Off label use of a drug is when a medication is used to treat a condition other than what it was approved for by the Federal Government. The manufacturer of Botox found out that augmenting sales by pushing off label uses of its successful anti-wrinkle drug could prove costly. A Virginia jury awarded $212 million against Allergan Inc., a maker of Botox. The lawsuit claimed after the man was injected with Botox to treat hand tremors, he fell ill and eventually suffered severe brain damage. The suit claimed the company failed to warn consumers about the risks of off-label use of the product according to the Chicago Tribune.
The Virginia plaintiff who alleged that use of the drug left him severely disabled, was awarded $12 million in compensatory damages and $200 million in punitive damages — the largest penalty ever in a Botox injury case. According to the pleadings and statements of counsel, the injured victim suffered brain damage and now requires round-the-clock care. The lawsuit, filed in U.S. District Court in Richmond, Virginia, alleged that Irvine-based Allergan failed to adequately warn the plaintiff’s treating doctor about the potential risks of Botox for off-label use. Known primarily as a wrinkle-buster, doctors also have prescribed the drug for treating serious medical conditions such as cerebral palsy, hemiplegic spasticity and chronic migraines. While the use of Botox on both cosmetic and medical purposes is only approved for very narrow uses by the FDA, Allergan has promoted it to doctors all over the country for uses other than wrinkles.
Allergan indicated that the company complied with all federal guidelines and might appeal the decision. Even if the decision by the jury is upheld, Allergan might have to pay only a small fraction of the penalty as Virginia state law caps punitive damages at $350,000. In September, Allergan agreed to pay the federal government $600 million to settle civil and criminal allegations that it illegally marketed and sold the drug through 2005 for unapproved uses, such as treating headaches.