Product recalls often vary greatly in terms of severity. In some cases, consumer goods are recalled because of a minor labeling error, posing little to no injury risk to anyone who purchased the product. On the other end of the spectrum, sometimes consumer products are subject to safety recalls because they have such a serious defect that consumers who use the item can suffer life-threatening or even fatal injuries. According to a recent report in CNN News, a common medication used to help control blood pressure and to prevent heart attacks has been recalled: “because it contains a chemical that poses a potential cancer risk.”
The drug has been recalled in 22 different countries thus far and has been distributed widely to consumers with heart conditions. If you or someone you love has used this medication, it is important to learn more about how defective drug recalls can lead to successful product liability lawsuits.
Valsartan May Cause Cancer in Heart Patients
The heart disease drug that has been subject to recall is known as valsartan, and the pharmaceutical company Novartis originally developed this product. It is also manufactured by the pharmaceutical companies Dexcel Pharma Ltd and Accord Healthcare. As of now, at least 2,300 batches of the medication have been recalled, and it is possible that more of the drug will be subject to the recall notice. On Novartis’s recall notice, the company explained that the drugs “do not meet our high-quality standards.” That language is vague and does not clarify precisely what the problem is with valsartan.
What is wrong with the valsartan batches that have been subject to recall? In short, as a result of “a change in the manufacturing process,” these batches of the drug may cause cancer when patients use them. The manufacturing process produced an impurity known as N-Nitrosodimethylamine (NDMA), which is “an organic chemical that is in a family of potent carcinogens,” according to the report.
How NDMA Can Cause Cancer in Heart Disease Patients
Here is some additional information about this chemical: it has previously been used in manufacturing rocket fuel, softeners, and lubricants. It is a common byproduct of pesticide manufacturing, as well as rubber tire manufacturing. When certain types of chemical reactions occur, it can be produced unintentionally. The latter is what produced the chemical in the recalled batches of valsartan.
How does NDMA cause cancer? As we mentioned, it is a carcinogen, and some studies on animals have demonstrated that NDMA can be toxic and cause tumors in the kidney, liver and respiratory tract. The U.S. Department of Health and Human Services (HHS) has linked NDMA to liver damage and has classified it as “a probable human carcinogen.”
Currently, valsartan batches in the U.S. have not been subject to the recall, but any Floridians who have traveled to Europe and taken the drug should contact their physicians immediately. In addition, anyone in Florida who uses this medication should monitor the news closely in the event that the recall expands to batches of valsartan sold to pharmacies in the U.S.
Contact a Product Liability Lawyer in Boca Raton
Consumer products should be safe for use. If you were injured after using a consumer product, you should speak with a Boca Raton product liability lawyer about your case. Contact Lesser Lesser Landy & Smith PLLC for more information about how we can assist you.