products liability

Riegel v. Medtronic


Do the Medical Device Amendments, which were intended to replace state regulation of medical devices with centralized federal regulation, forbid injured patients from asserting state-law claims against manufacturers that received premarket approval from the Food and Drug Administration?



In 1996, a catheter burst during Charles Riegel's angioplasty. Riegel and his wife filed a product liability complaint against the catheter's manufacturer, Medtronic, Inc. A federal district court dismissed the complaint, holding that the Medical Device Amendments ("MDA") preempted most of the claims. The U.S. Court of Appeals for the Second Circuit affirmed the dismissal and the Riegels appealed to the U.S. Supreme Court. The MDA generally forbids states from imposing requirements on devices that received premarket approval from the Food and Drug Administration ("FDA"). Because the complaint depends on state law, Medtronic argues that letting it proceed would impose state requirements, usurp the power of the FDA, and stifle innovation in the medical field. Mrs. Riegel, who was substituted as plaintiff after her husband died, argues that while Congress gave the FDA power to regulate medical devices, it never meant to stop private citizens from suing negligent manufacturers. The outcome in this case will likely depend on the Supreme Court's style of statutory interpretation as well as its beliefs about the best way to manage the complex world of medical devices.

Questions as Framed for the Court by the Parties 

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.


In 1996, Dr. Eric Roccario attempted to unclog a "diffusely diseased" and "heavily calcified" artery supplying Charles Riegel's heart. When several attempts using other devices failed, Dr.


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Philip Morris U.S.A. v. Williams


1. Whether, when the Supreme Court remands a case and instructs a state court to apply a constitutional standard, the state court can then decide the case using a procedural rule not previously mentioned in litigation.

2. Whether punitive damages 97 times greater than compensatory damages can be awarded based on the reprehensibility of a defendant’s conduct rather than the harm actually suffered by the plaintiff.


Court below: 


In 1997, Mayola Williams’s husband Jesse Williams died from lung cancer as a result of smoking cigarettes manufactured and marketed by Philip Morris USA Inc. Mayola Williams sued Philip Morris alleging negligencestrict product liability, and fraud. At trial, the court rejected Philip Morris’s request for a jury instruction on punitive damages which stated that Philip Morris could not be punished for harms suffered by nonparties. The jury awarded Williams $79.5 million dollars in punitive damages. In Philip Morris USA v. Williams (“Williams II”), the U.S. Supreme Court vacated the decision of the Oregon Supreme Court upholding this award and instructed the lower court to apply its standard of prohibiting punishment of a defendant for damage to nonparties. On remand, the Oregon Supreme Court upheld its decision, finding that a state procedural law not previously addressed justified the trial judge’s denial of the requested instruction. In this case, the Court will decide whether a lower court can decline to apply a standard that the Court has articulated and instead uphold its ruling on state procedural law grounds. This decision will affect the Supreme Court’s institutional supremacy and state courts’ treatment of punitive damages awards.

·   [Question(s) presented]

·   [Issue(s)]

·   [Facts]

·   [Discussion]

·   [Analysis

Questions as Framed for the Court by the Parties 

When this case was last before it, this Court reversed the decision of the Oregon Supreme Court and held that due process precludes a jury from imposing punitive damages to punish for alleged injuries to persons other than the plaintiff. Philip Morris USA v. Williams, 127 S. Ct. 1057, 1065 (2007). This Court then remanded the case to the Oregon Supreme Court with directions to “apply the [constitutional] standard we have set forth.” Ibid. On remand, however, the Oregon Supreme Court refused to follow this Court’s directive. Instead, the Oregon court “adhered to” the judgment that this Court had vacated because it found that Philip Morris had procedurally defaulted under state law and thereby forfeited its claim of federal constitutional error. App., infra, 22a.

The questions presented—the second of which was accepted for review but not reached when this case was last before the Court—are:

1. Whether, after this Court has adjudicated the merits of a party’s federal claim and remanded the case to state court with instructions to “apply” the correct constitutional standard, the state court may interpose—for the first time in the litigation—a state-law procedural bar that is neither firmly established nor regularly followed.

2. Whether a punitive damages award that is 97 times the compensatory damages may be upheld on the ground that the reprehensibility of a defendant’s conduct can “override” the constitutional requirement that punitive damages be reasonably related to the plaintiffs harm.


In 1950, Jesse Williams began smoking cigarettes and eventually smoked three packs a day of Marlboros, which are manufactured and marketed by Philip Morris USA Inc. (“Philip Morris”). Jesse Williams was diagnosed with lung cancer and died in 1997. Jesse Williamss widow, Mayola Williams (“Williams”), alleges that for approximately forty years Philip Morris knew that smoking cigarettes causes cancer, that millions were addicted to cigarettes, and that Philip Morris had either denied this knowledge or assu

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