Beovu Lawsuit | Vision Loss, Blindness & Eye injury

Beovu is a drug that is used to treat age-related macular degeneration. However, the medication was not even on the market for a year before there were reports of serious side effects. Essentially, a drug that was meant to improve and save patients’ vision may end up costing them the ability to see, even leading to blindness. While it is rare for new medications to result in lawsuits so soon after they have been released, that is exactly what has happened to Beovu. Perhaps the drug should never have been approved in the first place, but it is little consolation to those who have lost their vision from it. There is no Beovu recall. There is no Beovu class action. It is good news that there is no Beovu class action because victims rarely benefit from class actions and lawyers line their pockets. There have been no global Beovu lawsuit settlements and no one knows future Beovu settlement amounts.

Beovu vision loss lawsuit updates (November 2023)

Updates- November 1, 2023-There have been no settlement or trials in these cases. No lawyer has filed a motion to consolidate into multidistrict litigation. There is likely to only be several hundred claims filed in Court. Novartis will not be able to stop Beovu lawsuits by arguing Federal Preemption. Federal Courts have rejected Novartis assertion that the lawsuits should be pre-empted because the FDA greenlighted the warning label. The manufacturer’s  motion to dismiss a Beovu lawsuit arguing federal preemption was nixed by the U.S. District Court for the Eastern District of Arkansas.

12-31-2021- “Novartis has been accused of failing to disclose accurate Beovu safety data in a whistleblower lawsuit from a former employee. Beovu side effects have been the subject of a class action lawsuit investigation. In the days leading up to the approval of Beovu, a macular degeneration injectable treatment, one Novartis employee was reportedly urging her employer to correct inaccurate Beovu safety data. Instead of correcting their misleading error, Novartis allegedly fired this employee for speaking up. In her whistleblower lawsuit, the former Novartis worldwide brand medical director contends that Beovu safety data inaccurately indicated that the stroke and heart attack risk for a competitor product was double the risks seen with Beovu. This information was reportedly inaccurate, with the employee describing the risks from the two drugs to be comparable.” Top class actions

5/30/2021- “Most recently, at the end of May 2021, Novartis announced the early termination of three clinical trials due to concerns related to “patient safety.” announced the early termination of three clinical trials due to concerns related to “patient safety.” JD Supra

2/12/2021- “A Nebraska woman recently filed a new Beovu lawsuit in the U.S. District Court for the District of Nebraska. She claims that after taking Beovu (brolucizumab), she suffered from serious injuries. She is seeking damages from manufacturer Novartis Pharmaceuticals. The plaintiff states in her complaint that she was prescribed Beovu by her doctor, and used it as directed. Beovu is used to treat wet age-related macular degeneration (AMD), a chronic eye disorder that leads to blurred vision or a blind spot in the visual field.” New York Legal Examiner

6/11/2020- “Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Beovu^® (brolucizumab) to include additional safety information regarding retinal vasculitis and retinal vascular occlusion¹.”

Has Novartis issued a Beovu recall?

Despite all the complications caused by Beovu,  there has been no Beovu recall by Novartis. The U.S. Food and Drug Administration (FDA) has  also failed and refused to recall Beovu. Nonetheless, the FDA approved changes to Beouvu’s label in 2021.  Marcia Kayath, Novartis’ Global Head of Medical Affairs and Chief Medical Officer stated in a press release after the label alteration “This label update provides clinicians with important information to guide treatment decisions. We believe Beovu continues to represent an important treatment option for patients with wet AMD, with an overall favorable benefit-risk profile,” She continued to state “As we proceed to examine root causes and potential mitigation strategies, we will continue to communicate findings with transparency and urgency to regulatory bodies and healthcare providers.”

Types of complications caused by Beovu:

• retinal vasculitis
• intraocular inflammation
• blindness
• loss of vision
• retinal artery occlusion
• Assorted vision issues
• Occlusive retinal vasculitis

Novartis Only Recently Received Approval to Sell Beovu

Beovu is made by the giant conglomerate Novartis. The drug is intended to treat Neovascular (Wet) Age-Related Macular Degeneration. It is called “wet” because blood vessels in the eye are abnormal and leak fluid and blood into the part of the retina that is responsible for central vision. This causes either blurred vision or a blind spot in the patient’s vision field. This is the more severe type of macular degeneration, and it comprises about 20% of the cases from this disease.

Novartis entered the picture with a treatment that it believed would help patients. Beovu is an injectable drug, and the injection is administered by intravitreal injection. Basically, the patient receives an injection directly into their eye. The inside of the eye contains a jelly-like fluid that can receive an injection. Beovu’s course of treatment is a monthly injection into the eye. After the first three treatments, patients would receive injections every 2-3 months afterwards.

Novartis Claims that Beovu Is a Successful Drug

Beovu is a blocker that treats wet macular degeneration by blocking vascular endothelial growth factor. This is a protein that is responsible for helping form new blood vessels. Too many blood vessels in the eye can be a problem because it can result in abnormal growth.  Beovu tries to slow the growth of these blood vessels to stop the fluid leaking.

