When tested, the recalled Artificial Tears used by the firefighter were found to contain large amounts of Pseudomonas Aeruginosa bacterial contamination.
A complaint has been filed in the U.S. District Court Middle District of Florida by a Florida fire captain against the manufacturers or distributors of EzriCare Artificial Tears, alleging the contaminated eye drops resulted in an infection in one eye that led to a loss of vision.
According to court documents, the plaintiff is Adam Disarro. He is represented by the Harris Law Firm Group of Miami.
According to the lawsuit, Disarro alleges that he is faced with partial blindness and an uncertain future of medical complications as a result of a Pseudomonas Aeruginosa infection caused by recalled Artificial Tears.
The use of EzriCare Artificial Tears has been linked to 50 infections in 11 states that have led to individuals suffering permanent vision loss, hospitalization and 1 death, leading the US Centers for Disease Control (CDC) to urge health care providers and consumers to stop using the product.
The CDC announced in early February it is investigating a multistate cluster of Verona Integron‐mediated Metallo‐β‐lactamase (VIM)‐ and Guiana‐Extended Spectrum‐β‐Lactamase (GES)‐ producing carbapenem‐resistant Pseudomonas Aeruginosa (VIM‐GES‐CRPA) linked with multiple infection types, including eye infections. Recent epidemiology and laboratory evidence link these infections to use of EzriCare Artificial Tears.
According to AboutLawsuits.com, the complaint filed by Disarro is the latest in a number of Artificial Tears lawsuits filed after an EzriCare and Delsam Pharma eye drop recall was announced, with allegations that the eye drops were marketed as safe, even though the manufacturers and distributors allegedly failed to perform proper microbial testing, which allowed contaminated eye drops to be distributed throughout the United States in recent months.
In its investigation, the CDC tested open bottles of EzriCare drops and identified Pseudomonas Aeruginosa bacteria that were resistant to carbapenem antibiotics as well as the antibiotics ceftazidime and cefepime. The CDC continues to test unopened bottles, according to its news release.
According to the CDC, May 17, 2022, to January 19, the center, in partnership with state and local health departments, identified 56 isolates from 50 case patients from 11 states (California, Colorado, Connecticut, Florida, New Jersey, New Mexico, Nevada, New YHork, Texas, Utah and Washington) with VIM‐GES‐CRPA; 38 cases are part of 4 facility clusters.
The CDC noted that the dates of specimen collection are from May to December 2022. Isolates have been identified from clinical cultures of cornea (10), sputum or bronchial wash (11), urine (6), other nonsterile sources (4), and blood (2), and from rectal swabs (23) collected for surveillance. These specimens were collected in both outpatient and inpatient healthcare settings. Patient outcomes include permanent vision loss resulting from ocular infection, hospitalization, and death of one patient with bloodstream infection.
In addition to demonstrating carbapenem resistance, isolates in this cluster are resistant to ceftazidime and cefepime; the subset of isolates that underwent antimicrobial susceptibility testing for ceftazidime‐ avibactam and ceftolozane‐tazobactam were also resistant to these agents. Isolates are sequence type (ST) 1203, harbor blaVIM‐80 and blaGES‐9 (a combination not previously observed in the United States) and are closely related based on analysis of whole genome sequencing (WGS) data.
Moreover, the review of common exposures among patients identified that the majority of patients used artificial tears prior to identification of VIM‐GES‐CRPA infection or colonization.
The most common brand reported was EzriCare Artificial Tears, a preservative‐free product dispensed in multidose bottles. Laboratory testing of EzriCare Artificial Tears by CDC identified the presence of VIM‐CRPA in opened EzriCare bottles; these VIM‐CRPA are undergoing further characterization, including testing for GES and to determine ST, to assess if they match the outbreak strain. Testing of unopened bottles of EzriCare Artificial Tears is ongoing.
In a statement on its website on Feb. 1, EzriCare noted that it was aware of the CDC investigation related to the over-the-counter eye drops, a formulation designed and imported by Aru Pharma Inc. and manufactured by Global Pharma Healthcare PVT Ltd.
“EzriCare has received no consumer complaints or adverse event report related to the investigation to date,” the company said in the statement posted to its website. “ Also, as of this date, EzriCare has not received communication from any regulatory agency providing any outcomes or details to EzriCare about the ongoing investigation.”