Administrative Agency Communications & Media

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Summary of Recent Precedential Trademark Trial and Appeal Board Decisions

From June through August 2015, the Trademark Trial & Appeal Board issued eleven precedential decisions. Over the course of the upcoming weeks, we are briefly summarizing each opinion and a “take away” for brand owners and...more

The FDA Takes the Kardashian Endorsement Machine to Task

When Kim Kardashian speaks, the FDA listens. Or, more precisely, when Kardashian, who has 46.8 million followers on Instagram, posts an enthusiastic endorsement—and advertisement—on the social media platform for Diclegis, a...more

Federal Court Nixes City’s Attempt to Use Copyright Law to Curtail Critic’s Speech on YouTube

A California city cannot hold one of its citizens liable for copyright infringement for using clips of city council meetings in his critical YouTube videos, a federal judge has ruled. The August 20, 2015 order in City of...more

Health Care and Life Sciences Practice Newsletter

Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business - An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...more

First FDA FSMA Rules Have Landed; More Likely to Follow by End of Year

Earlier today, FDA finalized the first set of major rules implementing the Food Safety Modernization Act (FSMA) – regulations addressing current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive...more

Two Additional Challenges to the FCC’s July 2015 Declaratory Ruling and Order

As anticipated, additional parties continue to join the consolidated appeal of the FCC’s July 10, 2015 Declaratory Ruling and Order. On August 26, 2015, inc. and its wholly-owned subsidiary ExactTarget, Inc....more

Work-Related Text Messages on Personal Cell Phones Are Public Records Says WA Supreme Court

From Washington, D.C. to Washington state, the manner in which government officials and employees create and store business records is making headlines. The latest development is a unanimous decision of the Washington Supreme...more

Washington Supreme Court Applies Public Records Act to Public Employees’ Private Cell Phones

On August 27, the Washington Supreme Court unanimously held in Nissen v. Pierce County that text messages sent or received by a public employee in his or her official capacity are public records within the meaning of the...more

For the First Time, FCC Will Collect Regulatory Fees from Companies That Manage Multiple Toll Free Numbers

Last year, the FCC announced that it would begin collecting FCC Regulatory Fees from a new class of contributors – "Responsible Organizations" or "RespOrgs." Carrier-affiliated RespOrgs already are subject to FCC regulation,...more

Food Litigation Newsletter - August 2015

This Newsletter Aims to keep those in the food industry up to speed on developments in food labeling and nutritional content litigation. RECENT SIGNIFICANT RULINGS - Class Certification Denied In Popcorners “All...more

Ninth Circuit Addresses Preemption in Recent Labeling Cases

The Ninth Circuit Court of Appeals recently addressed preemption in the context of food and cosmetic labeling. Food Manufacturers Can Label Honey as “Honey” - In June, the Ninth Circuit issued an opinion in Brod v....more

FDA is “Keeping up with Kardashians’” Social Media Posts

On August 7, 2015, the FDA sent a warning letter to drug maker, Duchesnay, over Kim Kardashian’s endorsement of its pills for morning-sickness. Kardashian had made an Instagram and Facebook post which vouched for the...more

Off-Label Marketing and the False Claims Act

In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided...more

Life Sciences Companies and Free %$&*@# Speech

Irish and NI life sciences companies operating in the US likely are familiar with the concept of “off-label” promotion–providing information about drug/device uses that have not been cleared by the FDA (even where the FDA has...more

FDA Update: New guidance released on mobile medical devices, medical devices data systems

Mobile devices, including cell phones and tablets, have had a major impact on the practice of medicine, how patients interact with their doctors, receive or implement treatments, as well as how software developers view the...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

CodeBroker, LLC Files Additional Challenge to the FCC’s July 2015 Declaratory Ruling and Order

On August 14, 2015, CodeBroker, LLC (“CodeBroker”) filed a petition for review of the FCC’s July 10, 2015 Declaratory Ruling and Order with the United States Court of Appeals for the District of Columbia Circuit....more

DirecTV’s Rob Lowe Ads Found to be Misleading

Last week, we posted about the FDA’s objections to Kim Kardashian’s promotion of a morning sickness drug on social media. In our effort to keep you up-to-date on celebrity advertising law issues, this week we turn our...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

FDA Cites Drug Company for Kim Kardashian Endorsement

This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains...more

Blog: Kim Kardashian Drug Endorsement Results in FDA Warning Letter

The U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a Warning Letter this week to Duchesnay, Inc. related to celebrity Kim Kardashian’s social media posts on Instagram, Twitter and...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

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

FDA Delays Calorie Disclosure and Menu Labeling Compliance for One Year

Restaurants now have an additional year to revise their menu boards to comply with the Food and Drug Administration’s new menu labeling rules. The FDA had previously finalized new menu labeling rules in connection with the...more

CPUC Likely to Hold Verizon Responsible for its Share of Costs Related to Underground Communications Facilities

The California Public Utilities Commission will decide whether Verizon is improperly shifting costs to California cities by refusing to pay its share of expenses related to the installation of underground service facilities....more

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