EzriCare Artificial Tears Lawsuit | Compensation Options
Numerous individuals have reported experiencing adverse effects from using Delsam Pharma or EzriCare Artificial Tears over-the-counter eye drops. The maker, Tamil Nadu, India-based Global Pharma Healthcare Private Limited, has issued a nationwide recall citing potential microbial contamination that can cause bacterial infections leading to vision damage or even death. The growing number of incidents has led to the filing of lawsuits against Global Pharma. Individuals who suffered vision loss or other serious health consequences from a bacterial infection related to EzriCare and Delsam Pharma artificial tear drops could be entitled to significant financial compensation. Here, Ethen Ostroff Law delves into the details of the Delsam Pharma and EzriCare artificial tears lawsuit, explains the potential damages involved, and outlines the legal process for pursuing a claim.
What are EzriCare and Delsam Pharma artificial tears?
EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears are over-the-counter products for dry eyes, minor eye irritations, and protection against discomfort. Both eye drop brands use the active ingredient carboxymethylcellulose sodium, with a concentration of 10 mg per milliliter. Other eye drop brands also use carboxymethylcellulose sodium. According to a clinical trial published in BMC Ophthalmology carboxymethylcellulose sodium is effective in relieving dry eye in patients who had cataract surgery.
Who is the manufacturer of EzriCare artificial tears?
Aru Pharma Inc. formulated, designed, and imported EzriCare Artificial Tears into the US. Global Pharma Healthcare Private Limited manufactures them in India.
Where are EzriCare eye drops manufactured?
Global Pharma Healthcare Private Limited manufactures EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears in India. Aru Pharma Inc. formulated, designed, and imported these eye drops into the US. EzriCare, LLC, created their labels and marketed them throughout the country.
EzriCare and Delsam Pharma Linked to Bacterial Infection
Many users of EzriCare and Delsam Pharma’s artificial tears experienced side effects due to the outbreak of Pseudomonas aeruginosa, a drug-resistant bacteria. The bacterial infection can result in vision loss, eyeball surgical removal, and death. Some users of EzriCare or Delsam artificial tears who developed bacterial infections had to take antibiotics for months or undergo surgery, but they continued to have vision problems.
On February 2, 2023, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) advised people to immediately stop using EzriCare and Delsam Pharma’s Artificial Tears due to the risk of bacterial eye infections. Global Pharma issued a recall for these brands and Delsam Pharma’s Artificial Eye Ointment.
In May 2022, the CDC launched an investigation into the bacterial outbreak. As of May 15, 2023, the agency found 81 patients in 18 states infected with the rare bacteria. Most of these patients used artificial tears, with EzriCare Artificial Tears being the most reported brand. The CDC said three people have lost their lives, and eight have lost their vision.
Are there alternatives to EzriCare and Delsam Artificial Tears?
There are. Alternatives to EzriCare and Delsam include other brands of over-the-counter artificial tears that may contain carboxymethylcellulose sodium or another type of active ingredient. Your doctor can recommend one if you are unsure of which brand to use.
Alternatives to Ezricare and Delsam artificial tears include:
- Blink-N-Clean Lens Drops
- HydraSense Night Therapy
- Optase Dry Eye Intense Drops
- Refresh Optive Mega-3 Lubricant
- Refresh Plus Preservative-Free
- Soothe XP
- Systane Complete Preservative-Free
- Systane Ultra Preservative-Free
What are the symptoms and side effects of EzriCare and Delsam artificial tears?
Eye infection symptoms include:
- Eye discharge
- Eye discomfort or pain
- Eye or eyelid redness
- Increased light sensitivity
Short-term side effects include:
- Blurry vision
- Changes in vision or eye pain
- Itching or swelling in the face, tongue, or lips
- Stinging sensation in the eye
Long-term side effects, which are serious but rare, include:
- Drug-resistant infections
- Vision loss
What are the treatment options available?
- Combination therapy with different antibiotics
- Drainage or removal of infected tissue
- Intravenous antibiotics
- Eye surgery
What brands of eye drops are being recalled?
