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.
The United States Fifth Circuit Court of Appeals found that the only other possible claim that Ms. Demahy could have brought against Actavis would have been a design defect claim. The Court, however, believed that Ms. Demahy’s claims were at best failure-to-warn, and thus the mandate by the Louisiana Supreme Court for the district court to dismiss these claims against the defendant encompassed all of Ms. Demahy’s claims. On these grounds, the Court of Appeals denied Ms. Demahy’s motion to set aside the judgment of dismissal as to the defendant Actavis.
Ms. Demahy had also appealed the dismissal of her claims against Wyeth, Inc. and Schwarz Pharma, Inc. Since Ms. Demahy had been taking the generic rather than the name-brand drug, her claims against Wyeth, Inc. and Schwarz were dismissed on the grounds that, under the Louisiana Products Liability Act, recovery was not available against a manufacturer if the manufacturer did not produce the offending product. On appeal, Ms. Demahy argued that cases forming the basis for the court’s decision to not hold Wyeth, Inc. and Schwarz liable were overruled by a more recent U.S. Supreme Court decision, Mensing. The ruling in Mensing provides that generic manufacturers cannot alter their labeling without taking direction from the name-brand manufacturers, and it also holds that failure-to-warn claims against generic manufacturers are preempted on impossibility grounds. Ms. Demahy essentially implies that a name-brand manufacturer should be held liable for damages caused using a generic product if the generic manufacturers could not alter their labeling independently. The 5th Circuit, however, held that the decision in Mensing does not impose a duty of care on name-brand manufacturers to customers using the generic-brand products. Thus, the 5th Circuit dismissed Ms. Demahy’s motion that would evacuate the judgment in favor of Wyeth, Inc. and Schwarz Pharma, Inc.
If you have suffered harm as a result of taking a generic or a name-brand prescription drug, an attorney at law may help you determine whether you have a viable case against one of the manufacturers.
For a free consultation, contact the Bernaird Law Firm at 504-527-6225.