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Off-Label Promotion and Product Liability

By Alan G. Minsk
January 31, 2016

The pharmaceutical industry has recently felt empowered and emboldened by one final court decision and another pending case that would seemingly allow companies to distribute, proactively, information about unapproved uses, i.e. , off-label, so long as the information is truthful and not misleading. However, companies must, nevertheless, consider potential product liability ramifications. There is no indication that, because firms may now be allowed certain latitude in one area, they are immune from product liability exposure.

Amarin Pharma v. FDA

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