Ropes & Gray has a long and successful track record partnering with major pharmaceutical companies, medical device manufacturers, hospitals, and other organizations in the health care and life sciences industries to manage issues across the full spectrum of internal investigations and white collar enforcement matters. As one of the leading enforcement defense practices in the country, we have extensive experience representing companies and their executives in criminal, civil, and administrative investigations conducted by international, federal and state agencies.
Our representations have spanned issues relating to the Federal Food, Drug and Cosmetic Act, the False Claims Act (“FCA”), the Foreign Corrupt Practices Act (“FCPA”), the federal Anti-Kickback Statute and the Stark Law; Medicare and Medicaid fraud and abuse and pricing issues; state consumer protection matters; financial statement and disclosure matters and other securities enforcement issues; as well as qui tam or “whistleblower” litigation. We have also represented numerous life sciences companies in Congressional investigations, and have served as counsel to the Medical Information Working Group (MIWG), an informal coalition of pharmaceutical and medical device manufacturers that confer on issues relating to government policies on promotional practices.
Our deep understanding of the regulatory environment, coupled with an appreciation for the nuances of doing business in the health care and life sciences industries, positions us to effectively partner with leading organizations facing complex and multi-faceted investigations and litigation, or other issues, which may stem from investigations. Our team includes partners whose practices are informed by years of experience excelling as federal prosecutors and enforcement officers at U.S. Attorney’s Offices (“USAOs”), the Department of Justice (“DOJ”), and the Securities and Exchange Commission (“SEC”). Furthermore, we have experience in many foreign countries across the globe and understand the complexities of working with government attorneys, as well as handling parallel proceedings involving simultaneous civil and criminal actions. Our ready access to corporate, securities, health care, and FDA regulatory experts enables us to provide efficient, cutting-edge advocacy for our clients.
- Cures Are on the House: House Passes 21st Century Cures Act, but Senate Awaits
(July 23, 2015)
- Medicare, Medicaid, and Enforcement Implications of the 21st Century Cures Act Recently Passed by the House
(July 23, 2015)
- CMS Proposes New Stark Exceptions and Clarifications in Proposed 2016 Physician Fee Schedule Rule
(July 15, 2015)
- OIG Releases New Guidance Offering “Practical Tips” to Health Care Boards for Overseeing Compliance Program Functions
(April 27, 2015)
- The Cure for the Common FDA Reform Legislation? House Committee Releases 21st Century Cures Discussion Draft
(February 2, 2015)