Patients who were taking drugs containing the substance Valsartan to treat high blood pressure were surprised to find out that there was a voluntary recall of some medications due to the presence of a carcinogen. As time has gone on, the problem has only gotten worse as more medications have been found to contain the substance.
There are a number of lawsuits against the makers of these drugs, both brought on behalf of all purchasers as well as on behalf of patients who have suffered their own injury from taking the drugs. Rosenfeld Injury Lawyers can help anyone who has taken Valsartan and suffered a cancer-related injury file a complaint that could help them receive compensation. Our firm is similarly reviewing Zantac cancer lawsuits involving similar NDMA contamination.
Valsartan is not a drug unto itself, but rather is an ingredient that is found in a class of drugs. This class of drugs is meant to treat high blood pressure and heart failure. Valsartan is an Angiotensin II receptor blocker. The total size of the market is valued at roughly $1.5 billion. There are many different types of drugs that contain the ingredient Valsartan, and these medications are manufactured in different places.
In November 2018, the FDA announced a voluntary recall of several medications that contain Valsartan. The specific problem was that impurities were detected in the manufacturing process that resulted in the introduction of possible carcinogens into the medications.
The specific substance that was found in Valsartan is N-nitrosodimethylamine. While this substance is not definitely a carcinogen, it is a probable cause of cancer if ingested at certain levels. At some point, the manufacturing process for the drug was changed, which resulted in the introduction of the impurity. The result was that some of these drugs contained up to 177 times the safe amount of the impurity. In December 2018, the FDA issued a warning letter to a major Chinese manufacturer of Valsartan alleging impurity control, change control and cross-contamination from one manufacturing process line to another. The FDA continues to investigate the cause of the manufacturing defect.
The exact scope of the problem is still becoming apparent since it is not known exactly how many different products this manufacturing defect affected. The extent of the recall has grown as impurities are found in different products containing Valsartan. Moreover, it is not precisely known yet the impact of the presence of the substance in the drug. While this harmful substance may have been in Valsartan for up to four years, the exact nature of the problem is just being quantified. In May 2019, the FDA released its initial testing results from the batches of Valsartan that it analyzed. According to the FDA, the levels of the impurity that were found would be sufficient to cause one additional case of cancer in every 8,000 patients that were taking the highest dose of the drug. Still, there is a difference of opinion among scientists about the severity of the issue and the chances that the impurity will cause cancer. Manufacturers are continuing to announce additional recalls as they find the impurity in their drugs.
Oftentimes, product liability lawsuits allege that a drug is dangerous because of the product’s design and composition. Here, the problems surrounding Valsartan stem from a defect in the manufacturing process. Nevertheless, this is still a product defect that is addressed by product liability law, and the manufacturer can still be held accountable for any injury that results from this. Even if the defect was introduced by the Chinese manufacturer, the American seller of the drug can still be held liable under product liability law.
As of April 2019, there have been approximately 50 lawsuits filed against the makers of drugs containing Valsartan.
In February 2019, these lawsuits were consolidated into a multi-district lawsuit in federal court in New Jersey. In the combination of lawsuits, there are over 40 named defendants. Some of the injuries that have been the subject of lawsuits are gastric cancer, colorectal cancer and liver cancer. The court has indicated that it will allow plaintiffs to submit a short form complaint to make it easier for them to file legal action. The last milestone in the case was a status conference on July 10 setting out procedural issues as the cases are still early in their lifecycle. Plaintiffs’ attorneys have informed the court that they anticipate up to 2,000 lawsuits being filed due to the tainted medication.
There is also a class-action lawsuit on behalf of purchasers of the drug that alleges that the manufacturers of these drugs misrepresented to patients that the drugs were similar to Diovan and were fit for their intended use. According to the plaintiffs, the manufacturers of these drugs knew or should have known about the manufacturing issues, but turned a blind eye to them and continued to sell their products.
Rosenfeld Injury Law is currently investigating further lawsuits based on this impurity. These cases are still early in their process and there are no major milestones scheduled yet. If you have taken any drug containing Valsartan within the past four years, you should be vigilant about any symptoms affecting the areas mentioned above and seek medical attention immediately if you notice any side effects. At the same time, you should also seek out a lawyer to discuss your legal options.
Valsartan Lawsuit Update: November 2019
Currently, the multi-district litigation is making its way through pre-trial proceedings. The multi-district litigation has been centered in the District of New Jersey. As of October 2019, there were 144 individual lawsuits that were a part of the multi-district litigation. The assigned judge to the case is Senior District Judge Robert B. Kugler.
The most important issue thus far in the pre-trial proceedings has been the motion to expand the scope of the multi-district litigation. The same contamination issues that potentially impacted Valsartan also affected two other blood pressure drugs. Losartan and Irbesartan are also the subject of patient lawsuits. The defendant in the lawsuit has opposed adding the other blood pressure medications to the multi-district litigation. There is a hearing about this motion expected in early December.
Although the rate of cancer tied to the NDMA contaminant that was found in the medication is low, it is estimated that as many as five million people may have been affected by the possibly tainted medication. This means that this case can expand in the future as the effects of the contaminant in Valsartan and possibly other medications become known.
Currently, the parties are identifying the scope of discovery. The court is assisting the parties in dealing with “macro” discovery issues. Discovery is a phase of the case that can last for at least a year so the case is still far from trial.