FDA Regulatory Expert Witness and Litigation Support

Legal disputes in healthcare and other regulated sectors frequently involve product liability or patent infringement matters related to pharmaceuticals, medical devices, cosmetics, foods, and other healthcare products and services. These cases often require Expert Witnesses with deep experience navigating FDA and other global regulatory frameworks.

tJûn17 Life Sciences' Principal Advisor, Dr. Stephen Amato, has extensive experience providing Expert Witness Reports and testimony in product liability and patent infringement matters, representing both plaintiff and defense interests from discovery through trial.

Dr. Amato provides attorneys, state and federal courts, and other parties with Expert opinions regarding interactions with regulatory agencies and the appropriateness of regulatory activities and decisions. His experience also includes patent infringement disputes arising during pharmaceutical and medical device development, where the regulatory and commercial stakes can be substantial.

Expert services may include:

• Case assessment and regulatory analysis
• FDA regulatory requirements and industry standards
• Medical-device labeling and warnings
• 510(k), De Novo and PMA requirements
• Clinical investigations and IDE requirements
• Adverse-event and postmarket reporting
• Regulatory compliance and standard-of-care issues
• Expert reports, deposition and trial testimony

Dr. Amato will review and interpret the facts and regulatory issues in dispute and provide an initial assessment of whether his expertise is appropriate and relevant to the matter.