The term pharmaceutical liability refers to the area of law that governs who (if anyone) is liable when a medicinal over-the-counter (OTC) or prescription drug causes harm because of a defect.
Hundreds of pharmaceutical liability lawsuits have been filed across the United States against drug manufacturers alleging that Zantac (and its generic versions) were contaminated with a cancer-causing chemical.
In this article, we’ll take a closer look at Zantac, the status of the Zantac lawsuits, and what you should do if you developed cancer after ingesting Zantac.
Zantac (the brand name version of the generic drug ranitidine) is a histamine-2 blocker that decreases the amount of acid created by the stomach. Zantac is primarily used to treat gastric ulcers, heartburn, acid indigestion, and other gastrointestinal conditions.
Zantac was developed by GlaxoSmithKline (GSK) and approved for prescription use by the U.S. Food and Drug Administration (FDA) on June 9, 1983.
In 1996, Zantac became available without a prescription. Several generic versions became available the following year.
In 2019, a pharmacy in New Haven, Connecticut, discovered the presence of the chemical N-Nitrosodimethylamine (NDMA) in some batches of Zantac.
Follow-up tests conducted by the FDA confirmed the presence of NDMA in Zantac and noted that the amount of NDMA could increase significantly over time when the medication is stored at higher than room temperatures.
So what is NDMA and does it cause cancer?
NDMA is a human carcinogen (a substance that could cause cancer).
The FDA set the acceptable daily intake limit for NDMA at 0.096 micrograms. In other words, the FDA believes that consuming up to 0.096 micrograms of NDMA per day over the course of your lifetime is reasonably safe.
However, when the FDA tested Zantac, it found that the amount of NDMA in some tablets (which are intended to be taken daily) exceeded the 0.096 microgram limit by as much as 9 times.
To be clear:
At least one study, conducted by the Memorial Sloan Kettering Cancer Center, suggests that the use of Zantac significantly increases a person's odds of being diagnosed with breast, testicular, thyroid, and kidney cancer. Other studies, however, have not found sufficient evidence to confirm a causal connection.
Regardless, most experts agree that NDMA contamination poses a potential carcinogenic risk of undetermined effect for those taking Zantac.
On April 1, 2020, the FDA recalled Zantac and all other prescription and over-the-counter drugs containing ranitidine from the market.
In its recall notice, the FDA acknowledged that this was merely the latest step in an ongoing investigation.
Hundreds of lawsuits have been filed by plaintiffs who took Zantac or a generic version of Zantac and were later diagnosed with cancer. Generally speaking, the lawsuits allege that:
Let’s take a look at a couple of related lawsuits:
As of April 2021, all Zantac-related lawsuits are still pending.
To successfully file a lawsuit against the manufacturer of Zantac or one of its generic versions, you need to prove that:
Your medical records should be sufficient to prove that you took Zantac (or a generic form of the drug) and that you received a cancer diagnosis.
Remember, scientists don’t even agree on whether Zantac causes cancer. The bulk of Zantac litigation will therefore involve experts on both sides presenting testimony. Ultimately, it will be up to the jury to decide who they believe.
If you think you may qualify, you should contact a pharmaceutical liability attorney in your area as soon as possible.