Cancer-Causing Impurities Made Recalled Valsartan an Unapproved Drugs: Lawsuit

According to allegations raised in a recently filed product liability lawsuit, certain generic versions of valsartan should be considered an “unapproved drug”, since they contain cancer-causing impurities that appear to be a byproduct of the manufacturing process, and therefore are not an identical copy of the brand-name drug Diovan.

In a complaint (PDF) filed last week in the U.S. District Court for the Northern District of Georgia, Margaret Ridley indicates that she developed liver cancer in 2018, following years of using tainted versions of generic valsartan distributed throughout the U.S. in recent years.

Ridley indicates that she received generic valsartan from December 2012 until July 2018, for treatment of her high blood pressure. However, it was not disclosed that the drug contained known carcinogens, including N-nitrosodimethylamine (NDMA) or N-Nitrosodiethylamine (NDEA), until the FDA started issuing drug recalls in July 2018.

The cancer-causing impurities in the recalled valsartan have been linked to a risk of liver cancer, colorectal cancer, stomach cancer and other digestive tract cancers.

The lawsuit was filed against Zhejiang Huahai Pharmaceutical Co., Aurobindo Pharma, Mylan, Prinston and Solco Healthcare, indicating that the generic drug makers were supposed to be selling identical copies of the brand-name drug Diovan. However, Diovan is not known to have ever contained NDMC or NDEA. Therefore, the impurities change the nature of the drugs and how they effect the body, making them new, unadulterated medications that were never approved by the FDA and were, thus, illegal, the lawsuit argues.

“NDMA and NDEA both have the ability to cause cancer by triggering genetic mutations in humans. This mutation affects the structure of the human body, and thus, NDMA and NDEA are, by definition, active ingredients in a drug,” Ridley’s lawsuit states. “FDA further requires that whenever a new, active ingredient is added to a drug, then the drug becomes an entirely new drug, necessitating a submission of a New Drug Application by the manufacturer. Absent such an application, followed by a review and approval by the FDA, this new drug remains a distinct, unapproved product.”

Since the first recalls were announced, the FDA has received thousands of inquiries from patients, doctors, nurses, pharmacists and academics about the contaminated valsartan, and have assigned a group of pharmacists and nurses to answer consumer’s questions about the recalls.

While this lawsuit was an individual claim, there are also a number of valsartan class action lawsuits pursuing damages for users of the medications who have not been diagnosed with cancer, seeking reimbursement for the cost of what were essentially worthless drugs, and funding for medical monitoring they may require for the rest of their lives due to their exposure to cancer-causing agents.

For individuals who have been diagnosed with, or died of, liver cancer, kidney cancer, stomach cancer, bladder cancer, colorectal cancer and other cancers, valsartan lawsuits are also being reviewed by product liability lawyers.