Nope, we didn’t bury the lead. Today we are talking about a generic, negligence per se, warnings case that wasn’t decided on preemption grounds. No Mensing. No Buckman. No preemption of any kind. Normally that would make us a little nervous, but no need. It was the learned intermediary doctrine’s day to be the hero.
Plaintiff’s husband was prescribed generic amiodarone for treatment of his atrial fibrillation. Cook v. Par Pharmaceutical, Inc., 2020 WL 1891256, at *2 (N.D. Ala. Apr. 16, 2020). Plaintiff alleged that her husband did not receive a medication guide with the drug and if he had, he would have been aware that he was being prescribed the drug off-label and would have discussed its risk with his doctors. Id. at *2-3. Of course the defendant raised preemption as a defense, but the court opted to examine its learned intermediary argument first. And as it turns out, that was enough.
Plaintiff’s negligence per se case was based on Alabama’s “little” FDCA which incorporates the federal Food, Drug, and Cosmetic Act’s labeling requirements. Id. at *4. Those labeling requirements, as of 1998, included patient labeling known as medication guides. The FDCA requires manufacturers to “ensur[e] that Medication Guides are available for distribution to patients by either: (1) Providing Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers…or (2) Providing the means to produce Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers….” Id. (quoting 21 C.F.R. § 208.24(b)(1)-(2)). Plaintiff argued that these regulations established the manufacturer’s duty of care to warn patients directly. As some courts have pointed out, the FDA requires distribution of medication guides to the distributors, not the end users. See Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 70 F. Supp.3d 1246, 1252 (N.D. Ala. 2014). So, to the extent plaintiff alleged that the FDA regulations impose a duty on manufacturers to ensure that consumers receive medication guides – they don’t. But, that wasn’t the direction this court took either.
Rather, the court focused on the manufacturer’s actual duty under Alabama law – the duty to “provide adequate warnings to the [physicians] who prescribe the drug.” Cook at *4. A duty that was not displaced by the FDA’s medication guide regulations. In fact, the FDA explicitly stated as much: “the written patient medication information provided [in the medication guides] does not alter the duty, or set the standard of care for manufacturers, physicians, pharmacists, and other dispensers.” Id. at *5 (quoting Prescription Drug Product Labeling; Medication Guide Requirements, 63 Fed. Reg. 66378, 66384 (Dec. 1, 1998)). By requiring medication guides, the FDA did not intend to affect state tort duties. Therefore, neither the FDCA nor the Alabama Code in any way constrain the learned intermediary doctrine or change Alabama law which measures the adequacy of a prescription drug warning not by its effect on the consumer, but by its effect on the physician. Id. at *5 (citation omitted).
Not being able to sidestep the learned intermediary doctrine, plaintiff tried to argue that ruling on the learned intermediary doctrine was premature because the court had not yet evaluated whether the warnings provided to plaintiff’s prescribing physician were adequate. But that’s not a pertinent issue. All of plaintiff’s failure to warn allegations were based on the failure of plaintiff’s husband to receive a medication guide. Therefore, the only issue before the court was that “as a matter of Alabama law, [defendant] had no duty to provide a medication guide to [plaintiff’s husband], and that is the only duty at issue in this case.” Id. The warning provided to the doctor was irrelevant.
It may be that preemption gets more of the spotlight in generic drug cases, but sometimes it’s nice to sing the praises of a different hero. Because if we are talking about things we’ve learned from the Covid-19 crisis, we have to include that heroes come in all shapes and sizes. So, we too take a minute to extend our thanks to everyone on the front lines – all the medical professionals and staff, the pharmacy and grocery store workers, the food pantry volunteers, the trucker drivers, the farmers, the scientists, the police and fire fighters, the factory workers making protective gear, the college student who shops for her elderly neighbor, and anyone who is giving back to ease someone else’s burden. Thank you all.