There are indeed open class-action lawsuits related to the controversy surrounding the approval of Aduhelm, the Alzheimer’s drug developed by Biogen. These lawsuits emerged in response to revelations about the drug’s approval process, which was widely criticized for irregularities and unusual coordination between Biogen and the FDA.
Aduhelm’s approval was granted through the FDA’s accelerated approval pathway despite two failed clinical trials, raising significant concerns about the drug’s efficacy and the integrity of the approval process. Investigations uncovered that Biogen had mounted a secret campaign, known as “Project Onyx,” to push the drug’s approval. This campaign involved undisclosed communications with a top FDA official, which ultimately influenced the agency’s decision to greenlight Aduhelm. A congressional investigation later concluded that the approval process was “rife with irregularities,” highlighting dozens of undisclosed calls and emails between Biogen and the FDA, as well as an inappropriate level of coordination between the two parties.
Following these disclosures, multiple class-action lawsuits were filed against Biogen. These lawsuits generally allege that the company misled investors and the public about the drug’s effectiveness and the nature of its approval, potentially exposing Biogen to significant legal liability. The lawsuits also reflect broader concerns about the accelerated approval pathway itself, which allows drugs to be approved based on surrogate endpoints without definitive proof of clinical benefit, increasing the risk that drugs may later be found ineffective or unsafe.
The controversy over Aduhelm’s approval has also spurred calls for reforms in the FDA’s accelerated approval process to improve transparency, documentation, and safeguards against undue influence by pharmaceutical companies. Experts have noted that companies like Biogen could face not only product liability class actions but also shareholder lawsuits if they fail to disclose critical information or if post-approval studies fail to confirm a drug’s benefit.
In summary, the Aduhelm approval controversy has led to active class-action litigation targeting Biogen, focusing on alleged misconduct in the drug’s approval and marketing. These legal actions are part of a broader scrutiny of accelerated drug approvals and the potential risks they pose to patients, investors, and the healthcare system.
