Riegel v. Medtronic – U.S. Supreme Court Expands Pre-Emption Defense in Medical Device Context
June 24, 2008
In Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008), the United States Supreme Court held that the pre-emption clause contained in the Medical Device Amendments (21 U.S.C. Section 360, et seq.) to the Food, Drug, and Cosmetic Act (21 U.S.C. Section 301, et seq.) bars common-law claims challenging the safety of a medical device that was granted premarket approval by the Food and Drug Administration (FDA). The following is an analysis of the Supreme Court’s decision.
Background
Plaintiff Charles Riegel sustained injuries when an Evergreen balloon catheter marketed by the defendant, Medtronic, Inc., ruptured while his doctor inserted it into his coronary artery. 128 S.Ct. at 1005. Thereafter, Riegel and his wife commenced an action in the United States District Court for the Northern District of New York to recover damages. They alleged claims premised upon negligence, strict liability and breach of warranty theories. Id. The District Court dismissed their action on the ground that the Medical Device Amendments (MDA) pre-empted the Riegels’ claims. Id., at 1005-06. The United States Court of Appeals for the Second Circuit affirmed. Id., at 1006.
Regulation of Medical Devices Under the MDA
The MDA established three levels of oversight for medical devices depending upon the risks that they present. Class I devices, which include, among other things, elastic bandages, are subject to the lowest level of oversight. Class II devices, which include items such as powered wheelchairs, are subject to additional “special controls.” Id., at 1003. Class III devices, which include the catheter at issue in Riegel, receive the most federal oversight. Id.
New Class III devices must undergo a “rigorous regime of premarket approval.” Id., at 1004. Moreover, once a device has received premarket approval, Section 360e(d)(6)(A)(i) of the MDA forbids the manufacturer to make, without FDA permission, changes in the design specifications, manufacturing processes, labeling, or any other attribute that would affect safety or effectiveness. Id., at 1005. Lastly, after the FDA grants premarket approval, the device remains subject to reporting requirements. Id. For example, pursuant to 21 CFR Section 814.84(b)(2), the FDA must be informed of new clinical investigations or scientific studies concerning the device that the applicant is aware of or reasonably should be aware of, and it must report incidents in which the device may have caused or contributed to death or serious injury.
Unlike the rigorous premarket approval process pursuant to which new Class III devices are subject, existing Class III devices can receive “grandfathered” approval. For example, pursuant to 21 USC Section 360c(f)(1)(A), devices sold before the MDA’s effective date may remain on the market until the FDA issues a regulation requiring premarket approval. Moreover, even “[a] new device need not undergo premarket approval if the FDA finds it is ‘substantially equivalent’ to another device exempt from premarket approval.” Id., at 1004 (citing 21 U.S.C. § 360(c)(f)(1)(A)). The FDA’s review of devices for substantial equivalence is known as the Section 510(k) process, which refers to the section of the MDA describing the review. Id.
Pre-Emption Under the MDA
Section 360(k) of the MDA includes a pre-emption provision which states:
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. § 360(k).
The Supreme Court’s Analysis
The Supreme Court’s analysis addressed the following, two questions:
whether the federal government established requirements applicable to Medtronic’s catheter; and if so,
whether the plaintiffs’ common-law claims are based upon New York requirements with respect to the catheter that are “different from, or in addition to,” the federal ones and that relate to safety and effectiveness.
Id., at 1006.
Whether the Federal Government Established “Requirements” That Apply to the Catheter
The Supreme Court answered the first question in the affirmative. It specifically concluded that the rigorous premarket approval process is “specific to individual devices.” Id., at 1007. The Court contrasted a device, such as the catheter, which undergoes premarket approval, to a device, the approval of which is grandfathered, as was the case in Medtronic v. Lohr, 116 S.Ct. 2240 (1996). In Lohr, the Court found that the grandfathered approval process did not impose device-specific “requirements.” Riegel, 128 S. Ct. at 1007 (citing Medtronic v. Lohr, 126 S.Ct. at 2240).
The Court noted:
[P]remarket approval is specific to individual devices. And it is in no sense an exemption from federal safety review – it is federal safety review. Thus, the attributes that Lohr found lacking in § 510(k) review are present here [i.e., in the case of a device which undergoes premarket approval] ... . While devices that enter the market through § 510(k) have never been formally reviewed under the MDA for safety or efficacy, the FDA may grant premarket approval only after it determines that a device offers a reasonable assurance of safety and effectiveness.
Id. (internal citations omitted) (emphasis in the original).
Whether Plaintiffs’ Common-Law Claims Rely Upon Any “Requirements” That Are “Different From, or In Addition to” Federal Requirements and That “Relate[ ] to the Safety or Effectiveness” of the Catheter
The Court commenced its analysis of the second question by noting that “safety and effectiveness are the very subjects of the Riegels’ common-law claims,” and therefore, it focused its remaining inquiry on whether New York tort law constitutes “requirements” under the MDA. Id. Based upon prior Supreme Court precedent, the Court concluded that the plaintiffs’ claims, premised upon state common-law, constituted “requirements.” For example, the Court noted: “In Lohr, five Justices concluded that common-law causes of action for negligence and strict liability do impose ‘requirement[s]’ and would be pre-empted by federal requirements specific to a medical device.” Id. The Court’s decision noted similar holdings in Bates v. Dow Agrosciences LLC, 544 U.S. 431, 443 (2005) (common-law actions were pre empted by the Federal Insecticide, Fungacide, and Rodenticide Act) and in Cipollone v. Liggett Group, Inc., 505 U.S. 504, 523 (1992) (common-law actions were pre-empted by a provision of the Public Health Cigarette Smoking Act of 1969, 15 U.S.C. Section 1334(b). Lastly, the Court noted that “excluding common-law duties from the scope of pre-emption would make little sense.” Id., at 1008.
Based on this analysis, the Riegel Court affirmed the dismissal of the plaintiffs’ complaint.
Conclusion
The Supreme Court’s decision in Riegel may act to deter the plaintiffs’ lawyers from filing claims involving devices that received premarket approval. However, the effect of the Court’s decision could be ephemeral, as certain members of Congress have suggested that they might seek legislation which nullifies Riegel. For example, Senator Edward Kennedy, who was the sole Senate sponsor of the MDA, responded to Riegel by noting: “In enacting legislation on medical devices, Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices ... . Congress obviously needs to correct the court’s decision. Otherwise, FDA approval will become a green light for shoddy practices by manufacturers.” Linda Greenhouse, “U.S. Supreme Court Makes it Harder to Sue Makers of Medical Devices,” International Herald Tribune, Feb. 21, 2008 at 1. Similarly, U.S. Representative Henry Waxman, who was on the Congressional panel that approved the MDA in 1976, stated: “This isn’t what Congress intended and we’ll pass legislation as quickly as possible to fix this nonsensical situation.” Id.
Given the foregoing, the long-term impact of the Supreme Court’s decision is unclear.
For more information, email David J. Harrington at david.harrington@hklaw.com or Richard J. Pelliccio at richard.pelliccio@hklaw.com or call toll free, 1.888.688.8500.