A state trial judge in Philadelphia has denied generic drug manufacturers’ motions to dismiss the state law claims of approximately 2,000 plaintiffs who sued over injuries allegedly caused by metoclopramide, the generic form of Reglan. The pretrial ruling by Common Pleas Court Judge Sandra Mazer Moss, who oversees the drug’s mass tort litigation, rejected the defendants’ argument that the Supreme Court’s decision in Pliva v. Mensing foreclosed any state law recovery by the plaintiffs. (In re Reglan/Metoclopramide Litig., No. 11090904 (Pa., Phila. Co. Com. Pleas Nov. 18, 2011).)
The plaintiffs offered “a number of reasons why Mensing does not foreclose failure-to-warn claims, many of which have been recognized by other state courts since that decision was delivered,” Moss said. She held that the generic drug manufacturers failed to carry the “heavy burden” Pennsylvania law imposed to show “with certainty” that there is no legal recovery possible on the state claims.
The plaintiffs argued that manufacturers should have engaged in risk management strategies, suspended drug sales, and communicated their drug labeling to the medical community beyond the label itself—considerations they contend were not raised in the Mensing decision.
Decided in June, Mensing held that state failure-to-warn claims conflicted with federal regulations governing inadequate warning labels used by generic drug manufacturers, and therefore were preempted under the Supremacy Clause. Since the 5-4 ruling was issued, lower courts have split on Mensing’s reach. Moss noted in her decision that some courts, including the Fifth and Sixth Circuits, have dismissed all state law claims while other federal and state courts in Alabama, Nevada, and South Carolina have carved out exceptions on the theory that Mensing forecloses only the state claims concerning the product label itself. Moss declined the plaintiffs’ request to issue a broad ruling on Mensing “carve outs,” concluding that any such decision “must await a state-by-state analysis.”
William Curtis of Dallas, who represents plaintiffs in metoclopramide cases, said the decision is a significant step in addressing the limited scope of preemption in generic drug cases.
“Judge Moss’s decision confirms a few basic things about the Mensing decision,” said Curtis. “Mensing is not a grant of immunity to the generic manufacturers. Instead, it says that one part of one cause of action—failure to warn by failing to change the content of the label—is now preempted. But the other causes of action against a generic manufacturer, such as negligence, misrepresentation, failure to communicate a warning, breach of warranty, and the like are still viable claims depending on the facts of the case and the state law.”
Developed in the 1960s, metoclopramide is prescribed to treat digestive disorders. The FDA approved it in 1980 under the brand name Reglan and the drug has been available in generic form since 1985. According to the FDA, the drug has been linked in studies to tardive dyskinesia, an incurable neurological disorder characterized by involuntary and repetitive muscle movements. Studies have shown that up to 29 percent of patients who use the drug for several years develop the disorder.