Drug and Device Blog
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Dechert LLP
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Sales Representatives In The Or – Real Risks
Friday, September 23, 2011
Today we look at a common topic – sales representatives – in a slightly different light.
We are all well-versed in the learned intermediary doctrine. More and more often, plaintiffs’
failure to warn claims in pharmaceutical and medical device cases are thwarted by
knowledgeable physicians who apply their independent medical judgment in deciding whether
a course of treatment is in the best interests of their patients. This is a good thing – and often
relegates the role of the sales rep in a products case to the back burner.
Of course, when we think about sales reps we typically picture a rep standing in a
doctor’s office with a sample case and some handouts trying to get a few minutes of a doctor’s
time to laud our clients’ products. But there is another arena in which sales reps play a critical
role – the operating room. A modern surgical suite can look something like a cross between a
NASA command center (if they were still in business) and your local auto repair shop.
Because of both the high tech nature of surgical equipment and the vast array of options
available to surgeons, it is increasingly common for medical device manufacturers to have
representatives attend surgeries. Often this is just to observe the use of the company’s
product, but sometimes the sales rep can “assist” the medical team by making sure the right
product is available, helping nurses locate the proper instruments, or calibrating a product
before use. From our experience in the Bone Screw litigation, for instance, we know that sales
reps often stand outside the sterile field and use laser pointers to help nurses pick out the size
instrumentation the doctor asks for.
Indeed, the AMA Code of Medical Ethics states:
“Manufacturers of medical devices may facilitate their use through industry representatives who can play an
important role in patient safety and quality of care by providing information about the proper use of the
device or equipment as well as technical assistance to physicians.”
AMAssociation. Opinion 8.047 Industry representatives in clinical settings. Code of Medical
Ethics.
With new and more complex medical devices and equipment entering the market each
year, it is easy to understand why surgeons favor the availability of consulting technicians or
medical device specialists. But, from a legal standpoint, the presence of medical device sales
