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UNITED STATES DISTRICT COURT 

MIDDLE DISTRICT OF FLORIDA 

IN RE: ZANTAC (RANITIDINE) 

PRODUCTS LIABILITY LITIGATION 

CARL WILLIAMS, 

Plaintiff, 

v. 

BOEHRINGER INGELHEIM 

PHARMACEUTICALS, INC.; 

SANOFI US SERVICES INC.; 

CHATTEM, INC.; 

PFIZER INC., 

GLAXOSMITHKLINE, LLC., 

 Defendants. 

MDL NO. 2924 

20-MD-2924 

JUDGE ROBIN L. ROSENBERG 

MAGISTRATE JUDGE BRUCE E. 

REINHART 

COMPLAINT [& JURY DEMAND] 

CIVIL ACTION NO: 9:20cv80737

THIS DOCUMENT RELATED TO: Carl Williams v. Boehringer Ingelheim Pharmaceuticals, Inc., et 

al.

INTRODUCTION 

1. N-Nitrosodimethylamine (“NDMA”) is a potent carcinogen. It used to be a 

chemical biproduct of making rocket fuel in the early 1900s but, today, its only use is to induce 

tumors in animals as part of laboratory experiments. Its only function is to cause cancer. It has no 

business being in a human body. 

2. Zantac (chemically known as ranitidine), the popular antacid medication used by 

millions of people every day, leads to the production of staggering amounts of NDMA when it is 

digested by the human body. The U.S. Food and Drug Administration’s (“FDA”) allowable daily 

limit of NDMA is 92 ng (nanograms) and yet, in a single dose of Zantac, researchers are 

discovering over 3 million ng. 

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3. These recent revelations by independent researchers have caused widespread 

recalls of Zantac both domestically and internationally, and the FDA is actively investigating the 

issue, with is preliminary results showing “unacceptable” levels of NDMA. 

4. To be clear, this is not a contamination case—the levels of NDMA that researchers 

are seeing in Zantac is not the product of some manufacturing error. The high levels of NDMA 

observed in Zantac are a function of the ranitidine molecule and the way it breaks down in the 

human digestive system. 

5. Plaintiff Carl Williams took Ranitidine from approximately the year 1990 until 

2019, for 29 years and, as a result, developed bladder cancer. His cancer was caused by NDMA 

exposure created by the ingestion of Zantac. This lawsuit seeks damages against the Defendants 

for causing her cancer. 

PARTIES 

6. Plaintiff Carl Williams (hereinafter “Plaintiff”), resides in Memphis, Tennessee. 

7. Defendant Boehringer Ingelheim Pharmaceuticals, Inc. (“BI”) is a Delaware 

corporation with its principal place of business located at 900 Ridgebury Road, Ridgefield, 

Connecticut 06877. BI is a subsidiary of the German company Boehringer Ingelheim Corporation. 

BI owned the U.S. rights to over-the-counter (“OTC”) Zantac between December 2006 and 

January 2017, and manufactured and distributed the drug in the United States during that period. 

8. Defendant Sanofi US Services Inc., (“Sanofi”) is a Delaware corporation with its 

principal place of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807, and is 

a wholly owned subsidiary of Sanofi S.A. Sanofi controlled the New Drug Application (“NDA”) 

for OTC Zantac starting in January 2017 through the present. 

9. Defendant Chattem, Inc. (“Chattem”) is a Tennessee corporation with its principal 

place of business located at 1715 West 38th Street Chattanooga, Tennessee 37409. Chattem is a 

wholly owned subsidiary of Sanofi S.A., a French multinational corporation. Chattem distributes 

OTC Zantac for Sanofi. 

10. Defendant Pfizer, Inc. (“Pfizer”) is a Delaware corporation with its principal place 

of business located at 235 East 42nd Street, New York, New York 10017. Pfizer was the original 

NDA holder for OTC Zantac, and controlled the NDA between August 2004 and December 2006. 

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11. Defendant GlaxoSmithKline, LLC (“GSK”) is a Delaware corporation with its 

principal place of business located at 5 Crescent Drive, Philadelphia, Pennsylvania, 19112 and 

Five Moore Drive, Research Triangle, North Carolina, 27709. GSK was the original innovator of 

the Zantac drug and controlled the NDA for prescription Zantac between 1983 and 2009. By 

controlling the Zantac NDA it also directly controlled the labeling for all Zantac products through 

2009. And, GSK’s negligence and misconduct related to Zantac as an innovator directly led to the 

failure to warn for other OTC versions of Zantac. 

JURISDICTION AND VENUE 

12. This Court has subject matter jurisdiction pursuant to 28 U.S.C. § 1332. There is 

complete diversity of citizenship between the parties. In addition, Plaintiff seeks damages in excess 

of $75,000, exclusive of interest and costs. 

13. This Court has personal jurisdiction over each Defendant insofar as each 

Defendants is authorized and licensed to conduct business in the State of Virginia maintains and 

carries on systematic and continuous contacts in this judicial district, regularly transacts business 

within this judicial district, and regularly avails itself of the benefits of this judicial district. 

14. Additionally, the Defendants caused tortious injury by acts and omissions in this 

judicial district and caused tortious injury in this district by acts and omissions outside this district 

while regularly doing and soliciting business, engaging in a persistent course of conduct, and 

deriving substantial revenue from goods used or consumed and services rendered in this judicial 

district. 

15. Venue is proper before this Court pursuant to Pretrial Order No.11 allowing direct 

filing of Plaintiff’s complaint in MDL 2924. However, the District Court in which venue would 

be proper absent the direct filing Order entered by this Court and to where remand could be 

ordered by the Court for trial would be in: Tennessee Western District Court. 

FACTUAL ALLEGATIONS 

I. Brief History of Zantac and Ranitidine 

16. Zantac was developed by GlaxoSmithKline (“GSK”) and approved for prescription 

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use by the FDA in 1983. The drug belongs to a class of medications called histamine H2-receptor 

antagonists (or H2 blockers), which decrease the amount of acid produced by the stomach and are 

used to treat gastric ulcers, heartburn, acid indigestion, sour stomach, and other gastrointestinal 

conditions. 

17. Due in large part to GSK’s marketing strategy, Zantac was a wildly successful drug, 

reaching $1 billion in total sales in December 1986. As one 1996 article put it, Zantac became “the 

best-selling drug in history as a result of a shrewd, multifaceted marketing strategy that . . .enabled 

the product to dominate the acid/peptic marketplace.”1 Significantly, the marketing strategy that 

led to Zantac’s success emphasized the purported safety of the drug. 

18. Zantac became available without a prescription in 1996, and generic versions of the 

drug (ranitidine) became available the following year. Although sales of brand-name Zantac 

declined as a result of generic and alternative products, Zantac sales have remained strong over 

time. As recently as 2018, Zantac was one of the top 10 antacid tablet brands in the United States, 

with sales of Zantac 150 totaling $128.9 million—a 3.1% increase from the previous year. 

19. On September 13, 2019, in response to a citizen’s petition filed by Valisure, Inc. 

(discussed in detail below), U.S. and European regulators stated that they are reviewing the safety 

of ranitidine. 

20. On September 18, 2019, Novartis AG’s Sandoz Unit, which makes generic drugs, 

stated that it was halting the distribution of its versions of Zantac in all markets, while Canada 

requested drug makers selling ranitidine to stop distribution. 

21. On September 28, 2019, CVS Health Corp. stated that it would stop selling Zantac 

and its own generic ranitidine products out of concern that it might contain a carcinogen. CVS has 

been followed by Walmart, Inc., Walgreens Boot Alliance, and Rite Aid Corp. to also remove 

Zantac and ranitidine products. 

22. On October 2, 2019, the FDA stated that it was ordering all manufacturers of Zantac 

and ranitidine products to conduct testing for NDMA and that preliminary results indicated 

unacceptable levels of NDMA so far. 

23. At no time did any Defendant attempt to include a warning about NDMA or any 

1 Wright, R., How Zantac Became the Best-Selling Drug in History, 1 J. HEALTHCARE MARKETING 

4, 24 (Winter 1996). 

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cancer, nor did the FDA ever reject such a warning. Defendants had the ability to unilaterally add 

an NDMA and/or cancer warning to the Zantac label (for both prescription and OTC) without prior 

FDA approval pursuant to the Changes Being Effected regulation. Had any Defendant attempted 

to add an NDMA warning to the Zantac label (either for prescription or OTC), the FDA would not 

have rejected it. 

