Generic Drug Warnings/Preemption – Contrary Opinions
In Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013) the Fifth Circuit affirmed the trial court’s dismissal of plaintiff’s failure to warn claims in connection with her use of the generic drug metoclopramide (brand-name Reglan). Penny Morris took the generic drug from early 2006 thru July 2008, but ingesting the drug for more than 12 weeks had been contra-indicated on FDA approved labels since a 2004 update and by “black box” labeling since 2009. The generic’s manufacturer PLIVA failed to adopt the 2004 FDA approved revisions. This failure formed the basis of her “failure to update” claim, i.e., the generic manufacturer failed to meet its duty under federal law to update its label to match that of the branded manufacturer.
However, the Fifth Circuit summarily dismissed her update contention, stating:
[A] claim that PLIVA breached a federal labeling obligation sounds exclusively in federal (not state) law, and is preempted. 21 U.S.C. ? 337(a); see Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4, 121 S. Ct. 1012, 1018 n.4, 148 L. Ed. 2d 854 (2001).
In Flugenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013), the Sixth Circuit reached the opposite conclusion in a case with nearly identical facts one month later, and reversed the lower court’s preemption based dismissal. After a lengthy de novo analysis of preemption and the recent Supreme Court cases of Wyeth and Mensing, the Court found that Fulgenzi’s case was different from the Mensing case, where the plaintiff had taken the generic when the label conformed to the brand drug maker’s label.
It would have been impossible for the generic company to have provided a stronger label in Mensing due to the duty of sameness. Here, however, the Court found that PLIVA’s duty to provide an adequate warning under state law did not conflict with its duty under federal law to adopt the stronger warning.
In our case, not only could PLIVA have independently updated its labeling to match that of the branded manufacturer through the CBE process, see Mensing, 131 S. Ct. at 2575, but it had a federal duty to do so, 21 C.F.R. ? 314. 150(b)(10). As a result, compliance with federal and state duties was not just possible; it was required. Impossibility preemption is inappropriate in such a case.
Id., at p. 15.