552 U.S. 312 (2008)
Charles Riegel underwent coronary angioplasty in 1996 shortly after suffering a myocardial infarction. His right coronary artery was diffusely diseased and heavily calcified. Riegel's doctor inserted an Evergreen Balloon Catheter manufactured by Medtronic, Inc. into the artery in an attempt to dilate it. The catheter had received premarket approval from the FDA in 1994, with changes to its label receiving supplemental approvals in 1995 and 1996. The device's labeling stated that use was contraindicated for patients with diffuse or calcified stenoses and warned that the catheter should not be inflated beyond its rated burst pressure of eight atmospheres. Riegel's doctor inflated the catheter five times to a pressure of ten atmospheres, and on its fifth inflation the catheter ruptured.1
Riegel developed a heart block, was placed on life support, and underwent emergency coronary bypass surgery.2 In April 1999 Riegel and his wife Donna brought suit in the United States District Court for the Northern District of New York. Their complaint alleged that Medtronic's catheter was designed, labeled, and manufactured in a manner that violated New York common law and that these defects caused Riegel to suffer severe and permanent injuries. The complaint raised claims of strict liability, breach of implied warranty, and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter.3
The District Court held that the MDA pre-empted Riegel's claims of strict liability, breach of implied warranty, and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter. It also held that the MDA pre-empted a negligent manufacturing claim insofar as it was not premised on the theory that Medtronic violated federal law. The court concluded that the MDA pre-empted Donna Riegel's claim for loss of consortium to the extent it was derivative of the pre-empted claims. The District Court later granted summary judgment to Medtronic on the remaining claims.4
The United States Court of Appeals for the Second Circuit affirmed these dismissals. The Riegels petitioned for certiorari. The Supreme Court granted review to resolve a conflict among the Courts of Appeals regarding the scope of the MDA's pre-emption provision. Charles Riegel having died, Donna Riegel is now petitioner on her own behalf and as administrator of her husband's estate.5
Whether the pre-emption provision enacted in the Medical Device Amendments of 1976 bars common-law claims challenging the design, labeling, and manufacturing of a medical device that has received premarket approval from the Food and Drug Administration?6
The MDA’s express pre-emption clause applies to a requirement that is different from, or in addition to, a federal requirement and that relates to the safety or effectiveness of a medical device under 21 U.S.C. §360k(a).7 The PMA process imposes requirements on medical devices that are applicable to the device within the meaning of the MDA’s pre-emption clause. The FDA’s PMA approval order sets forth device-specific requirements after a rigorous review focused on safety and effectiveness.8
Yes. Charles Riegel underwent coronary angioplasty in 1996 shortly after suffering a myocardial infarction. His right coronary artery was diffusely diseased and heavily calcified when his doctor inserted the Evergreen Balloon Catheter manufactured by Medtronic into the artery.9 The catheter had received premarket approval from the FDA in 1994 with supplemental label approvals in 1995 and 1996 after the manufacturer submitted detailed studies showing reasonable assurance of safety and effectiveness.10 The Riegels filed suit alleging that the catheter was designed, labeled, and manufactured in violation of New York common law duties of care which would require the device to meet standards different from or in addition to those imposed by the FDA approval.11
These common law claims relate directly to the safety and effectiveness of the device because they challenge the very attributes reviewed and approved during the PMA process.12
The MDA pre-empts the Riegels common-law claims of negligence, strict liability, and implied warranty relating to the safety and effectiveness of the PMA-approved catheter.13
Related opinions on this issue
Justice Stevens joined all but Parts II–B and II–C of the Court’s opinion. He agreed that the PMA process imposes device-specific requirements within the meaning of the MDA’s pre-emption provision. He also agreed that petitioner’s common-law claims are pre-empted to the extent that they would impose requirements different from or in addition to the federal requirements.
He wrote separately to emphasize that the MDA does not pre-empt all state-law claims. In particular, the MDA does not pre-empt claims based on a violation of federal requirements.14
Justice Ginsburg dissented from the breadth of the holding. She argued that the MDA’s pre-emption provision is not as broad as the Court suggests. The provision pre-empts state requirements that are different from or in addition to federal requirements.
It does not pre-empt common-law claims that are based on duties that parallel federal requirements. The Court’s broad reading of the pre-emption provision is inconsistent with the presumption against pre-emption and with the statute’s text and history.15
Whether the premarket approval process imposes device-specific requirements within the meaning of the MDA's pre-emption clause?16
The PMA process imposes requirements on medical devices that are applicable to the device within the meaning of the MDA’s pre-emption clause. Unlike the substantial equivalence review under section 510(k), the PMA process is a rigorous device-specific safety review. It results in an FDA approval order setting forth requirements for the particular device.17
Yes. The Evergreen Balloon Catheter received premarket approval from the FDA in 1994 after the manufacturer submitted a multivolume application. The application included full reports of studies on safety and effectiveness, a full statement of components and properties, a description of manufacturing methods, and proposed labeling.18 The FDA granted approval only after determining there was reasonable assurance of safety and effectiveness.
