On February 6, 2020, the U.S. Judicial Panel on Multidistrict Litigation has opted to create a multidistrict litigation (MDL) docket for Zantac personal injury claims, sending the lawsuits to the U.S. District Court for the Southern District of Florida. The federal lawsuits, which are consolidated for purposes of discovery from district courts all over the United States, will be overseen by Judge Robin L. Rosenberg. This is Judge Rosenberg’s first time overseeing an MDL since being appointed in 2014 by Former President Obama.
On September 13, 2019, the U.S. Food and Drug Administration (FDA) reported the discovery of the N-nitrosodimethylamine (NDMA) in Zantac, a common heartburn medication available in both prescription and over-the-counter versions and that discovery began a series of warnings and recalls nationwide, as well as the filing of class actions and individual lawsuits. The generic form of Zantac is known as Ranitidine and it is commonly used to prevent and treat heartburn, ulcers, and gastroesophageal reflux disease (GERD). Zantac went to market in 1983.
DMA is an environmental contaminant found in water along with meat, dairy, and vegetables. It’s classified as a B2 carcinogen, meaning it’s a probable human carcinogen. Exposure to high amounts of NDMA is thought to cause gastric or colorectal cancer, according to the World Health Organization. It’s extremely toxic to the liver. Even small amounts may be linked to liver damage. The chemical was once used to make rocket fuel. Today the chemical is only used for research purposes in the United States, according to the Environmental Protection Agency. It’s also a byproduct of many manufacturing processes at industrial sites, including tanneries, pesticide manufacturing plants, and rubber and tire manufacturers. Other applications for NDMA include inducing carcinogenesis in laboratory rats for cancer research. NDMA may also be found in a number of food products, such as cured meats, and is an ingredient in tobacco fumes. Fortunately, NDMA does not appear to accumulate in tissues.
This is not the first time that NDMA has been implicated in a pharmaceutical drug. On July 13, 2018, the drug Valsartan, a commonly prescribed drug for blood pressure, was recalled due to the NDMA contaminent. However, the NDMA in Valsartan appears to be a contaminant from the manufacturing process whereas the NDMA in Zantac appears to be metabolized in the body once exposed to water in the digestive system.
Ranitidine is available both by prescription and in an over-the-counter version available without prescription. Zantac is an H2 (histamine-2) blocker which decreases acidity in the stomach. There are alternative H2 blockers on the market that do NOT contain NDMA, such as Pepcid and Tagamet (famotidine and Cimetidine).
Since September 2019, the pressure on the pharmaceutical industry and the FDA has increased, causing Sandoz Inc to begin voluntary recalls of its generic version of the Ranitidine drug. It was followed closely by recalls initiated by 14 other generic manufacturers. In fact, in 2019 multiple drugstores stopped selling the drug. CVS and Walgreens no longer sell Zantac and other Ranitidine medications. CVS has offered customers who recently bought Zantac or another Ranitidine drug a refund. The chain will continue to sell other over-the-counter (OTC) heartburn medications, like Pepcid and Tagamet, which don’t contain Ranitidine.
On October 8, 2019, GlaxoSmithKline recalled prescription Zantac and, on October 18, 2019, Sanofi announced its voluntary recall of over-the-counter Zantac.
On November 12, 2019, the FDA advised all companies to recall their Ranitidine if testing showed levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine). Although the FDA advisory states that the level of contamination is “low,” the levels have been found to be between 3,000 and 26,000 times higher than what the agency has determined to be “safe.”
Proof of Use:
In order to successfully pursue civil litigation for those affected by cancer, consumers must prove that they took Zantac (or another form of Ranitidine). This can often be done with a prescription record or transcript, a medical record, or by proving purchase of over-the-counter Zantac. Proof may include receipts, notes in medical records, family affidavits, etc.
Proof of Injury:
Second, to support a civil claim for Ranitidine use, a consumer should be able to prove he or she has an injury from use. Accordingly, the consumer must show that he or she has been diagnosed with one or more of the cancers listed below, keeping in mind that the science may still be evolving and that such cancers will have to be substantiated by scientifically valid analyses:
Proximate Cause (linking injury to use):
Perhaps the trickiest part of setting forth a civil claim is proving that the use of Zantac and/or Ranitidine was actually what caused the cancer, or at least that it was “more likely than not” caused by it. As one might expect, heavier use of the drug over a longer period of time is a factor. The latency in the body before developing cancer is also a factor. Many civil litigators require proof of at least a year of significant exposure (you took Zantac regularly for a year), and at least a year of latency (about a year passed between the time you first took Zantac and the time you developed one of the listed primary cancers). Again, this is not exact, and all circumstances are different.
The companies who have been sued in the MDL include Sanofi-Aventis U.S., which recalled over-the-counter Zantac on October 18, 2019 after the U.S. Food and Drug Administration found unacceptable levels of NDMA in ranitidine samples, as well as GlaxoSmithKline, which first received FDA approval to sell the drug and recalled prescription Zantac on October 8, 2019, and Boehringer Ingelheim Pharmaceuticals Inc. and Pfizer Inc., which both sold Zantac.
Consumers and health care professionals should report any adverse reactions with ranitidine to the FDA’s MedWatch program which can be found at the following FDA website: www.fda.gov/medwatch/report.htm
Information on this sheet was researched and provided via government and private websites and available public information. It is subject to change and modification. Nothing shall be construed as giving legal advice.
For questions, please contact the help of the leading Ohio personal injury attorney Jami S. Oliver for your legal options. Call 614-220-9100 to schedule an appointment.