David W. Ohlwein
David has extensive experience in healthcare regulatory contracting and transactions matters, including: life science company transactions and providing counsel on the federal Anti-kickback statute (AKS), False Claims Act (FCA), HIPAA, Stark Act, and FDA compliance.
Biography – View PDF Bio
- Bar Admissions
- Education & Honors
- In the News
- Papers, Presentations, & Publications
- Tennessee, 2003
- Illinois, 1990 (Inactive)
- Senior Legal Director, Medtronic Spinal & Biologics
- Assistant General Counsel, Guardsmark, LLC
- Assistant General Counsel, OSI Industries, Inc.
- DePaul University, J.D., 1990
- University of Iowa, B.B.A., Finance, 1987
- Lead counsel in wide variety of commercial transactions for $3.5 billion division of medical device company, including research, product development, consulting, purchase; supply; distribution, sales, mergers, acquisitions and divestitures; product development and manufacturing agreements.
- Extensive experience providing counsel on compliance with applicable healthcare laws and regulations, including the federal Anti-kickback statute (AKS), False Claims Act (FCA), HIPAA, and Stark Act.
- Significant experience providing counsel and advice to marketing, quality, sales, and operations to ensure compliance with applicable FDA laws, regulations and guidance documents.
- Extensive experience providing counsel and advice in security services and food manufacturing industries including wide variety of commercial transactions, OSHA/EPA program implementation and auditing, labor/employment, food safety and USDA compliance, and corporate governance.
- Author, “Recent FDA Regulatory Guidance Involving Medical Devices,” Pro Te: Solutio, Vol. 11, No. 2, September 2018.
- Author, "Off-Label Use: Protected Commercial Speech or Misbranding?" Pro Te Solutio, Vol. 8, No. 5, July 2016.