Healthcare
Sidley’s Healthcare practice serves all sectors of the industry. Our clients include some of the world’s leading pharmaceutical, biotechnology and medical device companies, diagnostic clinical laboratories, health IT companies, DME suppliers, pharmacies, hospitals, skilled nursing facilities, medical groups, physician-owned companies, professional associations, and research institutions. Sidley offers the resources of more than 1,700 lawyers on four continents, enabling our healthcare lawyers to serve our clients in the United States and internationally.
“Sidley Austin has developed a successfully integrated healthcare and FDA practice, widely viewed as the premier service provider for some of the leading medical device and pharmaceutical companies. Clients particularly praise its expertise in regulatory compliance, although the group also houses skilled litigators and transactional specialists. The team is spread across offices in California, Washington, DC and Illinois. Sources say ‘It's an excellent firm. It has a deep bench and a great deal of expertise in many subject areas. It's simply a strong and solid healthcare team.’"
Chambers USA, 2011 Chambers USA, 2011
Our practice is characterized by several key features. First, we are highly integrated across offices. This allows us to draw on resources throughout the firm to serve clients nationwide. Second, our regulatory and enforcement lawyers work hand-in-hand. We believe that the best regulatory advice is informed by an in-depth understanding of the current enforcement environment and that the best defense in an enforcement matter requires a nuanced understanding of regulatory issues. Third, we work very closely with colleagues in other legal areas including our
Food, Drug and Medical Device Regulatory,
Compliance and Enforcement,
White Collar and
Products Liability practices. This allows us to provide seamless advice on legal and business issues that encompass multiple areas of law. We also work regularly with our transactional Mergers & Acquisitions (M&A) colleagues, performing healthcare fraud and abuse and reimbursement due diligence, as well as drafting and negotiating transaction documents related to purchase, sale or financing transactions for a wide range of healthcare entities. Finally, with several physicians, a pharmacist, a PhD scientist, a lawyer with a Masters of Public Health, and other lawyers with extensive experience in scientific and medical matters, we bring an important clinical perspective to a range of legal issues. Among those issues are quality of care, legislative policy, coverage and reimbursement, and off-label promotion.
We serve our global clients from the United States as well as from our offices in Europe and Asia. These services are highly integrated. We strive to provide borderless advice on issues – such as compliance, pricing, and privacy – that require an understanding of both local law and tradition as well as an understanding of the relationships among the laws of numerous jurisdictions.
On the compliance front, working closely with our food and drug law professionals, we assist clients in developing and maintaining coordinated global compliance programs and, when potential trouble arises – whether it relates to sales and marketing, clinical trials, or other issues – we conduct internal investigations and, as needed, defend external investigations. On the pricing front, we counsel numerous clients on local pricing and reimbursement regimes in the EU and China, and also advise our clients on the increasingly complex rules governing drug and device reference pricing so that they can implement effective global pricing strategies at launch and maintain such strategies over the lifecycle of their products. In the EU in particular, we counsel our clients on the increasingly close links between pricing and reimbursement procedures and marketing authorization/pharmacovigilance procedures in which the safety/efficacy ratio of new and existing drugs is reviewed. And on the privacy front, we regularly advise a wide array of manufacturer clients on the US and ex-US rules governing privacy, data protection, information security, internet and computer law, standardization of electronic data interchange, e-commerce, consumer protection, outsourcing, information management and records retention and responding to cybercrimes and network intrusions. Our work involves day-to-day counseling, the development of compliance programs, and assistance on issues – such as data breaches and disputes – that involve third parties.
“This firm’s healthcare practice is expansive both in terms of geographic reach and expertise. The lawyers have dual expertise in general healthcare and FDA regulatory work and the team’s prowess in investigations is highly prized.”
“As a client you don’t want to be blindsided by anything, and these guys stand out for always looking ahead and keeping us informed of developments in the industry.” Sources say “"An excellent, well-rounded practice with great industry expertise."
Chambers USA, 2010
Our team comprises former government officials, including the Acting General Counsel of the U.S. Department of Health & Human Services (HHS); Acting Chief Counsel of the U.S. Food and Drug Administration (FDA); Head of the FDA Special Prosecution Task Force; the Special Assistant to the Chief Counsel of FDA; Legislative Counsel and Parliamentarian of the House Energy & Commerce Committee; staff for the former Chairman of the House Rules Committee; staff for a variety of members of Congress; eight former assistant U.S. attorneys; four former associate White House counsels; and General Counsels to the Department of Agriculture and the Office of Management and Budget.
More than 60 lawyers and other professionals provide services in five major areas:
regulatory counseling;
defense of government enforcement proceedings;
civil litigation;
public policy and government affairs; and
transactions and due diligence.
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