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Drug & Device News
Class Action Off-Label Drug Lawsuit Dismissed
A U.S. District Court judge sitting in Los Angeles dismissed an off-label drug promotion multi-district litigation on Dec. 17, 2008. The suit claimed that Amgen Inc., Da Vita Inc. and Fresenius Medical Care Holdings Inc. pushed doctors to use the anemia drugs Epogen and Aranesp to treat people with kidney disease, cancer and HIV even though the drugs are not approved for those uses. Judge Pillip Gutierrez ruled in In re Epogen & Aranesp Off-Label Mktg. and Sales Practices Litig., MDL08-1934 (ARG) (C.D. Calif.), that the seven plaintiff health-benefits plans could not sue the defendant drug companies using federal racketeering laws or state unfair business practices laws. The court determined the suit was barred because the Federal Food and Drug Administration has exclusive jurisdiction over enforcement of the rules against promoting off-label drug uses. “Allowing plaintiffs to proceed on a theory that defendants violated RICO by engaging in off-label promotion, without specific allegations that defendants made false or misleading statements, would, in effect, permit plaintiffs to use RICO as a vehicle to enforce the FDCA [Food, Drug and Cosmetic Act] and the regulations promulgated thereunder,” wrote the court. Justice Gutierrez did, however, leave it open for the plaintiffs to amend their suit to keep it alive, although it was not clear on what basis this could be done.
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.