Kickback Suit for Allergan’s Promotion of Botox for Pediatric Migraine Upheld by Judge

Allergan must still face allegations that it violated the False Claims Act by incentivizing physicians to prescribe off-label Botox for pediatric migraine, although a federal circuit court judge dismissed charges that the company defrauded Medicare by promoting the practice.

In writing for the U.S. District Court of the Eastern District of Texas, Judge Rodney Gilstrap said complainant Braedon Hearrell failed to state a sufficient claim based on the Stark Act (also known as the Physician Self-Referral Law), which prohibits doctors from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship.

But Gilstrap upheld Hearrell’s allegations that Allergan “knowingly hired key opinion leaders to recruit physicians to participate in Allergan’s promotion of Botox for pediatric migraine therapy” and that the company “knowingly paid cash payments to KOLs [key opinion leaders] in exchange for referrals to pediatric specialists who would, in turn, administer Botox for treatment of pediatric migraines.”

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