Practice Areas & Industries: Duane Morris LLP


Product Safety, Compliance and Recalls Return to Practice Areas & Industries

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Practice/Industry Group Overview

Duane Morris lawyers working in a number of different cities and a variety of legal disciplines come together to form an integrated product safety, compliance and recall practice with a global reach. Duane Morris lawyers have a wealth of experience assisting clients in designing and implementing product recalls on a national and worldwide basis, and in representing clients involving compliance, reporting, recall and penalty proceedings before the U.S. Consumer Product Safety Commission (CPSC) and the Food and Drug Administration (FDA).

Our clients include leading manufacturers, importers, distributors and retailers. We provide sophisticated and practical counsel to clients on a wide range of issues arising from product development, marketing, promotion and distribution, including safety reviews, compliance with labeling requirements and standards, state and federal regulation of consumer warranties, records management, minimum advertised pricing (MAP), and a variety of related manufacturing, import-export, customs and distribution issues. Our lawyers also advise clients on issues that can arise regarding rebate programs, gift cards/gift certificates and consumer information privacy, providing dispute avoidance and resolution advice and class action defense.

The services that Duane Morris lawyers provide to clients regarding consumer product safety and the CPSC include:

  • Addressing challenges posed by the Consumer Product Safety Improvement Act (CPSIA);
  • Identifying CPSC regulations that apply to the company's products, and determining when and how each regulation must be implemented;
  • Developing systems of documenting compliance with CPSC regulations, including testing and inspections (internal and third party) and conformity certificates;
  • Communicating with customers, as well as with subcontractors and suppliers, regarding the parties' expectations on product safety and CPSC compliance issues, and negotiating terms for warranties, indemnities, insurance and other compliance matters;
  • Training employees and industry groups regarding product safety and risk management issues;
  • Communicating with CPSC management and compliance staff regarding proposed regulations and to obtain rulings and interpretations on exemptions and other compliance issues;
  • Advising companies regarding possible reporting obligations to the CPSC under Sections 15 and 37 of the Consumer Product Safety Act and preparing and presenting product hazard reports as appropriate; and
  • Advising companies regarding possible obligations to recall products, negotiating the terms of recalls with CPSC compliance staff, counseling clients regarding logistics, public relations and other issues that arise in product recalls, and assisting clients with international compliance issues when their products are distributed in multiple countries.

We have guided clients through highly publicized product safety crises, government investigations and product recalls, including defect reporting and risk management audits. Our attorneys have represented manufacturers, importers distributors and retailers of products including:

  • Toys
  • Clothing, footwear and textiles
  • Electronic products
  • Batteries
  • Refrigerators
  • HVAC equipment and controls
  • Security/alarm system controls
  • Drugs and nutritional supplements (including child-resistant packaging)
  • Fireworks
  • Furniture
  • Cleaning products
  • Paint
  • Home improvement and construction materials
  • Mobile homes
  • Sporting goods; and
  • Boating and marine equipment.

Government regulators throughout the world share product recall and defect reporting data, and they have agreements in place to undertake cross-border enforcement efforts. Our product safety and recall team can advise clients regarding regulatory and safety/defect reporting requirements in the U.S., Canada, the EU and Asia. Through a global network of more than 60 law firms throughout Europe, Asia, North and South America and the Pacific Rim, we seamlessly manage defect reporting, product recalls and related regulatory and litigation issues on a global basis.

In addition, we assist clients in their relationships with and work with standards organizations such as the American Society for Testing and Materials (ASTM) and the International Organization for Standardization (ISO) in developing and improving product standards.

Articles Authored by Lawyers at this office:

New Jersey Trial Court Grants Summary Judgment in Accutane Mass Tort Cases
James J. Ferrelli, April 14, 2015
In an opinion issued on April 2, 2015, the Honorable Nelson C. Johnson, JSC, granted the motion of defendants Hoffmann-LaRoche, Inc. and Roche Laboratories, Inc. for summary judgment in the In re Accutane Multicounty (mass tort) Litigation (MCL) on the grounds that the defendants' post-April 2002...

Drug Quality and Security Act Does Not Apply to Veterinary Compounding
Patrick C. Gallagher,Rachael G. Pontikes,Alison T. Rosenblum, March 30, 2015
While the Drug Quality and Security Act (DQSA) provided a new regulatory framework for compounded medications for use in human medicine, it does not apply to veterinary compounded medications. There has been some confusion in the industry, but veterinary compounded medications are still regulated...

FDA Establishes the Office of Pharmaceutical Quality
, March 03, 2015
In a press conference earlier this year, Dr. Janet Woodcock, head of the U.S. Food and Drug Administration's (FDA) pharmaceutical division, stated that the FDA has been working on "establish[ing] consistent quality standards for all drugs, whether brand name or generic" over the past 10...

FDA Issues Additional Guidances on Implementation of Drug Supply Chain Security Act
, March 03, 2015
The U.S. Food and Drug Administration (FDA) continues to publish draft guidance implementing the Drug Supply Chain Security Act (DSCSA). This Alert highlights key facts on three recent draft Guidance for Industry, which focus on: interoperable exchange of information, annual reporting by wholesale...

Pennsylvania Supreme Court Adopts New Standards for Strict Liability Claims
, February 17, 2015
On November 19, 2014, the Pennsylvania Supreme Court issued its much-anticipated decision in Tincher v. Omega Flex, Inc. (No. 17 MAP 2013), in which it addresses the proper standard under Pennsylvania law for strict liability claims relating to allegedly defective products. Although the court...

FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act
Carolyn A. Alenci,Frederick R. Ball, December 10, 2014
Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing prescription drug products through the pharmaceutical distribution...