Widespread Eye Drop Recall Intensifies Following FDA Alert and Health Incidents

Eye Drop Lawsuits

The Food and Drug Administration (FDA) has confirmed the expansion of a nationwide recall for compromised eye drops, following findings of bacterial and fungal impurities in test samples.

Whole Health Solutions, led by Dr. Sam Berne, has initiated a voluntary recall of all existing batches of the company’s range of eye solutions, including MSM Drops at 5% and 15% concentrations, Organic Castor Oil Eye Drops, and MSM Mist 15% Solution.

The FDA has disclosed that two concerning incidents have been reported in relation to the contaminated eye drops, indicating the risk of severe infections or even vision loss for users.

Dr. Sam Berne has a history of assisting patients in New Mexico with vision and overall well-being, using alternative approaches. The company’s website, however, includes a disclaimer clarifying that the FDA has not evaluated their claims. It states: “This product is not intended to diagnose, cure, or prevent any disease.”

Earlier on August 22, the FDA publicized test results that revealed the presence of bacterial and fungal contaminants in Whole Health Solutions’ MSM Drops 5% Solution. According to U.S. regulations under the Food, Drug, and Cosmetic Act, all eye drops sold must meet sterile conditions to be considered safe for public use. The FDA emphasized that these particular eye drops were being marketed unlawfully, as they contained methylsulfonylmethane (MSM), a substance not approved as an active ingredient in ophthalmic solutions.

The regulatory body stated clearly, “No eye drops that include MSM as an active ingredient are legally available on the market.”

Consumers, retailers, or wholesalers who have purchased any of the implicated Whole Health Solutions eye drop products are urged to cease usage immediately and return the items to Sun Star Organics, located at 988 Main Street, Orange, CA 92867.

The FDA is also inviting healthcare providers and consumers to report any health issues or quality-related concerns about a medication through the FDA’s MedWatch Adverse Event Reporting program.

What Types of Damages Could Be Awarded in a Product Liability Lawsuit

In a product liability lawsuit, various types of damages may be awarded to compensate the injured party. The exact nature and extent of damages often depend on the severity of the injury, the circumstances of the case, and jurisdictional laws. Here are some types of damages that could be awarded:

Compensatory Damages:

• Medical Expenses: These cover the costs incurred for medical treatment resulting from the use of the defective product.
• Lost Wages: If the injury caused you to miss work, you could be compensated for lost income.
• Pain and Suffering: Compensation for physical pain and emotional distress can be included under this category.
• Loss of Consortium: Sometimes the injury affects the plaintiff’s relationship with their spouse, for which damages may be awarded.

Special Damages:

• Future Medical Expenses: If the product defect has caused long-term health issues requiring future medical care, this could be covered.
• Future Lost Wages: If the injury has led to a disability that affects your ability to earn in the future, compensation may be awarded.
• Punitive Damages: Gross Negligence or Malice: In cases where the defendant’s conduct was exceptionally careless or malicious, punitive damages may be awarded to punish and deter such behavior.

Damages for Specific Conditions:

• Blindness: If the product led to blindness, damages could include costs for adaptation (e.g., training for Braille, a guide dog), as well as increased medical expenses and lost earning capacity.
• Loss of an Eye: Similar to blindness, loss of an eye could involve compensation for medical costs, prosthetic expenses, and any life adjustments needed.
• Wrongful Death: If a defective product leads to death, surviving family members may be entitled to damages, which could include funeral expenses, loss of consortium, loss of financial support, and emotional distress.

Each jurisdiction may have specific laws that affect the types of damages that can be awarded, including caps on certain kinds of damages. Therefore, it’s crucial to consult with legal experts to understand the full scope of potential compensation in a product liability lawsuit.

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).