Life Sciences — Medical Device and Pharmaceutical Litigation

The confluence of technological and clinical advancements, an aging population, and increasing incidence of chronic disease has led to skyrocketing growth in the medical device and pharmaceutical industries. As companies push technological boundaries to meet new demand, they face an increasingly complex array of litigation and compliance issues. 

Drawing on our significant experience working with medical device and pharmaceutical companies, from start-up ventures to leading international companies, we know we can achieve better legal outcomes by looking at issues through multiple lenses. Our legal team brings together lawyers from diverse practices to ensure that our clients’ needs are addressed from all angles, leading to a thorough and effective resolution.  

With offices and local counsel relationships in many key international jurisdictions, Crowell has the capability and experience to coordinate and handle international litigation on specific products, thereby ensuring clients are able to leverage the knowledge gained in each jurisdiction and disseminate it to other jurisdictions litigating the same product. This not only provides consistency in arguments made across jurisdictions, but also helps clients reduce the cost of international litigation by using the same counsel in multiple jurisdictions world-wide. 

Medical Device Litigation and Investigations

In the medical device space, we assist clients with litigation mitigation strategies, counsel on emerging trends, and help craft and implement robust strategies for enforcing our client’s rights or defending them in litigation, when needed. Central to our litigation success is developing a comprehensive litigation strategy that incorporates our clients’ legal and business objectives and the regulatory and legislative landscape.  

Our services include:  

• Defending against individual and mass action litigation related to product defect claims 
• Enforcing our innovative clients’ patent rights for medical device products as well as defending them against claims of patent infringement  
• Serving as national coordinating, local, and trial counsel in individual and aggregated proceedings involving all types of medical-device related litigation and arbitration 
• Handling investigations, including Foreign Corrupt Practices Act (FCPA) and False Claims Act (FCA) matters 

Pharmaceutical and Biologics Litigation 

Crowell is home to a team of litigators representing and advising clients across a wide breadth of litigation issues in the pharmaceutical sphere, including intellectual property and product liability. Our team’s intellectual property litigation experience includes representing clients in patent infringement cases arising under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act (BPCIA), challenging and defending patents before the Patent Trial and Appeal Board (PTAB), and enforcing and defending our biotechnology clients in trade secrets disputes across the country, including under the Defend Trade Secrets Act (DTSA). Our Chambers-ranked product liability team has defended clients in some of the largest pharmaceutical multidistrict litigations and regularly litigate individual cases in courts across the U.S.

Our group includes first-chair life sciences trial litigators (both non-jury and jury), lawyers with technical degrees, including advanced degrees in the relevant disciplines, and lawyers experienced in working with experts to develop the relevant testing and opinion testimony that in many cases is critical to success. Our life sciences patent litigation team has been victorious in courts throughout the country.

Our lawyers also have experience advising clients regarding the relevant regulatory framework governing their businesses. Our lawyers work with clients to address matters in nearly every aspect of litigation arising under the Hatch-Waxman Act, BPCIA, DTSA, and the FDCA. In addition to litigation, we also are experienced with citizen petitions filed with the Food and Drug Administration (FDA) on various regulatory issues that may concern approval, exclusivity, forfeiture, or other issues critical to the successful commercialization of biopharma products. In addition, we have experience with patent term extensions under 35 U.S.C. §156 for both drug and medical device products.