In a series of recent decisions involving metoclopramide, the Pennsylvania Superior Court found that various claims against generic manufacturers under Pennsylvania law were not preempted pursuant to the Supreme Court’s Mensing and Bartlett cases. Hassett v. Dafoe, --- A.3d ---, 2013 WL 3874882 (Pa. Super. Ct. July 29, 2013) and In re Reglan/Metoclopramide Litigation (Appeal of Teva Pharmaceuticals USA, Inc.), --- A.3d ---, 2013 WL 3874905 (Pa. Super. Ct. July 29, 2013). The court also held for the first time in In re Reglan/Metoclopramide Litigation (Appeal of Morton Grove Pharmaceuticals Inc.), --- A.3d ---, 2013 WL 3874931 (Pa. Super. Ct. July 29, 2013) that a generic manufacturer designated as the Reference Listed Drug (RLD) holder may be liable under a failure-to-warn theory.
The court in Hassett acknowledged that the plaintiffs’ failure-to-warn claims were preempted under PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011). However, it rejected the defendants’ argument that the other claims plaintiffs brought -- strict liability design defect, negligence, breach of express and implied warranty, fraud, and misrepresentation in drug advertising and promotion -- were essentially warnings-based claims and therefore preempted under Mensing’s rationale. The court instead relied on express preemption cases in nonpharmaceutical contexts to find that such claims based on false advertising and promotion, failure to test, and breach of warranty involve types of communications other than labeling, and accordingly are not preempted. The court also discussed whether Pennsylvania’s design defect claim imposed “absolute liability” of the type that might not pose an impossibility conflict under Bartlett. But the court chose not to directly address that issue, instead holding that “without a careful analysis of the applicable state law, preemption of all design defect claims [was] premature.” Id. at *11.
In the companion case, In re Reglan/Metoclopramide Litigation (Appeal of Morton Grove Pharmaceuticals Inc.), the court held that a generic manufacturer designated as the RLD holder following the brand-name manufacturer’s withdrawal of the brand-name product can be liable for failing to change the drug label. If the holder of an NDA ceases marketing a drug, then FDA may appoint another company as the RLD. The question presented here was whether a generic company designated as an RLD has the power to change a drug’s label and accordingly to be held liable for failure-to-warn. Although multiple state and federal courts have rejected the RLD theory of liability, the court agreed with the plaintiffs’ argument that Morton Grove stepped into the shoes of the brand-name manufacturer and assumed the authority to update the drug’s label. The court first explained that neither Wyeth v. Levine, 555 U.S. 555 (2009), nor Mensing, addressed whether a generic holder which is subsequently designated as the RLD can unilaterally change its label. The court then concluded there was “no indication that only brand-name manufacturers that obtained NDA approval, rather than RLDs generally,” can change the label. 2013 WL 3874931, at * 6. Absent authority that the RLD holder was powerless to change the label, preemption did not apply.
Battles like these about the scope of preemption under various state laws will continue to play out in the wake of Bartlett and Mensing.