'Dear Doctor' Letters Constitute 'Labeling' Under Mensing, Judge Rules

BURLINGTON, Vt. - Claims that the makers of generic metoclopramide failed to provide adequate warnings through dissemination of nonpromotional information are preempted because such information can be defined as "labeling," a Vermont federal judge has ruled. Kellogg v. Wyeth, et al., No. 2:07-82 (D. Vt.).

On Feb. 3, Judge William K. Sessions III of the U.S. District Court for the District of Vermont explained that under Mensing, the drug makers cannot proffer such information without running afoul of the requirement that the information be consistent with labeling approved by the Food and Drug Administration.

From 2000 to mid-2004, Ethel Kellogg …