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Amid continuing concerns over manufacturing problems with certain generic blood pressure drugs, which may cause carcinogenic impurities to contaminated ingredients, a recently filed class action lawsuit alleges that consumers may have faced a cancer risk from valsartan pills distributed as far back as 2012.
According to a complaint (PDF) filed earlier this month in the U.S. District Court for the District of New Jersey, Prinston Pharmaceutical Inc., Solco Healthcare U.S., and Zhejiang Huahai Pharmaceutical Co. knew or should have known that they were distributing contaminated valsartan pills for years, yet failed to recall the drugs because they feared permanently losing market share to competitors.
The lawsuit was filed by Dennis Kaplan, who alleges that he purchased generic valsartan pills made by the drug makers between October 2017 and July 2018, believing it was therapeutically equivalent to brand-name Diovan. However, due to a failure to follow the proper manufacturing processes, Kaplan indicates that the valsartan was contaminated with N-nitrosodimethylamine (NDMA), which is a known carcinogen.
While Kaplan does not claim that he has yet been diagnosed with cancer or suffered a personal injury, the complaint seeks class action status to secure reimbursement for consumers who were trying to ensure their own health, yet received drugs that were tainted with cancer-causing agents.
“[F]or years, Defendants willfully ignored warnings signs regarding the operating standards at the Zhejiang Huahai Pharmaceuticals (“ZHP”) manufacturing plant in China, and continued to allow ZHP to manufacture their Valsartan products for sale to consumers in the United States even after Defendants knew or should have known that their Valsartan products manufactured by ZHP contained or likely contained NDMA and/or other impurities,” according to the complaint. “These adulterated Valsartan drugs were introduced into the American market at least as far back as 2015 for Defendants to profit from their sale to American consumers, such as Plaintiff and Class Members. However, evidence now suggests that the contamination dates back at least as far as 2012.”
To date, the FDA has suggested that the chance of actually developing cancer from using the recalled drugs is low, but those numbers were based on use over only four years. Estimates have not been released for the cancer risk from recalled valsartan pills that may have been used longer.
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 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.
In September, 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 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 firstname.lastname@example.org.
In addition to the complaint filed by Kaplan, a number of other valsartan recall class action lawsuits have been filed nationwide, with many seeking damages for the cost of future medical monitoring for individuals who may face a continuing risk of developing cancer.
For individuals diagnosed with liver cancer, kidney cancer, pancreatic cancer, stomach cancer and other cancers, valsartan injury lawsuits are also being reviewed by product liability lawyers.