The Chinese pharmaceutical manufacturer responsible for dozens of valsartan recalls around the world is now facing legal headaches in the United States.
According to FiercePharma.com, Zhejiang Huahai Pharmaceutical recently disclosed that it had been named a defendant in multiple valsartan lawsuits filed on behalf of American consumer in Missouri, New Jersey, Illinois, and New York.
The lawsuits accuse the company of gross negligence, fraudulent concealment, breach of contract, and unjust enrichment.
Zhejiang Huahai Pharmaceutical manufactures the active pharmaceutical ingredient (API) used by numerous generic drug makers to make valsartan, a medication indicated to treat high blood pressure and heart failure.
In fact, until recently, about half of the API used to make valsartan in the United States had been procured from Zhejiang Huahai.
In June, the company reported that its valsartan API had been contaminated with N-nitrosodimethylamine, or NDMA, a chemical that has been declared a probable carcinogen by the U.S. Environmental Protection Agency. Since then, numerous generic drug makers in the United States and around the world have announced valsartan recalls.
The contamination issue appears to have resulted from a change in production methods at Zehjiang Huahai’s Zinhai, China manufacturing facility, which occurred in 2014.
In late September, the U.S. Food & Drug Administration (FDA) banned imports from Zehjiang Huahai, after an inspection of the company’s Zinhai plant uncovered quality control problems and other deficiencies.
Similar import bans were subsequently announced by regulators in the European Union and Canada.
Animal studies suggest NDMA exposure may be associated with cancer, including tumors of the liver and kidneys. The chemical has also been linked to liver damage.
The FDA’s scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there might be one additional case of cancer over the lifetimes of these 8,000 people.
The FDA has advised valsartan patients to check with their pharmacy to determine if their medication is included in the recall.
Patients with a recalled medication should contact their doctor for a replacement. However, they should not stop taking their medicine before they’ve obtained a replacement, as doing so could result in adverse health consequences.
Pharmacists and nurses staffing the FDA’s dedicated hotline (855-543-3784) are also available to answer any questions consumers might have regarding recalled valsartan.