Criminal Law, Constitutional Law, Science, Computers & Technology

California Moves One Step Closer to Passing Privacy Bill Requiring a Search Warrant for Providers' Customers' Emails

by Amy L. Pierce | Pillsbury Social Media, Entertainment &... on 5/17/2013

In a 33-1 vote, on May 13, the state Senate approved Senator Mark Leno's bill that would require state law enforcement officials to obtain a search warrant before asking service providers to disclose the contents of their...more

The First Amendment and Off-Label Promotion: United States v. Caronia

by Quinn Emanuel Urquhart & Sullivan, LLP on 4/11/2013

For years, the U.S. Department of Justice has aggressively pursued and brought charges over “off-label promotions”—the promotion of drugs for uses that have not received FDA approval—by pharmaceutical manufacturers and their...more

Cyber Law Tracker: FBI Prohibited From Issuing National Security Letters

by Steven J. Bonafonte, Alex Hernandez, Timothy Ronan, James Shearin | Pullman & Comley, LLC on 4/3/2013

In a detailed opinion issued just this month, the U.S. District Court for the Northern District of California struck down an oft-used FBI counterterrorism tool. Under the statute at issue, the FBI has issued tens of...more

Bills on Use of Mobile-Device-Location Data Reintroduced

by Brad Guyton | Davis Wright Tremaine LLP on 3/26/2013

Updating our entry on this issue posted during the last Congress, on March 21, 2013, lawmakers in the House and Senate reintroduced companion bills intended to curb government use of mobile users’ geolocation data. The...more

Bill Introduced On Warrantless GPS Tracking

by Dennis Olle, Pedro Pavon | Carlton Fields on 3/26/2013

On March 21, a bipartisan group of legislators in the House of Representatives introduced a new bill, the Geolocation Privacy and Surveillance Act, which would force law enforcement to obtain a warrant to track suspects with...more

Court Upholds Executive’s Conviction Stemming from Off-Label Drug Promotion

by Christopher R. Hall, Gregory G. Schwab | Saul Ewing LLP on 3/25/2013

The U.S. Court of Appeals for the Ninth Circuit has upheld the wire fraud and misbranding convictions and sentence of InterMune Inc. founder W. Scott Harkonen. United States v. Harkonen, No. 11-10209 (9th Cir. March 4, 2013)....more

White Collar Watch - March 2013

by Andrea P. Brockway, Brett S. Covington, Christopher R. Hall, Nicholas J. Nastasi, Gregory G. Schwab, Brian Simons, Matthew Smith | Saul Ewing LLP on 3/22/2013

In This Issue: - Eleventh Circuit Holds that Production of Foreign Bank Account Records May be Compelled in Criminal Investigation Under Required Records Exception to Fifth Amendment Privilege - Supreme Court...more

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

Ninth Circuit Affirms Prosecution for Off-label Marketing

by Lane Powell PC - White Collar Criminal... on 3/13/2013

Over the past two years, courts began to recognize that at least some off-label marketing is protected lawful commercial speech under the First Amendment. Specifically, the Second Circuit in New York in a case called United...more

Ninth Circuit Affirms Conviction in Harkonen, Rejects the Defendant’s “Off-Label” First Amendment Challenge

by Vernon Francis, Thomas Lee | Dechert LLP on 3/13/2013

On March 4, 2013, a panel of the United States Court of Appeals for the Ninth Circuit issued its opinion in United States v. Harkonen,1 a case in which the CEO of a pharmaceutical company was prosecuted for transmitting...more

Casinos Go Virtual

by Peter Hahn | Pillsbury Social Media, Entertainment &... on 3/12/2013

In late February 2013 the New Jersey Legislature passed legislation allowing on-line wagering, subject to certain limitations. This legislation was signed into law by Governor Chris Christie. Under the new law, licensed...more

Ninth Circuit Off-Label Marketing Decision Suggests More Prosecutions Will Be Coming

by David Douglass | Sheppard Mullin Richter & Hampton LLP on 3/8/2013

The Ninth Circuit has reopened a door for off-label marketing prosecutions, and it is important to review your compliance and risk management programs in light of this recent decision. Last December, the pharmaceutical and...more

