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Mass Tort, Product, and Consumer Litigation

Overview

With an eye towards effectively managing current challenges while mitigating future risk, we work closely with clients to achieve their desired business outcomes as they relate to product regulation and litigation and environmental torts.

Crowell advises clients on the full lifecycle of their products, from the early stages of development and engineering, to manufacturing and testing, to marketing and labeling, to distribution and sales. Our lawyers understand the agreements needed, the regulatory agencies involved, and the approvals and review necessary to thrive in the marketplace. Once in market, we protect our clients and their products from unforeseen challenges that arise, including disputes over environmental concerns, regulatory inquiries and alleged product defects.

When the inevitable disputes arise over products, environmental contamination, or premises liability, we combine product and industry experience with aggressive and creative legal strategy. We help clients quickly and efficiently resolve regulatory actions, as well as single plaintiff litigations, class actions, mass actions, and multidistrict litigation (MDL).

Forward-Thinking Businesses, Practical Concerns

Leading national and global companies across industries turn to Crowell to handle matters related to their products. Our experience covers products such as:

  • Pharmaceuticals
  • Medical Devices
  • Cars
  • Trucks
  • Automotive Parts
  • Chemicals
  • Toys
  • Clothing
  • Food and Beverage
  • Furniture
  • Cosmetics

Litigation

Our team has proven experience helping clients bring their products to market, guiding and protecting them in the regulatory arena both before and after sales begin, and defending them in court against any allegations of defect. This product lifecycle perspective informs our approach to litigation both large and small, including:

  • Representing clients in class actions, mass plaintiff cases, and some of the largest multi-district litigations in the country.
  • Serving as national coordinating counsel for clients with nationwide state and federal court litigation dockets.
  • Managing individual product liability dockets and litigate individual cases throughout the country and abroad.
  • Representing clients in arbitration proceedings of all shapes and sizes.
  • Pursuing indemnity or other recovery from responsible entities.

Regulatory

When a company faces agency scrutiny, our close government contacts and vast regulatory experience enable us to provide fast and effective counsel. And using our litigation experience, we ensure that any legal response considers the potential impact on a defense strategy should litigation ensue – which it frequently does. We regularly represent clients in front of the CPSC, FDA, and NHTSA.

Public Relations

We work hand-in-hand with clients through every step of a crisis, including the quick handling of incident investigations, crafting appropriate responses to government and media inquiries, and developing statements to employees and other stakeholders. These efforts require a steady eye towards mitigating potential litigation risk.

Insights

Event | 12.03.24

29th Annual Drug & Medical Device Litigation Conference

2024 has been a pivotal year for drug and medical device litigation, marked by significant case law developments that have reshape the landscape.

Representative Matters

Medical Devices

  • Serve as U.S. national counsel for product liability litigation for an international medical device company, successfully defending them in dozens of hip implant lawsuits and claims over the past decade without a single adverse judgment or settlement.
  • Serve as national counsel for one of the largest U.S. health care and medical device companies in IVC filter litigation involving thousands of claims in more than ten U.S. jurisdictions and in Canada.

Pharmaceuticals 

  • Lead counsel for a Fortune 20 company in two of the largest pharmaceutical MDLs in the country. Served in a defense group leadership position in the largest of the MDLs, for which all claims have been dismissed.
  • National and international counsel for the entire docket of pharmaceutical, medical device, and dietary supplement product liability litigation for a global company. 
  • Lead counsel for a pharmaceutical company in multi-jurisdictional litigation involving allegedly tainted pharmaceutical. We favorably resolved part of the litigation while we are aggressively litigating the remainder to meet client objectives.
  • Lead counsel for a pharmaceutical company in mass action in West Virginia involving supply of allegedly tainted radio-pharmaceutical. Favorable resolution reached.

