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Supreme Court hears arguments on Telecommunications Act, drug labeling

By Brian Jackson

[JURIST] The US Supreme Court [official website, JURIST news archive] heard oral arguments [day call, PDF; merit briefs] Wednesday in the consolidated cases of Isiogu v. Michigan Bell Telephone Co. and Talk America Inc. v. Michigan Bell Telephone Co. [oral argument transcript, PDF] on whether, pursuant to the Telecommunications Act of 1996 [text, PDF], a state utility commission may require an incumbent carrier like Bell Telephone to provide connectivity to its network at cost. The US Court of Appeals for the Sixth Circuit had reversed [opinion, PDF] a previous Federal Communications Commission (FCC) [official website] ruling that the state commission did have that power. The dispute centers on whether so-called "entrance facilities may function as interconnectivity junctions to the incumbent network. The FCC, in a prior order, had ruled that entrance facilities need not be provided to competitors at cost, but that interconnectivity facilities must be provided at cost. Petitioners' argument centers on the plain meaning of the terms, that an entrance facility can be used to link two networks for interconnectivity, and deference to the FCC, which also filed an amicus brief [PDF] with the court.

In the consolidated cases Actavis Elizabeth, LLC v. Mensing, Actavis v. Demahy and PLIVA v. Mensing [oral argument transcript, PDF], the court heard arguments on whether generic drug manufacturers can be held liable for not including more information on a label than mandated by the Food and Drug Administration (FDA) [official website]. In the opinion below, the US Court of Appeals for the Fifth Circuit held [opinion, PDF] that, just as claims against manufacturers of name-brand drugs are not preempted by the Food Drug and Cosmetic Act (FDCA) [materials], claims against manufacturers of generic drugs are similarly not preempted. Petitioners argue mainly that the Hatch-Waxman Act [21 USC § 355] mandates that generic drugs be labeled with the same warnings as name-brand drugs, and thus they cannot be held liable at the state level for a federally-imposed conformity. Because this is an untenable situation, Petitioners argue that federal preemption should apply, and attempted to distinguish this case from the court's decision in Wyeth v. Levine [JURIST report], by saying that, unlike generics, manufacturers of name-brand drugs had the "ability, had the obligation, to ... actually change the label."

Full post as published by JURIST - The Paper Chase on March 30, 2011 (boomark / email).