Katharyn Grant (US)

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Amarin and FDA settle off-label suit

As we reported last August, US District Judge Paul Engelmayer ruled that Amarin Pharma has a First Amendment right to truthfully promote its prescription drug Vascepa for off-label uses. August 10, 2015,  article. Shortly afterward, Amarin and the government entered settlement talks. August 31, 2015 update. We are now able to report that on March 8, … Continue reading

Amarin wins injunction against FDA over off-label marketing

In June, we wrote about Amarin Pharma’s suit asking a federal court to hold that the FDA’s prohibitions on off-label promotion as applied to “speech Amarin proposes to make and [doctors] wish to receive” about its product Vascepa® “are unconstitutional.” June 11, 2015 article. On August 7, the court ruled that Amarin has a constitutional … Continue reading

Court declines to extend Lanham Act to standard setting organization’s disciplinary activities

In a recently unsealed opinion, the U.S. District Court for the District of Columbia granted summary judgment to the Certified Financial Planner Board of Standards (CFP Board), on a Lanham Act false advertising claim brought by plaintiffs alleging that the CFP Board unfairly enforced its disciplinary rules against them. Mem. Op., Camarda, et al., v. … Continue reading

FDA releases final guidance for size, shape and other physical attributes of generic drugs

On June 18, 2015, the FDA issued its final guidance regarding Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules. June 2015 Guidance. The final guidance is largely the same as the draft guidance FDA released in December 2013, with the exception of editorial changes made primarily for clarification. The guidance is intended … Continue reading

FDA seeks to appease drug company in off-label marketing dispute

The FDA has long treated off-label marketing – the promotion of drugs for uses that have not received FDA approval – as evidence of intent to violate the “misbranding” provisions of the Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq. According to the FDA, pharmaceutical manufacturers and their representatives may not … Continue reading

Lawsuit accuses MillerCoors of falsely advertising Blue Moon as a “Craft” beer

A proposed class action lawsuit filed in San Diego County (California) Superior Court accuses MillerCoors LLC of engaging in deceptive and misleading advertising and violating California’s Consumer Legal Remedies Act by describing its Blue Moon beer as an “Artfully Crafted” product of the “Blue Moon Brewing Company.” According to the plaintiff, MillerCoors’ advertising “misleads consumers to … Continue reading

Alamo trademark settlement creates uncertainty for Texas businesses

A recent consent order confirms that, as the owner of the Alamo, the state of Texas also owns the mission’s image and can restrict others from using its distinctive silhouette to sell commercial products. On April 30, 2015, US District Judge Fred Biery signed a consent order and final judgment prohibiting two rival beer makers from using images the State … Continue reading

Cybersquatting and political campaigns: No laughing matter

As the number of 2016 presidential contenders begins to swell, an issue that often accompanies political campaigns has reared its ugly head. It’s political cybersquatting. Consider this recent Lady Liberals’ Facebook post: What’s in a name? That which we call a “domain” Cybersquatting, or domain squatting, is registering, trafficking in or using an Internet domain … Continue reading

Regulators Asked to Ban Use of “Diet” on Soda Labels

On Thursday, the consumer advocacy group, U.S. Right to Know (RTK), asked the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) to prohibit the Coca Cola Company and PepsiCo Inc. from using the allegedly “deceptive” term “diet” in advertising Diet Coke and Diet Pepsi. According to RTK, “the use of the term … Continue reading

NAD advises DirecTV to change Rob Lowe ads

Following a complaint by cable provider Comcast, the Better Business Bureau’s National Advertising Division (NAD) urged DirecTV to abandon certain advertising claims found in its popular series of television ads featuring actor Rob Lowe. See April 7, 2015 Press Release here. The commercials, which promote the benefits of DirecTV’s satellite television subscription services over cable, … Continue reading

GNC reaches agreement with New York Attorney General to expand testing of its herbal supplements

On Monday, GNC Holdings Inc., one of the nation’s leading retailers of health and wellness products, committed to expand testing and authentication procedures for its herbal supplements beyond current U.S. Food and Drug Administration requirements. See GNC Press Release (Mar. 30, 2015); NY AG Press Release (Mar. 30, 2015). NY Attorney General investigates herbal supplement … Continue reading

