A Miramar woman’s lawsuit claims she lost her right eye and is now legally blind after a bacterial infection caused by bacteria-tainted artificial tears.
Clara Olivia’s lawsuit also alleges that she had to switch to EzriCare’s artificial tears because that brand was “underwritten” by Leon Medical Center in Doral’s insurance arm, HealthSpring.
Both Leon Medical Center and HealthSpring were defendants in the suit, along with Global Pharma Healthcare, the Indian company that manufactured the artificial tears, and the companies involved in importing, distributing and selling the artificial tears, EzriCare, EzriRx and Aru Pharma.
The lawsuit was filed Tuesday in Miami-Dade’s 11th Circuit Court by Ryan Yaffa of the Coral Gables law firm Grossman, Roth, Yaffa & Cohen.
Neither defendant responded to emails or calls from the Miami Herald.
Artificial tears and the real problem
The FDA has announced four market recalls announced in the past month. Purely Soothing eye drops have been recalled due to lack of sterility. Cracked caps may affect the sterility of brimonidine tartrate ophthalmic solution, which is removed by Weston’s Apotex.
But the biggest recalls came from Global Pharma, which recalled all batches of EzriCare lubricating eye drops and Delsam Pharma (sodium carboxymethyl cellulose) following a CDC investigation into an outbreak of “strain Pseudomonas aeruginosa extremely resistant to drugs.
Delsam Pharma eye ointment was later withdrawn from the market by Global.
“The majority of patients reported using artificial tears,” the CDC study noted. “Patients reported more than 10 brands of artificial tears, and some patients used multiple brands. EzriCare artificial tears, an over-the-counter preservative-free product packaged in multi-dose vials, were the most commonly reported brand names. This was the only common artificial tear product identified in all four groups of health centers.”
Olivia’s lawsuit cited a statement from EzriCare dated Feb. 1, the day the CDC first announced the outbreak: “As of today, we are not aware of any evidence definitively linking […] bud with EzriCare artificial tears; however, we have taken immediate action to stop the distribution and sale of EzriCare artificial tears. Where possible, we contacted customers to advise them not to continue using the product.”
EzriCare, EzriRx Aru Pharma and Walmart were the defendants in the lawsuit filed in February in Florida federal court by Coral Gables attorney Rebecca Vinacour and Houston-based Jory Lange of The Lange Law Group, on behalf of Teresa Phillips. , neighbors of Starka. . Phillips’ lawsuit alleges that he contracted the infection from Pseudomonas aeruginosa.
According to the latest data from the CDC, the outbreak has affected 64 people in 13 states: Florida, California, Texas, New York, Colorado, Connecticut, Illinois, New Jersey, New Mexico, Nevada, Utah, Washington and Wisconsin. Of these 64, 37 were in four groups of health centers. One person died and there were eight reports of vision loss.
Olivia’s lawsuit indicated that she should be included in that figure.
He lost his right eye
The lawsuit states that Olivia (68) has been wearing contact lenses for 30 years, which is why her eyes are dry. To solve that problem, he used drops he got through HealthSpring Insurance along with contact lenses from LEON Medical Center.
“HealthSpring routinely supplied Olivia with lubricating eye drops manufactured by Bausch & Lomb,” the lawsuit states. “However, in May 2022, Olivia realized that the eye drops approved by her insurer had changed. This time they gave her EzriCare artificial tears.”
On Aug. 1, with her right eye “noticeably red, swollen, and abnormally watery,” Olivia was told by an ophthalmologist at LEON Medical Center and others that she had a scratch on her cornea. Three days of antimicrobials and antibiotics did not prevent the eye’s condition from worsening, the lawsuit states, so Olivia went to the Bascom Palmer Eye Institute on Aug. 4.
There, doctors increased the strength and frequency of the medications already prescribed and performed an examination that revealed a “peripheral corneal ulcer.” A diagnostic corneal scraping was performed, and three days later, according to the lawsuit, an examination showed that Olivia’s vision was failing and that the size of the ulcer had increased: the fungus had adhered to the ulcer. Doctors added antifungal and antiviral drugs.
When Olivia returned to Bascom Palmer on Aug. 10, according to the lawsuit, she was told that crops taken on Aug. 4 showed “moderate growth pseudomas aeruginosa“.
The change in treatment did not stop the problem, the lawsuit alleges. On August 29, doctors attempted penetrating keroplasty, a corneal transplant, but during the operation, “the surgeon noticed scleral abscesses” that made it impossible to safely remove the cornea. The operation was aborted.
The lawsuit stated that on the day of the aborted operation, the doctors and two specialists in ophthalmic plastic and reconstructive surgery who were examined the following days were of the same opinion: with what had already happened to the right eye, with the already attempted treatment and “the risk Before the infection spreads systemically creating a life-threatening condition,” removing Olivia’s right eye was the best option.
“On September 1, 2022, Olivia’s right eye was surgically removed and replaced with a plastic implant,” the lawsuit states. “With reduced visual acuity of 20/200 in her remaining left eye, Olivia is now legally blind.”