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When the Second Circuit issued its December 3, 2012 decision in United States v. Caronia, the opinion was proclaimed by many to signal a sea change in the prosecution of off-label promotion....more
On May 6, 2013, the United States Senate passed the Marketplace Fairness Act of 2013 (the "Act") by a vote of 69 to 27. The legislation (S. 743) now moves to the House of Representatives for consideration....more
Our preview of the oral arguments at the Illinois Supreme Court during the May term concludes with Performance Marketing Association, Inc. v. Hamer. PMA will be heard by the Court during the 9:00 a.m. session on Thursday, May...more
In a March 28, 2013 decision, New York’s highest state court, the New York State Court of Appeals, held that New York’s “click-through” nexus statute, Tax Law § 1101 (b)(8)(vi), does not violate the United States Constitution...more
Much attention has been paid to the Marketplace Fairness Act currently under consideration in Congress. Understandably, that coverage has focused on whether the bill, which would permit states to require out-of-state...more
On March 28, 2013, the Court of Appeals, New York’s highest court, issued a decision in Overstock.com, Inc. & Amazon.com, LLC, et al., holding that New York’s “click-through nexus” statute does not violate the Commerce Clause...more
On April 5, 2013, Judge Edward R. Korman of the United States District Court for the Eastern District of New York found that the Secretary of Health and Human Service’s (“HHS”) decision to limit over-the-counter (“OTC”)...more
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
On March 28, 2013, in Overstock.com, LLC v. New York State Dept. of Taxation and Finance, the New York Court of Appeals, New York's highest court, upheld the New York State "click-through nexus" statute against a challenge...more
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
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
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
Recently, the Third Circuit reexamined the test for antitrust standing in Ethypharm S. A. France v. Abbott Laboratories. The importance of the opinion, however, lies not just in the court’s affirmation of the multifactor test...more
Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more
In this presentation: - Internet Selling - Internet Buying - Nexus - Sales and Use Tax Audits - Conference Hosting Please see full presentation below for more information....more
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
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
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
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
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
The U.S. Court of Appeals for the 2nd Circuit upheld a First Amendment challenge to the federal prosecution of pharmaceutical salesperson Alfred Caronia for off-label marketing, http://www.ca2.uscourts.gov/decisions. Given...more
A recent decision by the U.S. Court of Appeals for the Second Circuit may significantly curtail enforcement efforts relating to the so-called “off-label” use of drugs approved by the Food and Drug Administration for specific...more
The US Court of Appeals for the Second Circuit, in a decision issued on December 3, 2012, in United States v. Caronia, threw out a criminal conviction of the defendant Alfred Caronia, a pharmaceutical sales person, for an...more
The Second Circuit, New York’s federal court of appeals, this week issued its long-awaited decision in United States v. Caronia and vacated the conviction of a pharmaceutical sales representative for off-label promotion. In a...more
In a much-anticipated opinion, the U.S. Court of Appeals for the Second Circuit vacated and remanded the conviction of Alfred Caronia, a former pharmaceutical sales representative convicted of conspiring to introduce a...more
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