Beovu Lawsuit

novartis lawsuit

Beovu is a drug that was designed to treat Wet Age-Related Macular Degeneration (Wet AMD). After development, the FDA also approved Beovu to treat Diabetic Macular Edema (DME). DME is a complication of diabetes that causes fluid to build up in the macula.

Dry AMD is the breakdown of light-sensitive cells in the macula. The result is a slow loss of vision but rarely blindness. Dry AMD makes up 80% of AMD cases.

Wet AMD is the more severe version of AMD. It’s caused by abnormal blood vessels growing beneath the retina. These blood vessels leak fluids and blood that cause a loss of vision in the center of the eye. With Wet AMD, the vision loss is worse than with Dry AMD and the risk of blindness is higher.

Beovu blocks vascular endothelial growth factor (VEGF). VEGF is a protein that helps with the growth of blood vessels. Beovu is one of the few anti-VEGF drugs on the market to treat Wet AMD. Anti-VEGFs stop the abnormal blood vessels from leaking, growing, and then bleeding under the retina.

Beovu’s advantage over its competitors is that after the initial three months, you only need the injection once every 12 weeks. Its closest competitor requires an injection once every four weeks and possibly up to eight weeks. 

Patients prefer a longer time between injections since doctors inject Beovu directly into the eyeball. This is not a pleasant experience. 

Anti-VEGF drugs for Wet AMD have been around for a while. The Food and Drug Administration (FDA) approved the first, Pegaptanib (brand name: Macugen), in 2004. Though all drugs have some risk, Anti-VEGFs had an acceptable safety record — until Beovu’s approval in 2019. Within the first few months of treatment, doctors noticed an unexpected side-effect: blindness. 

If you or a loved one believe you were harmed by Beovu, Join the Many can answer all of your questions and help you determine if you may qualify for a settlement from the drug makers. 

History of Beovu

Beovu history

Beovu has a short history since the FDA only approved it in late 2019. Unfortunately, it only took a few months for Beovu to accumulate as many negative reports as other drugs have over several years. For example, it took years for Belviq, a weight loss drug, years to accumulate the negative history Beovu did in its first four months. 

The FDA approved Beovu on October 18, 2019. On February 23, 2020, the American Society of Retina Specialists (ASRS) issued a warning about Beovu. There were 14 reported cases of retinal vasculitis. Out of the 14 patients, 11 had suffered severe vision loss. 

Beovu patients were receiving injections into their eyes to prevent or slow vision loss from Wet AMD. Unfortunately, Beovu was no cure for many patients. Beovu was a cause of blindness. Understandably, the patients were quite angry about the results.

Is Beovu an Effective Drug?

It’s hard to call a drug that is sold to prevent blindness but causes blindness an effective drug. Still, there have been many reports of patients being successfully treated with Beovu. The European Union’s European Medicines Agency reports Beovu is as effective as Aflibercept (brand name: Eylea). The FDA approved Aflibercept in the US in 2011.

Beovu’s advantage over Eylea is that Beovu injections occur every 12 weeks after the initial loading period. Doctors must give Eylea injections every four weeks. Eylea and Beovu may cause blindness. But, Eylea only causes severe side-effects such as blindness in fewer that one in 2,000 injections. Beovu causes severe side effects such as blindness in up to one out of every 100 patients.

Since the two drugs are equally effective, your only advantage with Beovu is fewer injections. To gain this advantage, you put yourself at a substantially higher risk of severe damage to your eyes. 

It had only been a little over four months after the FDA approved Beovu when the ASRS issued a warning against Beovu. Further research showed more reasons for concern with Beovu. 

Reported Side Effects From Taking Beovu

According to the Mayo Clinic, the more common side effects of Beovu include:

  • Blindness
  • Bloody eye
  • Blurred vision
  • Lost vision
  • Eye redness

The less common side effects include:

  • Burning, itching, or dry eyes
  • Eye discharge or excessive tears
  • Headaches
  • Changes in vision
  • Pain in the front of the eye
  • Redness of the whites of the eye
  • Seeing flashes of light
  • Floating spots or a curtain appearing across the field of vision

So we have a blindness prevention drug that commonly causes blindness and bleeding eyes. The more common side effects are worse than, the rarer side effects. 

It gets worse. Novartis, the pharmaceutical company that makes Beovu, initially failed to warn patients about many of these risks. It wasn’t until several months after the ASRS reported on these risks that Novartis finally updated Beovu’s warning label.

All Names Beovu Goes By

Beovu is the brand name in the US. Its generic name is brolucizumab-dbll. In some other countries, it’s sold under the brand name, Vsiqq. 

Overview of the Research on Beovu

Beovu research

In July 2020, the National Library of Medicine published an article analyzing reported retinal vasculitis cases by the ASRA. By the time the data-gathering phase for this article closed, there were 25 patients with adverse events. Since treatment is based on a per-eyeball basis, these incidents involved only 26 eyes. Patients usually need treatment in only one of their eyes.

