What is the lawsuit about?
Valsartan is the generic name of a very popular and effective blood pressure medication that has been used since 1996. Originally developed and manufactured by Novartis under the trade name Diovan, Valsartan became available for other manufacturers to produce as a generic drug in 2012. A number of other pharmaceutical manufacturers including manufacturers in China and India began manufacturing the bulk drug for use by distributors in the U.S. to manufacture their own version of the medication with their own branding. However, the procedure for making the raw drug by the Chinese and Indian manufacturers was modified by some of these companies resulting in the introduction of a by-product and contaminate called NDMA (N-nitrosodimethylamine) into the final raw or bulk product. NDMA is a potent carcinogen in animals and probably carcinogenic to humans, even in relatively small amounts. The Valsartan personal injury lawsuits involve individuals who have taken generic versions of Valsartan for a certain period of time, and who have been diagnosed with cancer, specifically liver, stomach, intestinal or kidney cancer.
What are the current actions by the FDA?
In July 2018, one of the leading Chinese valsartan manufacturing companies, Zhejiang Huahai Pharmaceuticals, discovered that the raw Valsartan it was producing was contaminated with NDMA. Before and after the discovery of this contamination, Zhejiang Huahai was a wholesaler of Valsartan in bulk to its distributors in the U.S. Other manufacturers in China, as well as India, had similar problems and sold bulk contaminated Valsartan to its U.S. distributors.
The FDA has done limited testing and has recalled a number of the generic products of U.S. distributors who have purchased bulk Valsartan from these Chinese and Indian manufacturers. But numerous products have yet to be tested and recalled. It is suspected that many more distributors of generic Valsartan contain Valsartan purchased from the contaminated sources and has resulted in significant exposure of the carcinogen to individuals taking the generic forms of the medication. Consequently, more recalls of the medication are expected in the future.
What is the current staus of claims?
Numerous lawsuits have been filed against a number of distributors of the generic form of the medication alleging that valsartan contaminated with NDMA was sold to individuals who were consequently exposed to significant amounts of the NDMA carcinogen, and developed various cancers as a result. These cases which were originally filed in various federal court jurisdictions throughout the country have been consolidated into a Federal District Court in New Jersey for the discovery phase of the litigation. The judge in this Federal District Court will be responsible for managing much of the discovery part of the litigation for establishing the rules for filing and managing all pending and future claims and lawsuits involving Valsartan.
What do you need to do?
If you or a family member currently take any generic form of Valsartan, it is important that you immediately contact your doctor to discuss your risk of exposure to the carcinogen, NDMA. You should discuss alternative therapies to minimize your risk from exposure to the carcinogen. If you have stopped taking any generic form of the medication since 2012, it is important that you get records from your pharmacy or pharmacists that will show the identity of the particular distributors or manufacturers of the generic medications you received from 2012 up until the date you stopped taking the medication. You may need this information for any future claims.
If you have taken any generic form of Valsartan since 2012 and have been diagnosed with stomach, intestinal, liver or kidney cancer, you should call our office immediately to discuss your legal options for compensation against the manufacturers and distributors of Valsartan. Time is of the essence. Your ability to file claims is limited and depends on numerous factors. Call The Cochran Firm – Dothan today for a free consultation: (334) 673-1555.
References and Resources:
The New York Times discusses the recall and how the contamination is related to the way Valsartan is manufactured. It is advised that patients check the ingredients on the medication or ask their health care providers about the medication they are currently taking. The health care provider will be able to prescribe a different, non-contaminated medication should the current medication be part of the recall.
The Washington Post covers the contaminants and how they were created through the manufacturing of Valsartan. The FDA believes that millions of people have been exposed to contaminated Valsartan products. It is advised that you do not stop taking the medication until you speak with your healthcare provider and start a new, non-contaminated medication. There are other health risks associated with stopping medication without direction from the health care provider.