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Judge Denies Defendants’ Preemption Motions In Valsartan MDL

On December 17, 2020, U.S. District Judge Robert B. Kugler ruled that the plaintiffs’ claims are not preempted in the Valsartan contamination multidistrict litigation (MDL). This ruling makes sure that claims against manufacturers, wholesalers, and pharmacies will continue in the MDL over their alleged failure to keep contamination out of Valsartan. 

Specifically, Judge Kugler noted that the defendants failed to take into account the U.S. Supreme Court precedent that the states’ policing powers can supersede federal law if that was the clear intent of Congress.

What is the Preemption Argument from Valsartan Manufacturers?

Valsartan manufacturers have asserted that they were prohibited by federal regulations determined by the U.S. Food and Drug Administration (FDA) from warning consumers about the contamination within the drug. They claimed that they could not alter their manufacturing process without FDA approval in addition to the Food, Drug and Cosmetic Act and the Drug Supply Chain Security Act (DSCSA)’s requirements which they claim can only be enforced by the government. 

Valsartan manufacturers, wholesalers, and pharmacies such as Teva Pharmaceuticals USA Inc., Mylan Pharmaceuticals Inc., AmerisourceBergen, Cardinal Health Inc., CVS and Walgreens all made the preemption argument.

Background on Preemption Arguments

Preemption arguments stem from the Supremacy Clause of the U.S. Constitution. It states that when state and federal law conflict, the federal law preempts (overpowers) state law. In the case of prescription drugs, Congress has allowed the U.S. Food and Drug Administration (FDA) to set the minimum national standards; therefore, their powers are viewed as federal law. The FDA has the primary responsibility to review the safety, efficacy, and labeling of medical products. 

Regarding drug manufacturers, states usually cannot penalize drug manufacturers for not including a warning that the FDA has already deemed to be unnecessary as long as the manufacturer follows all of the FDA’s other guidelines. Therefore, manufacturers cannot be held accountable to differing laws and regulations that may be enacted in 50 different states. 

The federal drug labeling preemption argument is based on the requirement that the brand-name drug has been tested and vetted by the FDA prior to entering the market. Since generic drugs are required by federal law to be a bioidentical drug, the argument is that different warnings are unnecessary and that generic manufacturers therefore cannot be held responsible for failing to provide additional or different warnings regarding their medication.

Injuries from Contaminated Valsartan

Valsartan’s contamination with the probable human carcinogen N-nitrosodimethylamine (NDMA) can create an increased risk for the following cancers: 

  • Bladder Cancer
  • Blood Cancer 
  • Breast Cancer
  • Colorectal / Intestinal Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Kidney Cancer
  • Liver Cancer
  • Lung Cancer 
  • Pancreatic Cancer
  • Pharyngeal Cancer
  • Prostate Cancer
  • Uterine Cancers 

What Was Judge Kugler’s Reasoning Behind The Ruling?

Judge Kugler explained that Congress’ intent in passing the DSCSA was to protect consumers from exposure to drugs that may be “counterfeit, stolen, contaminated or otherwise harmful” by creating a national system for product tracing. He determined that the DSCSA does not preempt state requirements pertaining to aspects of distributing drugs: “Although the preemption clause seeks to eliminate inconsistent state regulations related to tracing of pharmaceuticals, Congress did not enact the DSCSA in an effort to displace all state law regarding defective pharmaceutical drugs. Under the defendants’ view of the Act, Congress would have barred most, if not all, relief for persons injured by defective pharmaceuticals.”  

Judge Kugler added that there is no danger of inconsistent rulings since the FDA has already researched the cause of the contamination sufficiently to develop an understanding about the chemical processes involved in creating it.

How Does It Impact the Valsartan MDL?

Valsartan MDL Judge Kugler’s rejection of the defendants’ dismissal motion based on the preemption argument is a boost for the plaintiffs in the Valsartan MDL. The personal injury, economic loss, and medical monitoring lawsuits that are at stake in the MDL may continue to move forward due to this ruling. 

GoldenbergLaw Can Help

If you or a loved one has been diagnosed with cancer after taking the blood pressure medication Valsartan, contact the Dangerous Drug Attorneys at GoldenbergLaw for a free consultation. With thirty-four years of experience, we have the knowledge, experience, and compassion to give you the Gold standard of advocacy that you deserve. Contact us today to discuss a free Valsartan lawsuit consultation and leave the sleepless nights to us!


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