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Ezricare Eye Drops Lawsuit Update – April 5, 2023

Timely Insights on Laws, Issues and New Developements
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Tears

EzriCare artificial tear drops have been linked to serious bacterial infections which have caused vision damage, eye amputations, and even, in a few cases, death.

The national product liability lawyers at Matthews & Associates are investigating artificial tears infection lawsuits for people who suffered serious injuries from infection caused by recalled EzriCare artificial tear drops. People who suffered vision loss or other serious health consequences from a bacterial infection related to artificial tear drops could be entitled to significant financial compensation.

EzriCare Lawsuit Events Timeline

March 25, 2023: NPR reported on the EzriCare recall.

March 8, 2023: Pharmedica USA and Apotex Corporation began recalls for eye drops after some contaminated products they made were linked to infections in several states, in February 2023. The recall will probably trigger more eye drop infection lawsuits as more people become aware of the link between the products and infection and injuries.

Pharmedica recalled two lots of Purely Soothing brand drops following sterility issues that the FDA said “could result in the risk of eye infections that may lead to blindness.” Purely Soothing is used to treat eye irritation. It was distributed through online retailers and trade shows.

The Apotex Corporation recalled six lots of its brimonidine tartrate ophthalmic solution which was meant to treat open-angle glaucoma or ocular hypertension. The recall cited cracks in bottle caps that threatened sterility. The company discovered four bottles with cracked caps. Apotex VP of global corporate affairs, business transformation, and strategic planning, said the root cause was vendor-related. No adverse health reports were tied to the product.

Recently reported infection outbreaks were linked to eye drops marketed by the EzriCare and Delsam Pharma brands recalled by the makers in February 2023. Most of the affected cases were found in 12 states, including California, Connecticut, Florida, and Utah.

February 9, 2023:  A consumer class action lawsuit regarding the contaminated EzriCare Artificial Tears eye drops was filed in federal court. Personal injury lawsuits were anticipated to follow in different state courts.

February 2, 2023: The FDA requested that Global Pharma initiate a nationwide recall of all EzriCare Artificial Tears eye drops that it manufactured. The recall notice said that EzriCare eye drop usage could lead to infections and “blindness.” The recall came several weeks too late for many.  Evidence had already shown the eye drops made by Global Pharma were the source of bacterial contamination that had already triggered 55 (reported) cases of severe infection.

February 1, 2023: EzriCare issued a new public statement which said the company had informed CDC and FDA about the problem. EzriCare also said it “took action to stop any further distribution or sale of EzriCare Artificial Tears.”

January 24, 2023: EzriCare acknowledged the potential contamination for the first time in a statement published on its website. EzriCare said it had not received any formal notice from the CDC or any other regulatory authority. The company also said it  had not been asked to issue a recall.

January 20, 2023: The CDC announced that EzriCare Artificial Tears lubricating eye drops appeared to be the source of contamination which had caused more than 50 serious bacterial infections in a dozen states.

EzriCare Artificial Tear Drops

The EzriCare company is based in Lakewood, New Jersey. It markets a small line of personal care products. Its Artificial Tears Lubricant Eye Drops are sold over the counter at Walmart and Amazon, and also OTC by other nationwide retailers.

The EzriCare Artificial Tears come in a 15 ml bottle in a solution with an active ingredient called carboxymethylcellulose sodium which is commonly found in many eye drops. This sodium substance produces the effect of actual tears, helping to moisten and soothe the eyes.

Although EzriCare is the brand attached to the Artificial Tears Drops, they are not made by EzriCare. The Artificial Tears drops were formulated and designed by Aru Pharma Inc., and the product is made in India by Global Pharma Healthcare PVT LTD.

EzriCare Artificial Tear Drops Linked to Serious Bacterial Infections

In January 2023, the CDC began to investigate reports of more than 50 bacterial infections in 12 states. The infections seemed to be related to OTC eye drop products. The CDC reports included infections of the cornea, intraocular fluids, respiratory tract, urinary tract infections.

CDC investigation found the source of the infections appeared to be EzriCare Artificial Tears. After performing chemical analysis testing on previously opened bottles of EzriCare drops, CDC identified they included a bacteria called Pseudomonas aeruginosa.

What is Pseudomonas aeruginosa?

Pseudomonas aeruginosa is typically found in soil and water. This bacteria bacteria often causes infections in humans, most commonly in the lungs or in the blood. Pseudomonas aeruginosa is especially dangerous as it constantly evolves to allude antibiotic treatments.

Thousands of Deaths from Pseudomonas aeruginosa

Testing has shown these bacteria resist most routine antibiotics. In 2017, Pseudomonas aeruginosa caused 2,7000 deaths among hospital patients in the U.S.

The CDC has isolated the specific strain of Pseudomonas aeruginosa, identifying it as Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa (“VIM-GES-CRPA”). This is a particularly dangerous strand of bacteria.

