EzriCare & Delsam Pharma Eye Drops Lawsuit
An outbreak of a potentially deadly antibiotic-resistant bacteria has been linked to EzriCare and Delsam Pharma Artificial Tears, an over-the-counter eye-drop formulation sold through major retailers, including Amazon and Walmart. The bacteria Pseudomonas aeruginosa may cause blindness, respiratory infections, sepsis, and death. Affected patients may be eligible to pursue significant compensation through an EzriCare Eye Drops lawsuit.
Hello. My name is David Kuttles. I’m a lawyer at The Lanier Law Firm. I work with the pharmaceutical and medical device product liability teams at The Lanier Law Firm, and today I want to talk with you about a recent recall concerning specific non-preservative artificial tears eyedrop products.
On February 1st, 2023, Global Pharma Healthcare recalled EzriCare Artificial Tears and DELSAM Pharma’s Artificial Tears. These products could have been purchased at companies such as Walmart or Amazon. The recall stems from a CDC investigation of a multi-cluster of antibiotic-resistant infections referred to as carbapenem-resistant Pseudomonas aeruginosa or CRPAA.
CRPA can cause infections in the blood, in the lungs, and in the eye, including conjunctivitis, keratitis, vision loss, pain, and even death. As it relates to the CDC’S investigation, CRPAA has been found in over 50 patients in 12 states following a review of specimens collected between May of 2022 and December of 2022. Patient outcomes in the cluster have included permanent vision loss resulting from ocular infection, hospitalization, and death. Most of the patients in the cluster have reported using artificial tears.
EzriCare Artificial Tears eyedrops were the most common brand of artificial tears reported in the cluster. Testing performed by the CDC of open bottles of EzriCare Artificial Tears also identified the presence of CRPA. The CDC’S investigation of the infection outbreak, which includes testing of unopened bottles of EzriCare Artificial Tears is still ongoing. The FDA and the CDC have recommended that patients and doctors stop using these specific products, and if you have used any of these products and you are experiencing complications, you should contact a physician right away.
If you have used EzrICare Artificial Tears or DELSAM Pharma’s Artificial Tears and you have experienced complications, you may have a claim. We invite you to contact the Lanier Law Firm for a free consult today. You are welcome to click on the button after this video, or you can contact us at 1-866-483-0319. Feel free to visit our website also at www.lanierlawfirm.com for more information about our law firm. Thank you for listening.
Sometimes the bacteria pseudomonas aeruginosa is getting into people’s bloodstream, and because the bacteria is resistant to antibiotic treatment, it can be very hard for doctors to treat, and it can result in some very serious injuries.
EzriCare & Delsam Pharma Eye Drops Case Updates
Rebecca Phillips: In the last several months, there has been a nationwide recall on EzriCare Artificial Tears and Delsam Artificial Tears, also an eye ointment. David Kuttles: The main defendants in this case are going to be EzriCare, Delsam Pharma and Global Pharma Healthcare, who is the manufacturer of these eyedrops. Federal inspectors have recently gone to India to inspect Global Pharma Healthcare’s Factory, which has revealed a host of problems including dirty equipment, dirty clothing, and even missing guidelines and procedures. This is not to say that retailers do not also hold some level of responsibility for the eyedrops that have been distributed to the market and have injured consumers.
Here is a timeline of the developments in the eyedrop lawsuit case:
May 15, 2023: New Cases Identified in Latest CDC Update
The CDC has identified 81 patients in 18 states with the P. aeruginosa infection. This is an additional 13 patients in two additional states since the March 21, 2023 update. The two additional states are Delaware and Ohio.
Nearly half of these new cases were patients who were tested before the update but confirmed afterward due to the length of time required to obtain test results. Most of the seven remaining cases were long-term care residents in facilities. Other known cases are patients who admitted to using Global Pharma’s products after the recall.
May 8, 2023: Updated FDA Guidance on Import Alerts
The FDA updates its guidance on import alerts to define when it may be appropriate to detain imported drugs without an inspection. According to the alert, it may be appropriate in the following circumstances:
- When an FDA inspection finds that an overseas drugmaker is out of compliance with current good manufacturing practices
- When the FDA receives information from foreign government authorities that inspections uncovered deficient practices or conditions
The guidance states that an import alert must remain in effect until the FDA is satisfied that the violation has been corrected. This means that Global Pharma will be unable to import drugs into the United States without completing significant corrective action, based on the results of a recent unannounced FDA inspection of its India-based factory.
