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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

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

Advertising Law - February 2015

FTC Consumer Protection Head Addresses Do’s, Don’ts for Privacy - Calling the current advertising climate “a technological revolution at the intersection of marketing and consumer data,” Director of the Federal Trade...more

B.C. Court Finds Methodology to Prove Causation is Required to Certify Pharmaceutical Class Actions

On January 22, 2015, the British Columbia Court of Appeal set aside certification of a class action against Apotex Inc. and Abbott Laboratories Ltd. in Charlton v. Abbott Laboratories Ltd. (Charlton), in which the plaintiffs...more

Proposition 65: OEHHA Proposes Revisions to Proposition 65 Warning Regulations

On January 12, 2015, the Office of Environmental Health Hazard Assessment (OEHHA) proposed important new regulations that would repeal and replace the existing Article 6 regulations regarding the all-important "clear and...more

The Learned Intermediary Defense Advances in Nevada

The learned intermediary doctrine can be a legal defense against product liability claims. It is most commonly applied in cases involving drugs and medical devices. A learned intermediary is a medical expert, such as a...more

The Internet of Things: The Inevitable Collision with Product Liability

The IoT – Internet of Things – is undergoing a rapid development that will continue to transform how we interact, conduct business and live our lives. The movement toward IoT’s ubiquitous application and use does not come...more

2014 Year in Review: OPDP Warning and Untitled Letters

In 2014, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 10 enforcement letters to pharmaceutical manufacturers. Of the 10 letters, nine were Untitled...more

CPSC’s Proposed Rule Would Expand Phthalate Ban

The Consumer Product Safety Commission (CPSC) recently published a long-awaited proposed rule that, if finalized in its current form, would permanently ban certain additional phthalates from children’s toys and child care...more

Generic Drug Cos. Face Failure-To-Warn Claims In Calif.

On Jan. 20, 2015, the U.S. Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956 (U.S. Jan. 20, 2015). This...more

OIG Reports Lack of Oversight on Hospital Use of Compounded Drugs

On January 22, 2015, the HHS OIG released a report regarding CMS’s oversight of compounded sterile preparations (CSPs) used in hospitals. After reviewing oversight efforts at CMS and the entities that accredit hospitals to...more

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