Zantac (ranitidine) heartburn medication was removed from the U.S. market earlier this year. Test results showing dangerous levels of a carcinogen (NDMA) triggered the recall. Hundreds of Zantac users have now filed lawsuits blaming the drug for their cancer diagnoses.
The U.S. Department of Justice (DOJ) is investigating two Zantac manufacturers. The DOJ wants to determine whether the drug makers violated federal law while selling Zantac. The investigation will attempt to answer several questions:
- When did manufacturers learn about NDMA in Zantac?
- When did manufacturers learn Zantac's active ingredient can break down in the stomach, forming additional NDMA?
- Did manufacturers conceal the cancer risk associated with Zantac?
Each of these questions may reveal facts related to potential violations of the False Claims Act (FCA). The investigation currently centers on Zantac manufacturers GlaxoSmithKline (GSK) and Sanofi.
Understanding the False Claims Act in Healthcare
President Lincoln signed the False Claims Act (FCA) into law in 1863. The law makes it illegal to provide substandard goods and services to the U.S. government.
The FCA is also known as a whistleblower law. This label stems from FCA provisions protecting and/or encouraging individuals to notify the government of illegal activity.
The FCA covers any products sold to the U.S. government, including drugs and medical devices.
Drug and medical device makers can violate the FCA in many ways, including:
- Requesting payment for products/services that do not meet federal regulatory requirements
- Requesting payment for products/services that are defective or contractually sub-par
In the 2019 fiscal year, the DOJ collected more than $3 billion in FCA settlements and verdicts. Of that $3 billion, $2.6 billion stemmed from healthcare-related violations.
It is possible Zantac manufacturers knew about the drug's cancer risk and chose to conceal it. If so, the companies may soon contribute their own dollars to the DOJ's FCA settlement tally.
Related News: 3M settled a False Claims Act lawsuit related to its Combat Arms earplugs in 2019. The earplugs in question are now the subject of 200,000+ hearing loss lawsuits.
Evidence Suggests Zantac Manufacturers Knew of Cancer Potential
GlaxoSmithKline (GSK) developed Zantac and brought the drug to market in the 1980s. Published documents suggest GSK knew about Zantac's cancer risk as early as 1981.
Dr. Silvio de Flora published a manuscript in The Lancet. The data showed dangerous NDMA-related compounds released from ranitidine. Ranitidine is Zantac's active ingredient.
Glaxo Group Research responded to Dr. Flora's publication. The response questioned the validity of Dr. Flora's work. It also mentioned internal Glaxo data on ranitidine. Glaxo's data showed an unnamed cancer-causing material in the drug.
These publications point to GSK having early knowledge of Zantac's cancer risk. It is unknown if Sanofi became aware of the problem prior to the recalls.
Both manufacturers already face consumer lawsuits related to Zantac. And, the DOJ investigation may find more evidence of FCA violations. If so, GSK and Sanofi may soon add a federal lawsuit to their list of legal problems.