People with high blood pressure who have taken certain generic versions of Diovan may be eligible to file a valsartan lawsuit. (Novartis makes the brand name Diovan, which has not been included in any recalls.)

What is Valsartan Used for?

Valsartan is an angiotensin II receptor blocker (ARB) that works by stopping a chemical in the body that causes blood vessels to restrict. When the blood vessels are relaxed, blood pressure is lowered. Lower blood pressure allows a greater supply of blood and oxygen to reach the heart and brain.

If high blood pressure is left unchecked, the patient may be at a higher risk of a stroke, heart attack, heart failure and kidney failure.

Doctors also may prescribe valsartan to treat left ventricular failure post-heart attack. The left ventricle of the heart is the main pumping chamber that may stiffen or enlarge due to a heart attack. When this occurs, blood can collect in the lungs.

What’s Wrong with Valsartan?

In July 2018, the U.S. Food and Drug Administration found a number of generic valsartan lots were contaminated with an impurity known as NDMA, which is short for N-nitrosodimethylamine.

NDMA is a chemical that has been used to make liquid rocket fuel. The Environmental Protection Agency says NDMA has been found to produce tumors in the liver, respiratory tract, blood vessels and kidneys of mice and rats. NDMA is now only used in the U.S. for the purposes of research, but it formerly was used to create antioxidants and additives for lubricants. NDMA also may be an unintended byproduct at water treatment plants that chlorinate water for disinfection.

The first batch of valsartan subject to recall included the active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals In Linhai, China. The FDA was surprised to find the contaminant, and believed the issue was related to changes in how the drug was manufactured, which were instituted up to four years prior.

The FDA continued to test different brands of valsartan and added more tainted batches that were identified at other manufacturing plants.

In some cases, two other similar contaminants, NDEA (N-Nitrosodiethylamine) and NMBA (N-Nitroso-N-methyl-4-aminobutyric acid),  was found.

Has There Been a Valsartan Recall?

Several different lots of valsartan were recalled by a variety of manufacturers in 2018 and 2019.

In April 2019, the FDA issued a press release that said the agency was working with manufacturers to remove medications from the market “if they contain a nitrosamine impurity at levels higher than the interim acceptable intake limits.”

That same press release said the FDA had identified 40 angiotensin II receptor blocker (ARB) drugs that did not contain any known nitrosamine impurities.

Is Valsartan Safe to Take Now?

The FDA says it is continuing to test medications for impurities and provides continual updates to recalled medications. Not only valsartan, but certain lots of losartan and irbesartan have been affected, too.

Recognizing the number of recalled lots of valsartan could lead to a shortage of the blood pressure drug, the FDA approved a new version of valsartan produced by Alkem Laboratories Ltd. in March 2019.

Is There a Valsartan Settlement?

Not at this time. A number of patients filed class action lawsuits after the realization that the medication they had been taking could have been tainted with potentially lethal impurities.

A current multidistrict litigation (MDL) has alleged that drug stores such as Walgreens, CVS and Throggs Neck Pharmacy “fraudulently dispensed” valsartan or failed to accurately represent the drug’s quality by neglecting to determine the contamination existed.

However, Law360 reports that court documents indicate CVS and Walgreens have asked a New Jersey federal judge to allow them to opt out as defendants. The pharmacies allege they have no liability in the valsartan lawsuit, and that only the manufacturers should be held accountable for the impure medications that were distributed.

In July, CVS sent a memo to the court, which reportedly said in part, “Pharmacies do not have a duty to test or inspect dispensed drugs, and plaintiffs cannot plausibly state a claim that the pharmacies should have known of the alleged valsartan impurity.”

CVS went on to say that pharmacies only provide the service of filling prescriptions through a doctor’s orders, and as such, are not in a category that should consider them “merchants” of prescription medications.

CVS also insisted that Congress passed the Drug Supply Chain Security Act in 2013, which the company says does not allow such actions such as the valsartan lawsuit to be filed against pharmacies.

The Valsartan Lawsuit MDL is Case No. 1:19-md-02875, in the U.S. District Court for the District of New Jersey.