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Drug and device product litigation brings together a multiplicity of causes of action, both statutory and common law, and intersects with the different regulatory regimes governing branded drugs, generic drugs, and medical devices. This course, presented by attorney Andrea Bierstein, explores the different causes of action that are commonly used in drug and device product liability litigation, highlights common variations in state laws, and dissects issues that arise in proving these cases. The course further looks at some types of related claims, such as consumer fraud and third-party payor claims, that may be brought alongside traditional product claims. Ms. Bierstein also untangles the numerous Supreme Court and circuit Court of Appeals decisions concerning the operation of federal preemption in product liability litigation involving branded drugs, generic drugs, and medical devices. Overall, the course provides an overview of the legal framework for this important and growing area of litigation.
I. Review the causes of action used to bring claims involving injuries arising from pharmaceutical drugs and devices
II. Grasp issues involved in proving the causal connection between a drug or device and the plaintiff’s injuries, including general and specific causation, the “learned intermediary” doctrine, and expert witnesses and Daubert challenges
III. Know the effect of direct-to-consumer advertising on pharmaceutical drug and device claims
IV. Understand how federal preemption affects the various types of pharmaceutical and device product claims
Born New York, New York. Admitted to bar: 1985, New York; 1986, U.S. District Court, Southern and Eastern Districts of New York; 1987, U.S. Court of Appeals, Second Circuit; 1993, Massachusetts; 1997, U.S. Court of Appeals, Third Circuit; 1999, U.S. Court of Appeals, Ninth Circuit; 2005 U.S. Court of Appeals, Eleventh Circuit; 2008, U.S. Court of Appeals, Seventh Circuit. Education: Princeton University (A.B., 1978); New York University (J.D., cum laude, 1984).
By almost anyone’s account, Ms. Bierstein is one of the premier appellate brief-writers and oral advocates in the nation. She is highly experienced in virtually all forms of civil litigation and is a former law professor who designed and taught a civil litigation clinic and taught courses in Evidence and Remedies. She has made the roster of New York Super Lawyers in each year from 2007 to 2011.
Ms. Bierstein resides in New York City.
Excellent presentation. Very comprehensive, thorough and informative.
This was an exceptionally comprehensive review of the law and its history. Superb course.
Very informative; well organized and great explanation of nuanced material
Really helpful and well presented!
Excellent, well-organized presentation
Very informative on difficult topic in short amount of time.
It is always so obvious when you are dealing with an expert when they are this relaxed in a presentation. She connected it together really nicely.
Great overview. Excellent job of identifying sources of law governing the issues.
Excellent!! I'll keep this presentation in my library!!
Andrea did a fantastic job with presentation. Highly recommended.
very thorough and well presented.
the speaker was very good
well done, Andrea B
I have some experience in this area, and Ms Bierstein did an exemplary job of organizing the current issues and laws.
Very well done.
Good overview and certainly alerted one to the various pitfalls involved in this type of litigation.
Very good presentation. Ms. Bierstein starts with first principles of strict liability doctrine and then builds and expands on them. That approach allows her to effectively take the listener through the latest developments in the law and the reasoning beh
This may be the best CLE course I've ever listened to. Thank you!
Excellent presentation of complicated subject matter.
Excellent, well-organzied, substantive presentation.
this was excellent, up to date, professionally presented, focused, precise, with good context
Well done - obvious that the presenter is an expert in the material and a very good speaker.