- Duane Morris Special Counsel Michael Swit Explores "Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices"
- Duane Morris Partner Frederick Ball Appointed to Food and Drug Law Institute Board
- Duane Morris Attorney Michael Swit to Speak at "Understanding Crucial Issues in the 510(k) Process" Webinar
- Duane Morris Attorney Michael Swit to Moderate at the 11th BVS La Jolla Biotech Day Celebration
- Duane Morris Special Counsel Michael Swit To Present "Digital Health: The Smartest Use of Your Phone"
- Duane Morris Special Counsel Michael Swit to Present "Generic Drug Approvals"
- Federal Trade Commission vs. Watson: The Supreme Court Takes Up "Reverse Payments"
- New Safety Test Requirements for Children's Products Become Effective in February 2013
- The Food and Drug Bar Travels to Brazil
Product Safety, Compliance and Recalls
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:
- Clothing, footwear and textiles
- Electronic products
- HVAC equipment and controls
- Security/alarm system controls
- Drugs and nutritional supplements (including child-resistant packaging)
- Cleaning products
- 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.