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, alleging that the company failed to adequately warn patients and doctors about these potential side effects.
As of July 6, 2023, there have been no trials or court-approved settlements in the Beovu lawsuits. Each case is being handled individually in various courts across the country, with some of the earliest lawsuits filed in Arkansas and Nebraska. Lawyers are still accepting cases, and Novartis has not been successful in dismissing claims based on preemption.
In the case of Barbara Frye and Edith A. Harris, both plaintiffs voluntarily dismissed their claims. Harris's case was dismissed with prejudice in March 2023, without any explanation provided in court documents. Similarly, Frye filed a stipulation of dismissal with prejudice in March 2023, again without any explanation. These dismissals closed the cases, but the reasons behind them remain unknown.
In September 2022, Novartis's motion to dismiss Frye's Beovu vision lawsuit case was denied by the judge. The trial was initially scheduled for the week of February 13, 2023, but has been rescheduled multiple times, with the current date set for the week of April 1, 2024.
The plaintiffs in the Beovu lawsuits allege that Novartis did not include warnings about 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 failing to provide adequate warnings.
In February 2020, the American Society of Retina Specialists (ASRS) shared an update regarding 14 cases of vasculitis in Beovu patients. Out of those cases, 11 individuals experienced occlusive retinal vasculitis, a condition where blood vessels in the eye become blocked, potentially leading to blindness. By the following month, the number of cases increased to 25, with 21 involving occlusion.
Novartis maintains that Beovu is safe and effective. In a June 2020 statement, the company referred to these reports as "rare post-marketing safety events." After reviewing information from the ASRS, Novartis announced in April 2020 that it would evaluate reports of severe vision loss, retinal artery occlusion, and/or vasculitis associated with Beovu. The company confirmed a safety signal of rare adverse events that may result in severe vision loss.
In February 2020, the FDA approved Novartis's label change, adding additional safety information about retinal vasculitis and retinal vascular occlusion. However, neither Novartis nor the FDA has mentioned a recall of Beovu.
Beovu's prescribing insert lists several vision-related side effects, including blurred vision, cataracts, eye hemorrhage, and blood vessel inflammation in the back of the eye. The original prescribing label did not include warnings about retinal vasculitis and retinal occlusion.
One case study reported a 77-year-old woman who experienced acute visual acuity loss in her right eye after taking two doses of Beovu. The woman was diagnosed with retinal vasculitis. It is worth noting that she had previously taken other medications for wet age-related macular degeneration without any eye inflammation.
The Beovu lawsuits are complex and ongoing legal battles. The plaintiffs argue that Novartis failed to adequately warn about the potential vision side effects, resulting in severe vision loss for some patients. As these cases move forward, it remains to be seen what the outcomes will be. However, the fact that these lawsuits are being pursued indicates a belief in the validity of the claims against Novartis. It is crucial to stay informed about these developments as more information becomes available.
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