II. Dangers of NDMA 

24. NDMA is a semi-volatile organic chemical that forms in both industrial and natural 

processes. It is a member of N-nitrosamines, a family of potent carcinogens. The dangers that 

NDMA poses to human health have long been recognized. A news article published in 1979 noted 

that “NDMA has caused cancer in nearly every laboratory animal tested so far.”2 NDMA is no 

longer produced or commercially used in the United States, except for research, such as a tumor 

initiator in certain animal bioassays. In other words, it is only a poison. 

25. Both the Environmental Protection Agency (“EPA”) and the International Agency 

for Research on Cancer (“IARC”) have classified NDMA as a probable human carcinogen. And 

the World Health Organization (“WHO”) has stated that scientific testing indicates that NDMA 

consumption is positively associated with either gastric or colorectal cancer and suggests that 

humans may be especially sensitive to the carcinogenicity of NDMA. 

26. As early as 1980, consumer products containing unsafe levels of NDMA and other 

nitrosamines have been recalled by manufacturers, either voluntarily or at the direction of the FDA. 

27. Most recently, beginning in the summer of 2018, there have been recalls of several 

generic drugs used to treat high blood pressure and heart failure—valsartan, losartan, and 

2 Jane Brody, Bottoms Up: Alcohol in moderation can extend life, THE GLOBE AND MAIL 

(CANADA) (Oct. 11, 1979); see Rudy Platiel, Anger grows as officials unable to trace poison in 

reserve’s water, THE GLOBE AND MAIL CANADA) (Jan. 6, 1990) (reporting that residents of Six 

Nations IndianReserve  “have  been  advised  not  to  drink,  cook  or  wash  in  the  water  because 

testing  has  found  high levels of N-nitrosodimethylamine (NDMA), an industrial byproduct 

chemical that has been linked to cancer”);  Kyrtopoulos  et  al,  DNA adducts in humans after 

exposure to methylating agents, 405 MUTAT. RESEAR. 135 (1998) (noting that “chronic exposure 

of rats to very low doses of NDMA gives rise predominantly to liver tumours, including tumors of 

the liver cells (hepatocellular carcinomas), bile ducts, blood vessels and Kupffer cells”).

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irbesartan—because the medications contained nitrosamine impurities that do not meet the FDA’s 

safety standards. The FDA has established a permissible daily intake limit for the probable human 

carcinogen, NDMA, of 96 ng (nanogram). However, the highest level of NDMA detected by the 

FDA in any of the Valsartan tablets was 20.19 μg (or 20,190 ng) per tablet. In the case of Valsartan, 

the NDMA was an impurity caused by a manufacturing defect, and thus NDMA was present in 

only some products containing valsartan. Zantac poses a greater safety risk than any of the recently 

recalled valsartan tablets. Not only is NDMA a byproduct of the ranitidine molecule, itself, but the 

levels observed in recent testing show NDMA levels in excess of 3,000,000 ng. 

28. Tobacco smoke also contains NDMA. One filtered cigarette contains between 5 – 

43ng of NDMA. 

29. In mouse studies examining the carcinogenicity of NDMA through oral 

administration, animals exposed to NDMA developed cancer in the kidney, bladder, liver, and 

lung. In comparable rat studies, similar cancers were observed in the liver, kidney, pancreas, and 

lung. In comparable hamster studies, similar cancers were observed in the liver, pancreas, and 

stomach. In comparable Guinea-pig studies, similar cancers were observed in the liver and lung. 

In comparable rabbit studies, similar cancers were observed in the liver and lung. 

30. In other long-term animal studies in mice and rats utilizing different routes of 

exposures—inhalation, subcutaneous injection, and intraperitoneal (abdomen injection)—cancer 

was observed in the lung, liver, kidney, nasal cavity, and stomach. 

31. Alarmingly, Zantac is in the FDA’s category B for birth defects, meaning it is 

considered safe to take during pregnancy. However, in animal experiments, for those animals 

exposed to NDMA during pregnancy, the offspring had elevated rates of cancer in the liver and 

kidneys. 

32. In addition, NDMA breaks down into various derivative molecules that, 

themselves, are associated with causing cancer. In animal studies, derivatives of NDMA induced 

cancer in the stomach and intestine (including colon). 

33. Research shows that lower levels of NDMA, i.e., 40 ng, are fully metabolized in 

the liver, but high does enter the body’s general circulation. 

34. Numerous in vitro studies confirm that NDMA is a mutagen—causing mutations 

in human and animal cells. 

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35. Overall the animal data demonstrates that NDMA is carcinogenic in all animal 

species tested: mice, rats, Syrian golden, Chinese and European hamsters, guinea-pigs, rabbits, 

ducks, mastomys, fish, newts, and frogs. 

36. Pursuant to the EPA” cancer guidelines, “tumors observed in animals are generally 

assumed to indicate that an agent may produce tumors in humans.” 

37. In addition to the overwhelming animal data linking NDMA to cancer, there are 

numerous human epidemiological studies exploring the effects of dietary exposure to various 

cancers. And, while these studies (several discussed below) consistently show increased risks of 

various cancers, the exposure levels considered in these studies are a very small fraction—as little 

as 1 millionth—the exposures noted in a single Zantac capsule, i.e., 0.191 ng/day (dietary) v. 

304,500ng/day (Zantac). 

38. In a 1995 epidemiological case-control study looking at NDMA dietary exposure 

with 220 cases, researchers observed a statistically significant 700% increased risk of gastric 

cancer in persons exposed to more than 0.51 ng/day.3

39. In a 1995 epidemiological case-control study looking at NDMA dietary exposure 

with 746 cases, researchers observed statistically significant elevated rates of gastric cancer in 

Persons exposed to more than 0.191 ng/day.4

40. In another 1995 epidemiological case-control study looking at, in part, the effects 

of dietary consumption on cancer, researchers observed a statistically significant elevated risk 

ofdeveloping aerodigestive cancer after being exposed to NDMA at .179 ng/day.5

41. In a 1999 epidemiological cohort study looking at NDMA dietary exposure with 

 189 cases and a follow up of 24 years, researchers noted that “N-nitroso compounds are potent 

carcinogens” and that dietary exposure to NDMA more than doubled the risk of developing 

3 Pobel et al, Nitrosamine, nitrate and nitrite in relation to gastric cancer: a case-control study in 

Marseille, France, 11 EUROP. J. EPIDEMIOL. 67–73 (1995).

4 La Vecchia et al, Nitrosamine intake and gastric cancer risk, 4 EUROP. J. CANCER. PREV. 469-

474 (1995). 

5 Rogers et al, Consumption of nitrate, nitrite, and nitrosodimethylamine and the risk of upper 

aerodigestive tract cancer, 5 CANCER EPIDEMIOL. BIOMARKERS PREV. 29–36 (1995).

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colorectal cancer.6

42. In a 2000 epidemiological cohort study looking at occupational exposure of 

workers in the rubber industry, researchers observed significant increased risks for NDMA 

exposure for esophagus, oral cavity, pharynx, prostate, and brain cancer.7

43. In a 2011 epidemiological cohort study looking at NDMA dietary exposure with 

3,268 cases and a follow up of 11.4 years, researchers concluded that “[d]ietary NDMA 

intake was significantly associated with increased cancer risk in men and women” for all 

cancers, and that “NDMA was associated with increased risk of gastrointestinal cancers” 

including rectal cancers.8

Figure 1 –Ranitidine Structure & Formation of NDMA 

6 Knekt et al, Risk of Colorectal and Other Gastro-Intestinal Cancers after Exposure to Nitrate, 

Nitrite and N-nitroso Compounds: A Follow-Up Study, 80 INT. J. CANCER 852–856 (1999)

7 Straif et al, Exposure to high concentrations of nitrosamines and cancer mortality among a 

cohort of rubber workers, 57 OCCUP ENVIRON MED 180–187 (2000).

8 Loh et al, N-nitroso compounds and cancer incidence: the European Prospective Investigation 

into Cancer and Nutrition (EPIC)–Norfolk Study, 93 AM J CLIN NUTR. 1053–61 (2011).

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44. In a 2014 epidemiological case-control study looking at NDMA dietary exposure 

with 2,481 cases, researchers found a statistically significant elevated association between NDMA 

exposure and colorectal cancer.9

III. How Ranitidine Transforms into NDMA Within the Body 

45. The high levels of NDMA produced by Zantac are not caused by a manufacturing 

defect but are inherent to the molecular structure of ranitidine, the active ingredient in Zantac. The 

ranitidine molecule contains both a nitrite and a dimethylamine (‘DMA’) group which are well 

known to combine to form NDMA. See Fig. 1. Thus, ranitidine produces NDMA by “react[ing] 

with itself”, which means that every dosage and form of ranitidine, including Zantac, exposes users 

to NDMA. 

