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

With product-liability
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