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Nancy Flanders
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Abortion Pill·By Carole Novielli
'Louisiana needs relief now': Oral arguments complete in state's abortion pill case against FDA
Oral arguments were heard today in the case of in Louisiana v. Food and Drug Administration (FDA) at the Fifth Circuit U.S. Court of Appeals in front of Justices Priscilla Richman, Stephen A. Higginson, and Dana M. Douglas.
The Solicitor General for the State of Louisiana presented oral arguments before the Fifth Circuit Court of Appeals. Also presenting were attorneys representing the FDA, abortion pill manufacturer Danco Laboratories, and abortion pill manufacturer GenBioPro.
The Plaintiffs were seeking a preliminary injunction to allow the State of Louisiana to enforce its pro-life laws while the lawsuit continues.
Louisiana argued that it has standing to bring the lawsuit due to the harms caused by the facilitation of illegal abortions in Louisiana, coupled with the impact on Louisiana’s Medicaid costs due to some women billing for abortion pill complications.
The state argues that it was targeted by the Biden administration, which vowed to do whatever possible to expand abortion following the 2022 Dobbs Supreme Court decision.
The state pointed out that, despite pill manufacturers' claims that the abortion pill has a stellar safety record, the FDA has put its 'head in the sand' when it comes to the reporting of complications, with non-fatal adverse events not required to be reported for the past decade.
This, coupled with deception in which women are urged to lie to ER personnel about complications, virtually guarantees that abortion pill complications have been underreported as well as misreported for many years, and may never be accurately reported.
The justices seemed critical of FDA representation's unwillingness to answer any questions unless related to the question of whether Louisiana had standing to sue.
The State of Louisiana's appeal requested "705 stay of the 2023 REMS" safety requirements on the abortion pill mifepristone, put in place by the FDA, which enabled mail-order and pharmacy dispensing of the drug. The State contended that removing the in-person dispensing requirement for the drug has caused irrevocable harm to the State, which has laws in place to protect preborn children from abortion.
"Today we were asking for a preliminary injunction so Louisiana can enforce its law as this lawsuit continues in the court," a media relations spokesperson from Alliance Defending Freedom (ADF), which is representing the Plaintiffs in the case, told Live Action News.
Following the hearing, Louisiana Attorney General Liz Murrill stated that the "arguments were very procedural... about standing, because this has been up to the Supreme Court and they issued a stay...."
Murrill reiterated that the FDA should reinstate the pre-Biden era rules, which she called "common sense":
"The evidence continues to show this is dangerous medication for women. There are a lot of contraindications to the use of this medication...
There's a Black Box warning on these pills for a reason. That's because women can become septic, they can hemorrhage... [or] require additional procedures...."
Louisiana Solicitor General Benjamin Aguiñaga began his oral argument before the Fifth Circuit by pointing to websites like Aid Access, which advertise their willingness to illegally ship abortion pills into the state.
Aguiñaga stated:
"You can buy an abortion pill online and get it by mail in Louisiana. The FDA has approved abortion pills by mail. Aid Access works with U.S. based abortion providers in so-called shield law states (this means that the states will protect the providers against legal action). Therefore, Aid Access can provide abortion services to all 50 U.S. states, including Louisiana."
Louisiana argued that it has standing to bring the lawsuit due to the harms caused by the facilitation of illegal abortions in Louisiana, coupled with the impact on Louisiana’s Medicaid costs due to some women billing for abortion pill complications.
But some justices seemed to question whether bad actors violating state laws were to blame, rather than the FDA's 2023 change.
Showing a clear bias, Talking Points Memo reported:
The state is arguing that the Food and Drug Administration is to blame for mifepristone being prescribed to Louisiana patients by blue state providers and entering the state through the mail, because it lifted the in-person dispensing requirement during the Biden administration.
It then had to add a couple more steps to find an injury, settling on the extra money it has to pay through Medicaid when certain patients who took that mifepristone go to the emergency room with complications.
