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Undoing Pliva Inc. v. Mensing
As always, Congress and the FDA retain the authority to change the law and the regulations if they so desire.” Pliva, Inc. v. Mensing, 131 S.Ct. 2567, 2581 (2011). These were the final words of Justice Thomas's majority opinion in a Supreme Court decision effectively shielding manufacturers of generic drugs from state law tort claims alleging harm resulting from inadequate drug labeling. Criticism of Pliva has been widespread in some circles, with the critics arguing that Pliva's holding creates a double standard in which brand-name prescription drug manufacturers can be held liable for inadequate drug labeling, but claims against generic drug manufacturers are preempted by federal law.
With Justice Thomas's words seemingly in mind, several U.S. Senators have introduced the Patient Safety and Generic Labeling Improvement Act (S. 2295, 112th Cong. (2d Sess. 2012)), a bill seeking to undo Pliva and hold generic drug manufacturers to the same labeling obligations as their brand-name counterparts. This article examines the relationship between Pliva and the Patient Safety and Generic Labeling Improvement Act, and discusses the potential ramifications for generic drug manufacturers should the Act be signed into law.
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.
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.
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.