21 U.S.C. § 360h
Notification and other remedies
An order issued under subsection (b) with respect to a device may require any person who is a manufacturer, importer, distributor, or retailer of the device to reimburse any other person who is a manufacturer, importer, distributor, or retailer of such device for such other person’s expenses actually incurred in connection with carrying out the order if the Secretary determines such reimbursement is required for the protection of the public health. Any such requirement shall not affect any rights or obligations under any contract to which the person receiving reimbursement or the person making such reimbursement is a party.
Compliance with an order issued under this section shall not relieve any person from liability under Federal or State law. In awarding damages for economic loss in an action brought for the enforcement of any such liability, the value to the plaintiff in such action of any remedy provided him under such order shall be taken into account.
1992—Subsec. (b)(1)(A)(ii). Pub. L. 102–300 substituted “or” for “and” after “properly designed” and “time of its design”.
1990—Subsec. (e). Pub. L. 101–629 added subsec. (e).
Notes of Decisions
Cited in 49
cases (3 in the last 5 years), 1982–2025 · leading case: Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000).
Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000). “21 U. S. C. § 360h(e)(1) (emphasis added).”
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). “" 21 U.S.C. § 360h(b)(1)(A). Thus the FDA may order the manufacturer to repair the device, replace it, refund the purchase price, cease distribution, or recall the device.”
Nina Michael v. Shiley, Inc., 46 F.3d 1316 (3d Cir. 1995). “Section 360h(d) defines the effect that a manufacturer’s compliance with an *1327 FDA notification, reimbursement, or recall order should have: Compliance with an order issued under this section shall not reheve any person of liability under Federal or State law.”
Talbott v. C.R. Bard, Inc., 865 F. Supp. 37 (D. Mass. 1994). “As a practical matter, if Congress intended to establish a fraud on the FDA exception to the preemption it provided for state law claims concerning Class III devices, which are comprehensively regulated by the FDA, it would have seriously threatened the balance it sought to…”
Blunt v. Medtronic, Inc., 2009 WI 16, 760 N.W.2d 396. “§ 360e(e)(1); 21 U.S.C. § 360h(e). As the Supreme Court noted: [t]he FDA has the power to withdraw premarket approval based on newly reported data or existing information and must withdraw approval if it determines that a device is unsafe or ineffective under the conditions in…”
Barbara Mitchell v. Collagen Corp., 67 F.3d 1268 (7th Cir. 1995). “21 U.S.C. § 360h(d). The Mitchells submit that this portion of the MDA “saves” all common law causes of action from preemption.”
Gross v. Stryker Corp., 858 F. Supp. 2d 466 (W.D. Pa. 2012). “§ 360e(e)(1); 21 U.S.C. § 360h(e)). The majority of Class III devices do not undergo this intensive PMA review.”
Stengel v. Medtronic, Inc., 676 F.3d 1159 (9th Cir. 2012). “See 21 U.S.C. § 360h(a). This is precisely the same theory that was rejected in Buckman.”
Jack McMullen v. Medtronic, Inc., 421 F.3d 482 (7th Cir. 2005). “” Sections 518(a) and (e) of the MDA, codified at 21 U.S.C. §§ 360h(a) and (e), give the Secretary of Health and Human Services the discretion to issue or withhold warnings concerning medical devices based on the Secretary’s assessment of the risks, and to issue recall orders…”
prod.liab.rep. (Cch) P 14,260 Lora Lohr v. Medtronic, Inc., 56 F.3d 1335 (11th Cir. 1995). “” 21 U.S.C.A. § 360h(d). While the savings clause almost certainly prohibits a holding that the MDA preempts all state law liability, our interpretation of § 360k(a) does not preclude all liability.”
Walker v. Johnson & Johnson Vision Prods., Inc, 552 N.W.2d 679 (Mich. Ct. App. 1996). “" 21 U.S.C. § 360h(d). Congress' inclusion of such a provision in the MDA is evidence that Congress intended to preserve state products liability claims against manufacturers of Class III medical devices rather than to preempt such claims.”
Mulligan v. Pfizer Inc., 850 F. Supp. 633 (S.D. Ohio 1994). “21 U.S.C. § 360h(b)(l)(A). Subparagraph (2) discusses the procedure for repair or replacement, and section (c) addresses reimbursement.”
21 U.S.C. § 360h(a): 13 cases
Nina Michael v. Shiley, Inc., 46 F.3d 1316 (3d Cir. 1995). “Section 360h(d) defines the effect that a manufacturer’s compliance with an *1327 FDA notification, reimbursement, or recall order should have: Compliance with an order issued under this section shall not reheve any person of liability under Federal or State law.”
Stengel v. Medtronic, Inc., 676 F.3d 1159 (9th Cir. 2012). “See 21 U.S.C. § 360h(a). This is precisely the same theory that was rejected in Buckman.”
Jack McMullen v. Medtronic, Inc., 421 F.3d 482 (7th Cir. 2005). “” Sections 518(a) and (e) of the MDA, codified at 21 U.S.C. §§ 360h(a) and (e), give the Secretary of Health and Human Services the discretion to issue or withhold warnings concerning medical devices based on the Secretary’s assessment of the risks, and to issue recall orders…”
Ethel Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir. 2005).
Worthy v. Collagen Corp., 967 S.W.2d 360 (Tex. 1998).
21 U.S.C. § 360h(a)(2): 1 case
Gates v. Medtronic, Inc., 192 F. Supp. 3d 704 (W.D. Tex. 2016).
21 U.S.C. § 360h(b): 2 cases
Haidak v. Collagen Corp., 67 F. Supp. 2d 21 (D. Mass. 1999).