46. The formation of NDMA by the reaction of DMA and a nitroso source (such as a 

nitrite) is well characterized in the scientific literature and has been identified as a concern for 

contamination of the American water supply.10 Indeed, in 2003, alarming levels of NDMA in 

drinking water processed by wastewater treatment plants was specifically linked to the presence 

of ranitidine.11

9 Zhu et al, Dietary N-nitroso compounds and risk of colorectal cancer: a case-control study in 

Newfoundland and Labrador and Ontario, Canada, 111 BR J NUTR. 6, 1109–1117 (2014).

10 Ogawa et al, Purification and properties of a new enzyme, NG, NG-dimethylarginine 

dimethylaminohydrolase, from rat kidney, 264 J. BIO. CHEM. 17, 10205-10209 (1989).

11 Mitch et al, N-Nitrosodimethylamine (NDMA) as a Drinking Water Contaminant: A Review, 

20 ENV. ENG. SCI. 5, 389-404 (2003). 

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Figure 2 –Mechanism for Decomposition of Ranitidine in NDMA

47. The high instability of the ranitidine molecule was further elucidated in scientific 

studies investigating ranitidine as a source of NDMA in drinking water and specific mechanisms 

for the breakdown of ranitidine were proposed, as shown in Figure 2 above.12 These studies 

underscore the instability of the NDMA group on the ranitidine molecule and its ability to form 

NDMA in the environment of water treatment plants which supply many American cities with 

water. 

48. These studies did not appreciate the full extent of NDMA formation risk from 

ranitidine; specifically, the added danger of this drug having not only a labile DMA group but also 

a readily available nitroso source in its nitrite group on the opposite terminus of the molecule. 

Recent testing of NDMA levels in ranitidine batches are so high that the nitroso for NDMA likely 

comes from no other source than the ranitidine molecule itself.

49. Valisure, LLC is an online pharmacy that also runs an analytical laboratory that is 

ISO 17025 accredited by the International Organization for Standardization (“ISO”) – an 

accreditation recognizing the laboratories technical competence for regulatory. Valisure’s mission 

is to help ensure the safety, quality, and consistency of medications and supplements in the market. 

In response to rising concerns about counterfeit medications, generics, and overseas 

manufacturing, Valisure developed proprietary analytical technologies that it uses in addition to 

FDA standard assays to test every batch of every medication it dispenses. 

12 Le Roux et al, NDMA Formation by Chloramination of Ranitidine: Kinetics and Mechanism, 

46 Environ. Sci. Technol. 20, 11095-11103 (2012). 

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50. As part of its testing of Zantac, and other ranitidine products, in every lot tested, 

Valisure discovered exceedingly high levels of NDMA. Valisure’s ISO 17025 accredited 

laboratory used FDA recommended GC/MS headspace analysis method FY19-005-DPA8 for the 

determination of NDMA levels. As per the FDA protocol, this method was validated to a lower 

limit of detection of 25 ng.13 The results of Valisure’s testing show levels of NDMA well above 2 

million ng per 150 mg Zantac tablet, shown below in Table 1. 

 

51. Valisure’s testing shows, on average, 2,692,291 ng of NDMA in a 150 mg Zantac 

tablet. Considering the FDA’s permissible limit is 96 ng, this would put the level of NDMA at 

28,000 times the legal limit. In terms of smoking, a person would need to smoke at least 6,200 

cigarettes to achieve the same levels of NDMA found in one 150 mg dose of Zantac. 

52. Valisure, however, was concerned that the extremely high levels of NDMA 

observed in its testing were a product of the modest oven heating parameter of 130 °C in the FDA 

recommended GC/MS protocol. So, Valisure developed a low temperature GC/MS method that 

13 US Food and Drug Administration. (updated 01/25/2019). Combined N-Nitrosodimethlyamine 

(NDMA) and N-Nitrosodiethylamine (NDEA) Impurity Assay, FY19-005-DPA-S.

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could still detect NDMA but would only subject samples to 37 °C, the average temperature of the 

human body. This method was validated to a lower limit of detection of 100 ng. 

53. Valisure tested ranitidine tablets by themselves and in conditions simulating the 

human stomach. Industry standard “Simulated Gastric Fluid” (“SGF” 50 mM potassium chloride, 

85 mM hydrochloric acid adjusted to pH 1.2 with 1.25 g pepsin per liter) and “Simulated Intestinal 

Fluid” (“SIF” 50 mM potassium chloride, 50 mM potassium phosphate monobasic adjusted to pH 

6.8 with hydrochloric acid and sodium hydroxide) were used alone and in combination with 

various concentrations of nitrite, which is commonly ingested in foods like processed meats and 

is elevated in the stomach by antacid drugs. 

54. Indeed, Zantac was specifically advertised to be used when consuming foods 

containing high levels of nitrates, like tacos, pizza, etc.14

55. The results of Valisure’s tests on ranitidine tablets in biologically relevant 

conditions demonstrate significant NDMA formation under simulated gastric conditions with 

nitrite present (see Table 2). 

56. Under biologically relevant conditions, when nitrites are present, staggeringly high 

levels of NDMA are found in one dose of 150 mg Zantac, ranging between 245 and 3,100 times 

above the FDA-allowable limit. In terms of smoking, one would need to smoke over 500 cigarettes 

14 See, e.g., https://www.ispot.tv/ad/dY7n/zantac-family-taco-night; 

https://youtu.be/jzS2kuB5_wg;https://youtu.be/Z3QMwkSUlEg; https://youtu.be/qvh9gyWqQns. 

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to achieve the same levels of NDMA found in one dose of 150 mg Zantac at the 25 ng level (over 

7,000 for the 50 μg level). 

57. Antacid drugs are known to increase stomach pH and thereby increase the growth 

of nitrite-reducing bacteria which further elevate levels of nitrite. This fact is well known and even 

present in the warning labels of antacids like Prevacid (lansoprazole) and was specifically studied 

with ranitidine in the original approval of the drug. Thus, higher levels of nitrites in patients 

regularly taking Zantac would be expected. 

58. In fact, NDMA formation in the stomach has been a concern for many years and 

specifically ranitidine has been implicated as a cause of NDMA formation by multiple research 

groups, including those at Stanford University. 

59. Existing research shows that ranitidine interacts with nitrites and acids in the 

chemical environment of the human stomach to form NDMA. In vitro tests demonstrate that when 

ranitidine undergoes “nitrosation” (the process of a compound being converted into nitroso 

derivatives) by interacting with gastric fluids in the human stomach, the by-product created is 

dimethylamine (“DMA”) – which is an amine present in ranitidine itself. When DMA is released, 

it can be nitrosated even further to form NDMA, a secondary N-nitrosamine. 

60. Moreover, in addition to the gastric fluid mechanisms investigated in the scientific 

literature, Valisure identified a possible enzymatic mechanism for the liberation of ranitidine’s 

DMA group via the human enzyme dimethylarginine dimethylaminohydrolase (“DDAH”) which 

can occur in other tissues and organs separate from the stomach. 

61. Liberated DMA can lead to the formation of NDMA when exposed to nitrite present 

on the ranitidine molecule, nitrite freely circulating in the body, or other potential pathways, 

particularly in weak acidic conditions such as that in the kidney or bladder. The original scientific 

paper detailing the discovery of the DDAH enzyme in 1989 specifically comments on the 

propensity of DMA to form NDMA: “This report also provides a useful knowledge for an 

understanding of the endogenous source of dimethylamine as a precursor of a potent carcinogen, 

dimethylnitrosamine [NDMA].”15

15 Ogawa et al, Purification and properties of a new enzyme, NG, NG-dimethylarginine 

dimethylaminohydrolase, from rat kidney, 264 J. BIO. CHEM. 17, 10205-10209 (1989).

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62. In Figure 3, below, computational modelling demonstrates that ranitidine (shown 

in green) can readily bind to the DDAH-1 enzyme (shown as a cross-section in grey) in a manner 

similar to the natural substrate of DDAH-1 known as asymmetric dimethylarginine (“ADMA,” 

shown in blue). 

Figure 3 – Computational Modelling of Ranitidine Binding to DDAH-1 Enzyme

63. These results indicate that the enzyme DDAH-1 increases formation of NDMA in 

the human body when ranitidine is present; therefore, the expression of the DDAH-1 gene is useful 

for identifying organs most susceptible to this action. 

