The Supreme Court ruled in 2009 that federal prescription drug laws one-up a plaintiffs’ state rights against generic drug manufacturers, based on ‘failure to warn’ labels, even as it ruled in 2011 that similar federal laws do not preempt plaintiffs’ state claims against brand-name drug makers.
Let’s get this straight: Three years ago (2009) in a highly publicized case (Wyeth vs. Levine) the U.S. Supreme Court (SCOTUS) awarded Diana Levine, a professional musician from Vermont, $6.8 million in a lawsuit she pursued against drug manufacturer Wyeth Pharmaceuticals after her hand and forearm were lost to gangrene because a health clinic physician accidentally injected her artery with the anti-nausea drug Phenergan. Wyeth appealed, but Levine’s victory held: Drug manufacturers were liable for any deficiency on the label whatever the Food and Drug Administration (FDA) approved.
Two years ago (2011) SCOTUS voted in Pliva vs. Mensing to overturn its earlier decision, ruling that generic drug companies do not have to update their warning labels like makers of brand-name equivalents. Research clearly said Phenergan could cause gangrene if it entered the bloodstream through an artery, but Wyeth’s label did not specify this until the FDA demanded a black-box warning in September 2009 after Levine defeated Wyeth.
Last fall Debbie Schork, a supermarket employee in Indiana, lost her hand to gangrene after receiving an intra-artery injection of the same drug Diana Levine was given, though she never knew what cocktail was loaded in the syringe. The financial outcomes were radically different: Ms. Schork could not ‘conclusively’ prove whether she had received Phenergan or its generic, promethazine; Ms. Levine could.
In March 2012 The New York Times launched an editorial campaign against generic drug preemption. The Times suggested, in Generic Drugs Proving Resistant to Damage Suits, that the law is “bizarre, irrational for allowing Ms. Levine to recover against Wyeth after receiving Phenergan by intravenous push, while another plaintiff, Ms. Schork, cannot recover for a similar injury, from a generic manufacturer of promethazine, the same medication.”
SCOTUS recognized its 2011 decision must make ‘little sense’ to plaintiffs who feel they have a right to sue generic drug companies and don’t concern themselves with forfeiting all future legal remedies. Justice Clarence Thomas wrote in favor, “Congress and the FDA retain the authority to change the law and regulations if they so desire.” In dissent Justice Sonia Sotomayor wrote that “generic companies nevertheless have a responsibility to report problems to the FDA and should be held liable for failing to warn patients.”
Though many experts continue calling the decision ‘senseless,’ Congress and the FDA are speculated not to react in an election year.