Archives for April 20, 2009

Off label drug use and medmal suits: should there be “Truth” in labeling?

Pardon my silliness with “truth”, it’s an actual cause for concern.  The question is: should the FDA’s package insert be admissible in court as The Word in a trial involving off-label use?

Frankly, I’d never thought about it.  Fortunately, two legal scholars at the Northwestern University Law Review (one of whom happens to be a law blogger) have though it through, and answer nay:


The FDA approves prescription drugs and medical devices for only the specific uses indicated in the product labeling that the manufacturer submits in the approval process. A physician may determine, however, that a use not indicated in the FDA-approved labeling—an “off-label” use—would benefit a patient. This Article argues that in medical malpractice cases involving an off-label use, the product’s label should not be admitted as evidence of either the standard of care or the physician’s alleged breach of that standard.

I can think of two meds I use ‘off-label’, IV phenergan and haldol, neither of which are FDA approved for that route but which have proven themselves safe and very effective (for a long long time before I became a physician). (DWL: I know there’s no 100% safe drug).

Thanks to Mark Hermann, JD of Drug and Device Law for co-authoring this, and for giving me a heads-up.