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Drug & Device News
Class Action Settled Decades After Infant Deaths
A settlement has been reached in a class action suit involving the deaths in the 1980s of 40 infants who were given E-Ferol, a vitamin E supplement manufactured by the now-defunct Carter-Glogau Laboratories Inc. and distributed by O'Neal, Jones & Feldman Inc. The $110 million settlement was approved by Judge Sidney Fitzwater, chief judge of the U.S. District Court for the Northern District of Texas. The FDA never approved E-Ferol, which was administered intravenously to premature babies to prevent blindness and lesser visual impairments. The plaintiffs' suit claimed that the manufacturer and distributor led hospitals to believe the supplement had indeed received federal approval, and that it caused problems such as liver and kidney failure in hundreds of babies. A 1980s investigation of E-Ferol, conducted by the Centers for Disease Control and Prevention, found that the emulsifier Polysorbate 80 was the cause of the problems.
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.
Second Circuit Reinforces Bankruptcy Code Settlement Payment Safe Harbor
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 ...."