‘Walmart faces suits over eyedrops that allegedly killed 1, blinded 5’.
‘Eyedrops linked to infection clusters; first lawsuit is filed’.
Let’s look into the history of these sizzling stories that are gaining attention online. The EzriCare eyedrops lawsuits and Delsam eyedrops lawsuits are the centerpiece of this news and this blog too.
To give you an insight, EzriCare LLC. and Delsam Pharma are the distributors of the Artificial Tears in the United States. The product is manufactured by Global Pharma, an Indian pharma company, and is reported to be contaminated by a harmful bacteria.
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Before digging deep into the lawsuit and its happening stories in the United States, let us know more about the eyedrops distributors Delsam Pharma and EzriCare, LLC., who are in trouble.
Delsam Pharma
Delsam Pharma LLC is an Over the Counter (OTC) medication Private labeler company located in New York. The company distributes eyecare & lubrication products which are available in leading stores like Walmart, Amazon, and eBay.
Delsam Pharma’s Artificial Tears is a widely used product to relieve irritation, dryness, and discomfort of the eyes due to
- Aging
- Specific medications
- A medical condition
- Eye surgery
- External causes, including wind or smoke
In addition to moisturizing your eyes, artificial tears encourage eye healing, while others aim to slow down tear evaporation.
Delsam Pharma Artificial Tears
The following are the details of Delsam Pharma’s Artificial Tears.
Ingredients
- Carboxymethylcellulose
- Boric acid
- Potassium chloride
- Sodium chloride
- Calcium chloride dihydrate
- Magnesium chloride
- Sodium chlorite
- Sodium hydroxide and water for injection
The company claims that its product containing lubricants keeps the eyes moist, electrolytes heal the eye surface, and the preservatives prevent bacterial contamination of their product. The dosage of the medication is 1- 2 drops in the affected eyes.
EzriCare, LLC
Generic OTC drug company EzriCare is situated in New Jersey. Aru Pharma Inc. imports EzriCare Artificial Tears to the United States. The product’s external label had just been created by EzriCare, LLC, which sold it in the United States. The company claims that it plays no part in the product’s formulation.
We need to know how artificial tear medications generally work to understand the Artificial Tears lawsuits.
How do artificial tears work?
Lubricating eyedrops called Artificial Tears are used to soothe dryness and irritation of the ocular surface. Artificial tears do not include the biologically active substances found in naturally occurring tears. They are used to mimic or replace the functions of the tear film and contain water, electrolytes, and certain polymers.
OTC and generic versions of artificial tears are available in the U.S. They are simple to use, available in various formulations, and generally create minimal risk for the users. The most common application of artificial tears is for Dry Eye Disease (DED).
Dry Eye Disease (DED)
An individual with dry eye disease has insufficient tears to lubricate and feed the eye. The dryness of the eyes, in turn, exposes the cornea and conjunctiva to evaporation and subsequent damage.
Around 6 million persons in the U.S. experience symptoms without a diagnosis, and there are approximately 16.4 million adults in the U.S. diagnosed with dry eye disease. The leading causes of DED are decreased tear production and increased tear evaporation.
Eyedrops Contamination by Pseudomonas
In December 2022, the FDA first became aware of the Pseudomonas aeruginosa outbreak. According to the Centers for Disease Control and Prevention, the new strain belongs to a kind of Pseudomonas aeruginosa that has never been observed in the United States before.
Certain strains of multidrug-resistant (MDR) P. aeruginosa are also resistant to carbapenems and nearly all other antibiotics.
A mobile genetic element that produces the carbapenemase enzyme is present in two to three percent of carbapenem-resistant P. aeruginosa. Bacteria may easily exchange mobile genetic elements, which causes resistance to critical medications to spread quickly.
The antimicrobial is rendered ineffective against β-lactam antibiotics by β -lactamases, hydrolytic enzymes that break the amide link of the traditional four-membered β-lactam ring.
The below-mentioned are the symptoms of Pseudomonas aeruginosa infection due to contaminated Artificial Tears.
- Yellow, green, or clear discharge from the eye
- Eye pain
- Blurry vision
- Eye discomfort
- Redness of the eye or eyelid
- Foreign body sensation inside the eyes
- Increased sensitivity to light
Pseudomonas conjunctivitis is an inflammation of the translucent membrane called conjunctiva covering the white portion of the eye and the inner surface of the eyelids due to Pseudomonas aeruginosa infection.
Those with weakened immune systems, recent eye surgery patients, and those with a history of eye infections are more susceptible to infection. The infection of these strains is so severe that it demands corneal transplants in many people who use the contaminated products. Several people had also experienced blindness.
Eyedrops Contamination Reports and FDA Actions
“To date, there are 55 reports of adverse events, including eye infections, permanent loss of vision, and a death with a bloodstream infection,”-says the FDA.
The contaminated Artificial Tears of Delsam Pharma and EzriCare LLC. have the following product codes:
Delsam Pharma’s NDC 72570-121-15, UPC-72570-0121-15
EzriCare NDC 79503-0101-15, UPC 3 79503 10115 7
The FDA had warned customers that using tainted artificial tears could increase the risk of eye infections that could result in blindness. Those who exhibit symptoms of an eye infection are advised to consult their doctor immediately or go to the hospital.
