Litigation Already Filed Against Zantac Even Without Official Recall from FDA
In September, national pharmacy chain CVS decided to pull the popular heartburn medication Zantac from its shelves and pharmacies due to a possible link to cancer and the Food and Drug Administration (FDA) allegedly finding trace amounts of a carcinogen known as N-nitrosodimethylamine (NDMA) in it and associated generic brands, such as ranitidine. Still, the FDA has not yet issued an official recall, bringing into question to what extent manufacturers will face potential product liability claims.
According to the agency, while NDMA can be harmful in large amounts, the levels found thus far in the product “barely exceed the amounts you might expect to find in common foods.” As a result, the agency simply plans on testing additional samples. Indeed, CVS indicated that it was suspending sales of the products “out of an abundance of caution.” Rite Aid, Walgreens, and Walmart took similar actions prior to now, with drug manufacturer Apotex choosing to recall ranitidine tablets sold over the counter. Meanwhile, the drugmaker Novartis announced that it does not plan on continuing to distribute generic versions of Zantac, and Sanofi, the makers of Zantac, announced that they are conducting their own investigations, while indicating that there are currently no plans to stop distributing or manufacturing the product.
Premature Claims Against Manufacturer Sanofi
In spite of any official recall being issued, a class action lawsuit has already been filed accusing Sanofi of intentionally concealing the risks in the medication, claiming that levels of NDMA significantly exceed the FDA-approved limit. The lawsuit claims that when the active ingredient ranitidine is ingested, it metabolizes into dangerous levels of NDMA, and Sanofi was aware that Zantac contained the carcinogen, yet chose to conceal these risks from the public.
In addition, according to the complaint, had these risks been disclosed, no reasonable person would have purchased and consumed the product. Attorneys for plaintiffs are seeking repayment for those who purchased the drug, as well as an injunction – brought under the state legal remedies and consumer protection laws – seeking that Sanofi either stop selling the product or add a warning label to it.
According to reports, while online pharmacy and laboratory company Valisure reportedly found that Zantac and generic versions contained NDMA levels that are significantly higher than the FDA’s recommended daily limits, the FDA did not find the same levels that Valisure did.
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Even before the FDA issues an official recall, manufacturers can face outrageous product liability claims. In these cases, having qualified defense representation is absolutely essential.
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