There is currently no widely publicized, open class action lawsuit specifically targeting Biogen for safety issues related to its Alzheimer’s drug Aduhelm. However, the drug and its approval process have been highly controversial and have attracted significant scrutiny, investigations, and legal risks that could potentially lead to class actions.
Aduhelm, approved by the FDA in 2021 through an accelerated approval pathway, was met with considerable criticism because it was approved despite two failed clinical trials and a negative vote from the FDA advisory committee. The approval process itself was later found to involve irregularities, including undisclosed communications between Biogen and the FDA, which raised concerns about the integrity of the approval. This controversy led to a congressional investigation concluding that the approval was “rife with irregularities” and inappropriate coordination between Biogen and the FDA.
Following these events, Aduhelm was eventually withdrawn from the market due to safety concerns and questionable clinical benefits. The accelerated approval pathway used for Aduhelm has been criticized for allowing drugs to reach the market without definitive proof of clinical benefit, increasing the risk that post-approval studies may fail to confirm effectiveness or reveal safety issues. This regulatory environment exposes companies like Biogen to potential product liability lawsuits if safety problems arise after approval.
Biogen has also been under investigation by the Department of Justice and the Securities and Exchange Commission related to Aduhelm’s launch and the company’s equity plans. These investigations suggest ongoing legal and regulatory challenges but do not specifically confirm an active class action lawsuit focused on drug safety.
Experts note that pharmaceutical companies approved under accelerated pathways, especially when safety or efficacy concerns emerge, are vulnerable to class action lawsuits from patients or shareholders. Such lawsuits typically allege securities fraud, misrepresentation of drug effectiveness, or failure to disclose safety risks. While Sarepta Therapeutics, another biotech company, currently faces a class action over safety concerns with its drug ELEVIDYS, no comparable publicized class action against Biogen for Aduhelm’s safety issues has been reported as of now.
In summary, although Biogen’s Alzheimer’s drug Aduhelm has been at the center of controversy, investigations, and regulatory scrutiny, there is no confirmed open class action lawsuit specifically addressing safety issues related to the drug. Nonetheless, the circumstances surrounding Aduhelm’s approval and withdrawal create a legal environment where such lawsuits could potentially arise in the future.
