Practice/Industry Group Overview
Pharmaceutical and medical device industries face increasingly complex challenges. Evolving case law, driven largely by Supreme Court decisions and sweeping new regulations, underscores the need for ongoing monitoring and analysis. With 30 years of related experience and a material presence in Washington, D.C., Wilson Elser understands this shifting landscape. We have helped countless pharmaceutical and medical device manufacturers with legal issues, whether simple and local or complex and multijurisdictional.
We have helped countless pharmaceutical and medical device manufacturers with legal issues, whether simple and local or complex and multijurisdictional.
The process of obtaining FDA clearance or approval of pharmaceutical and medical devices can be especially challenging. Even after a product is cleared or approved, companies frequently face complications related to compliance, labeling, marketing, recalls and litigation. Wilson Elser works in close collaboration with its drug and device clients to develop and implement strategies to successfully navigate this regulatory labyrinth.
Wilson Elser serves domestic and foreign manufacturers of drugs and medical devices in connection with regulatory compliance, claims and litigation. We act in various capacities, including national coordinating counsel, litigation and trial counsel, in defending suits against name-brand and generic drugs and approved or cleared medical devices. The firm’s national in-house infrastructure facilitates the handling and defense of large, cross-jurisdictional mass tort litigation with dockets numbering in the hundreds. The firm’s national network of 24 strategically located offices provides an essential forum for developing and coordinating uniform mass tort defense strategies.
Wilson Elser attorneys proactively identify innovative ways to resolve disputes at the earliest opportunity utilizing dialogue, arbitration, mediation or other forms of alternative dispute resolution. When early or alternative resolution solutions are not practical, our attorneys do not hesitate to try cases in court. Whether in local or district courts, Wilson Elser is proud of its reputation as one of the largest and most successful trial firms in the country. Our attorneys understand the limitations of a “one size fits all” litigation approach and devise intelligent closure strategies unique to our clients and their business realities. Many also enjoy practical medical experience from previous careers, further enhancing their ability to resolve the complex legal issues that have come to define this practice.