In a previous Gavel post, we reported that Zantac, a name-brand medication (chemically Ranitidine) used for treating acid reflux and heartburn, was voluntarily recalled when studies showed that when digested, it could potentially produce a cancer causing agent known as NDMA. NDMA, short for N-Nitrosodimethylamine, is a probable human carcinogen that was once used as an ingredient in rocket fuel and is currently used to actually create cancer in rats for cancer research.

The link between Ranitidine and NDMA was discovered in a study run by Valisure, a pharmaceutical company that independently researches and tests the safety of medications. These researchers found that Zantac tablets contain NDMA at levels up to 3,000 times greater than the FDA’s daily intake limit. Most experts agree there is no safe level of a carcinogen like NDMA in the human body. Once the FDA made these findings public, voluntary recalls were announced from nearly every manufacturer of Ranitidine including Sanofi, the manufacturer of Zantac. Zantac has been on the market since the early 1980s and was available over the counter and by prescription.

The alarming results of Valisure’s study and the voluntary recall immediately triggered several lawsuits against manufacturers of Ranitidine. These suits allege that Zantac use has been linked to the following types of cancer:

• Liver cancer
• Bladder cancer
• Stomach cancer
• Kidney cancer
• Prostate cancer
• Colon cancer
• Pancreatic cancer

Every year, doctors wrote more than 15 million prescriptions for Zantac. Countless additional patients bought Ranitidine over the counter in the non-prescription form.  

In February 2020, the Judicial Panel on Multidistrict Litigation created MDL 2924 to consolidate pretrial discovery for the flood of expected Zantac cancer cases. The suits accuse Sanofi SA, Pfizer Inc., Boehringer Ingelheim Pharmaceuticals Inc. and GlaxoSmithKline — as well as generic drug makers, retailers, distributors and active pharmaceutical ingredient makers of injuries associated with NDMA in their medication.

Court dismisses generic claims  

U.S. District Court Judge Robin L Rosenberg recently dismissed all the claims against the generic or store brand versions of Zantac, “With Prejudice” stating that the claims are preempted by federal law. With Prejudice essentially means that these claims can’t be brought again.  Pursuant to recent court decisions, including at the U.S. Supreme Court level, drug manufacturers may be shielded from liability in certain cases when they follow the previously established FDA requirements for an approved drug or medication. In her ruling, Judge Rosenberg held that preemption blocks liability against both name-brand and generic manufacturers for labeling claims brought by injured plaintiffs. The defendants are protected under preemption because these entities cannot alter brand name drug labels or designs which have been approved by the FDA.  

The preemption dismissal determined that since the brand name product, Zantac, was approved by the FDA, federal law does not allow the generic manufacturers and other similar parties to change the labels from what was approved for the brand name version of the drug. The duty of the generic makers and retailers is to label their products the same as the brand name product, the judge wrote, so no state law can compel them to change the label of the drug on their own.  Various court opinions from the United States Supreme Court on down, have held that the generic duty of “sameness” precludes plaintiffs from bringing claims based on “failure to warn’ when  these parties' “hands are tied” with respect to what they can disclose on their labels.  

Cases against brand name manufacturers continue

The above discussed “Preemption” dismissal is a significant decision for users of generic Ranitidine who are now being told that even if the drug caused their cancer, they do not have a claim. Even if plaintiff attorneys could prove a general causation link between Ranitidine and cancer and a specific causation between their client’s use of Ranitidine and their specific cancer, if the plaintiff used a generic version of this product rather than the name brand, their case is over. This seems unfair, but unless Congress passes specific legislation to override these decisions, it’s the current state of the law.

In looking on the bright side, attorneys for the plaintiffs said they were pleased that the cases against the brand name manufacturers, such as GlaxoSmithKline, Boehringer Ingelheim, Sanofi and Pfizer, are still going forward.

As attorneys for the Plaintiffs recently stated:  "The brand manufacturers 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. We look forward to holding the manufacturers of this dangerous drug accountable."  

Main Street Law Firm is continuing to keep on top of the evolving Zantac litigation and will update you in the future.

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