Judge Dismisses Zantac Claims on Federal Preemption
In two recent rulings, U.S. District Court Judge Robin L Rosenberg dismissed a host of claims against Zantac defendants based on federal pre-emption. In short, preemption is a doctrine that can shield drug manufacturers from liability in certain cases where they follow the FDA requirements for an approved drug or medication.
In her ruling Judge Rosenberg held that pre-emption 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 U.S. Food and Drug Administration.
Judge Rosenberg stated “a claim based on allegations that a generic drug’s labeling renders the drug misbranded is a preempted claim because the drug’s manufacturer cannot independently and lawfully change FDA approved labeling. Likewise, a claim based on an allegation that a generic drug’s formulation renders the drug misbranded is a preempted claim because the drug’s manufacturer cannot independently and lawfully change a drug formulation that the FDA has approved.” Judge Rosenberg rejected plaintiffs’ arguments that claims should not be preempted because of misbranding as NDMA was not disclosed by the drug maker.
Background on Zantac Litigation: What You Need to Know
Prior to being recalled in early 2020, Zantac was one of the most widely used medications for the treatment of heartburn, acid reflux and acid related digestive issues. Chemically known as ranitidine hydrochloride, Zantac (or ranitidine) is a class of drugs called histamine H2-receptor antagonists (H2 blockers), which decrease the body’s production of stomach acid, providing temporary relief from acid related conditions. Zantac has been on the market since the early 1980s and was available over the counter and by prescription.
Over the years, numerous scientific studies have linked Zantac with a known carcinogen, N-nitrosodimethylamine, more commonly known as NDMA. NDMA is an extremely toxic substance and was formerly used as a key ingredient in rocket fuel. NDMA is so toxic that its used by scientists to induce cancer in lab rats when necessary for research purposes.
FDA Takes Action Against Zantac
On September 13, 2019, the U.S. Food and Drug Administration (FDA) announced that it was investigating the link between Zantac and cancer. In the summer prior to its September announcement, the FDA became aware of independent laboratory testing that found NDMA in ranitidine. Researchers reported finding 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 of a carcinogen like NDMA in the human body.
On April 1, 2020, the FDA issued an immediate market withdrawal request of all ranitidine-based medications including Zantac. Further FDA testing confirmed that NDMA levels increase in ranitidine even under normal storage conditions. NDMA was found to increase significantly in samples stored at higher temperatures, including temperatures the product may be exposed to during distribution and handling by consumers. FDA testing also revealed the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA the product may contain.
Types of Cancer Linked to Zantac
Lawsuits have been filed that claim the side effects of and range of potential injuries from ingesting NDMA are significant. Zantac use has been linked to the following type 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.
If your firm needs help getting Zantac claims prepared to file with MDL 2924, click the button below to get in touch. The Case Works Zantac Team is specially trained to work with victims to maximize the value of their claim. As a seamless extension of your firm, our Zantac Team will ensure your clients receive exceptional service and the care they deserve. We can help your firm get claims proven up and ready to settle.
Click the button below to get in touch with us for a free consultation.