Infections from Eye Drops Cause Serious Injuries and Death

People who used the contaminated eye drops have developed severe infections in the cornea and intraocular fluids. These infections have resulted in permanent vision loss, vision impairment, even eye amputations. Bacteria in Ezricare eye drops has caused some people to develop urinary and respiratory tract infections. In at least one case, the infection caused by the eye drops triggered sepsis (a bloodstream infection) that led to a patient’s death.

How Did Artificial Tears Drops get Contaminated?

It’s not clear how the EzriCare Artificial Tears eye drops were contaminated. CDC ran laboratory tests on previously opened bottles of EzriCare eye drops bottles from different production lots. Some came from reported infection victims; others came from from non-infected consumers.

Testing the bottles confirmed Pseudomonas aeruginosa bacteria was in the eye drops. Advanced analysis of the bacteria strain found in the bottles matched the strain detected in victims of the outbreak. This testing proved EzriCare eye drops was the infections’ source.

Because all eye drop products are preservative-free, bacteria can unfortunately run wild in them.

Assembly Line Errors?

Bacteria contamination in the bottles most likely occurred in the manufacturing process, perhaps on the assembly line, or perhaps at the manufacturing facility.

CDC Reports the Strain

The CDC reported that its testing could identify “the presence of the outbreak strain in opened EzriCare bottles with different lot numbers collected from two states.” The CDC isolated the outbreak strain from 13 sputum or bronchial washes, 11 cornea swabs, seven urine samples, two blood samples, 25 rectal swabs, and four other nonsterile sources.

What did Walmart and Amazon Know About Global Pharma?

EzriCare has disclosed that its Artificial Tears eye drops are made by Global Pharma, based in Tamilnadu, India. The company produces many popular brands of OTC healthcare products from its manufacturing plant in the Chennai region of Southeastern India. Global Pharma is known to have some quality control problems. In March 2023, FDA added Global Pharma to its “red list,” which indicates problems with the manufacturer. Global Pharma made the list by failing to comply with FDA manufacturing requirements. It also ignored FDA requests. This evidence could be crucial in EzriCare eye drops infection lawsuits. Plaintiffs’ attorneys are sure to ask what EzriCare, Walmart, and Amazon did when they learned of Global Pharma’s problems. Or they will look at what those companies failed to do after discovering the problems.

EzriCare Eye Drops Infection Lawsuits

Plaintiffs’ attorneys will work to hold Global Pharma accountable for bacteria contamination in the EzriCare eye drops. EzriCare will be the target of lawsuits meant to hold the company liable for injuries caused by the contaminated eye drops. Tort law in America holds product manufacturers and retailers strictly liable for injuries caused by manufacturing defects. Negligence is not necessarily required to establish a tort claim.

EzriCare will be alleged in these lawsuits to have direct liability for all injuries linked to infections caused by contaminated EzriCare eye drops. In addition, EzriCare Artificial Tears product was sold at major retailers such as Walmart and Target. That means those and other retailers which sold the eye drops will also face liability for injuries the eye drops caused.

Settlement Values of Contaminated Eye Drops

Potential compensatory damages in product liability lawsuits over injuries caused by contaminated EzriCare eye drops will depend mostly on the nature and extent of the injuries. The CDC has noted that some of the injuries caused by the contaminated eye drops have been very serious. At least one person has died from an eye drop infection.  Many have been hospitalized. CDC reports that many who have experienced these eye infections may have suffered permanent vision loss or impairment.

Some possibly comparable lawsuits involving similar situations have brought between $100,000 and more than $1 million.

Here are a few potentially comparable settlements and verdicts in cases of vision damage or other injuries related to bacteria infections similar to those linked to the EzriCare eye drops.

  • Lussow v Brinker Int’l. (Illinois) $950,000:  Contaminated food at an Illinois’ Chili’s restaurant led to a woman’s suffering salmonella bacteria infection. The woman was hospitalized, though she suffered no permanent injuries. She settled the case.
  • Schmidlin v Sutton (Ohio) $250,000:  Pseudomonas aeruginosa infection in the prostate and testicle of a 54-year-old man resulted in surgical removal of his testicle. Contaminated medical equipment was thought to cause the infection. The jury awarded damages.
  • Shellum v Fairview Health (Minnesota) $3,174,507: A Pseudomonas aeruginosa bacterial infection resulted in total blindness in a woman’s eye, which had to be removed. The 68-year-old sued the hospital for failing to maintain a sterile environment. The jury gave her an award.

Of course, we can only speculate about what EzriCare Artificial Tears cases may be worth. Each would be handled separately, and any payout or remuneration would depend on the extent of any injury, the age of the plaintiff, other health factors, actual and potential earnings, lost earnings, etc. These listed cases may or may not be relevant to any EzriCare claims. We offer them only as a kind of possible benchmark, for want of something more similar to any Artificial Tears eye drop litigation claims.

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