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

The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...more

California Court Rules That Retailer Must Make Its Website Accessible For Users With Visual Disabilities Under the ADA

In a significant decision for all businesses that maintain an online presence, a California court recently ruled that a luggage retailer violated the Americans with Disabilities Act (“ADA”) and California state law by failing...more

Federal Court Issues $1 Million Contempt Award for Repeated Cell Phone Unlocking Misconduct

On March 18, United States District Judge Ursula Ungaro of the United States District Court for the Southern District of Florida entered an order against a Hong Kong-based company that was improperly distributing prohibited...more

Abstract Ideas Cannot be Permitted to Burden the "Basic Tools of Modern-Day Commercial and Social Interaction"

In a case originally filed in 2012, Judge Amy Totenberg granted Judgment on the Pleadings in favor of United Parcel Service, Inc. (“UPS”), and against Mobile Telecommunications Technologies, LLC (“MTel”), relating to U.S....more

When the cost of default is $1.2 million | World Trademark Review

In Neutron Depot, LLC v Bankrate Inc the US District Court for the Southern District of Texas entered judgment in plaintiff Neutron Depot’s favour, enjoining defendant Insurance Depot Marketing Corporation from any activity...more

Off-Label Enforcement Developments (Vascular Solutions, Inc. Acquittal and Amarin Settlement)

Two important cases involving the permissible scope of speech regarding off-label marketing recently resolved in ways that should bolster efforts by drug and device manufacturers to secure their First Amendment rights to make...more

Amarin Settles Off-Label Promotion Case Against the FDA

The Amarin settlement represents another important development in the FDA’s enforcement of off-label promotion. On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in...more

Amarin/FDA Settlement: A Significant First Amendment Victory for Off-Label Marketing

On March 8, 2016, Amarin Pharma, Inc. and FDA entered into a formal settlement, close to a year after the U.S. District Court for the Southern District of New York granted a preliminary injunction against FDA’s threats to...more

Amarin Pharma Settles First Amendment Claims Against FDA: Potential Implications

Irish drug company Amarin Pharma, Inc. (Amarin) and the U.S. Food and Drug Administration (FDA) agreed, on March 8, 2016, to settle claims that FDA regulations barring Amarin from making “truthful” and “non-misleading”...more

A Proposed End to “Amarin Pharm v. FDA” has FDA Agreeing to Abide by District Court’s Order

We have been closely following Amarin Pharm, Inc. v. FDA with respect to the preliminary injunction granted by the Southern District of New York that prohibited the FDA from taking action against Amarin over truthful,...more

Virtual Learning: The Scope of Preemption Under the California Uniform Trade Secrets Act

Companies seeking protection under the California Uniform Trade Secrets Act (“CUTSA”) should consider the effects of CUTSA preemption on their litigation strategy. Under the well-known Silvaco Data System v. Intel Corporation...more

Dialing-In: TCPA Hot Issues for 2016

The year 2015 saw a continued wave of class action filings under the Telephone Consumer Protection Act (TCPA). However, unsettled law continues to place a compliance burden on companies that communicate with consumers by...more

Ninth Circuit Poised to Address the “Without Authorization” Debate under the Computer Fraud and Abuse Action Again

Imagine if you could manage all of your social media platforms on one app. Believe it or not, there was an app for that (or, at least a website), created by a company named Power Ventures (“Power”). Back in 2008, Power...more

Mobile Apps Like Uber and Airbnb Raise Novel ADA Title III Issues

Last week, Buzzfeed reported that the United Spinal Association opposed Uber’s CEO’s nomination for Time Magazine’s Man of the Year award because Uber cars are allegedly not wheelchair accessible. This controversy raises an...more

Landmark Decision of German Federal Court of Justice on Blocking of Copyright-infringing Websites

On 26 November 2015, the German Federal Court of Justice ruled that Internet access providers (IAP) can be liable for copyright infringements on third parties’ websites and can thus be ordered to block access to such...more

TCPA Connect - September 2015

No Need to Wait for the U.S. Supreme Court—Seventh Circuit Rules on Mooting Offers in TCPA Suits - The latest court to weigh in on an offer of judgment in a Telephone Consumer Protection Act Suit: the Seventh Circuit...more

Blog: Trend Watch: First Amendment Challenges To FDA Promotional Requirements Continue

In the wake of Amarin Pharma’s victory in securing a preliminary injunction against the Food and Drug Administration’s (FDA) prohibition of off-label communication of Vacepa , Pacira Pharmaceuticals has filed a First...more

First Amarin Pharm v. FDA, Now Pacira Pharm, Inc. v. FDA

The Southern District of New York certainly is becoming a hotbed for issues relating to the FDA’s ability to take enforcement action against manufacturers who promote their FDA-regulated products for uses outside the approved...more

New Jersey Federal Baked Goods Fraud Class Actions Are Toast

On this date in 1901 (September 2nd), Teddy Roosevelt for the first time uttered in public the immortal phrase, "Speak softly and carry a big stick". It is hard to find people who do not admire that statement. It is harder...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

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 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

Advertising Law - July 2015 #4

FTC And Florida AG Team up Against Medical Alert Systems - Together with the Florida Attorney General, the Federal Trade Commission filed suit against Lifewatch for allegedly using deceptive robocalls to urge older...more

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