The national legal battle over abortion access continues as the U.S. Department of Justice and a distributor of abortion medication, mifepristone, urges the U.S. Supreme Court to review a Fifth Circuit decision that threatens to remove the drug entirely from the market for an extended time.

As we mentioned in our April 13, 2023 alert, the Fifth Circuit ruled that the abortion drug mifepristone can remain on the market but under strict conditions that effectively prohibit its use beyond seven weeks of pregnancy and bar its distribution by mail.

Danco Laboratories ("Danco"), the distributor, filed a petition for a Writ of Certiorari to the U.S. Supreme Court, seeking a review of an appellate panel's judgment issued last month upholding Judge Kacsmaryk's order reinstating the 2011 FDA restrictions on mifepristone. See

The Petition

Danco filed its petition Friday, September 8, to reverse the Fifth Circuit panel's decision. In its petition, Danco presented to the Supreme Court two questions: "Whether an association can demonstrate Article III standing to enjoin a government action by arguing that some unspecified member may be injured at some future time by the challenged action" and "Whether the Fifth Circuit erred in upholding the preliminary injunction of FDA's 2016 and 2021 actions based on the court's review of an incomplete administrative record." Here are some of the highlights from the petition.

Article III Standing

Danco argues that the Fifth Circuit's analysis conflicts with the Supreme Court's precedent in at least three ways, any of which should have prevented the suit from going forward.

With respect to the panel's ruling on associational standing, the associations of doctors who are opposed to abortion do not prescribe mifepristone and are not subject to government action or inaction.

... the Fifth Circuit found injury based on statistical possibility... In the panel's own words, [Plaintiffs'] proof of injury rested on three pieces of evidence: (a) 'data show[ing] that a definite percentage of women who take mifepristone will require emergency-room care'; (b) data 'show[ing] that millions of women take mifepristone'; and (c) [Plaintiffs'] 'testi[mony] that hundreds of their members are OB/Gyns and emergency-room doctors who care for women in these circumstances.

Such a 'probabilistic' standing analysis ignores the requirement that organizations must 'make specific allegations establishing that at least one identified member had suffered or would suffer harm.' ... 'speculation does not suffice.'

See, Writ of Certiorari at pages 2 and 19, respectively.

The Fifth Circuit relied on prior injuries of women suffering complications from mifepristone as a predictor of future injury.

In the Fifth Circuit's view, 'prior instances' of care 'to women suffering complications from mifepristone,' and 'mifepristone's continued availability,' showed that [Plaintiffs'] 'members are reasonably likely to be injured again.'... Even setting aside whether pre-Dobbs instances would recur in jurisdictions that have since outlawed nearly all abortions, 'past exposure' lacking a continuing effect 'does not in itself show a present case or controversy regarding injunctive relief.'

Id. at pages 19 and 20.

The Fifth Circuit's analysis directly conflicts with precedent, holding that an injury is not certain when it rests on a chain of possibilities and speculation made by independent actors not before the court. at page 20.

Judicial Review of FDA's Actions

Danco argues that the Fifth Circuit's ruling on the merits was equally flawed and in conflict with the Supreme Court's decisions. The following sets forth Danco's arguments with respect to the merits of the Fifth Circuit's decision:

  1. The reviewing court in APA cases must uphold an agency's decision if it can "reasonably discern" the agency's path and cannot "substitute its own policy judgment for that of the agency." According to Danco, the Fifth Circuit disregarded these rules. at page 27.

  2. The Fifth Circuit failed to defer to the FDA. In the Fifth Circuit's view, if the agency continued to require serious adverse event reporting, it might have found additional adverse events. According to Danco, the Fifth Circuit provided no basis for this, and an agency can make predictions based on the evidence presented. at page 29.

  3. By ordering a return to the pre-2016 labeling, Danco argues that the Fifth Circuit has required Danco to ask for FDA approval for an obsolete and less effective dosing regimen, along with outmoded guidance for the mifepristone. at pages 31 and 32.

If the U.S. Supreme Court denies review, their stay is lifted and the Fifth Circuit's decision goes into effect, and if the U.S. Supreme Court reviews the case, the stay will be lifted once the U.S. Supreme Court sends down its ruling.

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