Bacteria in Artificial Tears Eye Drops Caused Corneal Ulcer, Scarring in Eye: Lawsuit

According to allegations raised in a product liability lawsuit filed last week, bacteria in Artificial Tears eye drops purchased through Amazon.com caused an Illinois woman to develop a corneal ulcer, eye scarring and permanent vision damage.

The complaint (PDF) was brought by Bette Kowalczyk in the U.S. District Court of the Northern District of Illinois, pursuing damages from the manufacturers of the recalled eye drops, including Ezricare, Delsam Pharma, Global Pharma Healthcare Private Ltd and Aru Pharma, Inc., as well as Amazon, Inc., which sold the contaminated Artificial Tears in April 2022.

The eye drops were part of a massive EzriCare Artificial Tears recall first announced by the U.S. Food and Drug Administration (FDA) in February 2023, after at least 55 reports were confirmed involving users who had suffered eye infections after exposure to bacteria in eye drops, with several resulting in permanent blindness and at least one death from a severe bloodstream infection.

Kowalczyk now joins a growing number of consumers who are pursuing Artificial Tears lawsuits, alleging that bacteria in the eye drops caused a wide range of health problems, including vision loss, eye infections, bloodstream infections and other injuries. At least four deaths have been linked to the eye drops, as well as a number of users who required surgical removal of their eye.

Kowalczyk indicates that she experienced decreased and blurry vision, discharge and discomfort in her right eye just a few weeks after purchasing the Artificial Tears from Amazon. In January 2023, she tested positive for Pseudomonas aeruginosa, which caused her to be hospitalized from late January until mid-March 2023.

Bacteria in the eye drops left her with a corneal ulcer, eye scarring and other damages, which require continuing treatment in both eyes. As a result, Komalczyk indicates she is now legally blind.

“What makes Pseudomonas aeruginosa remarkably dangerous is due to its natural resistance to antibiotics and its ability to grow extensive colonies in conditions of partial or total oxygen depletion,” the lawsuit states. “Advanced antibiotic drug regimens are often required for treatment, which can lead to other serious adverse effects.”

According to a recent report by the U.S. Centers for Disease Control and Prevention (CDC), the recalled Artificial Tears eye drops have been linked to 81 cases of bacterial contamination, including multiple reports of vision loss, four reports of consumers requiring removal of an eyeball, and four reports of deaths.

Kowalczyk presents claims of manufacturing defect, design defect, failure to warn, negligent failure to warn, breach of warranty, negligence, and negligence per se.