Life Sciences - Medical Products & Technology
McDermott’s Medical Products & Technology Group is a global interdisciplinary team focused on counseling medical device and technology companies on the broad spectrum of legal needs they face. With leading practitioners from the Firm’s corporate, health, intellectual property, regulatory and trial practices, we provide our clients with comprehensive and integrated legal solutions. Our group includes 16 former senior prosecutors from U.S. Attorney’s Offices across the country and from the U.S. Department of Justice in Washington, D.C. Virtually all held senior supervisory positions. In addition, many of our lawyers came from the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA), or have served as in-house counsel for medical product and technology companies.
We advise medical product and technology companies on strategy in all stages of their development. From individuals and small privately held businesses to Fortune 500 companies, we serve clients’ strategic growth objectives through acquisitions, investments, securities, joint ventures, licensing, venture financing and grant funding from public and private sources. We assist clients with issues surrounding royalty monetization; due diligence; advertising; off-label promotion; premarket approval/510(k) requirements; FDA inspections of manufacturing, research and other activities (including criminal investigations and FDA enforcement actions, such as warning letter replies, investigator disqualifications); and drafting and prosecuting patent applications. Our experience also covers contract review, including clinical trial agreements, antitrust counseling, health care reimbursement, fraud and abuse counseling, federal tax matters, corporate maintenance and clinical research compliance.
Drawing on a team of more than 180 intellectual property lawyers, many with advanced scientific degrees, we work with clients to protect their intellectual property. We provide a comprehensive array of services, including patent, trademark and copyright prosecution; validity; non-infringement clearance analysis and opinions; portfolio evaluation; due diligence reviews; and licensing analysis and management. We routinely engage in “bet the company” litigation on behalf of medical device and technology companies. We have handled cases before the U.S. Court of Appeals for the Federal Circuit, U.S. district courts, state courts, the International Trade Commission, EU Member State courts, and arbitration proceedings in the United States and internationally.
Medical product companies look to us for our experience on a full range of regulatory issues throughout the product life cycle, from pre-market testing to all post-marketing related matters. Our advice spans both FDA regulation and international governmental issues, including the CE process in the European Union. We team with clients on the product approval process, including interpreting statutory and regulatory requirements; setting approval strategies for PMAs and 510(k)s; and interacting with the FDA, including negotiating requirements, meeting with the agency, and developing strategy for and participating with our clients in advisory committee meetings.
We advise medical product companies on privacy and confidentiality issues associated with electronic creation, transfer and storage of medical records and related security issues. We counsel clients with respect to the requirements of state, federal and international laws, including issues arising in connection with contributions to joint databases, utilization reviews and outcomes research, and U.S. and international clinical research undertakings.
Whether it’s dealing with EU dawn raids, addressing medical product global codes of conduct, appointing and terminating distributors, global compliance or manufacturing in China, we have the skill, experience and local knowledge across our global network of offices to assist clients in facing these challenging issues. We have experience with EU competition (antitrust) advice, EU registration of devices and EU environmental law in the manufacture of devices. Our lawyers have also advised medical device companies concerning EU-related privacy matters in connection with registry and ongoing clinical trials. We have worked with multinational pharmaceutical and medical device corporations on EU marketing authorizations, clinical trials and investigations, Good Manufacturing Practices and Good Distribution Practices. McDermott has a wide range of experience handling matters involving the U.S. Foreign Corrupt Practices Act (FCPA). Our lawyers have advised a number of clients regarding compliance with the FCPA, respecting both the anti-bribery provisions of the FCPA, which are applicable to all U.S. persons and administered and enforced by the U.S. Department of Justice, and the record-keeping and accounting provisions, which are applicable to public companies and administered and enforced by the U.S. Securities and Exchange Commission.
Contacts
- Bernadette M. Broccolo
+1 312 984 6911
Send E-mail - James W. Hill M.D.
+1 949 757 7157
Send E-mail - Byron S. Kalogerou
+1 617 535 4441
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