The companies are Genentech
, which is based in South San Francisco and is now a part of the Roche Group, and Farmingdale, New York-based OSI Pharmaceuticals, which is now a part of Astellas Pharma. They were taken to court when a former Genentech employee alleged that the company provided doctors and medical professionals with misleading information about the drug.
There is no finding in this ruling that the companies are legally liable for the claims.
The drug, Tarceva
, is approved to treat non-small-cell lung cancer and advanced-stage pancreatic cancer.
The companies led doctors to believe that the drug would work in a broad patient population, according to the complaint, when, in fact, "there was little evidence to show that Tarceva was effective" to treat certain patients with non-small-cell lung cancer, according to a news release
from the Department of Justice. It worked only on a narrower patient population, including patients who had never smoked and people who carried a particular mutation in a protein that is involved in the spread and growth of cancer cells.
The complaint also suggests that the company failed to report all the adverse events related to the drug. That could mean doctors were choosing to use it to treat lung cancer
patients instead of a treatment that has been proved to have more success.
The Department of Justice said the company made these claims to medical professionals between January 2006 and December 2011.
The whistle-blower in the case was a former Genentech employee, Brian Shields.
Shields was a product manager who tried to bring the problem to the attention of his managers. Instead of receiving an appropriate response, the complaint suggests, he faced retaliation for doing so and was told he was "not a team player."
Under the False Claims Act, Shields is entitled to about $10 million of the settlement. Another $62.6 million will go to the federal government. State Medicaid programs will get $4.4 million.
"Pharmaceutical companies have a responsibility to provide accurate information to patients and health care providers about their prescription drugs," said a statement from the head of the Justice Department's civil division, Benjamin C. Mizer
. "The Department of Justice will hold these companies accountable that mislead the public about the efficacy of the products."