Product Liability, Commercialization, & and IP Legal Disputes

Legal disputes among stakeholders often arise in the healthcare and other regulated sectors, and may involve product liability or patent infringement allegations.  Such disputes may include the design, manufacturing and/or utilization of pharmaceuticals, medical devices,  cosmetics, foods, and other healthcare products or services.  These types of cases often require the testimony of demonstrated and proven Expert Witnesses that have deep expertise working within the FDAs and other global regulatory frameworks.  tJûn17 Life Sciences' Principal Advisor Dr. Stephen Amato has deep experience in providing court approved Expert Witness Reports and testimony in such matters, and has frequently served in both product liability, as well as patent infringement cases, at all litigation phases.  This includes discovery through trial.

In the aforementioned types of cases, Dr. Amato has provided attorneys, state and federal level courts and other parties with Expert opinions as to how stakeholders typically interact with global regulatory agencies, as well as to opine on the appropriateness of regulatory activities, for example.  Moreover, many patent infringement disputes arise during the pharmaceutical and/or medical device development process - sometimes very high stakes disputes......

Dr. Amato's experience working at the interface between regulatory agencies and industry participants has helped tJûn17 Life Science Advisors to cultivate a deep, contextual and experience-based knowledge of issues related to overall healthcare product commercialization, patent infringement, product safety, regulatory and quality assurance challenges.  As part of the work towards litigation resolution, and in preparation of his Expert Reports, Dr. Amato provides in depth analyses in diverse areas including labeling, adverse event reporting, regulatory enforcement actions, quality assurance measures, post-market surveillance requirements, and other areas of global healthcare activity. 

As examples, Dr. Amato has served to provide Expert Reports and/or testimony in commercialization disputes involving the following types of issues:

• Regulatory challenges to product marketing claims, in some cases involved the Federal Trade Commission (FTC)
• Legal actions involving allegations that an FDA-regulated product is unsafe, not effective or inappropriately designed and/or manufactured
• Legal challenges to intellectual property protection, including patents
• Commercial disputes between stakeholders

Dr. Amato will review and interpret the facts in dispute, and will initially provide an opinion as to whether his Expert testimony will help you prevail in your legal matter.

Please contact Dr. Amato at stephen.amato@tjun17.com to discuss further, for a list of recent cases he has worked on, as well as sample Expert Reports, and/or Expert Testimony at Deposition and Trial.  Attorney and other stakeholder recommendations regarding Dr. Amato's effectiveness in working towards resolution of healthcare product/service commercialization legal disputes are available as well.