The federal judge in Florida, Judge Robin Rosenberg, who’s overseeing the Zantac multidistrict litigation (MDL, has denied requests by branded drugmakers, including GlaxoSmithKline, Sanofi, Pfizer, and Boehringer Ingelheim, to dismiss class actions by consumers who suffered from severe health problems after taking the now discontinued heartburn drug, Zantac.
The global recalls of Zantac took place in 2019 and 2020. However, the legal saga stemming from the health risks caused by the drug is just getting started.
In the world of the pharmaceutical industry, however, companies are not exactly new to scandals, ethical issues, and even lawsuits. In fact, another heartburn medication, Nexium, has also been the target of many lawsuits filed in the United States.
In the case of Zantac, however, it was recalled because it contained unacceptable levels of a potential cancer-causing agent called NDMA (N-Nitrosodimethylamine).
Now, its manufacturers just lost a bid to dismiss the class actions they’re facing. Continue reading the article to learn more about the latest court ruling over Zantac.
Manufacturers Can’t Escape Class Actions
Judge Robin Rosenberg ruled on Oct. 8 that Zantac manufacturers should gear up for lawsuits filed by plaintiffs who were formerly prescribed Zantac and are now seeking refunds or medical monitoring of their cancer.
The drugmakers in question include:
- Boehringer Ingelheim
These manufacturers sold Zantac products in the years leading up to its widespread recall in 2019. The judge allowed lawsuits claiming personal injury to continue as well. Rosenberg also encouraged plaintiffs to keep pursuing other complaints they suffered from economic losses from different state laws.
These include violations of state consumer protection statutes, unjust enrichment, and breach of quasi-contract.
Why was Zantac taken off the market?
In 2020, the U.S. Food and Drug Administration (FDA) ordered manufacturers to withdraw their Zantac products from the shelves. This applied to both generic and branded versions of the drug.
Laboratory testing found that ranitidine, the active ingredient of Zantac, can decay at room temperatures. This chemical decay can create unacceptable levels of a carcinogenic compound, NDMA. As a result, consumers can be exposed to high levels of the cancer-causing agent.
And unsafe NDMA levels can lead to cancer. It is a contaminant that’s also present all around us. We can find it in foods like bacon and cheese, beverages like beer, and even in shampoo, detergents, and pesticides.
But just like several things in life, having too much of it can do more harm than good to us. Excessive levels of exposure to NDMA can cause different forms of cancer, including esophageal, colon, stomach, pancreatic, and prostate cancer.
In some cases, it can also result in leukemia or non-Hodgkin’s lymphoma. Although more research is needed to fully understand what other harms this carcinogen can cause, plenty of animal studies show that the compound can be potentially dangerous.
It can allow for the development of tumors in the liver, blood vessels, and respiratory tract. Consuming small amounts of NDMA isn’t bound to cause life-threatening harm to a person. But since Zantac contains levels of the compound that exceed daily acceptable intake, this means that it poses serious health risks.
The lead lawyers for the plaintiffs–Tracy Finken of Anapol Weiss, Robert Gilbert of Kopelowitz Ostrow Ferguson Weiselberg Gilbert, Michael McGlamry of Pope McGlamry, and Adam Pulaski of Pulaski Kherkher– accused the drugmakers of being involved in a decades-long scheme to hide the risks linked to Zantac use, Reuters reported.
“We look forward to holding them accountable,” the lawyers said.
To date, plaintiffs’ lawyers claim that over 100,000 people who used Zantac now have cancer. More than 800 lawsuits are now pending before the U.S. district judge. These include complaints filed by people who claim they developed cancer after taking the medication.
However, the real number of claims may be more than this. A registry used in tracking filed and unfiled Zantac claims by law firms include more than 110,000 claims.
Moreover, a USA Today report in 2019 also said that “Zantac was prescribed more than 15 million times a year with little worry about the safety of the medication, available for decades.”
What the Brand-Name Companies Have to Say
Drugmakers GSK and Sanofi argued that the plaintiffs failed to set a threshold level of NDMA exposure that would trigger a significantly increased risk of cancer that would necessitate monitoring.
However, Rosenberg said this is not necessary. Pointing to how plaintiffs cited studies and the FDA’s recall order to back up their claims, the judge concluded that the “allegations are sufficient to plead ‘significantly increased risk’ at this time.”
According to FiercePharma, representatives for Sanofi and Boehringer Ingelheim said the companies “remain confident in the strength of our defenses.”
“In particular, as both FDA and the European Medicines Agency have recently published, the weight of the scientific evidence does not support the plaintiffs’ claims that Zantac causes cancer,” Sanofi’s spokesperson added.
The Future of Zantac Litigation
Earlier this year, Sanofi was hit with accusations of widespread email deletion linked to its 2019 recall of Zantac. At the time, a representative for Sanofi stated that the company “did not intentionally destroy any emails related to the Zantac litigation.”
Fast forward to today, and brand-name Zantac manufacturers are now looking at a complex legal battle soon. Generic companies also faced lawsuits over generic versions of the heartburn medication. However, in July, Rosenberg rejected claims against those drugmakers.
According to Reuters, those companies expressed their plan to the court to pursue reimbursement of defense costs from the plaintiffs.
Valisure, an independent online pharmacy, was the first one to discover the link of Zantac and its generic versions to the cancer-causing agent, NDMA. It alerted the FDA of its initial findings during its routine testing of every batch of each drug in June 2019.
Valisure also added that medical literature dating back to the early 1980s showed an association between the compound ranitidine and cancer.
Two popular high blood pressure medications, valsartan and losartan, were also taken off the market in 2018 because of NDMA contamination.