Emery CEO states that he is “ worried that if [ ranitidine ] just sits at home at room temperature , it could gradually generate NDMA .” While these levels of NDMA are much lower than those reported in the Stanford study and Valisure petition , this is another plausible way by which ranitidine is causing NDMA exposure .
CANCERS CAUSED BY NDMA INGESTION
Numerous studies connect NDMA exposure to the formation of tumors in animals . One such well-designed animal study measured the dose response relationship of NDMA ( and NDEA ) consumption to the formation of liver and esophageal tumors . Other animal studies have found correlation between NDMA exposure and subjects developing tumors in the bladder , stomach , intestines , colon , kidney , lungs , and numerous other organs . Studies have NDMA is a highly absorbable toxin , and therefore can be absorbed into almost any organ it passes through . There are very few epidemiological studies that observe NDMA ’ s effect on humans . NDMA is classified as a probable human carcinogen , therefore , it would be unethical to conduct a clinical study that knowingly administered NDMA to human test subjects . However , NDMA occurs naturally in certain foods , such as cured and salted meats , which have resulted in natural human consumption of small amounts of NDMA . As a result , various studies have been designed to measure the rates of colorectal , stomach , and liver cancer against the levels of dietary NDMA consumption . These studies reported a range of increased risks of developing various cancers when subjects consumed large amounts of NDMA . Specifically for stomach cancer , one study reported a doubling of the risk , and another reported up to a seven-fold increase in the risk . Additionally , a study that observed the effects of high dietary consumption of NDMA in nearly 10,000 Finnish men and woman found a doubling of the risk of developing colorectal cancer . A 2011 epidemiological study that observed NDMA dietary exposure in 3,268 cases reported “[ d ] ietary NDMA intake was significantly associated with increased cancer risk ” for all types of cancer .
However , only a select group of cancers are being pursued in the litigation . Based on extensive research conducted alongside well-credentialed experts , the Science and Expert Committee submitted the five most viable cancer types which will be pursued in the Multi- District Litigation ( MDL ). Based on a combination of ranitidine-specific epidemiology , NDMA dietary studies , and occupational exposure studies , the five cancers that are most uniformly supported by the literature are bladder , esophageal , stomach , liver and pancreatic .
These cases will move forward in the litigation , and we anticipate a Daubert ruling from Judge Rosenberg in August of 2022 .
CURRENT STATUS OF THE LITIGATION
In 2020 , these cases were centralized in the Southern District of Florida in front of the Honorable Robin L . Rosenberg . Pursuant to Honorable Rosenberg ’ s order , four types of cases were consolidated into the multidistrict litigation : bodily injury cases , the consumer class action , third party payers , and medical monitoring . Bodily injury cases require plaintiffs to have a qualifying cancer diagnosis that is caused by Zantac in order to recover damages . The consumer class action does not require the plaintiffs to have been diagnosed with cancer , but rather seeks to reimburse plaintiffs for the cost of any adulterated drug ( Zantac ) that they would have not have purchased had they known it was adulterated . Similarly , third party payers , or health insurance companies , are seeking to recover money paid , pursuant to individual health insurance contracts with their clients , for each prescription of Zantac that the consumer would not have purchased had he known it was adulterated . Finally , medical monitoring cases seek to reimburse undiagnosed plaintiffs for necessary costs incurred by additional treatment and continued follow up with medical professionals to ensure they have not gotten cancer from Zantac .
Currently , expert depositions for both sides are being scheduled and will conclude by May 2022 . Judge Rosenberg has outlined a preliminary Bellwether Pool , which will gradually narrow into the Initial Discovery pool after her Daubert ruling . We anticipate the first Bellwether trial to take place in July of 2023 .
CONCLUSION
For decades , the manufacturers of Zantac and ranitidine silently exposed millions of people to a known carcinogen . Despite an abundance of information and numerous opportunities to warn the public of their dangerous product , the defendants in this litigation never attempted to make the drug safe , or tell public that it was dangerous . In a blatant disregard for public safety , defendants knowingly encouraged their customers to take Zantac in a way that promotes cancer development — making millions of dollars at the expense of millions of people .
Citations available on request
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