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Riegel v. Medtronic, Inc.

Supreme Court of the United States · 2008 · Constitutional Law

Constitutional LawTortsFederal PreemptionMedical Devices21 U.S.C. § 360k(a)Medical Device Amendmentsexpress preemptionpremarket approval

Facts

The device at issue was Medtronic's Evergreen Balloon Catheter, a Class III medical device that received FDA premarket approval in 1994, with supplemental label approvals in 1995 and 1996. During Charles Riegel's 1996 coronary angioplasty, his doctor used the catheter despite labeling stating that use was contraindicated for patients with diffuse or calcified stenoses, and inflated it to 10 atmospheres even though the label warned not to exceed its rated burst pressure of eight atmospheres. The catheter ruptured on the fifth inflation, and Riegel suffered serious injuries requiring life support and emergency coronary bypass surgery. The Riegels sued under New York common law, alleging defective design, labeling, and manufacture.

Issue

Does the Medical Device Amendments' express pre-emption clause, 21 U.S.C. § 360k(a), pre-empt New York common-law claims challenging the safety or effectiveness of a Class III medical device that received FDA premarket approval? More specifically, does FDA premarket approval create federal requirements applicable to the device, and do common-law tort duties count as state requirements that are different from or in addition to those federal requirements?

Rule

Under 21 U.S.C. § 360k(a), state requirements are pre-empted when (1) the Federal Government has established requirements applicable to the particular device, and (2) the plaintiff's state-law claim would impose requirements relating to safety or effectiveness that are different from, or in addition to, the federal ones. FDA premarket approval imposes device-specific federal requirements, and state common-law duties such as negligence, strict liability, and implied warranty are state requirements for purposes of the statute. State-law claims premised on violations of FDA requirements are not pre-empted because they parallel, rather than add to, federal law.

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One of 10 multiple-choice questions for this case. Pick an answer to see why.

In Phoenix, Nora Patel was injured when an implanted spinal stimulator malfunctioned. The stimulator is a Class III device that received FDA premarket approval, and Nora sues under Arizona negligence law alleging the device should have been designed with an additional automatic shutoff feature not included in the FDA-approved design.

Is Nora's claim most likely preempted under 21 U.S.C. § 360k(a)?

Explanation. Yes. The majority held that FDA premarket approval is federal safety review that imposes device-specific federal requirements on the approved device. It also held that common-law negligence duties count as state requirements. A claim insisting the device should have included an extra safety feature would impose a requirement different from or in addition to the PMA-approved design, so it is preempted.