Remember the year of the eye drop recall (2023)? Well, a recently filed lawsuit is claiming one woman’s purchase and use of EzriCare artificial tear drops led to her suffering a serious eye infection.
This latest development comes 2 years after the Centers for Disease Control and Prevention (CDC) initially called for the immediate discontinued use of artificial tear brands across the United States—including EzriCare products—and the wave of reported fatalities, vision loss, and filed lawsuits that followed.
Let’s start with some background on those recalls.
A brief rundown:
January 2023: The CDC advised immediate discontinuation of artificial tear eye drops due to an outbreak of an antibiotic-resistant form of bacteria (Carbapenem-resistant Pseudomonas aeruginosa)
- This outbreak was linked to 10 different brands of over-the-counter (OTC) artificial tears, including EzriCare Artificial Tears.
February 2023: That voluntary recall for EzriCare was escalated to a Health Alert Network (HAN) Advisory, with eyecare providers (ECPs) and patients mandated to immediately stop use of the drops.
May 2023: The CDC confirmed a total of four deaths, 81 cases across 18 states, 14 reports of vision loss, and four reports of enucleation.
To note: A reported 85% of impacted consumers used EzriCare Artificial Tears.
And the lawsuits that were filed?
We last reported (in June 2023) that 14 lawsuits were filed in federal courts between February and June of 2023 by consumers alleging injuries due to the recalled contaminated products.
At the time, the plaintiffs' demands ranged from refunds for their product purchases to compensation for pain, suffering, medical bills, and loss of quality of life directly related to using the aforementioned products.
- Since then: Other class action lawsuits have been filed—including (in April 2024) one against EzriCare and Walmart (a seller of the EzriCare artificial tears).
Gotcha. Now talk about this latest filing.
Filed in a New Jersey federal court (headquarters of EzriCare, notably) on Jan. 31, the class action lawsuit alleges that a woman (Tabitha Starling) suffered from a serious eye infection after using EzriCare artificial tear eye drops that were sold at Walgreens.
- The exact verbiage: "Plaintiff has suffered, and continues to suffer, economic damages due to defendants’ misconduct and seeks injunctive relief and restitution for the full purchase price of the artificial tear products she purchased.”
The alleged issue with these drops: They were reportedly contaminated with P. aeruginosa bacteria strain—the same rare drug-resistant strain we mentioned earlier.
And who are the defendants?
Quite a few:
- EzriCare LLC
- EzriRix LLC
- Global Pharma Healthcare Private Ltd. (manufacturer of EzriCare Artificial Tears)
- Walgreen Co.
- Walgreens Boots Alliance Inc.
Explain the reasoning behind this lawsuit.
The plaintiff (Starling) is alleging that the EzriCare Artificial Tears (purchased from Walgreens) were contaminated with P. aeruginosa bacteria as a direct result of the defendants’ “negligent, reckless and / or intentional misconduct.”
As such: This caused the product to be in violation of the FDA’s Current Good Manufacturing Practice (cGMP) regulations, according to the filing.
- Quick refresh on cGMP: These regulations consist of minimum requirements—such as methods, facilities, and controls used in the manufacturing, processing, and packaging—drugs must meet to ensure a product is safe for use.
And in this instance?
The alleged violations include a lack of appropriate microbial testing and proper controls concerning tamper-evident packaging as well as formulation issues (the use of multi-dose bottles without a preservative) with the EzriCare drops.
- Per the suit: “These violations (plus the presence of bacteria) pose a significant and severe risk to consumers … who purchased and used (this) product.”
Can we get the story on the plaintiff’s alleged experience with these drops?
First off: Starling reportedly purchased the EzriCare eye drops in February 2022 from a Florida Walgreens location and began to experience “redness, visual impairment and pain in her eyes” by May 2022.
Then: After seeking medical care, she was reportedly diagnosed with bacterial keratitis, given an oral prescription medication, and later referred to a corneal specialist.
- The specialist diagnosed her with an “epithelial defect, diffuse edema, hypopyon and hazy view of the left cornea.”
After that: The plaintiff alleges she was advised a culture came back positive for the P. aeruginosa bacteria and was diagnosed with a pseudomonas corneal ulcer of the left eye with significant corneal stromal edema with early scarring along the periphery.
- This apparently only became larger and more pronounced at follow-up visits, despite prescribed medications.
Next: In the months that followed, Starling alleges she was eventually fitted for a scleral lens (August 2023) and was advised at a follow-up visit that she would require regular scleral lens refittings in the future.
And her claim in the lawsuit?
The suit states that she continues to undergo treatment, follow-up care, and suffers from “serious and potentially permanent injury to her eyes and vision.”
“Plaintiff’s injuries are debilitating and permanent,” according to the suit.
So what are the companies being accused of?
Starling is claiming all companies are guilty on 13 counts:
- Strict products liability—failure to warn
- Strict products liability—defective design and manufacture
- Negligence / gross negligence
- Products liability—negligent failure to warn
- Products liability—negligent design and manufacture defect
- Negligence—negligent misrepresentation and omission
- Fraud
- Fraudulent concealment
- Breach of implied warranty
- Negligent failure to timely recall
- Violation of the New Jersey Consumer Fraud Act
- By misrepresenting the sterile, uncontaminated, and safe nature of the product
- Punitive damages under:
- New Jersey common law
- New Jersey Punitive Damages Act
- New Jersey Products Liability Act
And what is the plaintiff seeking?
Starling is asking for compensatory and punitive damages and a “prayer for relief,” which includes an award of special damage such as past and future medical / incidental expenses and loss of earnings or earning capacity.
She is also demanding a jury trial.
So what happens next?
Click here for a step-by-step look at what to expect.
*Disclaimer: The information provided in this article does not and is not intended to constitute legal advice; instead, all information, content, materials available herein are for general information purposes only.