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Experimental Drugs and the Compassionate Use Doctrine
People with chronic illnesses and incurable diseases are often willing to do almost anything to improve their health. That includes seeking alternative treatments and trying unapproved drugs. While gaining access to drugs not yet approved by the Food and Drug Administration (FDA) can be a difficult task, many people will go to nearly any lengths to get them, to include suing a drug manufacturer to force it to provide them the drug. That's what happened in the case of Gunvalson v. PTC Therapeutics Inc., Slip Copy, 2008 WL 4003377 (D.N.J.,2008), a case recently overturned on appeal. In this month's issue, we look at the reasoning of the district court. In next month's issue, we'll see why the appellate court disagreed, and discuss the implications of the compassionate use doctrine for drug research and for individual patient outcomes.
A Boy and His Family Fight for Medication
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.
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.
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.