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In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the U.S. Supreme Court held that most product liability claims against manufacturers of the riskiest, most critical, and most extensively regulated medical devices are preempted by federal law. The Court left open a small window for state law claims premised on violations of FDA regulations ' known as “parallel claims” ' but did not define the contours of such claims. After Riegel, the federal appellate and district courts have reached divergent conclusions regarding the level of specificity required to plead a parallel claim that survives a motion to dismiss. This article provides an overview of the case law on the topic.
Background
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.
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.
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.
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.
The Second Circuit affirmed the lower courts' judgment that a "transfer made … in connection with a securities contract … by a qualifying financial institution" was entitled "to the protection of ... §546 (e)'s safe harbor ...."