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According to allegations raised in a recently filed wrongful death lawsuit, recalled valsartan pills caused a kidney cancer diagnosis for a Louisiana man, after he used tainted versions of the generic hypertension drug distributed with carcinogenic impurities.
The complaint (PDF) was filed by Elizabeth E. Gremillion in the U.S. District Court for the Western District of Louisiana on November 15, on behalf of herself and her deceased husband, Cecil B. Gremillion.
Zhejiang Huahai Pharmaceutical Co., Solco Healthcare and Walgreens are named as defendants, indicating that they knew or should have known that generic valsartan drugs distributed in recent years contained an impurity known as N-nitrosodimethylamine (NDMA), which is a known human carcinogen and is believed to be a chemical byproduct of the generic drug manufacturing process that has been in pills distributed by the companies for years.
Gremillion’s husband was prescribed valsartan for the treatment of hypertension in July 2016, and the lawsuit indicates that he took pills from several lots impacted by recent valsartan recalls issued earlier this year. However, before the drugs were pulled from the market, Cecil Gremillion was diagnosed with kidney cancer in November 2017, and died due to complications associated with the disease in May 2018.
“Cecil Gremillion died nearly two months prior to the (notice of a valsartan) recall by the FDA,” the lawsuit notes. “As such, from the time that he was first prescribed Valsartan until the time of his death, he was never made aware that the Valsartan he was consuming on a daily basis was adulterated and contained the dangerous carcinogen, NDMA.”
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 email@example.com.
Gremillion’s claim joins a number of pending valsartan recall class action lawsuits filed in courts nationwide, which seek damages and medical monitoring for individuals who took contaminated pills and may face a future risk of kidney cancer, liver cancer, bladder cancer and other digestive tract cancers.
Over the coming months and years, as families realize that cancer diagnosed in recent years may have been caused by the tainted pills, it is expected that additional valsartan wrongful death lawsuits will also be filed.