Generic Valsartan Manufacturer Accused of Hiding Key Documents in Lawsuits Over Contaminated Pills

Motion for sanctions comes in advance of the first federal Valsartan lawsuit bellwether trial, where evidence will be presented about chemical contaminants that caused users to develop various forms of cancer.

Plaintiffs involved in thousands of Valsartan cancer lawsuits being pursued against generic drug manufacturers that distributed contaminated versions of the blood pressure drug several years ago, are seeking sanctions against one of the Defendants involved in the litigation, who they say has admitted to concealing key documents related to liability for years.

Zhejiang Huahai Pharmaceutical Co. (ZHP) is the main generic drug manufacturer linked to a series of Valsartan recalls in 2018, when it was discovered that changes to the manufacturing process of the blood pressure medication led to the development of cancer-causing chemical byproducts including N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) and other contaminants.

Currently, ZHP and other generic manufacturers face more than 1,300 product liability lawsuits filed in federal courts nationwide, each raising similar allegations that the chemical contaminants caused some former users to develop various forms of cancer, including liver cancer, colorectal cancer, stomach cancer, prostate cancer, bladder cancer, esophageal cancer and other malignancies.

Due to similar allegations and relevant laws raised in claims filed throughout the federal court system, all Valsartan cancer lawsuits have been consolidated into a multidistrict litigation (MDL) in the District of New Jersey, where U.S. District Judge Renee Bumb has been presiding over coordinated discovery and pretrial proceedings for several years.

To help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the claims, Judge Bumb has instructed the parties to prepare several “waves” of early bellwether trials. However, plaintiffs indicate that ZHP has withheld certain key documents in their position throughout the pretrial discovery process, which are relevant to the claims.

During a hearing late last month, plaintiffs called for sanctions against ZHP for concealing important liability documents for years before illegally destroying them. Judge Bumb directed the plaintiffs to file a brief regarding the request, which they did in a proposal for sanctions hearing (PDF) submitted on September 2.

The allegedly missing and destroyed documents include certificates of analysis and internal inspection reports. Plaintiffs say the documents were destroyed after the Court specifically ordered the company to preserve the files.

The proposed sanctions hearing would seek to establish a timeline of ZHP’s document preservation requirements, establish that the company violated court orders to preserve the documents, what the company did to satisfy its obligations to preserve the documents, and how the manufacturer has tried to legally capitalize on the destruction of the documents.

No date for the sanctions hearing has yet been set.

Valsartan Lawsuit Bellwether Trials

The first Valsartan bellwether trial is expected to get underway this month, involving claims brought by Gaston Roberts, who developed liver cancer after using versions of the drug that were later recalled.

Following that trial, Judge Bumb has ordered the parties to prepare a second “wave” of early test cases, which are likely to begin in late January or early February 2026.

While the outcome of these Valsartan lawsuit bellwether trials will not have any binding impact on other remaining claims, they will be closely watched and the average payouts awarded by juries could influence how much the drug makers may have to pay to settle each individual Valsartan cancer claim.

Following the second wave of bellwether trials, if agreements are not reached to resolve large numbers of claims pending in the Valsartan MDL, it is expected that Judge Bumb may begin remanding large numbers of claims back to U.S. District Courts nationwide for individual trial dates throughout the federal court system in the coming years.