64. Figure 4 below, derived from the National Center for Biotechnology Information, 

illustrates the expression of the DDAH-1 gene in various tissues in the human body. 

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Figure 4 – Expression levels of DDAH-1 enzyme by Organ 

65. DDAH-1 is most strongly expressed in the kidneys but also broadly distributed 

throughout the body, such as in the liver, prostate, stomach, bladder, brain, colon, and prostate. 

This offers both a general mechanism for NDMA formation in the human body from ranitidine 

and specifically raises concern for the effects of NDMA on the kidneys, specifically kidney cancer. 

66. In addition to the aforementioned in vitro studies that suggest a strong connection 

between ranitidine and NDMA formation, in vivo clinical studies in living animals add further 

weight to concern over this action and overall potential carcinogenicity. A study published in the 

journal Carcinogenesis in 1983 titled “Genotoxic effects in rodents given high oral doses of 

ranitidine and sodium nitrite” specifically suspected the carcinogenic nature of ranitidine in 

combination with nitrite. The authors of this study concluded: “Our experimental findings have 

shown that simultaneous oral administration in rats of high doses of ranitidine and NaNO2 [nitrite] 

can produce DNA fragmentation either in liver or in gastric mucosa.”16

16 Brambilla et al., Genotoxic effects in rodents given high oral doses of ranitidine and sodium 

nitrite, 4 CARCINOGENESIS 10, 1281-1285 (1983). 

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67. The human data, although limited at this point, is even more concerning. A 

studycompleted and published in 2016 by Stanford University observed that healthy individuals, 

both male and female, who ingested Zantac 150 mg tablets produced roughly 400 times elevated 

amounts of NDMA in their urine (over 47,000 ng) in the proceeding 24 hours after ingestion.17

68. Likely due to the perceived high safety profile of ranitidine, very few 

epidemiological studies have been conducted on this drug. 

69. A 2004 study published by the National Cancer Institute investigated 414 cases of 

peptic ulcer disease reported in 1986 and followed the individual cases for 14 years.18 One of the 

variables investigated by the authors was the patients’ consumption of a prescription antacid, either 

Tagamet (cimetidine) or Zantac (ranitidine). The authors concluded that “[r]ecent use of ulcer 

treatment medication (Tagamet and Zantac) was also related to the risk of bladder cancer, and this 

association was independent of the elevated risk observed with gastric ulcers.” Specifically, the 

authors note that “N-Nitrosamines are known carcinogens, and nitrate ingestion has been related 

to bladder cancer risk.” NDMA is among the most common of the N-Nitrosamines. 

70. A 1982 clinical study in rats compared ranitidine and cimetidine exposure in 

combination with nitrite. When investigating DNA fragmentation in the rats’ livers, no effect was 

observed for cimetidine administered with nitrite, but ranitidine administered with nitrite resulted 

in a significant DNA fragmentation.19

71. Investigators at Memorial Sloan Kettering Cancer Center are actively studying 

ranitidine to evaluate the extent of the public health implications of these findings. Regarding 

ranitidine, one of the investigators commented: “A potential link between NDMA and ranitidine 

is concerning, particularly considering the widespread use of this medication. Given the known 

carcinogenic potential of NDMA, this finding may have significant public health implications[.]” 

17 Zeng et al, Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine, 37 

CARCINOGENESIS 625-634 (2016).

18 Michaud et al, Peptic ulcer disease and the risk of bladder cancer in a prospective study of 

male health professionals, 13 CANCER EPIDEMIOL BIOMARKERS PREV. 2, 250-254 (2004).

19 Brambilla et al, Genotoxic Effects of Drugs: Experimental Findings Concerning Some 

Chemical Families of Therapeutic Relevance, Nicolini C. (eds) Chemical Carcinogenesis. NATO 

Advanced Study Institutes Series (Series A: Life Sciences), Vol 52. Springer, Boston, MA 

(1982).

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IV. Defendants Knew of the NDMA Defect but Failed to Warn or Test 

72. During the time that Defendants manufactured and sold Zantac in the United States, 

the weight of scientific evidence showed that Zantac exposed users to unsafe levels of NDMA. 

Defendants failed to disclose this risk to consumers on the drug’s label—or through any other 

means—and Defendants failed to report these risks to the FDA. 

73. Going back as far as 1981, two years before Zantac entered the market, research 

showed elevated rates of NDMA, when properly tested. This was known or should have been 

known by Defendants. 

74. Defendants concealed the Zantac–NDMA link from consumers in part by not 

reporting it to the FDA, which relies on drug manufacturers (or others, such as those who submit 

citizen petitions) to bring new information about an approved drug like Zantac to the agency’s 

attention. 

75. Manufacturers of an approved drug are required by regulation to submit an annual 

report to the FDA containing, among other things, new information regarding the drug’s safety 

pursuant to 21 C.F.R. § 314.81(b)(2): 

The report is required to contain . . . [a] brief summary of significant new 

information from the previous year that might affect the safety, effectiveness, or 

labeling of the drug product. The report is also required to contain a brief 

description of actions the applicant has taken or intends to take as a result of this 

new information, for example, submit a labeling supplement, add a warning to the 

labeling, or initiate a new study. 

76. “The manufacturer’s annual report also must contain copies of unpublished reports 

and summaries of published reports of new toxicological findings in animal studies and in vitro 

studies (e.g., mutagenicity) conducted by, or otherwise obtained by, the [manufacturer] concerning 

the ingredients in the drug product.” 21 C.F.R. § 314.81(b)(2)(v). 

77. Defendants ignored these regulations and, disregarding the scientific evidence 

available to them, did not report to the FDA significant new information affecting the safety or 

labeling of Zantac. 

78. Defendants never provided the relevant studies to the FDA, nor did they present to 

the FDA with a proposed disclosure noting the link between ranitidine and NDMA. 

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79. In a 1981 study published by GSK, the originator of the ranitidine molecule, the 

metabolites of ranitidine in urine were studied using liquid chromatography.20 Many metabolites 

were listed, though there is no indication that NDMA was looked for. Plaintiffs believe this was 

intentional—a gambit by the manufacturer to avoid detecting a carcinogen in their product. 

80. By 1987, after numerous studies raised concerns over ranitidine and cancerous 

nitroso compounds (discussed previously), GSK published a clinical study specifically 

investigating gastric contents in human patients and N-nitroso compounds.21 This study 

specifically indicated that there were no elevated levels of N-nitroso compounds (of which NDMA 

is one). However, the study was rigged to fail. It used an analytical system called a “nitrogen oxide 

assay” for the determination of Nnitrosamines, which was developed for analyzing food and is a 

detection method that indirectly and non-specifically measures N-nitrosamines. Furthermore, in 

addition to this approach being less accurate, GSK also removed all gastric samples that contained 

ranitidine out of concern that samples with ranitidine would contain “high concentrations of Nnitroso compounds being recorded.” So, without the chemical being present in any sample, any 

degradation into NDMA could not, by design, be observed. Again, this spurious test was 

intentional and designed to mask any potential cancer risk. 

81. There are multiple alternatives to Zantac that do not pose the same risk, such as 

Cimetidine (Tagamet), Famotidine (Pepcid), Omeprazole (Prilosec), Esomeprazole (Nexium), and 

Lansoprazole (Prevacid). 

V. Plaintiff-Specific Allegations 

82. Plaintiff began using over the counter Ranitidine in approximately 1990 and 

continued to use it through 2019. Plaintiff took 150 mg per day. 

83. On or about August 24, 2019, Plaintiff was diagnosed with bladder cancer. 

20 Carey et al, Determination of ranitidine and its metabolites in human urine by reversed-phase 

ionpair high-performance liquid chromatography, 255 J. CHROMATOGRAPHY B: BIOMEDICAL 

SCI. & APPL. 1, 161-168 (1981).

21 Thomas et al, Effects of one year’s treatment with ranitidine and of truncal vagotomy on 

gastric contents, 6 GUT. Vol. 28, 726-738 (1987).

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84. Based on prevailing scientific evidence, exposure to Ranitidine (and the attendant 

NDMA) can cause bladder cancer. 

85. Plaintiff’s bladder cancer was caused by ingestion of Ranitidine. 

86. Had any Defendant warned Plaintiff that Ranitidine under brand name Zantac 

could lead to exposure to NDMA or, in turn, cancer, Plaintiff would not have taken Zantac. 

87. Plaintiff did not learn of the link between his cancer and Zantac exposure until 

September 2019, when she learned that Zantac contained high levels of NDMA. 

