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A Tennessee man indicates that he developed colon cancer from valsartan, indicating that he unknowingly received generic versions of the hypertension drug for years that were contaminated with cancer-causing impurities, according to allegations raised in a recently filed lawsuit.
The complaint (PDF) was filed by Jerry Hollland in the U.S. District Court for the Eastern District of Tennessee on January 24, naming a number of drug manufacturers and distributors as defendants; including Zhejiang Huahai Pharmaceutical Co., Teva Pharmaceuticals, Actavis LLC, Mylan Laboratories and Aurobindo Pharma.
According to the lawsuit, Holland was prescribed generic valsartan in January 2014, and used drugs sold or manufactured by the defendants until October 2018. During that time, he took various forms of generic valsartan for the treatment of his hypertension, many of which were affected by a number of valsartan recalls which began in July 2018.
In September 2017, Holland indicates that he was diagnosed with colon cancer, but says he had no way of knowing it may have been caused by the blood pressure medications at the time.
It was not until this summer, when the FDA began recalling batches of valsartan due to contamination with the carcinogenic chemical N-nitrosodimethylamine (NDMA), that Holland and other consumers began to realize that cancer diagnosed in recent years may be caused by the valsartan drugs, with liver cancer, colon cancer and stomach cancer from valsartan being some of the most commonly reported.
FDA officials have suggested that NDMA, which is a known human carcinogen, was a byproduct of the manufacturing process used by Zhejiang Huahai and some other generic manufacturers, resulting in widespread contamination that impacted most of the valsartan supply in the United States.
Similar manufacturing problems have also resulted in recalls for other generic hypertension drugs in recent months, including losartan and irbesartan pills, which have been recalled because they contained a similar chemical, N-nitrosodiethylamine (NDEA), which is also considered a human carcinogen.
“Plaintiff would not have consented to taking valsartan, had Plaintiff known of or been fully and adequately informed by Defendants of the true increased risks and serious dangers of taking the drug, which was rendered unreasonably dangerous by the presence of NDMA and/or NDEA,” the lawsuit states. “Plaintiff and Plaintiff’s physician reasonably relied on Defendants’ representations and omissions regarding the safety and efficacy of valsartan.”
Given common questions of fact and law presented in claims pending in several different U.S. District Courts, a motion was filed with the U.S. JPML in late October, calling for the establishment of a federal valsartan recall MDL, or multidistrict litigation. The request seeks to centralize the cases before one judge in New Jersey, to reduce duplicative discovery, avoid contradictory pretrial rulings and serve the convenience of common witnesses, parties and the judicial system.