Federal Court Okays Valsartan Class Action

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A federal court sitting in New Jersey has just issued an order green-lighting a class action lawsuit against several manufacturers of generic valsartan. Valsartan is a drug used to treat high blood pressure, heart disease, and certain kidney disease.

This case started when the Food and Drug Administration (FDA) learned that millions of valsartan pills had been contaminated with the nitrosamines “NDMA” and “NDEA.” Nitrosamines are considered to be probable cancer-causing chemicals. The discovery of carcinogens in any medicine would obviously be cause for great alarm, and this led the FDA to demand the recall of millions of pills between 2018 and 2021. Millions of people were exposed.

After the contamination came to light, thousands of people filed their own individual lawsuits against the drug companies, attempting to link individual cancers that they developed to the contaminated drugs.

Class Actions for Patients Who Did Not Develop Cancers

Also filed were the class actions that have just been certified for further handling. These class actions were brought on behalf of patients who purchased the defective drugs and did not develop cancers, and on behalf of “third-party payors”—usually, the health insurance plans that paid costs toward those same drugs. In these class actions, the plaintiffs want refunds for buying worthless and potentially harmful medicines. And they also sought medical monitoring: a promise that the drug companies that made the drugs will pay for periodic cancer screening and other treatment.

Other than the fact that plaintiffs in these class actions did not develop cancers (yet, if ever), the difference between these cases is that the class actions would automatically join most anyone who qualifies.

Drug Companies’ Response

The drug companies opposed the formation of class actions. They argued several reasons, including that the class actions were too unmanageable, too complex to be treated as a homogenous class, and that the cause of any damage would differ from class member to class member. Although the court agreed that the case would be “likely onerous and a steep climb of effort” to supervise, the companies’ objections were overruled, and the court certified the class actions.

What Does It Mean?

Certifying the class actions for treatment does not mean that the court has issued a judgment yet, but denial of class certification would have meant the end of the road for many patients. Now, further work—including possibly in the appeals court or in front of a jury at a trial—will take place to ultimately determine which class members are entitled to an award and how much that might be. Cases like this sometimes end in a negotiated settlement rather than a jury verdict. Class certification is an important step toward a fair resolution on behalf of valsartan users.