Science, Computers & Technology Products Liability Consumer Protection

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Defective products: anxiety damage recognised and provisionally compensated by interim relief judge

By three court orders issued on 28 January 2016, the Nanterre Civil Court interim relief judge (Juge des référés du Tribunal de grande instance de Nanterre) granted a provision to 13 patients who had taken the Médiator® drug,...more

FDA Issues Draft Guidance on ‘Emerging Signals’

New guidance could present liability concerns for device manufacturers. On December 31, 2015, the Food and Drug Administration (FDA or Agency) issued a Draft Guidance for Industry titled “Public Notification of Emerging...more

Legal Issues Raised by the Driverless Vehicle Revolution – PART 2

Part 1 of this article, published in the December 2015 Business Litigation Report, described emerging driverless vehicle technology and related patent and patent ligation issues. Part 2 continues this discussion with the...more

Wyeth v. Levine’s ‘Clear Evidence' Language: Clearly Misunderstood

In 2009, the United States Supreme Court in Wyeth v. Levine affirmed a judgment rejecting a prescription drug manufacturer’s contention that plaintiff’s claim that the manufacturer should have strengthened its U.S. Food and...more

CPSC Unveils “Regulatory Robot” Designed to Offer Glimpse of Possible Regulatory and Statutory Obligations

The Consumer Product Safety Commission (CPSC) introduced its “Regulatory Robot” this month. Touted as a web-based tool to help manufacturers and importers, particularly small businesses, identify the various CPSC rules and...more

Self-Driving Cars: Legal Issues Ahead

Companies including Apple, Google, Tesla, Toyota and Uber are all developing and testing self-driving car technology. Toyota announced in November that it would spend $1 billion over the next five years on research centers...more

Hoverboards Under Attack

Multiple UK retailers have asked customers to throw out their hoverboards, the self-balancing scooters that have clambered onto holiday wish lists this season, due to suspected safety issues with the devices. The retailers...more

EC Promulgates Final Novel Foods Regulation

The European Commission (EC) published the final novel foods regulation in the December 11, 2015, issue of the Official Journal of the European Union. Under the regulation, food consisting of engineered nanomaterials should...more

What the Toxic Substances Control Act Overhaul Means to Manufacturers

The U.S. Senate passed the long-pending bill (S. 697) to overhaul the Toxic Substances Control Act, which will bolster the government’s power to regulate a wide variety of chemicals. The practical effect of the Frank R....more

Product Liability Alert: Changes to California Prop. 65 Warning Requirements May Create New Pitfalls for Consumer Businesses – Key...

California’s Proposition 65 requires businesses to provide “clear and reasonable” warnings when they “expose” Californians to listed chemicals identified by the state to cause of cancer or reproductive harm (currently, over...more

California Changes Course in Amendments to Proposition 65 Warning Label Requirements

Businesses in California have been thrown another curveball in following developments related to the state’s Proposition 65, the much-criticized statute requiring prolific warnings of exposure to toxic substances and fueling...more

Class Action Issues at the Supreme Court (and Elsewhere)

In addition to being on the warpath about cy pres class action settlements, we try to keep an eye on various other issues related to the much-abused Fed. R. Civ. P. 23. First, we’re pleased as punch to let you know that all...more

Breaking News - FDA Generic Drug Anti-Preemption Proposal Again

We just read on 360 this morning that the FDA has again postponed its schedule for finalizing the generic drug labeling changes (the so-called "Supplemental Applications Proposing Labeling Changes for Approved Drugs and...more

California Issues New Draft of Proposition 65 Warnings Overhaul - Significant Changes Respond to Public Comment

In January 2015, California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed the most significant revisions to the Proposition 65 warning regulations since the 1980s. Not surprisingly, OEHHA received...more

Must Playground Equipment & Surfaces Comply with CPSC Lead Limits for Children’s Products?

Over the past few months, numerous national media outlets have published stories about the potential health risks of a material commonly used on playground surfaces—crumb rubber. Crumb rubber is a granule material typically...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

Health Hackers: Problems in Applying Traditional Products Liability Theories to Latent Cyber-Vulnerabilities in Medical Devices

October is National Cyber Security Awareness Month (yes, that’s a thing), so it seems fitting to write about an unprecedented alert recently released by the FDA to health care providers that warned of a medical device’s...more

Consumer Products “Either/Or”: California Issues Guidance on Alternatives Analysis for Safer Products

California’s Green Chemistry Initiative has taken another step forward with the issuance of guidance on the heart of the law, the analysis of safer substitutes for chemicals in consumer products. On September 24, 2015, the...more

Another Major Earthquake: California Creates Big Fissures in Proposition 65 Regulations – Proposals Could Shatter Defenses

In the midst of making Proposition 65’s longstanding warning regulations far more onerous, and vexatious litigation far more likely, California’s Office of Environmental Health Hazard Assessment (OEHHA) has unveiled still...more

How Does a Bad Idea Get Implanted?

Not so long ago we discussed how Pennsylvania law clearly precludes prescription medical product strict liability, but plaintiffs keep asserting that cause of action anyway. The plaintiff bar is nothing if not persistent. ...more

District Court Holds That FDCA Does Not Prohibit and Criminalize Truthful Off-Label Promotion of FDA-Approved Prescription Drugs

On August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved...more

The Internet of Things and the Inevitable Collision with Products Liability PART 2: One Step Closer

The Internet of Things and the Inevitable Collision with Products Liability, published in February 2015, identified a number of factors leading to the emergence and phenomenal growth of the Internet of Things (IoT). It also...more

No Prescription For Consumer Protection

Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a square peg into a ham sandwich. It doesn’t fit, and the combination isn’t very...more

FDA Gives Food Industry Three Years to Phase Out Partially Hydrogenated Oils from Food Products

On June 16, 2015, the Food and Drug Administration ("FDA") issued a declaratory order, requiring a phasing out of the use of partially hydrogenated oils ("PHOs"). In its order, the FDA stated that partially hydrogenated oils...more

PHOs Banned in the U.S.: Landmark FDA Order Declares Partially Hydrogenated Oils No Longer Generally Regarded as Safe

On June 17, 2015, the U.S. Food and Drug Administration (FDA) issued its much-anticipated Final Determination Regarding Partially Hydrogenated Oils (Order), finding there is “no longer a consensus that partially hydrogenated...more

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