Valsartan Lawsuit Alleges Tainted Pills Caused Fatal Liver Cancer

Published on May 10, 2019 by Sandy Liebhard

The family of a Kentucky man who recently succumbed to liver cancer has filed a valsartan lawsuit alleging his wrongful death resulted from the ingestion of tainted prescription pills.

Valsartan Lawsuit Allegations

According to the May 1st filing in the U.S. District Court, District of New Jersey, Kelly Shepherd Jr. was prescribed valsartan to control high blood pressure. Between July 2014 and May 2018, he took generic valsartan tablets manufactured by Hetero Labs, Mylan Laboratories and Camber Pharmaceuticals. (Case No. 1:19-cv-12038)

Shephard was diagnosed with liver cancer in May of 2017, and died in June 2018. His family claims that his valsartan pills were tainted with carcinogenic nitrosamines that ultimately caused his death.

“Decedent Plaintiff and his physicians did not know of the specific increased risks and serious dangers, and/or were misled by Defendants, who knew or should have known of the true risks and dangers, but consciously chose not to inform Decedent Plaintiff or his physicians of those risks and further chose to actively misrepresent those risks and dangers to the Decedent Plaintiff and his physicians,” the complaint states.

Heart and Blood Pressure Drug Recalls

Valsartan was one of several heart and blood pressure medications recalled by generic dug makers over the past year due to possible contamination with NDMA or NDEA. The compounds belong to a class of chemicals called nitrosamines and were recently detected in active pharmaceutical ingredients supplied by Hetero Labs of India and China-based Zhejiang Huahai Pharmaceutical Co.

Nitrosamines occur in bacon and other cured meats. They have been linked to gastrointestinal tract cancers, including colon cancer, stomach cancer, and esophageal cancer, as well as liver cancer, kidney cancer, and pancreatic cancer.

According to the U.S. Food & Drug Administration, nitrosamines may have been present in the recalled valsartan, irbesartan, and losartan products for as long as four years. The contamination likely occurred when Hetero Labs and Zhejiang Huahai Pharmaceutical altered their product methods.

The FDA estimates that if 8,000 people took the highest valsartan dose (320 mg) containing NDMA from the recalled batches daily for four years, there may be one additional case of cancer over the lifetimes of the 8,000 people.

If 18,000 people took valsartan at the highest dose (320 mg) containing NDEA from recalled batches daily for four years, there may be one additional case of cancer over the lifetime of these 18,000 people.

The recalls are ongoing, and the FDA continues to update its lists of affected valsartan, losartan and irbesartan products.

Valsartan Lawsuits Centralized in New Jersey

The Shephard family’s valsartan lawsuit is among dozens pending in a multidistrict litigation now underway in the U.S. District Court, District of New Jersey. The proceeding includes personal injury claims for cancer, as well as class action lawsuits that seek economic damages for consumers who purchased contaminated valsartan products.

In March, plaintiffs’ attorneys said they would likely file thousands of additional valsartan lawsuits within the next two years. The proceeding already involves numerous defendants, including Hetero Labs, Zhejiang Huahai, Teva Pharmaceutical Industries Ltd., Mylan NV, and CVS Health Co.

At this time, the litigation does not include claims for recalled losartan or irbesartan medications, but that could change in the future.