Products Liability Communications & Media

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American Spirit Cigarettes — Tobacco is back with ad deception…

On August 27, 2015, the Food and Drug Administration sent a warning letter to Santa Fe Natural Tobacco Co. Inc. and Reynolds American Inc., the company that owns Santa Fe Natural Tobacco and produces American Spirit...more

Advertising Law - July 2016 #3

Wikipedia Link Trips up Ninth Circuit False Ad Suit - Ruling that a California federal court incorrectly relied upon a Wikipedia link when considering a summary judgment motion in a false advertising suit, the Ninth...more

Slack-fill Litigation on the Rise

The recent filing of a proposed class action targeting Mondelez International, Inc. for the amount of empty space in its Sour Patch Watermelon candy boxes is the latest lawsuit targeting consumer goods manufacturers for...more

Augmenting Reality: A Pokémon Go Business and Legal Primer

We have become inured to the sight of people staring at their phones rather than engaging with one another or enjoying their real-life surroundings. But, over the past two weeks, enslavement to mobile devices rose to new...more

GMO Disclosures and Claims: A Possible End to the U.S. GMO Labeling Controversy?

On July 7, 2016, the U.S. Senate passed an important amendment to S. 764 to establish a mandatory nationwide labeling approach for genetically engineered (GE) foods, more popularly referred to as genetically modified...more

Forget About Vermont!: Congress Passes GMO “Labeling” Legislation

On July 14, 2016, the House of Representatives passed S.764 creating a National Bioengineered Food Standard. Importantly for food manufacturers and distributors, the law – expected to be signed by President Obama – will...more

New FDA Draft Guidance on Updates to Certain Generic Labeling

On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for...more

Another Off-Label Promotion Third Party Payor Case Lacks Causation

July in D.C. is hot and sticky. When scorching day follows scorching day, area residents look forward to evening thunderstorms, not just to water otherwise thirsty lawns and gardens but to cool things down. Lightning can be...more

In Limine Gag Orders – Can We Play, Too?

Lately, we’ve seen some plaintiffs add gag order requests to their complement of in limine motions in advance of significant trials. Those of us who participated in the Bone Screw litigation remember plaintiffs attempting –...more

Nationwide GE Labeling Leaps Forward

Four years after California’s genetically engineered (GE) food labeling initiative was defeated, but just days before Vermont’s GE law is to go into effect, the U.S. Senate is poised to impose such labeling nationwide. The...more

Can Plaintiffs Sue a “Celebrity Spokesperson”?

We’ve thought a lot about the various secondary entities that plaintiffs sometimes sue in prescription medical product liability litigation – such as sales reps, physicians, hospitals, pharmacies, distributors, and a number...more

A Symbolic Victory? FDA's Final Rule On Stand-Alone Symbols In Medical Device Labeling Raises Important Litigation Risk Questions

FDA this week released a final rule that will undoubtedly raise new litigation questions for medical device manufacturers in the context of product liability claims. The final rule, for the first time, permits medical device...more

Advertising Law - June 2016

First Circuit Affirms Ruling Against Jerk.com - In a victory for the Federal Trade Commission, the First Circuit Court of Appeals affirmed a Commission ruling that website Jerk.com, a self-described reputation management...more

Senate Appropriations Bill Targets FDA Rulemaking Agenda

The Senate Appropriations Committee is looking to tinker with the Food and Drug Administration’s rulemaking agenda through its fiscal year 2017 funding bill for the Department of Agriculture and FDA (S. 2956). Passed...more

A Tall Drink of Water: Ninth Circuit Affirms Dismissal of Costco VitaRain Class Action on Plausibility and Causation Grounds

On May 5, 2016, the Ninth Circuit affirmed a district court’s decision to dismiss, without leave to amend, a class action complaint alleging a violation of the Washington Consumer Protection Act against Costco for the...more

A Blow Against False Claims Act Liability For Off-Label Promotion

Recently, we noted that one of the first decisions we wrote a post about had been affirmed by the Second Circuit. Of the district court decision, we had penned “It is nice to see a judge with a proper understanding of how...more

FDA Finally Decides that “Evaporated Cane Juice” Is Misleading Consumers

Evaporated cane juice, a term usually used to inform about sweeteners derived from the fluid extract of sugar cane, is present on the ingredient lists of many products we see on grocery store shelves. However, newly finalized...more

Your Food Labels Are Getting a Makeover

If you are one of those consumers that studies food labels (I’m right there with you) or, more importantly, a packaged food supplier, be prepared: your food labels will be getting a makeover. On May 20, the FDA released...more

California Plaintiffs Say that Size Matters: Consumer Fraud Class Action Challenges Slack-Fill in Protein Products

According to named plaintiffs in a consumer fraud action filed in December in the Southern District of California, size matters when making it comes to making a purchase. In fact, Plaintiffs claim that the average consumer’s...more

FDA Releases Final Guidance Regarding the Food Labeling Term “Evaporated Cane Juice”

The US Food and Drug Administration (FDA) has released final guidance stating its view that sweeteners derived from sugar cane should not be declared in the statement of ingredients as “evaporated cane juice.” ...more

FDA to Issue Revised Guidance on Nutrition and Supplement Facts and Serving Size Regulations

This Friday, May 27, 2016, the US Food and Drug Administration (FDA) will publish its revised Nutrition and Supplement Facts and Serving Size regulations. The Serving Size regulation in public inspection view is close to 180...more

Legal Update: Regulation of E - Cigarettes

On May 5, 2016, the federal Food and Drug Administration (FDA) announced new regulations governing the sale of e-cigarettes, hookahs, dissolvable tobacco, pipe tobacco, cigars and other tobacco products (ENDS). The new rule...more

Advertising Law - May 2016 #3

Fake Subscription Notices, Real FTC Lawsuit - Fake subscription notices are the subject of a new lawsuit filed by the Federal Trade Commission in an Oregon federal court. The defendants, a web of dozens of...more

Mass Appeal of Off Label Use

Hardly a week goes by without our blogging about accusations of off label promotion. This week is no exception. On Monday, we discussed a nice New York opinion rejecting a plaintiff argument that off label promotion saved a...more

FTC Targets “All Natural” and “100% Natural” Claims on Personal Care Products

As we have previously reported, FDA is currently seeking public comments on the use of the term “natural” on food labeling. The announcement came as a surprise since FDA had previously declined requests from consumers, the...more

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