States Defend FDA's Abortion Pill Restrictions At 4th Circ.

By Kevin Stawicki
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Law360 (August 4, 2020, 6:38 PM EDT) -- Nearly a dozen states and the U.S. Food and Drug Administration are urging the Fourth Circuit to hit pause on an injunction that requires the agency to increase access to the so-called abortion pill, arguing that the U.S. Supreme Court's recent abortion ruling bolsters their case.

In an amicus brief filed Monday, Texas, Indiana and nine other states backed the FDA's recent request to undo the injunction that blocks the agency's restrictions on patients' ability to get Mifeprex, a pill that ends pregnancy at up to 10 weeks, at a retail pharmacy.

The lower court misapplied the Supreme Court's ruling in June Medical Services v. Russo , which struck down a Louisiana law requiring abortion providers to have admitting privileges at nearby hospitals, by relying on a cost-benefit test for abortion laws, the states said.

U.S. District Judge Theodore D. Chuang improperly used the cost-benefit balancing test rejected by Chief Justice John Roberts when he should have adhered to the test that considers whether the law imposed an "undue burden" on abortion access, the states said.

"A balancing test that would invalidate laws without a substantial obstacle lies outside common ground shared with the chief justice, and therefore does not control," Texas and the other states wrote in the brief.

Whether June Medical eliminated the cost-benefit test for abortion laws was a question that immediately arose after the justices decided the case in June. The Supreme Court created the test four years ago in Whole Woman's Health v. Hellerstedt , while simultaneously saying that the test had essentially existed since 1992, when the Supreme Court in Planned Parenthood v. Casey  barred laws that impose an "undue burden" on abortion access.

If the cost-benefit test no longer exists after June Medical, it will be easier for anti-abortion laws and regulations to withstand legal challenges, as some courts applying the test have found that many abortion laws lack significant medical benefits.

Monday's brief comes days after the FDA urged the Fourth Circuit on Thursday to put the injunction on pause as the appeal proceeds. Judge Chuang improperly determined that the FDA restrictions requiring patients to be handed the medication at a clinic or hospital from a health care provider who has preregistered with the drug's manufacturer were an "undue burden," the agency said in its brief.

"The court ignored that the requirements apply to a drug pertaining to just one method of abortion that is approved for just a subset of pregnant women (those through 10 weeks pregnant), and that another method of abortion is widely available," the agency wrote.

There's also no basis to conclude that the coronavirus pandemic necessitates dismantling the restrictions, the agency said, noting instead that the court "inappropriately compels FDA to increase access to a certain method of abortion during a global pandemic."

Julia Kaye, a staff attorney at the American Civil Liberties Union Foundation who represents the physician groups, said in an email Tuesday that given the resurgence of COVID-19, it is "unconscionable that the Trump Administration and 11 states would continue their quest to subject people seeking abortion care and their families to entirely unnecessary viral risks."

"The administration and the states supporting them should focus on getting COVID-19 under control, not exposing patients to needless risks just to score political points," Kaye said.

The suit, filed by the American College of Obstetricians and Gynecologists and other physician groups in May, claims that the restrictions violate a patient's rights to equal protection of the law under the U.S. Constitution and that COVID-19 only heightened the risk for women seeking the pill.

"Despite this national medical consensus, defendants have maintained the requirement during the pandemic, forcing patients to put themselves at increased risk of contracting COVID-19 as a condition of obtaining abortion or miscarriage care and needlessly raising exposure risks for clinicians and other health care staff," the physicians association said in the complaint.

Counsel and representatives for the states and the FDA did not immediately respond to requests for comment Tuesday.

The physician groups are represented by Julia Kaye, Anjali Dalal, Ruth Harlow, Rachel Reeves, Jennifer Dalven and Lorie Chaiten of the American Civil Liberties Union Foundation and John A. Freedman, R. Stanton Jones, David J. Weiner, Jocelyn A. Wiesner, Andrew Tutt and Gina Colarusso of Arnold & Porter.

The FDA is represented by Joshua Dos Santos of the U.S. Department of Justice's Civil Division and Acting Assistant Attorney General Ethan P. Davis and Senior Counsel to the Assistant Attorney General Sophan Joshi.

The amici states are represented by their respective attorneys general.

The case is American College of Obstetricians and Gynecologists et al. v. U.S. Food and Drug Administration et al., case number 20-1824, in the U.S. Court of Appeals for the Fourth Circuit.

--Additional reporting by Jeff Overley. Editing by Bruce Goldman.

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Case Information

Case Title

Amer College of Obstetricians v. FDA

Case Number



Appellate - 4th Circuit

Nature of Suit

2440 Other Civil Rights

Date Filed

July 29, 2020

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