Originally Published MX March/April 2002
GOVERNMENTAL & LEGAL AFFAIRS
Preventing and Defending Product-Liability Claims
To avoid product-liability litigation, device manufacturers should start by reviewing their marketing strategies.
Kevin M. Quinley
Photo by Nick Koudis/PhotoDisc
claims becoming increasingly commonplace, medical device companies must exercise
utmost caution when preparing advertising and promotional materials for their
products. Such material can trigger claims of defective warnings, overpromotion,
and false advertising, which can spawn expensive claim settlements, whopping
jury awards, runaway legal fees, and negative publicity. It can erode market
share, deflate a company's stock price, and cripple growth plans.
It is therefore vital for medical device manufacturers to find ways to avoid product-liability claims arising from advertising and overpromotion. This article provides device companies with specific strategies designed to prevent product-liability claims, as well as tips on how to defend against such claims when they arise.
The Regulatory Context
FDA defines health