Navigating Regulatory Waters in the Wake of Wyeth v LevineTripp Haston examines developments and trends in US federal pre-emption following the Supreme Court decision in Wyeth v Levine.

摘要

Two arguably inapposite quotes come to mind as I begin this article on the ramifications for pre-emption in the US following the decision by the country's Supreme Court in Wyeth v Levine.May you live in interesting times. Ancient Chinese proverbThe more things change, the more they stay the same. French novelist Alphonse KarrThe first quote springs to mind as those handling US regulatory portfolios for pharmaceutical and medical device companies grapple with how best to retain any product liability protections based on regulatory decisions by the Food and Drug Administration in the wake of the Supreme Court's decisions in Levine and Riegel v Medtronic2.