UNITED STATES DISTRICT COURT

DISTRICT OF NEW JERSEY

MARILYN ABRAHAM and FREDA SMITH,

on behalf of themselves and all others similarly 

situated,

Plaintiffs,

v.

DR. REDDY’S LABORATORIES, INC.,

 Defendant.

Civil Action No. 

CLASS ACTION COMPLAINT

AND DEMAND FOR JURY 

TRIAL

Plaintiffs Marilyn Abraham and Freda Smith (collectively, “Plaintiffs”) bring this action 

on behalf of themselves and all others similarly situated against Defendant Dr. Reddy’s 

Laboratories, Inc. (“Dr. Reddy’s” or “Defendant”). Plaintiffs make the following allegations 

pursuant to the investigation of their counsel and based upon information and belief, except as to 

the allegations specifically pertaining to themselves, which are based on personal knowledge.

NATURE OF THE ACTION AND FACTS COMMON TO ALL CLAIMS

1. This is a class action lawsuit regarding Dr. Reddy’s’ manufacturing of ranitidinebased over-the-counter and prescription medications that contain dangerously high levels of 

N-nitrosodimethylamine (“NDMA”), a carcinogenic and liver-damaging impurity.

2. Ranitidine is an over-the-counter and prescription medication that is designed to 

decrease the amount of acid created by the stomach. Ranitidine is intended to be used for the 

treatment of heartburn associated with indigestion and sour stomach. However, Dr. Reddy’s’

manufacturing process has caused its ranitidine medications to contain dangerously high levels 

of NDMA.

3. NDMA is a semivolatile organic chemical. According to the U.S. Environmental 

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Protection Agency, NDMA “is a member of N-ni-trosamines, a family of potent carcinogens.” 

While NDMA is not currently produced in the United States other than for research purposes, it 

was formerly used “in production of liquid rocket fuel,” among other uses. NDMA is listed as a 

“priority toxic pollutant” in federal regulations. See 40 CFR § 131.36. Exposure to NDMA can 

cause liver damage and cancer in humans. NDMA is classified as a probable human carcinogen, 

and animal studies have shown that “exposure to NDMA has caused tumors primarily of the 

liver, respiratory tract, kidney and blood vessels.”

4. On September 13, 2019, the FDA issued a statement announcing the presence of 

NDMA in ranitidine-containing medications.1 The FDA’s notice states that “NDMA is 

classified as a probable human carcinogen (a substance that could cause cancer) based on results 

from laboratory tests.” Since then, the FDA’s own testing “has found unacceptable levels of 

NDMA in samples of ranitidine.”2

5. Further, on April 1, 2020, the FDA requested that all ranitidine “manufacturers to 

withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market 

immediately.”3 This decision was made because FDA “determined that the impurity in some 

ranitidine products increases over time and when stored at higher than room temperatures may 

1 Food & Drug Admin., Statement Alerting Patients and Health Care Professionals of NDMA 

Found in Samples of Ranitidine (Sept. 13, 2019), https://www.fda.gov/news-events/pressannouncements/statement-alerting-patients-and-health-care-professionals-ndma-found-samplesranitidine (last accessed Apr. 21, 2020).

2 Food & Drug Admin., 10/2/19: UPDATE – FDA Provides Update on Testing of Ranitidine for 

NDMA Impurities (Oct. 2, 2019), https://www.fda.gov/drugs/drug-safety-and-availability/fdaupdates-and-press-announcements-ndma-zantac-ranitidine (last accessed Apr. 21, 2020).

3 Food & Drug Admin., All Ranitidine Products (Zantac): Press Release – FDA Requests 

Removal (Apr. 1, 2020), https://www.fda.gov/safety/medical-product-safety-information/allranitidine-products-zantac-press-release-fda-requestsremoval?utm_campaign=FDA%20MedWatch%20-%20All%20Ranitidine%20Products%20%28

Zantac%29&utm_medium=email&utm_source=Eloqua (last accessed Apr. 21, 2020).

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result in consumer exposure to unacceptable levels of this impurity.”4

6. On October 23, 2019, Dr. Reddy’s confirmed it “had initiated a voluntary 

nationwide recall on October 1, 2019, (at the retail level for over-the-counter products and at the 

consumer level for prescription products) of all of its ranitidine medications sold in US due to 

confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by 

the FDA.”5 The recall affects all products with an expiration date of September 2019 to March 

2022.6

A. Dr. Reddy’s Markets Its Ranitidine Medications As Safe

7. Dr. Reddy’s marketed its ranitidine medications as safe and effective products.

8. On Dr. Reddy’s website, Dr. Reddy’s touts that its “focus on quality helps ensure 

product safety and efficacy, regardless of the drug form.”

9. Dr. Reddy’s also notes it has “uniform standards for all products, regardless of 

geography.” These standards involve a “four-step process” that includes adopting a “Quality by 

Design (QbD) approach in Manufacturing and clearly identify sources of variability and 

minimize them on an ongoing basis,” “[i]dentify[ing] and eliminat[ing] defects,” and 

undertaking a “‘risk-based’ approach to manufacturing and mitigate risks wherever they are 

likely to impact quality.”

10. In short, when consumers purchase or are prescribed ranitidine medications 

manufactured by Dr. Reddy’s respectively, they expect that the medications will be safe and 

4 Id.

5 Food & Drug Admin., Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine 

Products in the U.S. (Oct. 23, 2019), https://www.fda.gov/safety/recalls-market-withdrawalssafety-alerts/dr-reddys-confirms-its-voluntary-nationwide-recall-all-ranitidine-products-usmarket (last accessed Apr. 21, 2020).

