GoldenbergLaw Partner Marlene Goldenberg Appointed To Valsartan MDL Leadership

Partner Marlene Goldenberg
Marlene Goldenberg

On May 6, 2019, New Jersey Federal District Court Judge Robert B. Kugler appointed GoldenbergLaw Partner Marlene Goldenberg to the Executive Committee as part of the leadership structure for the Valsartan Multidistrict Litigation (MDL). Marlene has previously served as the head of the discovery committee for the Abilify MDL in the Northern District of Florida and helped lead discovery, science, and briefing on over 800 Medtronic Infuse Bone Graft cases. Marlene and GoldenbergLaw look forward to holding these Valsartan manufacturers accountable for their actions.

Valsartan and Cancer

Valsartan (and other Sartan drugs such as Losartan and Irbesartan) are used to help treat high blood pressure and other heart-related conditions. Millions of Americans take this generic drug. Certainly no person taking this drug would take it knowing it could cause cancer.

Many of these medications are manufactured for generic companies overseas in China by Zhejiang Huahai and in India by Hetero Labs, among others. It has now been reported that for at least four years, many brands of Valsartan contained carcinogenic substances, such as NDMA, NDEA, and NBMA. These contaminated products were then sold to many companies in the U.S. for use in their sartan drugs. The U.S. companies failed to properly monitor and test their products before selling them to consumers.

How Does Contaminated Valsartan Cause Cancer?

NDMA is N-nitrosodimethylamine. It has been classified as a probable carcinogen and is often given to rats in medical studies to cause cancer! NDMA is so toxic it is contained in rocket fuel and has no approved uses in the United States. NDEA and NBMA have similar carcinogenic properties.

After consulting with some of the finest toxicologists in the country, the dose and duration of the exposure will help to determine if a patient’s cancer can be attributed to contaminated Valsartan. Unfortunately, most people take Valsartan daily and in high doses. Many American patients will have consumed enough NDMA or other nitrosamines to trigger genetic mutations and cancer.

The cancers linked to contaminated NDMA (the contaminant found in Valsartan) are digestive tract cancers where these substances would have been processed by the body. This includes liver, kidney, stomach, and colorectal cancer.

FDA Recall

In July 2018 the FDA recalled the first Valsartan medications, but the recalls didn’t stop there. In October 2018, certain lots of Irbesartan began to be recalled. Then in December, 2018, certain batches of Losartan were recalled as well. And the recalls keep coming almost every month. Just last week, another batch of Losartan was recalled because of toxic contamination. The FDA is continuously updating the list of recalled medications.

Have You Received A Recall Letter?

Patients around the country have and continue to receive recall notices regarding their contaminated medications. If you or a loved one has received a letter, you should talk with your doctor right away about your options. If you or one of your loved ones developed liver, kidney, stomach, or colorectal cancer after taking Valsartan or Losartan over the past four years, please contact the Minnesota defective drug lawyers at GoldenbergLaw so we can discuss your legal rights.

Will There Be a Sartan Drug Recall?

After learning about the Valsartan recall due to contamination, many patients were switched from Valsartan to other sartan drugs. But now many are questioning the safety of these sartan drugs after learning that the European Medicines Agency (EMA) is investigating candesartan, irbesartan, losartan, and olmesartan for the same reason. It’s only a matter of time before the EMA and FDA determine if there should be a sartan drug recall.

The EMA announced that low levels of N-nitrosodiethylamine (NDEA) were detected in losartan, prompting the precautionary investigation into other sartan drugs because of the similar chemical structure. “National authorities in the EU are currently considering whether to recall medicines containing Aurobindo Pharma’s irbesartan from pharmacies as a precaution,” the EMA said.

The EMA will be increasing supervision on Chinese company Zheijiang Huahai to review the manufacturing process of other active substances. The investigation will help the European Commission to determine if there should be a sartan drug recall.

If the European Union decides to issue a sartan drug recall, the FDA may follow suit. GoldenbergLaw will continue to update on the Valsartan and sartan investigation.

If you or a loved one took Valsartan and was diagnosed with liver, colorectal, stomach, intestinal, or kidney cancer, please contact us. We have successfully resolved similar cases, including many involving the high blood pressure medication Benicar. Call GoldenbergLaw, and leave the sleepless nights to us.

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