I reported in last week’s Mealey’s Emerging Drugs & Devices about a sleeper of a drug preemption ruling in December that somehow slipped below everyone’s radar.

The case is Kellogg v. Wyeth, 2008 U.S. Dist. LEXIS 104073 (D. Vt. Dec. 17, 2008), out of the U.S. District Court for the District of Vermont. Judge William K. Sessions III ruled (1) that there is no congressional intent to preempt all failure-to-warn state tort claims and (2) that generic drug manufacturers are free, perhaps even required by federal law, to add new warnings to drug labels. These are familiar issues to drug litigation lawyers. But what makes this one interesting is the coincidence of subject matter and jurisdiction. Kellogg involves metoclopramide and it came out of a Vermont court. That should prick up legal ears because metoclopramide is generic for Reglan and because of the Vermont forum. Of course, the Wyeth v. Levine, 2006 VT 107 (2006) (Petition for writ of certiorari granted Jan. 18, 2008, 128 S. Ct. 1118) drug preemption case pending in the U.S. Supreme Court involves Reglan and it stems from a Vermont state court verdict in which the lower court and the state high court denied preemption. There are differences, of course: In Levine, the plaintiff lost her arm when Reglan was injected intravenously through an artery (the latter a medical mistake). In Kellogg, the plaintiff took metoclopramide orally over the long term and suffered tardive dyskinesia, a neurological disorder similar to Parkinson’s disease. Levine involves Reglan’s label; Kellogg involves metoclopramide’s generic label. In Levine, the defense argues that the FDA considered and rejected a warning about IV “push” administration. In Kellogg, the defendants argue that their generic warning labels have to be identical to Reglan and can’t be changed. The latter is a familiar debate still playing out in courts nationwide.

In both cases defendants argue that they can’t make changes or the FDA will come after them. Judge Sessions wasn’t having it: “There is no evidence that FDA has ever brought, or threatened to bring, an enforcement action against (or otherwise sanctioned) a drug manufacturer who sought to strengthen or add a warning to its label. Likewise, there is no evidence that FDA has proposed to withdraw approval for a generic drug because its manufacturer sought to strengthen a label warning.”

Judge Sessions mentions Levine in his opinion, and the docket sheet indicates that at least one of the parties might have wanted to wait for the Levine ruling from the Supreme Court. But the judge went ahead with his denial of summary judgment.

Maybe it’s something about Vermont. Unless Levine is a silver bullet, maybe we have 10 more years of preemption tests ahead of us.