Sanofi, GSK, Pfizer, Boehringer must face Zantac class-action lawsuits: Court

New Delhi: Rejecting the arguments by the branded drugmakers in the Zantac lawsuit, in a federal court in Florida, Judge Robin Rosenberg in separate rulings allowed the proposed class actions to proceed against Sanofi, GlaxoSmithKline, Boehringer Ingelheim, and Pfizer, which sold Zantac, an antacid contaminated with N-nitrosodimethylamine (NDMA), a leading cause of various cancers.

The lawsuits were launched by people who took Zantac and Ranitidine contaminated with NDMA and later developed cancer.

Zantac is the trade name for Ranitidine, a histamine H2 antagonist which is used to treat duodenal ulcers, Zollinger-Ellison syndrome, gastric ulcers, GERD, and erosive esophagitis. Zantac was developed and released by GlaxoSmithKline, but it was widely available in generic versions manufactured by a variety of companies.

According to a Reuters report, the lawsuit claimed that the drugmakers were engaged in a decades-long scheme to conceal the dangers and risks associated with Zantac use, despite research that linked ranitidine, the generic name of the drug, to a probable carcinogen, N-nitrosodimethylamine (NDMA).

The lawsuits are part of the broader multidistrict litigation (MDL) over Zantac and ranitidine after various drugmakers, including the defendants, launched recalls of their products in 2019.

More than 800 lawsuits are now pending before Rosenberg, including lawsuits by people who say they developed cancer after using the medication. A registry used to track filed and unfiled cases by law firms includes 110,000-plus claims.

The lawsuits were filed after the U.S. Food and Drug Administration announced it was investigating whether the drug causes levels of NDMA to rise in users' bodies.

In April 2020, the USFDA requested all manufacturers withdraw their products from the market.

Last year, the Medical Dialogues Team had reported that through an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac), the USFDA had determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.

As a result, pharmaceutical companies began the process of recalling the drug worldwide.

Following this, lawsuits started flowing in. Fierce Pharma reports, legal firms sued branded drugmakers for allegedly deceiving consumers about the drug's risks even before the FDA's order.

"Manufacturers including GlaxoSmithKline, Sanofi, Boehringer Ingelheim and Pfizer engaged in a decades-long scheme to conceal the inherent dangers and risks associated with Zantac use despite abundant medical and scientific literature that linked ranitidine to NDMA, and we look forward to holding them accountable," victims' lawyers issued a statement, following the court's judgement, reports Fierce Pharma.

The lead lawyers for the plaintiffs--Tracy Finken of Anapol Weiss, Robert Gilbert of Kopelowitz Ostrow Ferguson Weiselberg Gilbert, Michael McGlamry of Pope McGlamry, and  Adam Pulaski of Pulaski Kherkher--hailed the rulings in a joint statement.

Pfizer, represented by Joseph Petrosinelli of Williams & Connolly, said it believed the plaintiffs had not adequately pleaded their claims and would continue to defend themselves against them.

However, GSK declined to comment, and the other defendants did not respond to requests for comment. They are being represented by lawyers at Arnold & Porter Kaye Scholer, Dechert and King & Spalding.

The multidistrict litigation (MDL) also encompasses two proposed class actions by people who claimed they were deceived into buying brand-name ranitidine seeking refunds and by plaintiffs who sought to recover the costs of testing to detect if they developed cancer.

The medical monitoring claims, brought under various states' laws, would be pursued through several state- and defendant-specific classes.

In view of the above case, drugmakers including GSK and Sanofi had argued that the plaintiffs had failed to allege a threshold level of NDMA exposure that would create a significantly increased risk of cancer that would warrant monitoring or specify how frequently they used the drugs.

Plaintiffs' lawyers claimed in a statement that they are pursuing claims on behalf of more than 100,000 people who have developed cancer after using Zantac. According to a Fierce Pharma article, hundreds of thousands of people across the country have consumed or purchased the medicine.

However, in response, Rosenberg said no threshold was needed, Reuters reports.

Noting the plaintiffs cited studies and the FDA's recall request to support their claims, she concluded the "allegations are sufficient to plead 'significantly increased risk' at this time."

Accordingly, the judge also allowed plaintiffs to keep pursuing in the other case claims they suffered economic losses under various state laws, such as violations of state consumer protection statutes, unjust enrichment, and breach of quasi-contract.

Rosenberg rejected arguments by the brand-name companies that the state-law claims were preempted by federal law because they would impose labelling requirements inconsistent with FDA labelling rules.

Rosenberg said the plaintiffs' claims were not barred to the extent they were enforcing state laws requiring accurate, non-misleading labels that paralleled federal law.