DOJ Investigates Drugmakers Over Zantac Cancer Risks & Potential False Claims Act Violations

Sanofi & GSK Are the Targets of a Federal Probe into Alleged Failures to Disclose Zantac Contamination & Cancer Risks

Did Sanofi and GlaxoSmithKline (GSK) violate the False Claims Act by failing to issue warnings about Zantac contamination and cancer risks?

Answering that question is the focus of an ongoing probe by the U.S. Department of Justice (DOJ). This DOJ Zantac investigation, launched in June 2020, comes on the heels of a 6-month probe conducted by the U.S. Food and Drug Administration (FDA). In the FDA inquiry, regulators found that:

• Some lots of Zantac (ranitidine) contained an impurity known as N-Nitrosodimethylamine (NDMA), a “potent carcinogenic,” according to the World Health Organization (WHO).
• NDMA levels in contaminated lots of Zantac heartburn medication can increase under normal storage conditions, at higher temperatures, and as the drug ages. NDMA has been linked to leukemia, breast cancer, kidney cancer, and other cancers.

While the FDA Zantac investigation triggered a national recall of over-the-counter (OTC) and prescription ranitidine in April 2020, the issues and questions related to Zantac cancer risks—and drugmakers’ role in disclosing them—are far from resolved.

Alleged False Claim Act Violations: The Focus of the DOJ Zantac Investigation

The False Claims Act (FCA) 31 U.S.C. § 3279(a)(1)(A)–(B) prohibits parties from knowingly submitting fraudulent statements, records, and/or claims to the federal government. Under the FCA, false claims can be either:

• Express false certifications, meaning a party explicitly, falsely, and knowingly affirms compliance with some regulation, statute, or contact
• Implied false certifications, meaning a party intentionally fails to disclose known regulatory violations, compliance issues, or contractual breaches to the proper government agency or authority  

In relation to the DOJ Zantac investigation, the specific nature of the allegations is unclear at this time, as DOJ investigators, Sanofi, and GSK have not issued public statements directly commenting on the probe. In fact, word of the investigation first became public in quarterly financial reports filed by Sanofi and GSK.

While it may be months or longer before more information about the DOJ’s probe is made public, experts suspect—based on public information related to Zantac contamination and recalls—that the DOJ wants to determine:

• How and how frequently Sanofi and GSK were testing Zantac for potential contamination
• When these drug companies first became aware of Zantac contamination
• What the drug companies did or did not tell regulators after becoming aware of Zantac contamination

To this end, everything from ranitidine testing results to internal company emails may prove to be essential evidence for the DOJ probe.  

Beyond the DOJ Probe: Drugmakers Face Many Zantac Lawsuits

Outside of government investigations into Zantac cancer risks, Sanofi and GSK are also in the hot seat in civil court complaints filed across the U.S. This includes cases in:

• New Mexico: The New Mexico Attorney General has filed cases against Sanofi and GSK, accusing the drug companies of violating the New Mexico False Advertising Act, the New Mexico Unfair Practices Act, and the New Mexico Public Nuisance Statute.
• Florida: More than 130 claims filed in courts across the U.S. have been consolidated into multidistrict litigation (MDL) in the U.S. District Court Southern District of Florida (20-MD-2924-Rosenberg – In Re: Zantac (Ranitidine) Products Liability Litigation). This Zantac MDL was established by an order from the Judicial Panel for Multidistrict Litigation on February 6, 2020.

Those who have been harmed by contaminated Zantac may have the option to join the MDL or file an individual claim. An experienced dangerous drug attorney can provide more answers and essential advice regarding the best options for pursuing a Zantac cancer lawsuit.