Behemoth brand name drug maker Wyeth scored a victory for all brand names in November — but the 8th Circuit Court of Appeals left generic drug makers exposed to tort attack. In the case, Mensing v. Wyeth, Inc., a three-judge panel of the 8th Circuit held that brand name drug manufacturers cannot be held liable for alleged inadequate warnings where the plaintiff never used the brand name. However, the panel held that warning claims against generic drug manufacturers are not preempted by the Food Drug And Cosmetic Act (FDCA).
The FDCA requires that generic drugs exhibit the same labeling as brand name bioequivalents. The ruling should send a strong signal to generic drug manufacturers that they will be subject to a number of lawsuits for inadequate warnings or label defects. Preparation to avoid those suits and to manage litigation must commence immediately.
A thorough discussion of the case can be found here.