An investigative report from The New York Times revealed in November 2024 that hundreds of volunteers who joined a trial to test an experimental Alzheimer’s drug were not warned that they would be at high risk for brain injuries. Some people who took the Alzheimer’s drugs Leqembi and Kisunla may not have been informed that they were at a higher risk for such a dangerous complication, and may now be eligible for compensation.
Alzheimer’s Drugs Leqembi and Kisunla Trials
“By 2021, nearly 2,000 volunteers had answered the call to test an experimental Alzheimer’s drug known as BAN2401,” the Times reported in 2024.
“To assess the drug’s effectiveness and safety, Eisai sought to include people whose genetic profiles made them especially prone to develop Alzheimer’s. But these same people were also more vulnerable to brain bleeding or swelling if they received the drug,” the article revealed.
Although the drug manufacturer Eisai told everyone that they would be given a genetic test to see which volunteers may be at higher risk for brain injuries, those results were not disclosed, leaving 274 volunteers to join the trial without truly knowing the risk they were taking on.
If these patients who entered the clinical studies were not adequately informed of that risk, they may be able to pursue an Alzheimer’s drugs Leqembi and Kisunla brain injury lawsuit.
‘Significant Side Effects’ of Experimental Drugs
The New York Times investigation revealed that some high-risk patients in the trial died and that more than 100 others suffered brain bleeding or swelling. Although some dealt with injuries that were mild and asymptomatic, others were serious and life-threatening.
“This is a medication that has some significant side effects, and we need to be aware of them,” said Dr. Matthew Schrag, a Vanderbilt University neurologist who assisted with the autopsy of a 79-year-old who volunteered for the trial and died after three doses of the drug, “her brain riddled with 51 microhemorrhages,” the Times reported.
Were Volunteers Aware of Alzheimer’s Drugs Leqembi and Kisunla Risk Factors?
Ultimately, the Food and Drug Administration approved Eisai’s Alzheimer’s drug, marketed as Leqembi. Later, the agency approved a second drug, Kisunla, made by Eli Lilly. That manufacturer “also chose not to tell 289 volunteers that their genetic profiles made them vulnerable to brain injuries,” The Times found.
In the Leqembi and Kisunla trials, volunteers were required to sign consent forms “that said people with certain genetic profiles faced higher risks of brain injuries from receiving the drugs, and that participants would be tested for them — but not told the results,” the outlet revealed. Some Alzheimer’s experts and bioethicists told the Times that they felt the companies “undercut the principle of informed consent.”
George Perry, editor of the Journal of Alzheimer’s Disease, said, “You have to ask patients if they want to know it, but then it should be disclosed. That would be part of informed consent.”
Volunteers in these trials should have been made fully aware of all the risks involved, and if they were not – and were ultimately put at serious risk of brain injury due to brain bleeding or swelling – the individuals involved and their families may be able to pursue legal action.
How Phillips Law Group Can Help
The companies involved with Alzheimer’s drugs Leqembi and Kisunla trials had a responsibility to inform the participants fully of the risks involved in participating in the trials. If volunteers and families were not given enough information to make informed choices, they deserve justice for any pain and suffering that may have followed.
Pharmaceutical companies for any drug trials that are aware of potential risks that do not disclose those risks to clinical trial participants may be able to be held liable for injuries that occur as a result. Eisai and Eli Lilly are no different.
If you or a loved one participated in clinical trials for Kisunla or Legembia and suffered a brain injury, please don’t hesitate to call the team at Phillips Law Group for more information. We can offer a free, no-obligation consultation to discuss your legal options and to help you seek justice.
Please contact us by calling 602-222-2222 to learn more today.
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