Oral Argument in the Mensing-Demahy Generic Drug Labeling Preemption Case

By Kurt R. Karst –      

Although we were not in attendance at today's argument before the U.S. Supreme Court in PLIVA Inc. v. Mensing (09-993), Actavis v. Mensing (09-1039), and Actavis v. Demahy (09-1501) concerning whether certain Circuit Court decisions “abrogated the Hatch-Waxman Amendments by allowing state tort liability for failure to warn in direct contravention of the Act’s requirement that a generic drug’s labeling be the same as the FDA-approved labeling for the listed (or branded) drug,” we did get a chance to review the unofficial transcript of the oral argument. 

Just as with the oral argument in Wyeth v. Levine, the Justices showed a keen interest in the case, interrupting all three attorneys of record with questions before they barely spoke their opening sentences.  Petitioners’ attorney, Jay Lefkowitz of Kirkland & Ellis LLP, did a fine job of arguing the case, emphasizing that based on the Court’s decisions in Arkansas La. Gas Co. v. Hall, 453 U.S. 571 (1981), and Buckman Co. v. Plaintiffs’ Legal Comm.,531 U.S. 341 (2001), the Supremacy Clause forecloses state-law claims that depend on speculation about how a federal agency would exercise its exclusive authority, or that otherwise impose or enforce duties to a federal agency.  Our fact checker went off when Repondents’ attorney, Louis Bograd of the Center for Constitutional Litigation, started discussing FDA’s ability to quickly take action on application supplements, and in particular equating certain FDA statistics we think are more akin to NDA supplements with ANDA supplements, stating that FDA “also processes supplement requests, according to its web site, in 97 percent of the cases or something, within 4 months.  It's not — it's — it is a matter of months, not — not years.”

It is always difficult to prognosticate about Supreme Court decisions.  At this juncture we cannot say how we think the Court might rule.