https://www.lezdotechmed.com/blog/product-liability/delsam-and-ezricare-eyedrops-lawsuits/
Delsam and EzriCare lawsuits are related to the contamination of Artificial Tears by Pseudomonas aeruginosa. Artificial Tears, lubricating eyedrops, are used to relieve dryness and irritation of the ocular surface. Artificial tears do not include the biologically active substances found in naturally occurring tears. There are around 16.4 million adult Americans with dry eye disease, and about 6 million Americans have symptoms but no diagnosis. Reduced tear production and increased tear evaporation are the main contributors of DED.
Artificial Tears contain water, electrolytes, and certain polymers and are used to replicate or take the place of the tear film's functions.
The FDA first learned about the Pseudomonas aeruginosa epidemic in December 2022. The new strain of Pseudomonas aeruginosa, according to the Center for Disease Control and Prevention, is a type that has never been seen in the United States before. According to the FDA, there have been 55 reports of adverse events to date, including eye infections, irreversible vision loss, and one death from a bloodstream infection.
Customers were forewarned by the FDA that using contaminated artificial tears increased their chance of developing eye infections, which can lead to blindness. It is advised that anyone displaying signs of an eye infection contact their doctor right away or visit the hospital. According to the FDA, Global Pharma has also broken the CGMP rules for current good manufacturing practice.
A woman from New Jersey filed a Pseudomonas aeruginosa infection complaint on February 11, 2023, claiming that the EzriCare eyedrops were contaminated with bacteria and caused a serious infection.
Carolyn Ward complained to the U.S. District Court for the District of New Jersey, asserting that because she was recovering from radiation treatment for eye cancer, she was already at risk for infection. She applied the ointment to lessen cancer-related ocular discomfort symptoms.
The tainted eyedrops have officially been removed from sale. In view of the increasing number of illness reports, the Centers for Disease Control and Prevention (CDC) advised doctors and patients to stop using EzriCare Artificial Tears eyedrops on January 20, 2023.
There have been reports of 55 infections in 12 states, which have led to hospitalizations, irreversible eyesight loss, and even one death. The states having the most reports of negative side effects with EzriCare eyedrops are California, Florida, New York, Texas, Colorado, Connecticut, New Jersey, New Mexico, Nevada, Utah, Wisconsin, and Washington.
The FDA was notified by the CDC to conduct an investigation into a multi-state cluster of infections caused by the product that were caused by Verona Integron-mediated Metallo-Lactamase (VIM) and Guiana Extended Spectrum-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa.
Global Pharma formally announced on February 2, 2023, a voluntary nationwide recall of Artificial Tears Lubricant Eyedrops that had been marketed in the United States under the trade names Delsam Pharma and EzriCare.
