Botox maker Allergan Inc. recently plead guilty to criminal misbranding charges stemming from their role in improperly marketing the popular injectable for “off label” uses. According to the Associated Press, Allergan will pay $375 million in fines based on the misdemeanor charge, in addition to $225 in civil fines.

Assistant Attorney General Tony West explains the case: “Allergan paid kickbacks to induce physicians to inject Botox for off-label uses, including coaching doctors how to miscode Botox claims leading to millions of dollars of false claims being submitted to federal and state programs.” Allergan unsuccessfully defended its actions on First Amendment grounds – arguing that the company had a constitutional right to educate doctors concerning the off label uses of the product.

In total, Allergan will pay the government close to $600 million in criminal and civil fines over the off label misbranding of Botox. Interestingly enough, the settlement has had a positive effect on Allergan Inc.’s stock, the Wall Street Journal reports that shares rose 3% following the announcement of the settlement.

Related Resources:

  • U.S. to aggressively pursue drug misbranding cases (Reuters)
  • The Day after Levine: Analyzing the Supreme Court’s Recent Ruling that FDA Approval of Label Warnings Does Not Preempt State Tort Law (FindLaw’s Writ)
  • Allergan Corporation Sued Over Alleged Botox Death (FindLaw’s Injured)

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