Constitutional Law Communications & Media Health

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Supreme Court Update: Zubik V. Burwell (14-1418) And Spokeo V. Robbins (13-339)

While a potential ninth justice made plans to give a high school commencement address, The Eight continued to demonstrate that, without a full complement of justices, this may be the Term Without Blockbusters. (Although, with...more

Anti-SLAPP Statute Raised in Planned Parenthood Protest Lawsuit

The DC anti-SLAPP statute has been invoked in a Superior Court lawsuit in which plaintiffs arguing that students need to be free from disruptions in the school environment are facing off against anti-abortion protestors....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

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

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 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

EXPECT FOCUS: Onboard Technology, NAIC Cybersecurity, DOL, ACA Litigation, SEC Regulation (Vol. III, Summer 2015)

In This Issue: IN THE SPOTLIGHT - - Your Data Breach Collided With My Personal Injury Coverage LIFE INSURANCE - - Phantom Injury Dooms “Shadow Insurance” Case - Latest NAIC Cybersecurity News...more

FDA Regulatory and Compliance Monthly Recap — September 2015

Pacira sues FDA, alleging it illegally attempted to restrict truthful and non-misleading speech about its post-surgery pain drug Exparel - The drugmaker filed a First Amendment suit seeking an injunction to prevent the...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...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

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

Two Federal Circuit Courts Weigh In Ahead of Gomez

Just two months before the U.S. Supreme Court hears argument in Campbell-Ewald Co. v. Gomez, two federal circuit court panels have ruled on jurisdictional issues presented in the case. Both the Seventh Circuit in Chapman v....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

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

Blog: Case to Watch: Amarin Pharma v. FDA

A potentially significant case being watched by the pharmaceutical industry is Amarin Pharma, et al., v. U.S. Food and Drug Administration, et al., Civ. A. 15-cv-3588 (S.D.N.Y.). The complaint, filed in May 2015, is a “First...more

"Defamation Claims Brought by Texas Health Care Providers Will Be Subject to Anti-SLAPP Act Requirements"

Health care providers should keep in mind that virtually any suit alleging defamation or other harm from a “communication” relating to the provision of services by a health care professional will be subject to the demanding...more

AZ Supreme Court Holds AZ Legislators Have Standing to Challenge AZ Law, But Media Mischaracterizing the Lawsuit

It seems that the media have become so accustomed to polarizing the topic of Medicaid expansion that reporters seem incapable of truly assessing the issues objectively and reporting accordingly. This has happened recently...more

What’s Next for the FDA’s Draft Social Media Guidances?

As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on...more

Status Updates - October 2014 #8

..Doctor in the mouse. What if you could input a list of your current symptoms to Google, and quickly be connected with a doctor for a brief consultation? For a limited trial period, Google seems to have set up such a system...more

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

Status Updates - June 2014 #4

..Are threats made on social media protected free speech, or potentially criminal acts? The U.S. Supreme Court has agreed to examine the constitutionality of a federal law making it a crime to transmit communications...more

FDA Issues Distribution of Risk Information Draft Guidance Amid Asserted Push to Release Guidance on Manufacturer Communications

The U.S. Food and Drug Administration (FDA or the Agency) issued the June 6, 2014, draft guidance (Draft Guidance) in response to stakeholder inquiries into the Agency’s views on disseminating new scientific or medical...more

FDA Issues Draft Guidance Relating to Distribution of New Risk Information for Approved Drugs and Biologics and Grants Two Citizen...

On June 6, 2014, the Food and Drug Administration (“FDA”) issued two documents that reflect the agency’s ongoing effort to clarify its regulatory approach regarding manufacturer communication of scientific and medical...more

Drug Quality and Security Act Creates New Laws for Compounding Pharmacies

On November 27, 2013, the Drug Quality and Security Act was signed into law. This new law provides clarity to the existing pharmacy compounding laws within Section 503A of the Food, Drug & Cosmetic Act (FDCA) and creates new...more

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