6 Id.

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effective for the purpose for which it is purchased. They do not expect, and Defendant does not 

disclose, that the medications contain the harmful impurity NDMA. 

B. Dr. Reddy’s Ranitidine Medications Contain Dangerous Levels Of NDMA

11. Contrary to the above assertions, Dr. Reddy’s ranitidine medications contain 

dangerously high levels of NDMA that would not be present if the medications were properly 

synthesized. As noted in paragraph 4 and 5, supra, the FDA has found unacceptable levels of 

NDMA in samples of ranitidine.

12. Further, on April 1, 2020, the FDA requested that all ranitidine “manufacturers to 

withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market 

immediately.”7 This decision was made because the FDA “determined that the impurity in some 

ranitidine products increases over time and when stored at higher than room temperatures may 

result in consumer exposure to unacceptable levels of this impurity.”8

13. The Medicines and Healthcare Products Regulatory Agency of the United 

Kingdom has issued an alert regarding ranitidine medications, noting recalls issued by 

companies are “a precautionary measure due to possible contamination of the active substance in 

Zantac, ranitidine, with an impurity called NDMA.”9 “The MHPRA has asked manufacturers to 

quarantine all ranitidine products which may contain the active pharmaceutical ingredient that is 

7 Food & Drug Admin., All Ranitidine Products (Zantac): Press Release – FDA Requests 

Removal (Apr. 1, 2020), https://www.fda.gov/safety/medical-product-safety-information/allranitidine-products-zantac-press-release-fda-requestsremoval?utm_campaign=FDA%20MedWatch%20-%20All%20Ranitidine%20Products%20%28

Zantac%29&utm_medium=email&utm_source=Eloqua (last accessed Apr. 21, 2020).

8 Id.

9 Medicine and Healthcare Regulatory Agency, Zantac – MHRA Drug Alert Issued as 

GlaxoSmithKline Recalls all Unexpired Stock (Oct. 8, 2019), 

https://www.gov.uk/government/news/zantac-mhra-drug-alert-issued-as-glaxosmithkline-recallsall-unexpired-stock (last accessed Apr. 21, 2020).

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potentially affected by this issue.”10

14. While the cause of the NDMA contamination in ranitidine medications is still 

being investigated by the FDA and other regulatory agencies, the Health Products Regulatory 

Authority of Ireland, in issuing a recall of ranitidine medications, has stated: “The reason for the 

recall is that a nitrosamine impurity has been identified in ranitidine active substance batches 

manufactured at a manufacturing site in India.”11

15. The “FDA has set the acceptable daily intake limit for NDMA at 0.096 

micrograms or 0.32 ppm [parts per million] for ranitidine”12 But Dr. Reddy’s’ ranitidine 

medications, according to testing by the FDA, have an NDMA content of 0.68 ppm, more than 

twice the acceptable daily limit:

Company Product Lots Tested NDMA level ppm

Dr. Reddy’s Rx Ranitidine 

300mg

C805265 0.68

16. Further, on April 1, 2020, the FDA requested that all ranitidine “manufacturers to 

withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market 

immediately.”13 This decision was made because FDA “determined that the impurity in some 

10 Id.

11 Health Products Regulatory Authority, Precautionary Pharmacy and Retail Level Recall of 

Several Batches of a Number of Ranitidine Medicines in Ireland (Sept. 23, 2019), 

https://www.hpra.ie/homepage/medicines/safety-notices/item?t=/precautionary-pharmacy-andretail-level-recall-of-several-batches-of-a-number-of-ranitidine-medicines-inireland&id=d26b0c26-9782-6eee-9b55-ff00008c97d0 (last accessed Apr. 21, 2020). 

12 Food & Drug Admin., Laboratory Analysis of Ranitidine and Nizatidine Products (Nov. 1, 

2019), https://www.fda.gov/drugs/drug-safety-and-availability/laboratory-tests-ranitidine (last 

accessed Apr. 21, 2020).

13 Food & Drug Admin., All Ranitidine Products (Zantac): Press Release – FDA Requests 

Removal (Apr. 1, 2020), https://www.fda.gov/safety/medical-product-safety-information/allranitidine-products-zantac-press-release-fda-requestsremoval?utm_campaign=FDA%20MedWatch%20-%20All%20Ranitidine%20Products%20%28

Zantac%29&utm_medium=email&utm_source=Eloqua (last accessed Apr. 21, 2020).

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ranitidine products increases over time and when stored at higher than room temperatures may 

result in consumer exposure to unacceptable levels of this impurity.”14

C. Plaintiffs Were Harmed By Purchasing Or Being Prescribed And 

Consuming Defective Ranitidine Medications Manufactured By Defendant

17. Plaintiffs and the Class and Subclasses were injured by the full purchase price of 

their Dr. Reddy’s ranitidine medications. These medications are worthless, as they contain 

harmful levels of NDMA, which is underscored by Dr. Reddy’s’ “voluntary nationwide 

recall...of all of its ranitidine medications sold in US due to confirmed contamination with 

[NDMA] above levels established by the FDA.”15 As the medications expose users to NDMA 

well above the legal limit, the medications are not fit for human consumption. Plaintiffs are

further entitled to statutory damages, damages for the injury sustained in consuming high levels 

of acutely-toxic NDMA, and for damages related to Defendant’s conduct.

18. Plaintiffs bring this action on behalf of themselves and the Class and Subclasses

for equitable relief and to recover damages and restitution for: (i) breach of the implied warranty 

of merchantability, (ii) violation of the Texas Deceptive Trade Practices Act, Tex. Bus. & Com. 

