Beovu Injection Lawsuit Over Retinal Injury, Blindness Cleared To Proceed

A federal judge is allowing a Beovu vision loss lawsuit to proceed, after rejecting arguments by the drug maker that the complaint should be dismissed due to federal pre-emption based on drug labeling laws.

Beovu (brolucizumab) was just approved just two years ago, as part of a class of medications known as anti-vascular endothelial growth factor therapy, or anti-VEGF. However, the FDA required a warning update last year, adding information for users and the medical community about the risk of severe eye inflammation, known as retinal vasculitis, which can result in blurry vision, visual floaters, dark spots, difficulty distinguishing colors and distorted images.

One of a growing number of Beovu injection lawsuits now being pursued by former users was brought by Kenneth Davison, who received three shots between January and April of 2020, for the treatment of wet age-related macular degeneration, and suffered retinal vein damage that has now left him blind in his left eye.

Novartis filed a motion to dismiss the claim in the U.S. District Court for the Middle District of Florida, arguing that the FDA’s approval of the warning label prevents any Beovu lawsuits alleging failure to warn and other defect claims.

However, in an order denying motion to dismiss (PDF) filed on September 23, U.S. District Judge William F. Jung rejected Novartis’s arguments and allowed the case to move forward.

“Given the standard for dismissal, the Court finds that Plaintiff’s complaint may stand as written,” Judge Jung wrote. “The complaint is clear; it is not missing elements, and it states plausible claims. Plaintiff’s complaint ultimately puts Defendant on clear notice of what it must defend.”

The concerns about Beovu injection retinal risks emerged after independent researchers with the American Society of Retina Specialists raised concerns about vision risks associated with the medication early last year.

In February 2020, the group sent warning to members about at least 14 cases of retinal vasculitis from Beovu, involving inflammation of the branches of the retinal artery. At least 11 of those cases involved a more severe instance of the inflammation known as a retinal vascular occlusion, where the vein becomes blocked and may result in permanent vision loss.

Due to the problems, some doctors have decided to stop carrying the eye drug in their inventories and the FDA required the manufacturer to add new warnings about the link between Beovu and retinal vasculitis in June 2020. However, consumers and the medical community are still trying to understand the risk.

While Novartis initially marketed and sold the drug for months without warnings about the Beovu retina problems, a warning update in June 2020 added new information to the drug label. The company is now urging patients to seek immediate care from an ophthalmologist if their eyes become red, sensitive to light, painful, or develop changes in vision.