The section on Judicial Deference seems to put a high bar in front of any lawsuit.
Based on this below, if the FDA looks at the evidence and comes to a conclusion, it seems like the Court is legally obliged to accept that conclusion. There are some exceptions under "arbitrary and capricious", but they look like they might be pretty hard to meet. I don't know how common it is for courts look past the Judicial Deference standard. If the plaintiffs are allowed to dispute the FDA's interpretation of research, introduce contrary research, and argue that the FDA cherry picked their sources of information, etc, maybe they have a shot. Maybe it just depends on the Judge.
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Under the Administrative Procedure Act (“APA”), an agency’s decision must be upheld unless arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. See 5 U.S.C. § 706(2)(A). Under this deferential standard, the agency’s decision is presumed valid, and the Court considers only whether it “was based on a consideration of the relevant factors and whether there has been a clear error of judgment.” Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416 (1971). An agency decision may be deemed arbitrary and capricious only in circumstances where the agency “has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.” Motor Vehicle Mfrs. ...’n v. State Farm, 463 U.S. 29, 43 (1983). The Court may not “substitute its judgment for that of the agency.” Id.
This deference is heightened even further in cases like this one involving scientific or technical decisions. “We will give an extreme degree of deference to the agency when it is evaluating scientific data within its technical expertise,” West Virginia v. EPA, 362 F.3d 861, 871 (D.C. Cir. 2004), for “we cannot decide . . . whether technical evidence beyond our ken supports the proposition it is asserted to support,” Simpson v. Young, 854 F.2d 1429, 1434 (D.C. Cir. 1988). “When examining this kind of scientific determination . . . a reviewing court must generally be at its most deferential.” Baltimore Gas & Elec. Co. v. NRDC, 462 U.S. 87, 103 (1983). Indeed, “in the face of conflicting evidence at the frontiers of science, courts’ deference to expert determinations should be at its greatest.” Cellular Phone Task Force v. FCC, 205 F.2d 82, 90 (2d Cir. 2000).