Medical Devices

From our work with medical device companies, we know we can achieve better legal outcomes by looking at issues through multiple lenses. Motivated by this perspective, our legal team brings together medical device lawyers from diverse legal practices to ensure that our client’s needs are addressed from all angles, leading to a thorough and effective resolution. 

Over the course of our work with medical device companies, we have developed substantial experience in growing areas of legal risk. 

Regulatory Counseling and Compliance

Each medical device client we work with faces regulatory risks and challenges that are unique to the particular products they make, the facilities where they manufacture them, and the ways in which they deliver them to market. We work with clients on their most difficult challenges, helping them to enhance compliance programs to meet applicable U.S. regulatory requirements, and to limit exposure if and when noncompliance occurs. With our focus on diligence and risk mitigation, Crowell & Moring can help clients avoid litigation and enforcement actions.

• Risk management advice and counseling.
• Advising O.U.S. medical device companies on compliance with regulations before, during, and after entry into the U.S. market.
• Pre-market development and review strategies.
• Preparing for, managing, and responding to FDA inspections and enforcement actions.
• Product labeling issues including indications for use and warnings.
• Complaint handling and reporting.
• Products investigations, addressing defects, and handling recalls.

Litigation, Trials, and Appeals

When medical device litigation is unavoidable, central to our litigation success is developing a comprehensive litigation strategy that takes into account our clients’ legal and business objectives, the regulatory and legislative landscape, and public sentiment. This interdisciplinary approach enhances our top priority: to protect the integrity of our clients’ products and reputations. Early stage conversations focus on identifying client goals, early case assessment, risk mitigation, and cost-savings.

• Individual and mass action litigation related to product defect claims
• National coordinating, local, and trial counsel in individual and aggregated proceedings
• Investigations, including FCPA and false claims act matters
• Corporate counseling on public disclosure requirements and corporate structuring to limit liability

Intellectual Property

Medical devices involve an exceptional amount of R&D – which raises a host of intellectual property issues. Our IP lawyers help medical device manufacturers and companies identify the IP assets of their devices, and provide guidance and counseling in the development, protection, and monetization of those assets.

• Designing and implementing patent portfolio strategies.
• Advising on new product clearances.
• Providing assistance on issues involving patent prosecution.
• Providing offensive and defensive litigation relating to patent infringement.
• Protecting IP rights through effective litigation in matters involving patent validity and enforceability.

Corporate and Transactional

Our corporate and transactional attorneys help medical device clients manage business issues involving mergers and acquisitions, including target company due diligence and divestitures. We also have extensive experience negotiating and drafting distribution and supply agreements, indemnification and warranties, SEC disclosures related to litigation, and security disclosures related to contractual arrangements in the medical device arena.

Emerging Issues

• Medical devices and the Internet of Things (IoT)
• Medical Devices and Digital Health

Domestic and International Government-Related Matters

• International policy and regulatory affairs consulting (Crowell Global Advisors)
• International trade issues, including customs and anti-dumping
• Domestic government contracting and procurement
• Domestic government affairs and strategic policy engagement

Health Care

• Federal health benefits programs
• Anti-kickback and Stark law issues
• Medicare reimbursement
• Privacy law
• Foreign Corrupt Practices Act (FCPA)