Beovu Lawsuit Over Eye Injury Cleared to Move Forward After Judge Rejects Novartis’ Motion to Dismiss

Novartis will continue to face a Beovu lawsuit, involving allegations that the drug maker failed to warn that the macular degeneration eye injection may cause severe retina damage, after a federal judge rejected an argument that the claims are pre-empted since the FDA approved the warning label.

Beovu (brolucizumab) was just approved just three 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 in 2020, adding new 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.

Over the past two years, a number of former users have filed a Beovu lawsuit against the drug maker, alleging that it failed to adequately research the side effects of the injection marketed for treatment of wet age-related macular degeneration, and withheld information from users and the medical community about the risk that they may be left with a long-term eye injury from Beovu.

One of the first complaints was brought by Barbara Frye, who received a Beovu injection in January 2020. Only a few months later, in March 2020, Frye was diagnosed with retinal vascular occlusion, which restricts blood flow to the retina, alleging that Beovu caused the eye injury.

The problems occurred shortly before Novartis updated the Beovu warning label in June 2020, adding information for consumers and the medical community for the first time about the risk. However, for months before that warning update, Novartis maintained that Beovu eye inflammation rates were low and defended the safety of it’s new drug.

In response to the Beovu lawsuit filed by Frye, Novartis argued that the prior FDA approval of the label preempts state law-based failure to warn claims. If the drug maker had been successful with the argument, it may have also had a widespread impact of preventing other consumers left with long-term eye injuries from Beovu from successfully pursuing claims.

In an order (PDF) issued on September 19, U.S. District Judge Kristine Baker, of the U.S. District Court for the Eastern District of Arkansas, rejected the preemption argument and cleared the Beovu lawsuit to move forward.

“The Court is not persuaded by Novartis’s assertions and arguments at this stage of the litigation,” she wrote, denying Novartis’s petition to dismiss. “Novartis, at all times, was responsible for the content of its labeling – in crafting the label and ensuring the warnings remain adequate as long Beovu was on the market.”

The ruling comes almost exactly a year after another federal judge, in the U.S. District Court for the Middle District of Florida, came to the same conclusion in a Beovu lawsuit filed 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.

Beovu Eye Injury Side Effects

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.

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.

2022 Beovu Lawsuit Update

Although common questions of fact and law have been raised in Beovu lawsuits filed against Novartis throughout the federal court system, there is not currently any centralized MDL, and coordinated pretrial proceedings have not been formally established. Therefore, cases are pending in various different U.S. District Courts nationwide before different federal judges.

Given the limited number of users prior to the Beovu warning label update in June 2020, the size and scope of the litigation is expected to be limited to only a few hundred potential claims that may be brought nationwide.

As cases continue to move forward and Beovu trials are scheduled, they will be closely watched by lawyers involved in the litigation and may have an impact on eventual Beovu settlement negotiations that may be reached to avoid each individual claim going before a jury in the coming years.