- EzriCare Artificial Tears Lubricant Eye Drops (carboxymethylcellulose sodium): 10 mg in 1 mL, 12 fl. oz. (15 ml) bottle. NDC 79503-0101-15, UPC 3 79503 10115 7
- Delsam Pharma’s Artificial Tears and Lubricant Eye Drops (carboxymethylcellulose sodium): 10 mg in 1 mL, 12 fl. oz. (15 ml) bottle. NDC 72570-121-15, UPC 3 72570 12115 8
- Delsam Pharma’s Artificial Eye Ointment (mineral oil 15%, white petrolatum 83%, 3.5 grams or 1/8 oz.) The recalled batch number is H29, NDC 72570-122-35, UPC 3 72570 12235 3
Why were EzriCare and Delsam Pharma artificial tears recalled?
Global Pharma recalled EzriCare Artificial Tears Lubricant Eye Drops after the CDC and FDA linked the products to a multistate outbreak of infections caused by the Pseudomonas aeruginosa bacterium. It also recalled Delsam Pharma’s Artificial Tears and Delsam Pharma’s Artificial Eye Ointment after the FDA recommended the recall for potential microbial contamination and leaking of eye ointment packages.
What is the cause of the bacterial outbreak?
On March 31, 2023, the FDA published a report following an 11-day unannounced inspection of the Global Pharma facility in India, where the EzriCare and Delsam eye drops were made. The report noted several sterilization and hygiene concerns at the facility. Among other things, they found:
- Areas of the sterile manufacturing area that had not been cleaned properly
- Greasy deposits on equipment
- Surfaces that encountered drug packaging that had not been properly sanitized or sterilized.
- Unqualified clean room operators
- Lack of appropriate microbial testing procedures
- Lack of proper controls
- Lack of sufficient cleaning procedures
What is the response of the FDA to Global Pharma's recall?
The CDC and FDA continue to investigate the bacterial outbreak linked to EzriCare Artificial Tears. Together, the agencies will test unopened bottles of EzriCare eye drops to see if the products were contaminated during manufacturing. As of July 2023, there have been no updates on testing results.
On May 26, 2023, in a news release, the FDA stated it is aware of continuing reports of adverse events associated with the use of EzriCare Artificial Tears and Delsam Pharma’s Artificial Eye Ointment. It also encourages consumers and healthcare professionals to report adverse events or quality problems to its MedWatch Adverse Event Reporting program.
In the meantime, the FDA warned people not to use recalled products. It said Global Pharma did not thoroughly test for bacteria, did not use an adequate preservative, did not have good manufacturing controls for tamper-evident packaging, and did not comply with current good marketing practices. The FDA placed Global Pharma on import alert to prevent the India-based manufacturer’s products from entering the US.
Are there lawsuits for Ezricare and Delsam eye drops?
There are. Hundreds of class action and individual lawsuits were already filed by those who endured side effects from using EzriCare and Delsam Pharma’s artificial tears and eye ointment. The plaintiffs filed the first lawsuits shortly after the EzriCare recall in February 2023. Plaintiffs in class action lawsuits demand refunds for the purchase price of the products, while plaintiffs in individual injury lawsuits demand compensation for EzriCare- or Delsam Pharma-related infections and eye problems.
The Delsam Pharma and EzriCare artificial tears lawsuit are in the preliminary stages. There are no approved settlements or jury trials scheduled yet. More users are expected to file new lawsuits.
What are the allegations in the Delsam Pharma and EzriCare artificial tears lawsuit?
- Global Pharma failed to adequately warn consumers about the potential risks associated
- Products were defectively designed
- The manufacturer failed to exercise reasonable care in the design, manufacturing, marketing, and distribution of the products
- Global Pharma breached either an express or implied warranty by selling a defective or dangerous products
- Global Pharma made false or misleading statements about the safety or effectiveness of EzriCare Artificial Tears
Who can bring an EzriCare or Delsam lawsuit?
You can file an EzriCare or Delsam lawsuit if you:
- Used EzriCare or Delsam Pharma artificial tears
- Got bacterial infection
- Suffered vision loss
- Were hospitalized
What can you recover in an EzriCare or Delsam lawsuit?
