Law360
May 9, 2023
David Coale Addresses “Elephant in the Room” in Ongoing FDA Legal Battle
In a new briefing, filed Monday, anti-abortion groups argue that U.S. District Judge Matthew Kacsmaryk of the Northern District of Texas correctly applied legal principles when he attempted to halt the agency’s approval of mifepristone. LPHS attorney, David Coale, explained in a recent interview with Law360, "the elephant in the room is limitations."
Coale highlighted a recent opinion from a conservative majority on a Fifth Circuit panel had expressed concerns that the statute of limitation to challenge the FDA's approval of the drug in 2000 has likely expired. Should the new panel of judges, presiding over the case come to the same concerns, Coale expects, “that creates serious standing problems. The plaintiffs' standing evidence isn't tied to specific FDA actions, and the plaintiffs don't really offer a fallback option for the court if it only accepts some portion of their claims."
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