The title of this post reflects a question that we’ve been asked repeatedly: Does preemption apply even if a physician puts a drug or device to an off-label use?

You’ve come to the right place for an answer: Of course it does.

“Off-label use” refers to a physician’s (entirely proper) decision to use a lawfully marketed drug or device for a purpose not indicated in the product’s package insert. If a physician prescribes a dosage outside of the range specified in the label, that’s off-label. If a physician prescribes a combination of drugs to treat a cancer, and that combination is recommended in the medical literature, but has not been approved by the FDA, that’s off-label.

Remarkably, if a physician uses a Q-tip to remove wax from your kid’s ear, that’s off-label. Those cotton-tipped swabs aren’t labeled for removing ear wax.

Physicians are permitted to make off-label use of drugs and devices and, to our eyes, off-label use does not affect the preemption analysis.

First, Riegel v. Medtronic, 128 S. Ct. 999 (2008), the Supreme Court case finding in favor of preemption for medical devices marketed pursuant to pre-market approval, involved a treating physician putting a device to off-label use.

The balloon catheter involved in Riegel was contraindicated for use in patients with calcified stenoses; Riegel’s right coronary artery was “heavily calcified.” The package insert also warned that the catheter should not be inflated beyond eight atmospheres; the physician inflated it to ten atmospheres.

The very case that established preemption for PMA-approved devices in the Supreme Court thus involved an off-label use. That surely goes a long way toward answering the question we’ve posed.

Moreover, that result makes sense. The FDA dictates what drug and device manufacturers can and cannot say in their labeling. If manufacturers could be liable for failure-to-warn when physicians chose to put products to off-label uses, then state law would be requiring manufacturers to give warnings that federal law prohibits manufacturers from giving. That’s precisely the situation that preemption is meant to avoid.

We’re not addressing here the preemption analysis that might apply if a manufacturer unlawfully promoted a product for off-label use. We’ll save that post for another day (or maybe never).

But, in a typical situation, off-label use of a drug or device should not strip a manufacturer of its preemption defense.

  • Anonymous

    The simple fact that the FDA is fallible in regards to what they conclude is safe for use suggests that preemption should not be allowed to be a factor in lawsuits of those harmed or died by a product the FDA approved.

  • laura

    “The very case that established preemption for PMA-approved devices in the Supreme Court thus involved an off-label use. That surely goes a long way toward answering the question we’ve posed.
    Moreover, that result makes sense.”

    What doesn’t make sense to me is why Riegel v Medtronic was used as the deciding case for all PMA-approved device cases. There are certainly many cases that were not muddied by off label, medical professional erred complications that would have provided a much clearer picture as to whether or not medical device preemption should be the law of the land. The same thing is happening in Wyeth v Levine. Why should either of theses cases be the decider for all PMA-approved medical device cases? It’s like using one rotten apple to decide whether to throw out the entire bushel.

  • laura

    A quick correction on my last post:

    Why should these cases be the deciders for all drug and PMA-approved medical device cases?

  • hg

    “We’re not addressing here the preemption analysis that might apply if a manufacturer unlawfully promoted a product for off-label use. We’ll save that post for another day (or maybe never).”

    Shucks, guys. Well, you don’t really have to. At least the current FDA/DOJ made it clear in Kent that no determination of theirs – including a finding of felony fraud – would open the door to state tort remedy. If that applies to approval or compliance fraud, one would naturally assume it applies to off-label fraud. The principle – perverse as it may seem – would be the same, n’est-ce pas?