PDF Edition - The Impact of Off-Label Promotion on Product Liability

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Your product is not approved for a particular use. You promote that product off-label, perpetuating the non-approved use.

If patients are injured and become plaintiffs they could then argue that you failed to warn about the dangers associated with that particular use of the product.

From a product liability standpoint, it will be nearly impossible for you to disclaim responsibility for warning about an off-label use. Especially after you have promoted the device or drug for that use.

Here’s the report that shows you how to minimize this risk.

If your company loses a product liability lawsuit, it could cost millions (even hundreds of millions) of dollars.

It could also cost you your job.

This is not mere scare talk. The facts are far too many drug and device company employees and management simply don’t know the rules. Training is spotty, sometimes nonexistent.

This report lays out a risk management approach that addresses product liability concerns associated with off-label promotion in 6 key areas:

  1. Policies and procedures
  2. Social media
  3. Compensation
  4. Training
  5. Monitoring
  6. Corrective action

Order today for the know-how to avoid the pitfalls in off-label promotion, including:

  • What triggers 90% of product liability cases (it’s not manufacturing or design flaws)
  • Common mistakes that lead to “failure to warn” claims in product liability lawsuits
  • How liability can arise even if your promotion includes warnings
  • How off-label promotion undermines the “learned intermediary” doctrine
  • Why it’s critical to inform doctors of product risks without promoting off-label uses
  • How FDA requirements differ from product liability laws
  • How to respond to unsolicited requests for off-label information
  • And much more

With hundreds of millions of dollars in fines and potential criminal indictments possible, it simply doesn’t make sense to risk an off-label violation. Protect your company — and yourself.

Order Your Copy Today!

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Table of Contents

  • Negative Perception, Off-label Promotion and Product Liability
  • Risk Management Approaches to Reduce Liability
  • Regulatory Considerations for Off-label Promotion

View the entire TOC

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  • Drug and device company executives
  • Regulatory affairs officers
  • Sales and marketing teams
  • Legal affairs officers
  • Compliance managers
  • Risk managers
  • Training personnel
  • Medical officers