Drugs

Implications of Justice Dept. Focus on Individuals

It’s still too soon to tell whether the Justice Department’s focus on individual accountability for corporate wrongdoing will have a real and lasting impact, according to a Washington Legal Foundation Legal Backgrounder by two Bryan Cave attorneys. Although the policy announced last fall by deputy attorney general Sally Yates did not include a new legal infrastructure changing the liability of corporate officers, the post says that “corporate executives, officers, and managers must pay attention to their roles and actions when faced with assertions of corporate liability and be cognizant of their own potential legal exposure. This awareness will undoubtedly have a counterproductive impact on a corporation’s ability to ferret out what happened, determine how extensive the wrongdoing was, and make prompt disclosures to the Department of Justice.”

Yates said she wanted to send a message to corporate wrongdoers, the brief says, and “change corporate culture to appropriately recognize the full costs of wrongdoing, rather than treating liability as a cost of doing business.”

The policy outlined six points of guidance in facilitating accountability for individual corporate wrongdoing:
corporations must provide all relevant facts about individuals involved in misconduct to receive any corporate credit for cooperation; individual conduct should be the focus at the outset of all civil or criminal investigations; “routine communication” should take place among civil and criminal attorneys investigating corporate wrongdoing; corporate resolutions will not protect individuals from civil or criminal liability; corporate cases should not be closed before there is a plan for addressing individual liability; and civil attorneys should consider pursuing litigation against individual wrongdoers despite their inability to pay.

The brief discusses three strategic and practical implications for practitioners defending corporate and individual clients in these actions: (1) the “all or nothing” approach to corporate credit; (2) placing individuals at the forefront of investigations along with, and in conflict with, corporations; and (3) consequences of dual-track criminal and civil proceedings.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome