On February 2, 2023, Global Pharma Healthcare voluntarily recalled all lots of their Artificial Tears distributed by EzriCare, LLC and Delsam Pharma. The reason for the recall was potential contamination by a rare, extremely drug-resistant strain of a bacteria called Pseudomonas aeruginosa.
As of May 15, 2023, 81 patients who were affected by the eyedrops have been identified by the CDC in 18 states (WI, WA, UT, TX, SD, PA, OH, NY, NV, NM, NJ, NC, IL, FL, DE, CT, CO, CA). According to the CDC, 14 patients experienced vision loss, four patients needed an eyeball to be surgically removed, and four patients died.
How did these killer eyedrops make their way into the United States marketplace? It turns out, the way they ended up in the marketplace was by making their way through a huge hole in how the FDA supervises over-the-counter drugs. Over-the-counter drugs have, for a long time, been a low priority for the FDA. The assumption has always been that even when these drugs don’t work, the drugs are unlikely to kill people. Over-the-counter drugs are essentially manufactured and sold based on an honor system. Companies don’t have to prove to the FDA that over-the-counter drugs are effective or safe, or that the drugs are being manufactured in safe conditions. Companies must simply file paperwork stating they used approved ingredients and comply with safe manufacturing practices.
Pseudomonas Aeruginosa: A Very Difficult Bacteria To Kill
Pseudomonas aeruginosa is a bacterium which is rod-shaped and less than a millimeter in length. Its odor, when cultivated in petri dishes, is reminiscent of corn tortillas. It is a very opportunistic, potentially lethal bacterium which can invade any compromised tissue. It can kill up to 50 percent of especially vulnerable people it infects.
The most notable feature of the bacterium is how difficult it is to kill. Some strains of the bacterium are extremely resistant to antibiotics and they continue to thrive even when doctors throw drug after drug at them.
How The Eyedrops Were Made, Sold And Evaded The FDA
The killer eyedrops ended up being sold by a couple of inexperienced entrepreneurs who used Global Pharma Healthcare, a small company in India, to manufacture the medicine. Prior to exporting the eyedrops, records show Global Pharma had never before exported medication to the United States. Eyedrops need to be manufactured with guarantees that they are sterile. The process to make sure eyedrops are sterile is expensive and demanding. Global Pharma shipped its eyedrops to the United States without the FDA ever having inspected its factory.
Marketing for the eyedrops advertised them as preservative-free. This means they didn’t have chemicals in them to prevent bacteria growth. Preservative-free eyedrops are typically sold in single-use bottles, or multiuse bottles which are specifically designed to keep them sterile. Both types of bottles are more expensive than the multiple dose bottles Global Pharma chose to use.
The FDA has an automated process for listing over-the-counter drugs. That process didn’t flag the wrong type of bottle being used. The process also didn’t flag the scarce backgrounds of the distributors and manufacturers.
The industry of generic drugs has expanded worldwide to manufacture cheap medications. Medicine regulators have not kept up. Rules aren’t always enforced and the rules in many locations are inadequate. Health risks, recalls and shortages result. Over 900 recalls were announced by the FDA in 2022. This triple the number of recalls announced in 2018.
India supplies 20 percent of generic drugs to the world. The country has seen increased scrutiny as of late regarding quality issues. Lapses in manufacturing of generic cancer drugs left patients without treatments that could possibly save their lives this year. Last year, over 60 children died in Gambia and their deaths were linked to drugs in syrup form from India.
When the FDA, in February, finally inspected Global Pharma’s processing facility, they found untrained workers who were wearing reused, dirty booties. They found filling machines with brown residue in them. The recall had already been issued at the time the FDA finally inspected the facility. The FDA performed tests on unopened eyedrop bottles and found bacterial contamination.
The two entrepreneurs who sold the eyedrops were able to sell them without ever being asked any questions about their safety.
The over-the-counter system currently used in the United States is from 1972. Back then, the FDA knew it needed to be more efficient in keeping up with over-the-counter drugs being made like cough drops, ointments and pain relievers. The FDA developed over-the-counter standards by enlisting experts who recommended safe ingredients for various categories of drugs. The process, though, took years to decades. The standards for eyedrops, which were finished in 1988, reference manufacturers in the United States which have long since moved overseas or closed.
The automated system the FDA uses only required a few basic things for Delsam Pharma and EzriCare to list regarding their eyedrops: the ingredients, the dosage, the name of the drug, and a label image showing usage information and warnings. After this information was submitted, the producs were assigned National Drug Codes, with Global Pharma registered as the manufacturer. That’s the entire process for getting the drugs listed and allowing them to be sold.
