Generic drug makers are facing a growing number of valsartan lawsuits, following recalls for heart and blood pressure medications that were manufactured with a contaminated active ingredient.
The complaint, which was filed in the U.S. District Court, Eastern District of Missouri, on September 11th, seeks class action status on behalf of consumers who purchased generic valsartan medications tainted with N-nitrosodimethylamine, a chemical that has been designated a “probable human carcinogen” by the U.S. Environmental Protection Agency. (Case No.: 4:18-cv-01525-RLW)
The complaint is similar to cases recently filed in New Jersey and New York federal courts that seek restitution for the economic losses allegedly incurred by consumers who purchased recalled valsartan.
Valsartan (brand-name Diovan) is a prescription drug used to treat high blood pressure and congestive heart failure.
Starting in July 13, 2018, the U.S. Food & Drug Administration (FDA) announced a series of valsartan recalls after testing indicated that active ingredient supplied by China-based Zhejiang Huahai Pharmaceutical Co. – a defendant in the Missouri lawsuit – had become adulterated with NDMA.
NDMA is an organic chemical that sometimes occurs as the by-product of certain manufacturing processes. The FDA believes that the NDMA contamination that prompted the valsartan recalls resulted from a change in Zhejiang Huahai’s manufacturing methods that was implemented in 2014.
The FDA has continued to add medications to the valsartan recall. So far, over 2,300 drug batches have been recalled in 22 countries. The recalls have ensnared dozens of generic drug makers and distributors.
The valsartan class action lawsuit alleges that Zhejiang Huahai and other defendants supplied, manufactured, distributed, and ultimately sold valsartan that was adulterated and defective because it contained NDMA, which rendered the drugs unsafe and dangerous.
“Plaintiff and the putative class members were injured by the full purchase price of their valsartan-containing medications and incidental medical expenses.” The complaint states. These medications are worthless, as they are contaminated with carcinogenic and harmful N-nitrosodimethylamine and are not fit for human consumption.”
Animal studies have linked NDMA to kidney, liver, and digestive-tract cancers. The chemical may also cause liver damage.
According to the FDA, if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily in the 4 years since Zhejiang Huahai altered its production process, there could be one additional case of cancer over the lifetimes of these 8,000 people.
It’s important to note that not all valsartan products currently on the market are affected by these recalls. The FDA has posted an updated list of products included in the valsartan recall, as well as a list of products not included in the recall.
Finally, the FDA has warned patients not to stop taking their medication even if it was included in a valsartan recall, as doing so could result in serious health consequences. Rather, they should contact their doctor to arrange for an alternative treatment.
Consumers trying to determine if their valsartan is included in the recalls, or who have any other questions regarding this matter, can contact the FDA’s dedicated hotline at 855-543-378. The number, which is being manned by a group of pharmacists and nurses, has received more than 6,000 inquiries since the first recall was announced.