Consumer Protection, Products Liability, Administrative Law

CPSC Seeks to Hold Former CEO Responsible for Buckyballs® Recall

by Ellen Adler, Erin M. Bosman, Julie Y. Park | Morrison & Foerster LLP on 5/10/2013

Last week the Consumer Product Safety Commission (CPSC) obtained an unprecedented ruling when Administrative Law Judge (ALJ) Dean Metry granted leave to name Craig Zucker in an administrative complaint against Maxfield and...more

FDA Proposes New Rules Regarding Growing, Harvesting, Packing And Holding Domestic And Foreign Produce

by Jason Reiser | Pepper Hamilton LLP on 2/14/2013

On January 5, 2013, the U.S. Food and Drug Administration (FDA), as part of a continuing overhaul of the United States’ food safety laws under the Food Safety Modernization Act (FSMA), published proposed rules regarding the...more

FDA Releases New Food Safety Rules

by Alejandro Bras, Michael Steel | Morrison & Foerster LLP on 1/11/2013

The Food and Drug Administration (FDA) recently released drafts of two long-awaited food safety rules as part of the agency’s ongoing implementation of the 2011 Food Safety Modernization Act (FSMA). The first proposed rule...more

Recent FDA Recalls

by Phillips Law Offices on 1/2/2013

The Food and Drug Administration (FDA) is the federal agency responsible for regulating and approving the sale of pharmaceuticals in the United States. While not always the case, FDA investigations, warnings and recalls...more

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

by Michael M. Gaba, Shannon Hartsfield Salimone | Holland & Knight LLP on 12/27/2012

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

Transvaginal Mesh Multi District Litigation

by Phillips Law Offices on 12/26/2012

Transvaginal mesh is a synthetic fiber sling that is implanted through the vagina. It is used to prevent instances of pelvic organ prolapse in women, a condition in which organs such as the bladder, uterus, and lower...more

Children's Ball Toys That Expand in Water Are Recalled

by Demas Law Group on 12/19/2012

There are people all over the United States who this week may be looking for a few last-minute stocking-stuffers that will complete the gifts that will be given to younger people. It’s often the case that these last-minute...more

New Safety Test Requirements for Children's Products Become Effective in February 2013

by Robert B. Hopkins, Paul S. Rosenlund | Duane Morris LLP on 12/14/2012

Manufacturers and importers of children's products, including toys, apparel, sporting goods and jewelry, will soon be subject to yet another safety-testing regulation addressing several vital issues related to such testing:...more

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

by Mari Spears | Sedgwick LLP on 12/4/2012

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

FDA Suspends Sunland, Inc.; Major Peanut Butter Producer Hit with First Food Facility Suspension Under the Food Safety...

by Duane Morris LLP on 12/1/2012

On November 26, 2012, the U.S. Food and Drug Administration (FDA) announced the suspension of the registration of Sunland, Inc., a producer of nuts, and nut and seed spreads, pursuant to the FDA's authority under Section 102...more

Generic Drug Law Update -- November 2012: Expanding Liability for Ineffective Product Recalls

by Kelly Savage Day | Sedgwick LLP on 11/14/2012

FDA-regulated companies may face civil liability if they fail to provide adequate notice of product recalls to their customers via information gathered in company customer databases. A group of California plaintiffs sued a...more

Generic Drug Law Update -- November 2012: New Bill Seeks to Expand Manufacturers Post-Sale Pharmacovigilance Duties

by Sedgwick LLP on 11/14/2012

Democratic legislators in both houses of Congress introduced legislation that seeks to reverse the U.S. Supreme Court’s recent decision in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), which bars state law tort suits against...more

Food Retailers: FDA Is Coming to Town

by Morgan Lewis on 11/6/2012

Agency's plan to conduct voluntary survey of retailers' foodborne illness risk signals FDA's increasing scrutiny in this area and the need for retailers to evaluate their food safety and risk management systems. ...more

Federal Court Ruling Validates Industry Concerns with CPSC Database

by Morrison & Foerster LLP on 11/1/2012

The Consumer Product Safety Commission’s (“CPSC”) product safety database suffered its first successful legal challenge in a recent ruling by a Maryland federal judge. U.S. District Judge Alexander Williams Jr.’s opinion in...more

FDA Unveils New System to Track Medical Devices

by Dinsmore & Shohl LLP on 10/22/2012

Originally published in Medical Devices Law & Industry Report on 10/03/2012. FDA’s New Plan - The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more

FDA Unveils New System to Track Medical Devices

by Dinsmore & Shohl LLP on 10/22/2012

Originally published in Medical Devices Law & Industry Report on 10/03/2012. FDA’s New Plan - The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more

