Drug and Medical Device

Committee Overview

The Drug and Medical Device Committee is the preeminent continuing legal education organization for trial counsel, corporate counsel and risk management professionals who are involved in the defense of drug and medical device litigation. Committee members explore a diverse selection of product areas, such as biologicals/vaccines, blood products, medical devices, over-the-counter and prescription drugs and much more.

The Committee will hold its annual Seminar in New York City on May 16-17, 2013. This year’s Seminar will once again serve as the preeminent substantive and networking event for attorneys who represent pharmaceutical and medical device manufacturers. The substantive program will offer a variety of presentations, including trial skills demonstrations, panel presentations, and individual presentations on substantive and procedural strategies and issues at the forefront of drug and medical device litigation, including legal and ethical issues arising in off-label marketing and litigation, using a retrospectoscope approach in state of the art cases, and understanding applicable regulatory science and the priorities of the current FDA administration. The Seminar will also feature the popular In-House Counsel only breakout and Young Lawyers Blockbuster session. Click here for more information, and please make plans now to join us.

In the last year, the Drug and Medical Device Committee has been a part of several important and successful programs and initiatives.

The Committee is currently preparing to host a webcast regarding the state of matters post-Mensing and the Foreign Corrupt Practices Act.

In 2012, the Committee began publishing its newsletter, Rx For The Defense on a quarterly basis. The articles covered numerous substantive and procedural topics such as "Issues to Consider When Deposing Prescribers in the Failure-to-Warn Context," "Texas Supreme Court Rejects Direct-to-Consumer Advertising Exception to the Learned Intermediary Doctrine," "Medicare Advantage Plans and Medicare Secondary Payer (MSP) Recoveries," and "FDA and Social Media - Data Smog, Digital Strangers and FDA's Road Not Taken." The newsletter is distributed electronically and is available to all members of the Drug and Medical Device Committee. Please e-mail the Committee’s Newsletter Editor, Melissa Roberts Tannery, if you are interested in contributing to an upcoming edition.

The Committee continues its tradition of coordinating an excellent collection of drug and medical device-related articles for publication in For The Defense. Past issues have included articles on topics relevant to drug and medical device litigation, including excluding regulatory violations from defect cases, defending cases involving pharmacovigilance, the latest innovator liability, evaluating adverse causation in clinical trials, managing physician-company conflict of interest, implied conflict preemption defense, product liability biologics and biosimilars, and defending biopharmaceuticals. We plan to coordinate another drug and device-dedicated issue of For the Defense in the summer of 2013.

The Committee also produces its popular Litigation Primer for lawyers new to the practice. This one-day program brings together many of the most outstanding trial lawyers and in-house counsel in the country to share their experiences with younger lawyers. Topics during the 2012 Primer included the FDA regulatory system, defenses in drug and medical device litigation, medical causation, the law of failure to warn claims and a number of other key topics for the new practitioner. The Litigation Primer is next slated for September 2014.

The Drug and Medical Device Committee is one of DRI's largest committees, and there are endless opportunities to become involved. Please contact Scott Sayler or Jim Rogers if you are interested in becoming active in the Committee.