The purpose of an import alert is to notify FDA field agents that an imported product should be detained without the necessity of a physical examination due to evidence in the FDA’s possession that calls into question the product’s safety and efficacy. This prevents unsafe products from being distributed in the United States.
April 19, 2023 Reassignment of California State Lawsuit
The California lawsuit filed by the Lanier Law Firm, Reynolds et al vs. Ezricare, LLC et al has been transferred to the United States District Court in the California Northern District in San Francisco.
March 14, 2023: Increased Infections Across More States
As of this date, 68 patients in 16 states have developed drug-resistant P. aeruginosa, including three who have passed away. Most of the affected patients used EzriCare artificial tears. This includes the following four states in addition to the 12 states impacted as of January 31, 2023:
- North Carolina
- South Dakota
March 2, 2023: Completion of FDA Global Pharma Healthcare Factory Inspection
The FDA completes the inspection of the Global Pharma Healthcare factory located in Tamilnadu, India with multiple deficiencies discovered.
February 24, 2023: Recall of Delsam Pharma’s Artificial Eye Ointment
Global Pharma Healthcare issues a voluntary recall of Batch H29 of the Artificial Eye Ointment distributed by Delsam Pharma due to potential bacterial contamination and compromised product packaging.
February 22, 2023: Ezricare Eye Drops Lawsuit in California
Lanier Law Firm files a complaint in California State court against EzriCare, Global Pharma Healthcare, Amazon, and others on behalf of a man who went blind in one eye after using the EzriCare eye drops. The complaint alleges strict products liability, negligence, and fraud, among other legal theories.
February 22, 2023: Artificial Eye Ointment Alert by the FDA
The FDA recommends the recall of Delsam Pharma’s Artificial Eye Ointment after warning that it not be purchased or used due to potential bacterial contamination. Delsam Pharma agrees to the recall.
February 21, 2023: FDA Warnings Regarding Ezricare Artificial Tears
The FDA officially warns consumers and health care providers against using or purchasing Delsam Pharma’s Artificial Eye Ointment due to the potential for bacterial contamination.
February 20, 2023: Commencement of Global Pharma Healthcare Factory Inspection by the FDA
The FDA initiates an unannounced inspection of the Tamilnadu, India factory operated by Global Pharma Healthcare Pvt. Ltd.
February 2: 2023: Volunarily Recall of Ezricare and Delsam Pharma Eye Drops
Due to possible contamination, Global Pharma Healthcare voluntarily recalled all lots of Artificial Tears Lubricant Eye Drops distributed by Aru Pharma Inc. and Delsam Pharma.
January 31, 2023: Clusters of Infections in Multiple States
At least 55 patients in 12 states have been infected by antibiotic-resistant Pseudomonas aeruginosa, according to the Centers for Disease Control & Prevention. This includes the state of Wisconsin in addition to the 11 states where the CDC completed its original investigation.
The majority of the infected patients reported using EzriCare Artificial Tears in a multidose bottle.
January 20, 2023: Public Alert Regarding EzriCare Artificial Tears
The CDC issues the first public warning urging customers and health care providers to discontinue using and prescribing EzriCare Artificial tears until more research regarding its safety can be completed.
January 19, 2023: Results of the CDC Investigation
The investigation results in the establishment of a link between the infection outbreak and EzriCare Artificial Tears.
January 3, 2023: Import Alert Against Global Pharmaceuticals Co. Ltd.
The FDA issues an import alert against all Global Pharmaceuticals Co. Ltd. products due to the company’s failure to follow current good manufacturing practices and provide an adequate response to the FDA’s request for records.
May 17, 2022: The CDC Investigates EzriCare Artificial Tears
The CDC works in partnership with state and local health departments to identify the source of “Verona Integron‐mediated Metallo‐β‐lactamase (VIM)‐ and Guiana‐Extended Spectrum‐β‐Lactamase (GES)‐producing carbapenem‐resistant Pseudomonas aeruginosa (VIM‐GES‐CRPA)” in 50 patients across the following 11 states, which have resulted in permanent vision loss, infections, hospitalizations, and one death:
- New Jersey
- New Mexico
- New York
Rebecca Phillips: So far, the CDC has seen that 68 people have been infected from these eyedrops across about 16 states. Most of those 68 people who have been infected across the United States did use EzriCare’s Artificial Tears. Their injuries ranged anywhere from eye irritation and redness, all the way up to death.
