Valsartan MDL Judge Denies Defendants' Preemption Motion

Valsartan MDL Judge Denies Defendants' Preemption Motion

Introduction

On December 18, U.S. District Judge Robert B. Kugler, overseeing the valsartan multidistrict litigation docket (MDL), denied three dismissal motions filed by the defendants stating that claims by buyers and users of the drug are not preempted by federal law.

The order was signed on Thursday and filed the next day, in which the New Jersey federal judge noted that it would be one in a series of the number of claims and arguments put forth in the motions to dismiss, and each would address different claims and arguments.

The manufacturers are facing allegations, which include that generic valsartan pills were distributed for years with cancer-causing impurities, including NDMA and NDEA, which appear to be a by-product of the drug manufacturing process. Several lawsuits have been filed in recent months by individuals who indicated that they were left with different types of cancer, including liver cancer, kidney cancer, gastric cancer, pancreatic cancer, and other injuries following exposure to NDMA or NDEA.

The defendants involved in the litigation filed a motion to dismiss three master complaints, arguing preemption under the Food Drug and Cosmetic Act (FDCA) and the Drug Supply Chain Security Act (DSCSA). The motion further contended that the claims were subsumed by the state's own product liabilities laws and also stated that certain claims, including unjust enrichment and punitive damages, were insufficiently alleged. The defendants also asked to dismiss or put a stay on those claims, which are linked to pending FDA investigations and regulatory actions until the same is finished by the federal agency.

The defendants include wholesalers AmerisourceBergen and Cardinal Health Inc.; pharmacies, CVS, and Walgreens; and the manufacturers, which include Teva Pharmaceuticals USA Inc. and Mylan Pharmaceuticals Inc.

Judge Kugler, through the order, indicated that manufacturers, wholesalers, and pharmacies couldn’t escape the lawsuits that claimed them for selling a blood pressure medication contaminated with a carcinogen. The order did not indicate when further opinion on the motions to dismiss will be issued.