Lawsuits Over Losartan, Irbesartan Consolidated With Valsartan Recall Claims

A panel of federal judges has determined that all losartan lawsuits and irbesartan lawsuits filed in U.S. District Courts nationwide should be consolidated with the pending valsartan litigation, since each of the claims involve similar allegations that cancer-causing chemicals contaminated the generic blood pressure drugs.

There are currently more than 150 product liability lawsuits and class action claims pending in the federal court system that have resulted in valsartan recalls issued since July 2018, after it was discovered that certain generic drug makers distributed pills that contained N-nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and other chemicals that are known to increase the risk of cancers.

Many of the complaints allege individuals developed various cancers following long-term exposure to the chemical, including liver cancer, stomach cancer, small intestine cancer, esophageal cancer, prostate cancer, pancreatic cancer and other cancers.

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Valsartan Lawsuits

Side effects of recalled valsartan may increase the risk of cancer, due to an impurity discovered in certain generic versions of the hypertension drug.

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Given common questions of fact and law raised in valsartan lawsuits, the U.S. Judicial Panel on Multidistrict Litigation (JPML) previously decided to consolidate and centralize all pretrial proceedings before U.S. District Judge Robert B. Kugler in the District of New Jersey earlier this year, and it is widely expected that several thousand valsartan cancer claims will ultimately be presented in the coming months and years.

In addition to problems with valsartan, similar recalls have also been issued by manufacturers of other generic blood pressure drugs which are part of the same class of medications, known as angiotensin II receptor blockers (ARBs), including losartan and irbesartan. Investigations suggest changes in the generic drug making process for the blood pressure and hypertension drugs resulted in the production of the chemical byproduct discovered over the past year.

In September, plaintiffs filed a motion to include claims involving cancer diagnosed following exposure to losartan, irbesartan or other ARBs in the valsartan MDL, indicating there are overlapping issues in the cases, including many situations where plaintiffs switched between various different types of blood pressure drugs found to contain NDM, NDEA or other cance-rcausing chemicals.

Although the drug makers opposed consolidating the cases, in a transfer order (PDF) issued December 18, the JPML determined it was appropriate to consolidate the cases, but limited the inclusion to only irbesartan and losartan, instead of all ARBs.

As a result of the decision, four additional lawsuits have been added to the MDL, but that number is expected to grow with future filings of irbesartan and losartan claims.

“The losartan and irbesartan actions present common questions of fact arising from the allegation that the same or substantially similar manufacturing processes are used in the production of valsartan, losartan, and irbesartan and result in the formation of nitrosamine impurities in the same manner,” the panel wrote in its decision. “Thus, the valsartan, losartan, and irbesartan actions will present common factual questions as to the cause of the nitrosamine impurities and, in particular, alleged common defects in the manufacturing process; when defendants knew or should have known of the impurities; and whether the amounts of nitrosamines in the medications presented a risk of cancer or other injuries.”

As part of the coordinated pretrial proceedings, it is expected Judge Kugler will establish a “bellwether” process, where the parties will use the fact sheet information about each valsartan cancer claim to select a representative group cases, which will be prepared for early trial dates in the MDL.

While the outcome of these early “bellwether” trials will not be binding on other plaintiffs, they are typically scheduled in complex pharmaceutical litigation to help the parties gauge how juries may respond to evidence and testimony which will be repeated throughout the litigation, and facilitate potential valsartan cancer settlements with the manufacturers and distributors of the contaminated pills.


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