Urgent FDA Advisory: Cease Use of Two Eye Drop Brands Due to Significant Health Hazards
Federal health oversight bodies are urgently instructing the public to discontinue the use of two specific brands of eye drops because they could be tainted with bacteria or fungi.
The U.S. Food and Drug Administration has issued a strong recommendation against the purchase and use of “Dr. Berne’s MSM Drops 5% Solution” and “LightEyez MSM Eye Drops – Eye Repair,” cautioning that these products carry severe health threats, including the risk of losing vision or even life-endangering infections. So far, there are no recorded cases of people suffering adverse effects from these products, according to the agency.
This recent advisory comes on the heels of multiple FDA alerts earlier this year, cautioning against the use of various eye drop products connected to a surge in antibiotic-resistant bacterial infections. This wave of infections has been associated with at least four fatalities and numerous cases of illness across 18 states.
The entity responsible for distributing Dr. Berne’s products is Dr. Berne’s Whole Health Products, while LightEyez Limited handles the distribution of LightEyez products.
The federal agency’s laboratory analyses revealed that these eye drops were tainted with microbial contaminants and failed to meet sterility standards mandated by the Federal Food, Drug, and Cosmetic Act. Both of these products are not only unregulated but are also being unlawfully sold in the United States, according to the FDA. Furthermore, these products list methylsulfonylmethane (MSM) as an active component, which is not a sanctioned ingredient for use in eye drop formulations.
The FDA has stated that utilizing these contaminated eye drops could lead to anything from minor eye issues to critical infections that could escalate into life-threatening conditions. The agency recommends that anyone exhibiting signs of an eye infection should promptly seek medical attention.
The FDA is directing people who have these eye drops to properly discard them, providing guidelines on how to do so.
While Dr. Berne has proactively initiated a voluntary recall of the “Dr. Berne’s MSM Drops 5% Solution,” LightEyez Limited, based in London, has yet to reply to the FDA’s warning or implement any safety measures to safeguard consumers, says the FDA.
As per FDA findings, the eye drop product from LightEyez was found to be contaminated with the bacteria Pseudomonas aeruginosa, which has the potential to lead to infections in various parts of the body, including blood and lungs. Health experts believe a resistant strain of this bacteria is likely responsible for the mortalities and other health complications linked to dubious eye drops.
Earlier this year, in February, Global Pharma Healthcare recalled all batches of its EzriCare and Delsam Pharma “Artificial Tears Lubricant Eye Drops,” citing the potential risk of bacterial contamination.
Damages and Injuries That Could Be Compensable Due to This Issue
If you’ve been affected by the use of these potentially contaminated eye drops, you may be eligible to file a lawsuit and seek compensation for various types of damages and injuries. Below are some of the categories for which compensation could be pursued:
- Medical Expenses: Any costs related to medical care, including emergency room visits, doctor’s appointments, diagnostic tests, treatments, and surgeries required to address the eye infection or other complications.
- Prescription Costs: Expenses related to any prescribed medications needed to treat eye infections or complications arising from the use of contaminated eye drops.
- Ongoing Care Costs: Expenses for long-term medical care, such as follow-up appointments, long-term medications, or any physical therapy needed to restore vision or treat complications.
- Loss of Wages: If the contamination has made you unable to work, either temporarily or permanently, you may be eligible for compensation for lost income.
- Pain and Suffering: Non-economic damages for physical and emotional distress, including pain, suffering, inconvenience, mental anguish, and loss of enjoyment of life.
- Loss of Consortium: Compensation for the adverse effects that your injuries may have on your relationship with your spouse or family.
- Wrongful Death: If a life-threatening infection from the eye drops led to the death of a loved one, the family could file a wrongful death claim for funeral costs, loss of future income, emotional suffering, and other related expenses.
- Punitive Damages: If it’s proven that the companies knowingly sold contaminated or faulty products, you may be entitled to punitive damages aimed at punishing the company for its reckless behavior.
- Legal Fees: Costs for legal representation can sometimes also be recovered, depending on the circumstances of the case.
It’s crucial to consult with one of our legal professionals who has expertise in product liability law to discuss your specific circumstances and potential for a claim. The types and amounts of compensation you may be eligible for will vary depending on your case.
Steps in the Claims Process
Navigating the claims process for compensation due to contaminated eye drops or any other defective product can be complicated. Here’s a general outline of the steps you might expect to take:
Step 1: Consult Our Lawyers
The first step in the claims process is to consult a lawyer who limits their practice to product liability and personal injury law. They can assess the viability of your case and guide you through the legal process.
Step 2: Gather Evidence
Once you’ve consulted a lawyer, you must gather all the evidence supporting your claim. This could include medical records, bills, photos of your injuries, and other documentation proving you’ve suffered due to the defective product.
Step 3: Notify Responsible Parties
Your lawyer will usually send a formal “Notice of Intent” to the company or companies responsible for the product. This notice outlines your intention to file a lawsuit for your injuries and invites them to settle before going to court.
Step 4: Investigation
After notifying the responsible parties, both sides will conduct an investigation. This could include interrogatories, depositions, and requests for documents to establish the facts of the case.
Step 5: Filing a Lawsuit
If no satisfactory settlement is reached, your lawyer will file a formal lawsuit in the appropriate jurisdiction. This will outline the allegations and the damages you’re seeking.
Step 6: Discovery
After filing the lawsuit, the discovery process begins. Both sides will exchange information relevant to the case, interview witnesses, and potentially even visit the location where the injury occurred.
Step 7: Pre-Trial Motions
Both parties may file various motions before the trial begins, such as motions to dismiss the case, motions for summary judgment, or motions to admit or exclude evidence.
Step 8: Negotiation & Settlement
Even after the lawsuit is filed, negotiations for a settlement can continue. Many cases are resolved at this stage without the need for a full trial.
Step 9: Trial
If a settlement is not reached, the case will go to trial. Both sides will present their evidence, and a judge or jury will decide your claim.
Step 10: Appeal
If you’re unhappy with the trial’s outcome, you can file an appeal to a higher court. However, appeals can be costly and time-consuming, with no guarantee of a different outcome.
Step 11: Collecting Damages
If you win the case, either through a settlement or a trial, the final step is collecting your damages. Your lawyer will usually take care of this process, ensuring that you receive the compensation you’re entitled to.
Consulting a legal professional for a detailed understanding of your specific situation is crucial, as the actual steps you need to take may vary based on the circumstances of your case.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products like this defective product. For your free consultation, contact our national product liability law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
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