Genentech Pays $20 Million to Settle Off-label Marketing Whistleblower Lawsuit

Genentech agreed to pay $20 million to settle a recent False Claims Act whistleblower lawsuit – $5.7 million of which is being paid to whistleblower John Underwood who initiated the lawsuit.  Underwood alleges Genentech pressured its sales representatives to market off-label uses of Rituxan, a drug approved in 1997 to treat non-Hodgkin’s lymphoma.

Pharmaceutical laws and regulations permit physicians to prescribe drugs for off-label, unapproved uses; however, drug companies such as Genentech are not  permitted to market those unapproved or off-label uses.  According to the lawsuit, Genentech marketed Rituxan to treat chronic lymphocytic leukemia, atoimmune hemolytic anemia, and rheumatoid arthritis – all of which constitute off-label uses of the drug.

Tagged: False Claims Act (FCA), Whistleblower Laws (Federal)