The U.S. Food and Drug Administration pulled Zantac from the market because it contained dangerous levels of NDMA, a highly potent organic toxin. More specifically, NDMA was found in ranitidine, the active ingredient of Zantac. Unless Sanofi, the manufacturer of Zantac, can prove that the NDMA level is safe, Zantac will not be sold again.
For more than 30 years, Zantac was a widely used histamine blocker that helped patients suffering from stomach ulcers and ailments such as acid reflux to manage their illnesses. Histamine is released by inflamed or damaged cells, and it can stimulate the production of stomach acid.
The FDA Recall
In late 2019, the FDA issued a recall of Zantac based on initial reports that the ranitidine used in its production had become contaminated with NDMA. NDMA occurs naturally in the environment and can be found in dairy and meat products. It can also enter the ecosystem from industrial processes such as wastewater treatment and the production of industrial solvents, lubricants, and pesticides.
Sanofi claimed that the NDMA found in Zantac was not significantly higher than the naturally occurring level in food or water.
Testing on animals exposed to NDMA found that the substance was a carcinogen, which means that it is a probable cancer-causing substance in humans.
A final factor behind the FDA’s decision to recall Zantac is that some studies have shown that NDMA is released by ranitidine in dangerous levels in temperatures that are higher than room temperature.
Based on these facts, the FDA’s recall will remain in place, and Zantac will not be sold again until Sanofi can prove that the NDMA level is at or under the safe 96 nanograms per day. At that point, the FDA says it “may consider” allowing Zantac and other ranitidine products back on the market.
NDMA and Safe Drug Research
Although Zantac had been on the market for almost 40 years before the FDA recall, the NDMA issue and the connection between ranitidine and various illnesses were only discovered recently.
The root cause of NDMA contamination in Zantac is still under investigation, but Zantac lawsuits are based on the claim that the manufacturer knew, or should have known, about the risks that ranitidine poses and that it failed to not only remove the product from the market, but to warn the public about those dangers. Countless Americans took Zantac as a result–many of them regularly and for a long time–as a standard part of their health regimen.
In addition to NDMA contamination, a link between histamine blockers such as Zantac and nutrient absorption has also been discovered, according to Mayo Clinic. Any illnesses that arise due to nutrient deficiencies of any type that can be provably linked to an individual’s use of Zantac can also be included in a product liability claim.
However, if you stopped taking Zantac and are still looking for other acid reflux medications, there are many other safe drugs on the market.
Awards and Compensation
The basis of any product liability claim lies in the fact that a manufacturer knew, or should have known about the inherent risks of using their product, but they failed to disclose that information to the public.
It is not clear whether Zantac will be sold again, but if you suffered from ulcers or indigestion and used Zantac either for a long time or for temporary relief, you may be able to file a lawsuit against Zantac’s manufacturer.
To arrive at a decision on your case, the court might take into account how long you used Zantac, what illnesses you developed by using it, and the expenses you had to bear as a result. You might be able to recover compensation for these expenses like:
- Medical bills
- Transportation costs
- Pain and suffering
- Mental anguish
- Lost wages
- Lost earning capacity
This is not a full list of compensation, and we can give you a better estimate of what you might be entitled to when you call us. Pintas & Mullins Law Firm helps patients who suffered injuries or illnesses as a result of product liability file a claim for damages based on the unique circumstances surrounding their case. Call us today at (800) 635-1144 for a free case evaluation and to determine whether or not you have grounds for a liability claim.