A September operation to remove Clara Oliva’s infected right eye may be the reason she is alive today. But the infection, in many ways, still claimed her life.
It was her good eye – the one Oliva, 68, expected would allow her to carry on her regular grandmother duties or continue her career as a cosmetologist. She begged doctors to save it. But a rare, deadly bacteria unfazed by antibiotics was afoot, and they couldn’t allow it to spread.
Now legally blind, Oliva's life has changed “1,000 percent.”
Nothing can restore her sight, Oliva says, but she hopes a lawsuit against the maker of recently recalled eye drops linked to a deadly outbreak of Pseudomonas aeruginosa can deliver accountability, and prevent others from meeting the same fate.
Recalled Ezricare eye drops linked to outbreak
Oliva, who lives in Miami, is suing India-based Global Pharma Healthcare, the maker of Ezricare Artificial Tears, which she was prescribed for her dry eyes last year. The suit also names Ezricare, EzriRx and Aru Pharma, the U.S.-based distributors of the drops.
The eye drops were recalled in early February after the Centers for Disease Control and Prevention linked them to an outbreak of Pseudomonas aeruginosa. As of Monday, the eye drops were thought to have infected 68 people across 16 states.
Three people have died, eight people have reported vision loss and there have been four reports of enucleation, the procedure to remove the eyeball Oliva underwent, according to the CDC.
Pseudomonas aeruginosa is a rare, extensively drug-resistant bacteria that had not been seen in the United States before last year, the CDC said.
'I couldn't sleep because of the pain'
Officials were able to trace the current outbreak to the use of over 10 different brands of eye drops, but noted that the most commonly reported brand used was EzriCare Artificial Tears, which is a preservative free eye-lubricant.
Oliva said she was prescribed the recalled drops in May to alleviate dry eyes brought on by contact lenses. Her insurance no longer covered the previous brand she used.
After months of using the drops, her right eye became swollen and red on August 1, and she sought treatment at a Leon Medical Centers facility in West Hialeah, Florida, where doctors diagnosed Oliva with a scratched cornea and prescribed her a suite of antibiotics, according to the lawsuit. Despite taking the medication, the eye’s condition worsened.
'Urgent threat':CDC warns against Candida auris, a drug-resistant fungus invading health care facilities
Three days later, Oliva wound up in the emergency room at the Bascom Palmer Eye Institute in Miami. Doctors there identified an ulcer in her eye, took culture samples for analysis and upped the dosages and frequency of her initially prescribed medication, according to the lawsuit.
Oliva would return 10 times to the doctor over the month of August, according to the lawsuit.
“I couldn’t sleep because of the pain,” Oliva said. She would spend entire days at the hospital.
The analysis on the sample taken from her returned on August 10, and showed the presence of Pseudomonas aeruginosa.
A couple of weeks later, doctors began an operation to remove part of Oliva's cornea and replace it with donor tissue. But the surgeon aborted the operation, according to the lawsuit. The extent of the infection was beyond the scope of the procedure.
There was little choice but to remove Oliva's eye.
More eye products recalled:Eye ointment recalled after earlier eyedrops recall linked to infection outbreak, death
“On September 1, 2022, Mrs. Oliva’s right eye was surgically removed and replaced with a plastic implant,” the lawsuit says. “Given her decreased visual acuity of 20/200 in her remaining left eye, Mrs. Oliva is now legally blind.”
Oliva continued to use Ezricare eye drops on her left eye until January, when her clinic called to tell her to stop using the drops and throw them away. Oliva said she was only told that the drops were under recall, but not why.
It wasn’t until she heard about the recall on a TV news segment that she and her family learned about the possible Pseudomonas aeruginosa contamination.
'I want justice'
The suit names six defendants:
- Global Pharma Healthcare Private LTD. (India-based manufacturer)
- Ezricare, LLC (New Jersey-based U.S. distributor)
- EZriRx, LLC (Delaware-based U.S. distributor)
- Aru Pharma, Inc. (New York-based U.S. distributor)
- Leon Medical Centers, LLC. (Oliva's healthcare provider)
- HealthSpring of Florida, Inc. (Oliva's health insurance plan)
Under Florida law, any entity involved at any point in the “stream of commerce” or distribution of a product can be held liable, Oliva’s attorney Ryan Yaffa said.
“These entities are manufacturing, supplying, advertising, promoting and selling a product that's contaminated to people located in our country. And in our state, which reached our client,” Yaffa said. “This product reached consumers and it’s harming people, and people are suffering significant damages.”
The allegations in the lawsuit total dozens of counts, ranging from negligence to breaches of expressed warranty.
Oliva seeks to recoup her medical expenses, plus other damages.
“We're not asking for a specific number at this point,” Yaffa said. “But in terms of her pain and suffering… we’ll ask a jury to order what they think is fair and just.”
Oliva can’t pick up her grand kids from school, or indulge her passion for cooking. Instead, she spends her days trying to relearn what were once basic tasks: how to walk without falling, how to bathe without assistance.
Watching TV or reading, simple pleasures available at home, aren’t feasible.
Oliva moved from one son’s home into another’s, because it’s more spacious, allowing her to move around the house without accidentally bumping into things.
Ezricare is facing multiple lawsuits over its eye drops, including two federal class action suits filed in Kentucky and New York.
USA TODAY's inquiries to the defendants in Oliva's lawsuit were not immediately returned Wednesday.
“The people responsible for this need to pay. They need to pay for the damage they’ve done,” Oliva said. “They’ve played with people's lives. Not just one person’s life, but the lives of an entire family… I want justice.”
Source link
