If you or a loved one are taking valsartan, you may or may not know about the recent recalls or lawsuits involving it. All of them involve valsartan-products manufactured in China by the pharmaceutical company Zhejiang Huahai Pharmaceutical (ZHP). They all note that ZHP-manufactured valsartan contains N-nitrodimethylamine (NDMA), which groups, such as the World Health Organization (WHO), categorized as a potential carcinogen.
Valsartan Worldwide Recalls
ZHP-manufactured Valsartan could be found in various countries throughout the world. The relatively low manufacturing costs in China made it attractive for countries such as the United States to import it. While these generic drugs may be cheaper to make in China, there are fewer regulations that ensure the safe manufacture of these drugs. This is the tradeoff you get when buying some generic drug imports. Because of the discovery of NDMA in ZHP-manufactured valsartan, the European Union, Taiwan, Canada, the United States, and South Korea announced successive recalls in July 2018.
In July, the European Union announced the first valsartan recalls. It followed a July 5th European Medical Association (EMA) announcement that they would review valsartan manufactured by ZHP. The EMA had also announced that only some of the valsartan medication was affected by the recall. They also advised that patients do not stop taking their valsartan medication unless instructed to do so by their health care provider.
Days later, the Taiwanese Food and Drug Administration announced their valsartan recall. This was after they discovered six Chinese-made valsartan brands that contained NDMA. The Taiwanese FDA also noted that these six-brands combined only account for a small percentage of heart-disease-related drugs. The Taiwanese government required healthcare facilities and pharmacies to recall the contaminated valsartan within one month. They also advised that patients do not stop taking the contaminated drugs, but that they should see a doctor for alternatives.
Around the same time as the Taiwanese recall, Health Canada, the Canadian government agency for public health issued a recall on July 9th. They advised the patients to continue taking their valsartan unless told to stop by their doctor.
The U.S. Food and Drug Administration (FDA) announced their recall four days later on July 13th. They also announced that they would review and investigating NDMA-levels in recalled products. They also advised that patients continue to take their medication unless instructed otherwise. They also advised that patients taking valsartan should check to see if the medication they are taking was recalled or not.
Tennessee Class Action Lawsuit
Recently, on October 16th, a class-action lawsuit was filed against ZHP in the U.S. District Court for the Eastern District of Tennessee. While the lawsuit does not allege that the plaintiffs suffered adverse health effects, it alleges they “were injured by paying the full purchase price of their valsartan-containing medications and paying for incidental medical expenses.” It also alleges that the medications are “worthless because they are contaminated with carcinogenic and harmful N-nitrodimetylamine and are not fit for human consumption.”
The lawsuit notes that the plaintiff seeks “equitable relief and to recover economic damages and restitution.” It also notes that there were violations of the Tennessee Products Liability Act. This includes a failure to warn, a breach of contract, a breach of implied warranty and merchantability, and unjust enrichment.
Throughout the United States, there have been similar lawsuits to the aforementioned one. Missouri resident James Jones filed an MDL class action lawsuit in the U.S. District Court for the Eastern District of Missouri on September 11th. He filed suit against ZHP and other valsartan manufacturers and distributors. Mr. Jones brought suit because he took generic valsartan drugs containing NDMA.
New York Lawsuit
On August 16th New York residents Elizabeth Duffy and John Duffy filed suit against Valsartan manufacturer’s Solco and Prinston as well as distributors Walgreens and Throggs Neck Pharmacy. They filed in the U.S. District Court for the Southern District of New York. Walgreens sold the contaminated products to John Duffy, while Throggs Neck sold contaminated products to Elizabeth Duffy.
What Should I Do If My Valsartan Medication Is on the Recall List?
If your medication is included in the recall list, continue to take your medication. Cancers take many years to fully develop. However, please contact your doctor, pharmacist, or other healthcare professional. They should provide the best option for you. They may either provide a valsartan medication that is not on the list or treatment alternatives.
What Should You Do?
If you have been taking one of the recalled valsartan drugs manufactured by Teva or Solco Healthcare and you have cancer, you should contact Miller & Zois to discuss whether you have a potential claim. Get a free online consultation.