If a medical device sales rep is present during your surgery

Surgeons understand how to perform surgeries, but your surgeon may not necessarily be an expert on the newest defibrillator or another medical device that may save your life. The people who know the most about these types of devices are usually those who work for the manufacturer that produced the device. Often, these sales representatives are now present in the operating room to provide technical support for the surgeon.

Whether that sales rep is liable if something goes wrong depends on a number of factors.

The manufacturer performs its duty to inform the physician

Your physician is the medical professional, so it is within his or her duty of care to understand the risks the device and the surgery pose to you. It is also the surgeon’s responsibility to inform you of these along with the potential benefits. As long as the manufacturer provided all the information to the physician, the sales rep will probably not face any liability.

The sales rep suggests an off-label use

Manufacturers have the responsibility to train their sales reps thoroughly. This includes not only the device’s uses, but also what the sales rep can and cannot say. Any discussion of an application of a device other than those it has received approval for could lead to sales rep liability. A court may consider these suggestions to be negligent misrepresentations.

The surgeon does not complete the procedure as instructed

If the sales rep notices your surgeon does not follow the approved use and installation procedures, he or she should document this. However, the sales rep is there only to provide technical support. She or he may not understand the need to deviate from the protocol because of a situation that does not fit the norm. Sales reps generally have very limited expertise.

The sales rep touches the patient

Your informed consent form should include the fact that a sales rep may be present in the OR during your procedure. However, that does not grant the sales rep the authorization to participate in the surgery. If he or she touches you, that could constitute gross negligence or physical battery.