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Table Of Contents
- Leader Eye Drops Lawsuit Overview
- Latest Leader Eye Drops Lawsuit Updates
- FDA Reports and Statistics
- Leader Eye Drops Injuries & Side Effects
- Symptoms of an Eye Infection from Contaminated Eye Drops
- Do You Qualify for a Leader Eye Drops Lawsuit?
- Leader Eye Drops Recall Information
- FDA Recommendation on Recalled Eye Drops
- Statute of Limitations for Leader Eye Drops Lawsuits
- FAQs
- 1. What specific injuries qualify for a Leader Eye Drops lawsuit?
- 2. How long will a Leader Eye Drops lawsuit take?
- 3. What compensation might I receive from a Leader Eye Drops lawsuit?
- 4. Are there any recalls on Leader Eye Drops?
- 5. What should I do if I experience side effects from using Leader Eye Drops?
- 6. How can an attorney help with my Leader Eye Drops lawsuit?
- 7. How much does it cost to file a Leader Eye Drops lawsuit?
- 8. Can I join an existing Leader Eye Drops class action?
- 9. What evidence do I need to preserve for my case?
- 10. Will my case go to trial or settle?
- Get a Free Leader Eye Drops Lawsuit Evaluation With Our Lawyers
Leader Eye Drops Lawsuit Overview
The Leader Eye Drops lawsuits center on over-the-counter eye drop products manufactured under unsanitary conditions, potentially exposing users to dangerous bacterial contamination.
Primary allegations against Cardinal Health include failure to maintain proper manufacturing standards and inadequate quality control.
The FDA has reported three adverse events related to these products as of the recall date.
These contaminated eye drops pose a significant risk of serious eye infections that could result in partial vision loss or blindness.
Latest Leader Eye Drops Lawsuit Updates
- June 3, 2024 – According to the Lawsuit Information Center, users of contaminated eye drops have filed lawsuits over infections and blindness, setting legal precedents that may impact cases involving brands like Leader [1].
- February 2, 2024 – According to the FDA, multiple eye drop brands—including Leader—were pulled from shelves due to contamination risks that could result in severe infections or vision loss.
- November 14, 2023 – According to TechTarget, the FDA’s investigation into contaminated eye drops—including Leader—sparked widespread recalls and potential legal action due to the risk of vision damage and bacterial infections.
FDA Reports and Statistics
The FDA identified serious concerns with the manufacturing process of Leader™ Brand Eye Drops, supplied by Velocity Pharma, LLC and manufactured by Kilitch Healthcare India Limited.
An October 2023 inspection revealed insanitary conditions, positive bacterial test results in critical drug production areas, and omitted or falsified contamination and sterility test results.
Cardinal Health, Inc., reported three adverse events related to the affected products, though specific details (e.g., infections, irritation) were not disclosed.
The FDA warned that these ophthalmic products, intended to be sterile, pose a heightened risk of harm by bypassing the body’s natural defenses, potentially causing eye infections that could result in partial vision loss or blindness [2].
“For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss or blindness. Ophthalmic drug products pose a potential heightened risk of harm to users because drug applied to the eyes bypass some of the body’s natural defenses. To date, Cardinal Health, Inc., and its subsidiaries have received reports of three (3) adverse events related to these listed products.”- The U.S. Food and Drug Administration.
Leader Eye Drops Injuries & Side Effects
Users of contaminated Leader Eye Drops may experience various eye infections and related complications that can lead to serious health issues, including permanent vision damage.
- Eye Infections: Bacterial contamination causing painful inflammation and potential tissue damage.
- Vision Loss: Partial or complete loss of vision in affected eyes.
- Severe Discomfort: Pain, burning, and intense irritation beyond normal eye drop use.
- Systemic Infections: Potential for bacteria to enter bloodstream causing broader health complications.
Symptoms of an Eye Infection from Contaminated Eye Drops
- Blurry vision
- Discharge
- Pain or discomfort
- Redness of the eyelid or eye
- Feeling like there is something in the eye
- Increased sensitivity to light
Do You Qualify for a Leader Eye Drops Lawsuit?
You may qualify for a Leader Eye Drops lawsuit if:
- You used Leader brand eye drops purchased between December 12, 2021, and October 31, 2023.
- You experienced serious side effects including eye infections, vision issues, or other complications.
- Your injuries required medical treatment or hospitalization.
- You can provide medical documentation linking your injuries to Leader Eye Drops use.
Evidence Required for a Leader Eye Drops Lawsuit
- Medical records documenting the eye infection or injury.
- Proof of Leader Eye Drops purchase (receipts, product packaging).
- Documentation of proper product usage according to instructions.
- Medical diagnosis linking injuries to contaminated eye drops.
Damages You Can Recover
- Medical expenses for treatment of eye infections and related conditions.
- Lost wages due to inability to work during recovery.
- Pain and suffering related to eye injuries and vision impairment.
- Potential punitive damages against the manufacturer for negligence.
Leader Eye Drops Recall Information
Cardinal Health issued a voluntary nationwide recall on October 31, 2023, affecting several Leader brand eye drop products.
