In a notable development in the ongoing valsartan litigation, lawyers are nearing a settlement agreement for those who sued Hetero, a manufacturer of the generic blood pressure medication that was tainted with carcinogenic impurities. This settlement, overseen by U.S. District Court Judge Renée M. Bumb in New Jersey, aims to provide relief to a subset of plaintiffs who allege they developed cancer after prolonged use of the contaminated drug.

Valsartan Recall and NDMA Contamination

The valsartan issue began in 2018 when the U.S. Food and Drug Administration (FDA) investigated claims that certain generic versions of the popular blood pressure medication contained unacceptable levels of potentially cancer-causing chemicals called N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA). This led to a global recall of multiple valsartan products, sparking widespread concern among the millions of Americans who had unknowingly consumed the tainted drugs.

Investigations revealed that the impurities were introduced due to changes in the manufacturing processes of certain generic valsartan suppliers, particularly those based in China and India. This raised alarms about the safety and quality control practices of these overseas pharmaceutical manufacturers, which had become increasingly relied upon to meet the demand for affordable generic medications in the U.S. market.

Valsartan Lawsuits and the Federal MDL

The discovery of the NDMA and NDEA contamination prompted a wave of product liability lawsuits against the various drug manufacturers and distributors involved in the valsartan supply chain. These claims were eventually consolidated into a multidistrict litigation (MDL) in the U.S. District Court for the District of New Jersey, presided over by Judge Bumb.

The valsartan MDL currently has over 1,200 active lawsuits, with plaintiffs alleging they developed various types of cancer, including bladder, liver, blood, and gastrointestinal cancers, as a result of their prolonged exposure to the tainted valsartan drugs. These plaintiffs are seeking compensation for their medical expenses, lost wages, and the pain and suffering caused by their diagnoses.

Hetero’s Valsartan Settlement

The valsartan MDL encompasses a diverse range of defendants, including over a dozen drug manufacturers and distributors. While lawyers are now nearing a settlement agreement for the claims involving Hetero, an India-based pharmaceutical manufacturer that was a relatively small player in the contaminated valsartan supply, the vast majority of the valsartan litigation is ongoing. It is important to note that while the Hetero settlement is a notable development in the valsartan litigation, the vast majority of the lawsuits are still progressing through the litigation process.

The Science Behind the Valsartan Lawsuits

At the heart of the valsartan litigation is the scientific evidence linking the NDMA and NDEA impurities to an increased risk of various types of cancer. Numerous studies have established the carcinogenic properties of these chemicals, with animal studies demonstrating their ability to cause liver, gastrointestinal, and kidney cancers.

The plaintiffs in the valsartan lawsuits allege that their prolonged exposure to the tainted medications, which they unknowingly consumed for years, directly contributed to the development of their cancers. This scientific link is a crucial component of the plaintiffs’ claims, and the court’s rulings on the admissibility and weight of this evidence will significantly impact the outcome of the litigation.