Ranitidine, more commonly known as Zantac, is an over-the-counter (OTC) and prescription drug sold by Sanofi. Zantac is probably the most popular form of ranitidine, as it first hit the U.S. market in the early 1980s and gained notoriety as the worlds best-selling prescription drug by 1987. Zantac belongs to a class of drugs known as H2 (or histamine-2) blockers, and is commonly used to relieve and prevent heartburn. Zantac is also used to treat and prevent serious ulcers in the stomach and instestines. Sanofi, the manufacturer of Zantac, recently issued a voluntary recall for all Zantac products after an alarming announcement by the US Food and Drug Administration (FDA).
Like all other pharmaceutical medicines, this drug is regulated by FDA. As recent as September 2019, the FDA announced that Zantac, and other generic forms of the drug, contain unsafe levels of nitrosodimethylamine (NDMA). NDMA is an environmental contaminant that is found in water and foods, including dairy products, vegetables, and grilled meats. Reports have suggested that NDMA is a possible carcinogen that can cause people to develop stomach, bladder, intestinal, colon, rectal, kidney or liver cancers.Consequently, officials have concerns whether the high levels of NDMA in Zantac, or other generic forms of ranitidine, are causing cancer.
The FDA’s annoucement came in response to a report received by a Connecticut lab called Valisure. The lab report indicated that the ranitidine medications contained high levels of NDMA, which spiked in the medication itself once consumed. In other words, Zantac and other ranitidine medications converted substances of the drug into NDMA once inside the body. More specifically, levels of NDMA inside the body increased by 400 times the standard limit accepatable by the FDA.
In response to the FDA’s announcement, large pharmaceutical companies across the nation have pulled ranitidine drugs from their shelves through recalls. In the meantime, the FDA has called for individuals to consult their prescribing physicians and, ultimately, stop taking the medication.
The experienced attorneys at Rosensteel Fleishman, PLLC may be able to help if you or a loved one who have been impacted by the use of Zantac and its generic forms. Learning that you or a loved one have been diagnosed with cancer is extremely difficult to cope with. Matters become even more challenging if the illness was caused by a defective drug. When you or someone you love suffers serious injuries as a result of a defective product, you may be entitled to compensation. Rosensteel Fleishman, PLLC understands how emotional these situations can be, so we pride ourselves on providing you with the information, resources, and support you need.
A personal injury claim of this nature may entitle you to the following types of damages:
A defective drug, such as Zantac, would warrant a products liability claim if you or a loved one have been diagnosed with cancer as a result of using the medication. Under a product liability claim, a plaintiff would seek damages by aruging that the product was (i) defectively manufactured, (ii) defectively designed, or (iii) the manufacturer failed to adequately warn of potential dangers, or “failure to warn.” Failure to warn is a product defect that can mean a variety of different flaws—including, improper labeling, insufficient instructions, or inadequate safety warnings. The latter rests on the legal premise that manufacturers and suppliers of products must give proper warnings of the dangers and risks of their products so that consumers can make informed decisions regarding whether to use them. Succsss of these claims often relies on the plaintiff’s own knowledge of the product. However, a negligent or intentional misrepresentation regarding a prodct may give rise to a product liability claim.
According to the most recent lawsuits, plaintiffs are arguing that the manufacturers of Zantac knew that the medication could convert to NDMA in the body, yet failed to warn users about the serious health risks--including cancer--that came with taking the medicine.
To date, there are estimates of around 800,000 yearly prescriptions of Zantac. Further, since the drug has been in the marketplace since the 1980s, millions of people have been exposed to the looming threat of a cancer that they could have avoided if properly warned. The drug manufacturer has a legal duty to warn of side effects of a drug when such effects are understood to occur. However, manufacturers are not expected to warn of unknown dangers. Oftentimes, the manufacturer discharges this duty by providing the necessary information to the patient’s prescribing physician or to the pharmacists. However, in this case, officials have reported that manuacturers of Zantac and related generic drugs, were well aware of the unsafe levels of NDMA in their product and failed to warn.
There are a few defenses available to manufacturers in a product liability action such as this. These defenses vary depending on the jurisdiction in which the action is filed. Here in North Carolina, certain legal defenses constitute full or partial defense to a product liability action. Among them are the following: (i) disclaimers, (ii) learned intermediaries, and (iii) contributory negligence. North Carolina recognizes all three of these defenses, so one would be wise to consult an experienced attorney that can employ various legal skills to overcome any challenges to your claim.
Contact the skilled attorneys at Rosensteel Fleishman, PLLC if you or a loved one have been diagnosed with a cancer and have used Zantac or any of the related generic drugs. You could be entitled to compensation. The initial consulation is free of charge.