Beovu Injection Side Effects

Some of the reported cases involved eyes that were asymptomatic. By this time, many doctors were far more careful with Beovu considering earlier reports of severe reactions. Doctors’ extra procedures to ensure safety uncovered these asymptomatic cases. Still, in 83% of cases, the research found occlusive eye disease. 

Occlusive eye disease is the blocking of blood vessels in the eye. Retinal vascular occlusion is the most severe form of retinal vasculitis. These adverse events cause eye pain and sometimes blindness. 

In August 2020, the American American Academy of Ophthalmology (AAO) in its Journal of Ophthalmology, published an article titled Is This a 737 Max Moment for Brolucizumab? Brolucizumab is the generic name for Beovu. The reference to the “737 Max” is about two accidents by the same type of airplane within a six-month period that killed almost 400 people. 

The AAO has called for thorough investigations to continue into the safety issues of Beovu. They also reminded doctors that there are several other anti-VEGF drugs available that have proven safety records.

How Much Did Novartis Know About These Safety Issues?

Whether Novartis knew about the risks of Beovu before it sought FDA approval to sell the drug is a legitimate question. With the AAO’s comparison of Beovu to the 737 Max disasters, it’s important to know that Boeing admitted to knowing of the risk in that situation. 

Another key piece of information is that Novartis hid the risk of another drug approved by the FDA in 2019 — the same year the FDA approved Beovu. To be fair to Novartis, the FDA closed its investigation of the incident without penalizing Novartis. But there’s still controversy surrounding the incident. 

We don’t know whether there was any manipulation of the Beovu data, but many lawyers who are currently suing Novartis are looking for any sign of data manipulation while the matters are in the discovery process. 

What we know is that Novartis was conducting three post-approval clinical trials on Beovu. In Novartis’ statement regarding these trials, you’ll see they canceled the trials in the interest of patient safety

Shouldn’t they have determined if it was a safe drug before they started selling it? Did the FDA know about these issues before they approved it? You need answers to these questions and Join the Many can connect you with the legal experts working to get to the bottom of the issue. 

The FDA’s Treatment of Beovu

It surprises many experts that the FDA hasn’t recalled Beovu yet. But the FDA updated its warning about Beovu in June 2020. Novartis stresses the drug is safe as long as the intervals between injections are no closer than eight weeks apart. Doctors are aware of the issues with Beovu and are taking their own steps to reduce the risk of Beovu.

What Do Doctors Think of Beovu?

It was doctors themselves that issued the first warnings about Beovu through a report by the American Society of Retina Specialists (ASRS) in February 2020 — only five months after Beovu’s application approval. 

Doctors believe the higher inflammatory reaction rates in the pre-approval clinical trials should have been a red flag for the FDA

Many hospitals that considered Beovu stopped the process after the ASRS report. Some doctors are having patients sign informed consent forms before administering Beovu injections. Informed consent forms are usually saved for risky procedures like surgery.

The consensus among doctors is not to use Beovu since there are safer alternatives. They question the decision to accept the additional liability exposure by giving patients a dangerous drug when they can provide similar drugs with equal effectiveness. 

Many wonders why Novartis put itself at substantial risk of lawsuits for only short-term profits. Yet Novartis didn’t even warn patients after doctors warned them. Novartis waited another four months after the ASRS report. 

A Brief History of the Novartis Beovu Lawsuit

It’s rare that lawsuits start so quickly after a drug’s approval. It usually takes more time for enough adverse reactions to occur to establish a pattern of safety risks. With Beovu, it was less than four months before lawsuits started and five months before doctors were warning against using Beovu.

Lawsuits take a while to wind through the court system. We just got our first published opinion regarding a motion to dismiss in September 2022. A judge in the Federal District Court for the Eastern District of Arkansas denied Novartis’ motion to dismiss a case brought by an Arkansas woman suffering from vision loss after Beovu treatments. 

Once a lawsuit gets by a motion to dismiss, defendants talk about settling the case. It’s too soon to see if the Arkansas case will go further or if the parties will settle. But there are many more cases across the nation. If there are a few more adverse rulings, Novartis will be more eager to settle.

Should You Sue Novartis?

Novartis knew there were serious safety issues with their drug, at least since February 2020. They allowed thousands of more patients to use a dangerous drug until they updated their warning as required by the FDA.

Now, Novartis has fought lawsuits against it for the past two years. The Beovu patients bringing the lawsuits have already suffered from vision loss. Now they’re having to endure a long fight against a giant pharmaceutical company. These people have lost their vision. Many have lost their income since they can’t perform their jobs if they can’t see. 

If the manufacturer of a dangerous product sells that product to you and the product harms you, it’s a long-standing rule that they must compensate you for your losses. If you have a Beovu-related injury, you have a right to compensatory damage payments to cover your medical bills and lost income. You have a right to noneconomic compensatory damages to cover both your mental as well as physical pain and suffering.

Join the Many to learn about your rights and how we can connect you with the best legal care for your case. No amount of money can truly make up for vision loss, but it can help.

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