KevinMD March 23, 2024
M. Bennet Broner, PhD

A recent TV advertisement attempted to recruit clients for a class action suit against a pharmaceutical manufacturer (PM) for a medication side effect (SE). The “cause of action” was unstated: was it the side effect’s existence or that the company failed to emphasize its severity?

The SE was acknowledged not only by the company but also the FDA, which nonetheless approved the medication (RX), determining that its benefits outweighed the side effect for a certain class of individuals. Subsequently, it was learned that the medication was useful for another, though unapproved purpose, for which people demanded it and physicians had no difficulty complying, as off-label use is an unwritten standard of care. As happens with increasing use, more people experienced...

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