AMARILLO, Texas (KAMR/KCIT) — U.S. District Judge Matthew J. Kacsmaryk did not rule during Wednesday’s preliminary injunction hearing concerning a lawsuit over abortion medication which has drawn national attention, and instead said that an order surrounding the case would come “as soon as possible.”
Both the plaintiffs and defendants in the lawsuit argued their respective sides for more than four hours altogether, surrounding whether or not Kacsmaryk should rule to withdraw or suspend the FDA approval of Mifepristone under a preliminary injunction motion brought forward by the plaintiffs in the case.
This comes after Kacsmaryk, the judge for the U.S. District Court for the Northern District of Texas Amarillo Division, scheduled a hearing surrounding the plaintiffs’ motion on Wednesday morning, with each side originally expected to have two hours to argue their perspective on the case.
How did we get here?
According to previous reports by MyHighPlains.com, an Amarillo nonprofit organization, the Alliance for Hippocratic Medicine, filed a lawsuit in the U.S. District Court for the Northern District of Texas Amarillo Division against the United States Food and Drug Administration surrounding the approval of Mifepristone for chemical abortions.
The aim of the overall case for the plaintiffs is for Kacsmaryk to suspend the approval of the treatment and/or put back safeguards surrounding the treatment they allege was taken away. According to previous reports, the defendants stressed throughout court documents that the treatment is, and continues to be, effective and safe, as it was in 2000 when it was first approved for sale and under the revised conditions.
Many documents were filed after the initial arguments were established. For example, both sides argued surrounding the need for both a preliminary injunction hearing and a trial, or if both should be combined. However, according to previous reports, Kacsmaryk ruled last month that the two will be separate.
What did the plaintiffs argue during Wednesday’s hearing?
Kacsmaryk, as well as the full courtroom, first heard from the plaintiffs in this case. Erin Hawley, one of the attorneys for the plaintiffs, first argued the alleged harm that has occurred and would continue, if mifepristone continues to be on the market.
Hawley said that the doctors involved in the lawsuit, including Shaun Jester, a doctor in the Dumas area who is listed in the lawsuit as the medical director of the Moore County OB/GYN, have suffered harm after they treated women with emergency surgery to complete an abortion after they allegedly took mifepristone. Hawley argued that this hindered the doctors’ ability to practice, taking away their time and resources for other patients, as well as going against the doctors’ medical and religious guidelines.
The continuation of having mifepristone on the market could also cause future harm, Hawley argued, claiming that 5-8% of women who use mifepristone for a chemical abortion need the procedure completed through surgery.
The plaintiffs also brought forward arguments they made in numerous documents, including that mifepristone was initially illegally approved by the U.S. FDA in 2000, stating that the agency did not fully assess the safety of the drug at that time. Hawley also argued that the agency ignored a citizen petition twice since that initial approval, stating that the treatment is harming the individuals who take it.
During her argument, Hawley also alleged that the mailing of mifepristone violates section 1461 of the Comstock Act of 1873, which states “every article or thing designed adapted or intended for producing abortion… as well as every article, instrument, substance, drug, medicine or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion” cannot be mailed and delivered by the U.S. Postal Service.
Hawley argued against a memorandum opinion from the Department of Justice, released in late December 2022, that the referenced portion of the Comstock Act does not prohibit the mailing, delivery or receipt by mail of mifepristone “where the sender lacks the intent that the recipient of the drugs will use them unlawfully.” The opinion states because there are many ways individuals can use the treatment throughout the country, the mailing of mifepristone “is an insufficient basis for concluding that the sender intends them to be used unlawfully.”
Hawley said that this memo was a “broad application” of the act, absolving any person of shipping or the USPS of any fault if something goes wrong with the drug. Hawley argued that there is no consensus in the courts that support this interpretation of the act and could result in a “sea change” for federal and state relations, based on each states’ respective laws on abortion.
Erik Baptist, the plaintiffs’ co-counsel, then took the stand, mainly arguing against the inclusion of mifepristone in subpart H of Title 21 of the Code of Federal Regulations. According to the FDA’s website, that portion of the code gives accelerated approval for new drug products that were “studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefits to patients over existing treatments.”
