“Defendants market and sell the Product without warning consumers that regular use of the Product causes the proliferation of certain bacteria, including but not limited to Streptococcus anginosus (S. anginosus) and Fusobacterium nucleatum (F. nucleatum), each of which can cause severe invasive infections and have been closely associated with multiple potentially deadly cancers, including oral cancer, head & neck cancer, colorectal cancer, pancreatic cancer, esophageal cancer, gastro-intestinal cancer, and breast cancer.”

💡 This establishes that defendants marketed a product as health-promoting while concealing its association with multiple deadly cancers.

“A recent study found that after three months of normal use, Listerine Cool Mint greatly affected the microbiome composition. Specifically, after the three-month period, F. nucleatum and S. anginosus were found to be significantly more abundant than at the measured baseline of patients.”

💡 This proves that recommended daily use directly causes proliferation of bacteria linked to cancer, contradicting marketing claims.

“Fusobacterium nucleatum is a bacteria that is closely associated with oral cancer, head & neck cancer, colorectal cancer, pancreatic cancer, esophageal cancer, and breast cancer. Studies have been conducted that closely link this particular bacteria with colorectal cancers, but also link oral concentration of this bacteria with prediction of colon cancer prognosis.”

💡 This demonstrates that the bacteria defendants’ product increases is not merely harmful but specifically linked to predicting cancer outcomes.

“Defendants market and label the Product as having the ability to ‘kill 99% of germs that cause bad breath, plaque & gingivitis’ and providing ‘a fresher and cleaner mouth than brushing alone.'”

💡 This shows defendants made affirmative health promises that directly contradict the concealed reality of bacterial proliferation.

“The Product that Plaintiff received was worthless because it has been shown to result in the proliferation of cancer-causing bacteria.”

💡 This establishes that a mouthwash causing cancer-bacteria proliferation has zero value, meaning consumers lost their entire purchase price.

“Defendants claim that ‘Listerine® antiseptic is the most extensively tested OTC mouthwash’ and that it had been ‘examined in more than 50 clinical trials more than 30 of which lasted 6 months or longer.’ Defendants further tout the ‘proven safety and tolerability of Listerine® in clinical studies’ and represents that ‘as powerful as LISTERINE® is, its safety is supported by fifteen 6-month studies conducted over a 20 year period in 3203 subjects.'”

💡 This proves defendants had extensive testing that should have revealed the bacterial proliferation, making their concealment intentional rather than ignorant.

“Upon information and belief, based on Defendants’ extensive testing of the safety and health consequences of the Product, Defendants are, or should reasonably have been aware of, the potential harmful effects of bacteria that proliferates with normal use of Listerine.”

💡 This establishes that defendants either knew or should have known about the cancer-bacteria risk from their own extensive testing programs.

“Defendants’ omission also violates 21 CFR § 201.80(e), which requires a manufacturer to revise its label ‘to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug’, § 314.80(b) which places the responsibility for post-marketing surveillance on the manufacturer, and 73 Fed.Reg. 49605 which mandates that ‘manufacturers continue to have a responsibility under Federal law … to maintain their labeling and update the labeling with new safety information.'”

💡 This proves defendants violated multiple federal requirements to update labels when serious health hazards are discovered.

“Consumers lack the meaningful ability to test or independently ascertain or verify whether a product has dangerous side effects, especially at the point of sale, and therefore must and do rely on Defendants to truthfully and honestly report any health hazards associated with the Product on the Product’s packaging or labels.”

💡 This explains why label omissions are so harmful – consumers have no way to discover the danger themselves and must trust manufacturers.

“Defendants’ concealment was material and intentional because people are concerned with the health effects of products that they are putting onto and into their bodies. Indeed, consumers that use the Product do so to prevent oral disease and kill harmful bacteria, not to increase such harmful bacteria’s prevalence in their mouth.”

💡 This establishes that the concealment was calculated to maintain sales by hiding a fact that would have stopped consumers from purchasing.

“As set forth below, mouthwash products, such as Defendants’ Product, that cause the proliferation of cancer-causing bacteria are in no way safe for humans and are entirely worthless.”

💡 This frames the ultimate harm – consumers paid for a health product that is actually worthless because it increases cancer risk.

“The oral rinse/mouthwash market is a fast-growing, competitive, and lucrative industry, with market size that was valued at USD 6.51 billion in 2021 and is expected to expand at a compound annual growth rate of 7.1% from 2022 to 2030. The market is expected to reach USD 15.7 billion by 2022–2032.”

💡 This establishes the massive financial incentive defendants had to conceal cancer-bacteria risks that could damage market position.

“Additionally, these bacteria have been shown to survive longer than other bacteria under acidic conditions, like those found in the gut, which suggests that they may travel from the mouth to the gut through the digestive tract.”

💡 This proves the bacteria don’t just stay in the mouth but can travel through the body, creating cancer risks throughout the digestive system.

“These articles, when taken together, implicate F. nucleatum with every stage of colon cancer and show that this bacteria both increases as prognosis worsens exacerbating cancer progression through influence of the microenvironment.”

💡 This demonstrates the bacteria defendants’ product increases is not just associated with cancer but actively worsens cancer outcomes.

“If anything, Defendants’ labeling suggests the opposite. Defendants label the Product as having the ability to ‘kill 99% of germs that cause bad breath, plaque & gingivitis.’ Germs are a broad category of microscopic living things that can cause disease, including bacteria, viruses, fungi, and protozoa. Accordingly, by stating that the Product contains ingredients which will ‘kill 99% of germs’ associated with common oral ailments, a reasonable consumer would understand that it would eliminate most harmful bacteria in one’s mouth. Unfortunately for consumers, daily use of the Product, as recommended by Defendants, does the opposite—it has been shown to cause the proliferation of more bacteria associated with multiple deadly cancers.”

💡 This proves the marketing is not just incomplete but actively misleading, promising the opposite of what the product actually does.