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Decision Excluding Causation Theory in Rezulin MDL Impacts Other Cases
In an important recent Daubert decision, Judge Lewis A. Kaplan of the Southern District of New York ruled that plaintiffs in the Rezulin multidistrict litigation may not rely on proposed expert opinion testimony that the medication can cause liver injury to a patient who did not experience markedly abnormal liver enzymes while on therapy. In Re Rezulin Products Liability Litigation, MDL 1348, 2005 U.S. Dist. LEXIS 3790 (SDNY Mar. 14, 2005), hereinafter (“In Re Rezulin“). Apart from its profound implications for the Rezulin litigation, the decision has far-reaching significance for pharmaceutical and toxic tort product liability cases.
Rezulin was a prescription medication used to treat type 2 diabetes. Like all medications, Rezulin had risks as well as benefits. In rare cases, some people who took Rezulin had an acute, idiosyncratic reaction to the medication, about which the FDA-approved label specifically warned. The hallmark of this reaction is a release of liver enzymes into the bloodstream, which is detectable by standard laboratory tests. Plaintiffs' experts proffered the novel theory that Rezulin could cause an injury without the release of enzymes into the bloodstream. Thus, they posited a theory of invisible and undetectable liver injuries, so that any liver disease diagnosed after a patient took Rezulin could be attributed to Rezulin (the “silent injury” theory).
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.