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FDA Announces More Changes to FSMA Implementation Rules

On September 19, 2014, FDA announced potential changes to four rules that the agency proposed in 2013 to implement the Food Safety and Modernization Act (“FSMA”). FSMA was signed into law in January 2011 in response to many...more

FDA Falls Asleep in Reporting Faulty Surgical Device

The FDA’s Medwatch program is supposed to enhance patient safety by publicizing adverse medical events, but you have to wonder how effective it is when the feds wait more than four months to post a serious problem with a...more

FDA Posts Largest-Ever Medical Device Recall

On August 29, 2014, the FDA issued 233 Class I medical device recalls for products manufactured by Customed. According to its website, Puerto Rico-based Customed is a medical supplies leader and distributes a wide range of...more

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

FDA Seeks Comments for Revised Draft Guidance Regarding the Distribution of Publications Discussing Off-Label Uses of...

The Food and Drug Administration (FDA) released a draft guidance that revises its 2009 guidance on Good Reprint Practices. The draft guidance reflects FDA’s current thoughts on this important topic that impacts drug and...more

CPSC is Now Publicly Posting “Letters of Advice” to its Website

In his keynote address at the annual conference of the International Consumer Product Health & Safety Organization (ICPHSO), Acting Chairman Adler announced that the agency had recently started posting what it calls “letters...more

DTSC Releases Initial Proposed “Priority Products” List for Safer Consumer Products Regulations

On March 13, 2014, the California Department of Toxic Substances Control (DTSC) released its initial proposed list of “Priority Products” for regulation under DTSC’s Safer Consumer Products program. The three categories of...more

Food And Beverage News And Trends

Food industry proposes front-of-package nutrition information. In the wake of the recently proposed changes to the Nutrition Facts panel labeling, the Grocery Manufacturer's Association proposed its own front-of-package...more

Prop 65 Law Alert: California Proposes Significant Changes to Proposition 65 Warning Requirements

On March 7, 2014, the Office of Environmental Health Hazard Assessment (“OEHHA”), the agency responsible for implementing California’s Proposition 65 (“Prop 65”), issued proposed changes to existing regulations that would...more

After Recalls, Pharmacies Wonder How Well They REALLY Know Their Subcontractors

Pharmacy compounding has been a very hot topic over the last 12 months. Whether it is news from Capitol Hill regarding possible legislation, regulation from the Food and Drug Administration (FDA) or action by a state board of...more

Infuse Bone Graft Lawsuit Website Launched By Hissey Kientz, LLP Law Firm

The law firm of Hissey Kientz, LLP announces the launch of its new website, Medtronic Bone Graft Lawyers (http://medtronicbonegraftlawyers.com/). A Yale University Study has linked the Medtronic Infuse Bone Graft to severe...more

Does Corn By Any Other Name Taste As Sweet?

Genetically modified organisms (GMOs) have received much attention in recent years, yet the concept of genetically engineering (GE) food is not new – U.S. farmers began growing GMOs in 1994 and now plant about 165 million...more

Medical Device Update: FDA Regulation of Tanning Beds, “Henceforth to be Known as Sunlamp Products”

Yesterday, we reported that FDA had announced its intentions of reclassifying sunlamp products and requiring labeling changes to include warnings discouraging young people from using them....more

FDA’s Medical Device “Enhancement” Reporting Has Potential Product Liability Implications

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more

Craft Beer Boom in Michigan [Video]

Michigan is going through a significant boom in its alcoholic beverage manufacturing. In a video produced by Crain's Detroit Business and Miller Canfield, lawyer Joe Infante discusses what this means for Michigan and...more

BioMet M2a Magnum Hip Replacements Linked to Painful Side Effects

BioMet M2a Magnum hip replacement devices have been linked to complications including metal poisoning, hip implant loosening, fretting and corrosion, dislocation and fractures at the site of the implant....more

Stryker hip replacements may cause serious complications

Stryker Corporation issued a voluntary recall of the Stryker Rejuvenate and Stryker ABG II modular hip replacement systems in July 2012 after stating that the metal-on-metal hip devices posed an increased risk for severe...more

GranuFlo Recall Website Launched By Hissey Kientz, LLP Law Firm

The law firm of Hissey Kientz, LLP is announcing the launch of its new website, GranuFlo Recall Help (http://www.granuflorecallhelp.com/). The site will serve as a source for news and legal information for patients and their...more

Zoloft Use During First Trimester of Pregnancy Can Increase Risk of Birth Defects

Use of the selective serotonin reuptake inhibitor (SSRI) antidepressant Zoloft during the first trimester of pregnancy can increase a child’s risk of being born with serious heart defects or other birth defects. ...more

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more

Patients continue to file lawsuits over faulty DePuy hip implants

DePuy Orthopaedics and its parent company, Johnson & Johnson, face thousands of lawsuits from patients who were injured as a result of problems with DePuy’s ASR hip replacements. ...more

Australia issues $1M fine for flammable children’s sleepwear

The Australian Federal Court has fined a children’s sleepwear brand $1 million in relation to its supply of unsafe children’s nightdresses and pajamas. According to Product Safety Australia, Cotton On Kids Pty Ltd supplied...more

US CPSC & Health Canada recall expanding toys

The United States (US) Consumer Product Safety Commission (CPSC) and Health Canada issued a joint recall of expanding toys in the US and Canada. The toys, which go by the names Water Balz, Growing Skulls, H2O Orbs...more

FAQ: The Link Between Actos and Bladder Cancer

The FDA has warned that patients taking Actos are more likely to be diagnosed with bladder cancer than users of other diabetes medications. ...more

Product Liability Advisory - November 2012: BPA Linked to Adverse Reproduction Effects in Rhesus Monkeys

A recent study published in the “Proceedings of the National Academy of Sciences” found that Bisphenol A (BPA) can adversely affect fetal development in rhesus monkeys. The study’s findings raise concerns regarding BPA...more

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