop or prevent postpartum hemorrhage, has been pulled off obstetric hemorrhage carts and stored outside of labor and delivery rooms in passcode-protected locked compartments as doctors conduct drills to time what the delays mean to bleeding patients. Outpatient reproductive care procedures have also been affected, as patients report having a hard time filling prescriptions and local pharmacies change whether they dispense the medication at all.

“Act 246 harms patients who require misoprostol or mifepristone to treat their physical conditions, as well as the medical professionals seeking to provide timely, appropriate, and compassionate care,” the lawsuit says.

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In the lawsuit, the plaintiffs argue that a postpartum hemorrhage is as “severe and dangerous as a gunshot wound,” but that medications such as epinephrine and lidocaine are readily available to treat gunshot wounds and are not designated controlled dangerous substances.

The Birthmark Doula Collective is a newer opponent of the law. The New Orleans-based organization offers its services during pregnancy, childbirth and after labor, with a focus on marginalized communities. Louisiana is among the worst states in terms of maternal mortality and morbidity, with Black women disproportionately at risk of dying due to complications with childbirth.

While doulas cannot prescribe or administer misoprostol to their clients, the lawsuit states the Birthmark is worried Act 246 will injure their clients’ quality of care. They are also concerned about how delays in accessing misoprostol will increase the “trauma and danger of a postpartum hemorrhage

”Birthmark’s clients are hindered in advocating for their own rights because patients, for instance, cannot go to court to challenge a law while hemorrhaging,” the lawsuit says.  

Nancy Davis and Kaitlyn Joshua have both become reproductive health advocates after being denied pregnancy care under Louisiana’s abortion ban. 

After her fetus was diagnosed to be developing without a skull, Davis said she was denied care in Louisiana and had to travel to New York for an abortion. 

When Joshua went to two Baton Rouge-area hospital emergency rooms bleeding from a miscarriage, she said she was denied care. Joshua shared her story on the Democratic National Convention stage in August, and both she and Davis have traveled around the country recounting their story during Vice President Kamala Harris’ presidential campaign. 

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Dr. Emily Holt, a New Orleans family physician, is suing on her own and on behalf of her patients. She recently opened her own clinic and had planned on dispensing misoprostol and mifepristone on site, but she does not have a controlled substances license. 

In the lawsuit, Holt argues “it will likely be costly and administratively burdensome for her small clinic to comply with the necessary protocols.”

Kaylee Self, a Shreveport pharmacist involved in the lawsuit, is suing on behalf of her business, her customers and as a pregnant woman. The lawsuit includes her concerns over delays in care should she need access to misoprostol during her pregnancy or childbirth. As a pharmacist, Self claims Act 246 will force her to spend more of her time dealing with legal compliance and requirements rather than filling prescriptions for patients. 

In an interview, Schilling said that because controlled substances are also closely monitored, it could lead to criminal consequences for patients following their treatment plans with a lawful prescription. In particular, patients who take misoprostol to prevent ulcers take 100-200 micrograms four times a day, an amount that could flag the patient for additional inquiry. 

“When dealing with any increase in criminalization, [it often] disproportionately falls on Black and brown people, and Louisiana has a long history of that,” Schilling said.

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This is a developing story that will be updated with reaction from the defendants in the lawsuit.

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