Case 2:21-cv-00702-CLM Document 15 Filed 07/19/21 Page 46 of 67
potentially harmful medical products can be placed in the stream of commerce and used by the American public prior to their full approval by the FDA. ii. No Statutory Preclusion Plaintiffs can locate no valid statute purporting to preclude judicial review of this agency action, either categorically, or prior to the exhaustion of administrative remedies. Defendants may cite to 42 U.S.C. § 247d-6d(b)(7), a provision of the Public Readiness and Emergency Preparedness Act (“PREP Act”), which states: “No court of the United States, or of any State, shall have subject matter jurisdiction to review, whether by mandamus or otherwise, any action by the Secretary under this subsection.” However, a “strong presumption in favor of judicial review of administrative action” governs the construction of potentially jurisdiction-stripping provisions like § 247d-6d(b)(7). INS v. St. Cyr, 533 U.S. 289, 298 (2001). “Even when the ultimate result is to limit judicial review, the Court cautions that as a matter of the interpretive enterprise itself, the narrower construction of a jurisdiction-stripping provision is favored over the broader one.” ANA Inti’l Inc. v. Way, 393 F.3d 886, 891 (2004) (citing to Reno v. American-Arab Anti-Discrimination Committee, 525 U.S. 471, 480-482 (1999)); see also Patel v. United States AG, 917 F.3d 1319, Fn. 4 (11th Cir. 2019) (“We are also mindful that there is a strong presumption in favor of interpreting statutes to allow judicial review of administrative actions; consequently, jurisdiction stripping is construed narrowly.”), (citing to Kucana v. Holder, 558 U.S. 233, 251-252 (2010). Thus the prohibition on judicial review in § 247d-6d(b)(7) must be construed narrowly so as to apply exclusively and specifically to declarations conferring the PREP Act “immunity” described in § 247d-6d(a), which are the only declarations made by the Secretary under “this subsection.” Section 247d-6d(b)(1) refers to the Secretary’s having first and beforehand made a declaration that a public health emergency exists (a declaration that is made under an entirely -46-
