Health Law

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News & Analysis as of May 25, 2013

Two New Developments in First Amendment Challenges to Off-Label Promotion: What's Next?

by King & Spalding on 3/14/2013

Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more

Appeals Court Rejects Drug Company Executive’s First Amendment Defense and Upholds Wire Fraud Conviction

by King & Spalding on 3/14/2013

A three-judge panel of the U.S. Court of Appeals for the Ninth Circuit, in a recent unpublished opinion, upheld the conviction and sentencing of former InterMune, Inc. executive Scott Harkonen for wire fraud. In 2009, a jury...more

United States v. Caronia: Second Circuit Rules Manufacturers Cannot Be Criminally Prosecuted for Off-Label Promotion of Drugs...

by Fuerst Ittleman David & Joseph, PL on 12/17/2012

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a landmark decision in United States v. Caronia, holding that “the government cannot prosecute pharmaceutical manufacturers and their...more

Federal Court Vacates Conviction for Truthful Off-Label Promotion of FDA-Approved Drug

by Jiayan Chen, James S. Cohen, Glenn Engelmann | McDermott Will & Emery on 12/11/2012

In a highly significant decision that may have far-reaching implications for the U.S. Food and Drug Administration’s (FDA) regulatory approach to off-label drug promotion, the U.S. Court of Appeals for the Second Circuit...more

In ‘Bitter Pill,’ FDA Seizes Domain Names of Firms Selling Illegal Pharmaceuticals

by Jeff Ifrah on 10/8/2012

In an aggressive step against businesses selling drugs online, the U.S. Food and Drug Administration, in conjunction with the U.S. Department of Homeland Security, took legal action earlier this month against more than 4,100...more

D.C. Circuit Holds That Former Purdue Pharma Executives Who Pleaded Guilty to Misdemeanor Misbranding May Be Excluded From...

by Ropes & Gray LLP on 8/2/2012

On July 27, 2012, in Friedman et al. v. Sebelius, the United States Court of Appeals for the D.C. Circuit held that the Department of Health & Human Services may exclude from participation in federal health care programs...more

Abbott Labs to Pay $1.6 Billion to Settle Consumer Protection and Misbranding Claims

by Mintz Levin - Health Law on 5/8/2012

Abbott Laboratories (Abbott), an Illinois company, will pay over $1.6 billion in penalties to the federal government and several states related to its alleged illegal promotion of the prescription drug Depakote for off-label...more

Criminalizing Knowledge: The Perverse Implications for Off-Label Promotion Prosecutions of the "Intended Use" Regulations

by Greg Gentry on 8/1/2009

The article examines the "Catch-22" life-science manufacturers are placed in when they know of an off-label use for the products they manufacture. Off-label use is pervasive in the medical field, in fact, it is often...more

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