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Health care reform includes aggressive fraud initiative: HHS OIG, DoJ, and Congress ramp up enforcement and prevention efforts

Jones Day
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USA
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April 30 2010

Health care fraud and abuse enforcement has not escaped the health care reform sweeping the country

Federal agencies expand outreach and ramp up resources for health care enforcement

Jones Day
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USA
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April 21 2011

HHS and the Department of Justice (DOJ) have initiated several programs to enhance awareness of health care compliance requirements and enforcement efforts and to significantly increase the resources devoted to detecting fraud and abuse in the health care industry

Bill to address integrity and accountability is introduced

Jones Day
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USA
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April 21 2011

On March 2, 2011, Senator Chuck Grassley (R-Iowa) introduced a bill (S.454) containing several measures designed to address health care fraud (Strengthening Program Integrity and Accountability in Health Care Act of 2011

Former CEO sentenced to home detention and probation in off-label case; motions for new trial are denied

Jones Day
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USA
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April 21 2011

On April 13, 2011, the former CEO of InterMune, W. Scott Harkonen, was sentenced to three years of probation, six months of home detention (stayed pending appeal), and 200 hours of community service, and ordered to pay a $20,000 fine, based on his 2009 federal wire fraud conviction for creating and distributing a false and misleading press release related to an unapproved use of the drug Actimmune

Recent developments in FCA cases: filings, motions, settlements, and trial verdicts

Jones Day
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USA
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April 21 2011

Recent notable False Claims Act (FCA) cases involving participants in the health care industry include the following

Former CEO sentenced to one month imprisonment and ordered to pay $1.9 million

Jones Day
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USA
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April 21 2011

On March 10, 2011, the former CEO of K-V Pharmaceutical, Marc Hermelin, was sentenced to 30 days in prison after pleading guilty to two federal charges of misbranding drugs

Purdue executives appeal order upholding exclusion

Jones Day
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USA
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April 21 2011

On January 31, 2011, three former Purdue executives filed an appeal to challenge Judge Ellen Segal Huvelle's (D.D.C.) order upholding the HHS Secretary's decision to exclude them from participation in federal health care programs

Former in-house counsel with pharmaceutical company reindicted

Jones Day
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USA
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April 21 2011

On April 13, 2011, a federal grand jury in Maryland returned an indictment charging Lauren Stevens, formerly a vice president and associate general counsel for GlaxoSmithKline (GSK), with obstruction of justice and making false statements to the Food and Drug Administration (FDA) in connection with an investigation into allegations that the drug Wellbutrin had been marketed for unapproved uses

U.S. Supreme Court rules that a drug’s adverse event reports may be material to investors even though not "statistically significant"

Jones Day
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USA
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March 28 2011

On March 22, 2011, the U.S. Supreme Court issued its long-awaited opinion in Matrixx Initiatives, Inc. v. Siracusano (No. 09-1156

SEC alleges securities fraud by biopharmaceutical company and executives

Jones Day
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USA
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September 6 2011

On August 1, 2011, the SEC brought suit against Immunosyn Corporation, Argyll Biotechnologies LLC, and four executives, alleging that they had committed securities fraud related to misleading statements regarding the status of regulatory approvals during 200610

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