Novartis AG will pay more than $35 million to end a suit in Pennsylvania federal court accusing it of violating federal and state False Claims Acts (FCA) by marketing the eczema cream Elidel for use on infants. Elidel was only approved for older patients. Donald Galmines, a Former Novartis sales representative accused the company of buying expensive dinners for physicians in exchange for them prescribing Elidel to children younger than 2 years old, despite the fact that the U.S. Food and Drug Administration (FDA) had explicitly refused to approve the drug for that age group.
Galmines filed his suit in 2005 and the federal government declined to intervene. The whistleblower alleged that as a sales representative he was encouraged to promote Elidel as safe on 80 percent of an infant’s body, but wasn’t told that side effects could include cancer. Galmines said Doctors who took him out to dinner or to conferences told him that “as long as the gifts kept coming, they’d prescribe to anyone I told them to.”
Novartis allegedly made its representatives capitalize on parents’ fear of steroids to get doctors to prescribe Elidel. Animal studies have shown the cream could cause skin cancer and non-Hodgkin lymphoma. The FDA later added a black box warning to the cream stating its cancer risks. Galmines will receive 29 percent of the settlement. In 2012, he had separately reached a $19 million settlement with Novartis in Texas regarding the use of Elidel on infants.
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