Two more people have died and more details are emerging about horrific eye infections in a nationwide outbreak linked to recalled eye drops from EzriCare and Delsam.
The death toll now stands at three, according to an outbreak update this week from the Centers for Disease Control and Prevention. A total of 68 people in 16 states are infected with a rare, largely drug-resistant disease Pseudomonas aeruginosa tension associated with the eye drops. In addition to the deaths, eight people have reported vision loss and four have had their eyeballs surgically removed (enucleation).
In a case report published this week in JAMA Ophthalmology, ophthalmologists at the Bascom Palmer Eye Institute, part of the University of Miami Health System, reported details of one case associated with the outbreak — a case in a 72-year-old man who has a persistent infection in his right eye with loss of vision despite weeks of treatment with multiple antibiotics. When the man first sought treatment, he reported pain in his right eye, which could sense movement only at that point, while his left eye had 20/20 vision. Doctors noticed that the whites of his right eye were completely red and that white blood cells had visibly accumulated on his cornea and in the anterior inner chamber of his eye.
The man’s eye tested positive for a P. aeruginosa strain resistant to multiple antibiotics – as was the bottle of EzriCare artificial tear eye drops he had been using. After further testing, doctors switched the man’s treatment plan to using hourly doses of antibiotics to which the strain of bacteria was least resistant. At a month-long follow-up visit, the redness and ocular infiltrates in the man’s eye had improved. But to date, the infection persists, the doctors reported, as does his loss of vision. (Graphics of his right eye at initial presentation and one month follow-up can be found here.)
Growing outbreak
The CDC identified the outbreak strain as VIM-GES-CRPA, which stands for carbapenem-resistant P.aeruginosa (CRPA) with Verona integron-mediated metallo-β-lactamase (VIM) and Guyana extended-spectrum β-lactamase (GES). This is a highly resistant strain that had never been seen in the US before the outbreak. CDC officials fear the outbreak will make these types of infections more common because the bacteria can colonize asymptomatically in humans, spread to others and share their resistance genes.
Authorities believe the outbreak strain was brought into the country in the contaminated eye drops, which are manufactured by Global Pharma, a manufacturer based in Chennai, India. The Food and Drug Administration reports that it has had a slew of manufacturing violations. The eye drops were supplied by Aru Pharma Inc. imported into the country and then branded and sold by EzriCare and Delsam Pharma. The products were available nationwide through Amazon, Walmart, eBay and other retailers.
ABC News reported on Thursday another case treated by doctors at the Bascom Palmer Eye Institute in which a 68-year-old Miami woman lost an eye after using EzriCare drops. The woman, Clara Oliva, developed an infection in her right eye last August and went to the Emergency Department because of intense pain she described as glass shards in her eye. Doctors found that the pain was due to a P.aeruginosa infection, but did not immediately link it to the eye drops. The doctors attempted to surgically repair the eye, but discovered extensive, irreversible damage and feared the drug-resistant infection would spread. On September 1, they completely removed her inflamed eye. Oliva, left legally blind from the enucleation and poor vision in her remaining eye, continued to use the EzriCare eye drops until January, when the CDC issued its first advisory on the outbreak. She is now suing EzriCare, Global Pharma, the medical center that prescribed her the eye drops, and her insurer.
Oliva is not alone in filing lawsuits. Last month, Jory Lange, a Houston-based attorney with expertise in food safety, filed two lawsuits on behalf of women affected by the outbreak.
“I think this outbreak is unfortunately likely to continue to grow,” Lange told Ars. For starters, people are still being diagnosed, he said. But the CDC also advised clinicians to look at infections from early last year. As of now, identified cases in the outbreak run from May 2022 to February 2023, but the CDC is advising clinicians to avoid any drug-resistant P.aeruginosa cases as early as January 2022. “We’ve talked to some people who were infected in that early time frame, so we think their cases will eventually be added,” Lange said.
“Simply terrifying”
For now, Lange represents Teresa Phillips of Starke, Florida, and Carolyn Ward of Post Falls, Idaho. In a federal lawsuit filed in Florida, Phillips alleged that in May 2022 she developed itching and persistent pain in her eyes after using EzriCare eye drops. Antibiotics initially prescribed did not stop the infection and, after testing positive for a P.aeruginosa infection, she was referred to an infectious disease specialist. Doctors used at least three different intravenous antibiotics for months to stop the infection. She eventually had to have surgery, and she has lingering complications from the infection, such as photosensitivity and problems with her tear ducts, Lange said.
In Ward’s case, filed in a New Jersey federal court, she developed eye infections in mid-August after starting using EzriCare eye drops earlier in the month. Ward is an eye cancer survivor who is immunocompromised. By September, the drug-resistant infection had spread, causing a large rash on her upper body, and P.aeruginosa was identified as the cause. She was given antibiotics that were ineffective against the infection and is suffering from medical complications, the lawsuit says.
In both cases, the women are suing EzriCare, Aru Pharma (the importer), and Walmart, where the products were purchased. Lange noted that Aru Pharma has filed for bankruptcy amid the outbreak lawsuit.
EzriCare did not immediately respond to Ars’ request for comment. But in a Feb. 1 statement, the company said it was “not aware of any test that establishes a definitive link to the Pseudomonas aeruginosa outbreak of EzriCare artificial tears. The company also noted that its “only role in introducing the product to the market was designing an exterior label and marketing it to our customers.” EzriCare, LLC had no role in the formulation, design of the packaging delivery system or the actual manufacturing of this product,” which was done by Global Pharma in India.
Lange said the defense in court was unlikely to be successful. First, “As a consumer, it’s incredibly concerning when a company has its brand on a product and says it’s my product – and then says I’m not responsible for it at all, I have no idea how this happened… That is very disturbing,” he said. “Then as a lawyer, you know, good luck with that defense.” In most states, EzriCare will be strictly liable because the name is on the product and it presents itself as the manufacturer to the consumer, he said.
Overall, “I just think this is a really scary outbreak,” Lange noted. “People trust that the eye drops they use are safe. And the idea that there are companies out there that are marketing eye drops that are contaminated with a deadly bacteria that kills people, and that Amazon and Walmart and eBay are selling them online – it’s just terrifying.”
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