Elidel, Novartis Pharmaceuticals Corporation’s medication for eczema, was recently at the center of a qui tam lawsuit alleging that the company pushed off-label uses of the drug for patients under two years old. Because studies conducted in animals indicated that Elidel might result in skin cancer and non-Hodgkin’s lymphoma, the Food and Drug Administration (FDA) didn’t grant Novartis approval to market it as an eczema treatment for infants. However, most eczema happens in that age group, and so Novartis encouraged their pharmaceutical sales reps to tell physicians that Elidel was a safe alternative to the typical treatment for infants, topical corticosteroids.
Donald Galmines, who used to be a Novartis sales rep, was the whistleblower in this qui tam lawsuit, brought under the False Claims Act. He said that while he worked for the company, they not only falsely stated that Elidel could safely go on up to 80 percent of a baby’s body, but they also provided kickbacks to doctors in the form of dinners and conferences at which the uses of Elidel were frequently discussed. In 2005, the FDA issued its strongest warning, a Black Box warning, against using Elidel on anyone under the age of 24 months. Galmines and his attorneys subsequently pursued his case despite the fact that the government chose not to intervene because the False Claims Act states that whistleblowers may move forward on their cases on the government’s behalf without the government’s direct involvement. In the end, because Galmines’s case settled successfully for over $35 million, he has received about 29 percent of the total recovery, with the rest going to the government as a reimbursement for the fraud.