Class Action Filed Following Artificial Tears Recall, Says Eye Drops Pose 'Serious and Dangerous Health Risk'

The companies behind EzriCare- and Delsam Pharma-brand Artificial Tears face a proposed class action lawsuit less than a week after the eye drops were voluntarily recalled over concerns the products could be contaminated with potentially deadly bacteria.

The 29-page complaint out of Kentucky alleges the presence of a rare, drug-resistant strain of bacteria in the eye drops stems from a lack of sufficient microbial testing, formulation issues and an absence of proper tamper-proof packaging controls on part of Global Pharma Healthcare Private Ltd. The strain of bacteria found in the eye drops is known to infect humans and can cause serious skin, eye and lung issues, the suit states.

So far, the outbreak of the bacteria—Pseudomonas aeruginosa—linked to the EzriCare and Delsam Pharma Artificial Tears has spanned 12 states, the filing says. As of January 31, out of the 55 people who have been identified as having been infected with the bacteria after using over-the-counter artificial tears, roughly three have suffered permanent vision loss, and one has died due to bloodstream infection, the case relays.

The Food and Drug Administration (FDA) urges consumers and healthcare providers not to purchase and to immediately stop using EzriCare and Delsam Pharma Artificial Tears. The FDA added that Global Pharma Healthcare Private Ltd. has been placed on “import alert”—meaning it cannot import the products into the United States—due to its “inadequate response to a records request” and failure to comply with current good manufacturing practices (CGMP) requirements.

The suit charges that the defendants – EzriCare LLC, EzriRx LLC, Delsam Pharma LLC, Global Pharma Healthcare Private Ltd., and Aru Pharma Inc. – knew or should have known the artificial tears were contaminated, yet failed to disclose this information to the public and continued to misrepresent the drops as safe.

FDA, CDC step in

The EzriCare and Delsam Pharma Artificial Tears are dryness- and irritation-fighting eye drops that share both active and inactive ingredients, the filing says. According to the suit, the current bacteria outbreak linked to the products began in May 2022 and has since spread across California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington and Wisconsin.

Per the Centers for Disease Control and Prevention (CDC), the specific strain of bacteria in the Artificial Tears is “incredibly drug-resistant and dangerous” and has been identified via lab testing in opened EzriCare bottles with different lot numbers from two states.

On January 24, EzriCare disclosed that it was made aware of a CDC investigation into a number of adverse event reports related to its over-the-counter eye drops, the filing shares. On February 1, EzriCare clarified that it had specifically received notice that the CDC’s investigation centered on a “multistate cluster” of infections and said that it would be taking immediate action to stop the distribution or sale of the drops despite the fact that the company was unaware “of any testing that definitively links the … outbreak to EzriCare Artificial Tears,” the suit says.

On February 2, a day after the recall was initiated, the FDA warned consumers and healthcare providers to stop buying and/or using the companies’ artificial tears, the lawsuit states.

“Using contaminated artificial tears increases risk [sic] of eye infections that could result in blindness or death,” the FDA warned. “Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately.”

Who’s covered by the artificial tears lawsuit?

The case looks to represent all consumers who bought EzriCare Artificial Tears and/or Delsam Pharma Artificial Tears for personal use in the United States or its territories at any time from May 1, 2022 to the present. 

Specifically, the suit looks to provide full refunds to these individuals.

I’ve bought EzriCare/Delsam Pharma Artificial Tears. What’s next?

Those who have had adverse reactions or encountered quality-control problems with EzriCare and/or Delsam Pharma Artificial Tears are encouraged to report their experiences to the FDA’s MedWatch Adverse Event Reporting program here.

As far as participation in the proposed class action, there’s generally nothing a consumer needs to do to join or add their name to a case after it’s initially filed. Put simply, it’s only if and when a class action settles that consumers who are covered by the case—the “class members”—will need to act, typically by filling out and filing a claim form online or by mail.

For now, eye drop buyers should sit tight as it could take months or years for the suit to move toward a resolution.

Those who were injured, however, may wish to contact a personal injury attorney to learn more about their rights to an individual claim.

If you’ve bought EzriCare and/or Delsam Pharma Artificial Tears, or simply want to stay in the loop on class action lawsuit and settlement news, sign up for ClassAction.org’s free weekly newsletter.