88. After being diagnosed with cancer, Plaintiff investigated what could have caused 

his cancer, but to no avail until recently when he heard about the connection of Zantac to NDMA 

and cancer. 

VI. Exemplary / Punitive Damages Allegations 

89. Defendants’ conduct as alleged herein was done with reckless disregard for human 

life, oppression, and malice. Defendants were fully aware of the safety risks of Zantac, particularly 

the carcinogenic potential of Zantac as it transforms into NDMA within the chemical environment 

of the human body. Nonetheless, Defendants deliberately crafted their label, marketing, and 

promotion to mislead consumers. 

90. This was not done by accident or through some justifiable negligence. Rather, 

Defendants knew that it could turn a profit by convincing consumers that Zantac was harmless to 

humans, and that full disclosure of the true risks of Zantac would limit the amount of money 

Defendants would make selling Zantac. Defendants’ object was accomplished not only through its 

misleading label, but through a comprehensive scheme of selective misleading research and 

testing, false advertising, and deceptive omissions as more fully alleged throughout this pleading. 

Plaintiff was denied the right to make an informed decision about whether to purchase and use 

Zantac, knowing the full risks attendant to that use. Such conduct was done with conscious 

disregard of Plaintiff’s rights. 

91. Accordingly, Plaintiff requests punitive damages against Defendants for the harms 

caused to Plaintiff. 

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TOLLING OF STATUTE OF LIMITATIONS AND ESTOPPEL 

92. Within the time period of any applicable statute of limitations, Plaintiff could not 

have discovered through the exercise of reasonable diligence that exposure to Zantac is injurious 

to human health. 

93. Plaintiff did not discover and did not know of facts that would cause a reasonable 

person to suspect the risk associated with the use of Zantac, nor would a reasonable and diligent 

investigation by Plaintiff have disclosed that Zantac would cause Plaintiff’s illnesses. 

94. The expiration of any applicable statute of limitations has been equitably tolled by 

reason of Defendants’ misrepresentations and concealment. Through affirmative 

misrepresentations and omissions, Defendants actively concealed from Plaintiff the true risks 

associated with use of Zantac. 

95. As a result of Defendants’ actions, Plaintiff could not reasonably have known or 

learned through reasonable diligence that Plaintiff had been exposed to the risks alleged herein 

and that those risks were the direct and proximate result of Defendants’ acts and omissions. 

96. Defendants are estopped from relying on any statute of limitations because of their 

concealment of the truth regarding the safety of Zantac. Defendants had a duty to disclose the true 

character, quality and nature of Zantac because this was non-public information over which 

Defendants continue to have control. Defendants knew that this information was not available to 

Plaintiff, Plaintiff’s medical providers and/or health facilities, yet Defendants failed to disclose the 

information to the public, including Plaintiff. 

97. Defendants had the ability to and did spend enormous amounts of money in 

furtherance of marketing and promoting a profitable product, notwithstanding the known or 

reasonably knowable risks. Plaintiff and medical professionals could not have afforded to and 

could not have possibly conducted studies to determine the nature, extent, and identity of related 

health risks and were forced to rely on Defendants’ representations. 

CAUSES OF ACTION 

COUNT I: STRICT LIABILITY – DESIGN DEFECT 

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98. Plaintiff incorporates by reference each allegation set forth in preceding paragraphs 

as if fully stated herein. 

99. Plaintiff brings this strict liability claim against Defendants for defective design. 

100. At all relevant times, Defendants engaged in the business of testing, developing, 

designing, manufacturing, marketing, selling, distributing, and promoting Zantac products, which 

are defective and unreasonably dangerous to consumers, including Plaintiff, thereby placing 

Zantac products into the stream of commerce. These actions were under the ultimate control and 

supervision of Defendants. At all relevant times, Defendants designed, researched, developed, 

manufactured, produced, tested, assembled, labeled, advertised, promoted, marketed, sold, and 

distributed the Zantac products used by Plaintiff, as described herein. 

101. At all relevant times, Defendants’ Zantac products were manufactured, designed, 

and labeled in an unsafe, defective, and inherently dangerous manner that was dangerous for use 

by or exposure to the public, including Plaintiff. 

102. At all relevant times, Defendants’ Zantac products reached the intended 

consumers, handlers, and users or other persons coming into contact with these products within 

this judicial district and throughout the United States, including Plaintiff, without substantial 

change in their condition as designed, manufactured, sold, distributed, labeled, and marketed by 

Defendants. At all relevant times, Defendants registered, researched, manufactured, distributed, 

marketed and sold Zantac products within this judicial district and aimed at a consumer market 

within this judicial district. Defendants were at all relevant times involved in the retail and 

promotion of Zantac products marketed and sold in this judicial district. 

103. Defendants’ Zantac products, as researched, tested, developed, designed, licensed, 

manufactured, packaged, labeled, distributed, sold, and marketed by Defendants were defective in 

design and formulation in that, when they left the control of Defendants’ manufacturers and/or 

suppliers, they were unreasonably dangerous and dangerous to an extent beyond that which an 

ordinary consumer would contemplate. 

104. Defendants’ Zantac products, as researched, tested, developed, designed, licensed, 

manufactured, packaged, labeled, distributed, sold, and marketed by Defendants were defective in 

design and formulation in that, when they left the hands of Defendants’ manufacturers 

and/or suppliers, the foreseeable risks exceeded the alleged benefits associated with their design 

and formulation. 

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105. At all relevant times, Defendants knew or had reason to know that Zantac products 

were defective and were inherently dangerous and unsafe when used in the manner instructed and 

provided by Defendants. 

106. Therefore, at all relevant times, Defendants’ Zantac products, as researched, tested, 

developed, designed, registered, licensed, manufactured, packaged, labeled, distributed, sold and 

marketed by Defendants were defective in design and formulation, in one or more of the following 

ways: 

a. When placed in the stream of commerce, Defendants’ Zantac products were 

defective in design and formulation, and, consequently, dangerous to an extent 

beyond that which an ordinary consumer would contemplate; 

b. When placed in the stream of commerce, Defendants’ Zantac products were 

unreasonably dangerous in that they were hazardous and posed a grave risk of 

cancer and other serious illnesses when used in a reasonably anticipated manner; 

c. When placed in the stream of commerce, Defendants’ Zantac products contained 

unreasonably dangerous design defects and were not reasonably safe when used in 

a reasonably anticipated or intended manner; 

d. Defendants did not sufficiently test, investigate, or study its Zantac products and, 

specifically, the ability for Zantac to transform into the carcinogenic compound 

NDMA within the human body; 

e. Exposure to Zantac products presents a risk of harmful side effects that outweigh 

any potential utility stemming from the use of the drug; 

f. Defendants knew or should have known at the time of marketing Zantac products 

that exposure to Zantac could result in cancer and other severe illnesses and 

injuries; 

g. Defendants did not conduct adequate post-marketing surveillance of its Zantac 

products; and 

 h. Defendants could have employed safer alternative designs and formulations. 

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107. Plaintiff used and was exposed to Defendants’ Zantac products without knowledge 

of Zantac’s dangerous characteristics. 

108. At all times relevant to this litigation, Plaintiff used and/or was exposed to the use 

of Defendants’ Zantac products in an intended or reasonably foreseeable manner without 

knowledge of Zantac’s dangerous characteristics. 

109. Plaintiff could not reasonably have discovered the defects and risks associated with 

Zantac products before or at the time of exposure due to the Defendants’ suppression or 

obfuscation of scientific information linking Zantac to cancer.

110. The harm caused by Defendants’ Zantac products far outweighed their benefit, 

rendering Defendants’ product dangerous to an extent beyond that which an ordinary consumer 

would contemplate. Defendants’ Zantac products were and are more dangerous than alternative 

products, and Defendants could have designed Zantac products to make them less dangerous. 

Indeed, at the time Defendants designed Zantac products, the state of the industry’s scientific 

knowledge was such that a less risky design or formulation was attainable. 

111. At the time Zantac products left Defendants’ control, there was a practical, 

technically feasible and safer alternative design that would have prevented the harm without 

substantially impairing the reasonably anticipated or intended function of Defendants’ Zantac 

products. For example, the Defendants could have added ascorbic acid (Vitamin C) to each dose 

of Zantac, which is known to scavenge nitrites and reduce the ability of the body to recombine 

ranitidine into NDMA.22

112. Defendants’ defective design of Zantac products was willful, wanton, malicious, 

and conducted with reckless disregard for the health and safety of users of the Zantac products, 

including Plaintiff. 