The state also argues that the Biden administration was targeting Louisiana and its anti-abortion regime when it lifted the restrictions temporarily in 2021 and permanently in 2023.
Judge Stephen Higginson sounded skeptical, asking, "I'm looking at six different steps…and we're gonna attribute that to the federal government?" He questioned whether the FDA’s role is a reason abortion pills are flowing into Louisiana: “Those are state shield laws,” he said. “The government has nothing to do with the shield laws.”
But Aguiñaga argued that the state was impacted because some women who use the pills seek treatment for complications, WBRZ reported.
He cited an emergency room doctor who testified that ER personnel are seeing abortion pill complications "every day," with a majority of those patients being on Medicaid. The implication is that aftercare for abortion pill complications is likely being billed to Louisiana taxpayers. Those economic harms to the State were cause for the Court to be assured that Louisiana has standing in the case.
"Non zero is enough" when it comes to such cases in proving economic injury, Louisiana's attorney claimed.
The State contended the decision to expand access to the drug following the Dobbs ruling was paramount to "targeting" by Biden administration officials at the Department of Health and Human Services (HHS), which oversees the FDA.
Texas and Florida made similar claims, pointing to statements made by those in the Biden administration including HHS Secretary Becerra, who said the administration would "use every lever" to "defend" and "strengthen" the so-called 'right' to abortion.
Then-President Biden described the overturning of Roe as “an extreme decision" and said he was “committed to doing everything in his power” to “protect access” to abortion.
Louisiana wrote in 2025:
"That targeted assault on pro-life states worked as intended.
While in-person abortions virtually vanished from Louisiana, mifepristone-induced abortions—authorized by out-of-state doctors mailing FDA-approved mifepristone—skyrocketed.
Said one mifepristone mailer: “We really don’t change things unless we’re legally required to.”
“We’re confident people in ... every state ... will still be able to get abortion pills by mail,” said another.
Live Action News has documented that for decades, the abortion industry has participated in a scheme to hide abortion pill complications by advising women to present to emergency rooms and falsely claim that they are experiencing natural miscarriages.
This deception virtually guarantees that complications have been underreported as well as misreported for many years, and quite possibly will never be accurately reported.
Following Louisiana's attorney, the Government's attorney representing the FDA was criticized by the justices for being unwilling to address any specifics other than the standing issues at hand.
The judges seemed interested in claims that, prior to the removal of in-person dispensing, about "4%" of women visited the emergency room after taking the abortion pill — but after 2023 REMS changes removing that requirement, that percentage has risen to nearly 11%, according to claims made in a published analysis from the Ethics and Public Policy Center.
"I find that very unsatisfactory, that the agency [FDA] won't give an opinion as to its own regulations," said Higginson.
"FDA is conducting ongoing review," the FDA's legal counsel stated. "I can't predict where FDA will come out on the review."
GenBioPro's attorney claimed that about half of women presenting to the ER were only there for "reassurance" and were not admitted. However, this points to a larger problem: the REMS for mifepristone requires that prescribers have the ability to "provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others, and ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary."
If women are simply on their own and are reporting to ERs instead, this means manufacturers are not policing the prescribers properly, as required.
Women seeking "reassurance" should have been advised to contact the prescriber first rather than add to the volume of patients visiting often overcrowded emergency rooms.
An investigative report led by Senator Bill Cassidy has accused abortion pill manufacturers of being unaccountable, and of putting profit over safety by failing to decertify prescribers of the drug when they are out of compliance with the REMS.
Danco attorney Jessica Ellsworth claimed mifepristone (200mg)/Mifeprex has a "well established safety profile."
But that safety record is dependent upon what has been reported to the FDA Adverse Event Reporting System Database (FAERS), and in 2016, Obama's FDA changed the REMS to no longer require the reporting of non-fatal adverse events due to the abortion pill.
