+1 202 637 3660
+1 202 637 5910
Partner, Washington, D.C.
Stephen J. Immelt is the Global Co-Head of Hogan Lovells' Litigation and Arbitration practice and a member of the International Management Committee. He is primarily based in Hogan Lovells' office in Washington, D.C. Prior to taking on this role in 2010, Steve served for four years as the head of the international offices of Hogan & Hartson (predecessor of Hogan Lovells) and as the managing partner of the firm's Baltimore office for ten years.
Steve focuses primarily on complex enforcement litigation relating to a range of healthcare issues. For more than 20 years, Steve has represented pharmaceutical companies, medical device companies, academic health centers and medical schools, clinical laboratories, and other providers of healthcare in connection with a wide variety of governmental investigations, both civil and criminal in nature, involving issues arising under federal and state laws that govern healthcare providers. These matters have included a wide range of issues arising under the Anti-Kickback Act, the Food Drug and Cosmetics Act, the Foreign Corrupt Practices Act, and the False Claims Act. Steve has particular experience in off-label and financial relationship cases. He has also handled a variety of issues arising from funded research, both in terms of compliance with regulatory requirements governing the use of research funds and allegations of misconduct by researchers.
His experience encompasses the conduct of internal investigations, congressional investigations, grand jury practice, and the development of compliance plans, as well as related civil litigation activity such as the defense of qui tam litigation initiated by government and private complainants.
Steve is a nationally recognized professional in this area and has handled matters in more than 20 federal districts. He speaks and writes frequently on healthcare fraud and compliance issues.
With regard to general civil litigation, Steve has handled numerous commercial matters, with cases involving health care, education, officers and directors liability, securities fraud, and a variety of business torts. He has particular experience with regard to actions arising from the alleged submission of false claims, including qui tam actions.
Steve served as an Assistant U.S. Attorney for the District of Maryland from 1979 through 1983. During his service in this office, he participated in numerous criminal trials dealing with political corruption, fraud, tax evasion, and conspiracy charges. Steve returned to private practice in 1983 and joined the firm in 1989.
- Representation of pharmaceutical and biologics companies in connection with numerous federal and state investigations of sales and marketing; pricing; Medicaid rebate; and FDCA promotional issues, including off-label marketing.
- Representation of a major orthopedic device company in connection with a criminal and civil investigation of sales and marketing practices. Resolution included negotiation of a deferred prosecution agreement, civil settlement agreement, and corporate integrity agreement.
- Representation of medical device companies in defending False Claims Act matters arising from reimbursement, FDCA promotional (including off-label marketing), and fraud and abuse theories.
- Representation of universities, academic health centers, and hospitals in connection with False Claims Act litigation involving allegations of billing, research, and program fraud.
- Representation of medical device companies in investigations of business activities in China.
- Representation of healthcare companies, including healthcare insurers, in a variety of matters involving alleged violations of federal and state laws, typically including False Claims Act allegations.
- Representation of an institutional pharmacy provider with respect to Medicare Part D and related issues.
- Numerous assignments relating to the development of compliance plans for corporate and institutional entities, including for operations outside the United States.
- Representation of a university in a False Claims Action relating to compliance with incentive compensation regulations.
- Representation of a software developer in a False Claims Action relating to allegedly inaccurate pricing submissions to GSA.
"Fraud and Abuse Developments Affecting Life Sciences Companies," AHLA/HCCA Fraud and Compliance Forum.
"Back to the Future: Anti-Fraud Enforcement Trends: The Prosecutor, Whistleblower and Defense Perspectives," American Health Lawyers Association Fraud and Compliance Forum, Keynote Panelist.
"Compliance Lessons Learned From the Medical Denle Experience," Pharmaceutical Regulatory and Compliance Congress, Panelist.
"Recent Developments in FCA Enforcement," National Institute on the Civil False Claims Act and Qui Tam, Panelist.
"Ethics Debate Regarding Physician Relationships with Industry," Society of Thoracic Surgeons, Panelist.
"Conducting Internal Investigations," AAMC Compliance Officers Forum, Presenter.
"Medical Device Enforcement Developments," ABA Health Care Fraud Institute, Presenter.
"A Critical Analysis of Deferred Prosecution Agreements and Federal Monitors in the Health Care Industry: Are They Working?" Seton Hall Law School Symposium, Panelist.
"Pharmaceutical Compliance Forum: Clinical Trials Case Study," Eighth Annual Pharmaceutical Regulatory Compliance Congress and Best Practices Forum, Washington, D.C.
"Overview of US Enforcement and Regulatory Trends," International Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, Brussels, Belgium.
Hogan Lovells Publications
19 April 2013
"OIG releases revised and expanded self-disclosure protocol." Health Alert, Hogan Lovells
07 January 2013
"Focus on Life Sciences Industry Trends for 2013." Life Sciences Alert, Hogan Lovells
19 October 2011
"OIG Releases Advisory Opinion Demonstrating Continued Concern with Physician-Owned Companies." Health Alert, Hogan Lovells
10 June 2011
"Senate asks OIG to probe physician-owned distributors." Health Alert, Hogan Lovells
09 July 2010
"OIG Settles Kickback Case with Physician-Owned Company for Leveraging Patient Referrals to Obtain Contract Business from Hospitals." Health, Hospitals, and Medical Devices Alert, Hogan Lovells
25 March 2010
"Health Reform Legislation Includes Significant Amendments to the False Claims Act and the Anti-Kickback Statute." Litigation Alert, Hogan & Hartson LLP
17 March 2010
"OIG Predicts Increased Scrutiny and Actions Against Individuals for Wrongdoing." Health Update, Hogan & Hartson LLP
19 February 2010
"Physician-Owned Companies." Health Update, Hogan & Hartson LLP
12 February 2008
"Foreign Corrupt Practices Act and the Healthcare Industry." Medical Device Update, Hogan & Hartson LLP
12 February 2008
"Foreign Corrupt Practices Act and the Healthcare Industry." Pharmaceutical and Biotechnology Update, Hogan & Hartson LLP
06 February 2008
"FCPA and the Healthcare Industry." Health Update, Hogan & Hartson LLP
24 February 2005
"Pharmaceutical Marketing Practices: European Authorities Tighten Controls." EU Bulletin, Hogan & Hartson LLP
18 July 2005
"Building a Shield: Compliance Plans." International Comparative Legal Guide to: Pharmaceutical Advertising 2005, Global Legal Group