In Lashley v. Pfizer, Inc., 2014 WL 661058 (5th Cir. Feb. 21, 2014), the United States Court of Appeals for the Fifth Circuit held that federal law preempts “parallel” state-law claims against generic drug manufacturers and affirmed a grant of summary judgment for brand-name manufacturers on grounds that they do not owe a duty to consumers of generic versions of the drug.
The Fifth Circuit’s decision arose out of two separate actions by Plaintiffs, whose cases were consolidated on appeal, against generic and brand manufacturers for injuries allegedly related to their use of metoclopramide—the generic version of Reglan. On appeal, the Fifth Circuit affirmed the district courts’ dismissals of the claims against the generic manufacturers as preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) and Mutual Pharm., Co. v. Bartlett, 133 S. Ct. 2466 (2013). The Court determined that all of Plaintiffs’ claims against the generic manufacturers turned on the adequacy of labeling and related information, and could thus be construed as failure-to-warn claims, which are preempted by Mensing. Lashley, 2014 WL 661058, at *2. Significantly, the Court also rejected arguments that some of Plaintiffs’ state law claims against generic manufacturers are parallel to federal law claims, and thus not preempted. Plaintiffs had pointed to two rulings allowing parallel state law claims against medical device manufacturers to proceed - Medtronic, Inc. v. Lohr, 116 S. Ct. 2240 (1996) and Hughes v. Boston Scientific, 631 F.3d 762 (5th Cir. 2011). The Court, however, distinguished between express preemption in the medical device context and implied preemption, and stated that “the inquiry [here] is not whether there is a ‘parallel’ claim where one looks for absence of conflict with the statute; the inquiry is whether the state-law claim is impliedly preempted.” Id. The Court accordingly held that even the supposedly “parallel” state law claims were impliedly preempted. Id. at *4. This ruling accentuates a circuit split on the question of whether plaintiffs suing generic companies can state a claim for parallel violations of federal law, such as “failure to update” the generic label to match the branded one. Compare Lashley, with Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013).
The Fifth Circuit also affirmed summary judgment in favor of the brand manufacturers because, under state law in Mississippi and Texas, the brand manufacturers owed Plaintiffs no duty because the Plaintiffs “did not ingest the . . . brand defendants’ products.” Id. at *4. The Fifth Circuit’s refusal to hold brand-name manufacturers liable for injuries caused by the generic version of their drug is a reaffirmation of the overwhelming majority of precedent rejecting so-called “innovator liability.”