Ezricare NY Lawsuit
Ezricare NY Lawsuit
Ezricare NY Lawsuit
Plaintiff Demany Browne (“Plaintiff”) brings this Class Action Complaint on behalf of
himself and all persons similarly situated who purchased EzriCare Artificial Tears and Delsam
Pharma Artificial Tears (collectively the “Products”) 1 manufactured, imported, sold, marketed,
labeled, and distributed by Defendants Ezricare LLC and Delsam Pharama LLC. (collectively
“Defendants”). 2 Plaintiff alleges the following based upon personal knowledge as well as
investigation by counsel, and as to all other matters, upon information and belief. Plaintiff further
believes that substantial evidentiary support will exist for the allegations set forth herein after a
INTRODUCTION
sell several over-the-counter pharmaceutical products, including the above-named Products, which
3. The presence of the Pseudomonas Aeruginosa bacteria in the Products is due to,
among other things, Defendants’ violation of Current Good Manufacturing Processes (as identified
by the Food and Drug Administration), including “lack of appropriate microbial testing,
formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use
1
Plaintiff reserves the right to amend, add to, or modify the definition of Products through facts obtained later in
investigation and discovery.
2
Plaintiff reserves the right to add or modify the Defendants who contributed to the deceptive and illegal conduct
alleged herein.
3
See FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination, FOOD
& DRUG ADMIN. (Feb. 2, 2023), located at https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns- con-
sumers-not-purchase-or-use-ezricare-artificial-tears-due-potential-contamination.
2
Case 1:23-cv-01019-DG-MMH Document 1 Filed 02/07/23 Page 3 of 20 PageID #: 3
bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident
packaging.” 4
4. These violations, along with the presence of this rare and, in some cases, deadly,
bacteria pose a significant and severe health risk to consumers, such as Plaintiff and the putative
5. Plaintiff and the putative class suffered economic damages due to Defendants’
misconduct (as set forth below) and seek damages for the purchase of the contaminated Products
they purchased.
PARTIES
Plaintiff
6. Plaintiff Browne is an individual and citizen of New York who resides in Brooklyn,
New York. Plaintiff purchased Delsam Pharma’s artificial tears dry eye relief from Walmart
Supercenter in Valley Stream, New York in approximately July 2022. Plaintiff purchased the
Product at the retail price charged by Walmart at that time. During that time, based on the false
and misleading claims by Defendants, Plaintiff was unaware that Defendants’ Product may be
adulterated and contaminated with the dangerous Pseudomonas Aeruginosa bacteria. Plaintiff
purchased Defendants’ Product on the assumption that the labeling of Defendants’ Products was
accurate and that the Products were unadulterated, safe, and effective and, most importantly, were
not contaminated (or were not at risk of being contaminated) with this deadly bacterium. Plaintiff
would not have purchased Defendants’ artificial tear product(s) had he known there was a risk the
product may contain the Pseudomonas Aeruginosa bacteria and cause severe infection. As a result,
Plaintiff suffered injury in fact when he spent money to purchase Defendants’ Products he would
4
Id.
3
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not otherwise have purchased, and/or paid more for the Products, absent Defendants’ deceptive
Defendants
7. Defendant EzriCare LLC is, and at all times relevant to this action was, a New
Jersey Limited Liability Company with its principal place of business located at 1525 Prospect
Street, Suite 204, Lakewood, NJ 08701. EzriCare LLC markets, advertises, labels, distributes, and
8. Defendant Delsam Pharma LLC is, and at all times relevant to this action was, a
New York Limited Liability Company with its principal place of business located in the Bronx,
New York 10567, and process may be served upon its registered agent, Kuppusamy Arumugam at
925 Protano Lane, Mamaroneck, New York, 10543. Delsam Pharma LLC markets, advertises,
9. On information and belief, the labeling for the Products, that Plaintiff and Class
members read and relied upon in making their decisions to purchase the Products were conceived,
designed, prepared and/or approved by Defendants and were disseminated by Defendants and their
agents through labeling, marketing and advertising containing the misrepresentations, from
Defendants’ headquarters.
