As the October 2014 Term gets under way, the U.S. Supreme Court is awaiting the Solicitor General's views on whether it should grant a certiorari petition to resolve whether "failure-to-update" claims against generic drug manufacturers are preempted. The petition, filed by generic drug manufacturer Teva Pharmaceutical USA Inc. ("Teva") in Teva Pharmaceuticals USA Inc. v. Superior Court of California, case number 13-956, asks the Court to provide clarity regarding the scope of its prior decision in Pliva Inc. v. Mensing, 131 S. Ct. 2567 (2011), holding that federal preemption bars failure-to-warn claims against a generic drug manufacturer whose labeling mirrors the Food and Drug Administration ("FDA") approved labeling for the brand-name equivalent of the generic drug. The question raised is whether plaintiffs can avoid preemption by arguing that the generic company did not timely change its label to mirror the brand equivalent's labeling. After briefing by the parties on the certiorari petition closed earlier this year, on June 30, 2014, the Supreme Court invited the Solicitor General to file a brief in this case expressing the views of the United States. That brief is expected to be filed in the coming weeks.
In the case leading to Teva's certiorari petition, a plaintiff sued several manufacturers of a generic form of the osteoporosis drug Fosamax, claiming they failed to immediately update their labeling to match the labeling of Fosamax or send a Dear Doctor Letter consistent with the updated labeling to healthcare providers, and thereby caused the plaintiff's alleged injuries. Teva argued that the plaintiff's claims were preempted as a thinly veiled attempt to enforce the Food, Drug, and Cosmetics Act ("FDCA"), which only the federal government has authority to do. Without the FDCA and the FDA, Teva argued, there would be no duty for generic companies to "update" their label. Teva also argued that it could not have sent a Dear Doctor Letter because it would have inaccurately implied a difference between the brand and generic drugs. But both a California state trial court and the California Court of Appeal rejected these arguments, holding that the plaintiff's claims were based on the alleged failure to properly update the label under California law, which parallels the federal safety requirements arising under the FDCA, and were not direct claims to enforce the FDCA. The California courts also reasoned that updating the generic label or sending a Dear Doctor Letter containing the same information as on the FDA-approved brand-name labeling would not have conflicted with Teva's federal duties.
Teva's petition for review with the California Supreme Court was rejected, and it subsequently filed a certiorari petition in the U.S. Supreme Court. The question presented by Teva is: "Whether the California Court of Appeal erred when it deepened an acknowledged circuit split and held . . . that federal law does not preempt state tort claims predicated on allegations that a generic drug manufacturer violated the FDCA by failing to immediately implement or otherwise disseminate notice of labeling changes that the [FDA] had approved for use on a generic drug product's brand-name equivalent."
Whether the U.S. Supreme Court grants Teva's certiorari petition should be closely watched because it may resolve a circuit split and the issue of whether failure-to-update claims are preempted under Mensing. The Solicitor General's forthcoming brief should provide insight into the likelihood of the petition being granted.