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$67M Settlement Reached in Tarceva False Claims Lawsuit

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Santa Clara, CA: Pharmaceutical companies Genentech Inc. and OSI Pharmaceuticals LLC will pay $67 million to resolve allegations of consumer fraud in that they made misleading statements about the effectiveness of the drug Tarceva to treat non-small cell lung cancer, the Department of Justice has announced.

Tarceva is approved to treat certain patients with non-small cell lung cancer or pancreatic cancer. Genentech and OSI Pharmaceuticals co-promote the drug.

The lawsuit specifically alleged that between January 2006 and December 2011, Genentech and OSI Pharmaceuticals made misleading representations to physicians and other health care providers about the effectiveness of Tarceva to treat certain patients with non-small cell lung cancer, when there was little evidence to show that Tarceva was effective to treat those patients unless they also 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.

Accordint to the terms of the settlement, the federal government will receive $62.6 million and state Medicaid programs will receive $4.4 million. The Medicaid program is funded jointly by the state and federal governments.

The lawsuit was filed by former Genentech employee Brian Shields, under the qui tam or whistleblower provisions of the False Claims Act, which permit private individuals to sue on behalf of the government for false claims and to share in any recovery. Shields will receive approximately $10 million.

The case is captioned United States ex rel. Shields v. Genentech, Inc., et al., Case No. CV 11 0822 MEJ (N.D. Ca.). The claims resolved by the settlement are allegations only, and there has been no determination of liability.

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Reader Comments

Posted by

on
My grandmother took this in 2006-2007 and she was a non-smoker with lung cancer. She was diagnosed in 6/2006 and passed 4/2007.
Is there anything we can do to make a claim?

Posted by

on
My mother was convinced to take this tarceva drug eventhough she was doing much better without it. She was sick as a dog taking it it got so bad she had to stop mid treatment. We all felt the drug was doing her more harm than good but her doctor quickly convinced her to restart it leaving her debilitated. I can't believe I'm just hearing of this lawsuit. Now I'm recovering from cancer surgery but the this drug left my Mom I'm afraid too try anything because deceitful pharmaceutical companies took my trust away and that might cost me my life.

Posted by

on
My late husband took this drug in late 2006-early 2007. I, also, am curious why the government received such a large amount of funds vs the families as stated above. This was an expensive medication that takes a larhe amount of a person's finances; not yo mention the side effects.

Posted by

on
My father was taken this drug and had ungodly side effects.. My mother is wanting me to find more information on the Tarceva class action lawsuit .
Thanks again

Posted by

on
My husband took Tarceva in January for 05. It made made him so sick and weak. He died in early April.

Posted by

on
I am asking myself why the government is receiving so much of the settlement monies instead of the patients or their families that were treated with Tarceva giving them false hope. The patients were the victims in this case not the federal government!

Posted by

on
My father took this drug given to him by his physician towards the end of his life ( within 6 months of him passing). The allergic reaction he had to this terrible drug was horrible and debilitating. From the time he began taking Tarceva he was never the same. Burning skin rashes developed of his entire body, he continued to take Tarceva in hopes that it would go away and he was led to believe it could halt his lung cancer, but it did not and we all had to watch as health declined almost immediately. He was finally advised by his physician to stop taking the drug, by then it was too late. Tarceva is a horrible drug and was extremely expensive costing $4-5,000 a month which made it even harder on my parents to go through. I am a registered nurse and this drug should be banned from ever being used on treating any cancer patient.

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