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CDC and FDA Issues New Warnings and Additional Recall Notices: Drug-resistant bacteria connected to eye drops leads to 3 deaths, 8 reported cases of vision loss, and 4 reports of surgical removal of eyeballs

By: Anapol Weiss

After the recall of EzriCare & Delsma Pharma: Artificial Tears Lubricant Eye Drops in February 2023, the U.S. Food and Drug Administration (FDA) has now issued voluntary recall of two more eye drops. Apotex and Pharmedica, the drugs’ companies, said they recalled their products, Apotex: Brimonidine Tartrate Ophthalmic Solution, 0.15%, and Purely Soothing: 15% MSM Drops, respectively, due to sterility concerns.

Bacterial contamination in eye drops can cause serious infections, vision loss, and sometimes even death. For instance, artificial tears sparked an outbreak of drug-resistant infections, which caused vision loss and fatality due to bloodstream contamination.

However, at the recall of Apotex: Brimonidine Tartrate Ophthalmic Solution, 0.15% and Purely Soothing: 15% MSM Drops, both Apotex and Pharmedica stated that they had no reported incidents of infection and were withdrawing the products from the market for safety reasons.

Litigation Update

March 14, 2023: The FDA has issued a warning and recall notice regarding certain eye drops due to concerns over their sterility. As of March 14, 2023, there have been reports of a rare strain of extensively drug-resistant P. aeruginosa in 68 patients across 16 states. Of these patients, 37 were linked to four healthcare facility clusters. Three people have died, and there have been 8 reports of vision loss and 4 reports of enucleation (surgical removal of the eyeball). This information has been identified by the CDC in partnership with state and local health departments.

List of Recalled Eye Drop Brands

Since the reported contamination and subsequent recall of EzriCare and Delsam Pharma’s artificial tears and artificial eye ointment in February 2023, manufacturers have been on increased alert about the sterility of their products. As of March 3, 2023, the following eye drops had been recalled.

1. EzriCare & Delsma Pharma: Artificial Tears Lubricant Eye Drops

Global Pharma manufactured the eye drop under EzriCare and Delsam Pharma brands. The company recalled the product on February 2, 2023, after it was connected to the outbreak of drug-resistant Pseudomonas aeruginosa. The bacteria is linked to severe infections.

As of March 1, 2023, the Centers for Disease Control and Prevention (CDC) had identified 64 patients across 13 states. One person was reported to have died from a bloodstream infection, and eight had lost their eyesight.

2. Delsam Pharma’s: Artificial Eye Ointment

Manufactured by Global Pharma Healthcare under the Delsam Pharma brand, the product was used for lubricating eyes and relieving dryness. The manufacturer recalled the product on February 24, 2023, three weeks after pulling artificial tears from the market over similar microbial contamination concerns.

According to the Global Pharma recall statement published by FDA, the eye product risked causing infections that could lead to blindness. In addition, they mentioned that some product packaging was leaking or could be compromised. However, at the time of the recall, the company had not received any reports of adverse incidents.

3. Apotex: Brimonidine Tartrate Ophthalmic Solution, 0.15%

Apotex Corp announced the voluntary recall of the eye drop on March 1, 2023, over lack of sterility. FDA published the recall a day later, on March 2, 2023. According to the company, cracks had developed on some of the bottle caps and could potentially compromise sterility and cause infections.

Apotex: Brimonidine Tartrate Ophthalmic Solution, 0.15%, is used by patients with ocular hypertension or open-angle glaucoma to reduce elevated intraocular pressure (IOP). The company recalled six lots of the product – 5ml pack (TJ9848, TJ9849, TK0258, and TK5341), 10ml pack (TK0261), and 15ml (TK0262).

4. Purely Soothing: 15% MSM Drops

Pharmedica USA LLC announced its voluntary recall of Purely Soothing: 15% MSM Drops product on March 3, 2023, due to non-sterility, and FDA published the statement the same day. The anti-inflammatory eye drop helped relieve symptoms of ocular irritation or swelling. However, the company stated that using the product could predispose someone to the risk of eye infections that could cause blindness.

The recall was worldwide as the product was available globally through online platforms such as Amazon Marketplace. But at the time of the recall, the company had not received any reports of injury incidents. The affected lots of the product included 2203PS01 and 1808051.

What Are the Risks?

Over 100 million people use eye drops & eye wash every year in the United States. Contamination of eye drops, thus, predisposes a huge portion of the population to potentially severe infections. Besides losing vision, drug-resistant bacteria can spread throughout the body and cause serious inflammations like the bloodstream infection reported in the artificial tears death case.

Any injuries resulting from using contaminated eye drops can potentially cause immense suffering to affected individuals and their families. Possible damages resulting from such incidents may include high medical expenses, lost wages/loss of earning capacity, pain and suffering (physical pain, emotional distress, loss of quality of life, etc.), or even financial and emotional damages to a family that loses their loved one.

What Should You Do If You Have the Recalled Eye Drops?

In the individual recall statements published by FDA, the eye drop companies urged consumers to discontinue using the products and discard them safely and appropriately.

If you have experienced any problems related to using the recalled eye drops, you should seek medical treatment. Also, you may report to the FDA’s MedWatch Adverse Event Reporting program if you experience adverse reactions to any of the products.

When Should You Contact a Lawyer After You’re Injured From Using Recalled Eye Drops?

Once you suspect your injury or illness is associated with using a contaminated eye drop or have lost a loved one whose death you suspect was caused by an eye drop-related infection, you should contact a lawyer immediately. A product liability lawyer can evaluate your case and help you commence the necessary legal process to recover your damages.

Among other things, our attorneys at Anapol Weiss can help you with the following:

  • Build a solid case – A product liability case involves going after large corporations, which have the resources and motivation to fight allegations, clear their name, and avoid potentially huge losses. While the recalled eye drops have been found with microbial contamination, the manufacturer would still investigate an infection incident to determine other possible causes. In this case, you need a product liability lawyer to build a strong case, defend your rights, and fight for fair compensation.
  • Advise you accordingly – Despite having solid evidence to prove liability, drug companies and their insurers vigorously defend against claims. Working with an attorney gives you an upper hand as they can advise on do’s and don’ts to protect your case.
  • Compute damages and pursue compensation – Finally, the attorney can help you compute fair damages based on the current and future financial losses associated with the injury. Being experienced in similar settlement negotiations, you can rely on their skills to negotiate aggressively for fair compensation.

Have You Been Injured After Using a Contaminated Eye Drop?

If you have been injured after using any recalled eye drops, you have a right to receive a settlement for damages. At Anapol Weiss, we can help evaluate your case to determine whether it merits compensation. Contact us today and brief us on your case details.