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The Products Liability Dilemma for Pharmaceutical and Medical Device CEOs

By Alan Minsk and Diana Rusk Cohen

The CEO of a large pharmaceutical company receives an internal report that several manufacturing plants do not meet Current Good Manufacturing Practices (CGMP). Another CEO is aware that the sales team may be promoting the company's product for unapproved, “off-label” uses. These cases present the CEO with a dilemma: He must decide whether to refrain from doing anything ' let the company's regulatory affairs or quality assurance personnel handle matters ' or act to address regulatory issues presented.

Refraining from Action

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