The Sixth Circuit Court of Appeals has recently submitted a question to the Food and Drug Administration requesting a response to its position on immunity. At issue is the claim by manufacturers that because the FDA regulates prescription drugs, once the drugs they make have received FDA “approval,” drug manufacturers cannot be held liable for the harm – sometimes life threatening – these products cause.
In the landmark case, Wyeth v. Levine, the U.S. Supreme Court determined that federal regulation of prescription drug labels does not grant manufacturers liability.
Makers of Reglan, a generic drug used to treat Gastroesohageal reflux (GER) and Gastroesophaegeal reflus disease (GERD) are now trying to use preemption arguments to avoid liability for harm caused by use of their dangerous products.
Reglan poses the threat of developing Tardive Dyskinesia (TD), a disabling and permanent movement disorder often characterized by shaking spells, blinking and slurred speech. Users have claimed that the generic drug’s label failed to warn consumers of the risks of use.
Last year, the Eight Circuit determined that generic manufactures must provide warnings, even if the name-brand drug label doesn’t contain the warning.
As New Mexico personal injury attorneys concerned about dangerous drugs, we believe manufacturers of dangerous products- both name brand and generic must be held accountable when their products injure consumers.