You can recover compensation for your losses, including:
- Emotional trauma
- Lost wages and reduced future earning capacity
- Medical expenses
- Physical pain and suffering
- Reduced quality of life
What is the average settlement amount for a contaminated eye drop lawsuit?
The settlement compensation in product liability lawsuits involving injuries caused by contaminated EzriCare eye drops will depend on the nature and extent of the injuries caused by the infection. Ethen Ostroff Law estimates that a contaminated eye drops lawsuit involving permanent vision damage or impairment would have an average settlement compensation in the range of $200,000 to $1 million, depending on the extent of vision loss or impairment.
How can you file an EzriCare or Delsam lawsuit?
- Talk to a product liability or personal injury lawyer to find out if you have a claim.
- Gather any documentation related to your use of EzriCare or Delsam products, including purchase receipts, medical records, and any correspondence with the manufacturer. Share this information with your attorney.
- Your attorney will gather evidence and draft the necessary legal documents.
- Your attorney will file the lawsuit in court.
- Your attorney may try to settle outside of court. Your case goes to trial if no settlement is reached.
- A judge or jury will make the final decision.
EzriCare and Delsam Pharma Artificial Tears Lawsuits Update 2024
June 5, 2023: 14 lawsuits were filed in federal courts involving contaminated EzriCare Artificial Tears. The plaintiffs alleged serious injuries, such as eye infections leading to sepsis and surgical procedures.
May 23, 2023: The CDC reported 81 infections in 18 states linked to recalled EzriCare eye drops, including four deaths, hospitalizations, vision loss, and surgical eye removal.
May 15, 2023: 81 patients in 18 states with P. Aeruginosa infections were identified, an increase of 13 patients and two states (Delaware and Ohio) since March 14, 2023. Four patients died.
May 4, 2023: A new EzriCare lawsuit was filed in California, alleging discomfort, pain, swelling, and blurred vision after using the product.
May 2, 2023: The FDA warned about the potential health risks of unapproved eye drops containing amniotic biomaterials.
April 8, 2023: An FDA report revealed sterilization failures and inadequate airflow at the manufacturing plant responsible for contaminated artificial tears and eye drops.
March 25, 2023: National Public Radio covered the EzriCare recall.
March 14, 2023: The CDC identified 68 patients in 16 states with the P. aeruginosa infection linked to EzriCare Artificial Eye Drops. The agency added the following states since its previous update: Illinois, North Carolina, Pennsylvania, and South Dakota.
March 8, 2023: The FDA issued Import Alert 66-40 for products imported by Global Pharma with a Detention Without Physical Examination status after the company failed to comply with Good Manufacturing Practices.
February 24, 2023: Delsam Pharma recalled the Delsam Pharma eye ointment.
February 20, 2023: The FDA initiated an unannounced inspection of the Global Pharma factory in India.
February 9, 2023: The first consumer class action lawsuit over the contaminated EzriCare Artificial Tears was filed in federal court.
February 2, 2023: Global Pharma recalled all EzriCare eye drops at the FDA’s request due to infection risks and potential blindness.
February 1, 2023: EzriCare issued a public statement acknowledging contact with the CDC and FDA and halting distribution of their product.
January 31, 2023: The CDC worked with the FDA to investigate the P. aeruginosa outbreak.
January 24, 2023: EzriCare publicly acknowledged contamination concerns but issued no formal notice or recall request.
January 20, 2023: The CDC identified EzriCare Artificial Tears as the source of bacterial infections in multiple states, including California, Florida, Nevada, New Jersey, Texas, Utah, and Washington.
Why Choose Ethen Ostroff Law for Your EzriCare Artificial Tears Lawsuit?
Ethen Ostroff Law and our affiliated firms are here to help victims of dangerous or defective products like EzriCare or Delsam artificial tears. We have experience representing clients in product liability and personal injury lawsuits. Our EzriCare and Delsam Pharma artificial tears lawsuit team will determine the cause of your injuries, identify all possible parties responsible, gather evidence to support your claim, and build a compelling case on your behalf.
Our goal is to secure the maximum financial compensation you are owed. We will tailor our approach according to the specifics of your case. Trust that Ethen Ostroff Law and our partners will fight for your rights and provide the support you need.