A woman allegedly suffered injuries as a result of her long-term use of the prescription drug product metoclopramide, which is the generic form of the brand-name drug Reglan. The woman and her husband sued three generic manufacturers of the drug under theories of defective construction and composition of the drug, defective design, breach of express warranty, and inadequate warning. The district court found that the plaintiffs’ only factually supported claim—inadequate warning—was preempted by federal law pursuant to PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), aff’d, 702 F.3d 177 (5th Cir.(La.) Oct 25, 2012), which held that state law claims against generic manufacturers of Reglan were preempted by FDA regulations. The district court dismissed the complaint. Note that the extension of to design defect claims has been declined in Bartlett v. Mutual Pharmaceutical Co., Inc., 678 F.3d 30 (1st Cir.(N.H.) May 02, 2012), cert. granted, 133 S.Ct. 694 (U.S. Nov 30, 2012).
The plaintiffs moved to amend their complaint to include the following claims. First, one of the generic drug manufacturers failed to comply with the 2004 FDA-approved label change. Second, the generic defendants failed to properly test their products and report that information. Third, the generic drug manufacturers breached an express warranty. Fourth, one of the generic drug manufacturers may be held liable for a failure to warn because of its status as a reference listed drug (“RLD”) holder. The district court denied the plaintiffs’ motion to amend.
The Fifth Circuit United States Court of Appeals affirmed the district court’s decisions. The court rejected the plaintiffs’ argument regarding a generic drug manufacturer’s alleged failure to comply with the 2004 FDA-approved label change. The court reasoned that Mensing held that federal law demands generic drug labels be the same at all times as the corresponding brand-name labels. This is known as the “duty of sameness.” Because no brand-name manufacturer sent a warning based on the 2004 label change, the generic manufacturers were not free to do so. This claim was preempted since it would be impossible for a generic drug manufacturer to comply with both the state law duty to warn and the federal law duty of sameness.
Moreover the court reasoned that the plaintiffs’ argument was logically incoherent in that it contended that a generic drug manufacturer had a duty to apply the 2004 warning label when they also assert repeatedly that no labels predating 2009 were adequate. Tort liability does not arise for failure to attach an inadequate label. Finally, the court held that a claim that a generic drug manufacturer breached a federal labeling obligation sounded exclusively in federal (not state) law, and is preempted.
The court also rejected the plaintiffs’ claim that one of the generic drug manufacturers may be held liable for a failure to warn because of its status as a RLD holder. The court found that the claim assumed, without authority, that the FDA considered the generic drug manufacturer to be a brand name manufacturer with the requisite duty to unilaterally change its product's labeling simply because the FDA designated it's metoclopramide as the RLD.
The court rejected the plaintiffs’ argument that the generic defendants failed to test and inspect the product according to federal law. The Federal Food, Drug, and Cosmetic Act (“FDCA”) provides no private right of action for the alleged violations. Such violations cannot be used as evidence of a breach of duty. State tort law did not instruct the manufacturers to communicate with the FDA about the possibility of a safer label. Finally, any “useful” reporting—at least from the standpoint of those injured—would ostensibly consist of some sort of warning, which is would circumvent the disfavored failure-to-warn claims.
The court rejected the plaintiffs’ claim that the generic drug manufacturers breached an express warranty by introducing a defective product into the stream of commerce. The court held that the claim was preempted. The court reasoned that Metoclopramide has legitimate therapeutic purposes, as evidenced by the FDA's approval of Reglan in the first place. Any state law-based holding that the generic manufacturers should have acted differently with respect to warnings or should have ceased manufacturing these products because of insufficient warnings not only violated the duty of sameness but conflicted with the FDA's exclusive authority to approve drugs and drug labels.
See: Morris v. PLIVA, Inc., 2013 WL 563506 (C.A.5 (La.), February 14, 2013) (not selected for publication in the Federal Reporter).