UNITED STATES DISTRICT COURT

DISTRICT OF NEW JERSEY

RENEE CLARK, on behalf of herself and all 

others similarly situated,

Plaintiff,

v.

AMNEAL PHARMACEUTICALS, LLC,

 Defendant.

Civil Action No. 

CLASS ACTION COMPLAINT

AND DEMAND FOR JURY 

TRIAL

Plaintiffs Renee Clark (“Plaintiff”) brings this action on behalf of herself and all others 

similarly situated against Amneal Pharmaceuticals, LLC (“Amneal” or “Defendant”). Plaintiff 

makes the following allegations pursuant to the investigation of her counsel and based upon 

information and belief, except as to the allegations specifically pertaining to herself, which are 

based on personal knowledge.

NATURE OF THE ACTION AND FACTS COMMON TO ALL CLAIMS

1. This is a class action lawsuit regarding Amneal’s manufacturing of ranitidinebased 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, Amneal’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 

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

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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. 

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.

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 November 8, 2019, Amneal announced the recall of Ranitidine Tablets, USP, 

150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, because 

of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.”5 

Amneal has instructed consumers to cease using recalled ranitidine medications.6

A. Amneal Markets Its Ranitidine Medications As Safe

7. Amneal marketed its ranitidine medications as safe and effective products.

8. On Amneal’s website page for its generic medications, Amneal touts that it

“deliver[s] quality, trust, and value.”

9. Amneal also notes that “for close to 20 years [consumers] have associated the 

Amneal name with an unwavering commitment to quality, service, and value.”

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

manufactured by Amneal, they expect that the medications will be safe and 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. Amneal’s Ranitidine Medications Contain Dangerous Levels Of NDMA

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

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

4 Id.

5 Food & Drug Admin., Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of 

Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, 

USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity (Nov. 

22, 2019), https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amnealpharmaceuticals-llc-issues-voluntary-nationwide-recall-ranitidine-tablets-usp-150mg-and-300mg

(last accessed Apr. 21, 2020).

6 Id.

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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 

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. However, the Health Products 

Regulatory Authority of Ireland, in issuing a recall of ranitidine medications, has stated: “The 

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).

10 Id.

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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 Amneal’s ranitidine 

medications, according to testing by the FDA, have an NDMA content of 0.52-2.17 ppm, 

significantly more than the acceptable daily limit for NDMA:

Company Product Lots Tested NDMA level ppm

Amneal Pharmaceuticals Ranitidine 

300mg

AR181795A, 

AR190878A, 

AR190876A, 

AR191177A, 

HB05819, HB06119, 

HL08718

0.52-2.17

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 

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

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).

14 Id.

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C. Plaintiff Was Harmed By Purchasing Or Being Prescribed And Consuming 

Defective Ranitidine Medications Manufactured By Defendant

17. Plaintiff and the Class and Subclass were injured by the full purchase price of 

their Amneal ranitidine medications. These medications are worthless, as they contain harmful 

levels of NDMA. This is underscored by Amneal’s voluntary recall of ranitidine medications 

“because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the 

FDA,” and its instruction to consumers to “stop using the product.”15 As the medications expose 

users to NDMA well above the legal limit, the medications are not fit for human consumption. 

Plaintiff is 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. Plaintiff brings this action on behalf of herself and the Class and Vermont

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

warranty of merchantability, (ii) violation of the Vermont Deceptive Trade Practices Act, 9 Vt. 

Stat. § 2451, et seq., (iii) unjust enrichment, (iv) fraudulent concealment, (v) fraud, and (vi) 

conversion.

PARTIES

19. Plaintiff Renee Clark is a citizen of Vermont who resides in Fair Haven, Vermont. 

During all relevant time periods, Ms. Clark was prescribed and consumed ranitidine medications

manufactured by Amneal. Ms. Clark originally learned about the ranitidine defect through news 

sources reporting NDMA in ranitidine medications. Each time Ms. Clark picked up her 

15 Food & Drug Admin., Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of 

Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, 

USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity (Nov. 

22, 2019), https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amnealpharmaceuticals-llc-issues-voluntary-nationwide-recall-ranitidine-tablets-usp-150mg-and-300mg

(last accessed Apr. 21, 2020).

