Lawsuits over the alleged link between valsartan and cancer have raised serious concerns about the safety of this widely prescribed blood pressure medication. Reports of contamination with N-nitrosodimethylamine (NDMA), a potential carcinogen, have led to widespread recalls and a surge in legal claims. Patients who relied on valsartan, an angiotensin II receptor blocker (ARB), now face the possibility of increased cancer risk, including pancreatic, colorectal, stomach, liver, and kidney cancers.
As the litigation unfolds, more than 1,200 valsartan, losartan, and irbesartan lawsuits have been consolidated into multidistrict litigation (MDL) in New Jersey. This legal action involves plaintiffs seeking justice for cancer diagnoses potentially linked to contaminated valsartan or similar blood pressure medications. The valsartan litigation has brought to light critical issues surrounding drug safety, manufacturing processes, and the responsibilities of pharmaceutical companies.Â
Overview of the Valsartan Lawsuit MDL
The valsartan lawsuit arises from an investigation by the U.S. Food and Drug Administration into impurities found in generic valsartan medications. These impurities, identified as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), are potential carcinogens that have raised serious health concerns. Plaintiffs allege that they purchased or used generic valsartan tainted with these nitrosamine impurities, which they claim present a risk of cancer and other serious injuries. The lawsuits further assert that defendants knew or should have known about these impurities as early as 2012 but failed to warn the public.
Alleged Injuries Leading to a Valsartan Lawsuit
The valsartan lawsuits claim that exposure to contaminated medication has led to various types of cancer, including:
- Bladder cancer
- Stomach cancer
- Liver cancer
- Colorectal cancer
- Kidney cancer
- Pancreatic cancer
Additionally, plaintiffs allege liver injuries requiring hospitalization. It’s important to note that the scientific community has not definitively established a single, individual cause of cancer from nitrosamine exposure.
Recent Developments in the Valsartan Litigation
Defendants Involved in the Valsartan Lawsuit
The valsartan litigation involves numerous defendants across the pharmaceutical supply chain. These include:
- API Manufacturers: Zhejiang Huahai Pharmaceutical Co., Ltd., Hetero Labs, Ltd., and othersÂ
- Finished Dose Manufacturers: Mylan Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and moreÂ
- Distributors: Solco Healthcare U.S., LLC, Camber Pharmaceuticals, Inc., among othersÂ
- Wholesalers: AmerisourceBergen Corporation, Cardinal Health, Inc., and McKesson CorporationÂ
The litigation also involves repackagers and pharmacies that sold contaminated valsartan. This wide range of defendants reflects the complexity of the pharmaceutical supply chain and the widespread nature of the alleged contamination.
Latest Court Rulings in Valsartan Lawsuits
Judge Kugler recently rejected a motion by valsartan drug makers and distributors to exclude expert testimony linking the contaminated drug to cancer. This ruling allowed valsartan trials to proceed with scientific study findings usable as evidence against the implicated parties. Additionally, Judge Kugler certified consumer and insurance companies’ claims against manufacturers and distributors of tainted valsartan.
Judge Bumb, who recently took over the litigation following Judge Kugler’s retirement, has pushed the litigation forward. She issued an order for plaintiffs and defendants to finalize the settlement terms for all three classes of valsartan plaintiffs: personal injury, economic loss, and medical monitoring. This could indicate a global settlement potentially on the horizon for personal injury plaintiffs.
Impact on Valsartan Patients and Future Outlook
The long-term effects of NDMA exposure through contaminated valsartan are a significant concern. NDMA has been linked to various types of cancer, including bladder, stomach, liver, colorectal, kidney, and pancreatic cancers. Animal studies have shown that ingesting high to moderate levels of NDMA caused major liver damage after just a few days and cancer after several weeks. The continuous long-term use of contaminated valsartan is particularly troubling, as some patients may have been ingesting NDMA once or twice daily for several years. The consolidation of over 1,200 lawsuits into multidistrict litigation has paved the way for a comprehensive examination of the alleged valsartan contamination and its potential health impacts.
Valsartan Lawsuit Information
N-Nitrosodimethylamine-Contaminated Valsartan and the Risk of Cancer, Deutsches Ärzteblatt International