Allergan Inc. Settles Botox Off Label Case for $600M

By Laura Strachan, Esq. on September 02, 2010 | Last updated on March 21, 2019

Beauty ain't cheap. Botox manufacturer Allergan Inc. recently settled civil and criminal charges that will cost them over $600 million in fines, reports Medical News. The Irvine-based Allergan was under investigation from 2000 to 2005 over misbranding charges relating to the off label use of one of their most popular (and profitable) products, Botox.

More specifically, company was accused of failing to fully inform users of the potential for migrane headaches, pain, spasicity, and juvenile cerebral palsy when using the product. Botox, which has both theraputic and cosmetic uses was only approved by the FDA for treating muscle contractions, overactive sweat glands, and crossed eyes during the time in question. In the end, Allergan plead guilty to the misdemeanor misbranding charge and agreed to settle the civil claims charged against the company under the civil false claims act. The DOJ also accused Allergan of paying kickbacks to physicians who used Botox for cosmetic purposes and teaching doctors how to bill for off-label uses.

The total cost of the Allergan marketing mishap ... $375 million in criminal fines and $225 million in civil fines. Assistant attorney general for the Justice Department is quoted by ABC News: "For nearly a decade Allergan illegally promoted Botox for uses that were not approved as safe and effective by the FDA." West also noted his hope that Allergan off label case will serve as a deterrent for others in the industry.

In paying the heavy fines, the drug maker is saving wrinkles and the cost of continued litigation in the matter. As part of the settlement, Allergan will also submit to additional monitoring, auditing, reporting, and mandatory disclosure with the Department of Justice over the next five years. Not the only drug company believed to be engaging in misbranding, West added that, "These are cases we plan to aggressively pursue."

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