Couple that with Big Abortion's scheme to hide complications (even prior to 2016) by advising women not to return to the prescribing clinic to report adverse events, but to instead go to an ER and lie, and the burying of complications seems evident.
Louisiana previously claimed that the FDA is like an 'ostrich with its head in the sand' when it comes to the reporting of abortion pill complications, stating:
The deficiencies in the FAERS data are of FDA’s own making.
FDA had removed the requirement that abortion prescribers report serious adverse events other than death to FDA — this stripped the FAERS database of actual reporting of non-fatal adverse events....
Faced with that fact, the Fifth Circuit expressed disbelief that, “[a]fter eliminating th[e] adverse-event reporting requirement [in 2016], FDA turned around in 2021 and declared the absence of non-fatal adverse-event reports means mifepristone is ‘safe.’”“This ostrich’s-head-in-the-sand approach is deeply troubling,” it said, “especially on a record that, according to [FDA’s] own documents, necessitates a REMS program, a ‘Patient Agreement Form,’ and a ‘Black Box’ warning.” Id.
“And it suggests FDA’s actions are well outside the zone of reasonableness.”... For those reasons, the Fifth Circuit emphasized that “[i]t’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision”—and thus “it [is] unlikely that plaintiffs’ arbitrary-and capricious challenges will fail on the merits.”
GenBioPro's attorney claimed the FDA's decision to change the 2023 REMS was "richly supported," but he failed to mention — as Live Action detailed in our abortion pill white paper — that studies supporting safety claims were largely the product of pro-abortion authors publishing in pro-abortion journals, with some on the abortion pill manufacturers' payroll.
Louisiana AG Liz Murrill told media following the hearing:
"I think there are a lot of good reasons why the FDA had the REMS protocol in place. The abortion industry engaged in a continuous efforts to remove those protocols and the drug manufacturers are profiting mightily off the backs of aborted babies. It's disgusting."
Murrill added:
"What continues to really be astonishing to me is that Danco and GenBioPro are here advocating for their ability to continue to profit from these abortions, these illegal abortions in our state.
I continue to find that very troublesome that they make a lot of money off the illegal distribution of drugs in our state.
And that they should be joining with us to prevent the illegal distribution of those drugs in our state especially when we have evidence of women being poisoned with these drugs that have their brand names on them."
"Despite repeated invitations from the court, the FDA’s attorney refused to defend the FDA’s decision to authorize mail-order abortion drugs. Rightly so. It was, and is, indefensible on many levels," Erik Baptist, Senior Counsel at ADF told Live Action News in a written statement.
He added:
Louisiana needs relief now. As we heard in the argument today, nearly 1,000 unlawful abortion drugs are flooding the state every month. This is an undisputed fact.
Meanwhile, the Biden FDA’s action continues to jeopardize the safety of women.The FDA is not above the law. We hope the Courts will provide relief and allow the pro-life states like Louisiana to protect women and babies.
Listen below:
A date for an expected ruling was not published, but depending on the outcome, the case may return to the Supreme Court.
Live Action News is pro-life news and commentary from a pro-life perspective.
Our work is possible because of our donors. Please consider giving to further our work of changing hearts and minds on issues of life and human dignity.
Contact editor@liveaction.org for questions, corrections, or if you are seeking permission to reprint any Live Action News content.
Guest Articles: To submit a guest article to Live Action News, email editor@liveaction.org with an attached Word document of 800-1000 words. Please also attach any photos relevant to your submission if applicable. If your submission is accepted for publication, you will be notified within three weeks. Guest articles are not compensated (see our Open License Agreement). Thank you for your interest in Live Action News!
