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The confluence of technological advancements, an aging population, and increasing incidents of chronic disease has led to skyrocketing growth in the medical device industry. From leading international companies to start-up ventures, as medical devices manufacturers and distributors push technological boundaries, they face an increasingly complex array of litigation and compliance issues.

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.
  • Drafting healthcare innovation partnership agreement for a major technology company and providing regulatory advice on healthcare, data, and artificial intelligence.
  • 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

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 (C&M International)
  • 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)

Click here for a listing of representative engagements.

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Crowell & Moring Lawyers Engage with Corporate Officers at National Bar Association Commercial Law Section’s Annual Corporate Counsel Conference (Mar.05.2021)
Firm News/Announcement
CPSC Acting Chairman Adler to ICPHSO: Caretaker No More! (March 1, 2021). Authors: Matthew Cohen and Carolyn W. Wagner.
Publications
Recalls in Review: Power Tools (February 24, 2021). Authors: Carolyn W. Wagner and Colleen Johnson.
Publications
"FDA and the Response to COVID: Lessons Learned, and Where the Agency Goes From Here," Healthcare Ounce of Prevention Seminar (HOOPS) 2021: Health Care in the Biden Era (February 23, 2021). Presenters: John Fuson, Chalana N. Damron, and Nicholas J. Diamond.
Speech/Presentation
Cybex Civil Penalty at CPSC Confirms Return of Enforcement Tool (February 12, 2021). Author: Matthew Cohen.
Publications
"GAO Calls on FDA to Prepare to Resume Inspections of Drug Manufacturers," Mass Tort, Product, and Consumer Litigation Alert (February 9, 2021). Contacts: John Fuson, Chalana N. Damron, Eryn Howington
Client Alert/Newsletter
"Prop 65 Update, Notice of Proposed Rulemaking: Amendments to Short-form Warnings," Retail Industry Leaders Association, Consumer Products Committee Monthly Call (February 9, 2021). Presenter: Sigourney R. Haylock.
Speech/Presentation
Recalls in Review: Candles and Candle-Related Products (January 31, 2021). Authors: Carolyn W. Wagner and Colleen Johnson.
Publications
New National Standard for Flammability of Upholstered Furniture (January 22, 2021). Authors: Carolyn W. Wagner and Eric A. Stahl.
Publications
"Florida’s New Year’s Resolution: A "More Rational, More Fair, and More Consistent" Summary Judgment Standard," Mass Tort, Product, and Consumer Litigation Alert (January 12, 2021). Contacts: Andrew D. Kaplan, Luke Bresnahan
Client Alert/Newsletter

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Crowell & Moring LLP is an international law firm with approximately 550 lawyers representing clients in litigation and arbitration, regulatory and policy, and transactional matters. The firm is internationally recognized for its representation of Fortune 500 companies in high-stakes litigation, as well as its ongoing commitment to pro bono service and diversity, equity and inclusion. The firm has offices in Brussels, Doha, London, Los Angeles, New York, Orange County, San Francisco, Shanghai, and Washington, D.C.

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