Health insurance company Humana has sued Teva Pharmaceuticals over its sale of valsartan-containing drugs (VCDs) which were contaminated by a probable carcinogen.
The FDA announced a voluntary recall of several VCDs in July 2018, and more VCDs have been recalled since then. The reason for the recalls is contamination with N-Nitrosodimethylamine (NDMA), a probable carcinogen as classified by the U.S. Environmental Protection Agency.
Humana seeks to recover “substantial” costs through the lawsuit. The insurer said these costs were incurred when they had to recall and replace Teva’s generic VCDs for members.
The lawsuit claims that FDA testing found that Teva’s VCDs contained levels of NDMA or NDEA, another probable carcinogen, which were “in some cases hundreds of times higher than the FDA’s February 28, 2019 updated interim limits for NDMA and/or NDEA impurities.”
The lawsuit alleges that “on information and belief, the contamination of [Teva’s] VCDs began in 2011” when Teva’s Active Pharmaceutical Ingredient manufacturer “changed the manufacturing process to include a solvent suspected of producing NDMA, NDEA, and potentially other contaminants.”
Teva has been selling these VCDs in the United States since January 2015, according to the lawsuit.
Teva “willfully ignored warning signs [for years] regarding the operating standards at several of the overseas manufacturing plants where [Teva’s] generic VCDs were manufactured for import to the United States,” according to the lawsuit.
The lawsuit claims that Teva has known “for some time” that generic drugs made overseas, “particularly in China and India,” have been suspected or found to be more dangerous and less effective than generics made in the United States or branded equivalents because of “their grossly inadequate manufacturing processes.”
The lawsuit notes that one Chinese company that provides Teva with ingredients, ZHP, has a “history of deviations” from FDA standards which began “almost as soon as ZHP was approved to export pharmaceuticals to the United States.”
The lawsuit claims that a May 2017 FDA inspection of a ZHP Chuannan facility found that “ZHP repeatedly re-tested out of specification (“OOS”) samples until obtaining a desirable result,” adding that “impurities occurring during analytical testing are not consistently documented/quantitated.” ZHP routinely invalidated OOS sampling results “without conducting any kind of scientific investigation into the reasons behind the OOS sample result,” according to the lawsuit.
The lawsuit alleges this May 2017 inspection found rusting equipment which was depositing rust into drug product, as well as equipment which was shedding cracking paint into drug product.
For more information on Valsartan, visit https://www.personalinjurylawcal.com/valsartan/