Several companies have recently recalled eye drops due to contamination. However, the risk of contamination is not new, and scientific studies have identified several types of contaminants commonly found in eye drops over the past several years.
Eye drop contamination is a significant health risk. As noted in one of the studies examining common forms of contamination:
“Contamination of eye drops can lead to serious ocular infections, especially when the ocular surface [defenses] are compromised with topical steroids. Application of contaminated eye drops may lead to potentially devastating consequences in patients with ocular surface diseases and after intraocular surgery where there are wound leaks.”
These consequences include blindness and even death in some cases. As a result, if you use eye drops, it is important to make sure your eye drops are not contaminated. Additionally, if you experience pain, loss of vision or other unexpected symptoms after using eye drops, you should talk to a doctor as soon as possible.
10 Types of Bacterial Infections Linked to Contaminated Eye Drops
The primary contamination risk associated with eye drops is the risk of bacterial contamination. While contamination is relatively rare overall, researchers have identified the following as among the most common types of bacterial contaminants found in non-sterile eye drops:
- Alpha Streptococcus
- Bacillus SPP
- Coagulase Negative Staphylococcus
- Enterobacter Cloacae
- Haemophilus
- Klebsiella Oxytoca
- Proteus
- Pseudomonas Aeruginosa (P. aeruginosa)
- Serratia SPP
- Staph Aureus
Most recently, the U.S. Centers for Disease Control and Prevention (CDC) have identified an outbreak of pseudomonas aeruginosa (P. aeruginosa) linked to eye drops distributed by EzriCare and Delsam Pharma. This includes eye drops sold under the brand names Artificial Tears and Artificial Ointment. As the CDC explains, pseudomonas aeruginosa is “extensively drug-resistant,” and the CDC advises individuals who have used these brands of eye drops to seek medical attention immediately if they develop any of the following symptoms:
- Abnormal light sensitivity
- Blurred vision
- Pain or discomfort in the eye
- Redness of the eye or eyelid
- Yellow, green or clear discharge from the eye
This is a very serious outbreak. According to the CDC’s latest data, among patients who were tested between May 2022 and April 2023, 14 experienced vision loss, four required surgical removal of the eye, and another four tragically passed away. As a result, this is not a contamination risk to be taken lightly, and anyone who has concerns (whether for themselves or for a family member) should heed the CDC’s advice to go to the doctor’s office or hospital as soon as possible.
How Do Eye Drops Get Contaminated?
In most cases, bacterial contamination of eye drops results from one of two factors. Either: (i) the manufacturer fails to maintain adequate sterilization during the manufacturing and packaging processes, or (ii) the bottle or lid used for packaging becomes compromised or is not adequately secured.
We have recently seen cases involving both of these issues. On March 2, 2023, Apotex Corp. issued a recall due to “cracks that have developed” in some of the bottles used to store its Apotex-brand eye drops. Previously, Kadesh Inc. issued a recall for its Puriton-brand eye drops after an investigation uncovered that the drops were “manufactured without necessary production controls and conditions to assure sterility.”
Regardless of why a manufacturer’s eye drops become contaminated, there is no excuse. Eye drops need to be sterile to ensure that they are safe for use, and manufacturers have access to all of the knowledge and tools they need to ensure their products’ safety. Yet, contamination remains a very real concern, and each year numerous people suffer life-altering (and in some cases life-threatening) complications that eye drop manufacturers could—and should—have prevented.
What Are Your Legal Rights if You Purchased Contaminated Eye Drops?
With all of this in mind, what are your legal rights if you purchased contaminated eye drops?
If you purchased eye drops contaminated with Pseudomonas aeruginosa (P. aeruginosa) or any other type of dangerous bacteria, you may be entitled to financial compensation from the manufacturer. Eye drop manufacturers—like all manufacturers—have an obligation to ensure that their products are reasonably safe for their intended use.
Eye drops that have the potential to cause blindness or death are not reasonably safe.
Patients and families affected by contaminated eye drops can file claims based on the law of products liability. This law says that product manufacturers are strictly liable when they sell defective products—meaning that proof of negligence isn’t required. So, even if a manufacturer had no reason to know that its eye drops were contaminated (or at risk for contamination due to packaging issues), the manufacturer can still be held liable for putting a dangerous product on pharmacy shelves.
How Do You File a Claim for Contaminated Eye Drops?
If you think you may have a claim for contaminated eye drops, your next step (after seeking treatment) is to speak with a products liability lawyer. Even when a manufacturer is strictly liable, filing a successful claim is not easy. The manufacturer (and its defense lawyers) will fight your claim by all means available, and you will need to be able to clearly prove that you are entitled to just compensation.
Along with helping prove that you are entitled to just compensation, your lawyer can also prove how much you are entitled to recover. Your lawyer can submit your proof to the manufacturer’s insurance company; and, if necessary, your lawyer can take your claim to court. The lifetime costs of infections caused by contaminated eye drops can be substantial, and you owe it to yourself and your family to protect your legal rights by all means available.
[View source.]
