Constitutional Law Science, Computers & Technology Civil Remedies

Read Constitutional Law updates, alerts, news, and analysis from leading lawyers and law firms:
News & Analysis as of

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

Blog: Significant Court Decision Issued Today re: Off-Label Promotion

A highly anticipated decision was issued today in the U.S. District Court for the Southern District of New York in the case, Amarin Pharma Inc. et al. v. Food and Drug Administration et al. (case no. 1:15-cv-03588). See this...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

Federal Circuit Review | July 2015

Nunc Pro Tunc Assignments Insufficient To Confer Retroactive Standing - In ALPS SOUTH, LLC v. OHIO WILLOW WOOD CO., Appeal Nos. 2013-1452, 2013-1488, 2014-1147, and 2014-1426, the Federal Circuit reversed the denial of a...more

Barbarians at the Gate: Seventh Circuit Finds Article III Standing for Data Breach Class Actions

As a result of the Supreme Court’s decision in Clapper v. Amnesty Int’l USA, 133 S. Ct. 1138, 1147 (2013), data breach class actions were largely considered dead in the water. The overwhelming majority of courts, relying...more

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers...more

Amarin Pharma v. FDA – More Briefs Filed Regarding Off-Label Promotion And The First Amendment

Our prior posts looked at the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit, which raises issues regarding the First Amendment and how it applies to speech by drug and device manufacturers...more

Spokeo v. Robins: The Case That Has Silicon Valley Buzzing, Even Though Plaintiffs Likely Don’t Have a Leg To “Stand” On

On April 27, 2015, the United States Supreme Court granted certiorari in Spokeo v. Robins and will soon decide whether a plaintiff must allege more than just the bare violation of a federal statute in order to invoke Article...more

Court Dismisses Data Breach Class Complaint For Lack Of Standing - May 2015

On May 4, 2015, the U.S. District Court for the Eastern District of Louisiana held that a putative class plaintiff lacked standing to pursue claims against eBay Inc. (“eBay”) arising out of a data breach that occurred in...more

US District Court in Texas Finds Plaintiffs Lack Article III Standing in PHI Breach

Beverly Peters v. St. Joseph Services Corporation d/b/a St. Joseph Health Care System was a class action that arose out of a data breach of the defendant-health care service provider. It was alleged in the action that...more

Sandoz Was Disinvited to the Patent Dance: The Federal Circuit's First Interpretation of the BPCIA Will Have to Wait

Since the 1984 enactment of the Drug Price Competition and Patent Term Restoration Act, Hatch-Waxman litigation has dominated the sphere of life-sciences patent litigation. The battle between proprietary and generic...more

Federal Circuit’s Sandoz v. Amgen Decision Forecloses Early Declaratory Judgment Suits by Biosimilars Applicants

On December 5, in the closely watched Sandoz v. Amgen case, the Federal Circuit held that a biosimilars applicant cannot use the Declaratory Judgment Act to challenge a reference product sponsor's patent prior to filing a...more

Federal Circuit Rules Against Patent Declaratory Judgment Actions Before Biosimilar Application Is Filed

On December 5, 2014, the Federal Circuit issued its opinion in Sandoz Inc. v. Amgen Inc. et al. In a unanimous panel opinion (Judges Dyk, Taranto and Chen), the Court held that clinical trials initiated to support a possible...more

Food Litigation Newsletter - October 2014 #2

In This Issue: - RECENT SIGNIFICANT DEVELOPMENTS AND RULINGS ..Court rules that ‘Kosher’ suit poses religious question; dismisses with prejudice ..Settlement terms approved in stevia sweetener...more

California District Court Finds Threat of Future Harm Sufficient to Confer Article III Standing in Data Breach Action

In a departure from the mounting body of case law finding that the “increased risk of future harm” is insufficient to confer Article III standing on victims of a data breach, the U.S. District Court for the Northern District...more

States Have the Right to Protect Businesses Against NPEs

State of Vermont v. MPHJ Technology Investments, LLC; In re MPHJ Technology Investments, LLC - Addressing the issue of state efforts to reign in non-practicing entities, the U.S. Court of Appeals for the Federal...more

Mylan Pharms., Inc. v. FDA (N.D.W.V.)

Mylan filed a complaint on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application applicants. Mylan then filed a motion for...more

PissedConsumer.com SLAPPs Back

From the land of Wayne Newton and Brittney Spears comes news of an interesting lawsuit implicating the Nevada anti-SLAPP statute. Techdirt.com explains that the lawsuit, Opinion Corporation d/b/a PissedConsumer.com v. Nevada...more

Judicial Efficiencies and Economy Support Bifurcation of Liability and Damages at Trial

Endo Pharmaceuticals, Inc. v. Actavis, Inc., et al. Case Number: 1:12-cv-08985-TPG (Dkt.55) - Endo brought suit against Actavis, as well as over a dozen other pharmaceutical manufacturers, for allegedly...more

Health Data Breach Victims Have Standing to Sue Says WV Supreme Court

The most common defense against class actions for data breach has itself been breached in a ruling last week by the West Virginia Supreme Court....more

Complaint Filed Against HHS Alleges Medicare LCDs Deprive Beneficiaries of Necessary Clinical Laboratory Services

On April 18, 2014, California Clinical Laboratory Association (“CCLA”) and “Jane Doe” (collectively, “Plaintiffs”) filed a lawsuit against HHS for equitable relief in the United States District Court for the District of...more

Federal Circuit Review - StoneEagle, Vederi, and Ancora Technologies (April 2014)

Inventor Cannot Use Declaratory Judgment Jurisdiction - In StoneEagle Services, Inc. v. Gillman, Appeal No. 13-1248, the Federal Circuit vacated a declaratory judgment and remanded with instructions to dismiss based on...more

67 Results
|
View per page
Page: of 3

Follow Constitutional Law Updates on:

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×