Product Risk Management

Overview

Crowell & Moring's Product Risk Management Group (PRM) offers a unique, multidisciplinary approach to businesses in identifying and managing the legal risks involved in design, manufacturing, marketing, distribution, and sale of products. Our lawyers and policy professionals help clients navigate the complex legal and regulatory regimes, both domestically and internationally, applicable to the design and sale of their products and services as clients develop strategies to grow their businesses. The PRM Group assists clients in taking innovative and proactive measures to protect their business from the array of challenges before them, including regulatory compliance, government investigations, and product liability, including class action and mass tort litigation related to claims and representations regarding product performance and safety. 

Clients report that our practice is one of a kind in its holistic, innovative, business-oriented, and end-to-end approach to risk management and mitigation.

Who we are. Our group consists of more than 25 lawyers and policy professionals from our offices across the United States as well as in Europe, and is led by former high-level government officials and nationally recognized prominent litigators in products liability and consumer protection. We were most recently selected to Law360's "Consumer Protection Practice Groups of the Year" listing, which describes our practice as helping "clients distinguish their products in a hectic, overcrowded market."

What we do. We help clients develop legal strategies that support business growth and minimize risk in a highly competitive and complex environment. We work with clients to address regulatory compliance and litigation relating to the design, manufacturing, marketing, distribution, and sale of products across a wide range of industries. Our practice is one of a kind in its holistic, innovative, practical, business-oriented, and end-to-end approach to risk management and mitigation.

Our team leverages deep knowledge in the wide range of legal fields this work requires, including:

  • government investigation and enforcement
  • product liability litigation
  • consumer class action defense
  • risk counseling
  • reputation and crisis management
  • sourcing, supply chain, distribution, and recall management
  • product safety
  • privacy and data protection
  • import/export
  • chemicals and environmental
  • warranty
  • regulatory compliance programs
  • due diligence evaluation of target acquisitions for product liability risks

 

This enables us to handle the full range of commercial and regulatory legal issues facing our clients in a comprehensive and integrated approach focused on mitigating risk.

Experience before government agencies. We regularly appear before regulatory authorities such as the U.S. Consumer Product Safety Commission, the Federal Trade Commission, the U.S. Food and Drug Administration, the National Highway Traffic Safety Administration, the Environmental Protection Agency, Customs and Borders Protection, the Occupational Safety and Health Safety Administration, state attorneys general and regulatory agencies, Health Canada, Transport Canada, and the European Commission. We have a track record of successfully litigating federal and state consumer protection and product safety enforcement matters, defending federal and state consumer class action litigation, and counseling on product recall issues.

Lifecycle management. Our Group works with companies across a wide range of industries that develop and sell products and services, including manufacturing, consumer products, food and beverage, telecommunications and media, and retail. We guide our clients as products and services are first conceived in design and in how best to position and monitor their innovations in the marketplace. We help our clients prepare for and address issues that may arise through the manufacturing of their products, distribution, and, ultimately, delivery to the end user. We coordinate with our Advertising and Media team to consider any media, branding or sweepstakes needs. We work with clients to maximize the value of their products and services, as well as their brands at every step of the lifecycle and distribution chain, and to minimize unpleasant surprises, whether from litigation, adverse regulatory action, or damage to brand reputation.

Product and service experience. We have represented some of the nation's leading companies in categories where the most narrow market share advantage is a battleground, including:

  • airlines
  • airplane and helicopter parts
  • alcoholic beverages
  • appliances, household and industrial
  • automobiles and auto parts
  • aviation and drones
  • building and construction materials
  • chemicals
  • children's products
  • cleaning products
  • cookware
  • cosmetics
  • diapers, tampons, and paper products
  • dietary supplements
  • e-cigarettes and chargers
  • filters for air and water
  • food and beverages
  • glass and glassware
  • herbicides and insecticides
  • home furnishings and accessories
  • hospitality
  • housewares
  • HVAC and refrigeration units
  • medical devices
  • mobile devices and handsets
  • office supplies
  • paints and thinners
  • paper products
  • personal care products
  • pet supplies
  • protective equipment
  • recreational vehicles
  • robotics
  • safety equipment
  • software
  • sports equipment
  • telecommunications services
  • televisions, computers, printers, and consumer electronics
  • textiles
  • toys

 

Our Approach

Work as a team to address the full life-cycle of our clients' innovations. We work as a team, bringing the best and most relevant talent to the multifaceted challenges faced by your business. We hope to be in it for the long haul with you. So we encourage clients to get to know all of our lawyers and to feel comfortable with the team.