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ranitidine medications, she was required to make a co-payment of approximately $1.25. When 

purchasing her ranitidine medications manufactured by Defendant, Ms. Clark 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. Clark 

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

from Amneal, and these representations and warranties were part of the basis of the bargain, in 

that she would not have purchased her ranitidine medication manufactured by Defendant at all, 

or would have only been willing to pay a substantially reduced price for her ranitidine 

medication, if she had known that it was not, in fact, properly manufactured, and contained the 

carcinogenic impurity NDMA. Ms. Clark understood that each purchase involved a direct 

transaction between herself and Amneal because her medication came with packaging and other 

materials prepared by Amneal, including representations and warranties that her medication was 

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

20. Defendant Amneal Pharmaceuticals, LLC is a Delaware corporation with a

principal place of business at 400 Crossing Boulevard, Bridgewater Township, New Jersey 

08807. Amneal conducts substantial business in the United States, including in the State of 

Vermont. Amneal has been engaged in the manufacturing of defective ranitidine throughout the 

United States, including in the State of Vermont. 

JURISDICTION AND VENUE

21. 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 

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

interest and costs.

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

resides in this District.

23. This Court has personal jurisdiction over Defendant because Defendant’s 

principal place of business is in this District.

CLASS ALLEGATIONS

24. Plaintiff seeks to represent a class defined as all persons in the United States who 

purchased or were prescribed ranitidine-containing medications manufactured by Amneal (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 also seeks to represent a subclass of all Class members who purchased 

ranitidine-containing medications manufactured by Amneal in Vermont (the “Vermont

Subclass”). 

26. Subject to additional information obtained through further investigation and 

discovery, the foregoing definitions of the Class and Vermont Subclass may be expanded or 

narrowed by amendment or amended complaint.

27. Numerosity. The members of the Class and Vermont Subclass are 

geographically dispersed throughout the United States and are so numerous that individual 

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joinder is impracticable. Upon information and belief, Plaintiff reasonably estimates that there 

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

Vermont Subclass. Although the precise number of members in the Class and Vermont Subclass

is unknown to Plaintiff, the true number of members in the Class and Vermont Subclass is 

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

Vermont Subclass 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. 

28. 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 Vermont Subclass and 

predominate over any questions affecting only individual members of the Class and Vermont

Subclass. 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 Plaintiff and the 

Class and Vermont Subclass;

(d) whether Defendant is liable to Plaintiff and the Class and Vermont Subclass

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for unjust enrichment;

(e) whether Defendant is liable to Plaintiff and the Class and Vermont Subclass

for fraudulent concealment;

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

violations of Vermont consumer-protection laws;

(h) whether Defendant is liable to Plaintiff and the Class and Vermont Subclass

for breaches of express and implied warranties;

(i) whether Plaintiff and the Class and Vermont Subclass have sustained 

monetary loss and the proper measure of that loss;

(j) whether Plaintiff and the Class and Vermont Subclass are entitled to 

declaratory and injunctive relief;

(k) whether Plaintiff and the Class and Vermont Subclass 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.

29. Typicality. Plaintiff’s claims are typical of the claims of the other members of 

the Class and Vermont Subclass in that Defendant mass marketed and sold defective ranitidinebased 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 Plaintiff and members of 

the Class and Vermont Subclass by manufacturing, distributing, and selling the defective 

ranitidine-containing medications. Plaintiff’s claims are typical in that they and members of the 

Class and Vermont Subclass were uniformly harmed in purchasing and consuming the defective

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ranitidine-containing medications. Plaintiff’s claims are further typical in that Defendant 

deceived Plaintiff in the very same manner as they deceived each member of the Class and 

Vermont Subclass. Further, there are no defenses available to Defendant that are unique to 

Plaintiff. 

30. Adequacy of Representation. Plaintiff will fairly and adequately protect the 

interests of the Class and Vermont Subclass. Plaintiff has retained counsel that is highly 

experienced in complex consumer class action litigation, and Plaintiff intends to vigorously 

prosecute this action on behalf of the Class and Vermont Subclass. Furthermore, Plaintiff has no 

interests that are antagonistic to those of the Class and Vermont Subclass.

31. 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 Vermont Subclass 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 Vermont Subclass, on an individual basis, to obtain 

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

Class and Vermont Subclass 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.