The makers of Beovu claim that the product works. They cite studies that show that patients gained an average of seven letters on a reading chart after a course of treatment using the drug. They also claim that 30% of patients gained as many as 15 letters on their vision tests. Finally, they also say that 93% of people maintained their vision after being treated with Beovu.

Beovu Was Supposed to Be a Very Profitable Drug

Beovu was approved by the FDA towards the end of 2019. Just in the last quarter of 2019, the drug did $35 million in sales. By the first quarter of 2020, the number grew to $68 million. Beovu promises to be a huge moneymaker for Novartis. There is little wonder why. Each vial of the drug is priced at $1,850. Yearly treatments with Beovu can run as much as $11,000.

However, the cost does not necessarily mean that patients are buying themselves a safe drug. With Beovu, reports of serious side effects began to mount practically immediately. This is rare among medications. Usually, problems are reported after the drugs have been on the market for years, but Beovu’s history became checkered almost as soon as the drug hit the market.

An Early Study Detailed Significant Dangers of Taking Beovu

Less than six months after Beovu hit the market, the American Society of Retina Specialists issued a note warning about the possibility of retinal vasculitis for Beovu patients. Retinal vasculitis is when retinal vessels become inflamed. This is much more serious than it sounds at first glance. This is a sight-threatening condition that could leave patients blind. The most severe type of this ailment is called occlusive retinal vasculitis. This is the condition that causes blindness.

While the early reports were based on 14 cases of retinal vasculitis, this was enough to persuade some doctors not to prescribe the drug. There is a more established competitor in the marketplace called Eylea that was certainly threatened by Beovu. Many doctors that were considering Beovu stopped after the reports emerged.

Novartis Defends Itself to Protect its Drug

Novartis claims that there were only isolated cases of retinal vasculitis. Its employees have publicly defended the drug and doctors’ rights to prescribe what they want. However, this has failed to reassure doctors who are now afraid to prescribe the drug. In addition, one Novartis employee claims that she was fired because she discovered that Novartis had reported incorrect information about Beovu and encouraged the company to correct it. While this did not involve retinal vasculitis, it shows the lengths that Novartis would allegedly go to in order to protect its possible cash cow. She is suing the company.

However, recent retrospective studies show that the problem may be far more widespread. One small ASRS study showed that 44% of patients who received one injection of Beovu showed signs of retinal vasculitis. According to this study, 85% of eyes had occlusive vasculitis after treatment with Beovu.

Even with a Black Box Warning, Novartis Will Still Sell the Drug

By June 2020, the FDA acted. The regulator required Novartis to use a black box warning about retinal vasculitis. This is the highest form of warning that the FDA could require, and it reserves this for dangerous drugs. No other drug in Beovu’s class has reports of retinal vasculitis, nor do they require a black box warning.

Nonetheless, Novartis has no plans to stop selling or to recall Beovu, regardless of the dangers. The company still believes that it will make money from what it thinks is a blockbuster drug. Even with the safety fears, Novartis plans on expanding its sales of the drug. However, there are patients whose eyesight may be at risk.

A Recent Lawsuit Was Filed in Nebraska

Now, the Beovu lawsuits are beginning to pile up as patients have been injured and lost vision from the drug. One recent lawsuit was filed by a Nebraska woman who alleges that she lost vision after taking Beovu. Here is some of what is in her lawsuit:

• Novartis allegedly misrepresented Beovu as safe when the drug causes serious medical problems.
• The company failed to warn doctors about the possible vision loss associated with the drug.
• Novartis allegedly misled customers about the safety of the drug.
• The company allegedly knew or should have known of the hazards of the drug.

Even with the new black box warning, patients can pursue lawsuits based on the fact that Beovu is a defective drug. Nonetheless, we expect there to be more lawsuits filed by people who received Beovu injections before the time that Novartis was required to issue a black box warning. There were over 50,000 patients treated with Beovu by this time. With reports of retinal vasculitis, we expect the number of court cases to grow.

The Nebraska lawsuit is one of the first cases to be filed in this litigation. It is too early to tell if the number of cases will reach the point where multidistrict litigation will be necessary. Even if there are as little as dozens of cases, it could still warrant an MDL.

In the meantime, these cases have just been filed and are very early on in their existence. It will still be years before Beovu cases advance through the court system. Nonetheless, that does not lessen your obligation to file a case before the statute of limitations expires. This could mean that you have as little as two years from the time that you notice possible vision loss to file a lawsuit.

Talk to a Beovu Lawsuit Attorney Today

If you have been injured by Beovu, you are entitled to compensation for your injuries. Vision loss can result in significant financial compensation. For instance, we are aware of  of prior lawsuit awards / settlements against other  wrongdoers ranging up to $1 million for near full vision loss. Even partial vision loss could lead to a six-figure settlement. If you or a loved one have taken Beovu and have suffered retinal vasculitis that has taken some of your vision, consult with a Beovu attorney today. We will fight for your legal right to receive compensation. If you are seeking an attorney for a Camp lejeune lawsuit,contact us.