FDA Warning
On June 13, 2018, the FDA issued a warning that alerted healthcare professionals to contamination in the product Valsartan. The contamination contained “impurities in certain commonly prescribed heart medicines.”
Companies Involved
Some of the companies involved include Zhejiang Huayi Pharmaceutical Co., Ltd. (ZHP), which is a Chinese-based manufacturer, Torrent, Teva, and Aurobindo. The warning letter was specifically addressed to ZHP in 2018 about the cancer-causing impurities of the medication used to treat high blood pressure and heart failure.
Torrent, Teva, and Aurobindo all acted as suppliers from the manufacturer ZHP, all of which have had significant issues with cleanliness and testing. Even after the warning, Aurobindo claimed that its batch of products was not contaminated. The company performed very little testing and ignored the red flags in the results of the tests. Later, they admitted to the contamination, as did the other three entities.
Testing
The entities have sufficient testing supplies to do proper testing on the valsartan product, however, each chose not to do so.
Current State of Litigation
The current state of litigation is that discovery is about to close, and bellwether trials are set to begin shortly. The bellwether pool is currently about 28 plaintiffs. The bellwether depositions will be completed by October 1, 2021, and the bellwether physician depositions will be completed by November 4, 2021.
Injury Criteria
Cancer criteria are labeled into two different groups, Tier 1 and Tier 2. Under Tier 1, the cancer injury is to the stomach, small intestine, colon, esophagus, and liver. Under Tier 2, the cancer injury criteria are prostate, pancreas, leukemia, non-Hodgkin’s lymphoma, and multiple myeloma.
Risk Factors
Risk factors that should be considered regardless of the cancer type are as follows: age of 65 to 81 diagnosed, alcohol use, BMI between 30 and 50, smoking, HPV, organ transplant, diabetic, previous exposure to radiation treatment, and manufacturing or industry workers.
“FDA warns API manufacturer involved in valsartan recall” https://www.fda.gov/news-events/press-announcements/fda-warns-api-manufacturer-involved-valsartan-recall-provides-information-patients-taking-these