Overview

Health Care and Life Sciences Group at Skadden, Arps, Slate, Meagher & Flom LLP and affiliates (“Skadden, Arps” or “Skadden”) represents a broad range of clients in all sectors of the health care industry, including services, pharmaceuticals and medical technology.  In order to serve the transactional, litigation, regulatory and other needs of our health care clients, the firm utilizes attorneys with a breadth of experience, including in:

• government enforcement, white collar crime and civil litigation
• mergers, acquisitions, and joint ventures
• corporate finance
• licensing
• corporate restructurings
• regulatory compliance and reimbursement counseling
• antitrust/competition governmental investigations and private class action litigation
• complex mass torts and products liability
• insurance
• intellectual property advice and litigation
• privacy counseling
• outsourcing
• political law
• tax
• labor and employment
• real estate

Government Enforcement, White Collar Crime and Civil Litigation

Skadden’s government enforcement and white collar crime litigators defend health care clients in criminal and civil investigations and litigation, as well as in related congressional and administrative proceedings. To address the particular needs of our health care clients, Skadden formed a Health Care Enforcement and Litigation Group, which specializes in representing health care clients in a wide variety of government enforcement investigations and proceedings. In this regard, Skadden has represented clients in connection with criminal allegations involving Medicaid and Medicare fraud, violations of the anti-kickback and anti-referral statutes, and insurance fraud. In a number of cases, we have negotiated favorable global settlements of complex parallel proceedings involving criminal, civil and administrative issues (i.e., exclusion from the Medicaid program). Skadden has extensive experience in defending False Claims Act proceedings brought against health care providers by federal and state authorities as well as related qui tam actions. Skadden also has represented health care clients in connection with Foreign Corrupt Practices Act investigations conducted by the Department of Justice and SEC and in conducting internal investigations on behalf of boards of directors and special board management committees. Skadden has significant experience defending pharmaceutical and life science companies, and their officers and directors, in investigations and actions brought by the SEC. Such actions often involve the adequacy of public disclosure regarding drugs in various stages of the FDA approval process.

Skadden also has extensive experience in defending class action litigation in both federal and state courts throughout the country. Whether the underlying issue is a disappointing drug trial, a miss in earnings, the discovery of potentially problematic foreign payments or the revelation of government enforcement actions, Skadden’s class action litigators know how to defend these issues in a cost effective and minimally disruptive manner. We have handled such actions for many companies in the health care field, including managed care, pharmaceutical and hospital corporations.

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Mergers, Acquisitions and Joint Ventures

Skadden, Arps has been active in major transactions around the world involving a broad range of health care companies, including mergers and acquisitions, private equity, strategic investing and joint ventures. For the ninth straight year, Skadden was named the best corporate law firm in the United States in Corporate Board Member magazine’s 2009 survey of “America’s Best Corporate Law Firms.” In 2009, Skadden ranked first by deal value in worldwide and U.S. announced M&A transactions in the medical and pharmaceutical industries according to mergermarket. We also ranked first in Biotechnology & Pharmaceutical M&A by dollar value for deals globally and in North America according to 2009 year-end rankings from BioPharm Insight.

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Corporate Finance

Skadden's Health Care and Life Sciences Group includes corporate finance attorneys who provide a full range of services enabling our health care clients to achieve their financing objectives. Our attorneys have experience with companies across the health care sector, including pharmaceutical companies, early-stage biotechnology companies, health care REITs, managed care companies and other service companies. Skadden understands the unique timing, disclosure, intellectual property and regulatory issues that health care companies often face, particularly in their early stages of development, and we have the experience to navigate our clients through the legal and other requirements necessary to promptly and efficiently access capital. We have extensive experience representing issuers and investment banks in public and private equity and debt offerings, convertible and derivative securities, international financings and venture capital transactions.

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License and Collaboration Agreements

Skadden has extensive knowledge of and experience in the field of pharmaceutical, life sciences and medical technology licensing and collaborations, as well as alternative transactions such as drug royalty purchases. We regularly counsel clients on all aspects of license, collaboration, joint venture, supply, financing and other agreements and transactions involving the development, manufacture and commercialization of pharmaceutical and life science products and medical devices. These agreements and transactions often involve critical strategic decisions and require sophisticated structuring, lengthy negotiations and complex documentation. Our attorneys in the Health Care and Life Sciences Group, many of whom have extensive experience in the life sciences (including advanced degrees in relevant disciplines) and in mergers and acquisitions, understand the strategic importance of these transactions to our clients and how best to achieve our clients’ objectives.

