Valsartan Lawsuits
Valsartan lawsuits claim manufacturers produced faulty drugs that were contaminated with the cancer-causing chemical NDMA. Lawsuits have been filed by consumers and insurers who are suing various parties in the valsartan supply chain.
Latest Valsartan Lawsuit Updates
As of November 2024, there were 1,278 active valsartan lawsuits pending in multidistrict litigation before Chief U.S. District Judge Renee M. Bumb of the U.S. District Court District of New Jersey. The lawsuits allege defendants are liable for making or distributing a drug they knew had potentially cancer-causing contaminants. Plaintiffs are seeking justice and compensation for damages.
- June 2024: At the end of May, Judge Bumb issued an order to defendants and plaintiffs to finalize the terms of the valsartan settlement for claims against the defendant Hetero. The parties would have until June 30 to finalize the terms. Lawyers were working toward final approval of Hetero’s class action and personal injury settlements.
- May 2024: Judge Renee M. Bumb was appointed to preside over the litigation following Judge Kugler's retirement.
- October 2023: U.S. Magistrate Judge Singh signed a pretrial scheduling order on Oct. 19 that scheduled a telephone status conference on Jan. 22, 2024, and set a deadline of Sept. 30, 2024, for all fact discovery.
- April 2023: The Third Circuit Court denied defendants’ motion for interlocutory appeal of Kugler's Class Certification ruling, paving the way for economic cases to be tried at the end of 2023 and/or early 2024.
- February 2023: Judge Kugler certified multiple MDL classes against makers and distributors/retailers of valsartan pills with cancer-causing impurities.
- December 2022: Judge Kugler rejected defendants’ motion to reconsider an earlier court decision allowing use of claimants’ experts’ testimony. The ruling allowed valsartan litigation to continue and affirmed the validity of valsartan-related cancer studies as evidence in court. Defendants requested Kugler either exclude claimants’ expert evidence in the case or certify a hearing over the same.
Because trials have not started, there are no jury verdicts yet. No out-of-court settlements have been made public.
Injuries Named in Valsartan Lawsuits
Plaintiffs are mostly people diagnosed with cancer or families of patients who died of cancer. They attribute their cancers to carcinogenic exposure from contaminated valsartan. The hypertension drug was recalled in 2018 after several batches of valsartan were found to be contaminated with N-nitrosodimethylamine. The chemical has caused cancer in laboratory animals and is a probable human carcinogen. It can also cause liver damage.
Multiple studies indicate people exposed to NDMA have an increased risk of developing cancer. A Swedish study involving 61,433 women, for example, linked the intake of NDMA-contaminated valsartan to a higher risk of gastric cancer. In France, research suggested a higher probability of developing liver cancer among 986,126 users of NDMA-tainted valsartan. Such studies are a foundational piece of valsartan lawsuits.
- Colorectal/colon/rectal
- Intestinal (including small intestine)
- Stomach/gastric
- Liver
- Esophageal
- Prostate
- Blood (including non-Hodgkin’s lymphoma, multiple myeloma, and leukemia)
- Bladder
- Lung
Although nitrosamines such as NDMA are present in other items consumers often encounter, such as smoked and cured meats and malt beverages, the levels are not usually high enough to pose much of a risk. The level of NDMA found in the contaminated valsartan tablets, however, exceeded strict federal limits.
According to the U.S. Food and Drug Administration, humans can safely consume 0.096 micrograms of NDMA per day. The recalled valsartan pills contained anywhere from 3 to 177 times the level deemed safe for human ingestion. Some testing revealed levels of up to 20 micrograms, which is more than 208 times the safe level of NDMA.
Cancer and Wrongful Death Claims
People diagnosed with cancer after taking valsartan faced expensive medical treatments and lost wages, having to take from work while sick and undergoing treatment. People also seek compensation for pain and suffering. Some plaintiffs are asking for punitive damages against the defendants.
Plaintiff Edwin Childs from Queens, New York started taking valsartan in 2012 and was diagnosed with colon cancer about four years later. He contends his condition is the result of his use of the contaminated blood pressure drug.
All actions involve common factual questions arising out of allegations that plaintiffs purchased or used generic formulations of valsartan medications containing the nitrosamine impurities NDMA and/or NDEA; that these 5 impurities present a risk of cancer and liver damage; and that defendants knew, or should have known, of the impurities as early as 2012.
