The U.S. Department of Justice (DOJ) has opened an investigation into how much Sanofi-Adventis US LLC and GlaxoSmithKline LLC (GSK) knew about a probable carcinogen in their heartburn drug Zantac, the drug companies said in separate filings with the U.S. Securities and Exchange Commission (SEC), Law360 reported.
The Justice Department’s Civil Division and the U.S. Attorney’s Office for the Eastern District of Pennsylvania in June notified Sanofi that it was investigating whether the company violated the False Claims Act by failing to tell federal drug regulators that its Zantac drug containing rainitidine was contaminated with the likely human carcinogen N-nitrosodimethylamine, or NDMA.
Also, in June, Sanofi, GSK, and other generic drug makers that manufactured Zantac products were hit with a lawsuit by New Mexico Attorney General Hector Balderas alleging the companies’ actions regarding the presence of NDMA in Zantac violated state laws.
Less than two weeks after the Justice Department notified Sanofi of its investigation, the DOJ notified GSK of similar intentions, seeking more information on its Zantac product to see whether GSK, too, violated the False Claims Act.
The Food and Drug Administration (FDA) called for the withdrawal of Zantac from the U.S. market in April after the agency discovered that over time levels of NDMA in Zantac could rise to levels considered unsafe for humans.
Sanofi, GSK, and other drug companies that made and sold Zantac products containing the active ingredient ranitidine, used to treat heartburn, GERD, and acid reflux, have been hit with dozens if not hundreds of lawsuits over claims NDMA in Zantac caused them to develop various cancer including stomach, small intestine, bladder, kidney, colorectal, esophageal, prostate, pancreatic, thyroid, leukemia, non-Hodgkin’s lymphoma, and multiple myeloma. The cancer victims say that the drug companies knew the risks with their Zantac products since the 1980s but failed to alert the FDA or warn consumers.
There is currently a Zantac multidistrict litigation (MDL) in Florida. Also about 40 people who claim they developed cancer after taking Zantac have asked their cases be consolidated in California. Among them is the case of a woman who claims her use of Zantac while pregnant caused her 8-year-old son to develop testicular cancer.
Beasley Allen attorney Frank Woodson is actively investigating potential claims involving regular Zantac/ranitidine use that may have led to cancer of the stomach, colon, intestines, kidneys, or pancreas. If you or a loved one may have been affected, please contact us.