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U.S. Supreme Court upholds Affordable Care Act: significant aspects of Affordable Care Act for generic pharmaceutical companies

Kelley Drye & Warren LLP
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USA
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June 29 2012

On June 28, 2012, the U.S. Supreme Court upheld the Patient Protection and Affordable Care Act (Pub. L. 111-148

Par files complaint against the Government claiming that FDA's off-label marketing regulations violate the First Amendment

Kelley Drye & Warren LLP
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USA
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October 27 2011

Par filed a Complaint for Declaratory and Injunctive Relief against the United States, the U.S. Food & Drug Administration (FDA), the Commissioner of the FDA, and the Secretary of the Department of Health & Human Services seeking a declaratory judgment that the application of FDA off-label marketing regulations to Par’s marketing of Magace ES violates the First Amendment

Relators run the risk that complaints in voluntarily dismissed cases may be unsealed

Kelley Drye & Warren LLP
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USA
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October 21 2011

Earlier this week we reported on a case in the U.S. District Court for the District of Columbia in which the court unsealed a relator's complaint after the relator voluntarily dismissed it, holding that "the rationale behind sealing FCA cases is to allow the United States ample time to investigate the allegations, and the FCA does not contain any language that suggests the purpose of sealing a case is to protect the relator’s identity.”

NJ appellate court holds that NJ False Claims Act cannot reach conduct occurring before March 2008

Kelley Drye & Warren LLP
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USA
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October 12 2011

The New Jersey Appellate Division for the Superior Court, Mercer County, recently held that the New Jersey False Claims Act, N.J.S.A. 2A:32C1 to 15 and N.J.S.A. 2A:32C17 to 18, which was enacted on January 1, 2008 and made effective on March 13, 2008, does not apply retroactively to allegedly false claims submitted prior to the statute’s effective date

Amgen seeks Supreme Court review of implied certification theory of liability under the False Claims Act

Kelley Drye & Warren LLP
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USA
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October 6 2011

The U.S. Courts of Appeals have been wrestling with the reach of the False Claims Act when the actual claim submitted to the government is not “factually false”

Court grants government's request to dismiss FCA case against defendants without deep pockets regarding off-label use of Celexa

Kelley Drye & Warren LLP
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USA
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July 14 2011

Relator, Linda Nicholson, brought a False Claims Act lawsuit against a retired psychologist, a non-profit shelter for adolescent children, and a family-owned pharmacy for allegedly submitting claims to Medicaid for the drug Celexa which were not eligible for reimbursement because the drug was allegedly intended for off-label use

Third Circuit Court of Appeals recognizes implied false certification theory of liability

Kelley Drye & Warren LLP
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USA
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July 13 2011

In a False Claims Act case against United Health Group and its subsidiaries, alleging violations of Medicare marketing regulations and the Anti-Kickback Statute, 42 U.S.C. 1320a-7b ("AKS"), the Third Circuit joined with the Second, Sixth, Ninth, Tenth, Eleventh, and District of Columbia Circuits in recognizing that there can be implied false certification liability under the FCA

Court in Southern District of New York dismisses relator's False Claims Act complaint because no law or regulation prohibited hospital's billing method

Kelley Drye & Warren LLP
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USA
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April 13 2011

A former independent consultant to Beth Israel Medical Center ("BIMC"), Cleuza Colucci, brought a False Claims Act action against the hospital, alleging that it billed for and received inflated Medicare payments by purchasing Kings Highway and Doctors Hospital and then taking advantage of rate increases resulting from consolidation with BIMC for purposes of billing Medicare

Georgia district court dismisses FCA claim based on a theory of promissory fraud

Kelley Drye & Warren LLP
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USA
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April 7 2011

After being fired as its CEO, Angela Parato filed a False Claims Act action against her former employer, Unadilla Health Care Center, Inc. (UnaHealth

District of Massachusetts court allows FCA action premised on violations of anti-kickback statute to continue

Kelley Drye & Warren LLP
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USA
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March 22 2011

Two relators, Bernard Lisitza and David Kammerer, filed separate False Claims Act qui tam actions against Johnson & Johnson, Ortho-McNeil-Janssen Pharmaceuticals, Inc., and Johnson & Johnson Health Care System (collectively, “J & J”

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