Zantac became one of the largest product recalls in medical drug history in 2019 when the popular heartburn drug was pulled from the market. The financial effects of this recall on the maker of the drug have been considerable. Recently, Sanofi announced that it was going to take a $186 million hit from the recall in the form of a write-down. Of course, this is just the loss in value from the recall as opposed to any liability that the company may face. Whether there will be large-scale liability in the wake of the recall still remains to be seen as the health dangers are yet to be known. Currently, there have been a small number of lawsuits filed.
Zantac Was one of the Most Popular Drugs in the Country
Ranitidine is the generic name of the drug that is known as Zantac. There were numerous versions of the drug including the branded version of the drug that was made by Sanofi as well as countless generic products. Zantac was one of the most popular and highest-grossing pharmaceutical products ever sold in the U.S. Almost immediately, Zantac’s revenues surpassed $1 billion as it became an over-the-counter product. In fact, by 1989, Zantac accounted for nearly half of Glaxo’s (its manufacturer at the time) revenues.
By September 2019, problems were becoming apparent with Zantac. In September 2019, the FDA alerted the public that it had found NDMA in samples of ranitidine. At the time, the FDA’s communication said that there were low levels of NDMA. The FDA had been investigating ranitidine for much of the year and decided to issue a communication when the results started to become apparent. The FDA had said that it was considering how to proceed in light of its findings. The FDA did not direct the public to stop taking these medications.
The Industry Voluntarily Recalls Ranitidine
However, after the FDA’s communication, industry began to act on its own. Makers of ranitidine products began to pull them off the market, initiating their own recall. The initial thought was that the possible levels of NDMA were very low. However, subsequent test results were more concerning. With the FDA calling for more testing, the amount of voluntary recalls increased.
In October 2019, Sanofi initiated its own voluntary recall of Zantac. The company described it as a precautionary measure while it learned more about the potential harms of the NDMA found in the product. Simultaneously, the major pharmacy chains including Walgreens and CVC pulled Zantac from their shelves. As of this writing, Zantac is not available on the market.
The issues with Zantac were discovered after other extensive contamination problems with valsartan. That class of medications became contaminated with NDMA after problems with the manufacturing process. All of these medications were pulled from the market.
Zantac experienced similar issues, albeit with a different cause. The popular medication was also found to have been contaminated with NDMA. Here, the cause was the inherent instability of ranitidine. The substance breaks down on its own over time. When it does, it can morph into NDMA.
Zantac Possible Contains a Carcinogen
The problem with NDMA is that it can potentially be a carcinogen when people are exposed to it at certain levels. NDMA is present in many things, including foods and drinking water. It is not known exactly how much NDMA is necessary to cause cancer in human beings, but exposure to it can be dangerous. Government authorities generally tend to be conservative when it comes to taking things off the market that have certain levels of NDMA.
As of now, the consequences of the issue are not yet known. While the NDMA was found in a small amount and it reportedly takes much more exposure to cause cancer, Zantac was a widely-taken drug so it is difficult to know the extent of the people who may have developed cancer. This is a developing situation that may take time to materialize and testing is still being performed. In addition, people may not develop cancer for years. Plus, there is only general information available that Zantac is contaminated as opposed to knowing the specific kind of cancer that it could cause.
The Costs of the Recall for Sanofi
For Sanofi, the consequences of the recall have been drastic. Not only was Zantac still a blockbuster drug, but there are numerous costs associated with the recall and pulling back the products that were on store shelves. These costs include refunding the customers the money that they paid for the drug as well as other costs of physically removing the products.
In the short term, Sanofi took a charge of $186 million against its earnings. This was to account for the impairment of the asset of Zantac. Its consumer sales were down in the most recent quarter as a result of the recall. However, depending on the ultimate impact of Zantac on consumers, the true costs could be in the future when there is a wave of litigation against the company.
Currently, there is a small number of Zantac lawsuits but the number is growing. As of February 2020, there have been 15 lawsuits filed by people who claim that they developed cancer after taking Zantac. These lawsuits have all been moved to South Florida where they are now a part of multi-district litigation. It is expected that the number of lawsuits against Sanofi and Boehringer Ingelheim is going to grow in the future given the sheer number of people who have taken Zantac over the years. Even if the rate of people who develop cancer from the contaminant is very low, the amount of people who have taken Zantac reaches tens of millions.
The lawsuits have alleged that Sanofi knew or should have known that Zantac contained a carcinogen. They cite previous studies that were performed that should have alerted the makers of the product to the potential of contamination. Studies explaining the possible harmful effects of ranitidine date as far back as to the 1980s, before Zantac was even sold.
If you or a loved one has taken Zantac and now has cancer, you should seek the help of a product liability attorney in order to file a lawsuit against the company that manufactured the drug. Call the attorneys at Sadaka and Associates to learn about your legal rights.