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Lawsuits Involving Fluoroquinolones Piling Up Against Manufacturers

Google “fluoroquinolones,” and page after page of search results come up about the dangers, risks and side effects of the antibiotic. Articles appear citing arrhythmia, nerve damage and type 2 diabetes all being associated...more

New Regulations on the Horizon for Commercial Drones

Currently, the use of drones or unmanned aircraft systems (UAS) for commercial purposes in general is not permitted in the United States, although there is one exception. The Federal Aviation Administration (FAA) allows...more

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

Xarelto’s Approval by the FDA

The controversy over Xarelto’s approval by the FDA and alleged irregularities in the conduct of the ROCKET-AF clinical trial continue to hang over the heads of Bayer and Janssen (a division of Johnson & Johnson), the...more

Heater-Cooler Devices Linked to Infections

Heater-cooler devices are used during cardiothoracic surgeries, and other medical and surgical procedures to warm or cool a patient. They include water tanks that provide temperature-controlled water to external heat...more

Class Action Lawsuit Filed Against Fitbit

Fitbit, Inc., a manufacturer of wearable health technology, is involved in a national class action lawsuit filed on January 5, 2016 in the Northern District of California over two of its wristbands, the Charge HR and the...more

Will Big Pharma’s free speech rights trump FDA, regulatory safety?

Recent developments in the law may have opened a new path for drug makers to exercise corporate free speech rights in ways that don’t look healthy for consumers. The case that concerns health watchdogs started when...more

States Consider Over 60 Bills Regulating Chemicals in 2016

Although legislation to overhaul the Toxic Substances Control Act (TSCA) is under near-final consideration, states continue to consider restrictions on chemicals. In the absence of TSCA reform, over 20 states are considering...more

The Netherlands Describes Tool for Risk Assessment of Nanomaterials in Cosmetics

On January 25, 2016, the Netherlands National Institute for Public Health and the Environment (RIVM) published a report that describes the content of a computer program that can be used for a risk assessment. According to...more

Driverless Vehicles — A new driving frontier

Just imagine the courtroom scene… The negligent party is in the courtroom being examined by plaintiff’s counsel...more

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

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