Baptist argued that pregnancy should not be considered an illness by the FDA, stating that the agency relied on non-textual language for this approval in 2000. Baptist alleged that the word “illness,” in this case, is not ambiguous and the FDA’s interpretation is not accurate, stating that other kinds of drugs included in this portion of Title 21 include treatment for HIV/AIDS and cancer.
“One of these is not like the other,” Baptist said during the hearing.
In the rebuttal portion of the hearing, Baptist gave some clarity on what the plaintiffs would like to see out of the preliminary injunction request, stating that a suspension of the treatment is more of an injunctive measure than just taking it off the market, which is their long-term goal. However, the plaintiffs stressed that it would be most practical and reasonable that Kacsmaryk’s decision on this preliminary injunction would impact the availability of mifepristone for the entire country.
What did the defendants argue during Wednesday’s hearing?
After the plaintiffs made their argument, Julie Straus Harris, a member of the defendants’ legal team, said that the plaintiffs are bringing forward an “extraordinary request,” banning a drug that has been on the market for more than two decades. As they did with this approval, Straus Harris stressed that the FDA’s decision to approve mifepristone was based on science and that the plaintiffs are not likely to succeed in their claims.
Throughout their argument, the team stressed that much of the plaintiffs’ argument is not timely, stating that the 2000 approval of the drug cannot be reopened because of the time that has passed.
Surrounding the Comstock argument, the defendants also said that it was not relevant, since the concerns had not been raised until this particular lawsuit and that mifepristone continues to be presented in a manner consistent with the memorandum. However, the team stressed that the opportunity to receive the treatment via mail began during the COVID-19 pandemic in April 2020 and could end as soon as May, with the President Joe Biden Administration recently announcing that the COVID-19 public health emergency declaration is expected to end then.
In her particular argument, Straus Harris said that the FDA said that the drug was safe and effective, but does not require individuals to take it and prescribe it. Straus Harris also challenged the argument surrounding the physicians having standing in this case, stating that past exposure to alleged “harm” does not mean they are eligible for relief. She also said that future impacts to the physicians must be certain and threatened injuries “must be impending.”
In regards to the argument surrounding the states’ involvement in the abortion debate, she said that the FDA does not set national policy, which impacts state powers. But, Straus Harris claimed that through this lawsuit, the states are trying to change national policy, taking the FDA’s power away in determining what drugs are safe and effective, something that could be an issue in the future.
Daniel Schwei, the co-counsel for the defendant, stressed mifepristone’s effectiveness to Kacsmaryk, stating that it has been reported in multiple studies as more than 96% effective. Schwei also argued that pregnancy, as a serious and life-threatening condition, should be considered under subpart H of Title 21.
As the counsel for Danco Laboratories, the intervenor for the defendants in this case, Jessica Ellsworth claimed that the plaintiffs did not meet any of the requirements they needed for a preliminary injunction. According to previous reports, Danco Laboratories is the distributor of mifepristone.
During her argument, Ellsworth claimed that the plaintiffs built their arguments on speculative claims and hypothetical situations, stating that the treatment success was overwhelmingly positive and had a “consistent record of safety.”
Ellsworth said that an injunction in this case would cause Danco Laboratories “irreparable harm,” as the distributor of mifepristone, stating that the harm would be “certain, great and unrecoverable.” Ultimately, she said that patients should be allowed to have access to FDA-approved drugs after consultation with their healthcare provider.
Ultimately, an injunction would change the status quo, something that Straus Harris stresses that injunctions should not do, pending litigation. An injunction in this case, of any kind, would be extremely harmful to the public, not giving them the ability to access mifepristone in any state in the country. She said that every state has some sort of allowance surrounding the use of mifepristone and that it would undermine “the administrative framework” of the FDA, disrupting lawful access that is available in every state.
As of Wednesday afternoon, no further documents have been filed in this case, except for the electronic minute entry for Wednesday’s proceedings, which were reported to have lasted 4 hours and 15 minutes. Kacsmaryk is expected to make an order/opinion in this case “as soon as possible,” stating at the end of the hearing that he would take the matter under advisement.