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Corporate Restructurings

Skadden has one of the leading corporate restructuring practices, advising corporations and their principal creditors and investors on troubled company bankruptcy, merger and acquisition, and financial restructuring situations.

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Regulatory Compliance and Reimbursement Counseling

Skadden also provides advice and counseling on complex regulatory and reimbursement matters arising under Medicare, Medicaid and other governmental and private health benefit payment programs. Compliance with such requirements and the risk of litigation associated with failures to meet these requirements calls for both structuring programs for compliance and, on occasion, the voluntary reporting of breaches of such obligations to government enforcement agencies. Skadden’s attorneys have considerable experience in the design, implementation and operation of such compliance programs and advising on the related reimbursement issues. Evaluation of compliance risks, structuring business relationships to meet federal requirements under the Stark physician anti-referral law and fraud and abuse statutes and their state law analogs are significant elements of Skadden’s Health Care Enforcement and Litigation practice. We have provided such counseling to virtually all sectors of the health care industry.

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Antitrust

Our antitrust attorneys advise clients on a broad range of matters in the health care arena. For example, we have represented clients before the U.S. and European authorities, including the Federal Trade Commission, the U.S. Department of Justice, the European Commission and Member States, in connection with mergers and acquisitions. We have advised manufacturers of medical devices and pharmaceuticals concerning distribution, licensing and joint marketing arrangements both in the United States and abroad. We have provided antitrust advice in connection with the formation of provider joint ventures and other associations, including joint ventures for high-tech equipment and capital-intensive product lines, and in connection with the relationships between provider associations and public and private health plan payors. We also have an extensive antitrust litigation practice, defending clients both in antitrust private treble damage class actions and in governmental enforcement suits. Some of our recent cases involve allegations relating to the settlement of Hatch-Waxman patent litigation and to monopolization claims regarding lifecycle management programs.

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Complex Mass Torts and Products Liability

Skadden’s Health Care and Life Sciences Group includes attorneys from the firm’s Complex Mass Torts and Products Liability practice who are at the forefront of health care litigation. In defending personal injury claims, warranty, consumer fraud and third-party-payor class actions, our Complex Mass Torts Group lawyers employ innovative strategies to achieve important victories for its clients. Skadden’s ability to partner with its clients in order to understand and respect their business needs has been a hallmark of our practice.

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Insurance

As the insurance industry has undergone substantial change through consolidation and has increasingly turned to the international capital markets, Skadden has been very active in representing participants in the health insurance industry worldwide. Our attorneys represent health insurance companies and their financial advisers and underwriters in a wide variety of corporate transactions, including mergers, asset acquisitions (including reinsurance “book of business” transfers and renewal rights deals), stock acquisitions, public and private financings, new business formations, joint ventures, restructurings and reorganizations. In addition, Skadden provides a broad range of regulatory advice to health insurance companies. In the regulatory area, we routinely advise on insurance law issues, including licensing, risk-based capital issues, securities issuances, investments, solvency, permissible activities and insurance products. We have assisted health insurance clients in the insurance regulatory aspects of corporate reorganizations, restructurings, establishments of subsidiaries and captive insurers, acquisitions, divisions, redomestications, joint venture or agency marketing programs, acquisitions of control and interaffiliate transactions.

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Intellectual Property Advice and Litigation

Skadden attorneys have substantial advisory and litigation experience in intellectual property matters, including patents, trademarks and false advertising, of particular importance to companies in the health care industry. For example, Skadden has represented numerous clients in litigation and counseling regarding pharmaceuticals, medical devices and health care-related technologies, including Endo Pharmaceuticals, Inc.; Genentech; Novo Nordisk of North American; Johnson Matthey, Inc.; and McKesson Corp. The firm also has provided patent advice to clients such as Pfizer Inc., GlaxoSmithKline and Bristol-Myers Squibb Company. Our attorneys also perform intellectual property diligence and advise clients regarding target and competitor patent and technology portfolios in the pharmaceutical, life science, medical device and related fields. We frequently provide advertising challenge and substantiation and trademark advice and counseling in connection with over-the-counter and related drug products.

