Litigation is an unfortunate fact of life for many life sciences companies as well as those who invest in such companies. Commercial disputes can arise with partners, collaborators, contractors, competitors, investors, and insurers. Oftentimes, such disputes hinge on a technical issue involving FDA laws and regulations.
Scott Lassman has experience working as an FDA legal expert on behalf of law firms representing litigants in commercial disputes. Scott has worked on a variety of cases, including patent infringement, “product hopping” (antitrust), securities litigation and insurance coverage. These cases raised FDA legal issues such as approval requirements and timing for Abbreviated New Drug Applications (ANDAs), approval of New Drug Applications (NDAs) under FDA’s Combination Rule, Good Clinical Practice (GCP) requirements, and Prescription Drug Marketing Act (PDMA) requirements. While not a large part of his practice, Scott will consider serving as a consulting or testifying expert for the right case.
You are invited to contact Lassman Law+Policy for more information on Scott's expertise and availability to serve as an FDA legal expert.