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Adulterated Valsartan Causes Cancer

If you or a loved one has been taking the drug, Valsartan, you may have a claim against pharmaceutical companies for the distribution and sale of Valsartan medication that has been contaminated with toxic, cancer-causing substances.

On July 13, 2018, the FDA recalled the drug, Valsartan.  Valsartan is the generic form of Diovan, which is used to treat high blood pressure and heart conditions.  Because it costs less, the active pharmaceutical ingredient (API) for Valsartan is manufactured in countries outside of the United States.  Several of the foreign API manufacturers changed the manufacturing process in 2012, and this change is believed to have caused unintended byproducts, which contaminated the drug with impurities, including N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and/or N-Methylnitrosobutyric acid (NMBA). These toxic substances are classified as probable human carcinogens, meaning that they are more likely than not to cause cancer in humans.  Zhejiang Huahai Pharmaceutical (ZHP) in China and Hetero Labs Limited (Hetero) in India are two of the API manufacturers that used the altered manufacturing process. ZHP has an estimated 45% of the US market share of the Valsartan API production. 

The APIs from ZHP and Hetero are used in finished pills, which are sold in the United States.  Many American pharmaceutical companies have made, distributed, marketed and/or sold Valsartan products containing the API containing toxic substances. It is believed that the contaminated pills have been sold in the United States since 2014 and that there have been millions of contaminated pills taken in the United States.  Based on tests, the API manufacturers were aware that Valsartan contained high levels of the toxic substances. The manufacturers minimized the information, citing testing inaccuracies. Eventually, after additional testing, the European Medicines Agency (EMA) issued recalls for Valsartan and the FDA followed.  The FDA initially issued a report that 1 in 8,000 people taking Valsartan may develop cancer, but scientific evidence show that the number of cancer cases is likely significantly higher.    

What is the current state of pending litigation?

Multidistrict Litigation (MDL) currently pends in the US District Court for the District of New Jersey Camden Vicinage, MDL No. 2875 In re: Valsartan Products Liability Litigation.  The MDL includes class actions for plaintiffs seeking only economic damages based on the purchase of a tainted product. It also includes plaintiffs who have suffered from personal injuries as a result of ingesting the Valsartan product.  Plaintiffs alleging personal injury, from all jurisdictions, are permitted to file suit directly in the New Jersey MDL. 

There are a small number of cases filed in New Jersey state court against some of the New Jersey manufacturers.  As the number of cases filed in New Jersey state court increases, it is anticipated that multicounty litigation (MCL) will be approved.      

Which products have been recalled? 

The recalled drugs now include some Losartan and Irbesartan products.  The list of recalled Valsartan, Losartan and Irbesartan products may be found on the FDA website at https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and 

How do I whether I have taken a recalled drug?

  • Obtain your pharmacy records.  
  • The pharmacy records should contain a National Drug Code (NDC) listed beside each Valsartan entry. This number is a universal product identifier for drugs in the United States.  
  • The NDC can be searched in databases such as http://www.ndclist.com/search; or http://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory.                     The search should identify the manufacturer of the drug.  
  • The FDA databank or the manufacturer’s own list of recalled products can then be used to determine if the manufacturer has issued a recall on your pill batch or lot.  
  • You may have received recall notices from pharmacies, doctors, and/or the manufacturers.  
  • If your drug has not been recalled, note that the recall list is continuing to be expanded.

What symptoms/medical problems do Valsartan drugs caused?

  • Liver, colorectal, intestinal, stomach, kidney and bladder cancers are the cancers.  
  • Significant liver injuries. 

What should I do if I think I have a case?

  • Save and turn over unused pills and the original container to your attorney.
  • Retain any recall notices.
  • Get a print out of your pharmacy records beginning in 2012.  
  • Contact an attorney before the statute of limitations expires.  Georgia has the “discovery rule” in products liability cases.  The statute of limitations runs 2 years from when the injured person knew or should have known that the injury resulted from the product.  Optimally, filing suit should occur within 2 years of the cancer diagnosis or liver injury; however, in reliance on the discovery rule, it is possible to file suit within 2 years of the recall date of July 13, 2018.  Consult further with any attorney to determine when the statute of limitations for your case expires, as it depends on which the state law that governs and other nuanced legal analyses.

If you or a loved one has suffered from injuries related to the ingestion of Valsartan, please call the Davis Injury Firm at 404-593-2620 for a case evaluation with an attorney.