Allison Torres Burtka
Failure-to-warn suits against generic drugmakers are preempted by federal law, the Supreme Court ruled 5-4, reversing decisions by the Fifth and Eighth circuits. The Court held that it was impossible for the generic manufacturers to comply with both federal law—which requires their labels to match the brand-name label—and state law, which requires a stronger warning. (Pliva, Inc. v. Mensing, 2011 WL 2472790 (June 23, 2011).)
The Court “created a new test for impossibility preemption,” said Louis Bograd, senior litigation counsel with the Center for Constitutional Litigation in Washington, D.C., who argued the case for the plaintiffs. “It’s a pretty radical departure from its preemption jurisprudence.”
Justice Sonia Sotomayor dissented. The majority “invents new principles of preemption law out of thin air to justify its dilution of the impossibility standard,” she wrote.
The outcome leaves many patients injured by inadequately labeled generic drugs with no remedy, while those injured by brand-name drugs can sue the manufacturer. “It creates a weird imbalance between generic and brand-name companies,” Bograd said.
Mensing included the consolidated cases of Gladys Mensing and Julie Demahy, who allege they developed the neurological disorder tardive dyskinesia from taking metoclopramide long term for their stomach conditions. Both were prescribed Reglan, the brand-name version, but their prescriptions were filled with generics. They argued that the generic manufacturers knew but failed to warn of risks exceeding those reflected on the label.
Justice Clarence Thomas wrote for the Court, “We recognize that from the perspective of Mensing and Demahy, finding preemption here but not in Wyeth makes little sense. . . . We acknowledge the unfortunate hand that federal drug regulation has dealt Mensing, Demahy, and others similarly situated.” In Wyeth v. Levine in 2009, the Court held that failure-to-warn claims against brand-name drugmakers were not preempted.
In the wake of Mensing, “once a drug patent expires, the brand-name company will abandon the product, and only generic products will be on the market,” said William Curtis of Dallas, who represents plaintiffs in Reglan and metoclopramide litigation. “In effect, nobody will be watching the safety of the product, and consumers will be at their own risk.”
Noting that 75 percent of prescriptions were filled with generics in 2009, Sotomayor wrote, “Today’s decision eliminates the traditional state-law incentives for generic manufacturers to monitor and disclose safety risks.”
The plaintiffs argued that the manufacturers could have used the FDA's “changes being effected” (CBE) process (to add or strengthen warnings on the label) or “dear doctor” letters to warn of increased risks, or they could have asked the FDA to change their labels.
The Court said the generic companies could not have unilaterally used the first two options, because doing so would make their labels inconsistent with that of the brand-name drug (dear doctor letters are also considered labeling). Regarding the third option, Thomas wrote, “Although requesting FDA assistance would have satisfied the manufacturers’ federal duty, it would not have satisfied their state tort-law duty to provide adequate labeling. State law demanded a safer label; it did not instruct the manufacturers to communicate with the FDA about the possibility of a safer label.”
Sotomayor disagreed. “Proper application of the longstanding presumption against preemption compels the conclusion that federal law does not render compliance with state law impossible merely because it requires an actor to seek federal agency approval,” she wrote.
The plaintiffs argued that the drugmakers’ affirmative defense of preemption requires them to prove that the FDA would not have allowed a proposed label change. But the Court disagreed.
The decision “shuts off most litigation against generic drug companies,” Bograd said.
Curtis noted, “There will be other ways to hold generic manufacturers liable—theories based on negligence, misrepresentations, warranties, and other theories.”
Lawyers say more plaintiffs who are harmed by generic drugs will now sue the brand-name manufacturer. Bograd said lower courts have come to different conclusions on brand-name liability for generic drugs.
Curtis said Levine and Mensing seem to envision that more plaintiffs will sue the brand-name manufacturer. “Presumably someone needs to be responsible for the safety of the warnings on the drug, and apparently that someone is always going to be the brand-name maker, no matter whose drug was taken.”
He noted that most of the pending Reglan/metoclopramide cases have both the brand-name and the generic company as defendants. “How the individual courts sort out the Levine and Mensing opinions, coupled with individual state tort law, will play out over the near future.”
The Court suggested that the FDA and Congress could change the law and regulations. Bograd said, “It’s absolutely urgent that they do,” adding that the FDA could fix the problem by saying generic manufacturers can use the CBE process and dear doctor letters to warn of increased risks.