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Richard W. Schulte of Wright & Schulte LLC: a Tireless Fighter for Victims of Generic Drug Labeling Practices
Date:4/18/2013

07 to treat her gastric reflux. In 2004, the U.S. Food & Drug Administration (FDA) ordered the maker of Reglan, the name-brand version of metoclopramide, to update the drug’s label to warn that it should not be used for longer than 12 weeks because of its association with tardive dyskinesia. However, Pliva did not follow suit and update the label of its generic metoclopramide to include the same warning.

While the generic metoclopramide lawsuit was filed before the U.S. Supreme Court issued its ruling in Pliva vs. Mensing, the claim was dismissed by a lower court in the wake of that decision. In an appeal to the Sixth Circuit, Richard Schulte of Wrigth & Schulte LLC argued that according to the federal rule of sameness, Pliva was obligated to update the warning label of the generic drug once the label on the brand name version was modified. In a unanimous decision, a three-judge panel of the Sixth Circuit agreed, finding that the company could have updated its label without violating its duty of sameness. According to Wright & Schulte, the Sixth Circuit ruling means that generic drug makers can no longer simply rely on the Mensing decision’s preemption defense to avoid liability for injuries allegedly caused by one of their products, but must be able to show they were diligent and timely in keeping their labels up-to-date.

This is not the first time Richard Schulte has taken up the fight on behalf of individuals allegedly injured by generic drugs. As Co-Lead Counsel in a multidistrict litigation underway in U.S. District Court, Eastern District of Kentucky, he is currently representing hundreds of people allegedly injured by the drug Propoxyphene, sold generically and under the brand names Darvon and Darvocet. On February 20th, Richard Schulte, together with his Co-Lead Counsel and the Center for Constitutional Litigation, filed an Amicus Brief in an important

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