In yet another pharmaceutical labeling preemption case to come before the Supreme Court, on December 16, 2014, the Solicitor General responded to the Supreme Court’s invitation to file a brief expressing its views on Petitioners’ petition for certiorari. The Petitioners filed their cert petition in the case, Teva Pharm. USA, Inc. v. Super. Ct. of Cal., Orange Cnty., No. 13-956, on February 7, 2014, and requested that the Court decide: “Whether the California Court of Appeal erred when it deepened an acknowledged circuit split and held—contrary to this Court’s decisions inBuckman Co. v. Plaintiffs’ Legal Committee and PLIVA, Inc. v. Mensing; the decisions of the Fifth and Eleventh Circuits in Morris v. PLIVA, Inc., and Guarina v. Wyeth, LLC and the plain language of the federal Food, Drug, and Cosmetic Act (“FDCA”)—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 United States Food and Drug Administration had approved for use on a generic drug product’s brand-name equivalent.”
As the Solicitor General explained, the Food and Drug Administration (“FDA”) approves two types of applications for new drugs under the FDCA—a new drug application for brand name drugs, and an abbreviated new drug application for generic versions. A generic drug’s labeling must be consistent with that of the brand name drug, with few exceptions. Respondent alleged that Petitions failed to update their generic drug labeling promptly.
It its amicus brief, the Solicitor General maintained that the Supreme Court should not hear the appeal because the Court does not have the jurisdiction to review a state court of appeals’ interlocutory decision. The Solicitor General further opined that, in any event, the appeals court’s decision that the state law claims were not preempted in this case was correct. The Solicitor General explained that “‘Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness,’ especially not in the sweeping and categorical manner [P]etitioners suggest.” Specifically, the Solicitor General likened this case to that of Wyeth v. Levine, where preemption of state law duty to warn claims were not preempted because the drug manufacturer could comply with both federal and state requirements. Finally, the Solicitor General stated that to the extent lower courts have disagreed about the status of such state law tort claims under the FDCA, it would be premature for the Supreme Court to address that issue at this time, as the issue has not been considered by the California Supreme Court nor has it been “fully ventilated” in the lower courts.