Device manufacturers are forbidden from making “changes in design, specifications, manufacturing processes, labeling, or any other attribute[] that would affect safety or effectiveness” without permission from the FDA.17The roots of federal medical device preemption lie in the Supremacy Clause of the United States Constitution, under which “the Laws of the United States . . . shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any state to the Contrary notwithstanding.”18 Recognizing the “undu[e] burden[]” imposed by potentially conflicting state-level regulations, Congress adopted a general “prohibition on non-Federal regulation” of medical devices by incorporating the express preemption clause into the MDA.19 That provision—21 U.S.C. § 360k(a)—expressly preempts any claim that imposes a state law “requirement” with respect to a medical device that is “different from, or in addition to” any federal requirement imposed by the FDA.20 Under the express preemption clause of the MDA:(a) Except as provided in subsection (b)521 of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and(2) which relates to the safety and effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

Rather, we’re examining Caplinger for what it might tell us about Judge Gorsuch’s broader views of FDCA preemption. His dissatisfaction with the Supreme Court’s tortured approach to express preemption in medical device product liability casesis very clear.Caplinger begins with the strong statement that, in enacting the Medical Device Amendments, Congress “[e]xercis[ed] its authority under the Supremacy Clause” in enacting 21 U.S.C. §360k(a). 784 F.3d at 1336.

When one considers “parallel claims” in the context of the FDCA as a whole, this “problem” isn’t really a problem at all, at least from the defense perspective. Why? Number one, the Medical Device Amendments contain an express preemption clause, 21 U.S.C. §360k(a), explicitly barring any state “requirements” (including tort requirements) that are “different from or in addition to” what the FDA requires. That means that Congress generally disfavors, inter alia, state tort claims against PMA medical devices. Number two, that preemption clause was layered on top of the FDCA’s original prohibition against private enforcement, §337(a) (“exclusive” enforcement by the federal government).

The Riegels alleged that the catheter was designed, labeled, and manufactured in a manner that violated New York common law, and that these defects caused Mr. Riegel’s injury and suffering.Both the district court and the U.S. Court of Appeals for the Second Circuit ruled in favor of Medtronic.The Second Circuit, which joined a number of circuits that have addressed this issue, reasoned in its 2006 opinion that because devices approved through the PMA process are subject to the standards set forth in their approved applications, such devices are subject to “a requirement applicable to the device under [the FDC Act],” and that the claims for strict liability, breach of warranty, and negligent design, testing, inspection, distribution, labeling, marketing, and sale would (if successful) impose state “requirements” that differed from, or added to, the PMA-approved standards for the device.The MDA provides federal oversight for devices and amended the FDC Act to add § 521 (21 U.S.C. §360k(a)), which states, in relevant part:[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement –(1) which is different from, or in addition to, any requirement applicable under this Act to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this Act.In granting review in this case, the Supreme Court was asked to address the following question:Whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. §360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food and Drug Administration.

defendant after discovering a defendant representative attended the surgery and was allegedly “responsible for the flow of saline.” The defendant demurred, arguing federal law preempted the plaintiff’s products liability claims.The appellate court determined federal law preempted the plaintiff’s negligence cause of action. The product at issue is a Class III medical device, which must undergo a “rigorous premarket approval process to provide reasonable assurance of its safety and effectiveness.” See 21 U.S.C. § 360c(a)(1)(C)(i)(II). The MDA contains an express preemption provision where Congress decreed, “no State…may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in the requirement applicable to the device under this chapter.” See 21 U.S.C. § 360k(a).Applying the preemption doctrine, the Court reasoned medical device manufacturers only face a federal standard of care. In Regwan, the state law claim involved a Class III device that received premarket approval for commercial distribution. Furthermore, the plaintiff’s negligence claim was based on common law duties that were different from, or in addition to the federal requirements and that “relate to safety and effectiveness,” given her claim was the defendant breached its duty of care by failing to confirm the correct amount of saline, while the product at issue came with numerous written federally mandated warnings requiring continuous saline flow for a successful implantation procedure. Liability under the plaintiff’s negligent undertaking theory hinged on whether the defendant representative gave additional oral warnings during surgery, whereas under the FDA requirement, the written warning label accompanying the device is sufficient. As a result, the defendant could have been

ysicians who use that information to diagnose and treat patients, medical malpractice is another possible cause of action.Some AI software is subject to FDA regulation as a medical device. Section 3060 of the Cures Act specified when software will be regulated as a medical device and subject to FDA review, and when it will not. On December 8, 2017, the FDA issued “Software as a Medical Device (SAMD): Clinical Evaluation” to explain its thinking on regulation of software. Software as a medical device (SaMD) isdescribed as software that utilizes an algorithm (logic, set of rules, or model) that operates on data input (digitized content) to produce an output that is intended for medical purposes as defined by the SaMD manufacturer. The risks and benefits posed by SaMD outputs are largely related to the risk of inaccurate or incorrect output of the SaMD, which may impact the clinical management of a patient.For medical devices, the FDA Act provides some liability protection. Specifically, 21 USC § 360k(a), preempts state requirements, including product liability claims which are “different from, or in addition to” the FDA regulation and “which relate[] to the safety or effectiveness of the device. . . .“ In Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008), the U.S. Supreme Court has upheld this preemption which might offer incentive to doctors who would like to integrate emerging AI technologies into their patient care.Nonetheless, doctors who rely upon AI to help diagnose and treat their patients could still be subject to medical malpractice liability. Medical malpractice liability is premised on a doctor’s breach of the standard of care. Even if a doctor relied on AI, she can still be held liable if a jury were to find that her actions fell below the standard of care. As noted in the GAO Report, perhaps, in the not too distant future, numerous AI technologies will be integrated into the standard of care. If that were to occur, then doctors might have more certainty that their reli

A Class III device is one that may present an unreasonable risk or is for a use in supporting or sustaining human life and, because special controls are not enough to ensure its safety, can in most circumstances only be sold after the manufacturer has provided independent evidence of safety and effectiveness sufficient to gain premarket “approval.” 21 U.S.C. § 360e.Ironically, the federal express preemption statute, 21 U.S.C. §360k, has been interpreted to provide that federal regulation for more risky devices has preemptive effect while federal regulation for less risky devices does not. The test under the statute as interpreted by the FDA is whether state law imposes “requirements” which are different from, or in addition to, any federal “requirement.”

The Declaration is effective retroactively to February 4, 2020 and provides immunity through October 1, 2024.Federal Preemption of State Law Claims The Medical Device Amendments of 1976 (MDA) created a scheme of federal safety oversight for medical devices while sweeping back state oversight schemes. The statute provides that a state shall not “establish or continue in effect with respect to a device intended for human use any requirement— . . . (1) which is different from, or in addition to, any requirement applicable under [federal law] to the device, and . . . (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under” relevant federal law. 21 U.S.C. §360k(a). The MDA calls for federal oversight of medical devices that varies with the type of device (Class I - III) at issue.

[ix] 21 U.S.C. § 343-1. [x] 21 U.S.C. § 360k. [xi] 21 U.S.C. § 379r.

Federal Preemption of FDA approved medical devices was built into the Medical Device Amendments (“MDA”) of 1976: “Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—which is different from, or in addition to, any requirement applicable under this chapter to the device, and which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.” (21 U.S.C. § 360k(a)) The provision has been interpreted as a two-prong test by the courts for determining if a state-law tort claim is preempted. First, the court must determine whether federal regulations exist for the device in question.