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Counterfeit Drugs: A New Source of Product Liability?
Drug counterfeiting robs pharmaceutical manufacturers of their investment in patents, trademarks, copyrights, and trade dress. It robs pharmacists and consumers of money, for worthless and sometimes dangerous products. It undermines the integrity of and consumer confidence in the American health care industry and in the government's ability to regulate it. More troubling than all these systemic evils, drug counterfeiting has the potential to allow controllable illnesses to ravage patients unchecked, to spread rather than stop disease, and to injure and kill.
Traditionally, however, manufacturers have at least been insulated from personal injury tort liability when counterfeit drugs cause harm: The counterfeiter alone possesses criminal intent and the manufacturer is remote to the injury. However, recently, under a number of theories, plaintiffs have alleged negligence on the part of pharmaceutical manufacturers for counterfeiting of their products. For example, a current lawsuit in St. Louis alleges that a breast cancer patient took a counterfeit form of Procrit' 20 times less potent than the genuine drug. According to a report in The San Francisco Chronicle, the attorney representing this plaintiff hopes to transform this suit into a class-action lawsuit. In another recently settled case involving the distribution of counterfeit Serostim', the only growth hormone approved by the FDA for the treatment of AIDS wasting, the lawsuit named the drug's manufacturer, along with the pharmacy and drug distributors.
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.
Compliance Officers: Recent Regulatory Guidance and Enforcement Actions and Mitigating the Risk of Personal Liability
This article explores legal developments over the past year that may impact compliance officer personal liability.