His lawsuit complaint says that on or about March 1, 2023, his eye started to bother him after he used EzriCare Artificial Tears eyedrops.
During that time, he was not aware that the Artificial Tear products were adulterated and contaminated with Pseudomonas Aeruginosa, a harmful species of bacteria. So he used more of it.
After further use of the Artificial Tears eye drops, he began to suffer complications that included:
- extreme pain and discomfort in the eyes and skull
- sensitivity to light
- sensitivity to touch
- blurred vision
The plaintiff was not aware that two months earlier, in January 2023, the CDC and FDA had announced a multi-state outbreak of a rare strain of Pseudomonas Aeruginosa eye infections linked to the use of artificial tears products made by the defendants in his case.
Related: Artificial Tears Lawsuit | Attorney
The FDA recommended a recall due to the Defendants’ Current Good Manufacturing Practice (CGMP) violations. These included a lack of proper microbial testing, a lack of proper packaging controls, and formulation issues.
On Feb. 2, 2023, the FDA warned citizens and health care personnel not to buy and to immediately cease use of EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.
FDA warned: “Using contaminated artificial tears increases risk of eye infections that could result in blindness or death. Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately.”
The agency said the OTC eye drop products made by Global Pharma Healthcare Private Limited were intended to be sterile.
FDA further wrote: “Global Pharma started a recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears. FDA recommended this recall due to the company’s current good manufacturing practice (CGMP) violations, 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.”
FDA reported that it was collaborating with CDC and state and local health departments to investigate a multistate outbreak involving a rare, extensively drug-resistant strain of Pseudomonas aeruginosa bacteria.
As of January 31, 2023, CDC had identified 55 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence to EzriCare Artificial Tears use.
FDA wrote: “Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections. CDC issued an alert recommending consumers stop using EzriCare Artificial Tears pending additional guidance from CDC and FDA.”
The 12 states listed in the eye drops recall were:
- New Jersey
- New Mexico
- New York
The California complaint filed May 3, 2023 says that as a direct result of using contaminated and defective Artificial Tears, plaintiff Jamie Foti suffered significant permanent injuries that include:
- permanent bodily injury
- pain and suffering
- aggravation of a pre-existing condition
- mental anguish
- loss of capacity for the enjoyment of life
- expense of hospitalization, medical and nursing care and treatment
- lost wages
- loss of ability to earn money in the future
- other economic damages.
The complaint says these losses are either permanent or continuing, and Mr. Foti will continue to suffer these losses in the future.
It further states that Defendants failed to properly and adequately test the product for the presence of bacteria before distributing it. It alleges that “Defendants’ negligence and extreme carelessness includes, but is not limited to their marketing, designing, manufacturing, producing, supplying, inspecting, testing, selling, and/or distributing the EzriCare Artificial Tears in one or more of the following respects:
- failing to comply with Current Good Manufacturing Practices
- failing to manufacture the Product with a preservative to decrease the risk of bacterial growth in the Product
- failing to manufacture and package the Product in single use containers, thus reducing the risk of bacterial growth in the Product from multiple uses;
- failing to warn Plaintiff of the hazards associated with the use of the product
- failing to properly test their products for microbials, as well as to determine adequacy and effectiveness or safety measures before releasing EzriCare Artificial Tears
The California lawsuit lists 12 Causes of Action:
- Strict Liability (against all defendants)
- Strict Liability Design and/or Manufacturing Defect
- Negligence/Gross Negligence
- Products Liability – Negligence-Failure to Warn
- Negligence – Design/Manufacturing/Design/Manufacturing Defect
- Negligence (Negligent Misrepresentation/Omission)
- Fraudulent Concealment
- Breach of Express Warranty
- Breach of Implied Warranty
- Negligent Failure to Timely Recall
- Negligence per se
The Complaint demands compensatory damages including but not limited to pain, suffering, emotional distress, loss of enjoyment of life, and other noneconomic damages in an amount to be determined at trial.
It also asks for economic damages in the form of medical expenses, out of pocket expenses, lost earnings, and other economic damages in an amount to be determined at trial.
Punitive Damages are also requested in the complaint, “for the wanton, willful, fraudulent, and/or reckless acts of the Defendants who demonstrated a complete disregard and reckless indifference for the safety and welfare of the general public and Plaintiff. . . ”
Several more lawsuits are expected to be filed in this ongoing litigation, as the Artificial Tears recall is a relatively recent development.