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:
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 firstname.lastname@example.org 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.
Dr. Stephen F. Amato, our Principal Advisor, has been working in the global healthcare industry as an employee of several large manufacturing organizations including Siemens Healthcare, Smith & Nephew, Anika Therapeutics, and Cardinal Health. As pertaining to healthcare associated litigation, specifically, Dr. Amato has served as an Expert Witness in a wide variety of product liability and patent infringement legal matters during the same time period, in support of both defendants and plaintiffs. Over the past 4 years, this has included cases involving products utilized by healthcare practitioners, including surgeons, primary care providers, skilled nurse practitioners and their associates, as well as with patient home healthcare-based devices. Dr. Amato's expert witness experience also includes review of cases involving intravenous vena cava filters, hernia repair devices, orthopedic implants and devices (including knee, and hip replacement devices), spinal implants, peritoneal dialysis products, and coagulation time diagnostic test strips. In this capacity, he has served as an expert reviewer and interpreter of regulatory associated documentation collected and evaluated during the due diligence, deposition and trial witness phases of civil complaints filed at both the state and federal levels.