US Supreme Court agrees to hear generic drug labelling case; Teva files to stop generic Copaxone

The USA’s highest court has agreed to hear appeals by Israel’s Teva Pharmaceutical Industries (Nasdaq: TEVA), USA-based Mylan’s (Nasdaq: MYL) UDL Laboratories and privately-held Icelandic firm Actavis that would decide whether generic drug companies could be sued under state law over allegations they had failed to provide adequate label warnings about potential side effects, according to various US news services, including Bloomberg and Yahoo.

The Supreme Court will consider whether federal law pre-empted law suits brought by two women alleging they suffered severe side effects because the drugmakers failed to supply sufficient warnings on drugs that had been approved by the Food and Drug Administration (FDA).

The Supreme Court decided a related issue in 2009 when it ruled FDA drug regulations do not protect pharmaceutical companies from being sued under state law over drug labeling, a case involving Wyeth (now a unit of Pfizer) and its antinausea drug Phenergan (promethazine; the Pharma Letter March 9, 2009). That law suit, Wyeth versus Levine, meant that arguments concerning a jury's fitness to "second-guess" the ability of the FDA to determine the safety of a drug were rejected, despite an almost identical case concerning medical devices being decided in favor of the manufacturer (Riegel versus Medtronic; TPL March 3, 2008) by eight votes to one.