An Individualized Motor Vehicle Recall Information Database? Will OEMs and Suppliers Get the Bill?

by Dickinson Wright on 9/13/2012

An Overview of Proposed Amendments to Defect Notification and Early Warning Reporting Regulations Tucked away in the recently enacted 584 page "Moving Ahead for Progress in the 21st Century Act" is a small provision...more

OSHA Issues Final Rule Implementing Consumer Products Whistleblower Complaint Procedures

by XpertHR - Partnered with LexisNexis on 7/25/2012

On July 10, 2012, the Occupational Safety and Health Administration (OSHA) issued its final rule setting forth procedures for filing and processing of retaliation complaints under the Consumer Product Safety Improvement Act...more

BPA: Emotions Trump Science at Every Turn

by LEVICK on 7/13/2012

Bisphenol A (BPA) is back in the news. This time, it’s the General Mills brand Progresso coming under fire for using the chemical as an acid-resistant sealant in the lining of its metal soup cans. Despite a mountain of...more

Do You Know Your Local Fireworks Laws?

by Lawyers.com on 7/5/2012

If you’re among the Michiganders who rejoiced at the news that The Great Lakes State legalized most consumer fireworks this year, you might want to temper your enthusiasm while in the Detroit suburb of Warren. Mayor James...more

CDC Lowers Threshold for Diagnosing Lead Poisoning

by Sedgwick LLP on 6/21/2012

For the first time in more than 20 years, the U.S. Centers for Disease Control and Prevention (CDC) in May revised its threshold for diagnosing lead poisoning in children. Adopting the recommendations of the Advisory...more

ALEC Leads the Legal War Against Consumers

by Lawyers.com on 5/7/2012

Meet ALEC — the nickname for the American Legislation Exchange Council — that has recently come to light as a cozy meeting place where Big Business is accused of “ghostwriting” its wish list of laws that state legislators...more

FDA Sends Warning Letters to DMAA Bodybuilding & Dietary Supplement Manufacturers

by Schmidt & Clark, LLP on 5/2/2012

May 1, 2012 - The U.S. Food & Drug Administration (FDA) has issued stern warning letters to 10 manufacturers and distributors of dietary supplements containing dimethylamylamine (DMAA) for marketing products whose safety has...more

FDA Announces Propecia, Proscar to Receive New Sexual Dysfunction & Side Effects Warning Label

by Schmidt & Clark, LLP on 4/13/2012

Two of pharmaceutical giant Merck’s best-selling drugs, Propecia and Proscar, will be required to carry warnings linking them to severe persistent sexual side effects, the U.S. Food & Drug Administration (FDA) announced...more

China Solicits Comments on Draft Rules for Writing Periodic Safety Update Reports

by McDermott Will & Emery on 4/11/2012

China’s State Food and Drug Administration recently issued draft guidance on drafting and preparing Periodic Safety Update Reports for drugs and is seeking comments from the public until 16 April 2012. China’s State Food...more

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Consumer Protection › Products Liability › Administrative Law

CPSC Seeks to Hold Former CEO Responsible for Buckyballs® Recall

FDA Proposes New Rules Regarding Growing, Harvesting, Packing And Holding Domestic And Foreign Produce

FDA Releases New Food Safety Rules

Recent FDA Recalls

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

Transvaginal Mesh Multi District Litigation

Children's Ball Toys That Expand in Water Are Recalled

New Safety Test Requirements for Children's Products Become Effective in February 2013

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

FDA Suspends Sunland, Inc.; Major Peanut Butter Producer Hit with First Food Facility Suspension Under the Food Safety...

Generic Drug Law Update -- November 2012: Expanding Liability for Ineffective Product Recalls

Generic Drug Law Update -- November 2012: New Bill Seeks to Expand Manufacturers Post-Sale Pharmacovigilance Duties

Food Retailers: FDA Is Coming to Town

Federal Court Ruling Validates Industry Concerns with CPSC Database

FDA Unveils New System to Track Medical Devices

FDA Unveils New System to Track Medical Devices

An Individualized Motor Vehicle Recall Information Database? Will OEMs and Suppliers Get the Bill?

OSHA Issues Final Rule Implementing Consumer Products Whistleblower Complaint Procedures

BPA: Emotions Trump Science at Every Turn

Do You Know Your Local Fireworks Laws?

CDC Lowers Threshold for Diagnosing Lead Poisoning

ALEC Leads the Legal War Against Consumers

FDA Sends Warning Letters to DMAA Bodybuilding & Dietary Supplement Manufacturers

FDA Announces Propecia, Proscar to Receive New Sexual Dysfunction & Side Effects Warning Label

China Solicits Comments on Draft Rules for Writing Periodic Safety Update Reports

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