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`Pharmaceutical Companies to Pay $67 Million To Resolve False Claims Act Allegations Relating to Tarceva | OPA | Department of Justice
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`JUSTICE NEWS
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`Department of Justice
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`Office of Public Affairs
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`FOR IMMEDIATE RELEASE
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`Monday, June 6, 2016
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`Pharmaceutical Companies to Pay $67 Million To Resolve False Claims Act
`Allegations Relating to Tarceva
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`Pharmaceutical companies Genentech Inc. and OSI Pharmaceuticals LLC will pay $67 million to resolve False Claims
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`Act allegations that they made misleading statements about the effectiveness of the drug Tarceva to treat non-small cell
`lung cancer, the Department of Justice announced today. Genentech, located in South San Francisco, California, and
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`OSI Pharmaceuticals, located in Farmingdale, New York, co-promote Tarceva, which is approved to treat certain
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`patients with non-small cell lung cancer or pancreatic cancer. OSI Pharmaceuticals LLC is the successor to OSI
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`Pharmaceuticals Inc., which was acquired by Astellas Holding US Inc. in 2010 and converted to a limited liability
`company in 2011.
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`“Pharmaceutical companies have a responsibility to provide accurate information to patients and health care providers
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`about their prescription drugs,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice
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`Department’s Civil Division. “The Department of Justice will hold those companies accountable that mislead the public
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`about the efficacy of their products.”
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`The settlement resolves allegations that, between January 2006 and December 2011, Genentech and OSI
`Pharmaceuticals made misleading representations to physicians and other health care providers about the
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`effectiveness of Tarceva to treat certain patients with non-small cell lung cancer, when there was little evidence to show
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`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.
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`As a result of today’s $67 million settlement, the federal government will receive $62.6 million and state Medicaid
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`programs will receive $4.4 million. The Medicaid program is funded jointly by the state and federal governments.
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`“This settlement demonstrates the government’s unwavering commitment to pursue violations of the False Claims Act
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`and recover taxpayer dollars spent as a result of misleading marketing campaigns,” said US. Attorney Brian Stretch for
`the Northern District of California.
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`“Pharmaceutical companies that make misleading or unsubstantiated statements about their products can put patients
`at risk,” said Deputy Commissioner Howard R. Sklamberg for FDA’s global regulatory operations and policy. “The FDA
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`will continue to work to protect the public's health by ensuring that companies do not mislead healthcare providers
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`about their products.”
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`“Drug manufacturers that make misleading claims about their product’s effectiveness can jeopardize the health of
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`patients — in this case, cancer patients,” said Special Agent in Charge Steven J. Ryan for the US. Department of
`Health and Human Services Office of Inspector General (HHS-OIG). “Our agency will continue to protect both patients
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`and taxpayers by holding those who engage in such practices accountable for their actions.”
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`The settlement resolves allegations filed in a lawsuit by former Genentech employee Brian Shields, in federal court in
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`San Francisco. The lawsuit was filed under the qui tam, or whistleblower, provisions of the False Claims Act, which
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`permit private individuals to sue on behalf of the government for false claims and to share in any recovery. Shields will
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`receive approximately $10 million.
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`APOTEX EX. 1065-001
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`https://www.justice.gov/opa/pr/pharmaceutical-companies-pay-67-miI|ion-resolve-false-claims-act-allegations-relating-tarceva
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`1/2
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`APOTEX EX. 1065-001
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`7/24/2017
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`Pharmaceutical Companies to Pay $67 Million To Resolve False Claims Act Allegations Relating to Tarceva | OPA | Department of Justice
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`This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement
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`for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May
`2009 by the Attorney General and the Secretary of Health and Human Services. The partnership between the two
`departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced
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`cooperation. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice
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`Department has recovered a total of more than $29.8 billion through False Claims Act cases, with more than $18.2
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`billion of that amount recovered in cases involving fraud against federal health care programs.
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`The settlement is the result of a coordinated effort by the Civil Division’s Commercial Litigation Branch and the US.
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`Attorney’s Office for the Northern District of California, with assistance from the HHS-OIG, the HHS Office of Counsel to
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`the Inspector General, the HHS Office of the General Counsel-CMS Division, the FDA’s Office Chief Counsel, the
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`FDA’s Office of Criminal Investigations, the Office of the Inspector General for the Office of Personnel Management, the
`FBI, the Department of Defense Office of the Inspector General, the Office of the General Counsel for the Defense
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`Health Agency and the National Association of Medicaid Fraud Control Units.
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`The case is captioned United States ex rel. Shields v. Genentech, Inc., et 6]., Case No. CV 11 0822 MEJ (N.D. 0a.).
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`The claims resolved by the settlement are allegations only, and there has been no determination of liability.
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`Topic(s):
`False Claims Act
`Healthcare Fraud
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`Component(s):
`Civil Division
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`Press Release Number:
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`16-653
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`Updated April 27, 2017
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`https://www.justice.gov/opa/pr/pharmaceutical-companies-pay-67-mi |lion-resolve-false-claims-act—allegations-relati ng-tarceva
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`2/2
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`APOTEX EX. 1065-002
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`APOTEX EX. 1065-002
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