Ass'n for Molecular Pathology v. United States Food & Drug Admin. PURSUANT TO COURT ORDER, No. 4:24-cv-00824 (E.D. Tex. Mar. 31, 2025).
21 U.S.C. § 360h(b)(1)(A): 1 case
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). “" 21 U.S.C. § 360h(b)(1)(A). Thus the FDA may order the manufacturer to repair the device, replace it, refund the purchase price, cease distribution, or recall the device.”
21 U.S.C. § 360h(b)(2)(C): 2 cases
United States v. Lane Labs-Usa Inc, 427 F.3d 219 (3d Cir. 2005).
United States v. Lane Labs-USA Inc, No. 04-3592 (3d Cir. Oct. 21, 2005).
21 U.S.C. § 360h(b)(l)(A): 2 cases
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). “" 21 U.S.C. § 360h(b)(1)(A). Thus the FDA may order the manufacturer to repair the device, replace it, refund the purchase price, cease distribution, or recall the device.”
Mulligan v. Pfizer Inc., 850 F. Supp. 633 (S.D. Ohio 1994). “21 U.S.C. § 360h(b)(l)(A). Subparagraph (2) discusses the procedure for repair or replacement, and section (c) addresses reimbursement.”
21 U.S.C. § 360h(c): 1 case
Haidak v. Collagen Corp., 67 F. Supp. 2d 21 (D. Mass. 1999).
21 U.S.C. § 360h(d): 15 cases
Talbott v. C.R. Bard, Inc., 865 F. Supp. 37 (D. Mass. 1994). “As a practical matter, if Congress intended to establish a fraud on the FDA exception to the preemption it provided for state law claims concerning Class III devices, which are comprehensively regulated by the FDA, it would have seriously threatened the balance it sought to…”
Barbara Mitchell v. Collagen Corp., 67 F.3d 1268 (7th Cir. 1995). “21 U.S.C. § 360h(d). The Mitchells submit that this portion of the MDA “saves” all common law causes of action from preemption.”
prod.liab.rep. (Cch) P 14,260 Lora Lohr v. Medtronic, Inc., 56 F.3d 1335 (11th Cir. 1995). “” 21 U.S.C.A. § 360h(d). While the savings clause almost certainly prohibits a holding that the MDA preempts all state law liability, our interpretation of § 360k(a) does not preclude all liability.”
Walker v. Johnson & Johnson Vision Prods., Inc, 552 N.W.2d 679 (Mich. Ct. App. 1996). “" 21 U.S.C. § 360h(d). Congress' inclusion of such a provision in the MDA is evidence that Congress intended to preserve state products liability claims against manufacturers of Class III medical devices rather than to preempt such claims.”
Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th Cir. 1999).
21 U.S.C. § 360h(e): 2 cases
Blunt v. Medtronic, Inc., 2009 WI 16, 760 N.W.2d 396. “§ 360e(e)(1); 21 U.S.C. § 360h(e). As the Supreme Court noted: [t]he FDA has the power to withdraw premarket approval based on newly reported data or existing information and must withdraw approval if it determines that a device is unsafe or ineffective under the conditions in…”
Gross v. Stryker Corp., 858 F. Supp. 2d 466 (W.D. Pa. 2012). “§ 360e(e)(1); 21 U.S.C. § 360h(e)). The majority of Class III devices do not undergo this intensive PMA review.”
21 U.S.C. § 360h(e)(1): 6 cases
Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000). “21 U. S. C. § 360h(e)(1) (emphasis added).”
Gross v. Stryker Corp., 858 F. Supp. 2d 466 (W.D. Pa. 2012). “§ 360e(e)(1); 21 U.S.C. § 360h(e)). The majority of Class III devices do not undergo this intensive PMA review.”
Blunt v. Medtronic, Inc., 2009 WI 16, 760 N.W.2d 396. “§ 360e(e)(1); 21 U.S.C. § 360h(e). As the Supreme Court noted: [t]he FDA has the power to withdraw premarket approval based on newly reported data or existing information and must withdraw approval if it determines that a device is unsafe or ineffective under the conditions in…”
Blunt v. Medtronic, Inc., 2007 WI App 191, 738 N.W.2d 143.
Milanesi v. C.R. Bard, Inc., No. 2:18-cv-01320 (S.D. Ohio Dec. 13, 2021).
21 U.S.C. § 360h(e)(1)(A): 1 case
Brown & Williamson v. FDA, No. 97-1604 (4th Cir. Apr. 25, 2000).
21 U.S.C. § 360h(e)(2): 2 cases
Gates v. Medtronic, Inc., 192 F. Supp. 3d 704 (W.D. Tex. 2016).
Brown & Williamson v. FDA, No. 97-1604 (4th Cir. Apr. 25, 2000).
21 U.S.C. § 360h(e)(2)(B)(i): 1 case
Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000). “21 U. S. C. § 360h(e)(1) (emphasis added).”
21 U.S.C. § 360h(e)(l): 6 cases
Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000). “21 U. S. C. § 360h(e)(1) (emphasis added).”
Blunt v. Medtronic, Inc., 2009 WI 16, 760 N.W.2d 396. “§ 360e(e)(1); 21 U.S.C. § 360h(e). As the Supreme Court noted: [t]he FDA has the power to withdraw premarket approval based on newly reported data or existing information and must withdraw approval if it determines that a device is unsafe or ineffective under the conditions in…”
In re Telectronics Pacing Sys., Inc., 168 F.R.D. 203 (S.D. Ohio 1996).
In re Telectronics Pacing Sys., Inc., 164 F.R.D. 222 (S.D. Ohio 1995).
Blunt v. Medtronic, Inc., 2007 WI App 191, 738 N.W.2d 143.
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