FDA Discovers Sterility Concerns at Eyed Drop Factory Associated with Injuries, Deaths

Eyed Drop Lawsuits

On April 4, 2023, PBS reported that U.S. health inspectors had found that a factory in India producing eyedrops linked to recent injuries and fatalities lacked adequate sterility measures.

Officials from the Food and Drug Administration (FDA) identified around a dozen issues related to the manufacturing and testing of eyedrops by Global Pharma Healthcare during an inspection conducted between late February and early March. The FDA released a preliminary report on the inspection on Monday.

FDA staff stated that the company’s procedures do not effectively guarantee product sterility. Inspectors noted a “deficient manufacturing process” between December 2020 and April 2022 for products later shipped to the United States.

The facility, located in Tamil Nadu state, produced eyedrops connected to 68 bacterial infections in the U.S., including three deaths and eight cases of vision loss. Four individuals required surgical removal of their eyeballs due to infection. In February, two U.S. distributors, EzriCare and Delsam Pharma, recalled the drops.

The outbreak is particularly concerning due to the bacteria’s resistance to standard antibiotics.

FDA inspectors visited the plant on February 20, over two weeks after the initial eyedrop recall on February 3. Agency records suggest this was the FDA’s first inspection of the facility.

A formal report and warning letter to the company is expected to follow the preliminary findings. An FDA spokesperson stated that the inspection indicates potential violations of FDA requirements for the company’s products.

FDA’s Jeremy Khan urged consumers to discontinue using these products, which could be harmful to their health.

The FDA is tasked with ensuring the safety of foreign products shipped to the U.S. but has faced challenges keeping up with international pharmaceutical supply chains, which increasingly originate in India and China.

FDA inspectors noted concerning sanitary conditions at the Global Pharma facility, with floors, walls, and ceilings that were not easily cleanable. During the visit, an FDA inspector observed uncovered filling machine equipment and inadequate procedures for ensuring proper bottle sealing. The report indicated that a manual visual inspection was the only test used to detect leaks.

The FDA, in collaboration with the Centers for Disease Control and Prevention (CDC), is investigating the U.S. bacterial outbreak. The CDC has identified the bacterial strain in opened EzriCare drop bottles collected from infected patients, and FDA officials are testing unopened bottles as well.

CDC officials are concerned about the bacteria spreading and additional cases being reported in the coming weeks and months. The agency has recommended that healthcare facilities treating patients adhere to strict infection control measures, as the bacteria can spread rapidly.

How to File a Lawsuit Seeking Damages After Injured by Bacteria-Contaminated Eye Drop Products

If you believe you have been injured by bacteria-contaminated eyedrop products, you may want to consider the following general steps to file a lawsuit. It’s always a good idea to consult with a qualified attorney for legal advice specific to your situation.

1. Consult our product injury attorneys: Reach out to a personal injury attorney with experience in product liability cases. Many attorneys offer free initial consultations to discuss your case and determine if you have a valid claim.
2. Gather documentation: Compile all relevant documentation, including medical records, receipts for the eyedrop products, and any correspondence with doctors or the product manufacturer. This information will help your attorney assess the strength of your case and establish a link between the contaminated product and your injuries.
3. Determine the liable parties: Your attorney will help you identify the parties responsible for your injuries. This may include the eyedrop manufacturer, the distributor, or other entities involved in the supply chain.
4. File the complaint: Your attorney will draft a complaint outlining the facts of your case, the legal basis for your claim, and the damages you seek. The complaint will be filed in the appropriate court and served to the defendants.
5. Discovery phase: Once the defendants have been served, the discovery process begins. During this phase, both parties gather evidence to support their case. This may involve exchanging documents, conducting depositions, and hiring expert witnesses.
6. Negotiations and settlement: Many product liability cases are settled out of court. Your attorney may engage in negotiations with the defendants to reach a settlement agreement that compensates you fairly for your injuries. If a settlement cannot be reached, your case will proceed to trial.
7. Trial: If your case goes to trial, both sides will present their arguments and evidence to a judge or jury. The judge or jury will then decide whether the defendants are liable for your injuries and, if so, the amount of damages you should be awarded.

Remember, it’s important to consult our qualified attorneys for legal advice specific to your situation, as this is only general information and not legal advice.

CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW

If you or a loved one suffered harm due to contaminated eye drops, you might have the right to seek justice and substantial compensation for your damages. The national product liability attorneys at Parker Waichman LLP are here to help you understand your legal options and file your defective product lawsuit if qualified.

The statute of limitations for filing a lawsuit is limited by law. Call Parker Waichman LLP today at 1-800-YOUR-LAWYER (1-800-968-7529) to receive a free, no-obligation consultation with one of our national product liability attorneys. Our toll-free number is available 24/7, so you can call us anytime, day or night. We are here to answer your questions, listen to your concerns, and help your family receive justice and financial compensation.