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Reining In Overbroad Criminal Subpoenas – Is Some Relief In Sight?

In the wake of the national financial crisis, both the U.S. Department of Justice (“DOJ”) and the U.S. Securities and Exchange Commission (“SEC”) publicly committed themselves to enhanced enforcement of federal financial laws...more

White Collar Watch - March 2014

In This Issue: - SEC at odds with Siemens over whether whistleblower protections extend to employees who report wrongdoing directly to their companies - Fourth Circuit decision tolling False Claims Act statute...more

Do Laws Have An Expiration Date?

Last week, I wrote about a bill, AB 129, currently pending in the California legislature that would amend California Corporations Code Section 107. As I had pointed out in an even earlier post last May, that statute...more

What To Do When You Are Served With a Search Warrant

In recent years, state and federal law enforcement agencies continue to increase their investigation and prosecution of white collar crime, particularly relating to the securities and healthcare industries. The search warrant...more

Recent Cases of Interest to Regulators

Investigative Powers - Sazant v. College of Physicians and Surgeons of Ontario, 2013 CanLII 22324 (S.C.C.), dismissing leave to appeal of a decision in 2012 ONCA 727 - In Sazant, a physician faced both criminal...more

U.S. Supreme Court: Silence Admissible

When faced with questions from a government investigator, a person’s silence can now be used in a criminal trial against the person who was questioned and declined to provide an answer....more

The Supreme Court's Decision In Salinas v. Texas: Implications For White Collar Investigations

At the outset of a white collar investigation, counsel will invariably advise the client that if a government investigator unexpectedly appears seeking to “just ask a few questions,” the client should politely decline and...more

DOJ Files Briefs in Key 3rd Circuit Case on N.J. Sports Betting Law

On June 7, 2013, the U.S. Department of Justice (DOJ) as well as the four major professional sports leagues and the National Collegiate Athletic Association (NCAA) filed their briefs in the U.S. Court of Appeals for the Third...more

Religious Institutions Update: May 2013

Intellectual property is a legal construct referring to creations of the mind for which exclusive rights are recognized. Common types include copyrights, trademarks, patents, industrial design rights, trade dress and,...more

Caronia And The First Amendment Defense To Off-Label Marketing: A Six Month Re-Assessment

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

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

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

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

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

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

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

DOJ Plans to Intervene in N.J. Sports-Betting Case

The U.S. Department of Justice announced on January 22, 2013, that it plans to intervene in the lawsuit brought by the four major professional sports leagues and the NCAA challenging a New Jersey state law that legalized...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...

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

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

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

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

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

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

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

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

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"

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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