In one wrongful death claim, the daughter of Peggy Watts of Manchester, Tennessee, is suing Zhejiang Huahai Pharmaceutical Co. Ltd. for the 2018 cancer-related death of her mother. Watts had taken prescription valsartan since 2014 and received a colorectal cancer diagnosis in 2018.
Can I File a Valsartan Lawsuit?
If you took valsartan or a combination medication that included valsartan and were later diagnosed with cancer, you may be eligible to file a valsartan lawsuit for compensation. A valsartan lawyer can assess your eligibility and examine any useful evidence you might have, including prescription bottles and tests for toxic contamination.
- You must have taken one or more of the following: valsartan, valsartan + HCTZ, valsartan + amlodipine, valsartan + HCTZ + amlodipine.
- At least six months of valsartan use between 2015 to 2018.
- Must have 6 months of use of valsartan before cancer diagnosis.
An individual state’s statute of limitations applies. This defines a strict timeline for when you can file a product liability claim. States have different statutes of limitations. Your lawyer will assess if your case is within timeline eligibility.
17 Cited Research Articles
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- United States Judicial Panel on Multidistrict Litigation. (2024, November 1). MDL Statistics Report - Distribution of Pending MDL Dockets by District. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-November-1-2024_0.pdf
- Schrenk, D. et al. (2023, March 28). Risk Assessment of N-nitrosamines in Food. European Food Safety Authority. Retrieved from https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.7884
- Kugler, R. (2022, December 22). The United States District Court for the District of New Jersey: Camden Vicinage. Retrieved from https://www.aboutlawsuits.com/wp-content/uploads/2022-12-22-Order-1.pdf
- Kugler, R. (2022, December 20). United States District Court District of New Jersey. Retrieved from https://www.aboutlawsuits.com/wp-content/uploads/2022-12-20-Motion.pdf
- Mansouri, I. et al. (2022, December 19). N-nitrosodimethylamine-Contaminated Valsartan and Risk of Cancer: A Nationwide Study of 1.4 Million Valsartan Users. Journal of the American Heart Association. Retrieved from https://www.ahajournals.org/doi/10.1161/JAHA.122.026739
- Kugler, R. & King, S. (2022, March 3). Case Management Order no. 25: Appointment of Parties’ Settlement Counsel. Retrieved from https://www.aboutlawsuits.com/wp-content/uploads/2022-03-03-Order.pdf
- U.S. District Court for the District of New Jersey. (2019, March 20). Childs vs. Zhejiang Huahai Pharmaceutical Co., et al. Retrieved from https://ecf.njd.uscourts.gov/doc1/119014444433
- U.S. Food and Drug Administration. (2019, March 1). FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-provides-update-its-ongoing-investigation-arb-drug-products-reports-finding-new-nitrosamine
- U.S. Judicial Panel on Multidistrict Litigation. (2019, March 15). MDL Statistics Report — Distribution of Pending MDL Dockets by District. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-March-15-2019.pdf
- U.S. Food and Drug Administration. (2019, March 12). FDA approves a new generic valsartan. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-new-generic-valsartan
- U.S. Food and Drug Administration. (2019, March 1). Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and
- Nguyen, T. (2019, February 19). A side reaction may have led to impurities found in valsartan heart drugs. Retrieved from https://cen.acs.org/pharmaceuticals/process-chemistry/side-reaction-led-impurities-found/97/web/2019/02
- U.S. Judicial Panel on Multidistrict Litigation. (2019, February 14). In Re: Valsartan N-Nitrosodimethylamine (NDMA) Contamination Products Liability Litigation MDL No. 2875: Transfer Order. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/MDL-2875-Initial_Transfer-01-19.pdf
- U.S. Food and Drug Administration. (2018, October 10). Laboratory analysis of valsartan products. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/laboratory-analysis-valsartan-products
- U.S. Food and Drug Administration. (2018, July 13). FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-several-medicines-containing-valsartan-following-detection-impurity
- U.S. Environmental Protection Agency. (2017, November). Technical Fact Sheet — N-Nitroso-dimethylamine (NDMA). Retrieved from https://19january2021snapshot.epa.gov/sites/static/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf
- United States District Court District of New Jersey. (n.d). Valsartan MDL 2875. Retrieved from https://www.njd.uscourts.gov/valsartan-mdl-2875
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