sjimmelt@hhlaw.com
PHONE
+1.410.659.2757
FAX
+1.410.539.6981
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Stephen
J.
Immelt
Partner,
Baltimore
Steve Immelt focuses primarily on complex enforcement litigation relating to a range of health care issues. Steve represents pharmaceutical companies, medical device companies, academic health centers and medical schools, clinical laboratories, and other providers of health care 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 health care providers. These matters include issues arising under the Anti-Kickback Act, Food Drug and Cosmetics 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 more typical 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 health care 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. He also represents providers in defending against emerging theories under the Medicare Secondary Payor Statute.
After commencing private practice in Baltimore, Steve was appointed as an Assistant U.S. Attorney for the District of Maryland in 1979. 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 Hogan & Hartson in 1989. He is currently active in firm management, serving as the firm's Managing Partner for International Offices and the Managing Partner for the firm’s Baltimore Office.
Recent Speaking Engagements
11.26.2007
“Bristol-Myers Squibb 2007 Settlement,” National Pharma Audioconference.
11.08.2007
“Pharmaceutical Compliance Forum: Clinical Trials Case Study,” Eighth Annual Pharmaceutical Regulatory Compliance Congress and Best Practices Forum, Washington, D.C.
10.24.2007
“Defending Against False Claims Litigation (State and Federal),” Seventh National Forum on Fraud and Abuse in the Sale and Marketing of Drugs, American Conference Institute, Philadelphia, Penn.
06.06.2007
“Overview of US Enforcement and Regulatory Trends,” International Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, Brussels, Belgium.
01.30.2007
“Anatomy of an Off-Label Marketing Investigation,” Pharmaceutical Marketing Compliance Congress, Washington, D.C.
01.23.2007
“Trends in FCPA and Foreign Government Investigations,” American Conference Institute, Government Investigations for Preparedness for Pharma, New York, New York.
04.23.2006
"Enforcement Trends/Looking Through the Academic Medical Center Lens," Health Care Compliance Association’s Tenth Anniversary Compliance Institute, Las Vegas, Nevada.
03.02.2006
“Developments in Health Care Fraud Prosecutions,” ABA’s Twentieth Annual National Institute on White Collar Crime in San Francisco, Calif.
01.30.2006
“Legal Perspectives on Business Risk Analysis,” Conference Board, New York; Moderated Panel “Current Developments in Pharmaceutical Compliance,” Third Annual Pharma Marketing Compliance Congress, Washington, D.C.
Representative Experience
Representation of pharmaceutical and biologics companies in connection with federal and state investigations of sales and marketing; pricing; Medicaid rebate; and FDA promotional issues, including off-label marketing.
Representation of an 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 academic health centers in connection with Office of Inspector General audits under the PATH initiative and other billing issues.
Representation of entities in defending False Claims Act matters arising from reimbursement, FDA promotional (including off-label marketing), fraud and abuse, and research misconduct theories.
Representation of academic health centers in connection with False Claims Act litigation involving allegations of billing and research fraud. Helped lead the successful defense of hospitals accused of improper billing of investigational devices, resulting in favorable ruling by the U.S. Court of Appeals for the Second Circuit.
Representation of health care providers in defending actions under the Medicare Secondary Payor Statute.
Numerous assignments relating to the development of compliance plans for health care entities, including for operations outside the United States.
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