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 of FDA provide authoritative, objective expert opinions that may make a difference in how disputes are resolved.

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. Areas of expertise include:

  • Medical device product development
  • Drug & biological product development
  • Premarket review process
  • Manufacturing
  • Product quality and safety
  • Compliance
  • Enforcement

Greenleaf’s Product Quality, Manufacturing, and Compliance Team identifies and promotes practices that will align a client’s approach with the FDA’s quality, safety, and compliance expectations. Greenleaf’s compliance experts have a proven track record of achieving success and providing services that are recognized as best in class by companies seeking to strengthen their quality management systems.

Greenleaf’s Medical Device and Combination Products Team guides clients through the complete regulatory process, from the earliest stages of product development, through the FDA review process, to marketing authorization and compliance with postmarket requirements and quality systems.

Greenleaf’s Drug and Biological Products Team specializes in providing strategic and technical guidance on medical product development, regulatory review, and postmarket requirements, working closely with clients to navigate today’s evolving FDA regulatory environment.

Services


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 have experience advising litigators on the nuances of FDA regulation, preparing expert declarations or reports, and testifying during depositions and at trial. Specific services include:

  • Sharing in-depth experience and knowledge regarding FDA regulation with litigators and their clients
  • Expert declarations
  • Expert reports
  • Deposition testimony
  • 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

Success Stories

  • 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 …

Litigation Support Services Resources

View or download the PDFs below to learn more about Greenleaf and our litigation support capabilities.

Connect With an Expert

Greenleaf’s Litigation Support Services Team is ready to help you achieve your regulatory goals.

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Connect with Expert - Litigation