Valsartan Lawsuits: What You Need to Know
Ryan Bradley | April 5, 2022 | Product Liability
Valsartan is a common medication used to treat high blood pressure. Doctors also prescribe it to prevent stroke and kidney malfunction. The drug accomplishes these goals by blocking the hormone angiotensin. This hormone causes the blood vessels to contract, increasing blood pressure.
In 2018, the U.S. Food and Drug Administration (FDA) worked with several drug manufacturers to announce a voluntary recall of some drugs containing Valsartan. The FDA had investigated claims that Valsartan-containing drugs were contaminated with a carcinogen called N-nitrosodimethylamine (NDMA).
As a result of this contamination, injured patients have filed lawsuits against the manufacturers of Valsartan products. Here are some facts you need to know about the Valsartan lawsuits.
What Is Valsartan?
Valsartan is the generic name for Diovan, Losartan, and Irbesartan. Valsartan is an angiotensin II receptor blocker. This means that the drug prevents your body from taking up angiotensin hormones released into your blood. The angiotensin hormones still get released, but your blood vessels don’t contract in response.
As a result, Valsartan prevents your blood pressure from elevating. Doctors have been prescribing Valsartan since the 1990s to improve survival after a heart attack and treat congenital heart failure.
What Is NDMA?
NDMA is a chemical compound that does not belong in Valsartan. In other words, Valsartan does not contain NDMA. Instead, NDMA gets introduced into Valsartan during the manufacturing process.
NDMA occurs naturally in:
- Cleaning products
Scientists classify NDMA as a group 2A carcinogen because the evidence shows that it probably causes cancer in high doses.
How Did NDMA Get into Valsartan?
After NDMA was found in Valsartan, scientists scrambled to determine where it came from. Did it contaminate one of the ingredients used to manufacture the drug? Was it introduced during the packaging? Did it inherently appear as Valsartan decomposed?
Oddly, all these theories were wrong. Valsartan doesn’t contain any of the elements of NDMA in its chemical structure. So the NDMA could not come from the ingredients of Valsartan. It could also not appear as a byproduct as Valsartan decomposes.
Instead, researchers found that the process used to manufacture Valsartan changed around the same time tests revealed NDMA. To make Valsartan, you need to synthesize a tetrazole ring, then break it down using a solvent.
A new manufacturing process began right before NDMA appeared in Valsartan. It used sodium azide to form the tetrazole ring. It then used the solvent dimethylformamide to break the ring. After the process ended, the manufacturer used sodium nitrite to remove any leftover sodium azide.
The solvent dimethylformamide breaks down into DMA, and the sodium nitrite contributes N. As a result, all of the components to make NDMA were introduced during the new manufacturing process. Scientists suspect that the new manufacturing process leaves residues in the equipment and on the pills that combine to form NDMA.
Injured patients began filing lawsuits almost immediately after the recall. The primary party to the litigation is Zhejiang Huahai Pharmaceuticals, the manufacturer that created and used the new process to make Valsartan. Other parties to the litigation include the distributors and retailers that sold the drug in the U.S.
Because of the number of cases and the similarities in the issues they raised, the U.S. Judicial Panel on Multidistrict Litigation consolidated all of the cases. By doing so, the parties can litigate the case more efficiently. These cases allege product liability, negligence, and other claims against the manufacturer, distributors, and retailers. None of these cases has made it past the pre-trial stages. Thus, there are no judgments or settlements that might predict what will come of the cases.
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