The promise of Leqembi and Kisunla—drugs that aim not just to ease symptoms but to slow Alzheimer’s disease—was compelling. Alzheimer’s is an awful disease. But as reports emerge of serious brain injuries among clinical trial participants, including bleeding and swelling. Victims who have suffered injuries in these clinical trials may have potential lawsuits for injuries because they were not fully informed of their potential genetic risks before enrolling.
This is very new litigation. This page explains how potential Leqembia and Kisunla lawsuits might work and what they would involve. If you have a potential brain bleed or brain injury lawsuit, call us today at 800-553-8082 or get a free consultation online.
Alzheimer’s Treatments with a Double-Edged Sword
Leqembi, developed by Eisai, and Kisunla, from Eli Lilly, represent a new frontier in Alzheimer’s treatment. Unlike earlier drugs that only managed symptoms, these medications target amyloid plaques in the brain, aiming to slow the disease’s progression. But as groundbreaking as this approach may seem, there’s a risk that targeting these plaques comes with dangerous side effects, particularly for individuals with certain genetic profiles.
In particular, people carrying the APOE4 gene, a variant associated with an increased risk of developing Alzheimer’s, appear to face elevated dangers when exposed to amyloid-targeting therapies like Leqembi and Kisunla. APOE4, though a known marker for Alzheimer’s risk, also seems to make individuals more vulnerable to side effects such as cerebral hemorrhage (brain bleeding) and cerebral edema (brain swelling). For some, what began as a hopeful pursuit of a treatment turned into a serious health crisis—raising pressing questions about whether they fully understood the risks involved.
The Critical Importance of Genetic Testing and Informed Consent
Both Eisai and Eli Lilly reportedly conducted genetic testing on study participants, identifying those with the APOE4 variant. But here’s where things get murky: reports indicate that many participants were not adequately informed of the additional risks their genetic profile posed. This gap in communication, if true, undercuts the principle of informed consent which is an absolute cornerstone of ethical research. Informed consent isn’t just a formality, especially for the vulnerable patients. It is a requried safeguard to ensure that participants understand exactly what they’re signing up for. This means being fully aware of all risks, especially heightened risks tied to one’s genetic makeup.
So we have people who are suffering who are hopeful about a new medication, only to discover later that you had an elevated chance of suffering a brain bleed or swelling because of your genetic profile. If this happened to you, you may have a compensation claim.
The Devastating Reality of Brain Bleeds and Swelling
Brain bleeding and swelling are not minor side effects. They are critical conditions that require immediate medical attention and can lead to permanent damage or even death. The stakes are even higher for Alzheimer’s patients, who may already be dealing with cognitive impairments. For families who enrolled their loved ones in the hopes of slowing down Alzheimer’s progression, these risks are nothing short of devastating. Some participants reportedly experienced significant neurological damage, while others did not survive the complications.
We all get that every drug has side effects, and clinical trials are designed to assess these risks in a controlled setting. But when there is a known genetic factor that could increase the severity of these side effects, participants have a right to know—and the companies involved have a responsibility to inform them fully.
Why Families May May Seek Settlement Compensation
In light of these reports, families affected by brain injuries in these studies are beginning to ask difficult questions. Did Eisai and Eli Lilly fulfill their ethical obligations? Was enough information provided for families to make an informed choice? If participants were not told about their increased genetic risk, these families may have grounds for legal action, arguing that the drug manufacturers failed to obtain proper informed consent.
Kisunla and Leqembia lawsuits will focus on the idea that Eisai and Eli Lilly knew or should have known that participants with the APOE4 gene faced additional risks. By not fully disclosing this, the argument goes, these companies may have violated research protocols and ethical guidelines, leaving families to bear the emotional and physical consequences. Families who find themselves in this position may be eligible for compensation—not only for medical expenses but also for the emotional toll endured.
Kisunla and Legembia Clinical Trial Lawsuits
When conducted clinical trials, pharmaceutical companies like Eisai and Eli Lilly have a legal obligation to disclose to prospective volunteers any and all known potential risks involved the trial. This is necessary so that trial participants can make informed decisions before agreeing to take part in the trial. If a pharmaceutical company is aware of a potential risk and fails to disclose that fact to prospective clinical trial participants, they can be held liable for resulting injuries.
In the case of Legembia and Kisunla, Eisai apparently did tell prospective clinical trial participants that certain people with a specific gene would be more at risk from brain bleeds if they used the drugs. What the company failed to tell participants, however, is whether their genetic testing revealed that they had that specific gene putting them at higher risk of brain bleeds.
As a result of this failure to disclose, around 100 clinical trial participants suffered brain bleeds and swelling after taking the drugs. Many of the these individuals suffered very serious health consequences as a result, and some of them even died. Any of these individuals (or their surviving family members) can now bring negligence lawsuits against Eisai and Eli Lilly and get compensation for their injuries.
Who Is Eligible for a Kisunla and Legembia Clinical Trial Lawsuit?
Individuals who are eligible to file a Kisunla and Legembia clinical trial lawsuit will be limited to the small group of about 100 people who agreed to participate in the clinical trials and suffered a brain bleed or related injury.
Potential Settlement Value of Kisunla and Legembia Lawsuits
At this very early stage of the litigation, predicting settlement values is speculative. However, we can make some reasonable estimates based on various assumptions and based on settlements in prior cases involving similar injuries.
Our lawyers predict that Kisunla and Legembia clinical trial lawsuits involving the most serious injuries (i.e., death, or brain bleeds resulting in permanent disability or injury) will have a settlement value of $1.2 to $3 million. The reason the value of these cases is so high is because these are very serious injuries and the liability on the part of the defendants is clear and easy to understand.
The other reason settlement values in these cases will be high is because there will not be that many plaintiffs. In a mass tort with thousands of plaintiffs, the settlement payouts to individual plaintiffs are always smaller because the settlement money has to be divided among more plaintiffs. In this litigation, however, the group of potential plaintiffs will be less than 100 and probably more like 50.
Contact Us About a Kisunla and Legembia Clinical Trial Lawsuit
If you participating in the clinical trials for Kisunla or Legembia and subsequently suffered a brain bleed (or your family member died), contact our national product liability lawyers today for a free consultation. Call us at 800-553-8082 or contact us online.