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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:
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.
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.
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