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Over the past few months, we’ve been following a shocking story about tainted eye drops manufactured by Global Pharma in India and sold in the United States under the brand names EzriCare and Delsam.
Reports of severe bacterial infections linked with permanent vision loss, eye removal, and in some cases even death have continued to come in since the U.S. Food and Drug Administration issued a recall in February.
In this blog post, we’ll provide a brief overview of what happened, why it happened, and what you should do if you own or have used any potentially contaminated eye drops.
Furthermore, if you have developed an eye infection related to a recalled product, contact the product liability attorneys at Truman Law Office right away at (502) 222-2222 to schedule a free case review to discuss your legal options. You may be entitled to financial compensation.
As of early April 2023, the following eye drops and other eye lubrication products have been recalled due to potential bacterial contamination:
EzriCare and Delsam branded “Artificial Tears” eye drops are manufactured by Global Pharma Healthcare and are part of the same outbreak. The other products on the list have been voluntarily recalled by their manufacturers for unrelated safety concerns.
If you have any of these products in your home, particularly EzriCare or Delsam products, you are strongly urged to discontinue using them immediately. You shouldn’t require any medical care if you’re not experiencing symptoms, but you may want to speak with your doctor or ophthalmologist for recommendations on safe products to use instead.
If you experience any of the following symptoms after using Delsam or EzriCare artificial tears (or any other brand), seek medical attention immediately:
The bacterial outbreak linked with Global Pharma has already led to severe complications, including vision loss and at least three deaths. Do not take chances—seek care right away.
Eye infections caused by EzriCare and Delsam artificial tears have been linked to drug-resistant pseudomonas aeruginosa (CRPA), a bacteria strain that can cause severe infections in blood, lungs, and other parts of the body. This specific strain of CRPA is so rare that it had never been reported in the United States previously.
EzriCare artificial tears lack anti-microbial preservatives. The reason that some eye drops lack preservatives is that they can sometimes irritate the eyes, especially if you apply them multiple times per day. However, bacteria like CRPA can proliferate and thrive in preservative-free eye drops and ointments if sterile conditions aren’t strictly maintained during the manufacturing process. The risk is especially high for reusable eye drop containers, which is why preservative-free eye drops usually only come in single-use disposable form.
Once it enters the eyes, a pseudomonas aeruginosa infection can quickly reach the cornea and even the bloodstream. A bloodstream infection can be fatal, with at least three deaths already linked to the eye drops.
The first known case of severe infection from EzriCare eye drops was initially reported by the Centers for Disease Control and Prevention (CDC) all the way back in May 2022. The CDC announced an ongoing investigation in January of 2023, and in February, EzriCare and Delsam artificial tears were officially recalled.
On March 31, 2023, the U.S. Food and Drug Administration published a report following an 11-day unannounced inspection of the Global Pharma Healthcare facility in India, where the EzriCare and Delsam eye drops were made.
The report noted several sterilization and hygiene concerns at the facility. Among other things, they found:
As of the date this blog was posted, there have been outbreaks in at least 16 states, involving 68 confirmed infections. In addition to the three people who have already died, eight people have suffered permanent vision loss, and four people have had to have an eye surgically removed. Others experienced adverse events such as respiratory and urinary tract infections.
And health care professionals fear that the outbreak could continue to linger for months or years, despite the recalls. On April 3, 2023, The New York Times reported that the strain of CRPA that caused the outbreak was not only resistant to drugs, but could spread from person to person.
Manufacturers of consumer products have a responsibility to ensure those products are safe to use and meet regulatory requirements. If you’ve suffered an eye infection due to recalled eye drops, you may be eligible to file a personal injury lawsuit.
Victims of EzriCare artificial tears eye infections may be able recover compensation for both economic and non-economic losses, such as:
Already, we are starting to see victims of Delsam and EzriCare artificial tears file lawsuits around the country, and more are sure to follow.
You deserve fair compensation for the losses you’ve suffered. But actually getting the full amount you deserve can be a difficult and complicated process. The best way to build a strong case and protect your legal rights is by speaking with a personal injury lawyer with experience handling product liability cases.
You will need to clearly establish several facts in your Delsam or EzriCare artificial tears lawsuit to prove not only that you deserve compensation, but justify the amount you are seeking. Your attorney can help you in several ways, including:
Drug companies should never put profits over the health and safety of their customers. Yet they often do anyway. And when that happens—and you get hurt—it’s important to work with an attorney who will get to know you and your story, work hard, and isn’t afraid to take on the big pharmaceutical companies and hold them accountable.
Attorney Karl Truman and his team have been leaders in the Louisville legal community for more than three decades, and over the years we’ve handled many drug injury and defective medical device cases for clients across Kentucky, Indiana, and nationwide. If you’re considering legal action for an eye infection or other serious injuries related to recalled eye drops, contact us today for a free case evaluation. Just call (502) 222-2222 or use our simple contact form to get started.
References
Grantham-Phillips, W. (March 24, 2023). 8 people with lost vision, 3 deaths; What we know about eyedrops recalled by the FDA. USA Today. Retrieved from https://www.usatoday.com/story/news/health/2023/03/24/ezricare-eyedrops-deadly-bacteria-outbreak/11521093002/
Silverman, E. (March 31, 2023). FDA report details problems at Global Pharma plant involved in eye drop recall. Stat. Retrieved from https://www.statnews.com/pharmalot/2023/03/31/eye-drops-recall-fda-global-pharma/
McPhillips, D. (April 3, 2023). FDA inspection finds sterilization issues at recalled eye drop manufacturer’s facility. CNN. Retrieved from https://www.cnn.com/2023/04/03/health/eye-drops-bacteria-fda-inspection/index.html
Jewett, C. and Jacobs, A. (April 3, 2023). Drug-Resistant Bacteria Tied to Eyedrops Can Spread Person to Person. The New York Times. Retrieved from https://www.nytimes.com/2023/04/03/health/superbug-eyedrops-blindness.html
The content provided here is for informational purposes only and should not be construed as legal advice on any subject.
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