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This post is only from the non-Butler Snow part of the Blog.

As our 50-state survey of the learned intermediary rule demonstrates, the rule now applies in all fifty states.  That includes statutes or high court decisions from 38 states and the District of Columbia, intermediate state appellate decisions from four more states, and federal appellate Erie predictions from seven more states and Puerto Rico.  All told, only three states lack binding appellate precedent approving of the learned intermediary rule:  Rhode Island, South Dakota, and Vermont.  All three of those states have federal district court precedent, and Rhode Island has unpublished federal appellate authority in addition.

Then there’s Oregon.  That state was an early adopter of the learned intermediary rule, see McEwen v. Ortho Pharmaceutical Corp., 528 P.2d 522, 528 (Or. 1974), but a subsequent decision held that the Oregon product liability statute, which basically adopted Restatement §402A in toto, meant that the rule did not apply in strict liability cases, because §402A did not reference the rule.  Griffith v. Blatt, 51 P.3d 1256, 1262 (Or. 2002).

But in Oregon strict liability litigation, or anywhere else that some plaintiff argues that for some reason the rule doesn’t apply, there is a backup argument – implied preemption.

For both prescription drugs and medical devices, FDA regulations provide that direct-to-patient warnings – called “adequate directions for use” – are not necessary for drugs or devices that are available only with a physician’s prescription.  For drugs, the relevant regulation is 21 C.F.R. §201.100(a-c).  That regulation provides that a prescription-only drug – one that can only be obtained through “a practitioner licensed by law to administer or prescribe such drugs” bearing “[t]he statement ‘Rx only’” – is “exempt” from requirements to provide adequate directions for use to patients.  Id. §201.100(a-b).  Those directions instead go to physicians:

Labeling on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the drug can use the drug safely and for the purposes for which it is intended. . . .

Id. §201.100(c)(1) (emphasis added).  The corresponding regulation for medical devices is 21 C.F.R. §801.109, which states that a prescription-only device is exempt from a layman-type warning if its labeling includes adequate directions for use that the prescriber needs to know about to prescribe the device safely.

Any labeling . . . distributed by or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or purports to furnish information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended. . . .

Id. §801.109(d) (emphasis added).  Often, if not always, the “special controls” for a given FDA regulated product will specify that said product can only be marketed for prescription use and is thus exempt from providing “adequate directions for use” to lay patients.  Such special controls are preemptive.  E.g., 76 Fed. Reg. 6551, 6553 (FDA Feb. 7, 2011).

Applicable FDA regulations thus mandate that “adequate directions for use” need not be provided directly to patients whenever a drug or device is:  (a) prescription-only, and (b) those directions are provided instead to the prescribing physician.  It won’t come up that much.  See Holloway v. Abbvie, Inc., 2024 WL 477523, at *3 (Mag. M.D. La. Feb. 7, 2024) (unnecessary to decide preemption where learned intermediary rule reaches same result as §801.109).  However, any purported state-law requirement for direct-to-patient warnings where the above FDA regulations expressly exempt the product from that type of requirement (New Jersey cases alleging direct-to-consumer advertising come to mind) should be barred by conflict preemption.  State law cannot require direct-to-patient warnings where applicable federal law provides an exemption from such requirements.