Recalled Valsartan Tablets Led To Colorectal Cancer Diagnosis, Lawsuit Claims

Following years of taking valsartan tablets that were later recalled due to manufacturing impurities, a California man indicates in a recently filed lawsuit that he has been left with colorectal cancer. 

The complaint (PDF) was filed by Daniel Winiecki in the U.S. District Court for the Central District of California, indicating that Zhejiang Huahai Pharmaceutical Co., Prinston Pharmaceutical Inc., and Solco Healthcare manufactured and sold recalled valsartan tablets that were contaminated with known human carcinogens.

Winiecki indicates that he began taking generic valsartan in March 2015 for the treatment of high blood pressure, and continued to use the medications until July 2018, when it was discovered that many tablets distributed in recent years contained cancer-causing impurities, known as N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA).

In March 2018, Winiecki was diagnosed with colorectal cancer, which he claims was caused by the recalled valsartan tablets, which he never would have used if he had known that they caused carcinogenic impurities.

“Plaintiff would not have consented to taking valsartan, had Plaintiff known of or been fully and adequately informed by Defendants of the true increased risks and serious dangers of taking the drug, which was rendered unreasonably dangerous by the presence of NDMA and/or NDEA,” the lawsuit states. “Plaintiff and Plaintiff’s 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 Plaintiff or Plaintiff’s physicians of those risks and further chose to actively misrepresent those risks and dangers to the Plaintiff and Plaintiff’s physicians.”

Winiecki presents claims of defective manufacturing and design, failure to warn, negligence and negligence per se, breach of warranty, fraud and negligent misrepresentation, seeking compensatory and punitive damages.

Since July 2018, a number of different generic valsartan recalls have been issued due to the presence of NDMA and NDEA, impacting a large portion of the pills distributed throughout the United States in recent years.

The FDA has assigned a group of pharmacists and nurses to answer consumer’s questions about the recalls. Since the first recalls, the agency indicates it has received more than 6,000 inquiries from patients, doctors, nurses, pharmacists and academics. Inquiries can be made by calling 855-543-3784 or by sending an email to druginfo@fda.hhs.gov.

While this lawsuit was an individual claim, there are also a number of valsartan class action lawsuits pursuing damages for users of the medications who have not been diagnosed with cancer, seeking reimbursement for the cost of what were essentially worthless drugs, and funding for medical monitoring they may require for the rest of their lives due to their exposure to cancer-causing agents.

For individuals like Winiecki diagnosed with colorectal cancer, liver cancer, kidney cancer, bladder cancer, stomach cancer and other cancers, valsartan lawsuits are also being reviewed by product liability lawyers.