10. On information and belief, in committing the wrongful acts alleged herein,
Defendants, in connection with their subsidiaries, affiliates and/or other related entities and their
employees, planned, participated in, and furthered a common scheme to induce members of the
public to purchase the Products, and Defendants participated in the making of such representations
and/or omissions of material fact in that it disseminated the contaminated Products or caused them
to be disseminated.
4
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11. The Court has jurisdiction over this action pursuant to 28 U.S.C. §1332(d)(2)(A),
the Class Action Fairness Act (“CAFA”), as the matter in controversy exceeds the sum of
$5,000,000 (five million dollars) exclusive of interest and costs, and at least one member of the
putative class is a citizen of a state different from at least one Defendant. Specifically, Plaintiff is
a resident and citizen of New York, while Defendant EzriCare LLC is a resident and citizen of
New Jersey, with its principal place of business in New York. None of the exceptions of 28 U.S.C.
12. This Court has personal jurisdiction over Defendants because they conduct and
transact business within the District, and contract to supply and supply the Products within the
District by, among other things, marketing, advertising, and selling the Products in the District.
Further, Plaintiff’s claims arise from Defendants’ conduct within the District.
13. Venue is proper because Plaintiff and many class members reside in this District,
Defendants do business in this District and in New York, and a substantial part of the events giving
STATEMENT OF FACTS
15. EzriCare LLC began labeling, advertising, marketing, and selling the Products on
5
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16. The Products are intended to be used in the following manner: (1) as a protectant
against further irritation or to relieve dryness of the eye; and (2) for the temporary relief of
17. The Products are purportedly “preservative free,” which removes any chemical
Sodium 10 MG in 1 ml. The inactive ingredients include Boric Acid, Potassium Chloride, Sodium
5
See EzriCare Artificial Tears Product Monograph, located at https://dailymed.nlm.nih.gov/dai-
lymed/fda/fdaDrugXsl.cfm?setid=ac1ea23c-f1c6-418f-921e- 58553ee919cb&type=display.
6
See Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears, CDC
HEALTH ALERT NETWORK, located at https://emergency.cdc.gov/han/2023/han00485.asp?ACSTrack-
ingID=USCDC_511- DM98842&ACSTrackingLabel=HAN%20485%20-%20General%20Public&deliv-
eryName=USCDC_511- DM98842.
7
Id.
6
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20. The NDC number for Delsam Pharma’s Artificial Tears is 72570-121-15.
21. Delsam Pharma LLC began marketing the Products on or about July 23, 2020.
22. The Products are a substantially similar product to EzriCare Artificial Tears. The
Products are simply different brands of the same chemical solution (in terms of active ingredients).
And like the EzriCare-branded Products, Delsam Pharma’s Products are intended to be used in the
following manner: (1) as a protectant against further irritation or to relieve dryness of the eye; and
(2) for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind
or sun.
23. According to its website, Delsam Pharma’s Products use preservatives “to keep
8
See https://delsampharma.com/store/delsam-pharma-artificial-tears.
7
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Sodium 10 MG in 1 ml. The inactive ingredients include Boric Acid, Potassium Chloride, Sodium
9
Id.
8
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26. The Pseudomonas Aeruginosa bacteria is not a new bacteria, but it is notorious for
being “versatile” and “innately drug resistant.” 10 It is most frequently found in the environment,
27. However, the Pseudomonas Aeruginosa bacteria is also known to infect humans,
and it can cause severe skin, eye, lung, and other infections throughout the body.
