For pharmaceutical, medical device and other FDA regulated companies, controversy arises at all stages of the product life-cycle, including product development, clinical trials, collaboration, supply, manufacturing, distribution, licensing, joint-ventures, profit-sharing, and royalty agreements. Our experience can assist regardless of when a dispute occurs in the product cycle.
We can also help you prevent disputes from arising in the first place. Our litigators frequently work directly with life sciences companies at the contract drafting table, putting our deep subject and industry experience to work for you at the start to discover potential issues, address them, and prevent them from creating litigation down the road. Our work in this area has included a broad range of FDA regulated products, including prescription and OTC drugs, medical devices, cosmetics, food and supplements.
Over the decades new theories of liability have emerged supplanting the traditional strict product liability doctrine for manufacturing defects, design defects, and marketing defects (or failure to warn). State or federal enforcement often leads to “follow-on” litigation. Our experience is well suited to defending against sophisticated new approaches that often draw on state law-based claims “paralleling” federal requirements. Our team of trial lawyers has appeared throughout the United States in state and federal courts and administrative agencies and has managed litigation for some of the world’s largest companies.
Our team has been involved in some of the largest litigation and proceedings in the country and has handled complex medical products litigation for clients on national and regional bases. Our litigation management team adds efficiency, thoroughness and cost savings in formulating and implementing programs to manage litigation using several project-focused strategies.
Manufacturing and Distribution Counselling
We counsel clients regarding supply and distribution of FDA regulated products, including supply agreements, facility and product licensing, registration, supplier and supply chain compliance, supplier verification, track and trace, and establishing and revising policies and procedures. We handle issues concerning labeling, claims substantiation, new dietary ingredients (NDI), packaging, and the changing regulatory and compliance landscape.
We counsel regarding traditional print, broadcast, and internet advertisements and promotional content, concerning regulatory compliance for conduct and promotional activities. Our experience extends from matters before the FDA to those where the FDA and FTC share jurisdiction over FDA-regulated product advertising and promotion. In addition to our focus on compliance, we bring our litigation experience to bear in defending governmental, competitor and consumer false and deceptive advertising, Lanham Act, and misbranding claims.
We represent clients in negotiating with state and federal agencies, including FDA, FTC, USDA, and CBP regarding inspections, product detention, and product recalls to matters involving enforcement and administrative proceedings (483s), warning letters, and injunctions.
- Products Liability
- Healthcare Liability
- Regulatory Compliance – Enforcement