Nancy Flanders
·
Abortion Pill
Carole Novielli
·
Abortion Pill
Nancy Flanders
·
Abortion Pill
Bridget Sielicki
·
Abortion Pill
Nancy Flanders
·
Investigative
Carole Novielli
·Abortion Pill
Carole Novielli
·
Investigative
Carole Novielli
·
Abortion Pill
Carole Novielli
·Abortion Pill·By Carole Novielli
'Louisiana needs relief now': Oral arguments complete in state's abortion pill case against FDA
Oral arguments were heard today in the case of in Louisiana v. Food and Drug Administration (FDA) at the Fifth Circuit U.S. Court of Appeals in front of Justices Priscilla Richman, Stephen A. Higginson, and Dana M. Douglas.
The Solicitor General for the State of Louisiana presented oral arguments before the Fifth Circuit Court of Appeals. Also presenting were attorneys representing the FDA, abortion pill manufacturer Danco Laboratories, and abortion pill manufacturer GenBioPro.
The Plaintiffs were seeking a preliminary injunction to allow the State of Louisiana to enforce its pro-life laws while the lawsuit continues.
Louisiana argued that it has standing to bring the lawsuit due to the harms caused by the facilitation of illegal abortions in Louisiana, coupled with the impact on Louisiana’s Medicaid costs due to some women billing for abortion pill complications.
The state argues that it was targeted by the Biden administration, which vowed to do whatever possible to expand abortion following the 2022 Dobbs Supreme Court decision.
The state pointed out that, despite pill manufacturers' claims that the abortion pill has a stellar safety record, the FDA has put its 'head in the sand' when it comes to the reporting of complications, with non-fatal adverse events not required to be reported for the past decade.
This, coupled with deception in which women are urged to lie to ER personnel about complications, virtually guarantees that abortion pill complications have been underreported as well as misreported for many years, and may never be accurately reported.
The justices seemed critical of FDA representation's unwillingness to answer any questions unless related to the question of whether Louisiana had standing to sue.
The State of Louisiana's appeal requested "705 stay of the 2023 REMS" safety requirements on the abortion pill mifepristone, put in place by the FDA, which enabled mail-order and pharmacy dispensing of the drug. The State contended that removing the in-person dispensing requirement for the drug has caused irrevocable harm to the State, which has laws in place to protect preborn children from abortion.
"Today we were asking for a preliminary injunction so Louisiana can enforce its law as this lawsuit continues in the court," a media relations spokesperson from Alliance Defending Freedom (ADF), which is representing the Plaintiffs in the case, told Live Action News.
Following the hearing, Louisiana Attorney General Liz Murrill stated that the "arguments were very procedural... about standing, because this has been up to the Supreme Court and they issued a stay...."
Murrill reiterated that the FDA should reinstate the pre-Biden era rules, which she called "common sense":
"The evidence continues to show this is dangerous medication for women. There are a lot of contraindications to the use of this medication...
There's a Black Box warning on these pills for a reason. That's because women can become septic, they can hemorrhage... [or] require additional procedures...."
Louisiana Solicitor General Benjamin Aguiñaga began his oral argument before the Fifth Circuit by pointing to websites like Aid Access, which advertise their willingness to illegally ship abortion pills into the state.
Aguiñaga stated:
"You can buy an abortion pill online and get it by mail in Louisiana. The FDA has approved abortion pills by mail. Aid Access works with U.S. based abortion providers in so-called shield law states (this means that the states will protect the providers against legal action). Therefore, Aid Access can provide abortion services to all 50 U.S. states, including Louisiana."
Louisiana argued that it has standing to bring the lawsuit due to the harms caused by the facilitation of illegal abortions in Louisiana, coupled with the impact on Louisiana’s Medicaid costs due to some women billing for abortion pill complications.
But some justices seemed to question whether bad actors violating state laws were to blame, rather than the FDA's 2023 change.
Showing a clear bias, Talking Points Memo reported:
The state is arguing that the Food and Drug Administration is to blame for mifepristone being prescribed to Louisiana patients by blue state providers and entering the state through the mail, because it lifted the in-person dispensing requirement during the Biden administration.
It then had to add a couple more steps to find an injury, settling on the extra money it has to pay through Medicaid when certain patients who took that mifepristone go to the emergency room with complications.