32. In the alternative, the Class and Vermont Subclass may also be certified because:

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

Vermont Subclass would create a risk of inconsistent or varying adjudications

with respect to individual members of the Class and Vermont Subclass that 

would establish incompatible standards of conduct for the Defendant;

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

Vermont Subclass 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 Vermont Subclass 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 Vermont Subclass as a whole, thereby making 

appropriate final declaratory and/or injunctive relief with respect to the 

members of the Class and Vermont Subclass as a whole.

COUNT I

Breach Of The Implied Warranty Of Merchantability

(On Behalf Of The Class And Vermont Subclass)

33. Plaintiff hereby incorporates by reference the allegations contained in all 

preceding paragraphs of this complaint.

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

proposed Class and the Vermont Subclass against Defendant.

35. 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.

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

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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, Plaintiff and 

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

Defendant to be merchantable.

37. Plaintiff and members of the Class and Vermont Subclass purchased the ranitidine

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

fitness for the purpose.

38. The ranitidine medications were not altered by Plaintiff or members of the Class

and Vermont Subclass.

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

Defendant.

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

without additional testing by Plaintiff and members of the Class and Vermont Subclass.

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

intended purpose, and Plaintiff and members of the Class and Vermont Subclass did not receive 

the goods as warranted.

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

Plaintiff and members of the Class and Vermont Subclass have been injured and harmed 

because: (a) they would not have purchased the ranitidine medications on the same terms if they 

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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.

43. As a result of Defendant’s breach of implied warranty, Plaintiff and each of the 

members of the Class and Vermont Subclass 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 Vermont Deceptive Trade Practices Act,

9 Vt. Stat. § 2451, et seq.

(On Behalf Of The Vermont Subclass)

44. Plaintiff hereby incorporates by reference the allegations contained in all 

preceding paragraphs of this complaint.

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

proposed Vermont Subclass against Defendant.

46. Vermont’s Deceptive Trade Practices Act (“VDTPA”), 9 Vt. Stat. § 2451, et seq.,

prohibits unfair or deceptive acts or practices in commerce. 9 Vt. Stat. § 2453(a).

47. In its sale of goods throughout the State of Vermont, Defendant conducts

commerce within the meaning and intendment of 9 Vt. Stat. § 2453(a).

48. Plaintiff and members of the Vermont Subclass are consumers who purchased 

products from Defendant for their personal use.

49. By the acts and conduct alleged herein, Defendant have engaged in unfair and 

deceptive acts and practices, which include, without limitation, misrepresenting that its ranitidine 

medication (i) would not contain dangerously high levels of NDMA and (ii) is generally 

recognized as safe for human consumption.

50. The foregoing deceptive acts and practices were directed at consumers.

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51. The foregoing deceptive acts and practices are misleading in a material way

because they fundamentally misrepresent the characteristics and quality of its ranitidine 

medication to induce consumers to purchase the same.

52. By reason of this conduct, Defendant engaged in deceptive conduct in violation of 

the VDTPA.

53. Defendant’s actions are the direct, foreseeable, and proximate cause of the

damages that Plaintiff and members of the Vermont Subclass have sustained from having paid

for and used Defendant’s products.

54. As a result of Defendant’s violations, Plaintiff and members of the Vermont

Subclass have suffered damages because: (a) they would not have purchased Defendant’s 

ranitidine medication on the same terms if they knew that Defendant’s ranitidine medication

contained high levels of NDMA; and (b) Defendant’s ranitidine medication does not have the 

characteristics, uses, benefits, or qualities as promised.

55. On behalf of herself and other members of the Vermont Subclass, Plaintiff seeks

to recover her actual damages, three times actual damages, and reasonable attorneys’ fees.

COUNT III

Unjust Enrichment

(On Behalf Of The Class And Vermont Subclass)

56. Plaintiff hereby incorporates by reference the allegations contained in all 

preceding paragraphs of this complaint.

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

proposed Class and Vermont Subclass against Defendant.

58. Plaintiff and the Class and Vermont Subclass conferred a benefit on Defendant in 

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

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59. Defendant voluntarily accepted and retained this benefit.

60. 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 IV

Fraudulent Concealment

(On Behalf Of The Class and Vermont Subclass)

61. Plaintiff hereby incorporates by reference the allegations contained in all 

preceding paragraphs of this complaint.

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

proposed Class and Vermont Subclass against Defendant.

