EzriCare, Delsam Artificial Tears Contaminated with Bacteria Class Action

How would you feel if you discovered that, in using certain eyedrops, you were dropping bacteria into your eyes? The complaint for this class action brings suit against EzriCare, LLC, EzriRx, LLC, Delsam Pharma, LLC, Global Pharma Healthcare Private, Ltd., and Aru Pharma, Inc., alleging that the two products, EzriCare Artificial Tears and Delsam Pharma Artificial Tears, are contaminated with Pseudomonas aeruginosa bacteria, which are largely resistant to drugs.

The Multi-State Class for this action is all consumers who bought EzriCare Artificial Tears or Delsam Pharma Artificial Tears products in the US or its territories (excluding California), between May 1, 2022 and the present, for personal use. A Kentucky Subclass has also been defined for those in the above class who bought the products in Kentucky.

The artificial tear products in this case are similar. Both are used to relieve dryness in the eyes, to protect against further irritation, or to relieve discomfort due to minor irritation or exposure to wind or sun. Both have as the active ingredient Carboxymethylcellulose Sodium 10mg in 1ml.

Delsam Pharma’s website says that the artificial tears product contains preservatives. However, the EzriCare product is supposed to be preservative free, the complaint alleges, “which removes any chemical used to prevent the growth of bacteria in the product.”

The bacteria found in both products, the complaint alleges, is resistant to drugs, including a long list of antibiotics, and “can cause serious skin, eye, lung, and other infections throughout the body.” The outbreak began in May 2022, the complaint alleges, and has so far been found in twelve states.

The complaint claims that “out of the 55 individuals who have been identified as having been infected with the Pseudomonas Aeruginosa bacteria from use of EzriCare artificial tears thus far, approximately three people have suffered permanent vision loss, and one person has died due to a systemic infection. Others have endured extensive treatment to treat their infections.”

How did the product become contaminated? The complaint quotes the Food and Drug Administration (FDA) as citing concerns with “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-evidence packaging.”

On February 1, 2023, the complaint alleges, Global Pharma Healthcare made a voluntary recall of all unexpired lots of both products. The following day, the FDA warned consumers not to buy the products and to stop using them because of bacterial contamination.

The complaint also quotes the FDA as saying it put Global Pharma Healthcare “on import alert … for providing an inadequate response to a records request and for not complying with CGMP requirements.” The alert is supposed to keep the products from entering the US.

Article Type: Lawsuit
Topic: Consumer
Tags: Bacteria, Contaminated with Harmful Substances, Contamination During Preparation or Use, Negligence, Pharmaceuticals, Strict Product Liability—Failure to Warn