WHAT’S UP WITH THE ZANTAC RECALL ADS?
On April 1, 2020, the FDA announced the immediate withdrawal of all prescription and over the counter Ranitidine and Zantac ® from the market. In its announcement, the agency stated that it “determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.” The impurity, NDMA, is a known cancer causing chemical. Before April’s announcement, it was thought the impurity formed in the body. While this continues to be a common thought in the scientific community, the FDA cautioned in its announcement that the impurity may result from when the drug is stored for longer periods of time at temperatures above 72 degrees. There are additional studies that will, hopefully, shed light on the reason for the impurity, but, for now, those studies have been delayed due to Covid-19.
According to studies of the contaminant NDMA (N-nitrosodimethylamine), possible side effects of ingestion are:
Currently, lawsuits and claims filed throughout the country have been consolidated in the U.S. Federal District Court for the Southern District of Florida through a multi-district litigation (MDL) process. While this litigation is in its infancy, there have been several thousand claims filed with the court through a census program. The utilization of this program is incredibly important as it will assist with determining the cause of the impurity found in ranitidine and Zantac ® and the effect NDMA has on the drug’s users.
Proof of cause and effect will be incredibly important and complex in this litigation as there are several hurdles consumers face in this litigation. For instance, those who were prescribed, generic Ranitidine was prescribed much more often than Zantac. This poses a significant problem as the U.S. Supreme Court has held that state law failure to warn claims against manufacturers of generic drugs are preempted be federal drug regulations. In other words, those consumers taking Ranitidine by prescription, only, are prohibited by law from making a claim against a generic manufacturer under a theory the company failed to warn the drug’s usage may cause cancer. Thus, in those cases, consumers will be forced to show evidence there is a defect in the manufacturing process of the generic manufacturer. Another concern, is proof of usage for those who purchased Ranitidine and Zantac ® over-the-counter. Requesting documents from pharmacy reward programs and/or medical savings accounts (MSA) will be imperative. Last, determining the manufacturer responsible for the consumer’s injury will be tasking; there are over 15 manufactures of Ranitidine and Zantac ®. In summation, given the widespread usage of Ranitidine and Zantac ® and the complex evidentiary and legal theories that must be overcome by the consumer, this litigation pending in Miami, FL may, very well, take several years to reach a conclusion.
For more information related to this article and Ranitidine and Zantac ® claims, call Knox Boteler at 251-433-7766 or email, Knox@BRWlawyers.com
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