What Families Need to Know About Brain Bleeds, Genetic Risks, and the Hidden Dangers of Alzheimer’s Drug Trials
Leqembi, an FDA-approved Alzheimer’s drug manufactured by Eisai and Biogen, has been presented as a groundbreaking step in slowing early cognitive decline. However, the excitement surrounding its release has been tempered by the serious and often fatal risks associated with a condition called ARIA, short for amyloid-related imaging abnormalities. These complications, including swelling and bleeding in the brain, have raised concerns among physicians and regulators alike—especially in light of cases where patients suffered seizures, strokes, and death.
One of the most concerning aspects of Leqembi’s clinical trials is the discovery that some participants were genetically predisposed to suffering these severe side effects, yet were never informed of their heightened risk. Families who trusted the drug’s promise are now left grieving, and asking hard questions about transparency, informed consent, and accountability.
ARIA, APOE4, and the Known Dangers
ARIA is not a new concern in Alzheimer’s drug trials, but the risks tied to Leqembi are especially disturbing. The condition typically includes swelling of brain tissue and bleeding from small vessels. Symptoms range from mild headaches to seizures and comas, and in some cases, the brain injuries have been fatal.
The issue becomes even more serious for patients who carry a genetic marker known as APOE4. Those with two copies of this gene face a significantly higher risk of suffering ARIA. Trial documentation shows that nearly 275 patients with this high-risk genetic profile were enrolled in the Leqembi study without being told about the gene or what it meant for their safety. Instead, genetic test results were deliberately withheld from participants—despite company knowledge that these individuals were at greater risk of severe outcomes.
One such patient, a 79-year-old woman, died after suffering over 50 microbleeds in her brain just weeks after beginning Leqembi treatment. Her death was directly linked to the drug, according to her autopsy. Her family never knew she was at high risk. The decision to keep patients in the dark, especially when brain damage and fatal outcomes are foreseeable, raises deep ethical and legal questions.
Informed Consent and Legal Accountability
In clinical trials, informed consent is not optional—it’s fundamental. Patients have the right to understand the risks involved with a treatment, including how their genetic makeup could increase those risks. Failing to disclose known, serious dangers undermines the entire premise of voluntary participation.
Eisai’s decision to conceal APOE4 test results from trial participants could open the door to legal action. Wrongful death claims, product liability lawsuits, and medical negligence cases may all be viable paths forward for families who believe their loved ones were harmed by incomplete disclosures and preventable outcomes.
Legal responsibility may rest not only with the drug manufacturers, but also with the review boards and research companies involved in administering the trial. These entities had a duty to ensure ethical standards were met and that patients were not exposed to undisclosed risks. Where that duty failed, accountability is warranted.
What a Wrongful Death Lawsuit May Involve
Wrongful death lawsuits tied to Leqembi and ARIA aim to hold those responsible accountable for the suffering and loss families have endured. These legal claims are often built around several key allegations:
- That drugmakers failed to disclose known risks tied to ARIA and APOE4;
- That informed consent was not obtained in a meaningful or ethical way;
- That the medication caused or significantly contributed to the death of the patient;
- And that financial and emotional damages resulted from the death.
Families who pursue wrongful death lawsuits may seek compensation for medical bills, funeral expenses, pain and suffering, loss of companionship, and other damages. In some cases, punitive damages may be awarded if it’s proven that the conduct of the drugmakers was especially reckless or concealed key information that could have prevented harm.
Financial Damages in ARIA-Linked Deaths from Leqembi
The financial impact of a death caused by ARIA complications can be overwhelming. Emergency medical care, hospital stays, imaging scans, neurological treatments, and long-term support all carry significant costs. Families often face these burdens while dealing with the emotional trauma of a sudden, preventable loss.
Wrongful death claims may include:
- Medical expenses related to treatment before death;
- Funeral and burial costs;
- Loss of financial support from the deceased;
- Pain and suffering endured by the deceased before passing;
- Emotional distress and loss of companionship for surviving family members.
If a pattern of concealment or corporate negligence is found, punitive damages may also be appropriate to send a message and deter future misconduct. Every case is different, and the total compensation depends on many factors, including the patient’s age, health, and family circumstances. But what remains consistent is the legal right to seek justice when harm results from corporate irresponsibility.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
If your loved one died after receiving Leqembi and suffered complications like ARIA, brain swelling, seizures, or hemorrhages, you may be eligible to file a wrongful death lawsuit. Parker Waichman LLP is a nationally recognized law firm with a long history of holding drug manufacturers accountable for preventable harm. We offer free consultations to families in all 50 states and will take the time to understand your case and explain your legal options.
You don’t need to face this alone. Contact us by calling 1-800-YOUR-LAWYER (1-800-968-7529) to speak with an attorney about your situation. There is no cost to call, and we never charge legal fees unless we recover compensation on your behalf.
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