Judge certifies a pair of classes in lawsuit claiming hypertension medication valsartan contaminated with carcinogens

Valsartan hypertension MDL overview: 

• Who: A federal judge in New Jersey certified a pair of classes in multidistrict litigation (MDL) against the manufacturers and distributors of the generic version of valsartan. 
• Why: The class action lawsuits revolve around the 2018 and 2019 recalls of the generic versions of valsartan, which were conducted over concerns the hypertension medication contained high levels of a pair of carcinogens. 
• Where: The MDL is in New Jersey federal court. 

A federal judge in New Jersey certified a pair of classes in a multidistrict litigation (MDL) of class action lawsuits filed against the manufacturers and distributors of the generic version of the hypertension drug Valsartan. 

U.S. District Judge Robert Kugler certified a valsartan-related consumer and insurer economic loss class and a medical monitoring class. The valsartan class action lawsuit MDL names manufacturers, retail pharmacies and wholesalers as defendants. 

The MDL revolves around recalls conducted in 2018 and 2019 for the generic versions of valsartan, originally sold under the trade names DIOVAN and EXFORGE, due to contamination by high levels of a pair of carcinogens. 

The U.S. Food and Drug Administration (FDA) classifies the carcinogens, which include N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), as “extremely toxic,” according to a news release. 

Judge rules defendants failed to comply with applicable quality, purity standards

In certifying the classes, Judge Kugler determined the contamination of the generic valsartan drugs resulted from the defendants’ failing to comply with applicable quality and purity standards for prescription drugs.

“The defendants’ own documents and testimony from the defendants’ employees, confirms that the defendants engaged in serious misconduct that resulted in their failure to prevent or detect the contamination,” class co-lead counsel John Davis of law firm Slack Davis Sanger says in the release.

Judge Kugler ruled in 2021 that while valsartan manufacturers would have to face claims of fraud over the recalls, consumers would have to drop their claims brought against the drug’s distributors. 

The judge determined claims made against generic valsartan distributors were not sufficient at that time, noting wholesalers and a host of retail pharmacies could not have known they were selling contaminated drugs. 

Were you affected by a recall of a generic version of valsartan? Let us know in the comments. 

The plaintiffs are represented by Slack Davis Sanger. 

The valsartan hypertension class action lawsuit MDL is In re: Valsartan Products Liability Litigation, Case No. 1:19-md-02875, in the U.S. District Court for the District of New Jersey.

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