Products Liability Administrative Agency

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Sweet(ener) Confusion: Court Divide Over Role of Primary Jurisdiction Doctrine in “Evaporated Cane Juice” Cases Grows

In Swearingen v. Santa Cruz Natural, Inc., No. C 13-04291 (N.D. Cal. April 2, 2014), Judge Illston of the U.S. District Court for the Northern District of California granted defendant’s motion to dismiss based on the primary...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

FDA Report to Congress: 1997 Guidance Provides Solid Foundation for 510(k) Modification Decisions

Interested stakeholders have until June 4, 2014, to comment on the FDA's long-anticipated report to Congress that includes its Proposed Policy on the Premarket Notification Requirements for Modified Medical Devices. The FDA...more

The Sixth Circuit Clarifies Admissibility of the CPSC’s Failure to Take Regulatory Action

The admissibility of the Consumer Product Safety Commission’s (CPSC) failure to take action to regulate products has been litigated in many courts throughout the United States, largely due to an ambiguous provision in the...more

What's in the Box? FDA Proposes Revisions to Nutrition Facts

On February 27, 2014, the U.S. Food and Drug Administration proposed three rules that would make landmark revisions to the iconic black and white Nutrition Facts panel if finalized. The proposed changes affect all packaged...more

CPSC Holding Third Party Testing Exemptions Workshop

The CPSC is voting soon on whether to hold a workshop to discuss potential ways to reduce third party testing costs through additional “determinations” that certain products or materials do not require third party testing....more

Consumer Protection Laws And Prescription Meds: A Poor Fit

Purchasers of prescription medications often file class actions in large, multidistrict litigation alleging that they were defrauded by manufacturers. In these actions, patients, many of whom disclaim any physical injury,...more

CPSC Adds Burden Reduction Work, ATV Study, and UL 250 Voluntary Standard Involvement to 2014 Operating Plan at Chairman...

CPSC’s November 20, 2013 Commission hearing started with an emotional farewell from Chairman Inez Tenenbaum and high praise from her fellow Commissioners for her dedication to consumers and the agency. I joined the Chairman’s...more

CPSC Likely to Proceed with October Hearing on Magnet Rule

This week, the Consumer Product Safety Commission (“CPSC”) will decide whether to hold a full Commission hearing to receive oral comments on a notice of proposed rulemaking on magnet set safety. If the meeting notice is...more

The FDA’s 510(k) Approval Process in Medical-Device Litigation

Any litigator knows evidence makes or breaks a case. One piece of admissible evidence may not determine a matter outright, but it may be that crucial nudge for a jury to tip the scales of justice for one side or the other. In...more

CPSC Seeks to Hold Former CEO Responsible for Buckyballs® Recall

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

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

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

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

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

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

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

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

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

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

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

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

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...

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

Meningitis Outbreak Spawns Dicey Treatment Claims

Meningitis—a life-threatening inflammation of the membranes surrounding the brain and spinal cord—has seldom been more prominent in the news, and for all the wrong reasons. The contaminated steroid made and distributed by a...more

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

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

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

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