The state also argues that the Biden administration was targeting Louisiana and its anti-abortion regime when it lifted the restrictions temporarily in 2021 and permanently in 2023.
Judge Stephen Higginson sounded skeptical, asking, "I'm looking at six different steps…and we're gonna attribute that to the federal government?" He questioned whether the FDA’s role is a reason abortion pills are flowing into Louisiana: “Those are state shield laws,” he said. “The government has nothing to do with the shield laws.”
But Aguiñaga argued that the state was impacted because some women who use the pills seek treatment for complications, WBRZ reported.
He cited an emergency room doctor who testified that ER personnel are seeing abortion pill complications "every day," with a majority of those patients being on Medicaid. The implication is that aftercare for abortion pill complications is likely being billed to Louisiana taxpayers. Those economic harms to the State were cause for the Court to be assured that Louisiana has standing in the case.
"Non zero is enough" when it comes to such cases in proving economic injury, Louisiana's attorney claimed.
The State contended the decision to expand access to the drug following the Dobbs ruling was paramount to "targeting" by Biden administration officials at the Department of Health and Human Services (HHS), which oversees the FDA.
Texas and Florida made similar claims, pointing to statements made by those in the Biden administration including HHS Secretary Becerra, who said the administration would "use every lever" to "defend" and "strengthen" the so-called 'right' to abortion.
Then-President Biden described the overturning of Roe as “an extreme decision" and said he was “committed to doing everything in his power” to “protect access” to abortion.
Louisiana wrote in 2025:
"That targeted assault on pro-life states worked as intended.
While in-person abortions virtually vanished from Louisiana, mifepristone-induced abortions—authorized by out-of-state doctors mailing FDA-approved mifepristone—skyrocketed.
Said one mifepristone mailer: “We really don’t change things unless we’re legally required to.”
“We’re confident people in ... every state ... will still be able to get abortion pills by mail,” said another.
Live Action News has documented that for decades, the abortion industry has participated in a scheme to hide abortion pill complications by advising women to present to emergency rooms and falsely claim that they are experiencing natural miscarriages.
This deception virtually guarantees that complications have been underreported as well as misreported for many years, and quite possibly will never be accurately reported.
Following Louisiana's attorney, the Government's attorney representing the FDA was criticized by the justices for being unwilling to address any specifics other than the standing issues at hand.
The judges seemed interested in claims that, prior to the removal of in-person dispensing, about "4%" of women visited the emergency room after taking the abortion pill — but after 2023 REMS changes removing that requirement, that percentage has risen to nearly 11%, according to claims made in a published analysis from the Ethics and Public Policy Center.
"I find that very unsatisfactory, that the agency [FDA] won't give an opinion as to its own regulations," said Higginson.
"FDA is conducting ongoing review," the FDA's legal counsel stated. "I can't predict where FDA will come out on the review."
GenBioPro's attorney claimed that about half of women presenting to the ER were only there for "reassurance" and were not admitted. However, this points to a larger problem: the REMS for mifepristone requires that prescribers have the ability to "provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others, and ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary."
If women are simply on their own and are reporting to ERs instead, this means manufacturers are not policing the prescribers properly, as required.
Women seeking "reassurance" should have been advised to contact the prescriber first rather than add to the volume of patients visiting often overcrowded emergency rooms.
An investigative report led by Senator Bill Cassidy has accused abortion pill manufacturers of being unaccountable, and of putting profit over safety by failing to decertify prescribers of the drug when they are out of compliance with the REMS.
Danco attorney Jessica Ellsworth claimed mifepristone (200mg)/Mifeprex has a "well established safety profile."
But that safety record is dependent upon what has been reported to the FDA Adverse Event Reporting System Database (FAERS), and in 2016, Obama's FDA changed the REMS to no longer require the reporting of non-fatal adverse events due to the abortion pill.
