Even for lawyers, the Federal Register is not the most scintillating read. So it was with a certain resignation that John Brenner sat down at his desk early one evening three years ago to read 76 densely worded pages of new drug labeling regulations issued by the Food and Drug Administra-tion. Brenner, then a drug liability partner at McCarter & En-glish in Newark, remembers thinking, “I need to read this-these are major changes in the labeling rules.” He resisted the urge to skip to the last ten pages where the actual changes to the regulations were laid out. Instead, he started slogging through the 65-page preamble, which set forth the agency’s rationale for the new rules. At comment 13, Brenner saw something that pulled him up short. “It was like a lightbulb went on,” he remembers. Taking the rules with him, he went out into the hallway to hunt down his colleagues. “Have you seen this?” he said to as many lawyers as he could find. “Does it say what I think it says?”
The language that surprised Brenner-and other drug liability lawyers who read it-centered on preemption, or the concept that federal law trumps inconsistent or contradictory state law. In that 2006 preamble, the FDA had stated for the first time in its own regulations that it considered agency approval of a drug label to “preempt conflicting or contrary state law.” The dry legal tone belied the blockbuster impact of what came to be known as the “preemption preamble,” but drug liability lawyers on both sides of the table knew instantly how big a deal it was. In essence, the FDA was saying that its approval of a drug label immunized the manufacturer from state law-based “failure-to-warn” claims, the most common grounds for drug liability suits. Suddenly, defense lawyers had a potent new weapon against drug liability cases-and plaintiffs lawyers had a big problem.
