A class action complaint (CAC) was filed in Kentucky this week for several people who bought eye drops later recalled for contamination that can lead to blindness and death. Richard Mosley is the plaintiff’s representative named in the case, on behalf of himself and several others who purchased similar eye drops’ products. Five defendants are named in the lawsuit complaint: Ezricare LLC, EzriRx LLC, Delsam Pharma LLC, Global Pharma Healthcare Private Ltd., Aru Pharma Inc.
The Artificial Tears Class Action Complaint reads:
“The presence of the Pseudomonas Aeruginosa bacteria in Defendants’ EzriCare and Delsam Pharma Artificial Tear products is due to Defendants’ violation of Current Good Manufacturing Processes [as identified by the FDA], including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging.
“These violations, along with the presence of this rare and, in some cases, deadly, bacteria pose a significant and severe health risk to consumers, such as Plaintiff and the putative class, who purchased and used Defendants’ artificial tear products. . . ”
The Pseudomonas Aeruginosa Bacteria
While Pseudomonas Aeruginosa bacteria is not a newly-discovered phenomenon, it is notorious for its versatility and its innate resistance to drug treatment. Though most frequently found in the environment in the soil and/or freshwater, Pseudomonas Aeruginosa bacteria may infect humans. It can cause serious skin, eye, lung, and other body-related infections.
Antibiotic Resistant
The Pseudomonas Aeruginosa bacteria is considered to be resistant to the following antibiotics: cefepime, ceftazidime, piperacillin-tazobactam, aztreonam, carbapenems, ceftazidime-avibactam, ceftolozane-tazobactam, fluoroquinolones, polymyxins, amikacin, gentamicin, and tobramycin.
Pseudomonas Aeruginosa and EzriCare / Delsam Pharma Artificial Tears
The current outbreak of the Pseudomonas Aeruginosa bacteria resulting from the use of the EzriCare and/or Delsam Pharma Artificial Tears began in May 2022. At least 68 people have reportedly been hospitalized, while 12 states have been affected so far: California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington, and Wisconsin.
The CDC has isolated the specific strain of Pseudomonas Aeruginosa, and identified it as Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa (“VIM-GES-CRPA”). This particular strand is incredibly drug-resistant and dangerous.
The CDC reported: “[L]aboratory testing identified the presence of the outbreak strain in opened EzriCare bottles with different lot numbers collected from two states.”
The CDC also reported that it isolated the outbreak strain from 13 sputum or bronchial washes, 11 cornea swabs, seven urine samples, two blood samples, 25 rectal swabs, and four other nonsterile sources.
Artificial Tears Eye Drops Recall
FDA announced the Artificial Tears recall on February 2, 2023. The recall references several versions of the lubricating eye drops sold in half fluid ounce (15 ml) bottles. It includes eye drops packed in boxes sold under the brand names EzriCare and Delsam. Recalled products contained these UPC and NDC codes –
- Ezricare (blue box): NDC 79503-0101-15 with UPC 3 79503 10115 7
- Delsam Pharma (white box): NDC 72570-121-15 with UPC -72570-0121-15
Consumers were advised to cease using these products now. Officials warned that at least 55 people had developed Pseudomonas aeruginosa infections after using the drops between May 17, 2022 and January 19, 2023. Most reported having used Artificial Tears products.
The FDA also said it is aware that several people who had used Artificial Tears suffered eye infections that rendered them permanently blind. The agency initially acknowledged that at least one person had died from an infection related to Artificial Tears.
Artificial Tears Vision Loss & Eye Removal Surgery
Eye infection reports caused by tainted eye drops gained national attention in January 2023 when CDC first said it was aware of a multi-state oubreak. The agency instructed people to cease use of Artificial Tears products. Just days later, the eye drops’ manufacturer released a statement, then a recall for Artificial Tears sold under the brand names Delsam Pharma and EzriCare.
Eleven states were initially named as affected by the eye drops. One death was reportedly caused by them. Now, the latest CDC update indicates at least three deaths have occurred out of 68 people known to have been hospitalized. That number might represent only a small sampling of the total eye drop infections, as more people become aware that the eye infections they may be suffering from were caused by tainted eye drops.
Plaintiffs’ attorneys are investigating possible eye drop lawsuits against the makers and distributors of EzriCare and Delsam Pharma’s eye drops. Several injuries and side effects caused by the contaminated eye drops include:
- Bloodstream infection
- Enucleation (removal of the eyeball)
- Eye Infection
- Partial Blindness
- Permanent Blindness
- Other injuries
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