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Landmark Reform of Federal Chemicals Law Will Significantly Impact Chemical Manufacturers and Users

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety Act for the 21st Century Act (“Lautenberg Act”), a sweeping and historic overhaul of our nation’s primary chemical management law, the...more

Product Liability Update: October 2016

Massachusetts Federal Court Dismisses Putative Class Action Because Defendant’s Unconditional Checks for Named Plaintiff’s Maximum Damages, Even Though Uncashed, Mooted Suit - In Demmler v. ACH Food Companies, Civil No....more

California Adopts New Regulations For Warnings Under Proposition 65: CAVEAT VENDITOR (Sellers Beware)

Come August 30, 2018, consumer products to be released into the California marketplace must meet new regulations under California’s infamous Proposition 65. On August 30, 2016, the California Office of Administrative Law...more

Consumer Fraud Allegations For A Prescription Medical Device Do Not Pass The Test

When we think of prescription medical devices, we usually think of the sorts of devices that are implanted during surgery and tend to end up in litigation—artificial joints, pacemakers, surgical meshes, and bone cements, to...more

NHTSA Releases Guidance on Enforcement of Safety-Related Defects in Automated Vehicle Technologies - Agency’s stance raises...

Last week, the National Highway Traffic Safety Administration (NHTSA) released its final Enforcement Guidance Bulletin on Safety-Related Defects and Automated Safety Technologies. The Guidance makes clear that the agency’s...more

GMO Food Labeling And CRISPR

A new law targeted at GMO food labeling instructs the Secretary of Agriculture to establish standards for identifying “bioengineered” food. While many might think CRISPR-modified foods will be covered by such a law, certain...more

FDA Regulatory and Compliance Monthly Recap — August 2016

FDA issues draft guidance on use of real-world data in medical device decision-making - The Food and Drug Administration’s draft guidance provides an overview of how the agency will determine the quality and reliability...more

Pokémon GO: An Indicator of Product Liability in the App Economy

As a big law firm involved in the defense of Product Liability cases, of course we are interested in how Product Liability law will evolve to address the App Economy. Mobile apps (apps) are software applications designed...more

New GMO Legislation Signed into Law

With Congress’s freshly enacted GMO labeling bill, the devil is in the implementing details. On July 29, US President Barack Obama signed legislation that establishes a national disclosure requirement for identifying...more

Update: Unraveling the Toxic Substances Control Act Reform Bill

In June, the U.S. Senate and House of Representatives passed the long-pending Toxic Substances Control Act (TSCA) reform legislation, which will bolster the government’s power to regulate a wide variety of chemicals. The bill...more

EPA Issues Final Rule Implementing Formaldehyde Emission Standards

Final rule seeks to reduce exposure to formaldehyde vapors by establishing emission standards and labeling requirements for certain wood products. Six years after the passage of the Formaldehyde Emission Standards for...more

European Chemical Agency Publishes Call for Evidence on the Use of Formaldehyde Releasers

On July 6, 2016, the European Chemicals Agency (ECHA) issued a call for evidence from relevant stakeholders to gather information on the uses of formaldehyde releasers. ECHA intends to issue a report to inform the...more

FDA Releases Draft Guidance For Updating Generic Drug Labels

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance...more

California Unveils Its First Green Chemistry Regulations for Children’s Foam-Padded Sleeping Products with Fire Retardants

Following up on the breakthrough amendments to the federal Toxic Substances Control Act (TSCA), California has reasserted its intention to proceed with its Green Chemistry Initiative to require substitution of safer chemicals...more

New FDA Draft Guidance on Updates to Certain Generic Labeling

On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for...more

New Proposed Legislation: Doctors Must Report Med Device-Related Deaths & Injuries

Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) announced plans to propose the Medical Device Guardians Act of 2016. According to a press release from Rep. Fitzpatrick, the Act is “a package of bills aimed...more

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more

EPA Chemical Data Reporting Rule Brings Challenges and Opportunities

Every four years, companies that manufacture or import chemical substances in the U.S. in quantities greater than 25,000 lbs./year by site must submit detailed manufacturing, processing and use information on each of these...more

Olympus Duodenoscope Recall: Lessons Learned on How to Manage a Class II Device Failure

Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad. This situation presents an...more

Man Claims Marijuana Made Him A Killer: The Increasing Scope of Product Liability in the Cannabis Industry: Kirk v. Nutritional...

Like the rest of the manufacturing world, cannabis Industry participants are beginning to face product liability risk following the legalization of marijuana. Last week, three sons of a woman killed by their father during an...more

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

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