Product News and Recalls

Florida Zantac Decision Likely to Have Major Impact

judge dismisses claims against generic manufacturers in Zantac caseA U.S. District Court judge in Florida recently dismissed a number of claims against generic manufacturers of Zantac products, as well as various packagers, retailers, and distributors of the products. Ranitidine is the active ingredient in the heartburn medications and is at the center of a firestorm of controversy over concerns of contamination with a carcinogenic compound called N-nitrosodimethylamine, or NDMA.

Thousands of plaintiffs across the country have sued ranitidine manufacturers over claims that they knew there was a problem with the drug and failed to warn the public, as well as suing for their negligence in doing so.

In legal circles, the news is that the judge’s decision appears to have upheld what is known as the preemption argument. Essentially, the question is whether decisions made by the FDA – a federal agency – should shield pharmaceutical manufacturers in cases brought in state courts. Judge Robin Rosenberg is presiding over the Florida Zantac MDL and has said that it should when it comes to generic manufacturers and others without control of the product labels. The Florida case marks Judge Rosenberg’s first time presiding over a multidistrict litigation.

In issuing her decision, the judge wrote that “state law would require them to redesign or re-label ranitidine products, which they could not do under their federal duty of sameness. They were not required to stop selling the products in order to comply with both federal and state law. Thus, the failure-to-warn and negligence claims are preempted.” Essentially, the decision says that the state imposed a rule on the generic drug manufacturers that they were unable to comply with (the re-design of a label) because federal rules say that drug labels can’t be redesigned without federal approval, which they did not have.

Despite this recent ruling, the numerous claims against brand Zantac manufacturers will continue in the MDL established in February of 2020. Plaintiffs remain hopeful that they will be able to obtain recoveries for various cancers they believe to be caused by Zantac use.