The recall was initiated after discovering unsanitary conditions in the manufacturing facility and positive bacterial test results in critical production areas.
The following recalled products were sold over the counter (OTC) for temporary relief of burning and irritation due to dryness of the eye, for use as a protectant against further irritation or to relieve dryness of the eye, and/or to relieve redness of the eye due to minor eye irritations:
Product Name | Package Description | Brand Name | NDC |
---|---|---|---|
Eye Irritation Relief (Polyvinyl Alcohol, 0.5%, Povidone, 0.6%, and Tetrahydrozoline Hydrochloride, 0.05%) | 0.5 FL OZ bottle (15 mL) | LEADER™ | 70000-0087-1 |
Dry Eye Relief (Carboxymethylcellulose Sodium, 1%) | 0.5 FL OZ bottle (15 mL) | LEADER™ | 70000-0089-1 |
Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) | 0.5 FL OZ bottle (15 mL) | LEADER™ | 70000-0090-1 |
Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) | 2 bottles, 0.5 FL OZ (15 mL) each | LEADER™ | 70000-0090-2 (Carton) 70000-0090-1 (Bottle) |
Dry Eye Relief (Polyethylene Glycol 400, 0.4% and Propylene Glycol, 0.3%) | 0.33 FL OZ bottle (10 mL) | LEADER™ | 70000-0088-1 |
Lubricant Eye Drops (Propylene Glycol, 0.6%) | 0.33 FL OZ bottle (10 mL) | LEADER™ | 70000-0587-1 |
FDA Recommendation on Recalled Eye Drops
If you purchased any leader eye drops that are affected by this recall, you should stop using them immediately and return them to the point of purchase for a full refund.
Wholesalers, Distributors, and Retailers that have the affected product that is being recalled should cease distribution of the products.
Cardinal Health is notifying all affected direct accounts of the recall and is arranging for the return of all impacted items.
Statute of Limitations for Leader Eye Drops Lawsuits
The statute of limitations for filing a Leader Eye Drops lawsuit varies by state, typically ranging from 1-3 years from the date of injury or discovery of injury.
Some states may provide additional time if the injury wasn’t immediately apparent. Consult with an attorney promptly to ensure your claim is filed within your state’s specific timeframe.
FAQs
1. What specific injuries qualify for a Leader Eye Drops lawsuit?
Qualifying injuries include documented eye infections, partial or complete vision loss, severe eye inflammation, or systemic infections resulting from contaminated eye drops that required medical treatment.
2. How long will a Leader Eye Drops lawsuit take?
The timeline varies depending on case complexity, but most product liability cases take between 1-3 years to resolve, either through settlement negotiations or trial proceedings.
3. What compensation might I receive from a Leader Eye Drops lawsuit?
Compensation typically covers medical expenses, lost wages, pain and suffering, and in cases of severe negligence, potential punitive damages. Each case is unique with amounts determined by injury severity and impact on quality of life.
4. Are there any recalls on Leader Eye Drops?
Yes, Cardinal Health issued a nationwide recall of certain Leader Eye Drops on October 31, 2023, due to contamination concerns and unsanitary manufacturing conditions.
5. What should I do if I experience side effects from using Leader Eye Drops?
If you experience side effects, stop using the product immediately and seek medical attention. Document your symptoms and treatment, and consult with an attorney to discuss your legal options.
6. How can an attorney help with my Leader Eye Drops lawsuit?
An attorney can help gather evidence, navigate legal procedures, negotiate with the defendant, and represent you in court if necessary. They ensure your rights are protected throughout the process.
7. How much does it cost to file a Leader Eye Drops lawsuit?
Most product liability attorneys work on a contingency fee basis, meaning you pay nothing upfront and attorneys only collect fees if you receive compensation.
8. Can I join an existing Leader Eye Drops class action?
Depending on the current litigation status, you may be able to join an existing class action or multi-district litigation. Your attorney can advise on the best approach for your specific circumstances.
9. What evidence do I need to preserve for my case?
Preserve the product packaging, receipts, medical records documenting your injury and treatment, photographs of symptoms, and a detailed journal of symptoms and their impact on your daily life.
10. Will my case go to trial or settle?
While most product liability cases settle before trial, each situation is unique. Your attorney will pursue the option most beneficial to your specific circumstances and seek maximum compensation.
See all related product liability lawsuits our attorneys covered so far.
Get a Free Leader Eye Drops Lawsuit Evaluation With Our Lawyers
Time is limited to pursue legal action against Cardinal Health for injuries caused by contaminated Leader Eye Drops.
Most states have a statute of limitations of only 1-3 years from the date of injury to file your claim. Don’t risk losing your right to compensation by waiting too long to act.
At Schmidt & Clark, LLP we offer:
- Free, confidential consultations to evaluate your case
- No upfront costs or fees to begin your lawsuit
- Payment only if we win your case and secure compensation
Contact our experienced legal team today to protect your rights and start your journey toward justice and compensation.
References:
- https://www.lawsuit-information-center.com/ezricare-eye-drops-lawsuit.html
- https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cardinal-health-inc-issues-voluntary-nationwide-recall-certain-leadertm-brand-eye-drops-supplied?amp=