A woman has filed a valsartan tablet lawsuit because she was diagnosed with kidney cancer after taking the generic medicine for years.

Plaintiff Susan G. says she took prescription generic valsartan to treat her high blood pressure from May 2011 through August 2018. In the fall of 2018, Susan says she was diagnosed with kidney cancer. She argues that her cancer developed due to contamination in her valsartan medication.

Valsartan belongs to a class of drugs known as angiotensin receptor blockers and works by relaxing blood vessels, allowing blood to flow more easily, which reduces blood pressure. The patent on the valsartan brand name Diovan ran out in September 2012, which led to the creation of generic versions of the drug.

Valsartan itself has not been linked to cancer, but a manufacturing company located in China allegedly has allowed valsartan to become tainted with N-nitrosodimethylamine (NDMA) and/or N-Nitrosodiethylamine (NDEA). The European Medicines Agency allegedly found that Zhejiang Huahai Pharmaceuticals was producing valsartan tainted with NDMA in May 2018.

The EPA says NDMA is an unintended byproduct of many industrial manufacturing processes and also of the chlorination of wastewater and drinking water at treatment plants. The Environmental Protection Agency (EPA)  classifies NDMA as a B2 carcinogen, which means it is “reasonably anticipated to be a human carcinogen.” Similarly, the FDA has classified NDEA as a “probable human carcinogen.”

According to the valsartan contamination lawsuit,  NDMA and NDEA are capable of causing cancer by causing genetic mutations in human cells.

Valsartan Tablet Lawsuit Allegations

Susan contends that the valsartan she took over the years was manufactured at the Chinese facility linked to the contamination. She says she would have never taken the medication if she had known of the pills were contaminated with NDMA and/or NDEA.

The valsartan tablet lawsuit also alleges the amount of the impurities was found “at dangerously high levels.” The manufacturer allegedly knew the valsartan was tainted with contaminants and that the levels of NDMA and/or NDEA  were above levels considered safe by state and federal regulators for many years.

The valsartan blood pressure medications affected by the recall due to possible NDMA and/or NDEA contamination include products from:

• Teva Pharmaceuticals, labeled as either Major Pharmaceuticals or Actavis
• AvKare
• Prinston Pharmaceutical In. labeled as Solco Healthcare LLC
• RemedyRepack Inc.
• A-S Medication Solutions LLC
• Bryant Ranch Prepack Inc.
• HJ Harkins Company Inc dba Pharma Pac
• Northwind Pharmaceuticals
• Mylan Pharmaceuticals, Inc.
• Hetero Labs, Inc. labeled as Camber Pharmaceuticals, Inc.
• NuCare Pharmaceuticals Inc.
• Preferred Pharmaceuticals, Inc.
• Torrent Pharmaceuticals Unlimited

The FDA’s statement said, “Based on information provided regarding ZHP’s manufacturing processes, we believed (but did not have proof) that the impurity resulted from changes that ZHP made to the manufacturing process for its API [active primary ingredient].”

Solco Healthcare LLC also recently announced a voluntary recall of a single lot of Irbesartan and seven lots of Irbesartan HCTZ tablets. The FDA says the recall was issued because trace amounts of NDEA have been found in the Irbesartan blood pressure tablets.

The Valsartan Tablet Lawsuit is Case No. 5:19-cv-00253 in the U.S. District Court for the Northern District of California.