On June 13, the Supreme Court of Alabama issued an order announcing that it will revisit a controversial January ruling, in which the court held that a name-branded drug maker may be held liable, under Alabama law, for injuries caused by a generic version of its drug, manufactured and distributed by a different company.
The court’s January ruling resolved an intra-state split regarding whether name-branded drug makers have a duty to warn consumers of the risks associated with competitors’ generic equivalents. The court resolved the split by holding that name-branded drug makers do have such a duty. The court’s reasoning rested on FDA regulations requiring that a generic-drug maker’s labeling—including warnings—conform with that of the name-branded drug maker, as the name-branded drug maker holds the initial FDA approval that underpins later applications for approval of generic drugs.
The January Alabama ruling was applauded by plaintiffs’ lawyers, because it carved a path forward, in the wake of a 2011 U.S. Supreme Court decision, which shielded generic-drug makers from similar claims for primarily the same reason—that the generic-drug makers were bound by the prior labeling decisions of name-branded drug makers and, accordingly, had no independent control over their warnings.
Business groups, however, condemned the Alabama ruling, fearing that the theory adopted by the court, but rejected by a majority of courts to have considered the issue, could open the door to a multitude of lawsuits seeking to impose liability on name-branded drug makers for products they did not make. Indeed, at present, there are hundreds of similar plaintiff-instituted cases pending across the country that involve the same name-branded drug at issue in the Alabama case—Pfizer’s Reglan, which is used to treat a variety of gastric ailments ranging from common heartburn to gastroparesis in patients with diabetes.
The Supreme Court of Alabama will reconsider its January ruling, with oral argument set for September. The case is Wyeth, Inc., et al. v. Danny Weeks and Vicki Weeks, No. 1101397.