28 Valsartan Lawsuits Selected For The Bellwether Process

28 Valsartan Lawsuits Selected For The Bellwether Process

Introduction

Last week, a document was submitted to the court by the attorneys representing plaintiffs who have filed lawsuits over Valsartan exposure indicating that a group of 28 cases has been selected from more than 600 complaints filed against manufacturers for the bellwether procedure of the recalled hypertension drug.

The parties had submitted the list of 28 valsartan cancer claims in January this year. The list included 13 cases selected by plaintiffs and 13 selected by the manufacturers along with two cases that were selected jointly by both sides.

The coordinated pretrial proceedings to determine the link between valsartan and cancer will continue until late 2021, following which the presiding judge will select individual cases for early trial dates.

The result of these early test trials will not hold an obligation on other cases and will be closely monitored by the parties as it would influence settlements for the plaintiffs, helping avoid the need for individual trials nationwide in the coming years.

Last month, Judge Robert B. Kugler of the U.S. District Court for the District of New Jersey, presiding over the Valsartan multidistrict litigation (MDL), upheld claims of fraudulent misrepresentation, fraudulent concealment, and other fraud-based claims against manufacturers.

However, Judge Kugler dismissed those claims without prejudice against the wholesalers and pharmacies, stating that they were too conclusory to fulfill Rule 9(b)’s particularity requirement.

Currently, the lawsuits are pending in the litigation docket and are consolidated under MDL No. 2875 in the United States District Court, District of New Jersey. Each claim raises similar allegations that long-term exposure to recalled Valsartan drug results in stomach cancer, liver cancer, esophageal cancer, prostate cancer, pancreatic cancer, and other injuries.

Earlier, 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.