FMG Partners Published in DRI's "In-House Defense Quarterly - Summer"


Medical Device Sales Representatives in the OR: Valuable Resource, Potential Liability, or Both?

By: Michael P. Bruyere and J. Scott Rees

In the medical device industry, sales representatives hold a particularly unique role. Medical devices, such as joint implants, pacemakers, bone screws, stents, and spinal implants are highly technical and complex products. Adding to the complexity, these medical devices are often on the cutting edge, and the end users, medical professionals, have limited experience with them. Given the complexity and the novelty of such devices, it is common for representatives to be in the operating room or to be involved indirectly in a patients treatment. As a result, manufacturers have seen a rise in product liability claims stemming from representations, instructions, and omissions of sales representatives and product trainers. This litigation trend involves both a rise in the number of claims as well as the typesof claims asserted by plaintiffs. In addition to conventional tort claims, including strict liability and negligent failure to warn, plaintiffs allege various novel theories of action. Accordingly, claims adjusters and claims counsel for medical device manufacturers must become familiar with the ever expanding world of medical device liability.

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