Generic valsartan manufacturers face mounting lawsuits in courts throughout the United States, following a massive, global recall for contaminated heart and blood pressure drugs.
One of the most recent cases involves a Louisiana man diagnosed with kidney cancer in November 2017. His wife alleges that tainted valsartan caused the disease and ultimately led to her husband’s wrongful death last May.
According to a complaint filed on November 15th in the U.S. District Court, Western District of Louisiana, Cecil B. Gremillion’s primary care physician prescribed valsartan in July 2016 to treat hypertension. Walgreens Store No. 7393 in Abbeville, Louisiana filled his prescriptions. (Case No. 6:18-cv-01497)
Mr. Gremillion used valsartan on a daily basis for over a year before receiving his kidney cancer diagnosis on November 17, 2017. He died on May 11, 2018, at the age of 70, from “malignant neoplasm of kidney.”
Until recently, the Zhejiang Huahai Pharmaceutical Company supplied Active Pharmaceutical Ingredient (API) for roughly half of the generic valsartan marketed in the United States. In June 2018, however, the Chinese manufacturer discovered an impurity, N-nitrosodimethylamine (NDMA), in its valsartan API. Shortly therefter, Zhejiang Huahai announced that it was recalling valsartan at the consumer level to protect human health.
The U.S. Environmental Protection Agency considers NDMA a probable human carcinogen. According to the agency, animal studies have linked the chemical to tumors of the liver, respiratory tract, kidneys and blood vessels.
Three months after Mr. Gremillion’s death, a letter arrived from Walgreens advising that his valsartan was among the drugs being recalled.
“As a result of ingesting and consuming Adulterated Valsartan on a daily basis for over one year, Cecil Gremillion was subjected and exposed to an increased risk of developing cancer and disease ultimately resulting in serious injuries, including but not limited to, the development of kidney cancer and his resulting death on May 15, 2018,” the complaint states.
Since June, numerous generic drug makers have recalled valsartan in the United States and 21 other countries.
According to the U.S. Food & Drug Administration (FDA), the NDMA detected in Zehjiang Huahai’s valsartan API may have resulted from a change in the company’s production methods that occurred in 2014. Consequently, it’s likely that adulterated valsartan circulated for the past four years.
The FDA recently barred drug products and API manufactured by Zehjiang Huahai from entering the United States. The import ban was implemented after an FDA inspection uncovered numerous deficiencies at the company’s factory in Zinhai, China, including problems with its quality control systems and the handling of products with impurities.
At least a dozen valsartan lawsuits are currently pending in federal courts throughout the United States. So far, however, most seek class action status on behalf of consumers who purchased allegedly dangerous and worthless valsartan.
In October, plaintiffs pursuing valsartan lawsuits asked the U.S. Judicial Panel on Multidistrict Litigation to centralize the federal docket in a single U.S. District Court. Among other things, the petition predicted that the litigation surrounding recalled valsartan would grow to include hundreds of similar claims. Furthermore, plaintiffs asserted that centralization would improve efficiency and preserve judicial resources.
If the Panel grants the plaintiffs’ petition, any valsartan cases currently pending in the federal court system would be transferred to the newly-created multidistrict litigation for coordinated discovery and other pretrial proceedings. In addition, any similar lawsuits filed in federal courts in the future would be eligible for transfer.