Denise Bense authored a section on “Medical Device Approvals” in DRI’s recently published “FDA Basics for the Drug and Medical Device Lawyer.” More
The unique perils of products liability laws and regulations are well known to companies involved with the manufacture or sale of commercial goods. Unlike other torts, when it comes to products liability, the evidentiary burden for plaintiffs is relatively low and the exposure for defendants can be extraordinarily high. Even the most vigilant, safety-conscious companies must be prepared to respond to serious products liability claims. In this era of globalized trade and extensive cooperation and communication among plaintiffs’ firms, companies should expect the frequency of products liability filings, particularly multi-jurisdictional class claims, to increase.
Cozen O’Connor has been a leader in products liability defense for more than three decades. Our attorneys represent foreign and domestic designers, manufacturers, and distributors of a diverse array of products, from food and drugs to industrial equipment and building materials. We help clients respond to major personal injury and property damage claims in the form of single-product cases, class actions, mass torts, and multidistrict litigation, as well as all types of congressional, regulatory, or criminal investigations. We routinely appear before state and federal courts, arbitration panels, and federal agencies, including the Food and Drug Administration and Consumer Product Safety Commission.
Members of the products liability team serve as ongoing national counsel to major products manufacturers. In this role, we build long-term client relationships and work closely with corporate counsel to minimize a company’s overall liability, establish efficient protocols for fielding claims, and limit the need for in-house litigation support. We advise clients about labeling, marketing, manuals and instructions, supply and distribution contracts, and insurance and indemnification issues. We analyze clients’ possible exposure to particular losses and mount an immediate and aggressive response to threatened or filed claims.
Our attorneys not only have deep knowledge of the relevant law, but also a keen understanding of the importance of adept case management and superior preparation. Cozen O’Connor’s Products Liability Group has designed a proprietary database that can be tailored to track specific industries and clients when issues arise. Additionally, we have formed a network of more than ten thousand accredited scientific experts, from metallurgists to pharmacologists, who work with our attorneys to interrogate every aspect of a case.
The firm has a successful track record of trying complex cases. More attorneys at Cozen O’Connor have first-chaired products liability trials than at any other comparably sized firm. This benefits our clients in numerous ways. Having regularly been through the crucible of trial, our attorneys’ strategic advice is based on an accurate understanding of how facts and arguments are likely to be perceived. Moreover, our reputation as trial lawyers gives us leverage in negotiations because adversaries know we settle only to serve our clients’ best interests – not to avoid court.
While our clients demand the highest-quality legal services, cost containment and budget predictability are also important concerns for well-managed companies. Particularly in products liability litigation, where the full scope of a problem may not be immediately clear, Cozen O’Connor works closely with clients to develop litigation strategies that limit exposure and prevent escalation. We staff tight teams led by senior attorneys who communicate directly with clients about strategy and ongoing claims management.
Serve as national trial counsel and national coordinating counsel for product manufacturers
Represent manufacturers, distributors, suppliers, and retailers
Defend against allegations of products liability, including negligence, strict liability, breach of warranty, and consumer protection violations
Manage single-product cases, class actions, mass torts, and multidistrict litigation
Advise clients regarding underlying potential liabilities and exposure to particular loss claims, and review contracts, warning labels, and sale or distribution protocols
Negotiate cross-jurisdictional global sourcing agreements between foreign makers of component parts and stateside assemblers or manufacturers
Food Contamination & Recall. Our attorneys routinely handle high-stakes food products liability claims and provide food-industry crisis management services. We help clients respond decisively at the first sign of trouble and defend clients in major food recall cases.
Safety Products. Cozen O’Connor is a leading advocate for the smoke alarm industry, serving as the national coordinating counsel and national trial firm for an international alarm products manufacturer. Our attorneys have successfully tried numerous cases to verdict in state and federal courts throughout the United States, often achieving wins for the defense on all counts.
Aviation. Our firm is known for its successful representation of aviation clients in a range of matters, including products liability, wrongful death and survival actions, personal injury, warranty claims and product recalls, and property damage. Because aviation litigation frequently involves multiple filings in multiple jurisdictions, Cozen O’Connor has a strong network of aviation attorneys in offices across the country and around the world.
Medical and Life Sciences. Cozen O’Connor’s attorneys combine sophisticated products liability experience with deep knowledge of the health care sector and cutting-edge medical technology. We are positioned to defend developers, designers, suppliers, manufacturers, and users of medical and life sciences products, particularly against claims of personal injury or wrongful death.
Additional Focus Industries. Cozen O’Connor also has extensive experience serving clients with exposures in the areas of sports equipment, automotive and off-road vehicles, construction equipment and building products, toxic torts and chemicals, firearms, and manufacturing equipment.
Cozen O’Connor’s team includes more than eighty lawyers who have distinguished themselves in the field of products liability. Our attorneys are named fellows of the American College of Trial Lawyers and the International Academy of Trial Lawyers, and are ranked by Chambers and Partners. In addition to being recognized by independent legal observers as among the nation’s “most influential” trial attorneys who are regularly involved in “significant verdicts,” our lawyers are also known for their intellectual gravitas. They serve on national boards and lecture frequently on products liability and tort defense.
While the design, manufacture, sale, and promotion of many products is now a global endeavor, the majority of U.S. products liability laws are determined by individual states and vary widely across the country. Top law firms, therefore, must be able to operate effectively on the international, national, and state level. Our attorneys have played lead roles in some of the most sprawling multi-jurisdictional products liability litigations to date, including in defense of asbestos, tobacco, and diet systems companies. With offices abroad and lawyers licensed across the United States, Cozen O’Connor has the capacity to respond to products liability matters wherever they arise.