Litigation Support Services
Greenleaf’s litigation support services include an outside network of experienced and knowledgeable FDA experts who were thoughtfully selected by Greenleaf and are adept at advising litigators representing FDA-regulated clients. The firm’s deep bench and network provide authoritative, objective expert opinions that may make a difference in how disputes are resolved.
Litigation Support Team
Greenleaf’s well-regarded professionals have spent decades working at the FDA in senior positions. Greenleaf’s robust blend of technical skill and FDA institutional knowledge enables the firm’s team to provide unmatched litigation support and expert witness services to FDA-regulated companies and their outside counsel in the midst of legal disputes.
Maura M. Norden, J.D.Executive Vice President, Medical Devices and Combination Products & General Counsel
Kalah Auchincloss, J.D., M.P.H.Executive Vice President, Regulatory Compliance & Deputy General Counsel
Daniel Schultz, M.D., F.A.C.S.Principal, Medical Devices and Combination Products
Cynthia SchnedarPrincipal, Regulatory Compliance
David ElderPrincipal, Regulatory Compliance
Heather Rosecrans, F.R.A.P.SExecutive Vice President, Medical Devices and Combination Products
Katherine Macaulay MuellerDeputy General Counsel
Madeleine Giaquinto, J.D.Director, Regulatory Affairs
Samantha EakesVice President, Regulatory Affairs
Maria BonnerVice President, Regulatory Compliance and Deputy General Counsel
Brooke RothExecutive Director, Finance
Catherine RoweExecutive Director of Operations, Medical Devices and Combination Products
Mark KramerExecutive Vice President, Medical Devices and Combination Products
Our Litigation Support Services
Areas of Expertise
Greenleaf and our network have extensive, in-depth experience regarding medical device product development, drug and biological product development, and the premarket review process, as well as manufacturing, product quality and safety, compliance, and enforcement of all FDA-regulated products. Our experts have the knowledge, qualifications, and experience required to explain and clarify these and other issues to our clients, the courts, or juries and are credible, persuasive expert witnesses and litigation advisors.
Areas of expertise include:
- Medical device product development
- Drug and biological product development
- Premarket review process
- Product quality and safety
Greenleaf’s Litigation Support Network works closely with litigators representing FDA-regulated clients in a wide array of disputes related to medical devices, drug and biological products, and product quality, manufacturing, and compliance.
Greenleaf and our network can advise litigators on the nuances of FDA regulation and provide support to lawyers as they develop a litigation strategy by identifying key FDA regulatory issues that may arise. Greenleaf consultants and our network of experts also have experience serving as expert witnesses, preparing expert declarations or reports, and testifying during depositions and at trial.
Specific services include:
- Sharing in-depth experience and knowledge of FDA regulation with litigators and their clients
- Identifying and consulting on FDA regulatory issues that may arise during the course of litigation and impact litigation strategy
- Preparing expert declarations and reports
- Providing deposition and trial testimony
Types of Litigation
Greenleaf’s team has worked with litigators engaged in a variety of disputes, including complex commercial litigation, unfair competition and false advertising cases, intellectual property litigation, product liability class actions, and securities class actions. Greenleaf professionals and our network of experts provide guidance on the following types of litigation:
- Complex commercial litigation
- Unfair competition / false advertising
- Intellectual property litigation
- Product liability class actions
- Securities class actions
- Other types of litigation, such as tax matters and contract disputes
Providing Litigation Support That Led to a Favorable Judgment for a Device Start-Up Firm
A medical device start-up was involved in a commercial dispute against a large multinational device manufacturer and sought Greenleaf Health’s services as an expert witness and consultant on the FDA regulatory grounds for the case. Greenleaf’s litigation support team prepared an expert report that reinforced the client’s arguments regarding the likelihood that the FDA would …
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Greenleaf’s Litigation Support Services Team is ready to help you achieve your regulatory goals.
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