Why should I choose The Lanier Law Firm to handle my EzriCare eye drop infection lawsuit?
The experienced pharmaceutical liability lawyers at The Lanier Law Firm have been helping people recover significant compensation from large companies for more than 33 years.
We are redefining legal care by providing compassionate, personalized service and using unconventional approaches when necessary to ensure that our clients receive the maximum compensation available under the law.
Our approach has earned us a national reputation for achieving historic verdicts and settlements against drug companies on behalf of our injured clients:
- $9 billion verdict against Takeda & Eli Lilly for cancer risk from Actos
- $4.85 billion national settlement for heart damage caused by Vioxx
- $1.05 billion verdict against DePuy Orthopaedics Inc. and Johnson & Johnson for defective hip implants
- $57 million national settlement for harm caused by Yaz birth control
- $56 million verdict against Biomet for defective hip implants
Our product liability attorneys refuse to give up until our clients are fairly and justly compensated
Where Were the Contaminated Eye Drops Sold?
Thirty-five cases are linked to four health care facility clusters. The CDC identified the bacteria in open bottles from multiple lots of EzriCare Artificial Tears.
These lots may have been sold through online vendors, including Amazon.com Inc. and Walmart, where members of the public in all 50 states could have purchased the product. Therefore, the number of outbreaks and affected states are expected to grow.
How Did the Eye Drops Become Contaminated?
The contamination of Ezricare and Delsam Pharma eyedrops likely occurred at the factory during the manufacturing process.
The FDA conducted an unannounced inspection from February 20 through March 2 at the manufacturing plant in India linked to contaminated eye drop products. The inspection revealed several issues with the plant’s manufacturing processes, procedures to ensure sterility, and adequate operator training.
In the report, the FDA outlined 11 observations about the plant, including:
- Manufacturing processes that lacked assurances of sterility
- Inadequate testing of sterility for products coming off production lines
- “Black, brown greasy deposits” on parts of machines used to fill bottles with the product
- Surfaces throughout the plant that were not “cleaned, sanitized, decontaminated, or sterilized.”
- Inadequate records of how the company cleaned key machines and spaces
- A lack of proper training for staff leading to unqualified clean-room operators
- Other issues outlined included dirty clothing used in cleanrooms and failure to test ingredients used in the products for reliability.
The outbreak and the subsequent findings by the FDA are raising questions about the frequency of foreign inspections. According to agency data, the number of foreign inspections in 2019 was 3,313 compared to 689 in 2022. Without adequate inspections for over-the-counter drugs, the FDA risks allowing further contaminated products onto U.S. shelves.
Rebecca Phillips: Pursuant to US regulations, the FDA requires something called current good manufacturing practices to be in place in manufacturing facilities, like Global Pharma Healthcare’s facility, that are producing pharmaceutical drugs and things like eyedrops. And so, if the manufacturers had been following current good manufacturing practices that are required under US regulations, the eye drops would be sterile and would not contain Pseudomonas aeruginosa.
What is carbapenem-resistant Pseudomonas aeruginosa?
P. aeruginosa is a gram-negative aerobic bacteria capable of causing a wide range of infections. According to the Monroe Family Medicine Program, it is extremely difficult to treat. These types of bacteria are also known as “superbugs.”
Carbapenem-resistant bacteria are dangerous microorganisms that can withstand the carbapenem class of antibiotics, a type of antibiotic often used to treat severe infections. According to Mayo Clinic, bacteria that survive these antibiotics are often resistant to most, if not all, known antibiotics.
They are most commonly spread in health care settings. Without effective antibiotics, bacteria rapidly self-replicate, and the infection may spread to distant sites throughout the body.
The specific strain of bacteria associated with this outbreak is Verona integron-mediated metallo-β-lactamase and Guiana extended-spectrum-β-lactamase (VIM-GES-CRPA). It is the first time this particular strain has been reported in the United States.
What are the symptoms and complications of EzriCare eye drop infections?
The early symptoms of infection from EzriCare eye drops are specific to the eyes and may include:
- Yellow, green, or clear fluids leaking from the eye
- Eye discomfort
- Redness of the eye or eyelid
- A sensation of a foreign body in the eye
- Light sensitivity
- Blurred vision
When antibiotic therapy fails to kill or suppress the bacteria, the following conditions may develop:
- Keratitis: inflammation of the cornea, the transparent outer covering of the eyeball
- Endophthalmitis: infection of the tissues or fluids inside the eyeball, which can cause permanent blindness
- Respiratory infection
- Urinary tract infection
As of January 31, 2023, three patients have gone blind in one eye, and one has died, according to NBC News.
