Communications & Media Science, Computers & Technology Constitutional Law

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U.S. Supreme Court Proposes Change to Rules Applicable to Searches of Electronic Data

The United States Supreme Court — which establishes rules of civil and criminal procedure, subject to the objection of Congress — has proposed a significant amendment to the rules applicable to searches of electronic data...more

Government Access to Private Data: Microsoft Opens a New Front in the Battle for Consumer Privacy

Prior to the Information Age, sensitive papers were stored in file cabinets and drawers. When home computers arrived, information was digitized and moved to hard drives or other electronic media, still possessed by the user....more

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

Will Big Pharma’s free speech rights trump FDA, regulatory safety?

Recent developments in the law may have opened a new path for drug makers to exercise corporate free speech rights in ways that don’t look healthy for consumers. The case that concerns health watchdogs started when...more

FDA and Amarin Pharma Reach Milestone Settlement Allowing Off-Label Drug Promotion

A milestone Settlement Agreement was reached March 8, 2016 between the Food and Drug Administration and Amarin Pharma, Inc. that expressly allows Amarin to promote its drug product, Vascepa®, for unapproved – i.e.,...more

Examining The Amarin/FDA Off-Label Promotion Settlement

A lot of firms have already expended a lot of ink discussing the proposed memorandum of settlement filed on March 8, 2016 in Amarin Pharma’s First Amendment litigation against the FDA We’ll try not to be repetitive of what...more

Apple Argues It Should Not Be Compelled to Write Software for the F.B.I.

On February 16, 2016, Magistrate Judge Sheri Pym in the United States District Court for the Central District of California issued an order compelling Apple, Inc. to provide technical assistance to the F.B.I. so it can access...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

The Law Behind the Apple vs. FBI iPhone Unlocking Debate

By now, you have probably read about how the FBI is asking Apple to create software that would help the FBI unlock the iPhone of one of the deceased San Bernadino attackers. You have probably heard the talking heads scream...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

FDA and Amarin Reach Settlement on First Amendment and Off-Label Statements

FDA agrees to allow truthful and non-misleading off-label promotion. On March 8, the US District Court for the Southern District of New York approved settlement terms in connection with Amarin Pharma, Inc., et al. v....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

Amarin and FDA Reach Settlement Agreement in Off-Label Speech/First Amendment Case

On March 8, 2016, Amarin Pharmaceuticals, Inc. (“Amarin”) and the Food and Drug Administration (“FDA” or the “Agency”) reached a settlement agreement in a closely followed case involving Amarin’s First Amendment rights to...more

Federal Court Orders Apple to Unlock San Bernardino Gunman’s Phone

Apple must help the FBI unlock an iPhone used by one of the attackers in the San Bernardino, Calif. assault in December, a federal magistrate judge ruled this week. The ruling handed the government an important victory in an...more

2015 IP Law Year In Review

Commil USA, LLC v. Cisco Systems, Inc., 135 S. Ct. 1920 (May 26, 2015) - ..Does a defendant’s belief that a patent is invalid serve as a defense to charges of inducing infringement? NO - ..Inducement requires...more

DOJ Acknowledges in Proposed Jury Instructions That Dissemination of Truthful and Non-Misleading Off-Label Use Information Is Not...

For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...more

Latest First Amendment Off-Label Notes - Has DoJ Finally Come Around?

As we mentioned before (when we provided a discount) Bexis spoke earlier this week at the ACI Promotional Review Summit on the “Brave New World . . . Post-Amarin” – that is to say, about the First Amendment and off-label...more

A New Year’s Resolution: Avoid The Rising Tide of Defamation Claims In The Health Care Arena

In college and graduate school, we all had professors that had “non-attribution/academic freedom” policies designed to foster open debate, critical thinking and robust discussion. To state the obvious, we are a long way from...more

Lessons from Latham & Watkins’ Representation of Pacira Pharmaceuticals In Ground-Breaking Settlement with FDA

FDA rescinds warning letter and admits to incorrect interpretation of drug’s labelling. What can the life sciences industry learn? On December 15, 2015, Pacira Pharmaceuticals, Inc. (Pacira) announced that the US Food &...more

Top Posts of 2015

In descending order, here were the top posts from 2015. #7 Will Net Neutrality Kill the Internet 3.0? In February, the FCC passed the net neutrality rules. This seems like one of those issues, like most, that seemed...more

Poetic Justice – 2015 Wrap Up (Part 1 of 2)

This is the time of year to anxiously look forward to all that is anticipated to come in 2016. But it is also the time to look back at all that has happened in 2015. Rather than simply give you links to all of my stimulating...more

New Settlement Highlights FDA’s Diminishing Power Over Off-Label Promotion

In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) announced that they have settled their dispute regarding the off-label promotion of Exparel, one of Pacira’s anesthetic...more

Breaking News – Pacira First Amendment Case Settles

We learned about it yesterday from a reporter, but were sworn to secrecy until today. Pacira Pharmaceuticals and the FDA settled their litigation with Pacira getting essentially everything it wanted – what the company calls...more

When They Don’t Have Anything, They’ll Try Anything

The rumblings began shortly after the industry First Amendment victory over the FDA in Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015). A couple of anonymous, obviously plaintiff-side,...more

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