Valsartan Recalled: What to Know About Pending Litigation

April 10, 2019

Many of the class action lawsuits filed against drug manufacturers in the U.S. allege that the drugs themselves, as formulated and prescribed, have dangerous or potentially deadly side effects. However, the lawsuits currently pending against the makers of Valsartan, a popular generic blood pressure medication, are a bit unusual in this respect—instead of arguing that the manufacturer erred by creating a drug with unreasonably harsh side effects, plaintiffs allege that Valsartan’s creators negligently or recklessly contaminated the drug with a cancer-causing chemical during the manufacturing process. Learn more about Valsartan and the harms alleged in the present litigation.

What is Valsartan?

This drug is included in the broad class of drugs known as “beta blockers” that are designed to treat a variety of heart-related conditions, including high blood pressure or hypertension. Specifically, Valsartan is an angiotensin II receptor blocker (ARB), which helps relax blood vessels and reduce the amount of work the heart must do to pump blood. Along with other generic beta blockers, Valsartan has been prescribed to treat everything from chronic hypertension to congestive heart failure, kidney disease, or diabetes-related kidney failure.

Why Valsartan Was Recalled

Like many drugs, Valsartan includes some side effects ranging from mild to uncomfortable. Some of the listed side effects of Valsartan include headache, dizziness, fatigue, diarrhea, and coughing. Valsartan may also make users more prone to viral infections, hypotension (low blood pressure), joint pain, back pain, and jaundice.

However, these side effects—while unpleasant—were expected and included as drug label warnings. Valsartan was instead recalled in July 2018, shortly after the U.S. Food and Drug Administration (FDA) discovered that multiple batches of Valsartan had been contaminated with the carcinogenic chemicals, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA).

It’s believed that this contamination occurred as a result of some changes to the manufacturing supply chain and production process. The presence of NDMA, in particular, has sparked great concern among healthcare workers and regulatory officials; this chemical is so adept at causing cancer it’s actually used to generate cancerous tumors in the lab rats pharmaceutical companies rely on to help them develop cancer-fighting treatments.

Although the FDA has estimated the increased cancer risk associated with NDEA- or NDMA-contaminated Valsartan as relatively low—only about one additional cancer diagnosis for every 8,000 Valsartan-taking patients—the sheer number of individuals who have been or are currently prescribed Valsartan means that this 1-in-8000 ratio is a significant figure.

Because Valsartan is designed to be taken orally, the carcinogens in each contaminated batch start working from the stomach out, creating a disproportionately negative impact on the digestive and excretory systems. As a result, some of the most common diagnoses attributable to the contaminated Valsartan include colorectal cancer, intestinal cancer, kidney cancer, liver cancer, and stomach cancer.

The Valsartan Litigation

Shortly after its initial recall in July 2018, the FDA halted all imports from certain Chinese factories associated with the contaminated Valsartan in an attempt to stem the number of individuals who could potentially be exposed to this drug. During the same time period, several class action lawsuits (as well as many more individual lawsuits) were filed against the pharmaceutical companies, manufacturing factories, and other intermediaries involved in the production and sale of Valsartan.

In February 2019, many of the earliest Valsartan lawsuits were consolidated into the multidistrict litigation (MDL) “In re Valsartan Products Liability LItigation,” currently pending in a New Jersey district court.

It’s likely that a few representative claims encompassed in the MDL will soon be selected to proceed as bellwether cases. These bellwether cases require the parties to present (and defend) their claims as to just one plaintiff and are often seen as “test cases” that can predict how the rest of the litigation should proceed. If the bellwether plaintiffs are successful, the manufacturers are more likely to settle the remaining claims without undertaking the hassle and expense of a trial. Meanwhile, if the bellwether plaintiffs aren’t able to show that their injuries stemmed from the manufacturers’ negligence, the remaining cases against these manufacturers may end up being dropped or dismissed.