In her dissent in Riegel v. Medtronic, Justice Ruth Bader Ginsburg cited Catherine Sharkey's article "Federalism in Action: FDA Regulatory Preemption in Pharmaceutical Cases in State Versus Federal Courts" to support the proposition that even though most states do not regard regulatory compliance as dispositive, it is a factor that may be taken into account by the jury, and a manufacturer in those states could present the FDA's approval of its medical device as evidence that it used due care in the design and labeling of the product. However, Justice Ginsburg wrote that the Court's broad reading of the statute at issue saves the manufacturer from any need to urge such a defense.

Read the Supreme Court opinion for Riegel v. Medtronic

Read Catherine Sharkey's article

Read the Washington Post's coverage of the Riegel ruling