The approval order imposed device-specific requirements that the manufacturer could not change without supplemental approval.19 This process differs fundamentally from the section 510(k) process at issue in Lohr because PMA approval focuses on safety rather than equivalence and requires the device to adhere closely to the approved specifications.20
The PMA process imposes device-specific requirements within the meaning of the MDA pre-emption clause.21
Whether state common-law claims of negligence, strict liability, and implied warranty impose requirements different from or in addition to federal requirements under the MDA?22
State common-law duties constitute requirements under the MDA. A tort judgment premised on the existence of a legal duty establishes that the defendant has violated a state-law obligation. Common-law liability is a potent method of governing conduct as recognized in precedents such as Cipollone and Bates.23
Yes. The Riegels claims alleged that the catheter was designed, labeled, and manufactured in a manner that violated New York common law. These claims would impose duties requiring the device to be safer or labeled differently than the version the FDA approved after weighing probable benefits against risks.24 Such duties are different from or in addition to the federal requirements because the FDA had already determined that the approved design, labeling, and manufacturing processes provided reasonable assurance of safety and effectiveness.25
Allowing a jury to impose liability under negligence or strict liability standards would disrupt the federal scheme by second-guessing the expert cost-benefit analysis performed by the FDA during PMA review.26
State common-law claims of negligence, strict liability, and implied warranty impose requirements different from or in addition to the federal requirements imposed by PMA approval and are therefore pre-empted.27
Related opinions on this issue
Justice Stevens concurred in the judgment that the common-law claims are pre-empted to the extent they impose different requirements. He noted that five Justices in Lohr had already concluded that negligence and strict liability claims impose requirements that can be pre-empted by device-specific federal rules. He agreed with the Court’s explanation of why the Riegels' claims are predicated on New York common-law duties that constitute requirements with respect to the device at issue that differ from federal requirements relating to safety and effectiveness.
He therefore joined the Court’s judgment and all of its opinion except for Parts III-A and III-B.28
Justice Ginsburg dissented on this point. She contended that common-law claims based on duties that parallel rather than add to federal requirements should not be pre-empted. The MDA text and history do not support removing all judicial recourse for consumers injured by approved devices.
She emphasized the presumption against pre-emption in fields of traditional state regulation such as health and safety. She would have held that the Riegels' claims of negligence, strict liability, and implied warranty are based on duties that parallel federal requirements rather than differing from them.29
Whether the MDA pre-empts all state-law claims or permits claims premised on violations of federal requirements?30
The MDA does not pre-empt all state-law claims. The pre-emption clause does not apply to a state-law claim based on a violation of federal requirements. The limited exemption for state requirements approved by the FDA indicates that Congress did not intend to pre-empt every possible state remedy.31
No. The MDA pre-emption clause applies only to state requirements that are different from or in addition to federal requirements.32 Claims premised on a violation of the federal PMA conditions or FDA regulations would impose duties that parallel rather than differ from federal law and therefore fall outside the scope of pre-emption.33 The District Court recognized that parallel claims would not be pre-empted but the Riegels did not raise that argument on appeal or in their certiorari petition.34 The existence of the section 360k(b) exemption process further confirms that Congress anticipated some state requirements could coexist with federal oversight when approved by the FDA.35
The MDA does not pre-empt all state-law claims and permits claims premised on violations of federal requirements.36
Related opinions on this issue
Justice Stevens concurred in part and in the judgment. He joined the Court in concluding that the PMA process imposes device-specific requirements and that common-law claims imposing different or additional requirements are preempted. He wrote separately to stress that the MDA's pre-emption provision does not eliminate all state-law remedies.
In his view, claims based on violations of federal requirements remain available because they impose parallel rather than differing duties. He cautioned against reading the majority opinion to suggest otherwise and noted that the text reaches common-law requirements but preserves room for non-conflicting state actions. He joined all parts of the opinion except III-A and III-B.37
Justice Ginsburg dissented from the overall breadth of pre-emption. She argued that the statute leaves room for state remedies that do not conflict with federal standards. She would reverse the judgment of the Court of Appeals because the Riegels' claims are not pre-empted.
Her view rested on the MDA's purpose to protect consumers and the absence of any indication that Congress intended to eliminate common-law recourse for injuries caused by defectively designed or labeled devices.38