He has experience in evaluating and enhancing quality system documentation, clinical evaluation reports, device risk assessments, clinical study protocols and reports, post market surveillance, labeling, professional education and user materials, websites, and promotional materials. He has extensive experience counseling and guiding clients through FDA, MDD and MDR regulatory compliance, submissions, inquiries and inspections, recalls, Field Safety Corrective Actions, and holds, and other matters with regulators and notified bodies. He has also played a key role in the coordination of complex, national discovery efforts on behalf of many well-known pharmaceutical and medical device companies.īurt frequently works hand-in-hand with in-house counsel, company management and personnel, and foreign lawyers on medical, clinical, quality and regulatory issues as well as litigation in the US, EU, and other countries.
Burt has unique and industry leading know-how in handling large volumes of MDL cases requiring expert reports and depositions and has extensive experience developing and preparing expert witnesses for trial. He is an effective and very experienced leader of national expert teams.
He works with and prepares company witnesses and leads the expert team.īurt has also served on trial teams involving a wide variety of pharmaceuticals and medical devices, including Baycol ®, Fen-Phen, Vioxx ® and Seroquel ®. He has also prepared and defended the depositions of several company witnesses including Apex witnesses, Board members, upper management, and corporate designees.īurt also represents AbbVie and Allergan in federal and state court personal injury and class action litigation. He is trial counsel in certain state court cases. He has developed experts, taken and defended expert witness depositions and prepared expert witnesses for trial. and Johnson & Johnson in MDL and state court litigation as well as foreign litigation and other non-litigation matters involving medical devices. Burt’s experience includes representing Ethicon, Inc. He also has extensive experience counseling clients in their response to foreign governments and litigation, third parties, and the media. He routinely counsels and guides clients through FDA, MDD, MDR and complex multi-jurisdiction regulatory and legal issues. Burt also is an expert in drug and medical device medical, clinical, quality and regulatory issues in the US, EU, and other foreign jurisdictions.
He also has significant experience in commercial litigation, class actions, mass torts, AG litigation, and IP litigation. He has led teams in the development of experts for US and foreign litigation and regularly works closely with lawyers around the world on expert, science, and regulatory matters. He has extensive experience in preparing and defending depositions and trial testimony of APEX witnesses, other high level management, and corporate designees in both US and foreign litigations. He served as lead or co-lead trial counsel in numerous trials. He is experienced in defending federal multidistrict litigation (MDLs) and state court coordinated litigation, as well as individual plaintiff cases. Burt is a trial lawyer who focuses on representing the needs of pharmaceutical and medical device companies, especially in the context of complex product liability matters.