DOJ Catch of the Week -- Genentech
By the C|C Whistleblower Lawyer Team
This week’s Department of Justice “Catch of the Week” goes to Genentech Inc. and OSI Pharmaceuticals LLC. On Monday, the San Francisco and New York-based pharmaceutical companies agreed to pay $67 million to resolve charges they violated the False Claims Act by making misleading statements about the effectiveness of the drug Tarceva, which is approved to treat certain patients with non-small cell lung cancer or pancreatic cancer. See DOJ Press Release.
According to the government, Genentech and OSI made misleading representations to physicians and other health care providers about the effectiveness of Tarceva when there was little evidence to show that Tarceva was effective to treat those patients unless they also (i) had never smoked or (ii) had a mutation in their epidermal growth factor receptor, which is a protein involved in the growth and spread of cancer cells.
DOJ Civil Chief Benjamin C. Mizer was very clear that “[p]harmaceutical companies have a responsibility to provide accurate information,” and that the government “will hold those companies accountable that mislead the public about the efficacy of their products.” The government health care agencies were equally clear in this messaging. FDA Deputy Commissioner Howard R. Sklamberg said his agency “will continue to work to protect the public’s health by ensuring that companies do not mislead healthcare providers about their products.” And Special Agent Steven J. Ryan for the U.S. Department of Health and Human Services Office of Inspector General added that his agency will continue to go after “[d]rug manufacturers that make misleading claims about their product’s effectiveness,” because of the risk such conduct will “jeopardize the health of patients – in this case, cancer patients.”
The allegations originated in a whistleblower lawsuit filed by former Genentech employee Brian Shields under the qui tam provisions of the False Claims Act. He will receive a whistleblower award of approximately $10 million out of the proceeds of the government’s recovery.