The Department of Justice (DOJ) is currently investigating two Zantac manufacturers to see if federal law were violated. Zantac is a heartburn medication that was removed from the market in early 2020 because there were dangerous levels of NDMA, a known carcinogen. Zantac has hundreds of lawsuits filed against them as people who have used Zantac believe that the drug led to their cancer diagnoses.
The Food and Drug Administration (FDA) recalled Zantac and requested that manufacturers remove the product from the market in April of 2020 when NDMA was found in samples. The FDA also found that the levels of NDMA in Zantac would slowly increase over time. The percentage of NDMA in drugs is generally low, but it is very alarming since an individual’s risk of cancer increases when NDMA is present.
Drug companies that made and sold products with NDMA present are having to research and determine how the carcinogen made it into the market product. One of the issues that arose is figuring out how manufacturers either did not know of NDMA’s presence or if the presence was concealed. This has led to the DOJ investigation of the makers of Zantac.
Federal Law Violations
The DOJ’s investigation is set to uncover whether or not the Zantac manufacturers’ violated the False Claims Act (FCA). The DOJ is seeking to find out when the manufacturers learned about NDMA in Zantac and if this knowledge and the risks of cancer were concealed. The manufacturers in question are GlaxoSmithKline (GSK) and Sanofi.
False Claims Act
The False Claims Act (FCA) was put into law in 1863 and prohibits people from intentionally submitting false claims to the government; in addition knowingly providing goods and services to the U.S. government below the traditional standard of quality is illegal. In the healthcare industry the FCA covers drugs and medical devices that were sold to the U.S. government. GSK and Sanofi, the Zantac manufacturers under investigation, could have violated the FCA if they requested payment knowing their product did not meet federal regulatory requirements or if they requested payment knowing their product was defective. If it is proven that the Zantac manufacturers knew about the potential cancer risk the drug posed when used, then the DOJ could pursue charging the manufacturers with a FCA violation.
Evidence of NDMA Knowledge
Zantac was first developed by GSK in the 1980s, and there are documents from 1981 which suggest GSK knew about the cancer risk. Data that was published in 1981 showed that ranitidine, Zantac’s active ingredient, released NDMA compounds. After this data was published, GSK responded by questioning the validity of the data. This is compelling evidence that suggests GSK was aware of the heightened risk of cancer developing due to Zantac usage.
Contacting an Attorney
If you were taking Zantac and developed a serious condition, contact our team of skilled attorneys today. You could be entitled to compensation for the harm sustained while taking the medication. Our team could walk you through your options.