Who is liable for EzriCare eye-drop infections?
Liability may be established based on strict liability or negligence. Anyone in the supply chain — from the manufacturer to the seller — can be liable, including:
EzriCare Artificial Tears were manufactured by Global Pharma Healthcare PVT Limited in India and imported by Aru Pharma Inc. EzriCare LLC designed the label and distributed the product through Amazon.com Inc., Walmart, and other large retailers.
Under the doctrine of strict liability, every party in the supply chain can be held liable for products that harm the public — regardless of whether a party was negligent — if at least one of the following can be proven:
- The product suffered a manufacturing defect.
- The product has an unsafe design.
- The product lacked adequate warnings or instructions.
Is EzriCare Artificial Tears a defective product?
EzriCare Artificial Tears may be liable on all three grounds. The CDC found contamination in the open bottles they tested and has begun testing unopened bottles. Contamination of the unopened bottles would establish strict liability based on a manufacturing defect.
Does EzriCare Artificial Tears have dangerous design flaws?
Even if contamination is not found in the unopened bottles, liability may be established based on an unsafe design. According to the Dry Eye Foundation, preservative-free eye drops in multidose containers inherently carry a high risk of bacterial contamination.
Contamination may occur when the eyelid, eyelashes, or other tissues touch the nozzle during application. The bacteria travel from the nozzle into the solution when the bottle is released after squeezing to dispense drops into the eyes.
Airborne bacteria can also enter the container at the same time. The highest risks of contamination occur in the following circumstances:
- Large drop size
- More frequent use
- Duration of use lasting weeks
- Not refrigerating after opening
- Ingredients that promote bacterial growth
The EzriCare label instructs consumers to store the eye drops at temperatures of 59 degrees to 86 degrees Fahrenheit, not at refrigerated temperatures, thereby increasing the risk of bacterial growth.
Did EzriCare provide adequate warnings?
The label did not warn the public that consumers could contract a superbug from using the product or that the product could result in blindness, sepsis, or other serious infections. After the CDC completes its analysis of the unopened bottles, the warnings that the company should have included will be more evident.
EzriCare Artificial Tears is considered a generic drug. In many strict liability cases, generic drugmakers cannot be held accountable for drug warnings because they use the same labels as name brands and cannot legally make changes. However, EzriCare designed its own label, choosing not to copy a name-brand label.
Negligence occurs in product liability cases when a party owes a duty of care to consumers and breaches that duty, resulting in harm. Examples of negligence involving EzriCare eye drops may include:
- Failure by the manufacturer to protect the product from bacterial contamination
- Failure by EzriCare to include adequate warnings or instructions
- Failure by Amazon.com or Walmart to require appropriate product testing and safety data before marketing
If Amazon.com or Walmart allowed the product to remain in inventory after reports of harm surfaced, they could be liable for negligence.
Did EzriCare know about the contamination?
Though the company claims it was not aware of the contamination, this has yet to be determined. The CDC is working with public health agencies in the affected states to determine the contamination source. These findings will aid in determining what EzriCare knew or should have known and when they knew it.
According to EzriCare, the company was not involved in the manufacture or import of the product and only designed the drug label. However, as the primary retailer, EzriCare had a duty to ensure its products were safe at all times while marketing them to the public.
Can I sue Amazon?
Amazon is a massive company that has successfully defended itself against strict liability cases in multiple jurisdictions. If you purchased EzriCare Artificial Tears from Amazon.com and contracted an infection, you may have a case against Amazon, depending on where you file suit and the nature of Amazon’s liability.
According to attorney Rebecca Phillips, based on state law and court precedent, California may be the most favorable jurisdiction to try a strict liability case against Amazon. If Amazon was negligent, it may be beneficial to pursue the case in other states.
What should I do if I have used EzriCare eye drops?
Discontinue use immediately and seek medical attention if you develop eye infection symptoms. The CDC is not recommending testing for asymptomatic patients at this time. If you test positive for P. aeruginosa, follow your medical provider’s recommendations and contact a lawyer promptly.
The Lanier Law Firm offers a free, no-obligation case evaluation, and if necessary, our attorneys will travel to you. After we accept your case, you can count on us to provide fervent advocacy and skillful representation in settlement negotiations or court.