In Riegel, 552 U.S. at 321–23, 128 S.Ct. 999, the Supreme Court held that state laws are preempted by the MDA if: (1) the Federal Government has established “specific requirements applicable to a particular device”; and (2) the plaintiff's claims are based on “state requirements” related to safety and effectiveness that are “different from, or in addition to” the federal requirements. See also Williams v. Cyberonics, Inc., 388 Fed.Appx. 169, 171 (3d Cir.2010) (applying the two-part test for federal preemption pursuant to Riegel ). The Supreme Court reasoned that a state law demanding a manufacturer's devices “to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme.”

They receive the most oversight from the FDA. Williams v. Cyberonics, Inc., 654 F. Supp. 2d 301, 304 (E.D. Pa. 2009) (citing Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008)), aff'd, 388 F. App'x 169 (2010).

When success on state law claims would require Plaintiffs to show that the device “was unsafe or ineffective despite the PMA process,” such claims “interfer[e] with the requirements already established by the MDA,” and are therefore preempted. Williams v. Cyberonics, Inc., 388 Fed.Appx. 169, 171 (3d Cir.2010). See also Riegel, 552 U.S. at 325, 128 S.Ct. 999 (state law that requires a manufacturer's device “to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme”).

" Generalized common law theories of liability ... are precisely the types of claims the MDA sought to preempt." Williams v. Cyberonics, Inc., 388 Fed.Appx. 169, 171 (3d Cir.2010) (citing Riegel, 552 U.S. at 325, 128 S.Ct. 999). However, parallel state duties— duties that are not different from, or in addition to, federal requirements— are not preempted by MDA. Medtronic, Inc. v. Lohr, 518 U.S. 470, 494-95, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996).

"Generalized common law theories of liability . . . are precisely the types of claims the MDA sought to preempt." Williams v. Cyberonics, Inc., 388 F. App'x 169, 171 (3d Cir. 2010) (citing Riegel, 552 U.S. at 325) . However, parallel state duties""duties that are not different from, or in addition to, federal requirements""are not preempted by MDA. Medtronic, Inc. v. Lohr, 518 U.S. 470, 494-95 (1996).

As numerous courts have explained in exhaustive detail, the Medical Device Amendments of 1976 (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 360k(a), preempts state tort claims relating to the safety and effectiveness of medical devices subject to the PMA process if the state claims are based on state requirements related to safety and effectiveness “different from, or in addition to” the federal requirements. See Riegel v. Medtronic, Inc., 552 U.S. 312, 321-22 (2008); see also, e.g., Williams v. Cyberonics, Inc., 388 Fed. App'x 169, 171 (3d Cir. 2010); Estate of Benn v. Medtronic, Inc., No. 22-6522, 2023 WL 3966000, at *3 (D.N.J. June 13, 2023); Marmol v. St. Jude Med. Ctr., 132 F.Supp.3d 1359, 1363 (M.D. Fla. 2015); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litig., 592 F.Supp.2d 1147, 1151-52 (D. Minn. 2009). As these courts have held, the MDA operates to preempt many state law theories of liability, including tort claims based on manufacturing and design defects, strict liability, negligence, failure to warn, and state consumer fraud statutes.

See Caplinger v. Medtronic, Inc., 921 F.Supp.2d 1206, 1222 (W.D. Okla. 2013), aff'd, 784 F.3d 1335 (10th Cir. 2015) (dismissing an express warranty claim because “[t]o succeed on the express and implied warranty claim, as alleged by plaintiff in her Amended Complaint, plaintiff must persuade a jury that the [device] was not safe and effective, a finding that would be contrary to the FDA's approval”); Williams v. Cyberonics, Inc., 388 Fed.Appx. 169, 171 (3d Cir. 2010) (“Success on appellants' breach of warranty claims would require them to show that the [device] was unsafe or ineffective despite the PMA process, thereby interfering with the requirements already established by the MDA, which has preempted safety and effectiveness determinations for a device.”); White v. Medtronic, Inc., No. 18-11590, 2019 WL 1339613, at *6 (E.D. Mich. Feb. 20, 2019), report and recommendation adopted, No. 18-11590, 2019 WL 1330923 (E.D. Mich. Mar. 25, 2019), aff'd, 808 Fed.Appx. 290 (6th Cir. 2020) (finding a very similar express warranty claim preempted for the same reasons where the plaintiff alleged “Medtronic represented that Infuse was safe and effective”).

. In light of Section 360k(a), the Supreme Court of the United States has construed the MDA as protecting Class III device manufacturers from liability under state law tort claims if the manufacturer has complied with federal regulatory requirements. SeeRiegel , 552 U.S. at 323-24, 128 S.Ct. 999 ; see also, e.g.,Williams v. Cyberonics, Inc. , 388 F. App'x 169, 171 (3d Cir. 2010) ("Generalized common law theories of liability ... are precisely the type of claims the MDA sought to preempt.")

To bring a parallel strict liability claim, it is not enough for the device simply to have stopped working. Williams v. Cyberonic, Inc., 388 Fed. Appx. 169, 171-72 (3d Cir. 2010). Instead, a plaintiff needs to explain how the medical device deviated from the FDA requirements.

The Supreme Court in Riegel defined the two steps we must use in deciding whether federal law preempts state law claims regarding a Class III device: "(1) the Federal Government has established requirements applicable to the device and (2) the plaintiff's claims are based on state requirements related to safety and effectiveness that are 'different from, or in addition to' the federal requirements."Williams v. Cyberonics, Inc., 388 F.App'x 169, 171 (3d Cir. 2010) (quoting Riegel, 552 U.S. 321-22)). In the first step, we determine whether the FDA established requirements applicable to the Device. If there are FDA requirements applicable to the Device, we must then determine whether the Freeds' products liability claims are "different from, or in addition to" the FDA's safety and effectiveness requirements for the Device.