Families misled about the effectiveness of Alzheimer’s drugs have several open class action lawsuits and legal avenues available, primarily centered around controversies involving recent FDA-approved treatments like Aduhelm (aducanumab) and Leqembi (lecanemab). These drugs, developed by companies such as Biogen and Eisai, have sparked significant debate due to questions about their clinical benefits versus their high costs and potential risks.
The most notable case involves Aduhelm, approved by the FDA in 2021 through an accelerated approval pathway. This approval was highly controversial because the drug’s clinical trials showed conflicting results regarding its ability to slow cognitive decline in Alzheimer’s patients. The FDA based its approval largely on the drug’s effect on reducing amyloid plaques in the brain—a biomarker associated with Alzheimer’s—rather than clear evidence that it improved patients’ cognitive functions. This decision led to widespread criticism, including resignations from FDA advisory committee members and concerns about the use of surrogate endpoints for approval. Many families and patient advocates felt misled because the drug was marketed as a breakthrough treatment despite uncertain clinical benefits.
As a result, several lawsuits have been filed alleging that Biogen and other involved companies misrepresented the drug’s effectiveness and safety, causing financial and emotional harm to patients and their families. These lawsuits often take the form of class actions, where groups of affected individuals collectively seek compensation for damages related to the drug’s marketing, pricing, and the FDA’s approval process. The claims typically focus on allegations of false advertising, failure to disclose risks, and misleading statements about the drug’s ability to slow or halt Alzheimer’s progression.
Similarly, Leqembi, which received full FDA approval in 2023, has also raised concerns, although it is generally viewed as having clearer evidence of modest clinical benefit compared to Aduhelm. However, the high cost of Leqembi and its injectable form, Iqlik, combined with ongoing questions about long-term effectiveness and safety, have led to scrutiny and potential legal challenges. Families who feel they were misled about the drug’s benefits or who experienced adverse effects may join or initiate class actions targeting the manufacturers.
The legal landscape is further complicated by the FDA’s accelerated approval pathway itself, which allows drugs to enter the market based on surrogate markers rather than definitive clinical outcomes. This pathway has been criticized for exposing pharmaceutical companies to product liability lawsuits if post-approval studies fail to confirm benefits or reveal safety issues. In fact, some experts warn that companies like Biogen and Eisai could face shareholder lawsuits and product liability class actions if the drugs do not deliver promised results or cause harm.
For families considering joining or initiating class actions, it is important to understand that these lawsuits often require demonstrating that the companies knowingly misled patients and healthcare providers about the drug’s effectiveness or safety. Evidence may include internal company documents, marketing materials, FDA communications, and expert testimony. Legal actions can seek damages for financial losses, emotional distress, and medical expenses incurred due to reliance on the drugs.
In addition to class actions against pharmaceutical companies, there may be related legal efforts targeting healthcare providers, insurers, or regulatory bodies for their roles in promoting or reimbursing these controversial treatments. Advocacy groups and legal firms specializing in pharmaceutical litigation are actively monitoring developments and may provide resources for affected families.
Overall, the open class actions related to Alzheimer’s drugs like Aduhelm and Leqembi reflect broader tensions in drug approval, marketing, and patient protection. Families misled about these drugs’ effectiveness have legal pathways to seek redress, but these cases are complex and evolving as more data on the drugs’ real-world impact emerges.