We partner with clients to develop comprehensive risk evaluation and early warning systems to reduce life-cycle costs for existing and new business ventures. Our experience, and the experiences of our clients, confirm that well-structured, front-end investment in these systems consistently produce significant cost savings and the avoidance of lawsuits and claims over the life of the products and services our clients create, sell, and support. When challenges are lodged, our clients are better prepared to defend them. We team clients with our experienced regulatory and prevention counselors, as well as tort litigators and trial lawyers, to develop compliance programs and business processes that envision how government regulators, courts, and opposing counsel may characterize events months or years in the future.

Embrace regulatory authorities. Our clients do not run and hide from regulatory agencies or from tort or regulatory legal requirements. Instead, they build good will and trust with agency officials over time. Crowell & Moring regularly helps our clients meet regulatory authorities and come to know them. Over and over, as other regulated entities suffer fallout from "run and hide" strategies, our clients build on the trust they have developed to avoid or mitigate adverse agency action.

"Become" our clients. We work intensely to build knowledge and understanding of our clients' products, industries, corporate philosophies, business goals, and strategies, then tailor our legal advice and representation to our client's needs and personality. We often come to serve as their institutional memory when it comes to developing new areas of business and evaluating a business idea's legal history and track record.

Understand, then achieve, victory. We learn early how our clients define "victory" in the potential outcome of their legal challenges and direct our counseling, litigation, and regulatory efforts to achieve that goal. We don't grandstand or pound our fists on tables for show. Our approach is tenacious, hardworking and detail-oriented. We dig deep into the facts and science to unlock issues and strategies for success.

Add value, not just bill time. We help you manage legal costs through application of the latest project management technology in order to stay on track and on budget, to staff and run matters efficiently and cost effectively. But, we also add continual value by watching out for your issues, business and legal team. We provide regular alerts and reports, and offer complimentary training programs on legal issues, so that you can stay on top of legal developments affecting your business. We invite you to participate with us at events and conferences, helping contribute to thought leadership and creating opportunities to make connections and build goodwill for your business.

Representative Matters

Transportation Product Regulation

  • Advising a component manufacturer client on Corporate Average Fuel Economy (CAFE) and Greenhouse Gas standards applicable to heavy duty trucks as administered by the EPA/U.S. National Highway Traffic Safety Administration (NHTSA).
  • Counseled a non-road engine manufacturer regarding the ability to manufacture and distribute engines meeting older emission standards as part of an equipment replacement program.
  • Advised a major heavy-duty engine manufacturer regarding new nonroad and onroad requirements promulgated by EPA.
  • Counseled a first tier supplier on warranty issues regarding cracking windshields.
  • Assisted an automotive component supplier with reporting a noncompliance with Federal Motor Vehicle Safety Standards (FMVSS) to NHTSA and successfully obtained a determination of inconsequent noncompliance, thus avoiding a costly recall campaign.
  • Advised a component supplier regarding U.S. Coast Guard requirements applicable to shift mechanisms used in small boats, including guiding that client through a service campaign.
  • Assisted a major airline carrier to comply with mandatory Customs and Border Patrol orders with respect to a quarantined plane needing treatment prior to resumption of commercial service.

Chemicals, Pesticides and Hazardous Materials

  • Counseling a large technology company regarding compliance with the e-waste laws and pending legislation in various states.
  • Advising a major chemical trade association's members on Occupational Safety and Health Administration's (OSHA) implementation of the Globally Harmonized System of Classification and Labeling (GHS).
  • Defended a pesticide manufacturer's product from proposed EPA label modification and possible cancellation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
  • Represented a pesticide manufacturer in several data compensation claims seeking payment for competitor’s use of data in  obtaining EPA registrations.
  • Assisted a client in responding to California's Proposition 65 60-day notice alleging violation of requirements for labeling products including known toxins resulting in no further action.
  • Represented a major transport company in an enforcement action for the alleged illegal disposal of hazardous waste.
  • Represented an aircraft parts supplier in an EPA Superfund removal action involving warehouses of surplus radium-containing aircraft components.

Consumer Product Safety and Recalls

  • Negotiated a pro-rated refund for affected consumers for a client undertaking a U.S. Consumer Product Safety Commission (CPSC) recall, avoiding payment of full refunds.
  • Negotiated a relabeling corrective action plan with the CPSC for a client, avoiding the necessity and attendant costs of a full scale recall.
  • Represented an appliance manufacturer before the CPSC and convinced the agency that no substantial product hazard existed from transformer failure, and thus avoiding the need for any corrective action.
  • Performed analyses of multiple companies' entire product lines under the new Consumer Product Safety Improvement Act (CPSIA) and advised these clients on steps for compliance. Major focus included identification of products requiring compliance with the new children’s products rules and other certification rules.
  • Providing counseling and representation in connection with the CPSC’s Chinese drywall investigation.
  • Provide due diligence evaluations of potential acquisitions for regulatory compliance and product liability risks.