Products
29. The current outbreak of the Pseudomonas Aeruginosa bacteria resulting from the
use of the EzriCare and/or Delsam Pharma Artificial Tears began in May 2022 and has been linked
to at least 12 states, so far: California, Colorado, Connecticut, Florida, New Jersey, New Mexico,
30. The U.S. Centers for Disease Control (“CDC”) has isolated the specific strain of
10
Beth Mole, Extremely drug-resistant germ found in eye drops infects 55 in 12 states; 1 dead, ARS TECHNICA
(Feb. 2, 2023), located at https://arstechnica.com/science/2023/02/extremely-drug-resistant-germ-found-in-eye-
drops- infects-55-in-12-states-1-dead/.
11
Id.
12
Id.
9
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31. The CDC reported that its “laboratory testing identified the presence of the outbreak
strain in opened EzriCare bottles with different lot numbers collected from two states.” 14
32. The CDC also reported that it was able to isolate the outbreak strain from 13 sputum
or bronchial washes, 11 cornea swabs, seven urine samples, two blood samples, 25 rectal swabs,
33. As a result of using the Products, out of the 55 individuals who have been identified
as having been infected with the Pseudomonas Aeruginosa bacteria from the use of the Products
thus far, approximately three people have suffered permanent vision loss, and one person has died
due to a systemic infection. Others have endured extensive treatment to treat their infections.
34. On January 24, 2023, Defendant EzriCare LLC first issued a statement on the
contamination of its artificial tears product, stating; “EzriCare became aware in the last few days
that the Center for Disease Control (CDC) is conducting an ongoing investigation related to
adverse events implicating various Over the Counter (OTC) eye drops.” 17
13
See Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears, CDC
HEALTH ALERT NETWORK, located at https://emergency.cdc.gov/han/2023/han00485.asp?ACSTrack-
ingID=USCDC_511-DM98842&ACSTrackingLabel=HAN%20485%20-%20General%20Public&deliv-
eryName=USCDC_511-DM98842.
14
Id.
15
Beth Mole, Extremely drug-resistant germ found in eye drops infects 55 in 12 states; 1 dead, ARS TECHNICA (Feb.
2, 2023), located at https://arstechnica.com/science/2023/02/extremely-drug-resistant-germ-found-in-eye-drops- in-
fects-55-in-12-states-1-dead/.
16
FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination, FOOD &
DRUG ADMIN. (Feb. 2, 2023), located at https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns- consum-
ers-not-purchase-or-use-ezricare-artificial-tears-due-potential-contamination.
17
EzriCare Artificial Tears - Discontinue Use (Feb. 2, 2023), located at https://ezricare-info.com.
10
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35. After the development of this story, on February 1, 2023, EzriCare issued another
statement: “EzriCare, LLC first received notice of the CDC's ongoing investigation into a
multistate cluster of Pseudomonas aeruginosa infections on January 20, 2023. As of today, we are
not aware of any testing that definitively links the Pseudomonas aeruginosa outbreak to EzriCare
Artificial Tears. Nonetheless, we immediately took action to stop any further distribution or sale
of EzriCare Artificial Tears. To the greatest extent possible, we have been contacting customers
to advise them against continued use of the product. We also immediately reached out to both CDC
and FDA and indicated our willingness to cooperate with any requests they may have of us.” 18
recall of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears. 19
37. Then, on February 2, 2023, the U.S. Food and Drug Administration (“FDA”) issued
a statement “warning consumers and health care practitioners not to purchase and to stop using
EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to bacterial contamination.”20
The FDA highlighted that it recommended Global Pharma initiate a product recall due to “the
appropriate microbial testing, formulation issues (the company manufactures and distributes
ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper
38. Further, the FDA also “placed Global Pharma Healthcare Private Limited on import
alert . . . for providing an inadequate response to a records request and for not complying with
18
Id.
19
See Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to
Possible Contamination, located at https://global-pharma.com/otc.pdf.
20
FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination, FOOD &
DRUG ADMIN. (Feb. 2, 2023), located at https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns- consum-
ers-not-purchase-or-use-ezricare-artificial-tears-due-potential-contamination.
21
Id.