Code §§ 17.41 et seq., (iii) violation of the Kentucky Consumer Protection Act, Ky. Rev. Stat. §§ 

367.110 et seq., (iv) unjust enrichment, (v) fraudulent concealment, (vi) fraud, and (vii) 

conversion.

PARTIES

19. Plaintiff Marilyn Abraham is a citizen of Texas who resides in Brownsville, 

14 Id.

15 Food & Drug Admin., Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All 

Ranitidine Products in the U.S. (Oct. 23, 2019), https://www.fda.gov/safety/recalls-marketwithdrawals-safety-alerts/dr-reddys-confirms-its-voluntary-nationwide-recall-all-ranitidineproducts-us-market (last accessed Apr. 21, 2020).

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Texas. During all relevant time periods, Ms. Abraham was prescribed and consumed ranitidine

medications manufactured by Dr. Reddy’s. Ms. Abraham originally learned about the ranitidine 

defect through news sources reporting NDMA in ranitidine medications. Each time Ms. 

Abraham picked up her ranitidine medications, she was required to make a co-payment of $3.40. 

When purchasing her ranitidine medications manufactured by Defendant, Ms. Abraham

reviewed the accompanying labels and disclosures, and understood them as representations and 

warranties by the manufacturer, distributor, and pharmacy that the ranitidine medication she 

consumed were properly manufactured and free from carcinogenic contaminants such as NDMA. 

Ms. Abraham relied on these representations and warranties in deciding to consume her 

ranitidine medication from Dr. Reddy’s, and these representations and warranties were part of 

the basis of the bargain, in that she would not have consumed her ranitidine medication 

manufactured by Defendant if she had known that it was not, in fact, properly manufactured, and 

contained the carcinogenic impurity NDMA. Ms. Abraham understood that each purchase 

involved a direct transaction between herself and Dr. Reddy’s because her medication came with 

packaging and other materials prepared by Dr. Reddy’s, including representations and warranties 

that her medication was properly manufactured, free from carcinogenic impurities such as 

NDMA, and safe for use.

20. Plaintiff Freda Smith is a citizen of Kentucky who resides in Versailles, 

Kentucky. During all relevant time periods, Ms. Smith was prescribed and consumed ranitidine 

medications manufactured by Dr. Reddy’s. Ms. Smith originally learned about the ranitidine 

defect through news sources reporting NDMA in ranitidine medications. When purchasing her 

ranitidine medications manufactured by Defendant, Ms. Smith reviewed the accompanying 

labels and disclosures, and understood them as representations and warranties by the 

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manufacturer, distributor, and pharmacy that the ranitidine medication she consumed were 

properly manufactured and free from carcinogenic contaminants such as NDMA. Ms. Smith

relied on these representations and warranties in deciding to consume her ranitidine medication 

from Dr. Reddy’s, and these representations and warranties were part of the basis of the bargain, 

in that she would not have consumed her ranitidine medication manufactured by Defendant if she 

had known that it was not, in fact, properly manufactured, and contained the carcinogenic 

impurity NDMA. Ms. Smith understood that each purchase involved a direct transaction 

between herself and Dr. Reddy’s because her medication came with packaging and other 

materials prepared by Dr. Reddy’s, including representations and warranties that her medication 

was properly manufactured, free from carcinogenic impurities such as NDMA, and safe for use.

21. Defendant Dr. Reddy’s Laboratories, Inc. is a Delaware corporation with a 

principal place of business at 107 College Road East, Princeton, New Jersey 08540. Dr. 

Reddy’s Laboratories, Inc. is a wholly owned subsidiary of Indian corporation Dr. Reddy’s 

Laboratories Ltd. Dr. Reddy’s conducts substantial business in the United States, and has $20 

million in annual sales of ranitidine.

16 Dr. Reddy’s does substantial business in the States of 

Texas and Kentucky. Dr. Reddy’s has been engaged in the manufacturing of defective ranitidine 

throughout the United States, including in the States of Texas and Kentucky.

JURISDICTION AND VENUE

22. The Court has jurisdiction over this action pursuant to 28 U.S.C. § 1332(d)(2)(A), 

as modified by the Class Action Fairness Act of 2005, because at least one member of the Class, 

as defined below, is a citizen of a different state than Defendant, there are more than 100 

16 Darshan Mehta, U.S. FDA Finds Ranitidine Drugs Sold by Strides, Ajanta Pharma Safe to 

Use, BLOOMBERG QUINT, Nov. 4, 2019, https://www.bloombergquint.com/business/us-fda-findsranitidine-drugs-sold-by-strides-ajanta-pharma-safe-to-use (last accessed Nov. 26, 2019).

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members of the Class, and the aggregate amount in controversy exceeds $5,000,000 exclusive of 

interest and costs.

23. Venue is proper in this Court pursuant to 28 U.S.C. § 1391 because Defendant’s 

principal place of business is located in this District.

CLASS ALLEGATIONS

24. Plaintiffs seek to represent a class defined as all persons in the United States who 

purchased ranitidine-containing medications manufactured by Dr. Reddy’s (the “Class”). 

Specifically excluded from the Class are persons who made such purchase for the purpose of 

resale, Defendant, Defendant’s officers, directors, agents, trustees, parents, children, 

corporations, trusts, representatives, employees, principals, servants, partners, joint ventures, or 

entities controlled by Defendant, and their heirs, successors, assigns, or other persons or entities 

related to or affiliated with Defendant and/or Defendant’s officers and/or directors, the judge 

assigned to this action, and any member of the judge’s immediate family.

