Litigation Update: Special Masters Are Appointed in Valsartan Contamination

by | Jan 12, 2021

U.S. District Judge Robert B. Kugler named former Pennsylvania federal Judge Lawrence F. Stengel, and former Delaware Judge Gregory M. Sleet as special masters in charge of overseeing settlement conferences in the multidistrict litigation regarding the alleged failures of the manufacturer of a popular blood pressure drug, Valsartan.

The MDL arose from an initial investigation led by the Food and Drug Administration (FDA) of certain contaminants found in Valsartan. There were a number of voluntary recalls of the drug before consumers filed class action lawsuits alleging the drugs they received caused cancer.

Judge Kugler recently denied three motions to dismiss because they would be invalidated under the Food, Drug and Cosmetic Act (FDCA) and the Drug Supply Chain Security Act. 

The FDCA was intended to protect consumers from harmful drugs by creating a national system for product tracing. The defendants argued that precise language regarding the protection of consumers is what preempts plaintiffs’ claims. However, Judge Kugler pointed out that this is limited to product tracing and does not relate to other aspects of distributing drugs.

The manufacturer argued that only the government could enforce FDCA regulations; however, Judge Kugler stated that they did not take into account that state police powers cannot be superseded by federal law unless Congress clearly intended so. In this case, the plaintiffs are alleging contract and tort claims where federal preemption would not apply.

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