Science, Computers & Technology, Commercial Law & Contracts, Constitutional Law

Marketplace Fairness Act of 2013 Passes United States Senate

by Stanley Kaminski, Carolyn Sprinchorn | Duane Morris LLP on 5/9/2013

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

Are "Click-Through" Internet Marketing Tax Laws Constitutional?

by Kirk Jenkins | Sedgwick LLP on 5/2/2013

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

Online Sales Taxes Emerging as New York Court of Appeals Shoots Down Overstock and Amazon’s Constitutional Objections

by Fuerst Ittleman David & Joseph, PL on 5/2/2013

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

Proposed E-Commerce Taxation Bill Might be Unconstitutional

by Michael Abate | Dinsmore & Shohl LLP on 4/26/2013

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

E-Commerce Providers Take Note: New York’s Highest Court Upholds “Amazon” Sales Tax Statute

by Hollis L. Hyans, Irwin M. Slomka | Morrison Foerster - Social Media on 4/25/2013

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

Federal Court Orders FDA to Approve OTC Sales of “Morning-After Pill,” Finds Current Age and Point-of-Sale Restrictions to be...

by Fuerst Ittleman David & Joseph, PL on 4/11/2013

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

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

Spotlight on SALT: New York Court of Appeals Upholds the State's "Click-Through Nexus" Statute

by Baker, Donelson, Bearman, Caldwell &... on 4/8/2013

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

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

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

A Cure For Antitrust Standing?

by Deirdre McInerney, Barbara Sicalides | Pepper Hamilton LLP on 3/7/2013

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

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

by Donald Zuhn | McDonnell Boehnen Hulbert & Berghoff LLP on 3/7/2013

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

Sales and Use Tax for Nonprofits: Updates & Expectations for 2013

by Walter R. Calvert, Tammara F. Langlieb, Jeffrey S. Tenenbaum | Venable LLP on 1/8/2013

In this presentation: - Internet Selling - Internet Buying - Nexus - Sales and Use Tax Audits - Conference Hosting Please see full presentation below for more information....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

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

Off Label Marketing – First Amendment Challenge Ruling

by Ellyn L. Sternfield | Mintz Levin - Health Law on 12/6/2012

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

‘Off-Label’ FDA Cases Can Run Afoul of First Amendment, Appeals Court Holds

by Jeff Ifrah on 12/6/2012

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

Second Circuit Rules Off-Label Prosecution Violates First Amendment

by Michael Volkov on 12/6/2012

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

Second Circuit Vacates Conviction Against Sales Representative for Off-Label Promotion

by Ara Beth Gershengorn | Foley Hoag LLP on 12/5/2012

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

"Second Circuit Vacates Conviction Based on Off-Label Promotion, Deals Blow to Government Theory in Drug Marketing Cases"

by John T. Bentivoglio, Jennifer L. Bragg, David B. Leland, Michael K. Loucks, Gregory M. Luce | Skadden, Arps, Slate, Meagher & Flom LLP on 12/5/2012

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

Second Circuit Holds First Amendment Bars Conviction Based Solely on Off-Label Promotion of FDA-Approved Drug

by Ropes & Gray LLP on 12/4/2012

In its long-awaited decision in United States v. Caronia, the Second Circuit ruled today that the First Amendment bars the criminal prosecution of pharmaceutical manufacturers or their sales representatives for truthful,...more

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Science, Computers & Technology › Commercial Law & Contracts › Constitutional Law