Dismissal of Generic Drugs Failure to Warn Claims Reversed By Federal Appeals Court Reverses


Since the 2011 U.S. Supreme Court ruling in PLIVA v. Mensing, patients taking generic drugs have had little legal recourse when those drugs cause injuries. However, a Federal Appeals Court has reversed a failure to warn lawsuit dismissal against PLIVA, in a case that will be watched closely by courts and patients across the country.

Generic-Drug-Label-Failure-To-Warn-Richard-Schulte-AttorneyThe 6th U.S. Circuit Court of Appeals in Cincinnati, Ohio has reversed a lower court’s dismissal of a generic drugs lawsuit filed against generic drug manufacturer PLIVA over claims that it failed to warn consumers and physicians about the increased risks of developing tardive dyskinesia, a neurological disorder that affects the face, when the gastric reflux drug metoclopromide is used for longer than 12 weeks.

In 2011, the Supreme Court ruled in PLIVA v. Mensing that consumers could not bring failure to warn lawsuits against generic drug manufacturers under state law because generic drug makers are bound by federal law to match a drugs label to its brand name equivalent. However, during the High Court trial, it was brought out that PLIVA failed to keep the generic drug metoclopromide updated with the warning label on the brand name counterpart Reglan.

While the Reglan warning label initially states that “Therapy longer than 12 weeks has not be evaluated and cannot be recommended,” in 2004 the brand manufacturer received approval by the U.S. Food and Drug Administration to change the warning label to include the statement “Therapy should not exceed 12 weeks in duration.” PLIVA did not update the label on the generic drug version to include the same warning, nor did they inform healthcare providers of the new warning. According to Reuters, in 2009, the FDA issued a black box warning for Reglan notifying consumers and physicians that treatment for longer than 12 weeks should be avoided.

The current failure to warn generic drugs lawsuit, filed in 2009 by Eleanor Fulgenzi alleges that she used PLIVA’s metoclopromide between 2004 and 2007 to treat her gastric reflux, while the generic drug carried the outdated warning, arguing that this makes the generic manufacturer liable for the injuries the drug alleged caused her to suffer. Originally, an Ohio district court found that the Supreme Court ruling in PLIVA v. Mensing barred her claims against the generic drug maker, however, the 6th Circuit Court disagreed and reinstated the case.

According to the federal rule of sameness, PLIVA was obligated to update the warning label of the generic drugs as the warning label on the brand drug was updated. In its unanimous decision, the three-judge panel wrote that “not only could PLIVA have independently updated its labeling to match that of the branded manufacturer … it had a federal duty to do so,” (Fulgenzi v. PLIVA Inc, 6th U.S. Circuit Court of Appeals, No. 12-3504)

According to Fulgenzi attorney’s Richard Schulte of Wright & Schulte LLC and Louis Bograd, studies have shown that nearly 80 percent of generic drug manufacturers provided drug labels that differed from the drug’s brand counterpart.

About Wright & Schulte LLC
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