FDAnews Announces — Product Liability Dangers of Off-Label Promotion: Case Studies Show You What to Avoid Webinar, July 16, 2014

Using case studies as illustrations, attorney Sara Dyson will walk attendees through the intersection of off-label promotion and product liability. By the end of this intensive 90-minute webinar, attendees will have the toolkit needed to head off violations.

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FDAnews

FDAnews

Falls Church, VA (PRWEB) June 25, 2014

Product Liability Dangers of Off-Label Promotion:
Case Studies Show You What to Avoid
**FDAnews Webinar**
July 16, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/offlabelpromo

A product is not approved for a particular use. The manufacturer promotes that product off-label, perpetuating the non-approved use.

If patients are injured and become plaintiffs they could then argue that the manufacturer 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 the company to disclaim responsibility for warning about an off-label use. Especially after promoting the device or drug for that use.

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

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.

Mark the calendar for Wednesday, July 16, when a recognized authority on product liability issues shows how to protect the manufacturers from fines, lawsuits, even prison time.

Using case studies as illustrations, attorney Sara Dyson will walk attendees through the intersection of off-label promotion and product liability. By the end of this intensive 90-minute webinar, attendees will have the toolkit needed to head off violations.

Here are just a few things attendees will 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.

Who Will Benefit:
Top management, compliance officials, regulatory and legal staff are certain to want to sign up, as well as advertising, marketing, sales and more. Here’s a list of suggested attendees to choose from:

  •     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

Meet the Instructor:
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.

Webinar Details:
Product Liability Dangers of Off-Label Promotion:
Case Studies Show You What to Avoid
**FDAnews Webinar**
July 16, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/offlabelpromo

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts
Easy Ways to Register:
Online:     http://www.fdanews.com/offlabelpromo
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.