The listing contains a disclaimer saying the drug hasn’t been reviewed or approved by the FDA. Companies don’t need to include this disclaimer in their advertising, though, and often suggest the opposite.
Global Pharma was founded in 1986. Until it entered the United States market, it sold medications to around two dozen countries located in Africa and Southeast Asia. It sold products like eyedrops and injectable antibiotics, which need to be manufactured in a sterile environment.
According to anonymous people familiar with the company, the company’s manufacturing facility is only fit for “less regulated” or “semiregulated” markets where inspection and testing requirements aren’t as strict as those in Europe or the United States. One of these anonymous people, who visited the manufacturing facility around five years ago, described the facility as decent, but only good enough for Third World standards.
FDA Inspection Finds Numerous Problems With Global Pharma
The FDA’s inspection of Global Pharma’s manufacturing facility in India lasted nearly two weeks. A 14 page report was the result. A sterile manufacturing expert told Bloomberg News that it was one of the longest reports he had seen, and a sign of “a weak quality culture.”
Sterile drug processing needs special rooms with unidirectional, filtered airflow to prevent microparticles from settling. Batches of drugs sent to the United States from Global Pharma originated in a room with nails protruding from walls that had cracked sealant. Inspectors wiped the bowl of a filling machine with a cloth, picking up greasy, brown deposits.
Employees filling important roles weren’t trained. A quality assurance manager was releasing batches with prefilled checklists. The company failed to establish the effectiveness of the filters they used to sterilize their solutions.
A Stanford professor told Bloomberg News that the FDA doesn’t have the necessary resources to inspect all over-the-counter drug manufacturing facilities, saying the public in America needs to know that nobody is looking. He said using the inspection protocol which was designed multiple generations ago with the domestic market in mind in order to attempt to monitor the whole planet is unrealistic.
The Dry Eye Foundation
The Dry Eye Foundation is a nonprofit located near Seattle. The nonprofit publishes eyedrop safety recommendations.
Sandra Brown, a board member of the nonprofit and a North Carolina eye doctor, told Bloomberg News (subscription required) that the first sign something was wrong regarding EzriCare Artificial Tears was its multiuse bottle. The bottle, according to Brown, was cheaply made and lacked a tip perforation. It was opened like a Super Glue bottle: a fang was inside the cap which people perforated the tip with. Brown theorized the fang might be how the eyedrops get contaminated. When the FDA inspected Global Pharma’s plant, they noted that the company purchased its bottlecaps from a supplier which was unnamed, and that the caps had not been tested for sterility. The company also never conducted tests regarding the closure system of the bottles. The company simply relied on a visual leak inspection.
Brown, along with the foundation’s president, Rebecca Petris, on January 23, posted a video describing flaws in EzriCare’s packaging, calling the flaws a possible violation of federal law which requires eyedrops in multidose bottles to contain adequate preservatives or packaging which minimizes contamination risk.
A lawyer representing EzriCare sent a cease-and-desist letter to the nonprofit. The nonprofit then removed the video.
The Dry Eye Foundation, in May, decided to test the FDA. They created a company named Ocean Tears LLC. They purposely included a fictional proprietary substance as an inactive ingredient. They successfully got the product listed with the FDA, meaning they would have been able to sell it had the product been real.
They then invented yet another eyedrop. This one was named Mermaid Tears. They purposely included a warning on the product label stating that the eyedrops were non-preserved and improperly packaged. The warning label advised those who accidentally swallowed the eyedrops to seek medical attention at an aquarium. This product, too, was successfully listed with the FDA, meaning they would be able to sell the product if it was real.
Suffered An Eye Infection From EzriCare Or Delsam Pharma Eyedrops? We Can Help
Nadrich & Cohen is representing those who have developed eye infections after using eyedrops sold by EzriCare or Delsam Pharma.
We are contingency fee lawyers. This means you will not be charged any legal fees until and unless we recover financial compensation for you. You won’t ever owe us any out-of-pocket fees or any upfront fees. The only fee we charge is a portion of whatever money we recover for you.
We have been handling product liability lawsuits for over 30 years. We have recovered over $350,000,000 for our clients.
Let us put our extensive experience to work for you. Call us today for a free consultation, text us from this page or fill out the free case evaluation form on this page if you or a loved one developed an eye infection after using eyedrops sold by Delsam Pharma or EzriCare. Call us now so we can fight for your right to justice and financial compensation. Click here to read more.