Contrary to popular belief – even among some lawyers – off-label use is not necessarily entirely off-label. That’s a good thing, too. One of the things we’ve harped on with this blog is that off-label use is legal, common, and in various fields can represent the prevailing medical standard of care.
One thing we’ve never argued on this blog is that off-label use (or any use) of prescription medical products is risk free. Thus, in cases of widespread off-label uses, by all means the FDA should have the ability to ensure (as is the case with labeled uses) that a product’s labeling informs prescribing doctors of relevant risks. The alternative view that we encountered back in the Bone Screwlitigation (flirted with by the Kessler-era FDA), that warnings pertaining to off-label uses were somehow “promotion” and should be prohibited, always struck us as illogical and counterproductive.
It turns out that the FDA can indeed require warnings about off-label uses.
Now for the kicker. The express language of these regulations – “required by” the FDA – places warnings about off-label uses in the prescription drug context squarely within the realm of “impossibility” preemption under the Levine-Mensing-Bartlett line of Supreme Court authority, since off-label use warnings are not something that a drug manufacturer can add to its label unilaterally without prior FDA approval. We’ve explained that rationale in greater detail here as to other types of label changes that require the Agency’s prior approval. It’s also the same reasoning that requires preemption in the context of black box warnings, as we’ve discussed here and here. So, if a plaintiff is demanding warnings about off-label uses, the defense has a preemption defense.
Number two, implied impossibility preemption under Levine-Mensing-Bartlett should apply generally to prohibit all plaintiffs from making any demands for warnings pertaining to off-label uses against all prescription medical devices because, for both drugs and devices, such warnings explicitly and repeatedly require FDA pre-approval. The FDA has always maintained tight control over the information that regulated manufacturers may provide that pertains to off-label uses. Whether or not we like that as a First Amendment proposition, it’s a fact, and it’s reflected in the FDA’s regulations pertaining to off-label use warnings for both prescription drugs and medical devices.
Number three, in the specific context of PMA medical devices, the FDA’s power to require off-label information in labeling means that a plaintiff’s demand for off-label warnings “different from or in addition to” what the FDA has required (or chosen not to require). That, in turn, mandates that such demands be expressly preempted under Riegel.
Federal preemption is the strongest defense available to manufacturers of prescription drugs and medical devices. Where available it should be employed to the maximum extent possible.