22 See, e.g., Vermeer, et al., Effect of ascorbic acid and green tea on endogenous formation of N 

nitrosodimethylamine and N-nitrosopiperidine in humans. 428 MUTAT. RES., FUNDAM. MOL. 

MECH.MUTAGEN. 353–361 (1999); Garland et al., Urinary excretion of nitrosodimethylamine 

andnitrosoproline in humans: Interindividual and intraindividual differences and the effect of

administered ascorbic acid and α-tocopherol, 46 CANCER RESEARCH 5392–5400 (1986).

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113. Therefore, as a result of the unreasonably dangerous condition of their Zantac 

products, Defendants are strictly liable to Plaintiff. 

114. The defects in Defendants’ Zantac products were substantial and contributing 

factors in causing Plaintiff’s injuries, and, but for Defendants’ misconduct and omissions, Plaintiff 

would not have sustained injuries. 

115. Defendants’ conduct, as described above, was reckless. Defendants risked the lives 

of consumers and users of its products, including Plaintiff, with knowledge of the safety problems 

associated with Zantac products, and suppressed this knowledge from the general public. 

Defendants made conscious decisions not to redesign, warn or inform the unsuspecting public. 

Defendants reckless conduct warrants an award of punitive damages. 

116. As a direct and proximate result of Defendants placing its defective Zantac products 

into the stream of commerce, and the resulting injuries, Plaintiff sustained pecuniary loss including 

general damages in a sum which exceeds the jurisdictional minimum of this Court. 

117. As a proximate result of Defendants placing its defective Zantac products into the 

stream of commerce, as alleged herein, there was a measurable and significant interval of time 

during which Plaintiff has suffered great mental anguish and other personal injury and damages. 

118. As a proximate result of the Defendants placing its defective Zantac products into 

the stream of commerce, as alleged herein, Plaintiff sustained loss of income and/or loss of earning 

capacity. 

119. WHEREFORE, Plaintiff respectfully requests this Court to enter judgment in 

Plaintiff’s favor for compensatory and punitive damages, together with interest, costs herein 

incurred, attorneys’ fees and all such other and further relief as this Court deems just and proper. 

COUNT II: STRICT LIABILITY – FAILURE TO WARN 

120. Plaintiff incorporates by reference each allegation set forth in preceding paragraphs 

as if fully stated herein. 

121. Plaintiff brings this strict liability claim against Defendants for failure to warn. 

122. At all relevant times, Defendants engaged in the business of testing, developing, 

designing, manufacturing, marketing, selling, distributing, and promoting Zantac products which 

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are defective and unreasonably dangerous to consumers, including Plaintiff, because they do not 

contain adequate warnings or instructions concerning the dangerous characteristics of Zantac and 

NDMA. These actions were under the ultimate control and supervision of Defendants. At all 

relevant times, Defendants registered, researched, manufactured, distributed, marketed, and sold 

Zantac and other ranitidine formulations within this judicial district and aimed at a consumer 

market. Defendants were at all relevant times involved in the retail and promotion of Zantac 

products marketed and sold in in this judicial district. 

123. Defendants researched, developed, designed, tested, manufactured, inspected, 

labeled, distributed, marketed, promoted, sold, and otherwise released into the stream of commerce 

its Zantac products, and in the course of same, directly advertised or marketed the products to 

consumers and end users, including Plaintiff, and therefore had a duty to warn of the risks 

associated with the use of Zantac products. 

124. At all relevant times, Defendants had a duty to properly test, develop, design, 

manufacture, inspect, package, label, market, promote, sell, distribute, maintain, supply, provide 

proper warnings, and take such steps as necessary to ensure its Zantac products did not cause users 

and consumers to suffer from unreasonable and dangerous risks. Defendants had a continuing duty 

to warn Plaintiff of dangers associated with Zantac. Defendants, as a manufacturer, seller, or 

distributor of pharmaceutical medication, are held to the knowledge of an expert in the field. 

125. At the time of manufacture, Defendants could have provided the warnings or 

instructions regarding the full and complete risks of Zantac products because they knew or should 

have known of the unreasonable risks of harm associated with the use of and/or exposure to such 

products. 

126. At all relevant times, Defendants failed and deliberately refused to investigate, 

study, test, or promote the safety or to minimize the dangers to users and consumers of their 

product and to those who would foreseeably use or be harmed by Defendants’ Zantac products, 

including Plaintiff. 

127. Even though Defendants knew or should have known that Zantac posed a grave 

risk of harm, they failed to exercise reasonable care to warn of the dangerous risks associated with 

use and exposure. The dangerous propensities of their products and the carcinogenic characteristics 

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of NDMA as produced within the human body as a result of ingesting Zantac, as described above, 

were known to Defendants, or scientifically knowable to Defendants through appropriate research 

and testing by known methods, at the time they distributed, supplied or sold the product, and were 

not known to end users and consumers, such as Plaintiff. 

128. Defendants knew or should have known that their products created significant risks 

of serious bodily harm to consumers, as alleged herein, and Defendants failed to adequately warn 

consumers, i.e., the reasonably foreseeable users, of the risks of exposure to its products. 

Defendants have wrongfully concealed information concerning the dangerous nature of Zantac 

and the potential for ingested Zantac to transform into the carcinogenic NDMA compound, and 

further, have made false and/or misleading statements concerning the safety of Zantac products. 

129. At all relevant times, Defendants’ Zantac products reached the intended consumers, 

handlers, and users or other persons coming into contact with these products within this judicial 

district and throughout the United States, including Plaintiff, without substantial change in their 

condition as designed, manufactured, sold, distributed, labeled, and marketed by Defendants. 

130. Plaintiff was exposed to Defendants’ Zantac products without knowledge of their 

dangerous characteristics. 

131. At all relevant times, Plaintiff used and/or was exposed to the use of Defendants’ 

Zantac products while using them for their intended or reasonably foreseeable purposes, without 

knowledge of their dangerous characteristics. 

132. Plaintiff could not have reasonably discovered the defects and risks associated with 

Zantac products prior to or at the time of Plaintiff consuming Zantac. Plaintiff relied upon the skill, 

superior knowledge, and judgment of Defendants to know about and disclose serious health risks 

associated with using Defendants’ products. 

133. Defendants knew or should have known that the minimal warnings disseminated 

with their Zantac products were inadequate, failed to communicate adequate information on the 

dangers and safe use/exposure, and failed to communicate warnings and instructions that were 

appropriate and adequate to render the products safe for their ordinary, intended and reasonably 

foreseeable uses. 

134. The information that Defendants did provide or communicate failed to contain 

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relevant warnings, hazards, and precautions that would have enabled consumers such as Plaintiff 

to utilize the products safely and with adequate protection. Instead, Defendants disseminated 

information that was inaccurate, false and misleading, and which failed to communicate accurately 

or adequately the comparative severity, duration, and extent of the risk of injuries with use of 

and/or exposure to Zantac; continued to aggressively promote the efficacy of its products, even 

after they knew or should have known of the unreasonable risks from use or exposure; and 

concealed, downplayed, or otherwise suppressed, through aggressive marketing and promotion, 

any information or research about the risks and dangers of ingesting Zantac. 

135. This alleged failure to warn is not limited to the information contained on Zantac’s 

labeling. The Defendants were able, in accord with federal law, to comply with relevant state law 

by disclosing the known risks associated with Zantac through other non-labeling mediums, i.e., 

promotion, advertisements, public service announcements, and/or public information sources. But 

the Defendants did not disclose these known risks through any medium. 

136. Defendants are liable to Plaintiff for injuries caused by their negligent or willful 

failure, as described above, to provide adequate warnings or other clinically relevant information 

and data regarding the appropriate use of their products and the risks associated with the use of 

Zantac. 

137. Had Defendants provided adequate warnings and instructions and properly 

disclosed and disseminated the risks associated with their Zantac products, Plaintiff could have 

avoided the risk of developing injuries and could have obtained or used alternative medication. 

138. As a direct and proximate result of Defendants placing defective Zantac products 

int the stream of commerce, Plaintiff was injured and has sustained pecuniary loss resulting and 

general damages in a sum exceeding the jurisdictional minimum of this Court. 

139. As a proximate result of Defendants placing defective Zantac products into the 

stream of commerce, as alleged herein, there was a measurable and significant interval of time 

during which Plaintiff suffered great mental anguish and other personal injury and damages. 

140. As a proximate result of Defendants placing defective Zantac products into the 

stream 

of commerce, as alleged herein, Plaintiff sustained loss of income and/or loss of earning capacity. 

