On July 20th, on the eve of trial, Biogen Inc. agreed to pay $900 million dollars to settle claims that the company violated the False Claims Act (FCA) by allegedly paying improper consulting and speaker fees and providing lavish meals and entertainment (in violation of the Federal Anti-Kickback Statute (AKS)) to medical providers to induce them to prescribe its multiple sclerosis drugs Avonex, Tysabri, and Tecfidera. The qui tam (or whistleblower) suit was filed in the District of Massachusetts in 2012 by former Biogen employee Michael Bawduniak and merged with multiple suits with similar allegations. The settlement is extraordinary in size, particularly in light of the United States’ decision declining to intervene in the suit, and highlights the risks associated with pharmaceutical and device manufacturers hiring providers as consultants and conducting speaker programs.
Bawduniak and his co-relators claimed that Biogen paid hundreds of healthcare providers to participate in expansive (and allegedly sham) consulting and speaker programs for which the company had little demand or use, and that providers were selected as consultants based on their prescribing volume rather than their expertise or speaking ability. Once the United States declined to intervene in 2015, the relators’ cases were unsealed and merged, and in 2018 their Complaint survived Biogen’s motion to dismiss.[1] Biogen argued inter alia that that the consulting and speaker programs were personal services...
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