Clinical Trials: Emerging Legal Threats
Strategies to Survive Heightened Government Scrutiny
Recording of a 90-minute CLE teleconference with Q&A
Conducted on Thursday, February 26, 2009
Recorded event now available
This seminar will examine the legal implications of conducting clinical research trials, litigation risks of clinical trials, and best practices for hospitals and physicians to avoid missteps that create liability exposure.
Description
In the wake of major recalls of new medications and medical devices that allegedly harmed patients and a 2007 Inspector General Report that the FDA had failed to provide adequate oversight of clinical trials, various government agencies are taking a hard look at clinical trials.
It is critical that physicians and hospitals participating in clinical research trials immediately review and update their policies and procedures, understand the common legal issues arising in clinical trials and take steps to minimize their liability for compliance shortfalls.
Listen as our panel of healthcare attorneys examines the legal implications of conducting clinical research trials, litigation risks of clinical trials and best practices for hospitals and physicians to avoid missteps that can create liability exposure.
Outline
- Fraud and abuse risks of conducting clinical trials
- False Claims Act implications
- Anti-kickback implications
- Litigation risks associated with clinical trials
- Informed consent
- Contracts/indemnification issues
- Medical risks
- Conflicts of interest
- Constitutional issues
- Best practices for compliance
- Medicare billing
- Privacy and security issues
- Register clinical trials with www.clinicaltrials.gov per FDA Amendment Act of 2007
- Develop or update written policies and procedures
- Comply with relevant government regulations
Benefits
The panel will review these and other key questions:
- What clinical trial activities give rise to potential False Claims Act liability?
- What are the Anti-kickback risks of conducting clinical trials?
- What should providers and hospitals do now to limit their liability for the risks of conducting clinical trials?
- What are the unresolved issues concerning Medicare billing for clinical trials?
Faculty
Katherine Benesch,
Partner
Duane Morris, Princeton, N.J.
She practices in the areas of healthcare law, litigation and alternative dispute resolution, with particular emphasis on fraud and abuse, including Stark Law, anti-kickback and False Claims Act issues. As an arbitrator, she handles many types of cases, including disputes over clinical research trials.
Kirk L. Dobbins,
Counsel
King & Spalding, Washington, D.C.
He is a member of the firm's FDA/Healthcare Practice Group. He brings more than 13 years of experience to his practice, including more than seven years advising and representing federal agencies. He frequently speaks at conferences and has written articles on Medicare coverage and policy for national publications.
Robert E. Wanerman,
Senior Counsel
Epstein Becker & Green, Washington, D.C.
He concentrates on reimbursement, regulatory, and compliance matters affecting healthcare manufacturers, service providers, and investors in healthcare organizations. He has extensive experience counseling clients in matters arising under the Medicare and Medicaid programs, the False Claims Act and clinical research rules.
Ordering
Online CLE - Audio Recording
Includes audio streaming of full program plus handouts (available 24 hours after live seminar).
CLE:
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Online CLE Audio $149.00
Available 24 hours after the live event
Recorded Event
Includes full event recording plus handouts (available after live seminar).
CLE: Pre-approved for self-study credit in: AK, AZ, CA, CT, HI, MO, MT, NY, TX, VT, WA, WV. Upon request, self-study credit is also available in: CO, FL, GA, ID, KY, ME, ND, NE, NH, NM, NV, OR, UT, WI, WY. If you are applying for self-study credit in one of these states, contact Strafford CLE at 1-800-926-7926 ext. 35 or CLE@straffordpub.com.
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Available ten business days after the live event
Customer Reviews
I liked the topic and the tools provided in the handouts.
Mildred Johnson
Texas Tech University Health Sciences Center
The speakers included a significant number of best practices, which are critical to application of the law.
Deirdre J. Kamber
Fitzpatrick Lentz & Bubba
I found the content very useful and was impressed by the high quality of each speaker's ability to articulate his presentation.
Andrew Lillie
Hogan & Hartson
Speakers were knowledgeable enough to talk about the subject matter in an easily digestible manner.
Daniel M. Cleary
Gotham Insurance/New York Marine & General Insurance
The information was relevant and well presented. The questions were good, and the speakers responded with clear knowledge.
Sheila Fox Morrison
Davis Wright Tremaine
Health Law Advisory Board
Partner
Arent Fox
Partner
Rivkin Radler
Principal
Ober Kaler
Partner
Garfunkel Wild & Travis
Partner
McDermott Will & Emery
Donald H. Romano
Of Counsel
Foley & Lardner
Partner
Foley & Lardner
Partner
Drinker Biddle & Reath
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