Couple that with Big Abortion's scheme to hide complications (even prior to 2016) by advising women not to return to the prescribing clinic to report adverse events, but to instead go to an ER and lie, and the burying of complications seems evident.
Louisiana previously claimed that the FDA is like an 'ostrich with its head in the sand' when it comes to the reporting of abortion pill complications, stating:
The deficiencies in the FAERS data are of FDA’s own making.
FDA had removed the requirement that abortion prescribers report serious adverse events other than death to FDA — this stripped the FAERS database of actual reporting of non-fatal adverse events....
Faced with that fact, the Fifth Circuit expressed disbelief that, “[a]fter eliminating th[e] adverse-event reporting requirement [in 2016], FDA turned around in 2021 and declared the absence of non-fatal adverse-event reports means mifepristone is ‘safe.’”“This ostrich’s-head-in-the-sand approach is deeply troubling,” it said, “especially on a record that, according to [FDA’s] own documents, necessitates a REMS program, a ‘Patient Agreement Form,’ and a ‘Black Box’ warning.” Id.
“And it suggests FDA’s actions are well outside the zone of reasonableness.”... For those reasons, the Fifth Circuit emphasized that “[i]t’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision”—and thus “it [is] unlikely that plaintiffs’ arbitrary-and capricious challenges will fail on the merits.”
GenBioPro's attorney claimed the FDA's decision to change the 2023 REMS was "richly supported," but he failed to mention — as Live Action detailed in our abortion pill white paper — that studies supporting safety claims were largely the product of pro-abortion authors publishing in pro-abortion journals, with some on the abortion pill manufacturers' payroll.
Louisiana AG Liz Murrill told media following the hearing:
"I think there are a lot of good reasons why the FDA had the REMS protocol in place. The abortion industry engaged in a continuous efforts to remove those protocols and the drug manufacturers are profiting mightily off the backs of aborted babies. It's disgusting."
Murrill added:
"What continues to really be astonishing to me is that Danco and GenBioPro are here advocating for their ability to continue to profit from these abortions, these illegal abortions in our state.
I continue to find that very troublesome that they make a lot of money off the illegal distribution of drugs in our state.
And that they should be joining with us to prevent the illegal distribution of those drugs in our state especially when we have evidence of women being poisoned with these drugs that have their brand names on them."
"Despite repeated invitations from the court, the FDA’s attorney refused to defend the FDA’s decision to authorize mail-order abortion drugs. Rightly so. It was, and is, indefensible on many levels," Erik Baptist, Senior Counsel at ADF told Live Action News in a written statement.
He added:
Louisiana needs relief now. As we heard in the argument today, nearly 1,000 unlawful abortion drugs are flooding the state every month. This is an undisputed fact.
Meanwhile, the Biden FDA’s action continues to jeopardize the safety of women.The FDA is not above the law. We hope the Courts will provide relief and allow the pro-life states like Louisiana to protect women and babies.
Listen below:
A date for an expected ruling was not published, but depending on the outcome, the case may return to the Supreme Court.
Live Action News is pro-life news and commentary from a pro-life perspective.
Our work is possible because of our donors. Please consider giving to further our work of changing hearts and minds on issues of life and human dignity.
Contact editor@liveaction.org for questions, corrections, or if you are seeking permission to reprint any Live Action News content.
Guest Articles: To submit a guest article to Live Action News, email editor@liveaction.org with an attached Word document of 800-1000 words. Please also attach any photos relevant to your submission if applicable. If your submission is accepted for publication, you will be notified within three weeks. Guest articles are not compensated (see our Open License Agreement). Thank you for your interest in Live Action News!
Nancy Flanders
·Abortion Pill
Carole Novielli
·Abortion Pill
Nancy Flanders
·Abortion Pill
Bridget Sielicki
·Abortion Pill
Nancy Flanders
·Investigative
Carole Novielli
·Abortion Pill
Carole Novielli
·Investigative
Carole Novielli
·Abortion Pill
Carole Novielli
·