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Beovu Lawsuits and Settlements: A Comprehensive Overview

Beovu Lawsuits and Settlements: A Comprehensive Overview

Beovu Lawsuits and Settlements: A Comprehensive Overview

Beovu (brolucizumab-dbll) is an FDA-approved prescription medication used to treat wet age-related macular degeneration (AMD). However, this drug has been linked to severe vision loss caused by retinal vasculitis and retinal vascular occlusion. As a result, numerous lawsuits have been filed against Novartis, the manufacturer of Beovu, with plaintiffs alleging that the company failed to adequately warn patients and doctors about the potential vision side effects.

As of July 6, 2023, there have been no trials or court-approved settlements in the Beovu lawsuits. These cases are currently being heard individually in various courts across the country, with some of the earliest lawsuits filed in Arkansas and Nebraska. Lawyers are still accepting cases, and so far, Novartis has not been successful in dismissing claims based on preemption.

In one particular case involving Barbara Frye and Edith A. Harris, both plaintiffs voluntarily dismissed their claims. Harris's case was dismissed with prejudice in March 2023, and Frye filed a stipulation of dismissal with prejudice in the same month. The reasons behind their decisions to dismiss are not disclosed in court documents. However, in September 2022, Novartis's motion to dismiss Frye's Beovu vision lawsuit case was denied. The trial was initially scheduled for February 2023 but has been rescheduled multiple times and is now set for April 2024.

The allegations made by the plaintiffs in the Beovu lawsuits revolve around the lack of warnings for occlusive retinal vasculitis on the drug's prescribing information until June 2020. Lawyers argue that Novartis put patients at risk of vasculitis, occlusive retinal vasculitis, and blindness by not providing adequate warnings.

In February 2020, the American Society of Retina Specialists (ASRS) reported 14 cases of vasculitis in patients who took Beovu, with 11 cases involving occlusive retinal vasculitis. By the following month, the number of cases increased to 25, with 21 of them involving occlusion.

Novartis has maintained that Beovu is safe and effective. In June 2020, the company referred to these reports as "rare post-marketing safety events." However, after reviewing the information from the ASRS, Novartis announced in April 2020 that it would evaluate reports of severe vision loss and vascular issues associated with Beovu. The drug maker acknowledged the confirmed safety signal of rare adverse events of retinal vasculitis and/or retinal vascular occlusion that may lead to severe vision loss.

Although the FDA approved a label change in February 2020 to include additional safety information regarding retinal vasculitis and retinal vascular occlusion, neither Novartis nor the FDA has issued a Beovu recall.

The potential side effects of Beovu listed in the prescribing insert include blurred vision, cataracts, eye hemorrhage, and blood vessel inflammation in the back of the eye. However, the original prescribing label did not include warnings about retinal vasculitis and retinal occlusion.

In August 2020, a case study was reported on a 77-year-old woman who experienced acute visual acuity loss in her right eye after taking two doses of Beovu. She was diagnosed with retinal vasculitis. Notably, she did not experience any eye inflammation when using other drugs for wet age-related macular degeneration.

The Beovu lawsuits are a complex and ongoing legal battle. Plaintiffs argue that Novartis failed to adequately warn about the potential vision side effects of Beovu, which resulted in severe vision loss for some patients. These cases are being pursued, indicating a belief in the validity of the claims against Novartis. As the litigation continues, it is important to stay updated on the developments surrounding these lawsuits and the potential settlements that may arise in the future.

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