Products Liability Communications & Media

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The Risks of Plaintiff Lawyer DTC Advertising

We have been riding the Philly subway for years, but only recently realized how much the ads on the car walls have changed. Not so long ago there were lots of ads for vocational schools, inducing today's un- or underemployed...more

Keeping it Legal: Managing FDA Compliance for Consumer-Generated Content

Social technology platforms allow manufacturers to leverage consumer-generated content about their products (“CGC”) more easily than ever before. Such CGC generally takes the form of written testimonials and product reviews...more

FDA Proposes Gluten-Free Labeling Standards for Fermented and Hydrolyzed Foods

On November 18, 2015, the FDA issued a proposed rule to set standards for making a “gluten-free” claim for foods that are fermented, hydrolyzed, or distilled, or that otherwise contain fermented or hydrolyzed ingredients....more

New FDA Guidance Doubles-Down on 1980 Fortification Policy and Potential Misbranding Risks of “Inappropriate Fortification”

FDA recently released its Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Guidance) to “clarify the existing policy” in response to questions FDA has received from the food industry, other federal...more

FDA Issues Final Food Biotechnology Labeling Guidelines for Plant Foods; Discourages “GMO Free” Claims

On November 19, 2015, FDA issued its final guidance for industry concerning the requirements for voluntarily indicating whether food products have or have not been derived from genetically engineered plants. The final...more

FDA Seeks Comments on the Meaning of “Natural”

On November 12, 2015, the U.S. Food and Drug Administration (FDA) requested comment on the use of the term "natural" in the labeling of human food products. The notice states that it is establishing "a docket to receive...more

Weight-Loss Claims: How Many Studies Does the FTC Really Think It Takes?

On Tuesday, the FTC announced that it has sent warning letters to 20 marketers of weight-loss dietary supplements. The letters question whether the companies possess adequate support for claims and describe the scientific...more

The FDA Gets Pulled Into the "Natural" Labeling Fray: Surprise Move May Change the Food Fight

In a surprising change of tack, the U.S. Food and Drug Administration (FDA) announced Tuesday that it will accept public comments on the use of "natural" claims on food labels. The move, which may signal FDA's intention to...more

Preemption Should Have Taken Down Performance Enhancement Class Action

Is it a food or is it a drug? The answer makes a difference because different laws apply. And then there are dietary supplements, which come under the “food” umbrella, but have some unique rules of their own. It can get...more

FDA’s Comment Period for “Natural” Food Labels Is Now Open

FDA took long-awaited and much-anticipated steps this week to address the requests of both consumers and food manufacturers and producers for guidance and regulation on use of the term “natural.” For years now, consumer...more

FDA Requests Public Comment on "Natural" Food Labels

The U.S. Food and Drug Administration this week issued a request for public comment on the use of the term "natural" in the labeling of food products. This represents the first time in 22 years that the FDA has indicated an...more

Generic Preemption Prevails in Testosterone MDL

What? You were expecting another of our insensitive blogpost headlines? Nope, we’re playing this one straight down the middle. In In re Testosterone Replacement Therapy Products Liability Litigation, 2015 WL 6859286...more

Happy Veteran’s Day/In Praise of Free Speech and a SD Fla. Decision

Yesterday was Veteran’s Day. This is a holiday that escapes the attention of too many people – until they stare at their empty mailboxes in puzzlement. It is a federal holiday, but most of us go about our usual business....more

South Korean companies: progress with risk in the United States - South Korea: Building for the future

South Korean companies have made great strides in the US consumer product market, yet they must be more proactive in preventing US class action lawsuits. South Korean companies have progressively exposed themselves to...more

FDA Requests Public Comment on How “Natural” Claims Should be Regulated; Opening 90-Day Comment Period

FDA is requesting public comment on how “natural” claims should be regulated. The 90-day public comment period will open on November 12, 2015, when the FDA notice is published in the Federal Register. In particular, FDA...more

FDA Requests Comments on Use of Term "Natural" on Food Labeling

After years of litigation and controversy around use of the term "natural" on food labels, the U.S. Food and Drug Administration (FDA) is now seeking comments on the issue. This action has important implications for companies...more

Much Ado About Nothing: The Defense of Judge Posner’s Internet Research

All the briefs are filed, and the next step in the saga of Rowe v. Gibson, No. 14-3316 (Aug. 19, 2015), is for the nine judges in regular active service on the Seventh Circuit to cast their votes in favor of or against...more

Warnings Causation Sinks "Failure to Update" Claim

This post is not from the Dechert side of the blog. “Failure to update” claims have multiple problems. You probably already know what we are referring to. Federal law requires that generic drug manufacturers...more

FDA Regulatory and Compliance Monthly Recap — October 2015

FDA releases draft ICH guidance with aim to improve pharmaceutical benefit-risk assessments - The agency released ICH guidance to regulate how pharmaceutical makers should present benefit-risk information in regulatory...more

California Court Gets It Wrong On HRT Class Action

We understand that not everyone shares our view of class actions, but we hold certain truths to be self-evident: The government, including its courts, cannot order someone to give money to someone else without due process of...more

Plaintiffs Allege GSK Hid Risk of Birth Defects

The Food and Drug Administration approved Zofran in 1991 for use in cancer patients who required chemotherapy or radiation therapy. The two women have sued GlaxoSmithKline (GSK), the maker of Zofran, accusing it of promoting...more

FTC Announces Red Light on Unqualified “Green Approved” Seals

Updated to clarify that this post is not about Green Seal, Inc. but the environmental seals or certifications warned against in a recent FTC update. Manufacturers of consumer products labeled with unspecified environmental...more

ATF Institutes a Voluntary Magazine Identification-Labeling Program

The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), in its recent ATF EXPLOSIVES Industry Newsletter, informed the industry of a new voluntary “process to better track industry-owned explosives storage magazines.”...more

Going on Offense against State Deceptive Trade Practices AG Actions

We have posted many times about cases where a manufacturer of a regulated product is sued over alleged violations of a state consumer protection or deceptive trade practices act because of something allegedly amiss in the...more

VW Group – A Storm in a Teacup?

We've all seen a lot of media coverage about the 1.2 million Volkswagen/Audi/Seat/Skoda vehicles sold in the United Kingdom that are fitted with "defeat" software and the storm clouds are brewing. But the reality is that...more

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