Will FDA Valsartan Recall End in Lawsuits?

Our lawyers are currently investigating the FDA’s recall of Valsartan in an effort to determine whether a sufficient medico-legal basis will exist to file Valsartan lawsuits for those impacted.  At this point, it is difficult to ascertain whether those who have taken Valsartan products contaminated with NDMA may have been adversely affected by taking the contaminated drug.  The viability of such claims will depend in large part on how long the medication was taken, from whom the medication was sourced, who manufactured the medication, what dose of the medication was taken, and the amount of contaminant contained in the medication.  A Valsartan lawsuit attorney can investigate the facts necessary to form a basis for possible Valsartan litigation.  First and foremost, though, is the need for those taking a contaminated Valsartan medication to consult their physician to determine if they have been taking a contaminated Valsartan product to determine whether a different medication may be indicated.  According to the FDA, Valsartan users should not stop taking the medication until completing a physician consultation.

The biggest concern for Valsartan users appears to be an elevated risk of cancer, although other concerns are possible organ damage or tumors.  Nonetheless, and importantly, at this time, the FDA is warning those taking Valsartan do not stop taking the medication unless and until you have consulted with your prescribing physician.  It is also important to note that not all Valsartan medication was contaminated with NDMA. The FDA has published a list of the recalled and non-recalled medications, which can be found here.  Valsartan lawsuit lawyers will continue to monitor the information being developed by the FDA and companies participating in Valsartan recalls.

According to the FDA, taking the highest Valsartan does (320 mg) from the recalled batches daily for the full four years may increase the risk of cancer to the point one additional case of cancer occurs in the lifetimes of a hypothetical group of 8000 such Valsartan takers.  This may seem like a relatively insignificant risk compared to the risks of developing cancer published by the American Cancer Society.  However, this is additional risk and one additional case of this terrible disease is one too many and may very well warrant a Valsartan law firm to file a product liability or failure to warn lawsuit supported by admissible scientific and epidemiological evidence.

The FDA announced the original Valsartan recall on July 13, 2018.  Since then, the FDA has been vigilant in posting updates to its website, as well as important information for those who have taken Valsartan.  It is not currently known how soon certain NDMA-contaminated Valsartan manufacturers may have become aware of their product being contaminated.  According to the FDA’s recalled-product list, those pharmaceutical companies recalling certain Valsartan products include Teva, Prinston, Solco, AvKARE (Teva / Actavis), Brant Ranch Prepack, H J Harkins, Northwind (Teva / Actavis) RemedyRepack (Prinston / Solco), A-5 Medication (Teva / Actavis & Prinston / Solco), Hetero Labs (Camber), NuCare (Prinston / Solco), Preferred (Hetero / Camber), and Torrent.  But, as the investigation continues, if lawsuits are filed and information and documents are obtained from suppliers and manufacturers, the FDA and Valsartan lawyers will have much more information to review.

It can be a difficult decision for a company to decide when a product has reached the point of being potentially-defective and dangerous.  However, given that NDMA has been found to increase the occurrence of cancer in animal studies, not recalling contaminated product would be unconscionable until more information can be obtained and reviewed by the government, medical and legal community.  If you or a loved one has concerns about your Valsartan prescription, first consult with your physician.  If after your consultation you are unable to alleviate your concerns or confirm you were taking a recalled Valsartan product, then it is important to consult with a lawyer or law firm handling Valsartan cases, especially if you have developed organ damage or cancer since beginning your Valsartan prescription, as legal claims can be time sensitive.  If you would like to speak with one of our attorneys investigating Valsartan, call one of our offices today.