Department of Justice Investigation
Following the worldwide recalls and ban by the United States Food and Drug Administration (FDA) of antacid medicine Zantac, the Department of Justice announced it is investigating GlaxoSmithKline (GSK) and Sanofi for potential violations of the False Claims Act. The False Claims Act (FCA) is also known as the “Lincoln Law”. It is a federal law of the United States that that imparts liability on people and companies (usually federal contractors) who defraud government programs. It is the primary tool of the Federal Government to combat fraud. The probe related to Zantac relates to an alleged failure of the drugmakers to properly and/or accurately report information about a potential carcinogen in the drugs to the federal government.
On July 29, 2020, both drug manufacturers said in separate documents filed with the U.S. Securities and Exchange Commission that they had received investigative demands from the Justice Department that sought information on N-nitrosodimethylamine, commonly referred to as NDMA, an organic chemical that had been detected in various versions of the heartburn medication ranitidine, which is sold under the brand name Zantac.
Zantac Withdrawn from the Market
In 2019, the drug manufacturers pulled Zantac products from the market as a result of an impurity, NDMA, that was linked to cancer. Sanofi has indicated that the federal probe is related to disclosures made regarding that impurity. A Sanofi spokesperson stated that the company is standing by science that supports the safety of over-the-counter (OTC) Zantac products, indicating that such products have been used by consumers for more than 20 years. GSK did not offer any comments on the investigation other than that the company is cooperating with the government inquiry.
After the recall of the Zantac products in October of last year, Sanofi lost approximately $186 million.
Reason for the Recall
The origin of the recall is a multi-year investigation by regulators including the FDA into drug impurities that could potentially cause cancer. The investigations began in 2018 with valsartan and losartan, which are heart medicines. Voluntary recalls of Zantac throughout the world increased last year and early this year. In April 2020, the FDA removed the medication and its generics from the American market.
In September 2019, Valisure, an online pharmacy and testing laboratory, filed a citizen petition with the FDA that notified the agency that its testing had found the NDMA impurity in heartburn drugs. In January 2020, a different laboratory alerted the agency to its own similar test findings, and later the FDA confirmed the findings.
NDMA was once used in the creation of rocket fuel. The levels of the chemical significantly increase if products are stored in high temperatures. Both the Environmental Protection Agency and the World Health Organization consider NDMA to be a likely human carcinogen.
Below is a video clip from CBS This Morning regarding the FDA Zantac recall.
Other Zantac Related Civil Lawsuits
In addition to the probe initiated by the Department of Justice, both GlaxoSmithKline and Sanofi disclosed a lawsuit that has been filed by the New Mexico Attorney General that alleges violations of New Mexico’s unfair practices act, negligence, public nuisance, and false advertising.
Many Zantac consumers have also filed civil lawsuits against the drugmakers. Both companies stated that they could not estimate the lawsuits’ potential financial implications.
Sacramento Drug Products Liability Attorney
I’m Ed Smith, a Sacramento Drug Products Liability Attorney. If you or someone you love has been diagnosed with a medical condition after using a hazardous medication, please reach out to my office for compassionate, free, and friendly advice at (916) 921-6400 or if you are calling from outside the local area, toll-free at (800) 404-5400.
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