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Practice Tip: Pleading Medical Device Complaints
The heightened pleading requirements of Bell Atlantic Corp. v. Twombly, 550 US 544 (2007), require that practitioners who plan to file a complaint in a medical device case be even more cautious than usual. Otherwise, they may be subject to a dismissal on the pleadings. To begin with, a product liability case for the failure of a medical device is unlike other product cases. For Class III Medical Devices ' those that are most critical to human health and subject to extensive federal pre-market approval regulations ' a mere failure of the product is insufficient to bring an action. When “ordinary” products fail, the plaintiff can sue under state causes of action in negligence, strict liability in tort or breach of warranty; however, when a Class III device fails, such actions are expressly preempted by the Medical Device Act. 21 U.S.C. 360k(a).
State-Based Causes of Action
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.
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.
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.