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Genentech whistleblower awarded $10 million in FCA settlement

A former Genentech product manager who alleged his company exaggerated the effectiveness of the drug Tarceva to treat lung cancer will collect more than $10 million as part of a False Claims Act settlement.

Brian Shields, 44, made the allegations in a qui tam or whistleblower lawsuit in federal court in San Francisco. 

Genentech Inc. and OSI Pharmaceuticals LLC agreed to pay $67 million to resolve the allegations.

The False Claims Act allows private individuals to sue on behalf of the government for false claims and to share in any recovery.

The companies didn’t admit liability.

San Francisco-based Genentech became a subsidiary of Roche in 2009. OSI was acquired by Astellas Holding US Inc. in 2010 and converted to a limited liability company in 2011. It’s based in Farmingdale, New York.

Shields worked at Genentich for four years before filing his qui tam lawsuit in 2011.

Shields’ lawyer, Kenneth Nolan of Nolan Auerbach & White, said in a statement: “Our client was the lone relator behind this important qui tam recovery. As a West Point graduate and an Army helicopter pilot, Brian Shields served our country with distinction and honor. Now, as a successful qui tam relator, he continues to live a life of valor.”

OSI and Genentech co-promoted Tarceva, a drug approved to treat certain patients with non-small cell lung cancer or pancreatic cancer. 

Shields’ lawsuit alleged that from 2006 through 2011, Genentech and OSI made misleading representations to doctors and other health care providers about the effectiveness of Tarceva to treat certain patients with non-small cell lung cancer.

The alleged misleading marketing led to false claims for reimbursement against state and federal Medicaid programs.

There “was little evidence to show that Tarceva was effective to treat those patients unless they had never smoked or had a mutation in their epidermal growth factor receptor, which is a protein involved in the growth and spread of cancer cells,” the DOJ said Monday.

Howard Sklamberg of the FDA said, ’“Pharmaceutical companies that make misleading or unsubstantiated statements about their products can put patients at risk.”

Since January 2009, the DOJ has recovered more than $29.8 billion through False Claims Act cases. More than $18.2 billion of that amount was recovered in cases involving fraud against federal health care programs.

The case was United States ex rel. Shields v. Genentech, Inc., et al., Civil Action CV 11-0822 MEJ (N.D. Cal.).


Richard L. Cassin is the publisher and editor of the FCPA Blog. He’ll be the keynote speaker at the FCPA Blog NYC Conference 2016

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