Patients have no recourse when generics aren't supported with adequate instructions, warnings
The Sixth Circuit ruled this month that Lala Smith, Alice Wilson, Dennis Morris and other plaintiffs could not pursue a claim against Wyeth, Inc., and other drug manufacturers. The Plaintiffs acquired tardive dyskenesia (a condition similar to Parkinson's Disease) as a result of taking metoclopramide, a generic prescribed to address gastro-esophageal reflux disease. They argued that they relied--to their detriment--upon the product instructions and warnings written by Wyeth, Inc., and published in the Physician's Desk Reference. The Plaintiffs claimed these warnings and instructions were inadequate.
The Court held that the claims against generic drug manufacturers were preempted by federal law intended to encourage the use of generics, and that the claims against the original manufacturer who wrote the product insert should also be dismissed, because the plaintiffs were never prescribed the name-brand medication.