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# Biogen Sued for Aduhelm Securities Fraud
- URL: https://www.fdaweb.com/biogen-sued-for-aduhelm-securities-fraud/
- Published: 2022-02-08T12:00:00.000Z
- Updated: 2026-09-14T17:31:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151107

The Oklahoma Firefighters Pension and Retirement System has filed a securities class action suit in Massachusetts federal court against Biogen and several of its top executives over the approval and marketing of its Aduhelm (aducanumab) to treat Alzheimer’s disease. The [suit](http://www.fdaweb.com/download.php?file=Oklahoma%5FFirefighters%5FPension%5Fand%5FRetirement%5FSystem%5Fv.%5FBiogen%5FInc.%5Fet%5Fal..pdf) details Biogen’s declining profits from its multiple sclerosis drugs and its search for a new blockbuster in Aduhelm.

It says the company decided to abandon Aduhelm after interim results of Phase 3 trials failed to show sufficient clinical benefit. However, the suit says, some company executives did not want to give up on the drug and began to meet with CDER Office of Neuroscience director **Billy Dunn** “in a back door effort to gain FDA approval for Aduhelm…. Dunn acted as a de facto advisor and cheerleader to Biogen, explaining how the data could be presented to allow FDA approval for Aduhelm. Dunn told Biogen of five different pathways through which it could get approval.”

The suit says investors were misled because when the company submitted Aduhelm for FDA approval, it portrayed the supporting data as demonstrating the drug was safe and effective and didn’t reveal that they were the same data that led the company to say the drug was futile and unapprovable just six months before. It says Biogen also did not disclose its collaboration with Dunn, “who shepherded Aduhelm through the FDA approval process despite vehement opposition within FDA.”

The suit reports the company’s “misleading” statements from before the 6/7/21-1/11/22 class period and those from during the class period. It asks the court to determine that the action is a proper class action suit, to award compensatory and punitive damages in an amount to be proven at trial, to award the plaintiffs in the class their costs and expenses, and award other relief as the court deems appropriate.

In the wake of the Aduhelm approval, three FDA officials, including Dunn, [defended](https://www.fdaweb.com/3-cder-officials-defend-aduhelm-approval/) their decision, and Public Citizen [called](https://www.fdaweb.com/woodcock-2-others-must-go-over-aducanumab-public-citizen/) for some of those involved to resign or be fired.