As per the FDA, Global Pharma had also failed to comply with the Current Good Manufacturing Practice (CGMP) regulations.
The following are the allegations against Global Pharma
- Lack of appropriate microbial testing
- Formulation issues
- Packaging flaws
- Inadequate preservatives in the product
- Lack of proper controls in tamper-evident packaging
The FDA advises the public to report any adverse reactions or quality issues of the eyedrops to the MedWatch Adverse Event Reporting Program. They have also placed Global Pharma, the eyedrops manufacturer, on a “red list” of import alerts for insufficient response to a records request.
Contaminated Eyedrops Infection Lawsuit
Let us follow the case studies of two claimants proceeding with a contaminated eyedrops lawsuit.
Carolyn Ward
According to NBC News, a lawsuit has been brought against Walmart, and the manufacturer of EzriCare drops after a lady contracted a bacterial illness.
On February 11, 2023, a Pseudomonas aeruginosa infection lawsuit was brought by a woman from New Jersey who claimed that the EzriCare eyedrops were tainted with bacteria, which led to a severe infection.
Carolyn Ward filed a complaint in the U.S. District Court for the District of New Jersey, claiming she was already at risk for infection because she was recovering from radiation therapy for eye cancer. She used the product to reduce eye irritation symptoms related to cancer.
The claimant in this lawsuit is seeking past and future economic and non-economic damages from EzriCare, LLC, Ezrirx, LLC, Aru Pharma, Inc., and Walmart, Inc.,
She experienced symptoms of Pseudomonas aeruginosa infection a few weeks after purchasing EzriCare Artificial Tears eyedrops in August 2022. Within two weeks of using the EzriCare eyedrops, she began to experience itchy and unrelenting pain in her eyes.
Her optometrist prescribed her antibiotics and steroids, but her symptoms did not subside. By the end of September 2022, the infection had spread to her back, torso, and belly, leaving her body covered in a sizable rash. The claimant still suffers from medical complications due to the tainted eyedrops.
The eyedrops infection lawsuit brings the following claims against the defendants.
- Product liability
- Breach of warranty
- Negligence
- Negligence per se
Teresa Phillips
Teresa Phillips, aged 60, had filed a lawsuit on February 9, 2023, against Walmart and EzriCare artificial tears.
The lawsuit was filed in the U.S. District Court for the Middle District of Florida.
Phillips claimed to have itchiness and unrelenting pain in her eyes in May 2022, a few weeks after using the eyedrops. The lawsuit claimed that even a course of antibiotics could not stop the eye damage in the claimant. She had to go for surgery to address the infection-related injuries.
To conclude, we shouldn’t anticipate an EzriCare class action lawsuit over these tainted eyedrops, according to the U.S.’s top attorneys. A class action lawsuit will need more plaintiffs to proceed. The fact is that many victims have not yet related their eye damage to the use of the eyedrops.
For those who were injured by the eyedrops, there is a chance for a bigger settlement payout.
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Damages Covered by Eye Drop Infection Lawsuits
The following are the damages covered in the happening eyedrops infection claims in the United States against Delsam Pharma and EzriCare.
- Eye Infection
- Partial Blindness
- Permanent Blindness
- Bloodstream Infection
- Other injuries caused by eyedrops
Is there any recall of contaminated eyedrops?
Yes. The contaminated eyedrops have been formally taken off the market. On January 20, 2023, the Centers for Disease Control and Prevention (CDC) urged medical professionals and patients to discontinue using EzriCare Artificial Tears eyedrops in light of the rising illness reports.
Currently, there are reports of 55 infections in 12 states that have resulted in permanent vision loss, hospitalization, and even one death. California, Florida, New York, Texas, Colorado, Connecticut, New Jersey, New Mexico, Nevada, Utah, Wisconsin, and Washington are the states with such reports of adverse events of EzriCare eyedrops.
The CDC alerted the FDA to do an investigation of a multi-state cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections caused by the product.
On February 2, 2023, Global Pharma officially announced a voluntary nationwide recall of Artificial Tears Lubricant Eyedrops sold under the brand names Delsam Pharma and EzriCare in the U.S.
Customers are contacted by EzriCare LLC and advised against using the product indefinitely on their website. They are prepared to comply in any CDC or FDA investigation into the product contamination.
The CDC and the FDA are presently collaborating with state and local health officials to examine the outbreak, even though the eyedrops have not yet been directly linked to the infections. In order to ascertain if contamination may have happened during manufacture, the CDC is currently analyzing unopened bottles of EzriCare Artificial Tears, according to the organization.
Are you suffering from vision loss or other eye damage due to EzriCare or Delsam Artificial Tears?
Contact an expert injury attorney and know the possibilities of filing a claim. Don’t leave your medical practice exposed to potential legal issues. Protect your patients and your reputation with our expert Medical Record Review Services.
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Complete and submit the report online at MedWatch. You can complete the form and submit it via fax at 1-800-FDA-0178.
You can also report adverse reactions by contacting FDA’s Consumer Complaint Coordinators.
Know more about the contaminated eyedrops lawsuit 2023 with our timely updates.
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