11
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CGMP requirements.” 22 According to the FDA, the import alert “prevents these products from
39. Because of Defendants’ actions, the Products are worthless and certainly worth less
40. Had Defendants not informed Plaintiff and the Class members of the existence of
Pseudomonas Aeruginosa bacteria in the Products (or that the Products risked containing
Pseudomonas Aeruginosa), they would not have been willing to pay the same amounts for the
41. Plaintiff and the Class members paid for Products that they reasonably believed did
not contain Pseudomonas Aeruginosa bacteria, but they did not receive what they paid for.
Unfortunately, the Products Plaintiff and the Class members purchased, received, and used were
contaminated and illegal to sell, thereby making the Products worthless or certainly worth less than
42. Based on Defendants’ actions, they were able to, and did, charge a premium price
for the Products over the cost of competitive products that did not contain Pseudomonas
Aeruginosa bacteria.
43. Plaintiff and the Class members all paid money for the Products. However, Plaintiff
and the Class members did not obtain the full value of the Products due to Defendants’ actions as
described above. Plaintiff and the Class members paid more for the Products than they would have
(if at all) had they known the truth about the Products. Consequently, Plaintiff and the Class
members have suffered injury in fact and lost money as a result of Defendants’ deceptive and
unlawful conduct.
22
Id.
23
Id.
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44. Plaintiff brings this case as a class action pursuant to Federal Rule of Civil
Procedure 23(a) and 23(b)(3) on behalf of himself and the following classes defined as follows:
All persons who purchased the Products within the United States for personal, family, or
household use during the Class Period. (the “Nationwide Class”)
All persons who purchased the Products within New York for personal, family, or
household use during the Class Period. (the “New York Subclass”)
(the Nationwide Class and New York Subclass collectively the “Class”)
45. “Class Period” means the period from three years prior to the filing of this
46. Excluded from the Class are Defendants’ current or former officers, directors, and
employees; counsel for Plaintiff and Defendants; and the judicial officer to whom this lawsuit is
assigned.
47. Plaintiff reserves the right to amend or otherwise alter the class definition presented
to the Court at the appropriate time in response to facts learned through discovery, legal arguments
advanced by Defendants, or otherwise. Plaintiff also reserves the right to create subclasses.
48. Plaintiff expressly disclaims any claims for personal injuries. Moreover, the
definition of the “Class” expressly excludes any individual’s claims for personal injuries as a result
49. The requirements of Federal Rule of Civil Procedure 23 are satisfied because:
50. Numerosity: The members of each class are so numerous that joinder of all
members is impracticable. While the exact number of Class members is presently unknown to
Plaintiff, based on Defendants’ volume of sales, Plaintiff estimates that the Class numbers are in
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the thousands. Defendants’ books and records will contain more detailed information regarding
51. Commonality: There are questions of law and fact that are common to the Class
members and that predominate over individual questions. These include the following:
d. Whether Defendants’ conduct injured consumers and, if so, the extent of the injury;
and
52. Typicality: Plaintiff’s claims are typical of the claims of the Class members because
Plaintiff suffered the same injury as the Class members by nature of their purchases of the Products
53. Adequacy: Plaintiff will fairly and adequately represent and protect the interests of
the members of each class. Plaintiff does not have any interests that are adverse to those of the
Class members. Plaintiff has retained competent counsel experienced in class action litigation who
intend to prosecute this action vigorously and have the financial means of doing so.
54. Superiority: A class action is superior to other available methods for the efficient
adjudication of this controversy. Class action treatment will permit a large number of similarly
situated persons to prosecute their common claims in a single forum simultaneously, efficiently,
and without the unnecessary duplication of effort and expense that numerous individual actions
would engender. Since the damages suffered by individual Class members are relatively small,
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the expense and burden of individual litigation make it virtually impossible for the Class members
to seek redress for the wrongful conduct alleged, while an important public interest will be served
55. Plaintiff knows of no difficulty that will be encountered in the management of this
CAUSES OF ACTION
56. Plaintiff repeats each and every allegation contained in the paragraphs above and
57. New York General Business Law Section 349 (“GBL § 349”) declares unlawful
“[d]eceptive acts or practices in the conduct of any business, trade, or commerce or in the
deceptive acts and practices in violation of GBL § 349, and as such, Plaintiff and the other Class
60. Defendants further omitted material facts, including the presence of Pseudomonas
Aeruginosa bacteria in the Products (or that the Products risked containing Pseudomonas
Aeruginosa).
