The DOJ announced that QOL Medical LLC, a Florida based pharmaceutical company, and its owner Frederick E. Cooper, (“QOL”) have agreed to pay $47 million to resolve allegations of violating the False Claims Act (“FCA”) through the submission of kickback tainted claims. The four relators, who are all former QOL medical employees, initially filed this matter under the qui tam provisions of the FCA and will receive $8,068,909 as a result of the settlement.
According to the DOJ, QOL manufactures and markets therapies for rare diseases. Sucraid is QOL’s principal product and the only FDA-approved therapy for Congenital Sucrase-Isomaltase Deficiency (“CSID”)—a rare genetic disorder that affects digestion of certain sugars. In 2018, QOL allegedly provided health care providers with Carbon-13 breath test kits to test for CSID and sales representatives told health care provides that the breath tests had the absolute ability to diagnose CSID. However, according to the DOJ, scientific literature showed that conditions other than CSID could lead to positive breath tests. QOL then paid a laboratory to analyze the Carbon-13 tests. In turn, QOL’s sales representatives received the results and were instructed to contact the health providers of patients with positive test results to market Sucraid. QOL’s sales representatives were allegedly instructed to turn positive Carbon-13 breath tests into Sucraid prescriptions.
As a result of the foregoing scheme, the Government alleged QOL caused kickback tainted claims to be submitted to federal healthcare programs, including Medicare and Medicaid, in violation of the Anti-Kickback Statute. QOL admitted, acknowledged, and accepted responsibility for several allegations as part of the settlement. QOL admitted to knowing Carbon-13 breath tests were not FDA-approved to diagnose CSIDs. But QOL still instructed its sales force to contact health care providers of patients with positive breath tests to convert the positive tests into prescriptions. Upon announcement of QOL’s settlement, Special Agent in Charge Roberto Coviello of the Department of Health and Human Services Office of Inspector General commented that “[w]e are committed to protecting taxpayer-funded health care programs and the patients served by those programs, and we will thoroughly pursue allegations of False Claims Act violations.”
The attorneys at Chilivis Grubman represent clients of all types and sizes in connection to False Claims Act investigations and litigation. If you need assistance with such a matter, please contact us today.