Law Commons^™

Mutual Pharmaceutical Co. V. Bartlett And Its Implications, Brian Wolfman, Anne King

Georgetown Law Faculty Publications and Other Works

The authors state that the U.S. Supreme Court’s preemption ruling in Mutual Pharmaceutical Co. v. Bartlett, which generally shields generic drug manufacturers from state-law damages liability for design-defect claims, may also have broader implications for preemption jurisprudence. In this article they describe the Supreme Court’s decision in Mutual and evaluate how it may affect future products-liability litigation.

Part I provides an overview of the case’s factual background and of federal generic drug regulation, while Part II discusses the Court’s majority opinion and the dissents. Part III analyzes the implications of the decision, offering ideas on how plaintiffs injured by …

State Law, The Westfall Act, And The Nature Of The Bivens Question, Carlos Manuel Vázquez, Stephen I. Vladeck

Georgetown Law Faculty Publications and Other Works

In a number of recent cases touching to varying degrees on national security, different courts of appeals have applied a strong presumption against recognition of a Bivens cause of action. In each of these cases, the courts’ approach was based on the belief that the creation of a cause of action is a legislative function and that the courts would be usurping Congress’s role if they recognized a Bivens action without legislative authorization. Thus, faced with a scenario where they believed that the remedial possibilities were either "Bivens or nothing," these courts of appeals chose nothing.

The concerns that …

Alien Tort Claims And The Status Of Customary International Law, Carlos Manuel Vázquez

Georgetown Law Faculty Publications and Other Works

Much of the recent debate about the status of customary international law in the U.S. legal system has revolved around the alien tort provision of the Judiciary Act of 1789, currently section 1350 of Title 28. In Filártiga v. Peńa-Irala, the decision that launched modern human rights litigation in the United States, the Court of Appeals for the Second Circuit relied on the view that customary international law has the status of federal common law in upholding section 1350’s grant of federal jurisdiction over a suit between aliens. The court’s position that customary international law was federal law was …

Wyeth V. Levine And Its Implications, Brian Wolfman

Georgetown Law Faculty Publications and Other Works

The U.S. Supreme Court’s decision in Wyeth v. Levine sharply limited the availability of implied preemption as a defense in pharmaceutical cases. In this Analysis & Perspective, attorney Brian Wolfman discusses the decision and its implications for prescription drug litigation as well as litigation in other areas that are regulated by the federal government.

After Wyeth, Wolfman says, a defendant in a prescription drug case must demonstrate a ‘‘tight fit between the labeling change proposed by the manufacturer (and rejected by the FDA) and the labeling change that the plaintiff contends would have prevented her injuries.’’ Moreover, he says, …

Why Preemption Proponents Are Wrong, Brian Wolfman

Georgetown Law Faculty Publications and Other Works

The basic idea of federal preemption is easily stated: It is a constitutionally mandated principle that demands that federal law trumps state law when the two conflict or in the rare instances when a federal law is so comprehensive that there’s no role left for state law to fill. But in practice, courts have often had difficulty applying the principle.

For plaintiff lawyers, preemption is an ever-present worry. When your client has been injured by a defective car, truck, medical device, boat, tobacco product, pesticide, or mislabeled drug, or has been victimized by a bank or other lending institution, the …

Sosa V. Alvarez-Machain And Human Rights Claims Against Corporations Under The Alien Tort Statute, Carlos Manuel Vázquez

Georgetown Law Faculty Publications and Other Works

Contrary to the claims of some observers, the Supreme Court's decision in Sosa v. Alvarez-Machain does not sound the death knell for the use of the Alien Tort Statute to maintain human rights claims against private corporations in the U.S. courts. The decision clarifies the nature of claims under the Alien Tort Statue to some extent, and places some limits on the theories available in actions against private corporations, but for the most part such suits remain as viable after Sosa as they were before. That is not to say, however, that victims of corporate human rights violations in developing …