7/24/2017
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`Pharmaceutical Companies to Pay $67 Million To Resolve False Claims Act Allegations Relating to Tarceva | OPA | Departmentof Justice
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`JUSTICE NEWS
`
`Departmentof Justice
`
`Office of Public Affairs
`
`FOR IMMEDIATE RELEASE
`
`Monday, June 6, 2016
`
`Pharmaceutical Companies to Pay $67 Million To Resolve False Claims Act
`Allegations Relating to Tarceva
`
`Pharmaceutical companies GenentechInc. and OSI Pharmaceuticals LLC will pay $67 million to resolve False Claims
`Act allegations that they made misleading statements aboutthe effectiveness of the drug Tarceva to treat non-small cell
`lung cancer, the Departmentof Justice announced today. Genentech, located in South San Francisco, California, and
`OSI Pharmaceuticals, located in Farmingdale, New York, co-promote Tarceva, whichis approvedto treat certain
`patients with non-small cell lung cancer or pancreatic cancer. OSI Pharmaceuticals LLC is the successor to OSI
`Pharmaceuticals Inc., which was acquired by Astellas Holding US Inc. in 2010 and converted to a limited liability
`companyin 2011.
`
`“Pharmaceutical companies have a responsibility to provide accurate information to patients and health care providers
`abouttheir prescription drugs,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice
`Department's Civil Division. “The Department of Justice will hold those companies accountable that mislead the public
`aboutthe efficacy of their products.”
`
`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
`effectiveness of Tarcevato treat certain patients with non-small cell lung cancer, when there waslittle evidence to show
`that Tarceva waseffective to treat those patients unless they also had never smoked or had a mutationin their
`epidermal growth factor receptor, whichis a protein involved in the growth and spread of cancercells.
`
`As a result of today’s $67 million settlement, the federal governmentwill receive $62.6 million and state Medicaid
`programswill receive $4.4 million. The Medicaid program is funded jointly by the state and federal governments.
`
`“This settlement demonstrates the government’s unwavering commitment to pursue violations of the False Claims Act
`and recover taxpayerdollars spent as a result of misleading marketing campaigns,” said U.S. Attorney Brian Stretch for
`the Northern District of California.
`
`“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 andpolicy. “The FDA
`will continue to workto protect the public's health by ensuring that companies do not mislead healthcare providers
`abouttheir products.”
`
`“Drug manufacturers that make misleading claims about their product’s effectiveness can jeopardize the health of
`patients — in this case, cancer patients,” said Special Agent in Charge Steven J. Ryan for the U.S. Departmentof
`Health and HumanServices Office of Inspector General (HHS-OIG). “Our agencywill continue to protect both patients
`and taxpayers by holding those who engagein such practices accountable for their actions.”
`
`The settlement resolves allegationsfiled in a lawsuit by former Genentech employee Brian Shields, in federal court in
`San Francisco. The lawsuit wasfiled under the qui tam, or whistleblower, provisions of the False Claims Act, which
`permit private individuals to sue on behalf of the governmentfor false claims and to share in any recovery. Shieldswill
`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-million-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 | Departmentof Justice
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`This settlementillustrates the government’s emphasis on combating health care fraud and marks another achievement
`for the Health Care Fraud Prevention and Enforcement Action Team (HEAT)initiative, which was announcedin 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
`cooperation. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice
`Departmenthas recovered a total of more than $29.8 billion through False Claims Act cases, with more than $18.2
`billion of that amount recoveredin casesinvolving fraud against federal health care programs.
`
`The settlementis the result of a coordinated effort by the Civil Division’s Commercial Litigation Branch and the U.S.
`Attorney’s Office for the Northern District of California, with assistance from the HHS-OIG, the HHS Office of Counsel to
`the Inspector General, the HHS Office of the General Counsel-CMS Division, the FDA's Office Chief Counsel, the
`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
`Health Agency andthe National Association of Medicaid Fraud Control Units.
`
`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 determinationofliability.
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`
`Topic(s):
`False Claims Act
`Healthcare Fraud
`
`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-million-resolve-false-claims-act-allegations-relating-tarceva
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`APOTEX EX. 1065-002
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`APOTEX EX. 1065-002
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