25. Plaintiff Abraham seeks to represent a subclass of all Class members who 

purchased ranitidine-containing medications manufactured by Dr. Reddy’s in Texas (the “Texas

Subclass”). 

26. Plaintiff Smith seeks to represent a subclass of all Class members who purchased 

ranitidine-containing medications manufactured by Dr. Reddy’s in Kentucky (the “Kentucky

Subclass”) (collectively, the “Subclasses”).

27. Subject to additional information obtained through further investigation and 

discovery, the foregoing definitions of the Class and Subclasses may be expanded or narrowed 

by amendment or amended complaint.

28. Numerosity. The members of the Class and Subclasses are geographically 

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dispersed throughout the United States and are so numerous that individual joinder is 

impracticable. Upon information and belief, Plaintiffs reasonably estimate that there are 

hundreds of thousands of members in the Class and tens of thousands of members in the 

respective Subclasses. Although the precise number of members in the Class and Subclasses is 

unknown to Plaintiffs, the true number of members in the Class and Subclasses is known by 

Defendant and may be determined through discovery. Members of the Class and Subclasses

may be notified of the pendency of this action by mail and/or publication through the distribution 

records of Defendant and third-party retailers and vendors. 

29. Existence and predominance of common questions of law and fact. Common 

questions of law and fact exist as to all members of the Class and Subclasses and predominate 

over any questions affecting only individual members of the Class and Subclasses. These 

common legal and factual questions include, but are not limited to, the following:

(a) whether the ranitidine medications manufactured by Defendant contain 

dangerously high levels of NDMA, thereby breaching the express and implied 

warranties made by Defendant and making the ranitidine-containing

medications unfit for human consumption and therefore unfit for their

intended purpose; 

(b) whether Defendant knew or should have known that the ranitidine-containing

medications contained elevated levels of NDMA prior to selling the 

medications, thereby constituting fraud and/or fraudulent concealment; 

(c) whether Defendant has unlawfully converted money from Plaintiffs and the 

Class and Subclasses;

(d) whether Defendant is liable to Plaintiffs and the Class and Subclasses for 

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unjust enrichment;

(e) whether Defendant is liable to Plaintiffs and the Class and Subclasses for 

fraudulent concealment;

(f) whether Defendant is liable to Plaintiff Abraham and the Texas Subclass for 

violations of Texas consumer-protection laws;

(g) whether Defendant is liable to Plaintiff Smith and the Kentucky Subclass for 

violations of Kentucky consumer-protection laws;

(h) whether Defendant is liable to Plaintiffs and the Class and Subclasses for 

breaches of express and implied warranties;

(i) whether Plaintiffs and the Class and Subclasses have sustained monetary loss 

and the proper measure of that loss;

(j) whether Plaintiffs and the Class and Subclasses are entitled to declaratory and 

injunctive relief;

(k) whether Plaintiffs and the Class and Subclasses are entitled to restitution and 

disgorgement from Defendant; and

(l) whether the marketing, advertising, packaging, labeling, and other promotional 

materials for the ranitidine-containing medications are deceptive.

30. Typicality. Plaintiffs’ claims are typical of the claims of the other members of 

the Class and Subclasses in that Defendant mass marketed and sold defective ranitidine-based 

medications to consumers throughout the United States. This defect was present in all of the

ranitidine-containing medications manufactured, distributed, and sold by Defendant. Therefore, 

Defendant breached its express and implied warranties to Plaintiffs and members of the Class 

and Subclasses by manufacturing, distributing, and selling the defective ranitidine-containing 

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medications. Plaintiffs’ claims are typical in that they and members of the Class and Subclasses 

were uniformly harmed in purchasing and consuming the defective ranitidine-containing 

medications. Plaintiffs’ claims are further typical in that Defendant deceived Plaintiffs in the 

very same manner as they deceived each member of the Class and Subclasses. Further, there are 

no defenses available to Defendant that are unique to Plaintiffs. 

31. Adequacy of Representation. Plaintiffs will fairly and adequately protect the 

interests of the Class and Subclasses. Plaintiffs have retained counsel that is highly experienced 

in complex consumer class action litigation, and Plaintiffs intend to vigorously prosecute this 

action on behalf of the Class and Subclasses. Furthermore, Plaintiffs have no interests that are 

antagonistic to those of the Class and Subclasses.

32. Superiority. A class action is superior to all other available means for the fair 

and efficient adjudication of this controversy. The damages or other financial detriment suffered 

by individual members of the Class and Subclasses are relatively small compared to the burden 

and expense of individual litigation of their claims against Defendant. It would, thus, be 

virtually impossible for the Class and Subclasses, on an individual basis, to obtain effective 

redress for the wrongs committed against them. Furthermore, even if members of the Class and 

Subclasses could afford such individualized litigation, the court system could not. Individualized 

litigation would create the danger of inconsistent or contradictory judgments arising from the 

same set of facts. Individualized litigation would also increase the delay and expense to all 

parties and the court system from the issues raised by this action. By contrast, the class action 

device provides the benefits of adjudication of these issues in a single proceeding, economies of 

scale, and comprehensive supervision by a single court, and presents no unusual management 

difficulties under the circumstances.

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33. In the alternative, the Class and Subclasses may also be certified because:

(a) the prosecution of separate actions by individual members of the Class and 

Subclasses would create a risk of inconsistent or varying adjudications with 

respect to individual members of the Class and Subclasses that would 

establish incompatible standards of conduct for the Defendant;

(b) the prosecution of separate actions by individual members of the Class and 

Subclasses would create a risk of adjudications with respect to them that 

would, as a practical matter, be dispositive of the interests of other members 

of the Class and Subclasses not parties to the adjudications, or substantially 

impair or impede their ability to protect their interests; and/or

(c) Defendant has acted or refused to act on grounds generally applicable to 

members of the Class and Subclasses as a whole, thereby making appropriate 

final declaratory and/or injunctive relief with respect to the members of the 

Class and Subclasses as a whole.

