A panel of federal judges has ruled that all lawsuits filed in U.S. District Courts across the country by plaintiffs who claim that they developed cancer from the generic blood pressure drugs losartan and irbesartan will be consolidated with the pending valsartan litigation. All of the claims involving generic valsartan, losartan and irbesartan involve similar allegations that the recalled medications were contaminated with cancer-causing chemicals that unnecessarily exposed users to an increased risk of cancer. If you or someone you love was diagnosed with cancer after using generic valsartan, losartan or irbesartan, you may be entitled to financial compensation for your medical expenses, lost wages and other damages. Contact a knowledgeable valsartan injury attorney today to discuss your legal options.
Valsartan, losartan and irbesartan are all generic blood pressure medications that fall under the category of angiotensin II receptor blockers (ARBs). These drugs are commonly used to treat high blood pressure and heart failure and they work by preventing angiotensin II from binding to angiotensin II receptors in the muscles surrounding blood vessels. By blocking the action of angiotensin II, the medications allow the blood vessels to dilate, which in turn reduces blood pressure. Unfortunately, the manufacturers of generic blood pressure medications have come under fire recently for distributing valsartan, losartan and irbesartan pills tainted with nitrosamines like N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), which have been known to cause cancers like stomach cancer, liver cancer, esophageal cancer, prostate cancer and pancreatic cancer. A growing number of generic valsartan, losartan and irbesartan drug products have been recalled during the past year over concerns that NDMA and NDEA contamination may expose users to an increased risk of cancer.
The first of many valsartan recalls was issued in July 2018, after it was discovered that certain generic drug makers distributed valsartan pills that were tainted with NDMA, NDEA and other carcinogenic (cancer-causing) chemicals. On July 13, 2018, the FDA announced a recall of several medications containing the active ingredient valsartan, after it was discovered that the drug products were contaminated with NDMA. According to the FDA, “The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.” Reports at that time indicated that valsartan active pharmaceutical ingredient supplied by Zhejiang Huahai Pharmaceuticals in China and Hetero Labs in India and distributed in the United States may have been tainted by NDMA as a result of changes made to the valsartan manufacturing process.
Since the first valsartan recall was announced, several other recalls have been issued by generic drug manufacturing companies over NDMA and NDEA impurities found in valsartan and in generic losartan and irbesartan products as well. The FDA has continued to provide updates on the steps the agency is taking to address ongoing concerns about the presence of nitrosamine impurities in ARB medications. Most recently, in November 2019, the FDA issued a warning letter to Mylan Pharmaceuticals citing “significant deviations from current good manufacturing practice for active pharmaceutical ingredients” at the company’s manufacturing facility in India. According to the FDA, “Mylan manufactures valsartan active pharmaceutical ingredient (API) and has been one subject of an ongoing global investigation into nitrosamine impurities in angiotensin II receptor blockers (ARBs) such as valsartan, losartan and irbesartan.”
Patients across the country rely on angiotensin II receptor blockers like generic valsartan, losartan and irbesartan to control their blood pressure and reduce their risk of heart failure. And while it was just last year that the presence of NDMA and NDEA was identified in valsartan, losartan and irbesartan products, the FDA indicates that nitrosamine-contaminated ARBs have been on the market in the United States for several years, during which time users may have been unknowingly exposed to an increased risk of cancer. Furthermore, while the risk to patients taking generic valsartan, losartan or irbesartan appears to be relatively small, the fact that the impurity existed at all and went unnoticed and unreported for years is cause for concern. “While the total exposure to these impurities for most patients was small, we are deeply concerned that patients were exposed to this impurity in the first place and that the presence of nitrosamines went undetected for a period of time,” FDA Commissioner Scott Gottlieb, MD, and Janet Woodcock, MD, director of the Center for Drug Evaluation and Research said in a statement issued by the agency earlier this year.
There are currently more than 150 product liability lawsuits and class action claims alleging side effects from recalled valsartan medications pending in the federal court system. Given the fact that the valsartan lawsuits all involve similar allegations that tainted generic valsartan drug products caused plaintiffs to develop cancer, the lawsuits were consolidated for coordinated pretrial proceedings in the U.S. District for New Jersey earlier this year. Now, because the growing number of lawsuits filed over recalled losartan and irbesartan drugs involve common questions of fact and because there are overlapping issues in the cases, including the fact that many patients switched between different types of blood pressure medications found to contain cancer-causing impurities, the U.S. Judicial Panel on Multidistrict Litigation (JPML) has determined that losartan and irbesartan should be consolidated with the pending valsartan litigation.