because Plaintiff and the other class members believed that the Products did not contain
62. Plaintiff and other Class Members paid extra money for accurately labeled Products
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free from Pseudomonas Aeruginosa bacteria. Had Plaintiff and reasonable consumers known that
the Products contained (or risked containing) Pseudomonas Aeruginosa bacteria, they would not
have purchased the Products at all or at least would not have paid as much for the Products.
63. Defendants engaged in its unlawful conduct as alleged herein willfully, wantonly,
64. Plaintiff and other Class Members have been injured inasmuch as they, having
viewed the Products label, and paid a premium for the Products. Accordingly, Plaintiff and other
Class Members paid more than what the Products they bargained for and received were worth.
65. Defendants’ conduct as alleged herein constitutes a deceptive act and practice in
the conduct of business in violation of New York General Business Law §349(a), and Plaintiff and
66. As a result of Defendants’ deceptive acts and practices, Plaintiff and other Class
Members are entitled to monetary and compensatory damages, restitution and disgorgement of all
moneys obtained by means of Defendants’ unlawful conduct, interest, and attorneys’ fees and
costs. This includes actual damages under GBL § 349, as well as statutory damages of $50 per unit
67. Plaintiff repeats each and every allegation contained in the paragraphs above and
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concerning its Products inasmuch as they misrepresented the Products were safe to use and free
72. Plaintiff and other Class Members have been injured inasmuch as they, having
viewed Defendants’ label, paid a premium for the Products. Plaintiff and other Class Members
paid more than what the Products they bargained for and received were worth.
73. Defendants engaged in unlawful conduct as alleged herein willfully, wantonly, and
75. As a result of Defendants’ acts and practices in violation of GBL § 350, Plaintiff
and class members are entitled to monetary and compensatory damages, restitution and
disgorgement of all monies obtained by means of Defendants’ unlawful conduct, interest, and
attorneys’ fees and costs, as well as statutory damages of $500 per Products purchased.
17
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76. Plaintiff repeats each and every allegation contained in the paragraphs above and
77. Plaintiff and the Class conferred a benefit on Defendants in the form of monies paid
79. Because this benefit was obtained unlawfully, namely by selling and accepting
compensation for Products unfit for human use, it would be unjust and inequitable for Defendants
WHEREFORE, Plaintiff, individually and on behalf of the members of the Class request
the Court:
(i) Enter an order certifying the proposed Class under Federal Rule of Civil Procedure
23(a) and (b)(3), as set forth above, naming Plaintiff as Class Representative of the Class, and
(ii) Enter an order declaring that Defendants are financially responsible for notifying
(iii) Issue judgment declaring that Defendants have committed the violations of law
alleged herein;
(iv) Issue judgment awarding statutory damages in the maximum amount for which the
law provides;
(v) Issue judgment awarding monetary damages, including but not limited to any
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compensatory, incidental, or consequential damages in an amount that the Court or jury will
(vi) Issue judgment providing for any and all equitable monetary relief the Court deems
appropriate;
(vii) Issue judgment awarding punitive or exemplary damages in accordance with proof
(viii) Issue judgment awarding Plaintiff his reasonable costs and expenses of suit,
(ix) Issue judgment awarding pre- and post-judgment interest to the extent the law
allows; and
(x) Awarding such further relief as this Court may deem just and proper.
REESE LLP
REESE LLP
Michael R. Reese
100 West 93rd Street, 16th Floor
New York, New York 10025
Telephone: (212) 643-0500
Email: mreese@reesellp.com
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