COUNT I

Breach Of The Implied Warranty Of Merchantability

(On Behalf Of The Class And Subclasses)

34. Plaintiffs hereby incorporate by reference the allegations contained in all 

preceding paragraphs of this complaint.

35. Plaintiffs bring this claim individually and on behalf of the members of the 

proposed Class and the Subclasses against Defendant.

36. Defendant, as the designer, manufacturer, marketer, distributor, and/or seller, 

impliedly warranted that the ranitidine medications (i) would not contain elevated levels of 

NDMA and (ii) are generally recognized as safe for human consumption.

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37. Defendant breached the warranty implied in the contract for the sale of the 

defective ranitidine medications because they could not pass without objection in the trade under 

the contract description, the ranitidine medications were not of fair or average quality within the 

description, and the ranitidine medications were unfit for their intended and ordinary purpose 

because the ranitidine medications manufactured, distributed, and sold by Defendant were

defective in that they contained elevated levels of carcinogenic and liver-toxic NDMA, and as 

such are not generally recognized as safe for human consumption. As a result, Plaintiffs and 

members of the Class and Subclasses did not receive the goods as impliedly warranted by 

Defendant to be merchantable.

38. Plaintiffs and members of the Class and Subclasses purchased the ranitidine

medications in reliance upon Defendant’s skill and judgment and the implied warranties of 

fitness for the purpose.

39. The ranitidine medications were not altered by Plaintiffs or members of the Class

and Subclasses.

40. The ranitidine medications were defective when it left the exclusive control of 

Defendant.

41. Defendant knew that the ranitidine medications would be purchased and used 

without additional testing by Plaintiffs and members of the Class and Subclasses.

42. The ranitidine medications were defectively manufactured and unfit for their

intended purpose, and Plaintiffs and members of the Class and Subclasses did not receive the 

goods as warranted.

43. As a direct and proximate cause of Defendant’s breach of the implied warranty, 

Plaintiffs and members of the Class and Subclasses have been injured and harmed because: (a) 

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they would not have purchased the ranitidine medications on the same terms if they knew that

the ranitidine medications contained harmful levels of NDMA, and are not generally recognized 

as safe for human consumption; and (b) the ranitidine medications do not have the 

characteristics, ingredients, uses, or benefits as promised by Defendant.

44. As a result of Defendant’s breach of implied warranty, Plaintiffs and each of the 

members of the Class and Subclasses have been damaged in the amount of the purchase price of 

the ranitidine medications and any consequential damages resulting from the purchases.

COUNT II

Violation Of The Texas Deceptive Trade Practices Act

Tex. Bus. & Com. Code §§ 17.41 et seq.

(On Behalf Of The Texas Subclass)

45. Plaintiffs hereby incorporate by reference the allegations contained in all 

preceding paragraphs of this complaint.

46. Plaintiff Abraham brings this claim individually and on behalf of the members of 

the proposed Texas Subclass against Defendant.

47. Plaintiff Abraham, the members of the Texas Subclass, and Defendant are each 

“persons” as defined by Tex. Bus. & Com. Code § 17.45(3).

48. Defendant’s ranitidine medications are goods under Tex. Bus. & Com. Code § 

17.45(1).

49. Plaintiff Abraham and members of the Texas Subclass are “consumers” as 

defined in Tex. Bus. & Com. Code § 17.45(4).

50. Defendant has at all relevant times engaged in “trade” and “commerce” as defined 

in Tex. Bus. & Com. Code § 17.45(6), by manufacturing, distributing, and selling ranitidine 

medications in Texas, directly or indirectly affecting Texas citizens through that trade and 

commerce.

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51. The allegations set forth herein constitute false, misleading, or deceptive trade 

acts or practices in violation of the Texas Deceptive Trade Practices-Consumer Protection Act, 

Tex. Bus. & Com. Code §§ 17.41, et seq. (“TDTPA”).

52. By failing to disclose the presence of harmful and carcinogenic NDMA in its 

ranitidine medications, despite affirmative representations to Plaintiff Abraham and members of 

the Texas Subclass that the ranitidine medications were safe for human consumptions and did not 

contain harmful carcinogens such as NDMA, Defendant engaged in deceptive business practices 

prohibited by the TDTPA, including engaging in acts or practices which are unfair, misleading, 

false, or deceptive to the consumer.

53. As alleged above, Defendant made numerous material statements about the 

benefits and characteristics of the ranitidine medications that were either false or misleading. 

Each of these statements contributed to the deceptive context of Defendant’s unlawful 

advertising and representations as a whole.

54. Defendant owed Plaintiff Abraham and other members of the Texas Subclass a 

duty to disclose the presence of NDMA in its ranitidine medications because Defendant

(a) Made incomplete representations about the characteristics and performance of 

the ranitidine medications generally, while purposefully withholding material 

facts from Plaintiff Abraham and members of the Texas Subclass that 

contradicted these representations

(b) Advertised goods with the intent not to sell them as advertised by representing 

that the ranitidine medications did not contain harmful impurities such as 

NDMA and were safe for human consumption, when in fact, Defendant knew 

about the presence of NDMA in its ranitidine medications. In 2003, it was 

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“proposed that elevated levels of NDMA in drinking water ... may be 

associated with the drug ranitidine.”17 Likewise, in 2004, a study found the 

use of Zantac to be “related to the risk of bladder cancer.”18 Furthermore, a 

2016 study by Stanford University found that individuals who took ranitidine 

medications had “NDMA levels [in their urine] more than 400 times greater 

than what the FDA considers acceptable.”19

55. To their detriment, Plaintiff Abraham and members of the Texas Subclass relied 

upon Defendant’s material representations, and/or relied on the absence of disclosure by 

Defendant, that its ranitidine medications (i) did not contain harmful or carcinogenic impurities 

such as NDMA, and (ii) were safe for human consumption.

