Clinical Trials: Emerging Legal Threats

Strategies to Survive Heightened Government Scrutiny

Recording of a 90-minute CLE webinar with Q&A


Conducted on Thursday, February 26, 2009

Program Materials

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.

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Outline

  1. Fraud and abuse risks of conducting clinical trials
    1. False Claims Act implications
    2. Anti-kickback implications
  2. Litigation risks associated with clinical trials
    1. Informed consent
    2. Contracts/indemnification issues
    3. Medical risks
    4. Conflicts of interest
    5. Constitutional issues
  3. Best practices for compliance
    1. Medicare billing
    2. Privacy and security issues
    3. Register clinical trials with www.clinicaltrials.gov per FDA Amendment Act of 2007
    4. Develop or update written policies and procedures
    5. 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
Katherine Benesch

Partner
Duane Morris

She practices in the areas of healthcare law, litigation and alternative dispute resolution, with particular emphasis...  |  Read More

Kirk L. Dobbins
Kirk L. Dobbins

Counsel
King & Spalding

He is a member of the firm's FDA/Healthcare Practice Group. He brings more than 13 years of experience to his practice,...  |  Read More

Robert E. Wanerman
Robert E. Wanerman

Senior Counsel
Epstein Becker & Green

He concentrates on reimbursement, regulatory, and compliance matters affecting healthcare manufacturers, service...  |  Read More

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