In 2011, a Louisiana woman appealed a decision issued by the state’s highest court in a case she filed after suffered damages from the drug metoclopramine. Julie Demahy filed a lawsuit in 2008, alleging that she had suffered damages from the generic version of metoclopramide, which she took between 2002 and 2007. The state court had dismissed Ms. Demahy’s claims against Actavis, the manufacturer of the generic version of the drug, and against prescription drug makers Wyeth, Inc. and Schwarz Pharma, Inc. Schwarz had acquired the name-brand rights to the drug in 2001.
As of 1985, the FDA required that generic manufacturers of the drug metoclopramide include a warning with the medication about the risk of tardive dyskinesia, an often irreversible neurological disorder. In 2004, Schwarz voluntarily requested a change to the name-brand label, adding a warning that the drug should not be used for more than 12 weeks. It was not until 2009 that the FDA issued a black-box warning that informed consumers about the risk of tardive dyskinesia and that warned customers that the drug should not be used for longer than 12 weeks except in rare cases.
Under federal law, generic drug labels are required to be the same as name-brand labels. This means that state law cannot require generic manufacturers to include more information than that which would be available on the name-brand product of a prescription drug, as this would be contrary to the federal law. On these grounds, the state court had found that Actavis was not responsible under a failure-to-warn claim brought by Ms. Demahy. On appeal, Ms. Demahy claims that the state court’s mandate to change the district court ruling in favor of the defendant was improperly interpreted as calling for the dismissal of all claims against Actavis; Ms. Demahy argued that Actavis could still be found liable outside of the failure-to-warn claim.