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Drug & Device News
FDA Certification Does Not Shield Generic Drug Maker from Suit
Generic drug manufacturers are not insulated from lawsuits by a Food and Drug Administration (FDA) approval process that certifies such drugs as the “bioequivalent” of their brand-name predecessors, a federal judge in Philadelphia has ruled. In the 29-page decision rendered in In re Budeprion XL Marketing & Sales Litigation, U.S. District Judge Berle Schiller refused to dismiss a suit brought by consumers who were previously taking Wellbutrin, a brand-name antidepressant drug, and claim they experienced side effects upon switching to generic buproprion. The suit alleges that two manufacturers ' Teva Pharmaceuticals and Impax Laboratories ' became aware of the potential problem but failed to warn the public about differences between the name-brand and generic versions of the product that affected the release rate of the active ingredient. Schiller applied the U.S. Supreme Court's recent decision in Wyeth v. Levine, and concluded that generic drug manufacturers, like manufacturers of the previously approved name-brand drugs their products mimic, also have a continuing duty to issue warnings about any new hazards that arise after approval.
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.
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 ...."