141. WHEREFORE, Plaintiff respectfully requests this Court to enter judgment in 

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Plaintiff’s favor for compensatory and punitive damages, together with interest, costs herein 

incurred, attorneys’ fees and all such other and further relief as this Court deems just and proper. 

COUNT III: NEGLIGENCE 

142. Plaintiff incorporates by reference each allegation set forth in preceding paragraphs 

as if fully stated herein. 

143. Defendants, directly or indirectly, caused Zantac products to be sold, distributed, 

packaged, labeled, marketed, promoted, and/or used by Plaintiff. At all relevant times, Defendants 

registered, researched, manufactured, distributed, marketed and sold Zantac within this judicial 

district and aimed at a consumer market within this district. 

144. At all relevant times, Defendants had a duty to exercise reasonable care in the 

design, research, manufacture, marketing, advertisement, supply, promotion, packaging, sale, and 

distribution of Zantac products, including the duty to take all reasonable steps necessary to 

manufacture, promote, and/or sell a product that was not unreasonably dangerous to consumers 

and users of the product. 

145. At all relevant times, Defendants had a duty to exercise reasonable care in the 

marketing, advertisement, and sale of the Zantac products. Defendants’ duty of care owed to 

consumers and the general public included providing accurate, true, and correct information 

concerning the risks of using Zantac and appropriate, complete, and accurate warnings concerning 

the potential adverse effects of Zantac and, in particular, its ability to transform into the 

carcinogenic compound NDMA. 

146. At all relevant times, Defendants knew or, in the exercise of reasonable care, should 

have known of the hazards and dangers of Zantac and, specifically, the carcinogenic properties of 

NDMA when Zantac is ingested. 

147. Accordingly, at all relevant times, Defendants knew or, in the exercise of 

reasonable care, should have known that use of Zantac products could cause or be associated with 

Plaintiff’s injuries, and thus, create a dangerous and unreasonable risk of injury to the users of 

these products, including Plaintiff. 

148. Defendants also knew or, in the exercise of reasonable care, should have known 

that users and consumers of Zantac were unaware of the risks and the magnitude of the risks 

associated with use of Zantac. 

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149. As such, Defendants breached their duty of reasonable care and failed to exercise 

ordinary care in the design, research, development, manufacture, testing, marketing, supply, 

promotion, advertisement, packaging, sale, and distribution of Zantac products, in that Defendants 

manufactured and produced defective Zantac which carries the potential to transform into the 

carcinogenic compound NDMA; knew or had reason to know of the defects inherent in its 

products; knew or had reason to know that a user’s or consumer’s use of the products created a 

significant risk of harm and unreasonably dangerous side effects; and failed to prevent or 

adequately warn of these risks and injuries. Indeed, Defendants deliberately refused to test Zantac 

products because they knew that the chemical posed serious health risks to humans. 

150. Defendants were negligent in their promotion of Zantac, outside of the labeling 

context, by failing to disclose material risk information as part of their promotion and marketing 

of Zantac, including the internet, television, print advertisements, etc. Nothing prevented 

Defendants from being honest in their promotional activities, and, in fact, Defendants had a duty 

to disclose the truth about the risks associated with Zantac in their promotional efforts, outside of 

the context of labeling. 

151. Despite their ability and means to investigate, study, and test the products and to 

provide adequate warnings, Defendants failed to do so. Indeed, Defendants wrongfully concealed 

information and further made false and/or misleading statements concerning the safety and use of 

Zantac. 

152. Defendants’ negligence included: 

a. Manufacturing, producing, promoting, formulating, creating, developing, 

designing, selling, and/or distributing Zantac products without thorough and 

adequate pre- and post-market testing; 

b. Manufacturing, producing, promoting, formulating, creating, developing, 

designing, selling, and/or distributing Zantac while negligently and/or intentionally 

concealing and failing to disclose the results of trials, tests, and studies of Zantac 

and the carcinogenic potential of NDMA as created in the human body as a result 

of ingesting Zantac, and, consequently, the risk of serious harm associated with 

human use of Zantac; 

c. Failing to undertake sufficient studies and conduct necessary tests to determine 

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whether or not Zantac products were safe for their intended consumer use; 

d. Failing to use reasonable and prudent care in the design, research, manufacture, 

and development of Zantac products so as to avoid the risk of serious harm 

associated with the prevalent use of Zantac products; 

e. Failing to design and manufacture Zantac products so as to ensure they were at least 

as safe and effective as other medications on the market intended to treat the same 

symptoms; 

f. Failing to provide adequate instructions, guidelines, and safety precautions to those 

persons Defendants could reasonably foresee would use Zantac products; 

g. Failing to disclose to Plaintiff, users/consumers, and the general public that use of 

Zantac presented severe risks of cancer and other grave illnesses; 

h. Failing to warn Plaintiff, consumers, and the general public that the product’s risk 

of harm was unreasonable and that there were safer and effective alternative 

medications available to Plaintiff and other consumers; 

i. Systematically suppressing or downplaying contrary evidence about the risks, 

incidence, and prevalence of the side effects of Zantac products; 

j. Representing that their Zantac products were safe for their intended use when, in 

fact, Defendants knew or should have known the products were not safe for their 

intended purpose; 

k. Declining to make or propose any changes to Zantac products’ labeling or other 

promotional materials that would alert consumers and the general public of the risks 

of Zantac; 

l. Advertising, marketing, and recommending the use of the Zantac products, while 

concealing and failing to disclose or warn of the dangers known (by Defendants) to 

be associated with or caused by the use of or exposure to Zantac; 

m. Continuing to disseminate information to its consumers, which indicate or imply 

that Defendants’ Zantac products are not unsafe for regular consumer use; and 

n. Continuing the manufacture and sale of their products with the knowledge that the 

products were unreasonably unsafe and dangerous. 

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153. Defendants knew and/or should have known that it was foreseeable consumers 

such as Plaintiff would suffer injuries as a result of Defendants’ failure to exercise 

ordinary care in the manufacturing, marketing, labeling, distribution, and sale of 

Zantac. 

154. Plaintiff did not know the nature and extent of the injuries that could result from 

the intended use of and/or exposure to Zantac. 

155. Defendants’ negligence was the proximate cause of Plaintiff’s injuries, i.e., absent 

Defendants’ negligence, Plaintiff would not have developed cancer. 

156. Defendants’ conduct, as described above, was reckless. Defendants regularly risked 

the lives of consumers and users of their products, including Plaintiff, with full knowledge of the 

dangers of their products. Defendants have made conscious decisions not to redesign, re-label, 

warn, or inform the unsuspecting public, including Plaintiff. Defendants’ reckless conduct 

therefore warrants an award of punitive damages. 

157. As a direct and proximate result of Defendants placing defective Zantac products 

into the stream of commerce, Plaintiff was injured and has sustained pecuniary loss and general 

damages in a sum exceeding the jurisdictional minimum of this Court. 

158. As a proximate result of Defendants placing defective Zantac products into the 

stream of commerce, as alleged herein, there was a measurable and significant interval of time 

during which Plaintiff suffered great mental anguish and other personal injury and damages. 

159. As a proximate result of Defendants placing defective Zantac products into the 

stream of commerce, as alleged herein, Plaintiff sustained a loss of income, and loss of earning 

capacity. 

160. WHEREFORE, Plaintiff respectfully requests this Court to enter judgment in 

Plaintiff’s favor for compensatory and punitive damages, together with interest, costs herein 

incurred, attorneys’ fees and all such other and further relief as this Court deems just and proper. 

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COUNT IV: BREACH OF EXPRESS WARRANTIES 

161. Plaintiff incorporates by reference each allegation set forth in preceding paragraphs 

as if fully stated herein. 

162. At all relevant times, Defendants engaged in the business of testing, developing, 

designing, manufacturing, marketing, selling, distributing, and promoting Zantac products, which 

are defective and unreasonably dangerous to consumers, including Plaintiff, thereby placing 

Zantac products into the stream of commerce. These actions were under the ultimate control and 

supervision of Defendants. 

163. Defendants had a duty to exercise reasonable care in the research, development, 

design, testing, packaging, manufacture, inspection, labeling, distributing, marketing, promotion, 

sale, and release of Zantac products, including a duty to: 

a. ensure that its products did not cause the user unreasonably dangerous side effects; 

b. warn of dangerous and potentially fatal side effects; and 

c. disclose adverse material facts, such as the true risks associated with the use of and 

exposure to Zantac, when making representations to consumers and the general 

public, including Plaintiff. 

164. As alleged throughout this pleading, the ability of Defendants to properly disclose 

those risks associated with Zantac is not limited to representations made on the labeling. 

