Malpractice issues in vascular device use

endovascular repair, is the physician expected to

relate complications of a specific device, or just

those of endovascular repair in general?

Ms. Rode:

If the specific risks associated with a particular

device are recognized in the medical literature and

acknowledged to have significant incidence rate, then the

patient should be informed. For instance, if there is a procedure

in which two devices may be used, and the

devices carry different risks, the patient needs to be

informed of the risks associated with both devices and

consent to it (eg, in hip-replacement cases or other cases

in which the choice of two devices is determined intraoperatively,

the patient needs to know that device selection

will take place during the procedure, and—if the risk

associated with each device differs—the risks associated

with each device).

Ms. Rode:

However, you should be prepared for the

added sex appeal of the “investigatory/guinea pig” spin

that the plaintiff’s counsel will use to inflate the

verdict/settlement value of a case involving off-label

products. Insurance carriers take that factor very seriously

in evaluating cases involving off-label devices, institutional

review board protocol, etc.

Given the different types of endografts used in

Instructions for Use (IFU). I always notify the

patients and family of this and note that the

patient may be at increased risk of short- and

long-term adverse events as a result of this. If

adverse events do occur, what is my liability?

I received very positive feedback on a previous post discussing basic medical malpractice considerations. So I thought it might be helpful to discuss some examples of medical malpractice considerations specific to vascular devices. This goes without saying, but consult an attorney in your state as laws very from state to state and this should not be perceived as legal advice.

Are we obligated to tell patients that some

peripheral stenting is not approved by the FDA

even though it is done very commonly?

Requirements regarding the disclosure of

off-label uses likely vary by state. In Pennsylvania, a physician

is under no obligation to advise a patient of the FDA

status of a medical device (eg, Southard v. Temple Univ.

Hosp., 781 A.2d 101 [Pa. 2001]). The law in your state

may vary and on this important topic, and you should

consult with local counsel.

I use many products off-label and outside of the

This will usually fall under the “standard of

care” discussion. If what you do falls under the accepted

“standard of care,” it should not expose the surgeon to

increased liability.

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