Law 245 - Drug and Medical Device Law
Prescription drugs and medical devices dominate the news. Whether through breakthrough medical advances in areas such as orthopedics, obstetrics, cardiology, oncology, or a variety of psychiatric disciplines, through billion-dollar sanctioning of companies for fraud, bribery or kickbacks, or through mass tort advertising by plaintiffs’ firms and resulting multi-million dollar jury awards, there is no denying the relevance of drugs and medical devices in today’s society and legal landscape.
In this course, we will explore the major areas in which attorneys are impacting the drug and medical device world. In addition to learning the substantive and procedural law applicable to this practice, you should come out of this class armed to better provide client with advice on
issues ranging from predicting future regulatory trends to creatively structuring, trying, and resolving complex mass torts at the multidistrict litigation level. This practice also requires a great deal of complex expert witness testimony in a wide range of medical and scientific disciplines. You should come out of this course with a greater understanding of the skills necessary to both defend and attack sophisticated expert witnesses at the pre-trial and trial level. Last, given the complexity of drug and device work, you should leave this class with enhanced skills relating to legal design—techniques relating to the use of graphics and visuals, including interactive demonstratives, to enhance legal advocacy skills which will prove useful in presenting complex material to judges, juries, and clients alike.
The last decade has seen a dramatic increase in the focus on, and relevance of, drug and medical device companies. As such, regulatory, compliance, and litigation issues have become paramount for these companies. This course should be of significant interest to those who want to practice in this world—whether in a government capacity regulating these companies, prosecuting them in private or government settings, or defending these companies’ interests in litigation.