Our lawyers know the pharmaceutical industry and have defended litigation involving a wide variety of experimental, prescription, biologic and over-the-counter drug products as well as medical devices. In addition to handling and trying these cases, our lawyers excel at providing counseling advice, including prelitigation risk assessments, labeling/warning reviews and preparation for FDA and other governmental interactions. We regularly handle products liability claims in parallel with ongoing governmental, criminal and administrative proceedings, and have advised clients in connection with both voluntary and involuntary product recalls.
Baker Botts has represented clients in product-related class action litigation for over 25 years. Our pharmaceutical practice group has served as national coordinating and regional counsel for numerous manufacturers and many prescription drug and medical device products, and defended thousands of pharmaceutical cases. Partners within the pharmaceutical practice group have handled pharmaceutical/medical device cases in more than 35 states.
Our lawyers are skilled in the multidistrict litigation (MDL) treatment of claims, both in terms of opposing MDL certification and coordinating MDL proceedings with pending state court litigation. Our work as national coordinating and regional counsel has made us adept at opposing certification, seeking decertification and defending against certified class actions. We are experienced in defending class action litigation under state consumer protection statutes, as well as under Magnuson-Moss and RICO.
Our lawyers are intimately familiar with preclinical and clinical development of pharmaceuticals, FDA oversight, in licensing of NCEs, licensing agreements, supply agreements, and collaboration and co-promotion agreements. Our lawyers have extensive experience conducting internal investigations and defending criminal and regulatory inquiries, and have advocated pharmaceutical clients’ interests before and against the Department of Justice, the Securities and Exchange Commission, the Federal Trade Commission, various state attorneys general and a variety of federal and state administrative agencies.
Health Care Fraud:
Baker Botts has represented multiple pharmaceutical companies relating to responses to Civil Investigation Demands (CIDs) focused on pricing, marketing practices and manufacturing standards. Our lawyers have negotiated with over 20 state attorneys general on behalf of pharmaceutical clients. In some instances, CIDs precede the filing of qui tam/False Claims Act cases. In others, underlying qui tam actions have prompted CIDs.
Baker Botts lawyers have handled putative class actions involving multiple products where plaintiffs have sought purely economic damages under various consumer fraud statutes, including RICO and antitrust.
Our national Practice provides distinct advantages to our pharmaceutical clients. We have an extensive network of knowledgeable and influential local counsel contacts across the United States. We have also developed a comprehensive and proven list of experts and consultants in a variety of relevant disciplines, including all the biological, chemical, statistical and pharmaceutical sciences.
Publications, Speeches & Presentations
SouthWest Benefits Association Compliance Conference, Dallas, Texas
French Competition Authority Fines Sanofi-Aventis EUR 40.6 Million for Disparaging Competing Generic ProductsFirm Thought Leadership
Baker Botts Antitrust Partner Michael Perry, along with Victor Rufino, Attorney General of CADE, Brazil’s competition authority, and Esther Flesch, Partner at Trench, Rossi and Watanabe, are speakers at the upcoming International Congress of Management in Health in Sao Paulo, Brazil.