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Why is the Dept. of Justice Investigating Zantac Maker?

December 23, 2020
Colson Hicks Eidson

Zantac and generic forms of this medication, both prescription and over the counter, have faced significant recalls over the last year. Now, The US Department of Justice (DOJ) is investigating two Zantac manufacturers. The DOJ is attempting to determine whether or not the drug manufacturers violated federal laws while selling the medication. Here, we want to discuss this ongoing investigation as well as give a brief overview of the Zantac recall.

Why have Zantac and generic ranitidine been recalled?

Zantac and other ranitidine medications have faced massive recall over the last year after investigations uncovered unsafe levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen. In a statement released on April 1, 2020, The US Food and Drug Administration (FDA) asked that all Zantac and ranitidine products be removed from the market immediately.

According to the FDA, “The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.”

Testing continued to show that NDMA levels increase inside these medications under normal storage temperatures and conditions, though the level of NDMA significantly increases at higher storage temperatures.

What is going on with the DOJ investigation?

The Department of Justice is investigating GlaxoSmithKline (GSK) and Sanofi, two of the Zantac manufacturers. GlaxoSmithKline is the original manufacturer of Zantac, and Sanofi currently holds the rights to Zantac brands in the United States. Both of these companies currently sell generic forms of ranitidine throughout the country.

Specifically, the DOJ is seeking to have several questions answered:

  • When did these manufacturers learn about unsafe NDMA levels in the medication?
  • When did the manufacturers learn that Zantac’s active ingredient can breakdown in the stomach, creating additional NDMA?
  • Did the manufacturers conceal cancer risks associated with Zantac?

Answers to these questions could reveal potential violations of the False Claims Act (FCA). The FCA was signed into law in the 1800s and made it illegal for manufacturers to provide sub-standard goods and services to the US government. Typically, the FCA is referred to as a whistleblower law. If it is discovered, through the course of the investigation, that these companies knew about the dangers posed by Zantac and the generic forms of the medication, and failed to disclose this information to the government, they could face significant repercussions.

Call our respected product liability team today

If you or somebody you care about has and diagnosed with cancer, and you think Zantac caused your illness, seek assistance from the nationally recognized product liability team at Colson Hicks Eidson as soon as possible. Our firm will conduct a complete investigation into your illness and your Zantac use so we can establish a link between the two. Our goal is to secure the compensation you are entitled to. When you need a Zantac attorney in Florida or throughout the United States, you can contact us for a free consultation by clicking here or by calling us at 305-476-7400.

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