Additional Evidence Surfaces Linking Zantac to Cancer

| Feb 1, 2021 | Products Liability

People who used the popular antacid have an elevated risk of stomach, esophageal, and colorectal cancer, according to a recent study.

This study focused on Zantac’s chemical composition, specifically proton pump inhibitors (PPIs) and H2 antagonists. The conclusions reinforced several other study results which showed a relationship between NDMA contamination and cancer. This connection usually happens when the NDMA in Zantac mixes with certain chemicals in the human stomach. 

NDMA poisoning could also happen in certain work environments or after people use certain cosmetics.

Zantac and NDMA Contamination

N-Nitrosodimethylamine is a common by-product of the manufacturing and storage process. NDMA is also one of the most dangerous carcinogens on earth.

As-needed medications like Zantac, which is a heartburn drug, usually spend lots of time in a medicine cabinet. Before that, these drugs usually spend lots of time on a store shelf. So, by the time someone takes a Zantac tablet, it has probably been stored at room temperature for several months. Long-term exposure to low-intensity heat triggers NDMA contamination. This contamination is especially likely in the popular extended release versions of Zantac and other drugs.

The NDMA problem first appeared on the FDA’s radar in mid 2019. Initial tests showed very low levels of NDMA contamination in Zantac. Since Sanofi and other drug companies submitted samples which had just come off the line, the levels were about the same in cured meat and other consumer products. 

A few months later, the FDA began requiring drug companies to submit samples which had been stored at room temperature for several months. Subsequent testing, which revealed extremely high levels of contamination, prompted an immediate partial recall. By April 2020, regulators in the United States and Europe had pulled most Zantac pills off the shelves. These regulators also advised patients to speak with their doctors and then stop taking this medicine.

Sanofi probably knew that only fresh samples would show low NDMA levels. Their knowledge of a risk, and their failure to warn people about that risk, could be an independent claim for damages. More on that below.

Manufacturing Defects

NDMA contamination is an example of a manufacturing defect. Generally, manufacturers are strictly liable for the injuries a manufacturing defect causes. This broad category usually includes every point in the manufacturing and sales process from the initial manufacturing stages to the delivery to a store shelf.

So, a Lexington personal injury attorney must show that the NDMA contamination occurred while the product was still under the manufacturer’s control. Since room temperature storage causes N-Nitrosodimethylamine contamination, this showing can be difficult to make.

The good news is that the burden of proof in these claims is only a preponderance of the evidence, a legal term which means “more likely than not.” Essentially, if there is any evidence of a high-level contamination during manufacturer control, that evidence would support a successful damage claim.

Failure to Warn

This theory might be a better approach in many cases. According to one study, regular Zantac use increased the risk of developing certain kinds of cancer by 240 percent. Almost anyone would agree that this figure is substantial.

Manufacturers always detail a medicine’s possible side effects. In many cases, there are more potential harmful consequences than potential benefits. So, why didn’t Sanofli simply bury a cancer disclaimer somewhere in the fine print.

Although cancer survival rates have improved considerably since the 1990s, the C-word is still a very scary word, especially to some people. Since these same people are most likely to need a powerful antacid, the company had an economic reason not to warn consumers about the risk.

Compensation is extremely high in these situations. If there is clear and convincing evidence that the defendant intentionally disregarded a known risk, additional punitive damages are usually available. Punitive damages are the best way, and normally the only way, to deter future misconduct. Unless the punitive damages award is big enough to get the company’s attention, it will be business as usual, and more people could get hurt.

Dangerous drug victims are also entitled to compensatory damages, for things like medical bills and emotional distress. The aforementioned preponderance of the evidence standard applies to compensatory losses.

Drug companies could be responsible for dangerous drug injuries under one of several legal theories. For a free consultation with an experienced personal injury lawyer in Lexington, contact the Goode Law Office, PLLC. Attorneys can connect victims with doctors, even if they have no insurance or money.