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First Amendment And Off-Label Promotion – Prosecute What I Do, Not What I Say

On December 3, 2012, the United States Court of Appeals for the Second Circuit vacated the conviction of Alfred Caronia (“Caronia”), who had been tried and convicted of participating in an unlawful conspiracy to introduce a...more

Court strikes down Illinois eavesdropping act, opens debate on privacy in the digital age

In two landmark rulings that may prompt further examination of how our laws identify and protect privacy interests, the Illinois Supreme Court has found unconstitutional Illinois’ long-standing electronic eavesdropping act....more

New Reprint Guidance Maintains Bipartisan Status Quo

On February 28, 2014, the FDA issued its most recent unofficial guidance on distribution by manufacturers of research concerning off-label uses. With minor textual revisions, this new Guidance essentially restates the safe...more

Health Reform + Related Health Policy News - January 2014, Issue 1

In This Issue: - Top News ..Congress Approves Budget Deal with Short-Term ‘Doc Fix' ..CMS “Two-Midnight” Rule delayed until March 31, 2014 ..Individuals with Canceled Insurance Policies May Apply for...more

Italy’s High Court Upholds Acquittal Of Google Executives In Video Privacy Case

On December 17, Italy’s highest court, the Italian Supreme Court of Cassation, issued a landmark ruling upholding the acquittal of three Google senior executives by the Milan Court of Appeals. Initially, an Italian trial...more

Supreme Court Requires Warrant to Search Computer Content

Background - In R. v. Vu, the property owner was criminally charged with production of marijuana, possession of marijuana for the purpose of trafficking and theft of electricity. The police had obtained a warrant...more

Supreme Court Of Canada To Police: Get A Warrant To Search Computers And Mobile Phones

Yesterday, the Supreme Court of Canada issued a unanimous decision in R. v. Vu recognizing important privacy interests in information stored in a computer or mobile phone. The court held that specific, prior judicial...more

On The Radar: Government Unmanned Aerial Vehicles And Their Effect On Public Privacy Interests From Fourth Amendment Jurisprudence...

The utility of Unmanned Aerial Vehicles (UAVs) in military operations and border security is well documented. As the technology becomes more affordable and available, domestic law enforcement agencies, other state and federal...more

BB&K Police Bulletin: Warrant to Search Electronic Records - Court Upholds Search of Computer and Storage Devices for Child...

Overview: The Ninth Circuit Court of Appeals recently found that probable cause supported a warrant authorizing the electronic search of computer equipment and digital storage devices belonging to a suspected child...more

D.A.R.E. to Market Off-Label Uses of Prescription Drugs? Make Sure You are in the Second Circuit: United States v. Caronia and the...

Truthful, non-misleading off-label promotion of prescription drugs is not illegal. At least, not in the Second Circuit. This, despite the billions of dollars in civil and criminal penalties assessed against pharmaceutical...more

FBI Hacking Into Electronic Devices: An Effective But Invasive Tool

Privacy and national security interests are notoriously tricky to balance. Lean too far one way, and you lose an important tool in preventing and detecting crime; lean too far the other way, and you are depriving Americans...more

BB&K Police Bulletin: GPS “Ping” - No Fourth Amendment Violation When GPS on Stolen Cell Phone Locates Thief

Overview: A California Appellate Court recently found no Fourth Amendment violation where police used the Global Positioning System (GPS) on a stolen cell phone to locate and detain the thief. The court reasoned that the...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

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

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

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

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

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

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

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

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?

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

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

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

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

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