63. Defendant had a duty to disclose material facts to Plaintiff and the Class and 

Vermont Subclass given their relationship as contracting parties and intended users of the 

ranitidine-containing medications, including the ranitidine medications. Defendant also had a 

duty to disclose material facts to Plaintiff and the Class and Vermont Subclass, 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.

64. 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 

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ranitidine.”16 Likewise, in 2004, a study found the use of Zantac (the brand name for ranitidine) 

to be “related to the risk of bladder cancer.”17 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.”18 During that time, Plaintiff

and members of the Class and Vermont Subclass were using the ranitidine medications without 

knowing it contained dangerous levels of NDMA.

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

66. In so failing to disclose these material facts to Plaintiff and the Class and Vermont

Subclass, Defendant intended to hide from Plaintiff and the Class and Vermont Subclass 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.

67. Plaintiff and the Class and Vermont Subclass 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.

68. As a direct and proximate cause of Defendant’s fraudulent concealment, Plaintiff

and the Class and Vermont Subclass suffered damages in the amount of monies paid for the 

16 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”).

17 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).

18 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-81028-RLR Document 1 Entered on FLSD Docket 04/30/2020 Page 17 of 21
18

defective ranitidine medications.

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

warranted.

COUNT V

Fraud

(On Behalf Of The Class and Vermont Subclass)

70. Plaintiff hereby incorporates by reference the allegations contained in all 

preceding paragraphs of this complaint.

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

proposed Class and Vermont Subclass against Defendant.

72. As discussed above, Defendant provided Plaintiff and members of the Class and 

Vermont Subclass with materially false or misleading information about their ranitidinecontaining 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. 

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

which Plaintiff and members of the Class and Vermont Subclass reasonably and justifiably 

relied, were intended to induce and actually induced Plaintiff and members of the Class and 

Vermont Subclass to purchase the defective ranitidine medications.

74. 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 

Case 9:20-cv-81028-RLR Document 1 Entered on FLSD Docket 04/30/2020 Page 18 of 21
19

ranitidine.”19 Likewise, in 2004, a study found the use of Zantac (the brand name for ranitidine)

to be “related to the risk of bladder cancer.”20 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.”21 During that time, Plaintiff

and members of the Class and Vermont Subclass were using the medications without knowing 

that they contained dangerous levels of NDMA.

75. The fraudulent actions of Defendant caused damage to Plaintiff and members of 

the Class and Vermont Subclass, who are entitled to damages and other legal and equitable relief 

as a result.

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

warranted.

COUNT VI

Conversion

(On Behalf Of The Class And Vermont Subclass)

77. Plaintiff hereby incorporates by reference the allegations contained in all 

preceding paragraphs of this complaint.

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

proposed Class and Vermont Subclass against Defendant.

79. Plaintiff and the Class and Vermont Subclass have an ownership right to the

19 VALISURE PETITION at 4-5.

20 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).

21 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-81028-RLR Document 1 Entered on FLSD Docket 04/30/2020 Page 19 of 21
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monies paid for the defective ranitidine manufactured by Defendant.

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

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

and the Class and Vermont Subclass bought the ranitidine-containing medications.

81. As a direct and proximate cause of Defendant’s conversion, Plaintiff and the 

Class and Vermont Subclass 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, Plaintiff, individually and on behalf of all others similarly situated, seeks

judgment against Defendant, as follows:

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

the Federal Rules of Civil Procedure and naming Plaintiff as the

representatives of the Class and Vermont Subclass and Plaintiff’s 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 Plaintiff, the Class, and the Vermont Subclass

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 Plaintiff and the Class and Vermont Subclass their 

reasonable attorneys’ fees and expenses and costs of suit.

Case 9:20-cv-81028-RLR Document 1 Entered on FLSD Docket 04/30/2020 Page 20 of 21
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DEMAND FOR TRIAL BY JURY

Pursuant to Federal Rule of Civil Procedure 38(b), Plaintiff 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

Vermont, NY 10019

Telephone: (646) 837-7150

Facsimile: (212) 989-9163

Email: jmarchese@bursor.com

aobergfell@bursor.com

BURSOR & FISHER, P.A.

Sarah N. Westcot (Pro Hac Vice Forthcoming)

2665 S. Bayshore Drive, Suite 220

Miami, FL 33133

Telephone: (305) 330-5512

Facsimile: (925) 407-2700

Email: swestcot@bursor.com

Attorneys for Plaintiff

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