Benjamin H. Wallfisch
Ben Wallfisch counsels life sciences companies and healthcare providers in connection with enforcement and regulatory matters, including conducting internal investigations and defending clients targeted by government investigations. Ben has represented numerous medical product companies, hospitals, and health systems relating to enforcement of federal and state fraud and abuse laws, including the Anti-Kickback Statute, the Stark Law, and state and federal false claims acts. In addition, Ben has assisted clients with voluntary disclosures of regulatory violations to appropriate government authorities. Ben also has significant experience advising clients on structuring and assessing corporate compliance programs.
Prior to joining the firm, Ben worked in the FDA/Healthcare practice of an international law firm in Washington, D.C., and as Policy Director of the Medical Device Manufacturers Association. Following graduation from law school, Ben served as a law clerk to the Honorable Edward C. Prado, U.S. Court of Appeals for the Fifth Circuit.
JD, with honors, The University of Texas School of Law, 2007
BA, University of Pennsylvania, 2000
While in law school, Ben was an Articles Editor for the Texas Law Review and a member of Order of the Coif.
Ben is licensed in Texas and the District of Columbia.
- Advising a major medical center in Texas on favorably resolving a voluntary disclosure to the OIG involving potentially improper claims to the Medicare and Medicaid programs.
- Represented a major medical center in responding to a federal subpoena and qui tam lawsuit involving Anti-Kickback Statute allegations in which we persuaded the DOJ not to intervene, and the case was fully dismissed.
- Advising on the CMS Self-Disclosure for a Montana medical center involving documentation of physician leases.
- Representing a physician who served as a consultant to a medical device manufacturer under federal investigation for alleged Anti-Kickback Statute violations.
- Representing a multinational pharmaceutical company in relation to various allegations of Anti-Kickback Statute violations, including alleged "white coat marketing."
- Representing a privately held pharmaceutical manufacturer in responding to a drug pricing investigation by the Texas Attorney General in which we negotiated a favorable settlement.
- Representing a major global medical device manufacturer in responding to a federal subpoena and qui tam lawsuit involving alleged fraud-on-the-FDA and Anti-Kickback Statute violations in which we persuaded the DOJ not to intervene.
- Defending a major global medical device manufacturer in qui tam litigation relating to improper Medicare billing for certain devices.
- Advising a California-based medical foundation relating to OIG self-disclosures and qui tam litigation.
- Representing a Texas children's hospital in defending a qui tam lawsuit and negotiating a favorable settlement.
- Defending a major research institution in qui tam litigation relating to allegations of research misconduct involving federally funded research grants.
- Representing a Texas hospital in a False Claims Act qui tam suit involving allegations of improper billing and supervision of surgical staff.
- District of Columbia Bar
- Texas State Bar
- Contributor to the Health Law Pulse blog
- Author, "With New Scrutiny, Life Sci Startups Become Risky Targets (subscription required)," Law360, October 26, 2017
- Co-Author with Lane Wood, "Texas Telemedicine Showdown," Austin Technology Council Weekend Update, September 30, 2016
- Co-author with Thomas Orsak, Ph.D. and Tamsen Barrett, "Health Care and Technology," Intellectual Property Law Section, State Bar of Texas, Ft. Worth, Tx., June 17, 2016
- Co-author with Rick Robinson, "A new look at an old safe harbor," Law360, July 16, 2015
- "IRS Releases Final Regulations on Medical Device Tax," Washington Health Care Update, December 11, 2012
- "Scientific Stimulus," Bio-Science Law Review, vol. 10, issue 1, 2009
- "Trends in False Claims Act enforcement," Norton Rose Fulbright Web Seminar, June 28, 2018
- "Under My Thumb: Regulation and Healthcare Disruption," SXSW Interactive Panel, March 14, 2016
- "Healthcare legislative update," Norton Rose Fulbright Web Seminar, September 30, 2015
- Panelist and Speaker, Compliance Session, MDMA Medical Technology Executive Forum, September 25, 2015
- "Data Regulation Challenges," Austin Technology Council Healthcare Tech Conference, September 24, 2015
- "Hot Legal Issues for Life Sciences Companies in 2015," BioAustin Seminar, August 5, 2015
- "Global Anti-Corruption Enforcement and Compliance," MDMA Webinar, June 23, 2015
- Panelist and Speaker, Compliance Session, Medical Device Manufacturers Association Annual Meeting, May 16, 2014
- "Introduction to FDA Regulation: Drugs & Biologics," BioAustin Seminar, February 12, 2014
- Panelist and Speaker, Medical Device Manufacturers Association Compliance Workshop, December 12, 2013
- "Developments in Health Care Fraud Enforcement," HealthCare Landscape 2013, January 25, 2013
- "Impact of the Patient Protection and Affordable Care Act on Physicians," with Dr. Scott Kercheville and Benjamin Koplin, Methodist Healthcare Ethics Follies, October 18, 2012
- "Introduction to Regulation of Prescription Drug Advertising," with William W. Vodra, FDLI/FDA-CDER In-House Training, June 18, 2009
Memberships and activities
- American Health Lawyers Association
- American Bar Association, Health Law Section
- Austin Bar Association, Health Law Section