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Bipartisan Senate Bill Would Introduce Largest Increase in FDA Oversight of Personal Care Products—Including Cosmetics—in over 70...

Personal care products, which include cosmetics, are a large, profitable, growth industry. In the United States, cosmetics are regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug & Cosmetic...more

California’s Green Chemistry Agency Issues New Guidance to Identify Future Consumer Products for Regulation

California’s Green Chemistry Initiative continues to build momentum. On April 16, 2015, the California Department of Toxic Substances Control (DTSC) released its final April 2015 Priority Product Work Plan for 2015–2017...more

Maryland, My Maryland: Aldara Case Dismissed for Multiple Reasons

Today’s date is rich in literary history. It is the birthday of Vladimir Nabokov, one of two writers whose prose style makes us want to snap our Pilot Varsity pens in despair, so great is the gap between those authors'...more

FDA Increasing Scrutiny of Cosmetic Marketing Claims, New Agency Warnings Suggest

In addition to truthful and non-misleading advertising requirements, which are enforced by the FTC and certainly familiar to readers of this blog, personal care and cosmetic products are also subject to the Federal Food,...more

First Circuit Decision Strengthens Preemption Defense in Name-Brand Pharmaceutical Litigation

On February 20, 2015, the U.S. Court of Appeals for the First Circuit affirmed the dismissal of plaintiffs’ state-law consumer protection claims against a name-brand pharmaceutical manufacturer, concluding they were impliedly...more

Baker v. Microsoft Corporation: Game Companies Beware, Ninth Circuit Court of Appeals Decision May Make It More Difficult to...

A Quick Overview - The Ninth Circuit Court of Appeals recently reversed a district court’s decision to strike the class action allegations of a putative class action against Microsoft. ...more

Product Liability Update - April 2015

In This Issue: - First Circuit Holds State Law Claims Against Drug Manufacturer for Allegedly Misleading Efficacy Representations in FDA-Approved Label Preempted by Food, Drug & Cosmetic Act Because Plaintiffs’...more

New Prop. 65 Regulations Being Considered in California

For nearly three decades, California’s Safe Drinking Water and Toxic Enforcement Act of 1986, better known as “Proposition 65," has, under specified conditions, required businesses that sell or distribute products in...more

Calif. Appellate Court Endorses Averaging Lead Exposure in Food and Beverage Prop. 65 Disputes

In a rare published decision concerning California’s expansive Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as “Prop 65,” the California Court of Appeal on March 17, 2015, dealt companies a victory in...more

New Jersey Casts a Broader Net (Opinion Rule)

It wasn’t too long ago that, down the shore, New Jersey hosted one of the most notorious litigation hellholes in the country. That’s not the case anymore, as the current (2014-15) ATRA Judicial Hellholes report explains in a...more

Notes From The Off-Label Underground

Keeping track of litigation over off-label use/promotion frequently sends us off on tangents. We’ve wandered into abortion cases, securities law cases, criminal cases – even cases brought by criminals....more

A Sane Tweak to Proposition 65

This space has addressed on several occasions recent attempts to modify California’s Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65. Many of the comments on proposed changes to...more

A Change of Pace for Product Liability Class Actions: Certification Denied in Two Recent Cases

Oft-referred to as “quintessential class actions”, the majority of product liability actions that have sought certification as class proceedings in the last 10 years have been granted certification. However, two recent...more

EPA Unveils Safer Choice Label

Last week, EPA unveiled the new Safer Choice label. According to the EPA website, a product with the Safer Choice label means that EPA scientists have reviewed every ingredient in that product to ensure they meet the rigorous...more

FDA Approves Biosimilar Agent Zarxio: Dawn of a New Era in Pharmaceutical Therapy and Product Liability Law

The FDA's approval on March 6, 2015, of Sandoz's Zarxio (filgrastim-sndz) is a momentous occasion for pharmaceutical therapy and product liability law in the United States. Catching up with Europe (where Sandoz's identical...more

Can The FDA Do That?

A little like one of those peanut-shaped asteroids, today’s post cobbles together a couple of recent developments that, other than having relevance to the FDA, do not have all that much in common....more

The Internet of Things will “rock” the retail sector

The Internet of Things will generate in the retail sector US $ 329 billion of revenues by 2018 according to a report published by SAP, but such massive growth has to deal with legal issues concerning not only privacy...more

No Consent To General Jurisdiction By Merely Registering To Do Business

Since Daimler AG v. Bauman, 134 S. Ct. 746 (2014), severely curtailed general personal jurisdiction, litigation tourist plaintiffs – those who file suit outside of their states of domicile (mostly in so-called litigation...more

First Circuit Finds Federal Preemption of State Tort Claims That Conflict With A Medication’s FDA-Approved Labeling & Warnings

An opinion issued by the U.S. Court of Appeals for the First Circuit on February 20, 2015 held that the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted claims that Lexapro’s U.S. Food and Drug Administration (FDA)...more

Olympus Sued Over “Superbug” Infections

The New York Times recently reported that 179 patients at the UCLA Ronald Reagan Medical Center were exposed to a potentially deadly “superbug” between October of 2014 and January of 2015. As of February 18, the infection of...more

Advertising Law - February 2015 #3

FCC Chair Announces New Net Neutrality Regs - The battle over net neutrality took a new turn when Federal Communications Commission Chairman Tom Wheeler announced his intention to reclassify broadband service as a...more

Arizona Applies Consumer Fraud Act to Pharmaceutical Manufacturers

Arizona has joined two other states in applying its consumer fraud law to pharmaceutical manufacturers. The Arizona Court of Appeals decision came in a products liability action against Medicis Corporation, related to a...more

Gingko, Roses, or Just Filler? The New York Attorney General's Attack on Supplements

We all know that a rose by any other name would smell as sweet. But what if the roses you give to your sweetheart are actually painted daisies or thorns without flowers? Or worse, if they do not contain flowers at all but...more

Some Ideas About 3D Printing

The other day we read a thoughtful Bloomberg piece on 3D printing in the medical device context by a trio of Alston & Bird litigators. We’ve given you the link, but it might be behind a paywall. The article indicates...more

SPECIAL FOCUS: D.C. Circuit Limits FTC’s Ability to Require Two Randomized Clinical Trials to Substantiate Disease Claims in...

On January 30, 2015, the U.S. Court of Appeals for the District of Columbia Circuit issued its long-awaited opinion in the POM case. In a press release, the Federal Trade Commission (FTC or the Commission) Chairwoman Edith...more

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