Eyedrop maker on hook for claims following infection outbreak

SAN FRANCISCO (CN) — The manufacturer of eyedrops recalled after users reported infections and even blindness must face the bulk of a lawsuit claiming its products are defective and had known risks. 

U.S. District Judge Jacqueline Scott Corley ruled to allow most claims against the maker and some distributors of EzriCare, LLC eyedrops, the subject of a recall this year, to proceed. She said the plaintiffs plausibly showed EzriCare failed in its duty to test the drops to make sure they were safe, and that Amazon as a distributor “cosigned” on the products’ safety.

The plaintiffs sued the companies and Global Pharma Healthcare Private Limited this past February, claiming the eyedrops left plaintiff Milton Reynolds blind in one eye and caused infections in other users. 

The eyedrops were recalled earlier this year after the U.S. Centers for Disease Control and Prevention reported an outbreak of Pseudomonas aeruginosa linked to the use of EzriCare Artificial Tears. 

U.S. health officials sent a health alert to doctors, saying the outbreak included at least 55 people in 12 states. The infections, including some found in blood, urine and lungs, hit people who said they had used the product, which is a lubricant used to treat irritation and dryness. The FDA recommended the recall based on manufacturing problems including lack of testing and proper controls on packaging.

In a 24-page order Tuesday, Corley denied EzriCare’s motion to dismiss for lack of personal jurisdiction and partially denied and granted pieces of its main motion to dismiss. She said the plaintiffs made relatively straightforward product liability claims against all of the defendants. 

The Joe Biden appointee found the plaintiffs adequately claim a design defect, as Reynolds experienced an infection that ate his cornea and caused him to go blind in one eye. She also said that the plaintiffs plausibly claimed the eyedrops “deviated” from their “intended result/design” and that to accept EzriCare’s argument would require her to infer that the products were intended and designed to result in infection and blindness. 

“Surely, EzriCare is not asking the court to draw the inference that a product that causes such damage is performing ‘safely,’” the judge said. 

Corley said that most of EzriCare’s assertions “strain credulity.” EzriCare argued the plaintiffs did not properly claim what role each company played, calling it “implausible” for plaintiffs to make the same claims about it, Amazon and Global.

The plaintiffs also properly argued that the product risks were known because medical professionals warned about placing a preservative-free eyedrop inside a multiuse bottle “because there is no preservative to kill bacteria,” the judge said. She also kept alive the claim for loss of consortium, saying that Reynolds’ wife suffered due to his injury.

However, Corley found the plaintiffs failed to establish which of EzriCare’s specific statements or specific conduct constitute fraud. She said they never cited a specific statement from EzriCare claiming that the product was “safe,” “not adulterated with harmful bacteria” or “prepared under sanitary conditions” — therefore, their fraud claim failed.

Corley also threw out the negligent conduct claim, plaintiffs did not show when EzriCare should have known there was a link between bacterial infections and their product. 

But Corley also denied EzriCare’s motion to stay regarding the role of Aru Pharma, Inc., which acted as an intermediary when it imported Global’s artificial tears to the United States. EzriCare argued a stay is necessary because Aru Pharma is in bankruptcy and could be difficult to procure discovery materials from. Corley disagreed, finding a stay would harm the plaintiffs.

“Mr. Reynolds is now blind in one eye and should not be required to stay his action while a bankruptcy proceeding entirely unrelated to him proceeds,” Corley said. 

As for Amazon’s motion to dismiss, the judge said that whether Amazon can be held liable for third-party sellers under an implied breach of warranty claim remains undecided by California courts, but state precedent may favor holding the company liable.

“Plaintiffs and Amazon both agreed allowing the implied warranty of merchantability claim to go forward would not lead to additional discovery, as the other claims’ discovery will encompass the discovery necessary for the implied warranty claim,” Corley said. “Moreover, since this is a novel legal theory, the court declines to rule on it without the benefit of a full record.”

Attorneys for both sides did not respond to requests for comment before press time. 

Plaintiffs must file an amended complaint by Nov. 20. The parties will return to court on Nov. 30. 

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