56. Defendant made these material representations to induce Plaintiff Abraham and 

members of the Texas Subclass to act, i.e. to purchase ranitidine medications manufactured by 

Defendant.

57. Defendant’s intentional concealment of and failure to disclose to Plaintiff 

Abraham and members of the Texas Subclass the presence of NDMA in its ranitidine 

medications, thus rendering the medications unsafe for human consumption, constitutes an 

“unconscionable action or course of action” under Tex. Bus. & Com. Code § 17.45(5) because, 

17 VALISURE, VALISURE CITIZEN PETITION ON RANITIDINE 4-5 (2019), 

https://www.valisure.com/wp-content/uploads/Valisure-Ranitidine-FDA-Citizen-Petitionv4.12.pdf (last accessed Apr. 21, 2020) (hereinafter “VALISURE PETITION”).

18 Dominque S. Michaud et al., Peptic Ulcer Disease and the Risk of Bladder Cancer in a Prospective 

Study of Male Health Professionals, 13 CANCER EPIDEMIOLOGY, BIOMARKERS & PREVENTION 250, 

252 (2004) https://pdfs.semanticscholar.org/3eeb/c399404a2b100d90c6698bd4fc73a748864e.pdf

(last accessed Apr. 21, 2020).

19 Jonathan Lapook, Potentially Dangerous Chemical Found in Popular Heartburn Pill Zantac, 

CBS NEWS, Oct. 8, 2019, https://www.cbsnews.com/news/zantac-ndma-levels-potentiallydangerous-chemical-zantac-ranitidine-heartburn-pills-2019-10-08/ (last accessed Apr. 21, 2020).

Case 9:20-cv-80791-RLR Document 1 Entered on FLSD Docket 04/30/2020 Page 17 of 26
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to the detriment of Plaintiff Abraham and members of the Texas Subclass, that conduct took 

advantage of their lack of knowledge, ability, and experience to a grossly unfair degree. That 

“unconscionable action or course of action” was a producing cause of the economic damages 

sustained by Plaintiff Abraham and members of the Texas Subclass.

58. As a result of Defendant’s unlawful acts in violation of the TDTPA detailed 

above, Plaintiff Abraham and members of the Texas Subclass sustained damages and are, 

therefore, entitled to damages and other relief as provided under the TDTPA.

59. Plaintiff Abraham and members of the Texas Subclass should be awarded treble 

damages as punitive damages under the DTPA. Awarding treble damages in this case is 

necessary to encourage private enforcement of Texas’s consumer protection laws.

60. Pursuant to § 17.50(d), Plaintiff Abraham and members of the Texas Subclass 

also requests attorneys’ fees, and any other relief the Court deems proper, as permitted by the 

TDTPA

COUNT III

Violation Of The Kentucky Consumer Protection Act

Ky. Rev. Stat. § 367.110 et seq.

(On Behalf Of The Kentucky Subclass)

61. Plaintiffs hereby incorporate by reference the allegations contained in all 

preceding paragraphs of this complaint.

62. Plaintiff Smith brings this claim individually and on behalf of the members of the 

proposed Kentucky Subclass against Defendant.

63. Plaintiff Smith and Kentucky Subclass members are consumers entitled to the 

protections of the Kentucky Consumer Protection Act, Ky. Rev. Stat. § 367.110 et seq. (the 

“KCPA”).

64. Defendant deceived Plaintiff Smith and members of the Kentucky Subclass in 

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violation of the KCPA by promoting and/or allowing sales of its ranitidine medications without 

disclosing the presence of harmful and carcinogenic NDMA in the medications, thus rendering 

the medications unsafe for human consumption. Such acts constitute unfair, false, misleading, 

and deceptive acts or practices in the conduct of trade and/or commerce. Said pattern of conduct 

was uniform in nature with respect to the marketing and sale of the ranitidine medications.

65. Defendant knowingly concealed, suppressed, and consciously omitted material 

facts from Plaintiff Smith and other members of the Kentucky Subclass knowing that consumers 

would rely on its uniform representations and warranties of safety and quality when purchasing 

the ranitidine medications. In 2003, it was “proposed that elevated levels of NDMA in drinking 

water ... may be associated with the drug ranitidine.”20 Likewise, in 2004, a study found the use 

of Zantac to be “related to the risk of bladder cancer.”21 Furthermore, a 2016 study by Stanford 

University found that individuals who took ranitidine medications had “NDMA levels [in their 

urine] more than 400 times greater than what the FDA considers acceptable.”22

66. Plaintiff Smith and members of the Kentucky Subclass did not become aware of 

any facts which would have called into question the false public perception of safety which Dr. 

Reddy’s had created, until after the ranitidine medications were recalled.

