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Judge Eyes Delaying Abortion Pill Case Until Roe Ruling (1)

June 8, 2022, 6:07 PMUpdated: June 8, 2022, 8:18 PM

A federal judge in Mississippi is weighing whether a pending US Supreme Court decision on the fate of Roe v. Wade should affect the timeline of a separate case over the state’s abortion pill restrictions.

Judge Henry T. Wingate of the US District Court for the Southern District of Mississippi said in a hearing Wednesday that he plans to decide “in the very near future” how to proceed with a lawsuit from generic mifepristone manufacturer GenBioPro against Mississippi State Health Officer Thomas Dobbs.

GenBioPro argues that the Food and Drug Administration’s regulations for dispensing and prescribing the abortion pill preempt the state’s stricter requirements, including that a licensed physician prescribe it in person. Dobbs wants the court to toss the claims.

Wingate, during a hearing on the motion to dismiss, asked how a high court decision on abortion would affect this case, and said he’s “not sure yet” whether to delay the matter.

A decision in the Mississippi mifepristone case could set a roadmap for the Biden administration and others seeking to challenge state abortion pill restrictions that go beyond what the FDA has deemed necessary. Several states require that a licensed physician prescribe mifepristone, even though the FDA has said it is still safe when prescribed by any certified health provider, including physician assistants and nurse practitioners.

Ken Parsigian, a partner at Latham & Watkins LLP representing GenBioPro, said Wednesday that even if the Supreme Court overturns Roe v. Wade, it “will have absolutely no effect on this decision whatsoever.”

He added that GenBioPro’s lawsuit deals with an FDA-approved medicine, and not issues of privacy at the center of Dobbs v. Jackson Women’s Health Organization, a Mississippi appeal that seeks to overturn Roe. The state law at issue in the high court case bans nearly all abortions after 15 weeks of pregnancy.

Doug Miracle, who works in the civil litigation division of Mississippi’s attorney general office, argued that the impact of a decision in Dobbs “will absolutely depend on what the opinion says.”

GenBioPro’s lawsuit deals closely with abortion, making it “intertwined” with the case currently before the Supreme Court, Miracle said. “This is not a straightforward preemption case,” he said.

Mifepristone, together with another medication called misoprostol, can be used to end a pregnancy within 70 days of a person’s last menstrual cycle. The drug is manufactured by GenBioPro and brand-name producer Danco Laboratories, and is subject to a risk evaluation and mitigation strategy—a drug safety program that the FDA can use to make sure the benefits of a medication outweigh its risks.

Legal Standing

GenBioPro alleges that Mississippi’s additional requirements severely burden its ability to provide mifepristone to patients.

Dobbs said in his motion that the case should be dismissed because GenBioPro is “attempting to assert the legal rights of third-party health-care providers and women,” which the company “has no standing to do.”

He also argued that the “police power to protect the health and safety of its citizens has been traditionally recognized as one of the most fundamental aspects of State sovereignty under our federal system of government.”

Miracle argued Wednesday that GenBioPro’s claims of personal injury are “speculative,” and that it “would be a different case” if the state had explicitly banned all medication abortion.

GenBioPro has roughly 60% of the mifepristone market, according to Parsigian, and Planned Parenthood Southeast said in conversations with the manufacturer that it won’t buy mifepristone from them to distribute in the state due to the dispensing restrictions.

“The fact that the number one player in the market” is not able to sell in Mississippi “is not speculation,” Parsigian said. “That’s what happens when you make it virtually impossible for a company to sell their product in the state.”

He also argued that the restrictions have forced patients to seek out medication abortion online, including through illicit markets. He cited a 2020 study published in the American Journal of Public Health that listed Mississippi as the state with the most demand for self-managed medication abortion through telemedicine. The study was based on online requests examined over a 10-month period from 2017 to 2018.

Parsigian said that a ruling in favor of GenBioPro would only deal with Mississippi’s current prescribing restrictions on the drug, and wouldn’t “prevent Mississippi from taking additional steps that are consistent with FDA’s regulations.”

The case is GenBioPro, Inc. v. Dobbs, S.D. Miss., No. 3:20-cv-00652, hearing 6/8/22.

(Updated with additional reporting throughout.)

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editor responsible for this story: Alexis Kramer at akramer@bloomberglaw.com