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Can Failure-to-Warn Claims Against Generic Drug Manufacturers Be Preempted?
This year, the U.S. Supreme Court in Wyeth v. Levine, 555 U.S. ___ (March 4, 2009), considered for the first time the preemption of state law-based claims in pharmaceutical product liability cases and held that the Food and Drug Administration's (FDA) approval of a drug label does not preempt state law failure-to-warn claims. Although the case involved a brand drug, the Court's decision was vital in determining the availability and scope of the preemption defense for both brand and generic drug manufacturers. Prior to the Court's decision, several federal and state courts addressed preemption in the context of claims against generic drug manufacturers. An analysis of these decisions indicates that the courts' various interpretations of the FDA's Changes Being Effected (CBE) labeling supplement regulations, 21 C.F.R. ' 314.70(c), are crucial to their ultimate holdings. In Wyeth v. Levine, the Supreme Court of Vermont's holding of no preemption relied heavily on its interpretation of the CBE regulation.
'Newly Acquired Information'
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.