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Off-label use — using a drug or medical device for an indication other than that set forth in the FDA-approved label — poses tricky legal issues.
Off-label use is entirely legal: The FDA doesn’t regulate the practice of medicine, so physicians can use drugs or devices for any appropriate purpose, approved by the FDA or not.
But if the physician is later sued for malpractice, a lay jury may give disproportionate weight to the fact that the use was off-label.
To help combat that problem, one of your humble scribes (Herrmann) teamed up with a co-author (Pearson Bownas, of Jones Day) to publish an article explaining why in cases of mere off-label use (as opposed to, say, making a contraindicated use), the package insert should not be admissible in evidence at trial. That article appears in today’s Northwestern University Law Review: Colloquy, the online journal affiliated with the Northwestern Law Review. For those who are interested, here’s a link to “Keeping The Label Out Of The Case.”