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Health Care and Life Sciences Law 2013

 
Author(s): Karen S. Lovitch, Scott D. Danzis
Practice Area: Health Care
Published: Oct 2013
PLI Item #: 42375
CHB Spine #: M4

Scott Danzis is a partner in the firm’s Food & Drug and Health Care practice groups. His practice focuses primarily on the regulation of medical devices, but also includes regulation of drugs, biologics, and tobacco products. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarket review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, quality system and manufacturing requirements, postmarket reporting, recalls, and enforcement actions.

From 2006 to 2008, Mr. Danzis served as the Special Assistant to the Chief Counsel of the U.S. Food and Drug Administration. While at FDA, he was broadly involved in a wide range of legal and regulatory matters related to medical devices and drugs. He also worked on implementing key provisions of the Food and Drug Administration Amendments Act of 2007.

Mr. Danzis has significant experience in the following areas:

  • FDA regulatory strategies, including strategies for the premarket review (510(k)s, PMAs) of medical devices;
  • Appeals and dispute resolution within FDA; IDEs, INDs, and clinical trial regulation;
  • Advertising, promotion, and scientific exchange, including responding to enforcement actions and investigations;
  • Imports and exports of FDA regulated products;
  • QSR and cGMP requirements, including responding to FDA 483s and enforcement actions;
  • Product recalls;
  • Adverse event and MDR reporting;
  • FDA consent decrees and OIG corporate integrity agreements; Regulatory due diligence;
  • Compliance with antifraud statutes, including the anti-kickback statute and the False Claims Act.

Mr. Danzis recently developed and edited a book on the regulation of in vitro diagnostic products and laboratory testing, In Vitro Diagnostics: The Complete Regulatory Guide (FDLI, 2010). He currently serves as an Adjunct Professor at the Georgetown University Law Center where he teaches a course on the regulation of drugs, biologics, and medical devices.

Mr. Danzis clerked for the Honorable Chester J. Straub on the U.S. Court of Appeals for the Second Circuit. He is a graduate of the University of Virginia School of Law where he was the Editor-in-Chief of the Virginia Law Review and elected to the Order of the Coif. He holds a Masters Degree from George Washington University in Health Care Management and Policy, and a Bachelor of Science from Cornell University.

PREVIOUS EXPERIENCE

U.S. Food and Drug Administration, Office of the Chief Counsel

U.S. Department of Health and Human Services, Agency for Health Care Policy and Research

HONORS AND RANKINGS

The Best Lawyers in America, FDA (2011-2014)

Washington DC Super Lawyers, FDA (2014)

PRESENTATIONS AND SPEECHES

"The New Drug Approval Requirement," Food & Drug Institute, Introduction to Law and Regulation (4/29/2004)

"Hatch-Waxman Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003," Covington Report (12/8/2003)

Practices

Food & Drug

  • Cosmetics
  • Human Pharmaceuticals
  • Medical Devices & Diagnostics

Industries

Health Care

  • Affordable Care Act Life Sciences
  • Life Sciences Litigation & Investigations

Education

  • University of Virginia School of Law, J.D., 2000
    -Virginia Law Review, Editor-in- Chief
    -Order of the Coif
  • The George Washington  University, M.H.S.A., 1996
  • Cornell University, B.S., 1993

Judicial Clerkship

  • Hon. Chester J. Straub, U.S. Court of Appeals, Second Circuit, 2001-2002

Bar Admissions

  • District of Columbia
  • Pennsylvania


Karen Lovitch is the Practice Leader of the firm’s Health Law Section.

Karen counsels health care clients on regulatory, transactional, and operational issues, including Medicare coverage and reimbursement, the development and implementation of health care compliance programs, and licensure and certification matters. In addition, Karen advises clients on the legal, practical, and fraud and abuse implications of business arrangements. Her expertise includes the anti-kickback statute, the Stark law, and state statutes prohibiting kickbacks and self-referrals.

Karen applies her compliance and regulatory experience in transactional as well as litigation contexts. In addition to counseling health care entities on regulatory matters arising in connection with mergers and acquisitions, she has successfully defended clients subject to state and federal surveys, Medicare and Medicaid overpayment and reimbursement appeals, and state licensure proceedings. Karen’s recent accomplishments include successful representation of an academic medical center in a Medicare reimbursement appeal that resulted in a $21 million settlement in favor of the provider. Karen also represents clients subject to state and federal investigations alleging violation of the anti-kickback statute, the federal False Claims Act, and other state and federal laws.

Karen has special expertise in the representation of laboratories and diagnostics companies. She regularly counsels on compliance with CLIA and state laboratory licensure laws, federal and state limitations on billing for diagnostic services, and legal restrictions on sales and marketing activities. Karen has served as regulatory counsel in a number of mergers and acquisitions involving laboratories and diagnostics companies.
 
In 2007, Nightingale’s Healthcare News, a monthly health care industry publication, recognized Karen as an Outstanding Young Healthcare Lawyer. Karen has written and lectured on a variety of issues confronting laboratories and others in the health care industry.

In November 2008, Karen completed the Harvard Business School's sevenday program on Leading Professional Service Firms.

Karen is a member of the West Virginia University Eberly College of Arts and Sciences Advisory Board, and she served on the Board of Directors of Suited for Change, a nonprofit organization that provides life skills and other assistance to low-income women seeking employment, from 2007 through 2010.

Karen is admitted to practice in the District of Columbia and the Commonwealth of Virginia. She is a summa cum laude graduate of West Virginia University and a member of Phi Beta Kappa. She graduated with her J.D., magna cum laude, from the Washington College of Law at the American University.

Admissions
District of Columbia
Virginia

Education
American University, JD
West Virginia University, BA