Implications of the US$1.4 Billion ZYPREXA Settlement

The US Department of Justice has concluded a landmark enforcement action involving alleged off-label promotion by Eli Lilly and Company (Lilly) of its atypical anti-psychotic drug, Zyprexa® (olanzapine). The US$1.415 billion settlement, which reflects the largest ever monetary payment to the United States, raises important issues for pharmaceutical and device compliance in terms of both ongoing settlement negotiations and compliance planning and implementation efforts. Additionally, the Corporate Integrity Agreement, which Lilly entered into in conjunction with the settlement agreement, contains a number of important provisions that reflect a continued focus on transparency by the Office of the Inspector General of the US Department of Health and Human Services.