If you or a loved one has been taking the drug, Valsartan, you may have a claim against pharmaceutical companies for the distribution and sale of Valsartan medication that has been contaminated with toxic, cancer-causing substances.
On July 13, 2018, the FDA recalled the drug, Valsartan. Valsartan is the generic form of Diovan, which is used to treat high blood pressure and heart conditions. Because it costs less, the active pharmaceutical ingredient (API) for Valsartan is manufactured in countries outside of the United States. Several of the foreign API manufacturers changed the manufacturing process in 2012, and this change is believed to have caused unintended byproducts, which contaminated the drug with impurities, including N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and/or N-Methylnitrosobutyric acid (NMBA). These toxic substances are classified as probable human carcinogens, meaning that they are more likely than not to cause cancer in humans. Zhejiang Huahai Pharmaceutical (ZHP) in China and Hetero Labs Limited (Hetero) in India are two of the API manufacturers that used the altered manufacturing process. ZHP has an estimated 45% of the US market share of the Valsartan API production.
The APIs from ZHP and Hetero are used in finished pills, which are sold in the United States. Many American pharmaceutical companies have made, distributed, marketed and/or sold Valsartan products containing the API containing toxic substances. It is believed that the contaminated pills have been sold in the United States since 2014 and that there have been millions of contaminated pills taken in the United States. Based on tests, the API manufacturers were aware that Valsartan contained high levels of the toxic substances. The manufacturers minimized the information, citing testing inaccuracies. Eventually, after additional testing, the European Medicines Agency (EMA) issued recalls for Valsartan and the FDA followed. The FDA initially issued a report that 1 in 8,000 people taking Valsartan may develop cancer, but scientific evidence show that the number of cancer cases is likely significantly higher.
Multidistrict Litigation (MDL) currently pends in the US District Court for the District of New Jersey Camden Vicinage, MDL No. 2875 In re: Valsartan Products Liability Litigation. The MDL includes class actions for plaintiffs seeking only economic damages based on the purchase of a tainted product. It also includes plaintiffs who have suffered from personal injuries as a result of ingesting the Valsartan product. Plaintiffs alleging personal injury, from all jurisdictions, are permitted to file suit directly in the New Jersey MDL.
There are a small number of cases filed in New Jersey state court against some of the New Jersey manufacturers. As the number of cases filed in New Jersey state court increases, it is anticipated that multicounty litigation (MCL) will be approved.
The recalled drugs now include some Losartan and Irbesartan products. The list of recalled Valsartan, Losartan and Irbesartan products may be found on the FDA website at https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and
If you or a loved one has suffered from injuries related to the ingestion of Valsartan, please call the Davis Injury Firm at 404-593-2620 for a case evaluation with an attorney.
About the Author Betty Nguyen Davis is an Atlanta attorney who solely focuses her practice on plaintiff’s personal injury work. Betty is consistently recognized by her peers as a top attorney in Georgia by Super Lawyers and Georgia Trend and is highly recommended by her clients as a aggressive and persistent, yet caring and accessible attorney.