Lawsuit: Valsartan Ingredient Maker’s Equipment Depositing Rust Into Drug Product
A lawsuit filed by health insurer Humana over valsartan-containing drugs (VCDs) contaminated with a probable carcinogen claims a manufacturer of valsartan ingredients had “equipment that was rusting” and depositing rust into “drug product.”
Humana is looking to recover “substantial” costs from Teva Pharmaceuticals through the lawsuit, costs the company said happened when they were forced to replace and recall Teva’s generic VCDs for their members.
The FDA announced the voluntary recall of several VCDs, including Teva’s, in July 2018. More VCDs have seen recalls in the time since. The valsartan recalls have occurred due to contamination with N-Nitrosodimethylamine (NDMA), a probable carcinogen.
The lawsuit alleges that ZHP, a Chinese company which makes drug ingredients for Teva, has a “history of deviations” from FDA standards, a history which started “almost as soon” as the company was approved for the export of pharmaceuticals into the U.S.
A May 2017 FDA inspection of a ZHP Chuannan facility found equipment that shedded cracking paint into drug product in addition to the previously mentioned rusting equipment, according to the lawsuit.
This inspection found that “ZHP repeatedly re-tested out of specification (“OOS”) samples until obtaining a desirable result,” according to the lawsuit, which says “impurities occurring during analytical testing are not consistently documented/quantitated,” adding that ZHP would invalidate OOS sampling results routinely “without conducting any kind of scientific investigation into the reasons behind the OOS sample result.”
It is alleged by the lawsuit that the contamination of Teva’s generic VCDs started in 2011 when Teva’s active pharmaceutical ingredient manufacturer changed their manufacturing process, introducing a solvent to it which is suspected of producing NDMA.
FDA testing found that Teva’s generic VCDs had levels of NDMA or NDEA, another probable carcinogen, which were sometimes hundreds of times higher than FDA limits.
The lawsuit accuses Teva, who has been selling VCDs in the United States since 2015, of willfully ignoring warning signs, for years, about the operating standards at the foreign manufacturing plants where their generic VCDs were made. The lawsuit says Teva has known “for some time” that generic medications made abroad, “particularly in China and India” have “grossly inadequate manufacturing processes” and have been found or suspected to be less effective and safe than their branded equivalents or generics made in the U.S.
The lawsuit seeks to recover damages based on numerous causes of action, including negligence, fraud and breach of express warranties.