67. Defendant knowingly accepted the benefits of its deception and improper conduct 

in the form of profits from the sales of the ranitidine medications. Specifically, Dr. Reddy’s 

20 VALISURE PETITION 4-5.

21 Dominque S. Michaud et al., Peptic Ulcer Disease and the Risk of Bladder Cancer in a Prospective 

Study of Male Health Professionals, 13 CANCER EPIDEMIOLOGY, BIOMARKERS & PREVENTION 250, 

252 (2004) https://pdfs.semanticscholar.org/3eeb/c399404a2b100d90c6698bd4fc73a748864e.pdf

(last accessed Apr. 21, 2020).

22 Jonathan Lapook, Potentially Dangerous Chemical Found in Popular Heartburn Pill Zantac, 

CBS NEWS, Oct. 8, 2019, https://www.cbsnews.com/news/zantac-ndma-levels-potentiallydangerous-chemical-zantac-ranitidine-heartburn-pills-2019-10-08/ (last accessed Apr. 21, 2020).

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20

ranitidine medications produce $20 million in annual sales.

68. As a proximate result of the above-described KCPA violations, Plaintiff Smith

and other members of the Kentucky Subclass: (a) purchased and used the ranitidine medications

when they would not otherwise have done so; and (b) suffered economic losses consisting of the 

cost of purchasing the ranitidine medications.

69. On behalf of herself and other members of the Kentucky Subclass, Plaintiff Smith 

seeks to recover compensatory and punitive damages as a result of Defendant’s conduct, along 

with reasonable attorneys’ fees and costs.

COUNT IV

Unjust Enrichment

(On Behalf Of The Class And Subclasses)

70. Plaintiffs hereby incorporate by reference the allegations contained in all 

preceding paragraphs of this complaint.

71. Plaintiffs bring this claim individually and on behalf of the members of the 

proposed Class and Subclasses against Defendant.

72. Plaintiffs and the Class and Subclasses conferred a benefit on Defendant in the 

form of monies paid to purchase Defendant’s defective ranitidine medications.

73. Defendant voluntarily accepted and retained this benefit.

74. Because this benefit was obtained unlawfully, namely by selling and accepting 

compensation for medications unfit for human use, it would be unjust and inequitable for the 

Defendant to retain it without paying the value thereof.

COUNT V

Fraudulent Concealment

(On Behalf Of The Class and Subclasses)

75. Plaintiffs hereby incorporate by reference the allegations contained in all 

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21

preceding paragraphs of this complaint.

76. Plaintiffs bring this claim individually and on behalf of the members of the 

proposed Class and Subclasses against Defendant.

77. Defendant had a duty to disclose material facts to Plaintiffs and the Class and 

Subclasses given their relationship as contracting parties and intended users of the ranitidinecontaining medications, including the ranitidine medications. Defendant also had a duty to 

disclose material facts to Plaintiffs and the Class and Subclasses, namely that they were in fact 

manufacturing, distributing, and selling harmful ranitidine-containing medications, including the 

ranitidine medications, containing NDMA that were unfit for human consumption. Such duty to 

disclose exists because Defendant had superior knowledge that the medications were defective 

and contained harmful levels of NDMA such that the transactions without the disclosure were 

rendered inherently unfair.

78. Defendant possessed knowledge of these material facts. In 2003, it was 

“proposed that elevated levels of NDMA in drinking water ... may be associated with the drug 

ranitidine.”23 Likewise, in 2004, a study found the use of Zantac to be “related to the risk of 

bladder cancer.”24 Furthermore, a 2016 study by Stanford University found that individuals who

took ranitidine medications had “NDMA levels [in their urine] more than 400 times greater than 

what the FDA considers acceptable.”25 During that time, Plaintiffs and members of the Class

23 VALISURE PETITION 4-5.

24 Dominque S. Michaud et al., Peptic Ulcer Disease and the Risk of Bladder Cancer in a Prospective 

Study of Male Health Professionals, 13 CANCER EPIDEMIOLOGY, BIOMARKERS & PREVENTION 250, 

252 (2004) https://pdfs.semanticscholar.org/3eeb/c399404a2b100d90c6698bd4fc73a748864e.pdf

(last accessed Apr. 21, 2020).

25 Jonathan Lapook, Potentially Dangerous Chemical Found in Popular Heartburn Pill Zantac, 

CBS NEWS, Oct. 8, 2019, https://www.cbsnews.com/news/zantac-ndma-levels-potentiallydangerous-chemical-zantac-ranitidine-heartburn-pills-2019-10-08/.

Case 9:20-cv-80791-RLR Document 1 Entered on FLSD Docket 04/30/2020 Page 21 of 26
22

and Subclasses were using the ranitidine medications without knowing it contained dangerous 

levels of NDMA.

79. Defendant failed to discharge their duty to disclose these materials facts.

80. In so failing to disclose these material facts to Plaintiffs and the Class and 

Subclasses, Defendant intended to hide from Plaintiffs and the Class and Subclasses that they 

were purchasing and consuming ranitidine medications with harmful defects that were unfit for 

human use, and thus acted with scienter and/or an intent to defraud.

81. Plaintiffs and the Class and Subclasses reasonably relied on Defendant’s failure to 

disclose insofar as they would not have purchased the defective ranitidine medications 

manufactured, distributed, and sold by Defendant had they known the ranitidine medications 

contained unsafe levels of NDMA.

82. As a direct and proximate cause of Defendant’s fraudulent concealment, Plaintiffs

and the Class and Subclasses suffered damages in the amount of monies paid for the defective 

ranitidine medications.

83. As a result of Defendant’s willful and malicious conduct, punitive damages are 

warranted.

COUNT VI

Fraud

(On Behalf Of The Class and Subclasses)

84. Plaintiffs hereby incorporate by reference the allegations contained in all 

preceding paragraphs of this complaint.

