| | ''Goico v. United States FDA'', No. 20-1248-JAR-KGG, 2020 U.S. Dist. LEXIS 226868, at *8-9 (D. Kan. Dec. 3, 2020). | | ''Goico v. United States FDA'', No. 20-1248-JAR-KGG, 2020 U.S. Dist. LEXIS 226868, at *8-9 (D. Kan. Dec. 3, 2020). |
| | + | <blockquote>See Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 56 (D.D.C.1998) ("[O]ff-label use of FDA-approved drugs by physicians is an established aspect of the modern practice of medicine."), vacated in part on other grounds, Wash. Legal Found. v. Henney, 202 F.3d 331, 340 U.S. App. D.C. 108 (D.C. Cir. 2000).</blockquote> |
| | <blockquote>Moreover, the FDA's "approval process generally contemplates that approved [devices] will be used in off-label ways," United States v. Caronia, 703 F.3d 149, 166 (2d Cir. 2012); see also Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206, 1218 n.3 (W.D. Okla. 2013) (noting that off-label use is not illegal or disfavored but an accepted and valuable part of the practice of medicine). Off-label use may even be a recognized standard of care. Caronia, 703 F.3d at 153. And congress has prohibited the FDA from "limit[ing] or interfer[ing] with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease." 21 U.S.C. § 396 (2014). Although the Infuse Device was approved as a system, the statutory definition supports our conclusion that each component is a "device" under the FDA that must follow specific federal requirements. See Riley v. Cordis Corp., 625 F. Supp. 2d 769, 780 (D. Minn. 2009) ("It makes no sense—indeed, it would probably be impossible—to pick apart the components of a medical device and apply different preemption analyses to different components."). Consequently, we conclude that the FDA established specific federal requirements for the Infuse Device, even when the Infuse Protein is used alone.</blockquote> | | <blockquote>Moreover, the FDA's "approval process generally contemplates that approved [devices] will be used in off-label ways," United States v. Caronia, 703 F.3d 149, 166 (2d Cir. 2012); see also Caplinger v. Medtronic, Inc., 921 F. Supp. 2d 1206, 1218 n.3 (W.D. Okla. 2013) (noting that off-label use is not illegal or disfavored but an accepted and valuable part of the practice of medicine). Off-label use may even be a recognized standard of care. Caronia, 703 F.3d at 153. And congress has prohibited the FDA from "limit[ing] or interfer[ing] with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease." 21 U.S.C. § 396 (2014). Although the Infuse Device was approved as a system, the statutory definition supports our conclusion that each component is a "device" under the FDA that must follow specific federal requirements. See Riley v. Cordis Corp., 625 F. Supp. 2d 769, 780 (D. Minn. 2009) ("It makes no sense—indeed, it would probably be impossible—to pick apart the components of a medical device and apply different preemption analyses to different components."). Consequently, we conclude that the FDA established specific federal requirements for the Infuse Device, even when the Infuse Protein is used alone.</blockquote> |