Class Action Lawsuit Filed Over Generic Valsartan Recalled Due to Known Carcinogen Impurity

Following a widespread recall of generic valsartan distributed in recent years with a carcinogenic impurity, a class action lawsuit has been filed against the several drug makers, indicating that consumers were cheated because they were told the medications were equivalent to the brand-name drug Diovan, yet contained a cancer-causing byproduct of the generic drug making process.

John Judson and Jo Ann Hamel filed the valsartan class action lawsuit (PDF) in the U.S. District Court for the Eastern District of California on October 11, naming Prinston Pharmaceutical Inc. Solco Healthcare U.S., Huahai US Inc., and Teva Pharmaceuticals as defendants.

According to the complaint, Judson, Hamel and other consumers purchased generic Valsartan products that they thought were equivalent to the original brand-name drug, Diovan. However, they later discovered that many of the generics were contaminated with N-nitrosodimethylamine (NDMA); an impurity known to be a cancer-causing agent.

The impurity is believed to have resulted from the generic drug manufacturing process, yet the name-brand Diovan did not have such carcinogencic impurities.

The lawsuit does not claim that plaintiffs developed cancer or suffered physical injuries from the recalled drugs, but instead says consumers paid premium prices for subpar drugs for years, after being told they were the equivalent to the popular brand name product.

The first valsartan problems surfaced on July 5, after European regulators announced that batches of the active ingredient supplied by Zhejiang Huahai Pharmaceuticals in China, tested positive for N-nitrosodimethylamine (NDMA).

The FDA followed with its own recall announcement on July 13, indicating that the agency had launched an investigation to determine the scope of the contamination and the potential risk to consumers. Since that time, the recall has been expanded several times, impacting a variety of manufacturers of the generic drug.

Late last month, the FDA stopped all imports of drug ingredients and medicines made by Zhejiang Huahai Pharmaceuticals (ZHP) in China, which manufactured many of the ingredients that contained NDMA as a by-product of manufacturing problems.

The lawsuit indicates that the manufacturers knew or should have known about the contamination at least six years ago, claiming that the manufacturers failed to follow FDA current good manufacturing processes (cGMP) when they made changes to their manufacturing process in 2012.

“If Defendants had not routinely disregarded the FDA’s cGMPs and deliberately manipulated and disregarded sampling data suggestive of impurities, or had fulfilled their quality assurance obligations, Defendants would have found the NDMA contamination almost immediately,” the lawsuit states. “If these sampling-related and quality-control-related cGMPs were properly observed by Defendants and ZHP, the NDMA contamination in Defendants’ Valsartan products would have been discovered in 2012.”

The FDA has assigned a group of pharmacists and nurses to answer consumer’s questions about the recalls. Since the first recalls, the agency indicates it has received more than 6,000 inquiries from patients, doctors, nurses, pharmacists and academics. Inquiries can be made by calling 855-543-3784 or by sending an email to druginfo@fda.hhs.gov.

As consumers nationwide continue to face concerns about the safety of pills they have taken in recent years, a number of valsartan recall class action lawsuits have been filed nationwide, seeking damages for the cost of the recalled drugs and medical monitoring. For those diagnosed with liver cancer, kidney cancer, pancreatic cancer, stomach cancer and other cancers, individual cases are being reviewed by valsartan lawyers.