165. At all relevant times, Defendants expressly represented and warranted to the 

purchasers of its products, by and through statements made by Defendants in labels, publications, 

package inserts, and other written materials intended for consumers and the general public, that 

Zantac products were safe to human health and the environment, effective, fit, and proper for their 

intended use. Defendants advertised, labeled, marketed, and promoted Zantac products, 

representing the quality to consumers and the public in such a way as to induce their purchase or 

use, thereby making an express warranty that Zantac products would conform to the 

representations. 

166. These express representations include incomplete warnings and instructions that 

purport, but fail, to include the complete array of risks associated with use of and/or exposure to 

Zantac. Defendants knew and/or should have known that the risks expressly included in Zantac 

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warnings and labels did not and do not accurately or adequately set forth the risks of developing 

the serious injuries complained of herein. Nevertheless, Defendants expressly represented that 

Zantac products were safe and effective, that they were safe and effective for use by individuals 

such as the Plaintiff, and/or that they were safe and effective as consumer medication. 

167. The representations about Zantac, as set forth herein, contained or constituted 

affirmations of fact or promises made by the seller to the buyer, which related to the goods and 

became part of the basis of the bargain, creating an express warranty that the goods would conform 

to the representations. 

168. Defendants placed Zantac products into the stream of commerce for sale and 

recommended their use to consumers and the public without adequately warning of the true risks 

of developing the injuries associated with the use of Zantac. 

169. Defendants breached these warranties because, among other things, Zantac 

products were defective, dangerous, and unfit for use, did not contain labels representing the true 

and adequate nature of the risks associated with their use, and were not merchantable or safe for 

their intended, ordinary, and foreseeable use and purpose. Specifically, Defendants breached the 

warranties in the following ways: 

a. Defendants represented through its labeling, advertising, and marketing materials 

that Zantac products were safe, and intentionally withheld and concealed 

information about the risks of serious injury associated with use of Zantac and by 

expressly limiting the risks associated with use within its warnings and labels; and 

b. Defendants represented that Zantac products were safe for use and intentionally 

concealed information that demonstrated that Zantac, by transforming into NDMA 

upon human ingestion, had carcinogenic properties, and that Zantac products, 

therefore, were not safer than alternatives available on the market. 

170. Plaintiff detrimentally relied on the express warranties and representations of 

Defendants concerning the safety and/or risk profile of Zantac in deciding to purchase the product. 

Plaintiff reasonably relied upon Defendants to disclose known defects, risks, dangers, and side 

effects of Zantac. Plaintiff would not have purchased or used Zantac had Defendants properly 

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disclosed the risks associated with the product, either through advertising, labeling, or any other 

form of disclosure. 

171. Defendants had sole access to material facts concerning the nature of the risks 

associated with its Zantac products, as expressly stated within their warnings and labels, and knew 

that consumers and users such as Plaintiff could not have reasonably discovered that the risks 

expressly included in Zantac warnings and labels were inadequate and inaccurate. 

172. Plaintiff had no knowledge of the falsity or incompleteness of Defendants’ 

statements and representations concerning Zantac. 

173. Plaintiff used and/or was exposed to Zantac as researched, developed, designed, 

tested, manufactured, inspected, labeled, distributed, packaged, marketed, promoted, sold, or 

otherwise released into the stream of commerce by Defendants. 

174. Had the warnings, labels, advertisements, or promotional material for Zantac 

products accurately and adequately set forth the true risks associated with the use of such products, 

including Plaintiff’s injuries, rather than expressly excluding such information and warranting that 

the products were safe for their intended use, Plaintiff could have avoided the injuries complained 

of herein. 

175. As a direct and proximate result of Defendants’ breach of express warranty, 

Plaintiff has sustained pecuniary loss and general damages in a sum exceeding the jurisdictional 

minimum of this Court. 

176. As a proximate result of Defendants’ breach of express warranty, as alleged herein, 

there was a measurable and significant interval of time during which Plaintiff suffered great mental 

anguish and other personal injury and damages. 

177. As a proximate result of Defendants’ breach of express warranty, as alleged herein, 

Plaintiff sustained a loss of income and/or loss of earning capacity. 

178. WHEREFORE, Plaintiff respectfully requests this Court to enter judgment in 

Plaintiff’s favor for compensatory and punitive damages, together with interest, costs herein 

incurred, attorneys’ fees, and all such other and further relief as this Court deems just and proper. 

COUNT V: BREACH OF IMPLIED WARRANTIES 

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179. Plaintiff incorporates by reference every allegation set forth in preceding 

paragraphs as if fully stated herein. 

180. At all relevant times, Defendants engaged in the business of testing, developing, 

designing, manufacturing, marketing, selling, distributing, and promoting Zantac products, which 

were and are defective and unreasonably dangerous to consumers, including Plaintiff, thereby 

placing Zantac products into the stream of commerce. 

181. Before the time Plaintiff used Zantac products, Defendants impliedly warranted to 

its consumers, including Plaintiff, that Zantac products were of merchantable quality and safe and 

fit for the use for which they were intended; specifically, as consumer medication. 

182. But Defendants failed to disclose that Zantac has dangerous propensities when used 

as intended and that use of Zantac products carries an increased risk of developing severe injuries, 

including Plaintiff’s injuries. 

183. Plaintiff was an intended beneficiary of the implied warranties made by Defendants 

to purchasers of its Zantac products. 

184. The Zantac products were expected to reach and did in fact reach consumers and 

users, including Plaintiff, without substantial change in the condition in which they were 

manufactured and sold by Defendants. 

185. At all relevant times, Defendants were aware that consumers and users of its 

products, including Plaintiff, would use Zantac products as marketed by Defendants, which is to 

say that Plaintiff was a foreseeable user of Zantac. 

186. Defendants intended that Zantac products be used in the manner in which Plaintiff, 

in fact, used them and which Defendants impliedly warranted to be of merchantable quality, safe, 

and fit for this use, even though Zantac was not adequately tested or researched. 

187. In reliance upon Defendants’ implied warranty, Plaintiff used Zantac as instructed 

and labeled and in the foreseeable manner intended, recommended, promoted, and marketed by 

Defendants. 

188. Plaintiff could not have reasonably discovered or known of the risks of serious 

injury associated with Zantac. 

189. Defendants breached their implied warranty to Plaintiff in that Zantac products 

were not of merchantable quality, safe, or fit for their intended use, or adequately tested. Zantac 

has 

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dangerous propensities when used as intended and can cause serious injuries, including those 

injuries complained of herein. 

190. The harm caused by Defendants’ Zantac products far outweighed their benefit, 

rendering the products more dangerous than an ordinary consumer or user would expect and more 

dangerous than alternative products. 

191. As a direct and proximate result of Defendants’ breach of implied warranty, 

Plaintiff has sustained pecuniary loss and general damages in a sum exceeding the jurisdictional 

minimum of this Court. 

192. As a proximate result of the Defendants’ breach of implied warranty, as alleged 

herein, there was a measurable and significant interval of time during which Plaintiff suffered great 

mental anguish and other personal injury and damages. 

193. As a proximate result of Defendants’ breach of implied warranty, as alleged herein, 

Plaintiff sustained a loss of income and/or loss of earning capacity. 

194. WHEREFORE, Plaintiff respectfully requests this Court to enter judgment in 

Plaintiff’s favor for compensatory and punitive damages, together with interest, costs herein 

incurred, attorneys’ fees and all such other and further relief as this Court deems just and proper. 

JURY TRIAL DEMAND 

195. Plaintiff demands a trial by jury on all the triable issues within this pleading. 

PRAYER FOR RELIEF 

196. WHEREFORE, Plaintiff requests the Court to enter judgment in Plaintiff’s favor 

and against the Defendants for: 

a. actual or compensatory damages in such amount to be determined at trial and as 

provided by applicable law; 

b. exemplary and punitive damages sufficient to punish and deter the Defendants and 

others from future wrongful practices; 

c. pre-judgment and post-judgment interest; 

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d. costs including reasonable attorneys’ fees, court costs, and other litigation 

expenses; 

e. any other relief the Court may deem just and proper. 

Dated: May 1, 2020 

 Respectfully submitted, 

/s/ Christopher LoPalo 

Christopher LoPalo 

NAPOLI SHKOLNIK, PLLC 

360 Lexington Avenue, Suite 1101 

New York, NY 10017 

Tel: (212) 397-0000 

Fax: (646) 843-7603 

CLoPalo@napolilaw.com 

Attorneys for Plaintiff

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