Riegel v. Medtronic, Inc.
2008 U.S. LEXIS 2013, 128 S.Ct. 999, 169 L. Ed. 2d 892 (2008)
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Rule of Law:
The Medical Device Amendments' express pre-emption clause bars state common-law claims that challenge the safety or effectiveness of a medical device that has undergone the Food and Drug Administration's rigorous premarket approval (PMA) process.
Facts:
- Medtronic, Inc. designed, manufactured, and marketed the Evergreen Balloon Catheter, a Class III medical device.
- In 1994, the FDA granted premarket approval (PMA) for the device after a rigorous review of its safety and effectiveness.
- The device's FDA-approved labeling stated its use was contraindicated for patients with diffuse or heavily calcified stenoses.
- The label also warned against inflating the catheter beyond its rated burst pressure of eight atmospheres.
- In 1996, Charles Riegel, whose right coronary artery was diffusely diseased and heavily calcified, underwent a coronary angioplasty procedure.
- During the procedure, Riegel's doctor inserted the Evergreen Balloon Catheter and inflated it five times to a pressure of 10 atmospheres.
- On the fifth inflation, the catheter ruptured.
- As a result of the rupture, Riegel suffered a heart block, required life support, and underwent emergency coronary bypass surgery.
Procedural Posture:
- Charles and Donna Riegel sued Medtronic, Inc. in the U.S. District Court for the Northern District of New York, a federal trial court.
- The District Court held that the MDA pre-empted most of the Riegels’ common-law claims and dismissed them.
- The Riegels, as appellants, appealed the dismissal to the U.S. Court of Appeals for the Second Circuit.
- The Court of Appeals affirmed the District Court's judgment, agreeing that the claims were pre-empted by the MDA.
- The Riegels, as petitioners, sought a writ of certiorari from the Supreme Court of the United States.
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Issue:
Does the pre-emption clause of the Medical Device Amendments of 1976 bar state common-law claims challenging the safety and effectiveness of a medical device that has received premarket approval from the Food and Drug Administration (FDA)?
Opinions:
Majority - Justice Scalia
Yes. The pre-emption clause of the Medical Device Amendments (MDA) bars state common-law claims challenging the safety and effectiveness of a medical device that has received premarket approval from the FDA. The PMA process imposes specific, device-related federal 'requirements' on a device's design, labeling, and manufacturing. Unlike the less stringent § 510(k) process considered in Medtronic, Inc. v. Lohr, which focuses on equivalence to an existing device, the PMA process is a rigorous federal safety review. State common-law duties, such as those underlying claims for negligence and strict liability, also constitute 'requirements' under the statute. Allowing a jury to find a manufacturer liable under state tort law would impose requirements 'different from, or in addition to,' the specific federal requirements established by the FDA's approval, thereby disrupting the balance Congress struck between safety and innovation. The MDA does not, however, pre-empt 'parallel' claims that are premised on a violation of the FDA's own regulations.
Dissenting - Justice Ginsburg
No. The MDA's pre-emption clause does not bar these state common-law claims. Courts must begin with a strong presumption against pre-emption, especially in traditional areas of state regulation like health and safety. The legislative history of the MDA, passed in the wake of the Dalkon Shield disaster, shows Congress intended to increase consumer protection, not eliminate existing common-law remedies. The pre-emption clause was aimed at conflicting state regulatory schemes, not at tort suits. For decades, the FDA's similarly rigorous premarket approval of new drugs has not been held to pre-empt state tort law, and Congress gave no indication it intended a different result for medical devices. The complete removal of judicial recourse for consumers injured by FDA-approved devices is a radical step that Congress would not have taken without explicit comment.
Concurring - Justice Stevens
Yes. While Justice Ginsburg's account of the legislative history is persuasive that Congress's principal concern was conflicting state regulations, not tort suits, the plain text of the statute compels pre-emption. The statutory term 'requirements' is broad enough to encompass common-law rules administered by judges. A majority of the Court in Lohr, as well as precedent like Cipollone, supports the view that the common-law duties underlying the Riegels' claims qualify as 'requirements' under the statute. Therefore, although the result may not align with the original legislative intent, the statutory language itself is clear and must be followed, leading to the conclusion that these claims are pre-empted because they impose requirements different from the federal PMA requirements.
Analysis:
This decision establishes a strong, bright-line rule of express pre-emption for medical devices that have undergone the FDA's PMA process, providing significant tort immunity to manufacturers. It clarifies and narrows the holding of Medtronic v. Lohr, distinguishing the extensive, device-specific 'requirements' of PMA from the more general nature of the § 510(k) clearance process. The ruling effectively channels litigation over PMA-approved devices away from claims of defective design or inadequate warnings and towards 'parallel claims' that allege a manufacturer's failure to comply with federal regulations. This creates a higher bar for plaintiffs and reinforces the primacy of the FDA's expert judgment in balancing safety and innovation for high-risk medical devices.