FDA continues to take aim at misleading internet advertising

On February 26, 2015, the U.S. Food and Drug Administration (FDA) issued warning letters to nine manufacturers of products sold over the Internet, informing each that they improperly advertise their products with disease-related claims. Focus on dietary supplements Five of the targeted companies manufacture foods or dietary supplements. The FDA’s recent actions signal its ongoing … Continue reading

FTC grinds the Oz Effect out of coffee bean weight loss claims

On January 26, 2015, the Federal Trade Commission filed a complaint in federal court against Texas-based Genesis Today, Inc., a marketer of dietary supplements; its branding subsidiary, Pure Health LLC; and its founder and CEO, Dr. Lindsay Duncan. During the Fall of 2014, the defendants and the FTC agreed upon the terms of a settlement … Continue reading

DC Circuit Court puts limits on FTC’s advertising substantiation requirements

On January 30, 2015, a three-judge panel of the US Court of Appeals for the District of Columbia reversed an FTC order that would have required POM Wonderful to substantiate various health-relating advertising claims with two randomized, well-controlled human clinical trials (“RCTs”).  POM Wonderful, LLC v. FTC. The DC Circuit’s ruling is the latest development … Continue reading

Court pares but does not dismiss male enhancement class action

On September 19, 2014, a federal district judge allowed a consumer class action to proceed against the marketer and seller of an over-the-counter “male enhancement product,” finding that the plaintiff adequately pled facts to support false advertising and unfair competition claims under California law.  See Dorsey v. Rockhard Laboratories LLC et al., slip op. (C.D. … Continue reading

Third Circuit does away with presumption of irreparable harm

In a much anticipated ruling, the Third Circuit held courts no longer may presume irreparable harm when considering a preliminary injunction motion in a Lanham Act false advertising case even where a plaintiff shows a likelihood of success on the merits.  Ferring Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc., No. 13-2290, slip op. (August 26, 2014).  Instead, a plaintiff seeking … Continue reading

FTC hosts public workshop on BioSimilar drug competition

On February 4, 2014, the Federal Trade Commission (“FTC”) hosted a day-long public workshop on “Follow-on Biologics: Impact of Recent Legislative and Regulatory Naming Proposals on Competition” to discuss the potential impact of state regulations and naming conventions on competition involving biologic medicines and follow-on biosimilar drugs. The workshop reflects the FTC’s renewed interest in … Continue reading

Medical experts cast doubt on multivitamin health benefits

A recent editorial published in the Annals of Internal Medicine argues that multivitamins should not be used for chronic disease prevention, and consumers should “stop wasting money” on these products. While the tone and content of the AIM editorial and reports are certainly open to debate, this pronouncement may raise concerns among supplement manufacturers and … Continue reading

Legal Update: Online sales of counterfeit sports apparel

Following on the heels of action by professional and collegiate sports organizations to stop online sales of counterfeit sports apparel, sporting good giants Adidas and Reebok have now brought suit against nearly 50 defendants they accuse of cybersquatting and/or fraudulently registering Internet domain names referencing their trademarks to facilitate the sale of counterfeit apparel. Adidas … Continue reading

It’s a counterfeit holiday time of year

With the holiday shopping season in full swing, the National Basketball Association, Major League Baseball and the National Hockey League have once again joined as plaintiffs in a civil action aimed at counterfeiters seeking to take advantage of the heightened demand for sports apparel. On December 12, 2013, the three professional sports organizations filed a … Continue reading

"Humane” producers of foie gras unable to duck false advertising claims

Last month, the United States District Court for the Northern District of California refused to dismiss federal Lanham Act claims, as well as claims based on California’s unfair-competition and false-advertising laws, against Hudson Valley Foie Gras (“HVFG”), a New York producer of foie gras and other duck products. See Apr. 12, 2013 Order. Foie gras … Continue reading

Hybrid Fuel Efficiency Claims Targeted in Class-Action Lawsuit

The owner of a new 2013 Ford C-Max Hybrid has filed a consumer fraud class-action lawsuit against the Ford Motor Company, alleging Ford has engaged in a “false and misleading marketing campaign” for its 2013 C-Max Hybrid and Fusion Hybrid vehicles. The complaint alleges the cars “consistently achieve[] gas mileage far below the advertised mileage … Continue reading