False Press Release Leads To Exclusion From Federal Programs

by Robert Rose | Sheppard Mullin Richter & Hampton LLP on 2/20/2013

Dr. Harkonen was the CEO of InterMune, Inc, a pharmaceutical company that developed, marketed and sold drugs for lung and liver diseases, including Actimmune. In 2002, the FDA had approved Actimmune to treat only two...more

A Charter Right to Search Google?

by Martin P.J. Kratz Q.C. | Bennett Jones LLP on 2/13/2013

The Internet has transformed society in so many ways. Even the ways we find information and the sources we rely upon have been fundamentally transformed. It appears our legal systems need to adapt to this new...more

Second Circuit Vacates Pharmaceutical Misbranding Conviction on Free Speech Grounds

by John L. Brownlee, William F. Gould, Timothy J. Taylor | Holland & Knight LLP on 2/1/2013

After two years of deliberation, the U.S. Second Circuit Court of Appeals has finally issued its decision in United States v. Caronia, holding that the government cannot prosecute pharmaceutical manufacturers or their...more

Court Finds State Ban on Sex Offenders’ Use of Social Media Tramples Speech Rights

by Jeff Ifrah on 1/25/2013

In a January 23, 2013, ruling, the U.S. Court of Appeals for the 7th Circuit held that an Indiana law that prohibited most registered sex offenders from using social media websites was unconstitutional because it was “not...more

Second Circuit Declares Off-Label Promotion Ban Unconstitutional: Implications for False Claims Act Defendants

by Aileen Mcgill | Patterson Belknap Webb & Tyler LLP on 1/17/2013

On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from...more

Telling People They Can Use A Drug In A Way Different Than How The FDA Says They Can Use A Drug Is Not A Crime, Says the Second...

by Matthew G. Kaiser | The Kaiser Law Firm PLLC on 1/3/2013

Alfred Caronia was a sales rep for a pharmaceutical company. And, despite what you might think by reading some of the literature, being a pharmaceutical sales rep is not a crime. It's even more emphatically not a crime after...more

Second Circuit Vacates Off-Label Promotion Conviction on First Amendment Grounds in U.S. v. Caronia

by King & Spalding on 12/22/2012

On December 3, 2012, a panel of three judges on the U.S. Court of Appeals for the Second Circuit overturned the November 2009 conviction of Alfred Caronia for conspiracy to introduce a misbranded drug into interstate commerce...more

Off-Label Marketing Questioned as a Viable Criminal Theory – But Stay Tuned

by Jeffrey L. Bornstein, Michael R. Gordon, Leanne E. Hartmann, Michael H. Hinckle, Steven M. Kowal, Megan C. Lambert, Suzan Onel, Michael D. Ricciuti, Mark A. Rush, Paul W. Shaw | K&L Gates LLP on 12/17/2012

On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...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

Second Circuit Rules That Certain Speech Regarding the Off-Label Use of Drugs Is Protected Under the U.S. Constitution

by Stuart M. Gerson, David C. Gibbons, Wendy C. Goldstein, Daniel G. Gottlieb, Benjamin S. Martin, Natasha F. Thoren | Epstein Becker & Green, P.C. on 12/13/2012

In a long-awaited decision, on December 3, 2012, a divided panel (2–1) of the U.S. Court of Appeals for the Second Circuit vacated the conviction of Alfred Caronia, a former pharmaceutical sales representative for Jazz...more

Short Wins - Off-Label Drug Use And the First Amendment In The Second Circuit; Machine Guns And Grenades In The Eighth Circuit

by The Kaiser Law Firm PLLC on 12/12/2012

It's an odd week for wins in the federal appellate courts. The Second Circuit ruled that the First Amendment protects (some kinds of) promotional activity for off-label use of drugs. Any time the First Amendment is...more

Does Misdemeanor Misbranding Survive Caronia?

by Jonathan Sack | Morvillo Abramowitz Grand Iason & Anello P.C.... on 12/11/2012

The Court of Appeals for the Second Circuit sent shockwaves through the pharmaceutical industry with its decision in United States v. Caronia. Alfred Caronia was a pharmaceutical sales representative convicted of a...more

Court’s Ruling about Off-Label Drug Promotion Defies Reason

by Patrick Malone & Associates P.C. | DC Injury... on 12/10/2012

Last week a federal appeals court made a ruling that chips away at a fundamental aspect of the FDA's gatekeeping function with new drugs. The court tossed a conviction of a drug sales representative who was promoting drugs...more

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