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.


  1. Finnan Haddie says:

    Now there’s a scary thought. It wasn’t all that long ago when there wasn’t a single chemotherapy drug labeled for use in gynecologic cancers because the drugs had only been tested in men.

  2. I can’t imagine what we would do in pediatrics if we were restricted to drugs that are actually approved for kids…

  3. The fact that drug labels are prejudicial and tend to mislead lay jurors are precisely the reasons that plaintiff attorneys will viciously fight to admit them as evidence.
    Just another shining example of why we need health courts to cut through this theatrical BS.

  4. What evidence is there that “lay jurors” are misled by drug labels in these cases? What evidence is there that judges are admitting it for the purpose of showing the standard of care? Are there a bunch of verdicts out there that would be reversed?

    Shouldn’t you have to show a problem before you propose a “solution” (assuming health courts solve anything, that is)?

  5. TheNewGuy says:

    And Matt shows up to defend the practice… right on cue.

  6. How dare someone ask a question that might cause thought? OUTRAGEOUS!! Physicians doing exactly the same thing they always have and never examining their situation or their beliefs and doing anything about them is certainly working wonders for them, isn’t it? That’s why we still have the third party payer system, after all!

    But I appreciate you caring enough to notice.

  7. You know, New Guy, instead of trying to argue issues of law, and stalking me, when both have such a minimal effect on your practice, you should probably be more focused on articles like this one rather than lawyer discussions on the admission of evidence where the actual impact on you is negligible at best:

    Right now your whole manner of providing for your family] is up for review in Washington with a President and Congress who are intent on doing SOMETHING. If I were you, I’d be a lot more worried about that and trying to steer the direction there given the massive impact that will have on your life.

  8. Stalking?

  9. I didn’t want to go there, but he shows up everytime I post just to note my presence. I like to think of it as a testament to my popularity, rather than him stalking.

  10. TheNewGuy says:


    Stalking is a pretty serious charge, Matt.

    The fact that we repeatedly encounter one another online has more to do with the fact that we apparently frequent the same blogs. In no way are you an obsession, or an interest of mine. I’ve simply seen you enough times and in enough places that I recognize you, and so I pop in to say hello. I do sometimes throw you an elbow or two, but we’re all adults here, and I honestly hope you don’t take that personally. As often as you punch back with your lectures about how we physicians are only imagining that there’s a problem with our tort system, it only seems fair to me.

    I’m not sure what else to say, other than to deny vehemently that I deliberately stalk/track/follow you around the blogosphere.

  11. “Stalking is a pretty serious charge, Matt”

    Not in this context it’s not. This is lighthearted fun. Neither of us are influencing policy as we’re probably not willing to spend the money to do so. Don’t take it seriously.

  12. TheNewGuy says:

    Then we’re good. No worries on my end.

  13. nurse 1961 says:

    I went to the blog and a hockey match broke out. Elbows?

  14. TheNewGuy says:

    figure of speech, Nurse 1961… Matt could probably take me one-on-one… something to do with all that experience eviscerating opponents in court.

    You know me… I’m just a simple doc.