Food and Beverage 

  • Advised an international ready-to-eat food manufacturer on a variety of food safety compliance issues, including meeting obligations under the Food Safety Modernization Act; implementing preventive controls across multiple manufacturing sites; advising on criteria for reporting concerns to FDA and preparing submissions to the Reportable Food Registry; responding to findings of objectionable pathogens in food and food preparation areas; coordinating recalls of products presenting safety concerns; navigating FDA inspections at multiple manufacturing sites; responding to FDA inspectional observations; and facilitating meetings with FDA to present on and discuss advances in food safety.
  • Helped a client develop strategy in response to FDA recall demands following discovery of salmonella in the client’s manufacturing facility. Crowell guided the company through meetings with FDA officials, including with the Director of FDA's Center for Food Safety and Applied Nutrition, to arrive at a reasonable recall plan to ensure consumer safety.

Product Risk Management 

  • Assisted a large international retailer with entering the U.S. market and developed their consumer product safety compliance program. We worked with them to ensure their products met all U.S. regulatory requirements, including FTC labeling requirements and CPSC and FDA mandatory and voluntary standards. We also built their compliance program from the ground up, drafting both their product safety policy and vendor management handbook.
  • Counseled a consumer electronics manufacturer and retailer with regard to the launch of an interconnected, animatronic product, including CPSC testing and certification requirements, FTC and FCC expectations, warranties, required product labels, product manuals, and warnings with regard to product use.

Automotive Litigation and Regulatory Actions

  • Represent major automobile manufacturer in more than a dozen high profile nationwide and multi-state consumer class action lawsuits in federal courts throughout the United States alleging consumer fraud, warranty, unfair competition, and false advertising claims under state and federal laws. These cases involve a range of automotive issues, including allegations related to thermal performance, oil consumption, fuel pumps, infotainment systems, brake pumps, transmissions, and connected car features.
  • Served as NHTSA regulatory counsel to a Chinese-owned manufacturer of automotive safety systems as they began the acquisition of most of the assets of a company that had undergone a worldwide airbag recall. We represented the client before DOJ, NHTSA, CFIUS, PHMSA, and provided general advice and counseling.

Occupational and Environmental Class Action Litigation

  • Represent a Class 1 railroad in three consolidated putative class actions alleging the railroad is liable for negligence, nuisance, and trespass for failing to design its tracks to protect against hurricane-related flooding in North Carolina. We have also represented CSX in numerous putative class actions involving train derailments and community evacuations.
  • Represent a global chemical company in PFAS litigation in the U.S. District Court for the Southern District of Ohio. Plaintiff alleges that he was exposed to PFAS (per-and polyfluoroalkyl substances) in firefighting foams and other equipment in a forty-year career as a firefighter. He seeks certification of a nationwide class of all persons – allegedly more than 99% of the U.S. population – who have detectable levels of PFAS in their blood. 
  • Represent several major oil companies in one of the largest dockets of litigation ever filed over product liability claims for alleged environmental damages resulting from a chemical known as MTBE. The litigation includes hundreds of cases filed nationwide over the effects of MTBE in groundwater when gasoline with the chemical spilled or leaked from storage facilities and service stations, most of which were consolidated in a multidistrict litigation. We play a leadership role in the defense of these cases in courts across the country.

Asbestos Litigation Coordination and Strategic Counseling

  • Serve as national coordinating counsel for a chemical manufacturer and a telecommunications company in asbestos litigation. Our work on behalf of these clients includes developing long-term national strategy, expert development, trial strategy, management of a centralized discovery and oversight of a large network of law firms.
  • Acted as national coordinating counsel for a construction equipment manufacturer in asbestos matters and continue to provide strategic input for its current docket. We assisted our client in developing its defense, preparing its corporate witnesses and experts, and developing and implementing its trial and motion strategy through its network of product trial counsel.
  • Provided due diligence reviews and counseling for asbestos dockets on multiple occasions when companies sought to purchase entities with asbestos dockets. We have also conducted numerous corporate structure analyses, investigated predecessor liability for asbestos matters, and effected tender requests/responses and indemnification approaches where applicable.

Insights

Event | 12.03.24

29th Annual Drug & Medical Device Litigation Conference

2024 has been a pivotal year for drug and medical device litigation, marked by significant case law developments that have reshape the landscape.

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Professionals

Insights

Event | 12.03.24

29th Annual Drug & Medical Device Litigation Conference

2024 has been a pivotal year for drug and medical device litigation, marked by significant case law developments that have reshape the landscape.