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

Actos: Blowing the Whistle

by Phillips Law Offices on 1/18/2013

The drug pioglitazone, marketed as Actos®, is prescribed to treat type 2 diabetes. Chemically related to the diabetes drug Avandia, Actos has come under fire in recent years for serious, sometimes fatal side effects....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

What Makes Side Effects Actionable?

by Phillips Law Offices on 1/11/2013

With increasing profits to be made in drug development and manufacturing and escalating reliance upon pharmaceutical treatment by the medical community, it seems that new drugs are entering the market every day to treat every...more

Stefanie Fogel On What’s Next For Food Labeling Issues In 2013

by Gene Grabowski | LEVICK on 1/7/2013

After a year that saw labeling issues come to the forefront of the food safety conversation, I sat down with DLA Piper trial lawyer Stefanie Fogel to get her take on how manufacturers, producers, and retailers can expect the...more

U.S. Government’s Use of the "Park Doctrine" to Police Pharmacies

by Frederick Ball, Rachael G. Pontikes | Duane Morris LLP on 1/7/2013

The U.S. government may be resurrecting the "Park Doctrine" as a tool to prosecute the owners of pharmacies for federal Food, Drug, and Cosmetic Act (FDCA) violations. In United States v. Park, 421 U.S. 658 (1975), the U.S....more

Companies Need to Review Their Insurance as FDA Announces First Rules Under FSMA

by Jonathan M. Cohen | Gilbert LLP on 1/7/2013

On January 4, 2013, the Food and Drug Administration (“FDA”) issued the first two rules that will put into effect the Food Safety Modernization Act (“FSMA”), a law passed by Congress in 2011 that is designed to prevent...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

Product Liability Law Medical Device Law Update: December 2012 - “A State of Profound Uncertainty”: The Crisis in Pennsylvania

by S. Vance Wittie | Sedgwick LLP on 12/24/2012

Since the mid-1960s, Pennsylvania has adhered to the strict liability tenets of section 402A of the Restatement (Second) of Torts. Its version of strict liability had a number of unique features, including the determination...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

Birmingham Medical News: Compounding Pharmacies Coming Under Greater Scrutiny

by James A. Hoover | Burr & Forman on 12/6/2012

With as many as 13,000 patients possibly exposed to fungal meningitis from tainted spinal steroid injections traced to a New England compounding pharmacy, the regulation of compounding pharmacies is once againheating up. The...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

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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

Actos: Blowing the Whistle

FDA Releases New Food Safety Rules

What Makes Side Effects Actionable?

Stefanie Fogel On What’s Next For Food Labeling Issues In 2013

U.S. Government’s Use of the "Park Doctrine" to Police Pharmacies

Companies Need to Review Their Insurance as FDA Announces First Rules Under FSMA

Recent FDA Recalls

FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

Transvaginal Mesh Multi District Litigation

Product Liability Law Medical Device Law Update: December 2012 - “A State of Profound Uncertainty”: The Crisis in Pennsylvania

Children's Ball Toys That Expand in Water Are Recalled

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

Birmingham Medical News: Compounding Pharmacies Coming Under Greater Scrutiny

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...

Meningitis Outbreak Spawns Dicey Treatment Claims

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

Congress Will Consider Greater Oversight of Compounding Pharmacies

Food Retailers: FDA Is Coming to Town

Federal Court Ruling Validates Industry Concerns with CPSC Database

Intermediates Compliance Warning

FDA Unveils New System to Track Medical Devices

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