Class-action lawsuit against an anti-Alzheimer’s drug brand Aduhelm

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Picture of Researcher: Ariana Arce​

Researcher: Ariana Arce​

Picture of Journalist: Aaron Vivanco

Journalist: Aaron Vivanco

Picture of Editor: Daniela Polo

Editor: Daniela Polo

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Class-action lawsuit against an anti-Alzheimer’s drug brand Aduhelm

Patients with Alzheimer’s disease who received Aduhelm developed amyloid-related imaging abnormality-edema (ARIA-E) or ARIA-hemorrhage (ARIA-H) and either had a seizure, a stroke, or died.

What is Aduhelm?

Aduhelm (aducanumab) is an antibody against beta-amyloid plaques in the brain. This medication is meant to slow down the progression of the cognitive decline caused due to Alzheimer’s disease and is administered as an intravenous monthly infusion.

Lawsuit: Biogen Inc

Biogen is a “Big Pharma” based in Cambridge, Massachusetts. The Aduhelm lawsuit is a claim against Biogen Inc for selling the anti-Alzheimer’s drug aducanumab, under the brand name Aduhelm, which may cause ARIA symptoms in patients, including brain hemorrhage and edema.
The Food & Drug Administration (FDA) Adverse Event Reporting System also reported cases of ARIA-E in patients with Alzheimer’s disease who had received Aduhelm.
The primary legal issue is whether Biogen Inc, the manufacturer of Aduhelm, failed to adequately warn doctors and patients about the increased risk of potentially fatal brain edema (ARIA-E) caused by Aduhelm (aducanumab).

Lawsuit: Investors of Biogen Inc against the company

The lawsuit was filed on behalf of Biogen Inc investors in the Massachusetts federal court, alleging that the company misled them about the efficacy of Aduhelm. The investors purchased Biogen Inc shares between June 7, 2021 and January 11, 2022.

Adverse effects of Aduhelm

Aduhelm results in the development of ARIA symptoms. Patients with Alzheimer’s disease and ARIA exhibit abnormalities in magnetic resonance imagining scans. The most common form of ARIA is ARIA-E, a type of cerebral edema.

ARIA manifests as following:

  • ARIA-E swelling (cerebral edema)
  • ARIA-H bleeding (cerebral hemorrhage)

ARIA symptoms include:

  • Headache
  • Dizziness
  • Nausea
  • Confusion/Mental disorientation

Aduhelm cancer research

Clinical studies have demonstrated that patients with Alzheimer’s disease who were administered Aduhelm developed mild, moderate, or severe ARIA-E or swelling of the brain that could be fatal.

A 75-year-old Canadian woman died after receiving the anti-Alzheimer’s medication Aduhelm, according to FDA’s quarterly adverse event reporting dashboard. When hospitalized, she was diagnosed with swelling in the brain or ARIA-E, a known side effect of Aduhelm.