Our Pharma and Life Sciences Industry Group provides a full range of legal and consulting services. We counsel pharmaceutical, medical device and biotech companies, as well as contract research organizations, research institutions, scientists, venture capitalists and investment banks. Our clients vary from small and midsized corporations focused on product development and research, to major multinational pharmaceutical and medical device companies throughout the world.
Our interdisciplinary group of lawyers and professionals have knowledge, insight and experience in navigating this dynamic, heavily regulated environment. We help our clients tackle all manner of business and financing pressures, regulatory scrutiny and litigation threats, both nationally and globally. Our lawyers and professionals work with Ph.D. chemists, policy analysts and other specialists, to form fully integrated groups of individuals with comprehensive expertise for serving our clients' specific needs.
Our multidisciplinary group assists pharma and life sciences companies with legal services, including:
- Clinical Research
- Compliance Counseling and Defense
- Consortia Management
- Corporate and Securities
- Customs and International Trade
- Government and Regulatory Affairs
- Intellectual Property
- Labor and Employment
- Product Liability and Mass Tort
Our group of lawyers, scientists and policy analysts has the experience and vision to help clients maintain compliance in an ever-changing regulatory environment. We collaborate with clients to devise and implement efficient and practical strategies to ensure compliance with applicable regulations, including the following:
- Advising clients on compliance with FDA’s human subject protection rules as well as requirements issued by HHS’s Office for Human Research Protections.
- Assisting research institutions and research sponsors in the design and implementation of research compliance programs.
- Assisting with the formation and education of in-house task forces devoted to research compliance.
- Drafting and negotiating clinical trial agreements.
- Preparing research informed consent documents.
- Drafting contracts between major research institutions and various service organizations to support the implementation of research protocols.
- Advising research sites and research sponsors responding to “whistleblower” allegations.
- Communicating with policymakers on legislative and regulatory developments related to clinical research both in North America and the European Union.
Compliance Counseling and Defense
Our Regulatory and Compliance Group counsels life sciences companies on regulatory requirements and science and policy issues across a broad range of areas.
- Marketing and Promotion of Drugs and Devices: We counsel clients on marketing, promotion, sales, research, and other business activities and arrangements of all types to ensure compliance with the full range of applicable federal and state laws and with non-regulatory requirements.
- Defending Government Investigations and Litigation: Our lawyers have defended pharmaceutical and medical device manufacturers in investigations and litigation arising under federal and state consumer fraud laws. We provide extensive counseling to life sciences companies regarding the federal Sunshine Law as well as state reporting laws.
- Privacy and Data Security Laws: We work with medical device companies, pharmaceutical manufacturers, pharmacies and other health care providers with respect to compliance with privacy and data security laws, breach readiness and response and litigation in North America, the European Union, Asia and Latin America.
- Foreign Corrupt Practices Act: We assist companies with the Foreign Corrupt Practices Act, the UK Bribery Law and other international anti-corruption laws.
Through the development of industry consortia, we facilitate a functional consensus-building process and assist companies in efficiently devising and executing their common initiatives in the United States, the European Union and around the world. We have formed and represent trade associations devoted to a wide variety of life sciences issues, including orally inhaled and nasal drug products for local and systemic treatment of a variety of diseases; protection of personal health information; clinical research; and metered dose inhalers containing chlorofluorocarbons and hydrofluorocarbons.
Our group has worked with public and private life science clients on all forms of strategic transactions, including stock and asset acquisitions, mergers, spin-offs and joint ventures. We also counsel corporate venture arms of life science clients in early- and late-stage preferred stock and convertible debt financings. In addition, our corporate practitioners have deep experience in commercial agreements.
Customs and International Trade
We craft and implement trade management strategies that emphasize the importance of export controls, import requirements and trade remedies. We have optimized the performance and security of our clients’ global supply chain and strategic business relationships with suppliers and customers by providing solutions for complying with cross-border trade and security requirements and procedures.
Government and Regulatory Affairs
Our group of lawyers, lobbyists, health policy and reimbursement specialists, scientific advisors and public policy and government relations professionals have a proven track record of major legislative and regulatory successes in Congress and federal agencies. We regularly help clients simultaneously address business and policy objectives by gaining recognition for their work and leadership in a particular health care area at the federal level. We are also experienced in the formation of focused life sciences industry consortia that address common scientific, regulatory and policy goals of clients.
Our lawyers and agents are experienced in patenting a wide range of technologies in the U.S., as well as handling global patent prosecution strategy. We counsel clients with regard to patentability, patent strategy, portfolio management, inventorship, patent landscapes, competitor monitoring, non-infringement opinions, patent validity opinions, freedom-to-operate opinions, patent prosecution ethics opinions and trade secrets. We also assist in the preparation and filing and defense of reexaminations, reissues, patent interferences and appeals before the Patent Trial and Appeal Board.
Labor and Employment
We cover the full range of labor and employment issues, including litigation, wage and hour and counseling and responding to agency audits. We defend all types of employment litigation, including age, race, gender and other discrimination actions; wrongful discharge suits; wage and hour claims; executive compensation disputes; non-competition/non-solicitation claims; and privacy, defamation and whistleblower suits. Our group is experienced in class action claims and has effectively crafted strategies to defeat class certification, establish the lawfulness of our clients’ actions and achieve a favorable settlement or win at trial.
Products Liability and Mass Tort
Our lawyers serve as trial counsel and as national coordinating counsel in complex products liability litigation, defending manufacturers of prescription and over-the-counter drugs and medical devices including orthopedic implants, antibiotics, contraceptives and antipsychotics. Our present and recent engagements as national coordinating counsel in major pharmaceutical and medical device litigation involve numerous products for many of the world’s largest pharmaceutical manufacturers.