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DOJ Opens Probe into Zantac After Firestorm of Allegations

Posted on 08/20/2020Back

DOJ Opens Probe Over Zantac Cancer Risk

Zantac manufacturers Sanofi-Aventis US LLC (Sanofi) and GlaxoSmithKline LLC (GSK) face a U.S. Department of Justice (DOJ) and U.S. Attorney’s Office for the Eastern District of Pennsylvania investigation into Zantac. The investigation will also cover the claim that the manufacturers violated the False Claims Act by not disclosing information on the potential presence of the human carcinogen N-nitrosodimethylamine (NDMA) which has been linked to cancer.

Zantac Manufacturers’ Response

In response to the investigation, both companies filed U.S. Securities and Exchange (SEC) Filings. Sanofi explained that it was notified of the investigation on June 6, 2020 and the probe requested “information and documents with Sanofi, including applications and communications with the [U.S. Food and Drug Administration]”. GSK said in its SEC filing that it received a civil investigative demand from the DOJ on June 18 requesting more information on Zantac.

GSK stated in response that “the group is cooperating with the DOJ to provide this information. The ultimate liability for legal claims may vary from the amounts provided and is dependent upon the outcome of litigation proceedings, investigations and possible settlement negotiations. The group’s position could change over time, and, therefore, there can be no assurance that any losses that result from the outcome of any legal proceedings will not exceed by a material amount the amount of the provisions reported in the group’s financial accounts.”

Sanofi also responded to the DOJ’s request and the firestorm of Zantac lawsuits: “It is not possible, at this stage, to assess reliably the outcome of these lawsuits or the potential financial impact on Sanofi.”

New Mexico Litigation

In June 2020, New Mexico’s Attorney General Hector Balderas sued Sanofi and other generic manufacturers including GSK claiming that the companies had violated the states’ Unfair Practices Act, False Advertising Act, and public nuisance and negligence laws.

In response, the drug manufacturers have argued that there is no evidence of a causal link between Zantac and the types of cancers purported to have been caused by the drug.

Multidistrict Litigation Developments

Sanofi, GSK and other pharmaceutical companies have been hit with a barrage of litigation over Zantac since the U.S. Food and Drug Administration (FDA) issued a warning about “low levels” of the human carcinogen NDMA in pills last year. The FDA has since requested that all drug manufacturers of Zantac and its generic brand, Ranitidine, withdraw their products from the market.

In June 2020, attorneys representing 40 Zantac plaintiffs who claim that the manufacturers hid the risks of Zantac producing a carcinogen causing cancer requested to have their cases consolidated in California. There is already an MDL in Florida for Zantac cases.

The plaintiffs in the California lawsuits include the mother of an 8-year-old boy who claims that her use of Zantac while pregnant with her son resulted in his development of testicular cancer. Other plaintiffs claim the drug led to bladder, kidney, prostate and thyroid cancer.

The plaintiffs argue that the manufacturers knew about the risks since 1980s and that GSK even attempted to discredit studies which showed that Zantac could create NDMA—a human carcinogen.

In response, legal counsel for Sanofi, Anand Agneshwar, commented during the Florida MDL hearing in May 2020 that “the law is supposed to lag science. It’s not supposed to lead it.”

How GoldenbergLaw Can Help You

GoldenbergLaw is currently investigating cases where an individual has taken Zantac or Ranitidine and developed cancer. We have been litigating defective pharmaceutical cases for over thirty years and have the knowledge, experience and compassion you deserve. Contact us today for a free consultation.

Category Dangerous Drugs News