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After taking valsartan tablets contaminated with cancer-causing impurities, an Arkansas woman indicate that she developed colorectal cancer, according to allegations raised in a recently filed lawsuit.
The complaint (PDF) was brought by Betty Selph in the U.S. District Court for the Western District of Arkansas on January 30, naming a number of generic valsartan manufacturers and distributors as defendants, including Zhejiang Huahai Pharmaceutical Co., Prinston Pharmaceutical, Incl. Solco Healthcare US, LLC, and Aurobindo Pharma USA.
According to the valsartan colorectal cancer lawsuit, Selph was prescribed the drug for treatment of high blood pressure in December 2014, and used various generic tablets until August 2018.
Starting in July 2018, and for months afterward, the FDA announced a number of generic valsartan recalls involving products from the defendants, due to the presence of N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA).
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.
“The valsartan ingested by Plaintiff was manufactured by the above-captioned defendants and was at least in part subject to the recent recall of valsartan issued by the United States Food and Drug Administration,” Selph’s lawsuit states. “On or about September 27, 2018, Plaintiff was diagnosed with colorectal cancer.”
Previous studies and the FDA’s own review indicate that patients would have to take the tainted medications for about four years before the risk of cancer appears, which is how long Selph reportedly took the recalled medications.
In the same month Selph was diagnosed with colorectal cancer from valsartan, 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 email@example.com.
While this lawsuit was an individual claim, there are also a number of valsartan class action lawsuits pursuing damages for users of the medications who have not been diagnosed with cancer, seeking reimbursement for the cost of what were essentially worthless drugs, and funding for medical monitoring they may require for the rest of their lives due to their exposure to cancer-causing agents.
For individuals like Selph diagnosed with liver cancer, kidney cancer, bladder cancer, stomach cancer and other cancers, valsartan lawsuits are also being reviewed by product liability lawyers.