85. Plaintiffs bring this claim individually and on behalf of the members of the 

proposed Class and Subclasses against Defendant.

86. As discussed above, Defendant provided Plaintiffs and members of the Class and 

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Subclasses with materially false or misleading information about their ranitidine-containing 

medications, including the ranitidine medications, manufactured by Defendant. Specifically, 

Defendant has marketed the ranitidine-containing medications as safe for human consumption. 

As indicated above, however, these representations are false and misleading as Defendant’s

ranitidine-containing medications contained elevated levels of NDMA. 

87. The misrepresentations and omissions of material fact made by Defendant, upon 

which Plaintiffs and members of the Class and Subclasses reasonably and justifiably relied, were 

intended to induce and actually induced Plaintiffs and members of the Class and Subclasses to 

purchase the defective ranitidine medications.

88. Defendant knew that the ranitidine containing medications were contaminated 

with this harmful impurity, but continued to manufacture it nonetheless. In 2003, it was 

“proposed that elevated levels of NDMA in drinking water ... may be associated with the drug 

ranitidine.”26 Likewise, in 2004, a study found the use of Zantac to be “related to the risk of 

bladder cancer.”27 Furthermore, a 2016 study by Stanford University found that individuals who 

took ranitidine medications had “NDMA levels [in their urine] more than 400 times greater than 

what the FDA considers acceptable.”28 During that time, Plaintiffs and members of the Class

and Subclasses were using the medications without knowing that they contained dangerous 

levels of NDMA.

26 VALISURE PETITION at 4-5.

27 Dominque S. Michaud et al., Peptic Ulcer Disease and the Risk of Bladder Cancer in a Prospective 

Study of Male Health Professionals, 13 CANCER EPIDEMIOLOGY, BIOMARKERS & PREVENTION 250, 

252 (2004) https://pdfs.semanticscholar.org/3eeb/c399404a2b100d90c6698bd4fc73a748864e.pdf

(last accessed Apr. 21, 2020).

28 Jonathan Lapook, Potentially Dangerous Chemical Found in Popular Heartburn Pill Zantac, 

CBS NEWS, Oct. 8, 2019, https://www.cbsnews.com/news/zantac-ndma-levels-potentiallydangerous-chemical-zantac-ranitidine-heartburn-pills-2019-10-08/ (last accessed Apr. 21, 2020).

Case 9:20-cv-80791-RLR Document 1 Entered on FLSD Docket 04/30/2020 Page 23 of 26
24

89. The fraudulent actions of Defendant caused damage to Plaintiffs and members of 

the Class and Subclasses, who are entitled to damages and other legal and equitable relief as a 

result.

90. As a result of Defendant’s willful and malicious conduct, punitive damages are 

warranted.

COUNT VII

Conversion

(On Behalf Of The Class And Subclasses)

91. Plaintiffs hereby incorporate by reference the allegations contained in all 

preceding paragraphs of this complaint.

92. Plaintiffs bring this claim individually and on behalf of the members of the 

proposed Class and Subclasses against Defendant.

93. Plaintiffs and the Class and Subclasses have an ownership right to the monies 

paid for the defective ranitidine manufactured by Defendant.

94. Defendant has wrongly asserted dominion over the payments illegally diverted to 

them for the defective ranitidine medications. Defendant has done so every time that Plaintiffs

and the Class and Subclasses bought the ranitidine-containing medications.

95. As a direct and proximate cause of Defendant’s conversion, Plaintiffs and the 

Class and Subclasses suffered damages in the amount of the payments made for each time they

were prescribed or paid money for the ranitidine medications.

PRAYER FOR RELIEF

WHEREFORE, Plaintiffs, individually and on behalf of all others similarly situated, seek 

judgment against Defendant, as follows:

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(a) For an order certifying the Class and the Subclasses under Rule 23 of the 

Federal Rules of Civil Procedure and naming Plaintiffs as the representatives

of the Class and Subclasses and Plaintiffs’ attorneys as Class Counsel;

(b) For an order declaring the Defendant’s conduct violates the statutes referenced 

herein;

(c) For an order finding in favor of Plaintiffs, the Class, and the Subclasses on all 

counts asserted herein;

(d) For compensatory, statutory, and punitive damages in amounts to be 

determined by the Court and/or jury;

(e) For prejudgment interest on all amounts awarded;

(f) For an order of restitution and all other forms of equitable monetary relief;

(g) For injunctive relief as pleaded or as the Court may deem proper; and

(h) For an order awarding Plaintiffs and the Class and Subclasses their reasonable 

attorneys’ fees and expenses and costs of suit.

DEMAND FOR TRIAL BY JURY

Pursuant to Federal Rule of Civil Procedure 38(b), Plaintiffs demand a trial by jury of any 

and all issues in this action so triable of right.

Dated: April 30, 2020 Respectfully submitted,

BURSOR & FISHER, P.A.

By: /s/ Andrew J. Obergfell 

 Andrew J. Obergfell

Andrew J. Obergfell 

888 Seventh Avenue, Third Floor

New York, NY 10019

Telephone: (646) 837-7150

Facsimile: (212) 989-9163

Email: aobergfell@bursor.com

BURSOR & FISHER, P.A.

Sarah N. Westcot (Pro Hac Vice Forthcoming)

2665 S. Bayshore Drive, Suite 220

Miami, FL 33133

Case 9:20-cv-80791-RLR Document 1 Entered on FLSD Docket 04/30/2020 Page 25 of 26
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Telephone: (305) 330-5512

Facsimile: (925) 407-2700

Email: swestcot@bursor.com

Attorneys for Plaintiffs

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