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Product Liability Dangers of Off-Label Promotion

Product Liability Dangers of Off-Label Promotion - Webinar CD/Transcript

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Product Liability Dangers of Off-Label Promotion: Case Studies Show You What to Avoid

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 products 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.

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.

Here’s how to learn what you need to know.

Using case studies as illustrations, attorney Sara Dyson walks you through the intersection of off-label promotion and product liability. By the end of this intensive 90-minute webinar CD and transcript, you’ll have the toolkit you need to head off violations in your workplace.

Here are just a few things you’ll discover:

  • Off-label use and promotion — what it is, how to avoid it
  • Traditional and nontraditional causes of action related to off-label promotion
  • 2 major defenses against liability
  • The FDA’s Good Reprint Practices guidelines on off-label product uses
  • Penalties for off-label violations
  • Illegal promotion vs. “scientific information exchange” — what’s legal, what’s not
  • High-profile cases in which drug/device firms have been held liable (or not)
  • The “Practice of Medicine” exemption — its strengths and weaknesses
  • Best practices for managing off-label promotion risks
  • Tips on creating an effective off-label compliance program
  • 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.

  • Compliance Officers
  • Executive Management
  • General/Corporate Counsel
  • Regulatory/Legislative Affairs Professionals
  • Risk Management Specialist
  • Sales and Marketing Personnel
  • Training Personnel
  • Medical Science Liaisons
  • Outside Attorneys

Sara Dyson Esq. is assistant VP for loss control of Medmarc Insurance Group, a provider of product liability insurance to the life sciences industry. She performs risk evaluations of life sciences companies and recommends tailored risk management solutions. She is responsible for developing educational resources in product liability, risk management and related specialties, including FDA compliance and regulation, post-market surveillance, product safety and recalls. Ms. Dyson earned her law degree from the University of Wisconsin and is a member of the Wisconsin and Virginia Bars.