Recently, the Centers for Disease Control and Prevention (“CDC”) and the Food and Drug Administration (“FDA”) issued warnings to consumers about two over-the-counter eye drops linked to bacterial infections. The CDC and FDA urged the public to stop using EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears immediately, as these eye drops may contain drug-resistant bacteria that can result in blindness and even death. Global Pharma Healthcare, the manufacturer of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears products, issued a voluntary recall of both products.

While eye drops may provide consumers and patients with various benefits, potentially defective eye drops raise serious risks that can lead to long-term injury or death. As we’ve discussed in prior posts, manufacturers of over-the-counter health products have a duty to ensure that their products are safe for all intended uses. Companies that release dangerous or contaminated products to the market may be held financially liable for the harm these products cause. However, these cases are often exceedingly complex; thus, those who develop an infection or suffer other injuries after using defective or contaminated eye drops should consult an attorney to learn more about their options and how to pursue a legal claim against the manufacturer.

Use and Risks of Over-the-Counter Eye Drops

Over-the-counter eye drops such as EzriCare and Delsam Pharma Artificial Tears products are saline-based solutions that provide moisture for dry or irritated eyes. In addition, eye drops may promote surface healing and flush out contaminated particles. Doctors may sometimes prescribe eye drops to their patients; however, anyone can purchase over-the-counter eye drops. Like any other pharmaceutical product, eye drops pose particular risks to users. While some risks may cause mild and short-term issues, contaminated or defective eye drops can leave consumers fighting for their vision and life.

Why Were Eye Drops Recalled?

The CDC and FDA explained that the manufacturer of EzriCare and Delsam Pharma issued a recall because of possible contamination. The CDC alerted the FDA of a multi-state investigation linking these eye drops with dozens of eye infections, vision loss, and hospitalizations. In working with local and state health departments, the CDC found 55 patients over 12 states infected with rare and potentially deadly drug-resistant bacteria. Following the first nationwide health alert, the FDA found that another manufacturer’s products, Delsam Pharma’s Artificial Eye Ointment, could be contaminated with the bacteria.

Most patients with the bacteria reported using artificial tears before their infection. The patients indicated using various brands of artificial tears or a combination of brands. However, the investigation revealed that many patients reported using EzriCare Artificial Tears.

Is There Harmful Bacteria in Over-the-Counter Eye Drops?

Contaminated artificial tears and similar ophthalmic solutions can cause severe ocular infections. The FDA and CDC found that EzriCare and Delsam Pharma products may contain the drug-resistant strain of pseudomonas aeruginosa. The safety agencies explained that, before this outbreak, the specific outbreak strain, VIM-GES-CRPA, had never been reported in the United States.

What Can Happen if I Get an Infection from Eye Drops?

According to reports from the FDA and CDC, the agencies have identified nearly 60 patients in 13 states infected with the drug-resistant bacteria. One individual died, and five others have experienced vision loss. Those who experience signs or symptoms of an eye infection should seek immediate medical attention. Some signs of a bacterial eye infection include the following:

• Clear, green, or yellow eye discharge,
• Eye pain or discomfort,
• Redness of eyelid or eye,
• Foreign body sensation in the eye,
• Light sensitivity, or
• Blurry vision.

The FDA and CDC advised patients to stop using these over-the-counter eye drops. Further, those prescribed these products should consult their treating physician to discuss alternative treatments.

Are My Eyedrops Safe?

Eye Drops have many potentially beneficial uses and can be a safe treatment option for those suffering from various eye conditions. However, understanding the safety and efficacy of these products is crucial to making an informed decision about whether these products are appropriate. Two primary eye drop options are eye drops with preservatives and preservative-free eyedrops.

Many people choose the preservative-free option because they decrease the chance of irritation. However, preservative-free eyedrops, like Ezricare, are more susceptible to bacterial growth. As such, patients should consider the pros and cons of both types of eyedrops.

Can Consumers File a Claim Against an Eyedrop Manufacturer?

In the case of Global Pharma, the FDA cited the manufacturer for various manufacturing violations. The FDA recommended a recall because of the eye drop manufacturer’s “good manufacturing practice” violations. The FDA found the following offenses:

• Lack of appropriate microbial testing,
• Formation defects, and
• Lack of proper controls for tamper-evident packaging.

Consumers may consider filing a product liability claim against the negligent manufacturer in cases like this. Drug-related product liability claims typically include the following types of allegations:

• Defective manufacturing,
• Dangerous side effects, and
• Marketing or failure-to-warn defects.

In some pharmaceutical injury claims, the consumer may find that more than one claim may apply. For instance, an eyedrop injury lawsuit may include allegations that the company produced a contaminated product and failed to warn consumers of the dangers of eye drops.

Who is Liable for an Eyedrop Infection or Injury?

Pharmaceutical injury claims may involve more than one responsible party. The victim can work with an attorney to determine the entities involved in the process. Some potentially liable parties in these cases may be the manufacturer, distributor, retailer, or shipping facility. Further, a doctor, pharmacy, or testing laboratory may be responsible for the victim’s injuries and damages in some complex cases.