Valsartan is a medication that is intended to treat high blood pressure. However, the manufacturers of the drug have recalled lot after lot of the drug due to an impurity that is was found to contain that can cause cancer in human beings. Eventually, most of the lots of this drug were recalled from the marketplace due to both the cancer risk and other harmful side effects. As a result, the manufacturers of the drug are now facing numerous Valsartan lawsuit product liability claims. If you have taken Valsartan and have either been diagnosed with cancer or experienced other severe side effects, you should promptly contact a Valsartan lawsuit attorney to discuss a possible Valsartan lawsuit.
What is Valsartan?
Valsartan is the name of a class of drugs that contain the specific ingredient. It is sold under a variety of different trade names. As such, there are several different manufacturers of the drug. It was approved by the FDA for use and came onto the marketplace in 1996. The drug works by acting as a blocker of angiotensin II. The medication acts at the receptor and activates aldosterone. The effect of Valsartan is that blood vessels do not narrow. It can also be used to treat to reduce heart failure and to help people whose hearts have been damaged in a previous cardiac episode.
The original manufacturer of Valsartan was Novartis Pharmaceutical. After the patent expired in 2012, numerous drugmakers launched their own generic versions of the drug. There are nearly 50 versions on the market worldwide. In 2010, sales of the drug in the U.S. were approximately $2 billion. The side effects of Valsartan are generally not considered to be severe. However, after many years of the drug being available in the market, the medication has been subject to many recalls. Specifically, the drug has been found to contain an impurity that is a possible carcinogen.
Recalls of Valsartan
The initial recalls were made in July 2018. At first, the recall was limited to Europe, and it was thought the issue that necessitated the recall did not affect the medications sold in the U.S. However, subsequent recalls were undertaken in the U.S. as various lots of the medicine were found to contain impurities. This Valsartan recall progressively spread to cover additional lots and has unfolded over many months. The FDA has published a list of the medications that have been affected by the Valsartan recall. Since there are many different drugs that contain the ingredient Sartan, dozens of products have been recalled.
Specifically, the drug has been found to contain an impurity called N- Nitrosodimethylamine. This ingredient has also been used to make jet fuel and other lubricants. It has also been used in intentional poisonings. While it would not intentionally be included in the pharmacology for a medication, it is a byproduct of chemical reactions. Not only can this damage internal organs, but the Department of Health and Human Services believes that it is a possible carcinogen. The manufacturers have had difficulty tracing the source of the impurity given that this drug is manufactured with supplies produced worldwide. Novartis claims that the recalls have been made as a precaution and there have been no reports of adverse events associated with its brand of Valsartan.
As with any defective pharmaceutical, there is the possibility of lawsuits against the manufacturers for any damages suffered by those who have used the product. Since the alleged defect involves a carcinogen, it may be years before the full effect of this imperfection is known. Given the large size of the market for Valsartan, if the carcinogen does cause damage, it will likely be widespread with the companies facing a large legal liability.
Class Actions Against the Manufacturers
Shortly after the initial recalls, the first Valsartan lawsuits were filed against manufacturers of the drug. There was a class action lawsuit filed against Prinston Pharmaceutical Inc., Huahai US Inc. and Teva Pharmaceuticals USA, Inc. in federal court in New Jersey. The lawsuit claims that the defendants should have known that the products being produced at a plant in China contained contaminants. Specifically, the complaint alleges that the impurity started being introduced in 2012, after the defendants changed their manufacturing process. According to the plaintiffs, not only did the defendants know about the impurity, but they also took steps to conceal it when health inspectors visited the manufacturing plant. When the FDA inspected the plant in 2017, it found that the manufacturer did not consistently document any impurities that were found in the medicine during the manufacturing process. In addition, the FDA had found that the manufacturing facility was not adequately maintained in order to ensure the quality of the product.
The plaintiffs are those who have been prescribed and have taken the medication. The damage that they have suffered is that they have been exposed to a carcinogen. They will likely have to be monitored for the rest of their lifetimes to ascertain whether or not they have developed tumors as a result of this medication. Additionally, there was a Valsartan lawsuit filed in federal court in Missouri against some of the same defendants with similar allegations.
As more revelations come out about additional plants, one can anticipate that the number of Valsartan lawsuits against the manufacturers of these medications will continue to grow. Right now, these suits have been filed as a class action since there are common grounds of complaint among the plaintiffs and they have suffered similar harms.
If you have been prescribed any drug that has Valsartan as an ingredient, you should promptly contact a Valsartan lawsuit lawyer to find out more about how you can file a legal claim against the manufacturer of the medication. At present, these legal actions are still in their early phases. There is not yet any visibility about when they would go to trial if they reach that stage. This means that any possible financial recovery is likely years away. However, no financial compensation is available to you unless you file a claim.