Food, Drug, Device, and Cosmetics Regulation

  • Represented and counseled clients on a wide variety of regulatory and compliance matters covering the full range of U.S. Food and Drug Administration (FDA)-regulated products including prescription and over-the-counter (OTC) drugs, biologics, medical devices, foods, dietary supplements, animal feed and veterinary products, and cosmetics.
  • Offered counseling on good manufacturing practices and quality systems regulations, FDA reporting requirements, product labeling, and product approvals. We also provided a full range of compliance services aimed at preparing clients for successful FDA inspections, including the development and evaluation of FDA compliance programs, evaluating the adequacy of Standard Operating Procedures (SOPs) and investigation reports, providing inspection management counseling and training, developing recall strategies, and assisting clients at regulatory meetings and in responding to Form FDA 483s and Warning Letters.
  • Provided regulatory advice concerning corporate transactions, and conduct regulatory due diligence for corporate financing and in mergers and acquisitions. On legislative matters, we have assisted clients in development of strategies, assisted clients with testimony, prepared clients for interviews with congressional committee staff and provided advice on pending legislation.

Product Quality and Supply Chain Counseling

  • Assisted manufacturer in developing process for regulatory and legal risk mitigation review and checklist from design through post-sale.
  • Provided legal and regulatory risk assessment to industrial client considering a third party branding strategy of consumer goods.
  • Developed product testing and quality assurance procedures with client, including drafting disclaimer and limitation of liability language for sales invoices, to reduce and shift legal risks for component supplier.

International

  • Provided regulatory advice regarding the European Commission REACH (Registration, Evaluation and Authorization of Chemicals) program to a large telecom company.
  • Advised clients regarding the impact of European Union (EU) Environment Health & Safety (EH&S)-driven product laws, such as Registration, Evaluation, Authorization, and Restriction of Chemical substances (REACH), Restriction of Hazardous Substance (ROHS), and the Waste Electrical and Electronic Equipment directive (WEEE).
  • Advised a children products manufacturer regarding liability and regulatory issues in Europe.
  • Advised U.S. importers on the U.S. Customs and Border Protection (CBP)/ CPSC Importer Self Assessment-CPSC program to reduce importation costs and increase speed to market.
  • Assisted U.S. importers on CBP enforcement actions, detention, seizures and penalties related to violations of other agency regulations.
  • Provided advice to clients regarding compliance with international agreements and laws related to environmental, health, safety, hazardous materials, and labor issues applicable to goods traded internationally.
  • Assisted foreign manufacturers with product quality and supply chain issues to ensure compliance with U.S. and international laws.
  • Assisted clients with negotiations of international agreements on environmental, health, safety, hazardous materials, and labor laws.
  • Advised clients in matters before Canadian agencies that deal with product health and safety regulations, including proposed action taken under Canada’s Chemical Management Plan involving review of the 23,000 chemicals on the Domestic Substances List (DSL).

Hazmat Transportation Counseling

  • Assisted a U.S. shipper in recovering a seized package abroad and successfully avoiding enforcement action.
  • Defended and negotiated settlements in actions brought against airlines and shippers by the Federal and Aviation Administration (FAA).
  • Assisted a liquor manufacturer respond to a letter of investigation related to a shipment.
  • Advised a major U.S. manufacturer regarding international shipment of gas samples and confirming that the samples are not covered by the HMR.

Food and Beverage

  • Assisted with preparing a successful response to inspectional observations (Form 483) following an establishment inspection by FDA.
  • Provided advice on meeting the requirements of the latest food safety legislation, including new requirements for menu and other nutrition labeling.
  • Assisted with preparing for biotechnology consultations at FDA for genetically modified food.
  • Provided advice on avoiding food adulteration problems and other compliance issues relating to adulterated food.
  • Provided advice on the scope and substance of FDA regulations covering food contact surfaces and guidance on complying with such requirements including:
    • Provided advice on FDA requirements for food packaging.
    • Assisted with the submission of food contact notifications.
    • Assessment of the sufficiency of testing products intended as food contact surfaces.
  • Provided advice on whether new products containing specific antimicrobial and antifungal constituents are regulated by FDA as food contact substances, and if so, whether they complied with applicable FDA regulations.
  • Assisted with preparing food additive petitions for submission to FDA.
  • Provided advice on labeling requirements for pet food and other pet care products.
  • Provided advice on safety requirements and other compliance issues for pet food and other pet care products.

Product Labeling Advice

  • Provided labeling advice on sporting apparel and accessories.
  • Advised on use of registration cards as precondition to warranty coverage and related warranty issues.
  • Assisted client in defending U.S. Environmental Protection Agency (EPA) allegation of inappropriate use of EnergyStar logo.
  • Performed legal and regulatory review of pesticide product labels, including directions for use, appropriate precautionary statements, and claims used in marketing.
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Professionals