The last two years have been pretty bad for the popular heartburn drug Zantac after testing revealed that it contained significantly high levels of the carcinogen N-Nitrosodimethylamine (NDMA). This led to Zantac being pulled off the shelves of major retailers and eventually a nationwide FDA recall.
- Can we estimate a settlement amount for the Zantac lawsuits?
Hundreds of individuals have now filed lawsuits against Zantac’s manufacturers. The suits alleged that taking Zantac caused the plaintiffs to develop certain types of cancer. Hundreds more Zantac cancer lawsuits are expected to be filed/tolled in the MDL (which really means the claims are “kinda filed” without all of the formalities).
The source of all the trouble is NDMA which was in Zantac. NDMA a cancerous poison metabolizes into carcinogens like formaldehyde.
The Zantac lawsuits pending in the federal court system have been consolidated into an MDL in Florida federal court (In re: Rantac (Ranitidine) Products Liab. Lit. (20-MD-2924).
Here is a timeline of events:
2016 Study on Zantac and NDMA Levels
One of the first negative reports about Zantac came in the form of a study published in the June 2016 edition of Carcinogenesis, which suggested possible links between Zantac and bladder cancer. They collected the urine samples of ten individuals who took a 150mg Zantac dose. The researchers found that their NDMA levels were comparable to individuals with schistosomiasis, a disease that can cause bladder cancer. They concluded that their results warranted a further evaluation of risks associated with Zantac.
NDMA Levels in Zantac
In a September 2019 letter to the FDA, Valisure, an online pharmacy and independent testing, announced that they performed testing and analysis of Zantac and found exceedingly high NDMA levels. They found that one Zantac tablet may carry between 2.5 and 3.5 million nanograms or NDMA. This amount grossly exceeds 96 nanograms, which is considered the safest maximum amount one can take daily. What this means is that many individuals have unknowingly been exposed to high NDMA levels that put them at high risk of developing cancer.
September 2019 FDA Statement on NDMA Found in Zantac
Weeks after Valisure raised the alarm, the FDA publicly acknowledged in a statement that Zantac medications contained significant NDMA levels. They announced that they were working with industry partners and international regulators to determine the source of the impurity. At that point, the FDA was not calling for patients to stop taking Zantac or pushing for the product to be pulled from the market. However, the FDA recommended that patients speak to a health care professional about taking other approved medications.
January 2020 Emery Pharma Citizen Petition
Around January 2020, Emery Pharma filed an FDA citizen petition regarding Zantac. This citizen petition came after Emery Pharma conducted a study that found that heat exposure caused Zantac to develop N-Nitrosodimethylamine (NDMA).
They urged the FDA to suspend Zantac sales, issue a recall, and order additional stability testing. They also requested that Zantac labels include warnings on how heat-exposure creates carcinogenic byproducts in the drug.
They found that even limited heat-exposure in settings such as a delivery truck can cause NDMA to develop. This study suggests that NDMA in Zantac is unavoidable because it is a natural chemical byproduct. This suggested that the NDMA in Zantac was not a “contamination issue,” therefore, manufacturing changes will not reduce NDMA levels in Zantac.
February 2020 Zantac MDL Created in Florida
The discovery of NDMA in Zantac quickly led to a wave of product liability lawsuits against the manufacturers of Zantac. By the start of 2020, there were already over 100 individual Zantac lawsuits pending in the federal court system.
In February 2020, the Judicial Panel on Multi-District Litigation created the Zantac Product Liability MDL and issued an initial transfer order centralizing over 140 Zantac lawsuits into the U.S. District Court for the Southern District of Florida. U.S. District Judge Robin Rosenberg will be presiding over this MDL. (Judge Bruce Reinhart is a magistrate judge who has been involved in the early skirmishes in this limitation.) The Zantac MDL on February 6, 2020.
Why Florida for the Zantac class action? Let’s hear from the MDL Panel:
The Southern District of Florida is an appropriate transferee district for this litigation. A large number of Zantac actions are pending in the Southern District of Florida, which is supported by the majority of responding plaintiffs. The district is a relatively convenient and accessible forum, with the resources and the capacity to efficiently handle what could be a large litigation. Additionally, centralization before the Honorable Robin L. Rosenberg allows us to assign this litigation to an able jurist who has not yet had the opportunity to preside over an MDL. We are confident that Judge Rosenberg will steer this litigation on an efficient and prudent course.
April 2020 FDA Removal Request
Around April 2020, the FDA requested that all Zantac manufacturers immediately withdraw their product from the market. They also advised the public to stop taking over-the-counter Zantac and stop purchasing additional drugs containing ranitidine.
The FDA also recommended that patients consider other approved over-the-counter medications for their condition. They noted that there are FDA-approved Zantac alternatives that do not have the same risks.
September 2021 Zantac Litigation Update
The one thing you need to get used to is that mass tort litigation like Zantac moves slowly. But these cases have progressed.
Right now, discovery is ongoing. Plaintiffs’ lawyers lost a battle last week that involved the discovery of whether some foreign defendants could be sued in the Florida class action. But this is not a big loss in the big picture of things. The Zantac litigation is getting bigger.
The first Zantac trial will be located in a place we have not mentioned once in this post: California state court. There are also lawsuits filed in California state court that might be pushed ahead of the federal MDL class action. The first California state court trial is expected next year in 2022.