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Privacy Counseling

The protection of personal privacy has been one of the most critical issues in the growth of the health care industry. Companies continually strive to balance the benefits that can be realized from processing data with the interests of individuals in ensuring that their personal data is protected. Skadden privacy lawyers advise a wide range of clients on complying with the Privacy Rule and Security Rule of the Health Insurance Portability and Accountability Act (HIPAA). This includes advice regarding the applicability of HIPAA to certain entities or in certain circumstances, the type of information that is protected and meeting HIPAA’s administrative requirements.

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Outsourcing

The firm’s outsourcing lawyers represent health care industry clients on a wide range of outsourcing matters, including information technology, human resources and business process outsourcing. The firm can support all stages of an outsourcing engagement from preparing the initial request for proposal and facilitating vendor selection to negotiating all aspects of the definitive agreement and schedules. We also stay involved with the client to ensure that the transition to the service provider is seamless and to support relationship management issues. Our outsourcing lawyers have handled sourcing both in the United States as well as global projects in a wide range of countries. The firm’s global footprint and its industry-specific expertise in health care allows our outsourcing lawyers to provide value-added services to our client base in a cost-efficient manner.

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Political Law

Skadden’s political law attorneys provide advice to numerous health care clients, with particular emphasis on campaign finance, ethics, lobbying and conflicts of interest in connection with federal, state and local laws. Our clients include several Fortune 500 health care companies, many of which we routinely advise on pay-to-play rules governing political activity that become applicable when pharmaceutical companies contract with state hospitals. We provide extensive advice on these rules, and clear all such political activity for several global pharmaceuticals. We routinely conduct on-site ethics training, and have been involved with ethics programs for HMOs and industry trade associations. In addition, we advise clients in matters concerning U.S. and non-U.S. lobby registration, often preparing campaign finance and lobby registration reports. We have implemented comprehensive compliance systems covering the regulation of government affairs, which involves monitoring campaign contributions, gifts and lobby registration laws at the federal level and in all 50 states.

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Tax

As business transactions in the health care area increasingly have taken on international dimensions, particularly in the pharmaceutical and life sciences industries, proper tax planning has become more important and more complex. Areas of particular concern to pharmaceutical and life sciences companies in which our tax attorneys possess special skills include, among others, inter-company pricing and licensing between U.S. parent companies and foreign manufacturing affiliates, and the tax structuring of product acquisitions, joint ventures, collaborations, license, co-promotion and distribution agreements, and tax treatment of research and development and other technology-related expenses. We frequently represent pharmaceutical, life sciences and other health care companies in resolving IRS audits of technology, transfer pricing and international tax planning issues. We also serve as tax counsel to the Pharmaceutical Research and Manufacturers of America and its members.

In addition, matters involving tax exempt organizations in the health care sector are increasingly complex and subject to ongoing scrutiny by the IRS and Congress. Our tax attorneys advise on a wide variety of issues in this area, including non-profit governance and conflict of interest questions, grant-making activities, joint venture and technology transfer agreements between non-profit and for profit enterprises, and IRS examinations.

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Labor and Employment

The Health Care and Life Sciences Group’s labor attorneys have substantial experience advising health care clients on such issues as physician staffing, hospital ancillary and support services, collective bargaining with physicians and other health care providers, hospital construction regulation and hospital finance. For example, the firm represented Primary Health Systems of New York, Inc., the successful bidder in the privatization of Coney Island Hospital in Brooklyn, N.Y., in negotiations with a coalition of municipal unions for contracts made effective upon the privatization. On behalf of the State University of New York, the firm negotiated a formal affiliation agreement between the state’s Health Science Center at Brooklyn, the state’s largest medical college, and Kings County Hospital Center, the largest New York City municipal hospital. We represented Health Science Center at Brooklyn in establishing a Clinical Practice Management Plan, under which faculty members are able to earn and pool private practice income.

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Real Estate

Skadden's real estate department represents clients across a broad spectrum of transactions involving medical office buildings, life science properties and senior housing facilities.

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