Debevoise lawyers have substantial cross-disciplinary experience in transactional, litigation and enforcement matters affecting the global health care industry. Our transactional work includes complex acquisitions, both leveraged and unleveraged, cross-border transactions and securities issues. We recently edited Health Care Mergers and Acquisitions Answer Book 2014 (Practising Law Institute, 2014), an extensive reference guide addressing structuring, regulatory, due diligence and documentation issues, among other things, in health care M&A and licensing deals.
Our litigation and enforcement practices include bet-the-company litigation, government and internal investigations, a wide variety of complex civil matters, intellectual property issues, advertising disputes, and international dispute resolution. We also regularly counsel health care clients regarding compliance programs, preventive measures and collateral consequences of criminal proceedings. We routinely represent board committees conducting independent investigations and compliance reviews. With an integrated and multidisciplinary approach, we offer cutting edge transactional advice and broad litigation and regulatory experience that allows our clients to successfully complete deals, conclude enforcement actions, resolve disputes and implement industry-leading compliance programs.
Our clients have included major companies such as Actavis, Bayer, Bristol-Myers Squibb, Galderma Pharma, GlaxoSmithKline, Hisamitsu, Johnson & Johnson, Merck, Nestlé, Novartis and Schering-Plough, among others.
Our corporate team regularly handles major transactions for leading health care and life sciences companies, as well as for top-tier private equity firms and financial advisors. These transactions range from big ticket, cross-border M&A to complex securities offerings to significant joint venture, licensing and collaboration agreements. We understand that these deals frequently involve long-range strategic opportunities and challenges for our clients, requiring a high degree of sophistication and creativity in their execution. For these reasons, our corporate lawyers have spent significant time focusing on the particular demands of the health care and life sciences industry, working hand-in-hand with our intellectual property, tax and employment lawyers to ensure that our clients’ interests are well served and with our litigators, whose experience and judgment in evaluating potential risks in the diligence process has proven invaluable to clients.
Investigations and Enforcement Actions. Debevoise has substantial experience litigating in defense of US health care related criminal prosecutions and civil investigations involving alleged FDA violations, including in connection with promotion, manufacturing, and research and development activities; False Claims Act liability, including anti-kickback, pricing and reimbursement issues; FTC investigations, including allegations of false and deceptive advertising practices; and individual Park liability. Our experience includes facilitating cooperation with investigations by the U.S. Department of Justice, U.S. Attorneys’ Offices, U.S. Congress, SEC, National Association of Medicaid Fraud Control Units, New York Attorney General, and other regulatory authorities; negotiating complex global settlements with multiple federal and state parties; defending against related civil litigation by the government and qui tam relators; and representing clients in health care program exclusion proceedings before the HHS Office of the Inspector General.
Foreign Corrupt Practices Act. We frequently represent companies in anti-corruption matters involving compliance with the US Foreign Corrupt Practices Act and the UK Bribery Act, among other anti-corruption laws and regulations, including defending clients in government investigations and conducting comprehensive compliance reviews on behalf of global pharmaceutical and medical device companies. Through our US and foreign offices, we have assisted health care companies with a broad range of non-US anti-corruption compliance issues in every major market in Europe, Asia, the Middle-East, Africa and Latin America, with legal teams that, collectively, include lawyers qualified in more than a dozen jurisdictions and fluent in more than 20 languages. Our work has assisted companies in managing anti-corruption regulatory risks relating to clinical trials, product registration, general sales and marketing practices, hospital and formulary sales, and relationships with hospitals, health care professionals and non-governmental organizations.
US Healthcare Compliance. We regularly advise health care companies and board committees on a broad array of practices regulated by US authorities, including in the areas of sales and marketing, manufacturing, research and development, pricing and reimbursement and individual liability. Our experience includes conducting compliance-related reviews and serving as compliance experts. We have significant experience negotiating and advising on Corporate Integrity Agreement implementation and compliance.
Securities and Corporate Governance Litigation. Debevoise has considerable experience in all types of securities disputes and other corporate governance litigation, including class actions, derivative litigation, internal investigations and complex matters involving overlapping civil litigation, federal and state enforcement actions and related legislative inquiries. Our experience includes representing major health care clients and individuals in matters arising from sales, marketing, and manufacturing practices and disclosure of risks associated with pharmaceutical products.
Products Liability, Mass Torts, and Consumer Fraud. We routinely defend companies faced with serious products liability and consumer fraud claims, ranging from individual cases to nationwide class actions and other forms of multiple-claims litigation involving thousands of claimants. We have represented major health care companies in claims arising from the use, sale and marketing of prescription and over-the-counter medications. We have developed substantial experience in the defense of mass torts, class actions, multi-district consolidations and other types of multi-state litigation.
Intellectual Property. Debevoise has extensive experience in obtaining, and defending against, motions for temporary restraining orders and preliminary injunctions in difficult trademark, trade dress, false advertising and cybersquatting cases involving pharmaceutical products. In connection with these cases, we regularly supervise consumer perception surveys and critique the surveys conducted by our adversaries. We also have litigated patent infringement claims related to pharmaceuticals, including claims involving purported Paragraph IV certifications for generic drugs. In addition to our litigation experience, we regularly advise clients in the clearance of rights and the selection, development, acquisition, registration and protection of trademarks, trade dress and domain names.