A growing number of class-action and individual injury lawsuits are continuing to be filed in federal courts across the United States in connection to the outbreak of an extensively drug-resistant bacteria associated with contaminated eye drops and subsequent product recalls.
Give me a quick recap on this recall.
The CDC advised in January 2023 an immediate discontinuation of artificial tear eye drops due to an outbreak of an antibiotic-resistant form of Carbapenem-resistant Pseudomonas aeruginosa that was connected to the use of 10 different brands of over-the-counter (OTC) artificial tears, including EzriCare Artificial Tears.
A voluntary recall for EzriCare was then escalated to a Health Alert Network (HAN) Advisory in February 2023 that mandated all eye care practitioners (ECPs) and patients immediately stop use of the eye drops. Also of note, a recall was issued for Delsam Pharma LLC’s artificial tears, as well as its artificial ointment.
In May 2023, the CDC confirmed a total of four deaths, 81 cases across 18 states, 14 reports of vision loss, and four reports of enucleation.
According to the CDC, 85% of consumers reported using EzriCare Artificial Tears.
Which products do these include?
The affected artificial tears include the following:
- EzriCare → NDC 79503-0101-15, UPC 3 79503 10115 7
- Delsam Pharma → NDC 72570-121-15, UPC-72570-0121-15
Now these lawsuits.
Since February 2023 and as of June 5, 2023, 14 lawsuits have reportedly been filed in federal courts—and pending in seven different federal districts—by consumers who allege they were injured due to the recalled, contaminated products.
And the defendants?
Among other distributors, the artificial tears manufacturer Global Pharma Healthcare Private LTD, EzriCare LLC, and Delsam Pharma have been named.
To note, the majority of patients infected by the products reported using EzriCare Artificial Tears, according to the CDC.
Who qualifies to file a lawsuit?
Any consumer who had used any of the recalled products and suffered injuries or side affects such as:
- Eye infection
- Partial or permanent blindness
- Bloodstream infection
- Other injuries caused by eye drops
However, the window of time to file a lawsuit varies by state; potential affected consumers might consider consulting a lawyer to determine if they meet criteria to file a complaint..
And what are the plaintiffs demanding?
Some lawsuits are demanding refunds for the purchase of the defective products while others are seeking compensation for pain, suffering, medical bills, and loss of quality of life (QoL) directly related to the use of the recalled products.
Give me a case example.
In Florida, a man sued five companies in February 2023—including EzriCare, EzriRx, Delsam Pharma, Arue Pharma Inc., and Amazon—in the U.S. District Court for an eye infection that led to blindness.
He cited that the companies were:
- Negligent in ensuring the products were free from causing unreasonable harm to consumers
- Strictly liable for the harm caused to himself as a result of the product use.
- Negligent per se because they failed to comply with the appropriate regulations to ensure product purity and safety.
- Engaged in deceptive and unfair trade practices by knowingly distributing and selling the contaminated products.
According to court filings, the case was dismissed and closed due to the plaintiff’s “lack of subject matter jurisdiction.”
Any others?
Oh, lots more.
In Kentucky, a man filed a class-action lawsuit against EzriCare LLC for its artificial tears; he demanded a refund for the product cost for himself as well as other consumers who purchased the product.
His complaint: the EzriCare products were contaminated due to violations of the FDA’s Current Good Manufacturing Practice (CGMP) regulations.
Also in Kentucky, a woman filed a lawsuit against four companies in May 2023 that alleged she developed sepsis and spent time in the intensive-care unit (ICU) due to a treatment-resistant eye infection from EzriCare’s Artificial Tears.
Her complaint: She was falsely led to believe the eye drops’ product labeling were accurate and the product was “untainted, safe, effective, and not contaminated by bacteria.”
She seeks both punitive and compensatory damages.
Go on …
Other lawsuits were filed in:
- New Jersey (six total lawsuits have been filed in NJ District Courts)
- Case 3:23-cv-00808 (February 2023)
- Case 3:23-cv-01657 (March 2023)
- Case 3:23-cv-01647 (March 2023)
- Case 3:23-cv-01652 (March 2023– original complaint was opened as 3:23-cv-01651)
- Case 3:23-cv-01649 (March 2023)
- Florida
- Case 3:23-cv-00153-MMH-MCR (February 2023)
- Complaint filed on June 6, 2023 without docket number issued yet (June 2023)
- California
- Case 8:23-cv-00771 (May 2023)
Note: this is not a complete list of filings.
So how can affected patients file a lawsuit?
It is recommended to consult with an attorney to determine eligibility requirements are met.
What comes next?
The CDC is expected to release its full findings from an inspection of the India-based Global Pharma Healthcare Ltd (the manufacturer of EzriCare and Delsam Pharma’s eye products) in the near future.
This will follow its preliminary inspection report, which was released in April 2023.
*Disclaimer: The information provided in this article does not and is not intended to constitute legal advice; instead, all information, content, materials available herein are for general information purposes only.