Tarceva Settlement Totals $67 Million For False Claims
Manufactured to treat non-small cell lung cancer, Tarceva manufacturers exaggerated information about the drug’s uses. Some of the inflated lacked research and evidence. After a whistleblower lawsuit was filed, the case was further investigated. The total legal settlement of $67 million will rectify the manufacturer’s false claim allegations and kickbacks to physicians.
Recently, the manufacturers of Tarceva – Genentech and OSI – were forced to pay $67 million for false claims made about their product. Produced to treat non-small cell lung cancer, the drug came under fire after being marketed as a treatment for those who have previously or currently smoke. The Justice Department states that Tarceva had misleadingly promoted its uses between January 2006 and December 2011.
What Is Tarceva?
There are two types of lung cancer: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). The most common type, NSCLC, may spread to other parts of the body including the bone, liver, small intestine, and brain.
In 2005, Tarceva was pushed to market for the treatment of NSCLC and pancreatic cancer. The drug delays the growth of cancer cells and slows them from spreading to other parts of the body. It was approved to be used by a small group of people – including those who had never smoked and who carried a specific element in a protein involved in the spread and growth of cancer cells. It should only be used as a solution when various other cancer medicines have not been successful.
Litigation Against Tarceva
After Tarceva’s approval, manufacturers allegedly promoted it to physicians and health care professionals as a drug that could be used broadly across many patients such as current and past smokers. The drug’s inflated data caused some doctors to use it as a first option for treatment rather than a back-up solution like it was approved for.
However, the wide range of claims being made were never supported by the FDA nor could manufacturers Genentech and OSI show evidence to back the claims.
In 2011, a whistleblower lawsuit was filed by Tarceva’s former senior product manager Brian Shields. The case depicted several methods of how manufacturers boosted the drug’s distribution – especially through kickbacks to physicians and exaggerating Tarceva’s effectiveness.
Evidence against Tarceva’s manufacturers piled up, stating they knew about the little evidence of the drug treating a majority of lung cancer patients. Additionally, the federal government emphasized a violation of the False Claims Act due to federal programs overpaying for the drug.
The final national settlement totaled $67 million. $62.6 million will go to the federal government – approximately $10 million of which will go to Brian Sheilds. State Medicaid programs will receive the other $4.4 million. The settlement money will rectify the false claim allegations, as well as claims made about kickbacks made to doctors.