Science, Computers & Technology Communications & Media Constitutional Law

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Status Updates: Appeals court upholds anti-cyberbullying law; better marketing through neural networks; restaurant owner turns the...

Cruel intentions. Laws seeking to regulate speech on the Internet must be narrowly drafted to avoid running afoul of the First Amendment, and limiting such a law’s applicability to intentional attempts to cause damage usually...more

Batting Down Generic Plaintiffs’ Amarin Hail Mary Pass

We received a couple of odd anonymous comments to our “breaking news” post about the Amarin First Amendment victory for truthful off-label promotion. Both of them raised the same suggestion: “Does the logic of this opinion...more

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs

The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more

Newest FDA Newsletter from AGG

Once a month, AGG’s terrific FDA team publishes a newsletter updating readers on the latest regulatory news affecting food/drug companies–including those from Ireland and Northern Ireland. The August newsletter is here and...more

Another One Bites the Dust: FDA Doesn’t Like the Fishy Smell of the Latest Court Decision on Off-Label Dissemination

In the most recent court decision, Amarin Pharma, Inc. v. United States Food and Drug Administration, No. 15 Civ. 3588 (PAE) (S.D. N.Y. August 5, 2015), a U.S. District Court granted Amarin's preliminary injunction to...more

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more

One Small Step for Amarin & One Giant Leap for Pharmaceutical Companies? - Only Time Will Tell

Friday’s ruling in Amarin Pharma, Inc. v. United States Food & Drug Administration is a monumental event. It signals the dawn of a new era for prescription drug promotion....more

What Comes Next In Amarin Pharm v. FDA?

The Southern District of New York’s preliminary injunction in Amarin Pharm, Inc. v. FDA—prohibiting the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug...more

Practical Implications from Amarin

Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...more

Amarin Wins Truthful Off-Label Speech Challenge

On August 7, Citing the First Amendment, a Southern District of New York court ruled that FDA cannot limit a manufacturer’s “truthful and non-misleading speech promoting off-label use” of a drug and evaluated specific...more

Northern District of California Requires A Warrant to Access Cellphone Geographic Information

We previously reported that government access to cellphone geographic information or CSLI without a warrant has become a vigorous debate between the government, defense attorneys, and the federal bench. In a lengthy opinion,...more

Amarin Obtains Preliminary Injunction Against FDA Regarding Off-Label and First Amendment Issues

In our prior posts about Amarin Pharma, Inc. v. FDA, we wondered what the Southern District of New York would make of Amarin’s request for an order prohibiting the FDA from taking enforcement actions against it over speech...more

Federal Court Grants First Amendment Injunction in Amarin Case

Federal Court Grants Requested Injunction in Amarin: Confirms Caronia Stands for Proposition that “the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the...more

Breaking News - Amarin Hits First Amendment Home Run Off FDA

Here’s a copy of today’s 71-page decision in Amarin Pharma, Inc v. FDA, No. 15 Civ. 3588 (PAE), slip op. (S.D.N.Y. Aug.7, 2015), in which the court granted a First Amendment-related injunction against the FDA’s prohibition...more

Warrantless access to cell phone location data may be heard by the Supreme Court

A number of courts have considered whether the Fourth Amendment requires the government to obtain a warrant to access historical and/or real time cell phone geographic location information, known as CSLI. CSLI is cell site...more

4th Circuit holds that obtaining cellphone location information without a warrant is unconstitutional

We have been watching the warrantless search cases closely. Yesterday, (August 5, 2015), the Fourth Circuit Court of Appeals held that it was unconstitutional when law enforcement used their cell phone location information...more

California Bill Requiring Mobile, Cloud Search Warrants Advances

On July 14, 2015, the California Electronic Communications Privacy Act (“Cal-ECPA”) unanimously passed the California State Assembly’s public safety committee. The bill would forbid warrantless cellular “stingrays” as well...more

Change in the Prevailing Winds in Consumer Data Breach Cases?

Seventh Circuit Rules Consumers Have Standing to Sue in Neiman Marcus Payment Card Data Breach Case - In Remijas v. Neiman Marcus Group, LLC, the Seventh Circuit reversed a district court decision dismissing consumer...more

Social media campaign ends in disbarment for lawyer

Lawyers using social media: beware! The Louisiana Supreme Court has disbarred a lawyer for launching a “viral campaign to influence and intimidate” judges who presided over her friend’s child custody dispute. In...more

Rand Paul And The Expiration Of The Patriot Act

During the last weekend in May, Kentucky Senator Rand Paul did something that is not easy to do – he managed to anger most Republicans and Democrats, the Senate Majority Leader (who is also the senior senator from Kentucky),...more

"City of Chicago Expands Tax Reach to Internet Services"

On June 9, 2015, the city of Chicago released two rulings that significantly expand the city’s 9 percent gross receipt tax to charges for cloud computing and other services delivered over the Internet. The first ruling (City...more

SCOTUS Decision in Spokeo Could Have Significant Impact on Data Breach Litigation

Following several significant data breaches in 2014 and 2015, including one reported just last week by the IRS, organizations of all types are on high alert to safeguard against data breaches and to prepare incident response...more

Do You Have The Right To Be Forgotten?

Most of us want to be remembered. But, depending on their past, some people want to be forgotten – or at least they want some of their past deeds to be forgotten. But do you have a right to be forgotten? In the United States,...more

Evening The Score On Off-Label Use Information

Two stories in 360 yesterday – the timing was pure coincidence – have us thinking again about the FDA’s muddled and increasingly untenable position on truthful off-label “promotion” – broadly defined as any accurate...more

Are You Ready for the Attack? Online Brand and Reputation Protection

It starts with an inaccurate, possibly fake, online review. Then a post appears on a consumer complaint forum. Suddenly, there is a surge of false postings about your company on social media sites. Invariably, these anonymous...more

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